ptv-20251231

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)


☐	REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934


☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to


☐	SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

For the transition period from to

Commission file number 001-39670

PURETECH HEALTH PLC

(Exact name of registrant as specified in its charter)

N/A

(Translation of Registrant’s name into English)

England and Wales

(Jurisdiction of incorporation or organization)

6 Tide Street, Suite 400

Boston, Massachusetts 02210

United States

(Address of principal executive offices)

Robert Lyne

Chief Executive Officer Tel: (617) 482-2333

E-mail: [email protected]

c/o PureTech Health LLC

6 Tide Street, Suite 400

Boston, Massachusetts 02210

United States

(Name, telephone, e-mail and/or facsimile number and address of company contact person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:



Title of each class:	Trading Symbol(s)	Name of each exchange on which registered:
American Depositary Shares, each representing 10 ordinary shares, par value £0.01 per share	PRTC	The Nasdaq Global Market
Ordinary shares, par value £0.01 per share*	*	The Nasdaq Global Market*


*	Listed not for trading, but only in connection with the registration of the American Depositary Shares on The Nasdaq Global Market.

Securities registered or to be registered pursuant to Section 12(g) of the Act: None.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by

the annual report: Ordinary Shares: 241,684,038 outstanding as of December 31, 2025.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or

15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been

subject to such filing requirements for the past 90 days: Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to

Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was

required to submit such files): Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth

company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the

Exchange Act.



Large accelerated filer	☐	Accelerated filer	☒	Non-accelerated filer	☐	Emerging growth company	☐

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided

pursuant to Section 13(a) of the Exchange Act. ☐


†	The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its

internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public

accounting firm that prepared or issued its audit report. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the

registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based

compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:



U.S. GAAP ☐	International Financial Reporting Standards as issued		Other ☐
	by the International Accounting Standards Board	☒

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has

elected to follow. Item 17 ☐ Item 18 ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

Special Note Regarding Forward-Looking Statements

This annual report on Form 20-F contains forward-looking statements that involve substantial risks and uncertainties. All statements

contained in this report, other than statements of historical fact, including statements regarding our and our Founded Entities'

strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of

management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”

“predict,” “project,” “target,” “potential,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify

forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking

statements in this annual report on Form 20-F include, among other things, statements about:

—our ability to realize value from our Founded Entities, which may be impacted if we reduce our ownership to a minority interest or

otherwise cede control to other investors through contractual agreements or otherwise;

—the success, cost and timing of our clinical development within our Wholly-Owned Programs and Founded Entities, including the

progress of, and results from, our Wholly-Owned Programs' and Founded Entities' preclinical and clinical trials of deupirfenidone

(LYT-100) and LYT-200, our technology platforms and other potential therapeutic candidates within our Wholly-Owned Programs

and therapeutic candidates being developed by our Founded Entities;

—our ability to obtain and maintain regulatory clearance, certification, authorization or approval of the therapeutic candidates

within our Wholly-Owned Programs or our Founded Entities, and any related restrictions, limitations or warnings in the label of

any of the therapeutic candidates if cleared, certified, authorized or approved;

—our ability to compete with companies currently marketing or engaged in the development of treatments for indications within

our Wholly-Owned Programs or our Founded Entities are designed to target;

—our plans to pursue research and development of other future therapeutic candidates;

—the potential advantages of the therapeutic candidates within our Wholly-Owned Programs and the therapeutic candidates being

developed by our Founded Entities;

—the rate and degree of market acceptance and clinical utility of our therapeutic candidates;

—the success of our collaborations and partnerships with third parties;

—our estimates regarding the potential market opportunity for the therapeutic candidates within our Wholly-Owned Programs and

the therapeutic candidates being developed by our Founded Entities;

—our sales, marketing and distribution capabilities and strategy;

—our ability to establish and maintain arrangements for manufacture of the therapeutic candidates within our Wholly-Owned

Programs and therapeutic candidates being developed by our Founded Entities;

—our intellectual property position;

—our expectations related to the use of capital;

—our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

—the impact of government laws and regulations; and

—our competitive position.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not

place undue reliance on our forward-looking statements, which speak only as of the date made. Actual results or events could differ

materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. You should refer to

Item 3.D - "Risk Factors" of this annual report on Form 20-F for a discussion of important factors that may cause our actual results to

differ materially from those expressed or implied by our forward-looking statements. Our forward-looking statements do not reflect

the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may undertake. Moreover, we

operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for

management to predict all risk factors and uncertainties. Except as may be required by law, we have no plans to update our forward-

looking statements to reflect events or circumstances after the date of this annual report on Form 20-F. We qualify all of our forward-

looking statements by these cautionary statements.

Additionally, certain information we may disclose (either herein or elsewhere) is informed by the expectations of various stakeholders

or third-party frameworks and, as such, may not necessarily be material for purposes of our filings under U.S. federal securities laws,

even if we use “material” or similar language in discussing such matters.

iii

SUMMARY OF RISK FACTORS

The risk factors described below are a summary of the principal risk factors associated with our business. These are not the only risks

we face. You should carefully consider these risk factors, together with the risk factors incorporated by reference into Item 3.D –

"Risk Factors". of this annual report on Form 20-F and the other reports and documents filed by us with the SEC.

—As of December 31, 2025, we had never generated revenue from the therapeutic candidates within our Wholly-Owned Programs,

and we may never be operationally profitable.

—We may require substantial additional funding to achieve our business goals. If we are unable to obtain this funding when

needed and on acceptable terms, we could be forced to delay, limit or terminate certain of our therapeutic development efforts.

Certain of our Founded Entities will similarly require substantial additional funding to achieve their business goals.

—Our ability to realize value from our Founded Entities may be impacted if we reduce our ownership or otherwise cede control to

other investors through contractual agreements or otherwise.

—We have limited information about and limited control or influence over our Non-Controlled Founded Entities.

—The therapeutic candidates within our Wholly-Owned Programs and most of our Founded Entities’ therapeutic candidates are in

preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for

substantial delays. We cannot give any assurance that any of our and our Founded Entities’ therapeutic candidates will receive

regulatory clearance, authorization or approval, which is necessary before they can be commercialized.

—Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials,

which would adversely affect our ability to obtain regulatory clearance, authorization or approvals or commercialize these

programs on a timely basis or at all, which would have an adverse effect on our business.

—Clinical trials of our or our Founded Entities’ therapeutic candidates may be delayed, and certain programs may never advance in

the clinic or may be more costly to conduct than we anticipate, any of which can affect our ability to fund our company and would

have a material adverse impact on our platform or our business.

—If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise

adversely affected.

—Use of the therapeutic candidates within our Wholly-Owned Programs or the therapeutic candidates being developed by our

Founded Entities could be associated with side effects, AEs or other properties or safety risks, which could delay or halt their

clinical development, prevent their regulatory clearance, authorization or approval, cause us to suspend or discontinue clinical

trials, abandon a therapeutic candidate, limit their commercial potential, if cleared, authorized or approved, or result in other

significant negative consequences that could severely harm our business, prospects, operating results and financial condition.

—Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of therapeutic candidates that we

may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory clearance,

certification, authorization or approval and potential commercialization.

—Even if we complete the necessary preclinical studies and clinical trials, the marketing approval and certification process is

expensive, time-consuming and uncertain and may prevent us from obtaining clearance, certification, authorization or approvals

for the potential commercialization of therapeutic candidates.

—If we are unable to obtain regulatory clearance, certification, authorization or approval in one or more jurisdictions for any

therapeutic candidates that we may identify and develop, our business could be substantially harmed.

—Certain of the therapeutic candidates being developed by us or our Founded Entities are novel, complex and difficult to

manufacture. We could experience manufacturing problems that result in delays in our development or commercialization

programs or otherwise harm our business.

—If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and

market any therapeutic candidates we may develop, we may not be successful in commercializing those therapeutic candidates if

and when they are approved.

—If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions

could be adversely affected.

—We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our

competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective

than ours, which may negatively impact our ability to successfully market or commercialize any therapeutic candidates we may

develop and ultimately harm our financial condition.

—We are currently party to and may seek to enter into additional collaborations, licenses and other similar arrangements and may

not be successful in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the

benefits of such relationships, which could cause us to expend significant resources and give rise to substantial business risk with

no assurance of financial return.

—We rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and

those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research,

or testing.

—If we or our Founded Entities are unable to obtain and maintain sufficient intellectual property protection for our or our Founded

Entities’ existing therapeutic candidates or any other therapeutic candidates that we or they may identify, or if the scope of the

intellectual property protection we or they currently have or obtain in the future is not sufficiently broad, our competitors could

develop and commercialize therapeutic candidates similar or identical to ours, and our ability to successfully commercialize our

existing therapeutic candidates and any other therapeutic candidates that we or they may pursue may be impaired.

—We may not be able to protect our intellectual property rights throughout the world.

—Our or our Founded Entities’ proprietary rights may not adequately protect our technologies and therapeutic candidates, and do

not necessarily address all potential threats to our competitive advantage.

—The failure to maintain our licenses and realize their benefits may harm our business.

—If we or our Founded Entities fail to comply with our obligations in the agreements under which we license intellectual property

rights from third parties or these agreements are terminated or we or our Founded Entities otherwise experience disruptions to

our business relationships with our licensors, we could lose intellectual property rights that are important to our business.

—Patent terms may be inadequate to protect our competitive position on therapeutic candidates for an adequate amount of time.

—Issued patents covering our Wholly-Owned Programs or our Founded Entities' therapeutics candidates could be found invalid or

unenforceable if challenged in courts or patent offices.

—If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely

affected and our business would be harmed.

—We and our Founded Entities may be subject to claims challenging the inventorship of our patents and other intellectual

property.

—Failures in one or more of our programs could adversely impact other programs and have a material adverse impact on our

business, results of operations and ability to fund our business.

—Our business is highly dependent on the clinical advancement of our programs and our success in identifying potential

therapeutic candidates. Delay or failure to advance our programs could adversely impact our business.

—Our future success depends on our ability to retain key employees, directors, consultants and advisors and to attract, retain and

motivate qualified personnel.

—The market price of our ADSs has been and will likely continue to be highly volatile, and you could lose all or part of your

investment.

—Holders of ADSs are not treated as holders of our ordinary shares.

—As a foreign private issuer, we are permitted to adopt certain home country practices in relation to corporate governance matters

that differ significantly from Nasdaq corporate governance listing standards. These practices may afford less protection to

shareholders than they would enjoy if we complied fully with corporate governance listing standards.

—If we are unable to maintain an effective system of internal control over financial reporting, we may not be able to accurately

report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public

reporting, which would harm our business and the trading price of our ADSs.

EXPLANATORY NOTE

Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information required in this annual report on

Form 20-F for the fiscal year ended December 31, 2025 (this "annual report on Form 20-F") of PureTech Health plc (the “Company”)

set out below is being incorporated by reference from PureTech’s “Annual Report and Accounts 2025”, portions of which are

included as exhibit 15.1 to this annual report on Form 20-F. Only the information set out below with specific reference to items and

pages of PureTech's "Annual Report and Accounts 2025" is deemed to be filed as part of this annual report on Form 20-F. Other

information contained within PureTech's "Annual Report and Accounts 2025" that is not specified, including graphs and tabular

data, is not included in this annual report on Form 20-F and is not deemed to be filed as part of this annual report on Form 20-F.

Photographs are also not included. References herein to PureTech's websites are textual references only and information on or

accessible through such websites does not form part of and is not incorporated into this annual report on Form 20-F.

References below to major headings include all information under such major headings, including subheadings, unless such

reference is a reference to a subheading, in which case such reference includes only the information contained under such

subheading. Unless the context otherwise requires, “PureTech” and “PureTech Health” refer to the Company, which is comprised of

PureTech and its subsidiaries (together, the “Group”).


ITEM 4.	INFORMATION ON THE COMPANY

A. HISTORY AND DEVELOPMENT OF THE COMPANY

The information set forth under the heading "History and Development of the Company" on page 184 of PureTech’s “Annual

Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

For a description of our principal capital expenditures and divestitures for the three years ended December 31, 2025 and for those

currently in progress, see Item 5. “Operating and Financial Review and Prospects—A. Operating Results”.

The United States Securities and Exchange Commission (the “SEC”) maintains an internet website that contains reports, proxy and

information statements, and other information regarding issuers, like us, that file electronically with the SEC. The address of that

website is www.sec.gov. We also maintain an Internet website at www.puretechhealth.com. The information contained on, or that

may be accessed through, our website is not part of, and is not incorporated into, annual report on Form 20-F.

B. BUSINESS OVERVIEW

The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:

“Highlights of the Year—2025” (for the years of 2023, 2024 and 2025) on page 1, “A Diversified Portfolio Positioned for Significant

Upside” on page 9, "Founded Entities" on pages 10 to 19, “ESG Report—Ensuring Drug Efficacy and Safety” on page 33, “Risk

Management—Risks related to regulatory approval" on page 60 and "Risk Management—Risks related to intellectual property

protection" on page 62, “Financial Review—Revenue” on page 70, in each case of PureTech's "Annual Report and Accounts 2025"

included as exhibit 15.1 to this annual report on Form 20-F; and “Consolidated Statement of Comprehensive Income/(Loss),”

“Notes to the Consolidated Financial Statements—Note 3. Revenue” and “Notes to the Consolidated Financial Statements—Note

4. Segment Information,” in each case of our audited consolidated financial statements included elsewhere in this annual report on

Form 20-F. Seasonality does not materially impact the Company's main business.

Competition

The biotechnology and pharmaceutical industries utilize rapidly advancing technologies and are characterized by intense

competition. There is also a strong emphasis on intellectual property and proprietary products. Our pipeline builds on validated

biology of known therapeutics while applying unique inventive steps that improve the clinical pharmacology. We further de-risk

programs with key experiments at an early stage to validate the underlying value proposition. We believe that our technology, drug

discovery and development expertise and capabilities enable such strong pipeline creation and provide us with a competitive

advantage. However, we will continue to face competition from different sources including major pharmaceutical companies,

biotechnology companies, academic institutions, government agencies, and public and private research institutions. In addition,

there are many companies that have approved therapeutics for some of our target indications. For any products that we eventually

commercialize, we will not only compete with existing therapies but also compete with new therapies that may become available in

the future.

In addition to the competition we will face from the parties described above, we face competition for certain of the product

candidates we are developing internally as well as the products we are advancing through our Founded Entities.

LYT-100

In the field of idiopathic pulmonary fibrosis (IPF), there are three approved drugs, pirfenidone (Esbriet), marketed by Roche,

nintedanib (Ofev), marketed by Boehringer Ingelheim, and nerandomilast (Jascayd), marketed by Boehringer Ingelheim. These

drugs have varying tolerability profiles with comparable efficacy, leading to sustained unmet need for novel therapies. In May 2022,

a generic version of pirfenidone was approved in the US. Generic pirfenidone is also starting to be prescribed in some EU countries.

Other potential competitive product candidates in various stages of development include, but are not limited to: United

Therapeutics’ treprostinil in Phase 3 clinical trials, BMS’ BMS-986278 in Phase 3 clinical development, Avalyn’s AP01 which is

expected to enter a Phase 2 or 3 trial Vicore Pharma’s buloxibutid in Phase 2b clinical development, Endeavor Biomedicines’

taladegib in Phase 2b clinical development, and Insilico Medicine’s rentosertib in Phase 2a clinical development.

LYT-200

We are aware of one current drug product candidate targeting galectin-9, FibroGen’s FG-3165. The FDA cleared FibroGen's

Investigational New Drug Application, or IND, for FG-3165 in June2024 for the treatment of solid tumors. There may be other

academic groups and/or companies that are involved in pre-clinical research centered around galectin-9 as a therapeutic target. In

the field of acute myeloid leukemia (AML), there are several approved monotherapies for the treatment of relapse / refractory (R/R)

AML. However, these therapies are only approved for patients with specific mutations – KMT2A (revumenib), NPM1 (ziftomenib),

IDH1 or IDH2 (enasidenib, ivosidenib, olutasidenib), or FLT3 (gilteritinib). LYT-200 seeks to be the first non-targeted therapy to be

approved in R/R AML. Additionally, if we are successful in developing LYT-200 as an immuno-oncology (IO) treatment we would

expect to compete with currently approved IO therapies and those that may be developed in the future. Current marketed IO

products include CTLA-4, such as BMS’ Yervoy, and PD-1/PD-L1, such as BMS’ Opdivo, Merck’s Keytruda and Genentech’s

Tecentriq, and T cell engager immunotherapies, such as Amgen’s Blincyto.

Government Regulation

Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including

the European Union, or EU, extensively regulate, among other things, the research, development, testing, manufacture, quality

control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval

monitoring and reporting, and import and export of drugs, biological products and medical devices. The processes for obtaining

regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with

applicable statutes and regulations, require the expenditure of substantial time and financial resources.

U.S. Regulation of Drugs and Biologics

In the United States, the FDA regulates drugs under the FDCA, and its implementing regulations, and biologics under the FDCA

and the Public Health Service Act and its implementing regulations. FDA approval is required before any new unapproved drug or

dosage form, including a new use of a previously approved drug, can be marketed in the United States. Drugs and biologics are also

subject to other federal, state, and local statutes and regulations. The process required by the FDA before such product candidates

may be marketed in the United States generally involves the following:

—completion of extensive preclinical laboratory tests and preclinical animal studies, certain of which must be performed in

accordance with Good Laboratory Practice, or GLP, regulations and other applicable regulations;

—submission to the FDA of an IND, which must become effective before human clinical studies may begin;

—approval by an independent institutional review board, or IRB, or ethics committee representing each clinical site before each

clinical study may be initiated;

—performance of adequate and well-controlled human clinical studies in accordance with Good Clinical Practice, or GCP,

requirements to establish the safety and efficacy, or with respect to biologics, the safety, purity and potency of the product

candidate for each proposed indication;

—preparation of and submission to the FDA of a new drug application, or NDA, or biologics license application, or BLA, after

completion of all pivotal clinical studies;

—potential review of the product application by an FDA advisory committee, where appropriate and if applicable;

—a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

—satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities where the proposed product drug

substance is produced to assess compliance with current Good Manufacturing Practices, or cGMP, and potential audits of

selected clinical trial sites to ensure compliance with GCP; and

—FDA review and approval of an NDA or BLA prior to any commercial marketing or sale of the drug in the United States.

An IND is a request for allowance from the FDA to administer an investigational drug product to humans. The central focus of an

IND submission is on the general investigational plan and the protocol or protocols for preclinical studies and clinical trials. The IND

also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and

pharmacodynamics of the product, chemistry, manufacturing and controls, or CMC, information, and any available human data or

literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety

concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor

and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore

may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified

investigators in accordance with GCP, which includes, among other things, the requirement that all research subjects provide their

informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other

things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A

separate submission to the existing IND must be made for each successive clinical trial conducted during product development and

for any subsequent protocol amendments. While the IND is active, progress reports summarizing the results of the clinical trials and

nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the

FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse

events, findings from other studies suggesting a significant risk to humans exposed to the drug, findings from animal or in vitro

testing suggesting a significant risk to humans exposed to the drug, and any clinically important increased rate of a serious

suspected adverse reaction compared to that listed in the protocol or investigator brochure.

Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any

clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the

subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also

include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety

monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on

access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for

subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing

preclinical studies and clinical trials and clinical study results to public registries.

The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted sequentially,

they may overlap or be combined.

—Phase 1. The investigational product is initially introduced into healthy human subjects or patients with the target disease or

condition. These studies are generally designed to test the safety, dosage tolerance, absorption, metabolism and distribution of

the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence

on effectiveness.

—Phase 2. The investigational product is administered to a limited patient population with a specified disease or condition to

evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety

risks.

—Phase 3. The investigational product is administered to an expanded patient population to further evaluate dosage, to provide

statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed

clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to

provide an adequate basis for product approval.

In some cases, the FDA may condition approval of an NDA or BLA for a product candidate on the sponsor’s agreement to conduct

additional clinical studies after approval. In other cases, a sponsor may voluntarily conduct additional clinical studies after approval

to gain more information about the drug within the approved indication. Such post-approval studies are often referred to as Phase 4

clinical studies. Concurrent with clinical trials, companies may complete additional animal studies and develop additional

information about the biological characteristics of the product candidate, and must finalize a process for manufacturing the product

in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently

producing quality batches of the product candidate and, among other things, must develop methods for testing the identity,

strength, quality and purity of the final product, or for biologics, the safety, purity and potency.

Special Protocol Assessment

The special protocol assessment, or SPA, process is designed to facilitate the FDA’s review and approval of certain drugs and

biologics by allowing the FDA to evaluate the proposed design of certain preclinical studies and clinical trials, including among

others, trials that are intended to form the primary basis for determining a product candidate’s efficacy. Upon specific request by a

clinical trial sponsor, the FDA aims to evaluate the protocol and respond to a sponsor’s questions regarding, among other things,

entry, criteria, dose selection, endpoints, trial conduct and data analyses, within 45 days of receipt of the request. The FDA

ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of

the product candidate with respect to effectiveness of the indication studied. All agreements and disagreements between the FDA

and the sponsor regarding an SPA must be clearly documented in an SPA letter or the minutes of a meeting between the sponsor

and the FDA.

Even if the FDA agrees to the design, execution and analyses proposed in protocols reviewed under the SPA process, the FDA may

rescind or alter its agreement where the FDA determines that a substantial scientific issue essential to determining the safety or

efficacy of the product candidate has been identified after the trial has begun, which can include, but is not limited to, the following

circumstances:

—identification of data that would call into question the clinical relevance of previously agreed-upon efficacy endpoints;

—identification of safety concerns related to the product or its pharmacological class;

—paradigm shifts in disease diagnosis or management recognized by the scientific community and the FDA; or

—the relevant data, assumptions, or information provided by the sponsor in the SPA submission are found to be false statements or

misstatements, or are found to omit relevant facts, such that the clinical relevance of critical components of trial design is called

into question, or appropriate safety monitoring and human subject protection are affected.

A documented SPA may be modified, and such modification will be deemed binding on the FDA review division, except under the

circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is

intended to improve the study. If the sponsor fails to follow the protocol that was agreed upon with FDA consistent with the SPA

agreement, or makes substantive changes in the protocol without the FDA’s agreement, then FDA will consider the results from the

study as a BLA or NDA review issue. The FDA will not be bound by an SPA agreement where the sponsor fails to conduct the trial in

accordance with the agreed SPA.

NDA and BLA Review Process

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of

product development, including, among other things, the results from nonclinical studies and clinical trials are submitted to the FDA

as part of an NDA or BLA requesting approval to market the product for one or more indications. The NDA or BLA must include all

relevant data available from pertinent preclinical studies and clinical trials, including negative or ambiguous results as well as

positive findings, together with detailed information relating to the product’s CMC and proposed labeling, among other things.

Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of the product, or from a

number of alternative sources, including studies initiated and sponsored by investigators. The submission of an NDA or BLA requires

payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

In addition, under the Pediatric Research Equity Act, or PREA, an NDA or BLA or supplement to an NDA or BLA must contain data

to assess the safety and effectiveness of the biological product candidate for the claimed indications in all relevant pediatric

subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and

effective. The FDA requires that a sponsor who is planning to submit a marketing application for a drug or biological product that

includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an

initial pediatric study plan within sixty days after an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA.

Unless otherwise required by regulation, PREA does not apply to any product candidate for an indication for which orphan

designation has been granted.

Within 60 days following submission of the application, the FDA reviews the submitted BLA or NDA to determine if the application is

substantially complete before the FDA accepts it for filing. The FDA may refuse to file any NDA or BLA that it deems incomplete or

not properly reviewable at the time of submission and may request additional information. In this event, the NDA or BLA must be

resubmitted with the additional information. Once an NDA or BLA has been accepted for filing, the FDA’s goal is to review

applications for original biologics or new-molecular-entity drugs within ten months after the filing date, or, if the application qualifies

for priority review, six months after the filing date. In both standard and priority reviews, the review process may also be extended

for a three-month period for the FDA to review additional information that is deemed a major amendment to an application.

The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and

whether its manufacturing is sufficient to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a

BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured,

processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. When reviewing

an NDA or BLA, the FDA may convene an advisory committee to provide clinical insight on application review questions. The FDA is

not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making

decisions.

Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA

will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP

requirements and adequate to assure consistent production of the product within required specifications. Additionally, before

approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

After the FDA evaluates the NDA or BLA and conducts inspections of manufacturing facilities where the investigational product and/

or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response letter. An approval letter

authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response

letter will describe all of the deficiencies that the FDA has identified in the NDA or BLA, except that where the FDA determines that

the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response letter without

first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete

Response letter, the FDA may recommend actions that the applicant might take to place a resubmitted NDA or BLA in condition for

approval, including requests for additional clinical studies, or other information supporting the application. Notwithstanding the

submission of any additional information or data, the FDA may delay or refuse approval of an NDA or BLA if applicable regulatory

criteria are not satisfied.

If the FDA approves a BLA or NDA, such approval will be granted for particular indications and may entail limitations on the

indicated uses for which such product may be marketed. For example, the FDA may approve the NDA or BLA with a Risk Evaluation

and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a

known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by

managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such

as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on,

among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved,

the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if

problems occur after the product reaches the marketplace. The FDA may require one or more post-market studies and surveillance

to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the

product based on the results of these post-marketing studies.

Regulation of Combination Products in the United States

Certain therapeutic products are comprised of multiple components, such as drug or biologic components and device components,

that would normally be subject to different regulatory frameworks by the FDA and frequently regulated by different centers at the

FDA. These products are known as combination products. Under the FDCA, the FDA is charged with assigning a center with primary

jurisdiction, or a lead center, for review of a combination product. The determination of which center will be the lead center is based

on the “primary mode of action” of the combination product. Thus, if the primary mode of action of a drug-device combination

product is attributable to the drug product, the FDA center responsible for premarket review of the drug product would have

primary jurisdiction for the combination product. The FDA has also established the Office of Combination Products to address

issues surrounding combination products and provide more certainty to the regulatory review process. That office serves as a focal

point for combination product issues for agency reviewers and industry. It is also responsible for developing guidance and

regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for

review of combination products where the jurisdiction is unclear or in dispute. A combination product with a primary mode of action

attributable to the drug or biologic component generally would be reviewed and approved pursuant to the drug approval processes

set forth in the FDCA. In reviewing the NDA or BLA for such a product, however, FDA reviewers would consult with their

counterparts in the FDA’s Center for Devices and Radiological Health to ensure that the device component of the combination

product met applicable requirements regarding safety, effectiveness, durability and performance. In addition, under FDA

regulations, combination products are subject to cGMP requirements applicable to both drugs and devices, including the Quality

Management System Regulation, or QMSR, currently applicable to medical devices.

Expedited Development and Review Programs for Drugs and Biologics

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program

is intended to expedite or facilitate the process for reviewing product candidates that meet certain criteria. Specifically, product

candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and

demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the

combination of the product candidate and the specific indication for which it is being studied. The sponsor of a fast track product

candidate has opportunities for more frequent interactions with the review team during product development and, once an NDA or

BLA is submitted, the application may be eligible for priority review. A fast track product candidate may also be eligible for rolling

review, where the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is

submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept

sections of the NDA or BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon

submission of the first section of the NDA or BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough

therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if

preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or

biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as

substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features,

as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to

expedite the development and review of the product candidate, including involvement of senior managers.

Any marketing application for a drug or biologic submitted to the FDA for approval, including a product candidate with a fast track

designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the

FDA review and approval process, such as priority review. An NDA or BLA is eligible for priority review if the product candidate has

the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition. For

new-molecular-entity NDAs and original BLAs, priority review designation means the FDA’s goal is to take action on the marketing

application within six months of the 60-day filing date (as compared to ten months under standard review).

Additionally, depending on the designs of the applicable clinical trials, product candidates studied for their safety and effectiveness

in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the

product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint

that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible

morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the

availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to

perform adequate and well-controlled confirmatory clinical studies to verify and describe the anticipated effect on irreversible

morbidity or mortality or other clinical benefit and may require such confirmatory studies be underway prior to granting accelerated

approval. Products receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to

conduct the required confirmatory studies in a timely manner or if such studies fail to verify the predicted clinical benefit. In addition,

the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely

impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for

approval but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the

FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA

review or approval will not be shortened. We may explore some of these opportunities for our product candidates as appropriate.

Rare Pediatric Disease Priority Review Voucher Program

In 2012, the U.S. Congress authorized the FDA to award priority review vouchers to Sponsors of certain rare pediatric disease

product applications. This program is designed to encourage development of new drug and biological products for prevention and

treatment of certain rare pediatric diseases. Specifically, under this program, a sponsor who receives an approval for a drug or

biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive priority review of a subsequent

marketing application for a different product. The Sponsor of a rare pediatric disease drug product receiving a priority review

voucher may transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of

times before the voucher is used, as long as the Sponsor making the transfer has not yet submitted the application. The FDA may

also revoke any priority review voucher if the rare pediatric disease drug for which the voucher was awarded is not marketed in the

U.S. within one year following the date of approval.

For purposes of this program, a “rare pediatric disease” is a (a) serious or life-threatening disease in which the serious or life-

threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates,

infants, children, and adolescents; and (b) rare diseases or conditions within the meaning of the Orphan Drug Act. Congress has only

authorized the Rare Pediatric Disease Priority Review Voucher program until September 30, 2029. Consequently, unless Congress

reauthorizes the program, the sponsor of the marketing application for a drug that receives Rare Pediatric Disease Designation will

only be eligible to receive a voucher if the FDA approves the product for use within the designated rare pediatric disease on or

before September 30, 2029.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or

condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000

individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the

United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug

or biologic. Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug

designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The

orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it

has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not

approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same indication or use

within the applicable disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority

to the product with orphan drug exclusivity within the relevant indication or use or if the FDA finds that the holder of the orphan

drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs relating

to the approved indication or use of patients with the disease or condition for which the drug or biologic was designated. Orphan

drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same indication or use , or the same

drug or biologic for a different indication or use . Among the other benefits of orphan drug designation are tax credits for certain

research and a waiver of the NDA or BLA application user fee.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the disease or

condition for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the

FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient

quantities of the product to meet the needs relating to the indication or use protected by orphan exclusivity .

Post-Approval Requirements for Drugs and Biologics

Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the

FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting,

product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved

product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are

continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved

NDA or BLA. Drug and biologic manufacturers and their subcontractors are required to register their establishments with the FDA

and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for

compliance with cGMPs, which impose certain procedural and documentation requirements upon NDA or BLA holders and any

third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the

change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of

any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to

use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to

maintain compliance with cGMPs and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur

after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of

unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result

in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess

new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences

include, among other things:

—restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product

recalls;

—fines, warning letters or holds on post-approval clinical studies;

—refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of

existing product approvals;

—product seizure or detention, or refusal of the FDA to permit the import or export of products;

—consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

—mandated modification of promotional materials and labeling and the issuance of corrective information;

—the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or

other safety information about the product; or

—injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims

relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the

approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising

and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the

product’s labeling and that differ from those approved by the FDA. Such off-label uses are common across medical specialties.

Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not

regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications

on the subject of off-label use of their products.

Hatch-Waxman Act and Drug Product Exclusivity

Section 505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing

authorization for a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and

efficacy. A 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of

the information required for approval comes from investigations that were not conducted by or for the applicant and for which the

applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This

regulatory pathway enables the applicant to rely, in part, on the FDA's prior findings of safety and efficacy for an existing product, or

published literature, in support of its application. Section 505(j) of the FDCA establishes an abbreviated approval process for a

generic version of approved drug products through the submission of an Abbreviated New Drug Application, or ANDA. An ANDA

provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of

administration, labeling, performance characteristics and intended use, among other things, to a previously approved product.

ANDAs are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data

to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or

performs in the same manner as, the innovator drug through in vitro, in vivo, or other testing. The generic version must deliver the

same amount of active ingredients into a subject's bloodstream in the same amount of time as the innovator drug and can often be

substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval for a drug through an NDA,

applicants are required to list with the FDA each patent with claims that cover the applicant's drug or a method of using the drug.

Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA's Approved Drug

Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in

turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.

Upon submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that: (1) no patent information on the drug

product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such

patent expires; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for

which the application is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired,

except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a

paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a

patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the

referenced product have expired. If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the

applicant must send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted

for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the

paragraph IV certification. If the paragraph IV certification is challenged by an NDA holder or the patent owner(s) asserts a patent

challenge to the paragraph IV certification, the FDA may not approve that application until the earlier of 30 months from the receipt

of the notice of the paragraph IV certification, the expiration of the patent, when the infringement case concerning each such patent

was favorably decided in the applicant's favor or settled, or such shorter or longer period as may be ordered by a court. This

prohibition is generally referred to as the 30-month stay. In instances where an ANDA or 505(b)(2) NDA applicant files a paragraph IV

certification, the NDA holder or patent owner(s) regularly take action to trigger the 30-month stay, recognizing that the related

patent litigation may take many months or years to resolve. Thus, approval of an ANDA or 505(b)(2) NDA could be delayed for a

significant period of time depending on the patent certification the applicant makes and the reference drug sponsor's decision to

initiate patent litigation.

The Hatch-Waxman Act also establishes periods of non-patent regulatory exclusivity for certain approved drug products, during

which the FDA cannot approve (or in some cases accept) an ANDA or 505(b)(2) application that relies on the branded reference

drug. For example, the holder of an NDA, including a 505(b)(2) NDA, may obtain five years of non-patent data exclusivity upon

approval of a new drug containing new chemical entities that have not been previously approved by the FDA. A drug is a new

chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule

or ion responsible for the therapeutic activity of the drug substance. During the exclusivity period, the FDA may not accept for

review an ANDA or a 505(b)(2) NDA submitted by another company that contains the previously approved active moiety. However,

an ANDA or 505(b)(2) NDA may be submitted after four years if it contains a certification of patent invalidity or non-infringement.

The Hatch-Waxman Act also provides three years of non-patent exclusivity to the holder of an NDA (including a 505(b)(2) NDA) for a

particular condition of approval, or change to a marketed product, such as a new formulation for a previously approved product, if

one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential to the approval of the

application and was conducted/sponsored by the applicant. This three-year exclusivity period protects against FDA approval of

ANDAs and 505(b)(2) NDAs for the condition of the new drug's approval. As a general matter, the three year exclusivity does not

prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for generic versions of the original, unmodified drug product. Five-year

and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would

be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials

necessary to demonstrate safety and efficacy.

Biosimilars and Reference Product Exclusivity

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological

products that are highly similar, or “biosimilar,” to or interchangeable with an FDA-approved reference biological product.

Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference

product in terms of safety, purity, and potency, is generally shown through analytical studies, animal studies, and a clinical study or

studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it

can be expected to produce the same clinical results as the reference product in any given patient and, for products that are

administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has

been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference

biologic. A product shown to be biosimilar or interchangeable with an FDA-approved reference biological product may rely in part

on the FDA’s previous determination of safety and effectiveness for the reference product for approval, which can potentially reduce

the cost and time required to obtain approval to market the product.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that

the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by

the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity,

another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing

product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate

the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as

interchangeable products.

Both drugs and biological products can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted,

adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of any existing

periods of regulatory exclusivity or patent term, may be granted based on the voluntary completion of a pediatric study in

accordance with an FDA-issued “Written Request” for such a study.

U.S. Drug Enforcement Administration Regulation

We are developing certain product candidates that utilize, or may utilize controlled substances regulated by the U.S. Drug

Enforcement Administration, DEA. The Controlled Substances Act of 1970, or CSA, establishes registration, security, recordkeeping,

reporting, storage, distribution and other requirements administered by the DEA. The DEA is concerned with the control of handlers

of controlled substances, and with the equipment and raw materials used in their manufacture and packaging, in order to prevent

loss and diversion into illicit channels of commerce. The DEA regulates controlled substances as Schedule I, II, III, IV or V substances.

Schedule I substances by definition have no established medicinal use, and may not be marketed or sold in the United States. A

pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of

abuse and Schedule V substances the lowest relative risk of abuse among such substances.

Annual registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance.

The registration is specific to the particular location, activity and controlled substance schedule. For example, separate registrations

are needed for import and manufacturing, and each registration will specify which schedules of controlled substances are

authorized. The DEA typically inspects a facility to review its security measures prior to issuing a registration. Security requirements

U.S. Regulation of Medical Devices

The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging,

storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion,

marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are

safe and effective for their intended uses and otherwise meet the requirements of the FDCA.

U.S. Medical Device Classification:

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a

510(k) premarket notification, or approval of a premarket approval, or PMA, application. Under the FDCA, medical devices are

classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical

device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices

with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s

General Controls for medical devices, which include compliance with the applicable portions of the QMSR, facility registration and

product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional

materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to

ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market

surveillance, patient registries and FDA guidance documents.

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices

are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially

distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally

known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some

implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to

that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are

unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.

510(k) Clearance Marketing Pathway

To obtain 510(k) clearance, a manufacturer must submit to the FDA a premarket notification demonstrating that the proposed

device is “substantially equivalent” to a predicate device already on the market. A predicate device is a legally marketed device that

is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for

which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially

equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take

longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial

equivalence.

If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k)

clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously

cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA

requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” process,

which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate

device.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would

constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification,

PMA approval or de novo reclassification. The FDA requires each manufacturer to determine whether the proposed change requires

submission of a 510(k), de novo request or a PMA in the first instance, but the FDA can review any such decision and disagree with a

manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to

cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA approval is obtained or a

de novo request is granted. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or

penalties.

PMA Approval Pathway

Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA

has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket

notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be

supported by extensive data, including data from pre-clinical studies and human clinical trials. The PMA must also contain a full

description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and

proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a

substantive review. If FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA,

although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts

from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the

approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally

conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to

ensure compliance with the QMSR.

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA

constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, or on

some form of post-market surveillance when deemed necessary to protect the public health. or to provide additional safety and

efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to

follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients.

Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the

approval.

Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or

changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a

PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the

supplement is limited to information needed to support any changes from the device covered by the original PMA and may not

require as extensive clinical data or the convening of an advisory panel.

De novo classification process

Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless

of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997 established a route to market for low-to-

moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the

“Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a

manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into

Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a

PMA application. Manufacturers may request de novo classification directly without first submitting a 510(k) pre-market notification

to the FDA and receiving a not-substantially-equivalent determination.

The FDA is required to classify a medical device within 120 days following receipt of a de novo request, although, in practice, the

process may take significantly longer. If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft

proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical

device. If FDA grants the de novo request, the device may be legally marketed in the United States. However, the FDA may reject

the request if the FDA identifies a legally marketed predicate device that would be appropriate for a 510(k) notification, determines

that the device is not low-to-moderate risk, or determines that general controls would be inadequate to control the risks and/or

special controls cannot be developed. After a device receives de novo classification, any modification that could significantly affect

its safety or efficacy, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance

or, depending on the modification, another de novo request or even PMA approval.

Clinical Trials for Medical Devices

Clinical trials are almost always required to support a PMA or a de novo request, and are sometimes required to support 510(k)

submissions. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the

FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the

investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study

investigators. If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor

to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. If the device under

evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application

to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such

trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is

implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease

or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE

application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the

device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after

receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are

deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a

conditional approval.

Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the

oversight of, an IRB for each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may pose

additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human

clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. An

IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the

investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring,

selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record

keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them. The

clinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously

follow the investigational plan and study protocol, control the disposition of the investigational device, and comply with all reporting

and recordkeeping requirements. Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial

at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.

Post-market Regulation

After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These

include:

—establishment registration and device listing with the FDA;

—QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing,

control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

—labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses

of cleared or approved products;

—requirements related to promotional activities;

—clearance or approval of product modifications to cleared devices or devices authorized through the de novo classification

process that could significantly affect safety or effectiveness, or that would constitute a major change in intended use of such

devices, or approval of certain modifications to PMA-approved devices;

—medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused

or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely

to cause or contribute to a death or serious injury, if the malfunction were to recur;

—correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and

product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that

may present a risk to health;

—the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in

violation of governing laws and regulations; and

—post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public

health or to provide additional safety and effectiveness data for the device.

Manufacturing processes for medical devices are currently required to comply with the applicable portions of the QMSR, which

cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality

assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QMSR also

requires, among other things, maintenance of a medical device file and complaint files. Medical device manufacturers are subject to

periodic scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with the QMSR requirements could

result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. The discovery

of previously unknown problems with marketed medical devices, including unanticipated adverse events or adverse events of

increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a

physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market

or voluntary or mandatory device recalls.

The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply

with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in a variety of

sanctions, including: warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; recalls, withdrawals, or

administrative detention or product seizures; operating restrictions or partial suspension or total shutdown of production; refusing or

delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products; withdrawing 510(k)

clearances or PMA approvals that have already been granted; refusal to grant export approvals for; or criminal prosecution.

FDA Regulation of Companion Diagnostics

If safe and effective use of a drug or biologic depends on an in vitro diagnostic test, then the FDA generally will require approval or

clearance of that diagnostic, known as a companion diagnostic, at the same time that the FDA approves the therapeutic product. In

August 2014, the FDA issued final guidance clarifying the requirements that will apply to approval of therapeutic products and in

vitro companion diagnostics. According to the guidance, if the FDA determines that a companion diagnostic device is essential to

the safe and effective use of a novel therapeutic product or indication, FDA generally will not approve the therapeutic product or

new therapeutic product indication if the companion diagnostic device is not approved or cleared for that indication. Approval or

clearance of the companion diagnostic device will ensure that the device has been adequately evaluated and has adequate

performance characteristics in the intended population.

Foreign Regulation

To market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements

of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization,

commercial sales and distribution of our products. The foreign regulatory approval process includes all of the risks associated with

FDA approval set forth above, as well as additional country-specific regulation. Because biologically sourced raw materials are

subject to unique contamination risks, their use may be restricted in some countries.

Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory

authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. Approval by

one regulatory authority does not ensure approval by regulatory authorities in other jurisdictions. The approval process varies from

country to country, can involve additional testing beyond that required by FDA, and may be longer or shorter than that required for

FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing, promotion, and reimbursement

vary greatly from country to country.

Regulation of medicinal products in the European Union

Non-clinical Studies and Clinical Trials

Similar to the United States, the various phases of preclinical and clinical research in the EU are subject to significant regulatory

controls.

Non-clinical studies are performed to demonstrate the health or environmental safety of new chemical or biological substances.

Non-clinical studies (pharmaco-toxicological) must be conducted in compliance with the GLP principles, as set forth in EU Directive

2004/10/EC (unless otherwise justified for certain particular medicinal products, e.g., radio-pharmaceutical precursors for radio-

labeling purposes). In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded,

reported and archived in accordance with the GLP principles, which define a set of rules and criteria for a quality system for the

organizational process and the conditions for non-clinical studies. These GLP standards reflect the Organization for Economic Co-

operation and Development requirements.

Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH, guidelines on Good

Clinical Practices, or GCP, as well as the applicable regulatory requirements and the ethical principles that have their origin in the

Declaration of Helsinki. If the sponsor of the clinical trial is not established within the EU, it must appoint an EU entity to act as its

legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU member states, the sponsor is liable

to provide ‘no fault’ compensation to any study subject injured in the clinical trial.

The regulatory landscape related to clinical trials in the EU has been subject to recent changes. The EU Clinical Trials Regulation, or

CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. Unlike

directives, the CTR is directly applicable in all EU member states without the need for member states to further implement it into

national law. The CTR notably harmonizes the assessment and supervision processes for clinical trials throughout the EU via a

Clinical Trials Information System, which contains a centralized EU portal and database.

While the EU Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in

which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, much like

the FDA and IRB respectively, the CTR introduces a centralized process and only requires the submission of a single application for

multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee

in each member state, leading to a single decision per member state. The CTA must include, among other things, a copy of the trial

protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the

medicinal product under investigation. The assessment procedure of the CTA has been harmonized as well, including a joint

assessment by all member states concerned, and a separate assessment by each member state with respect to specific

requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via

the centralized EU portal. Once the CTA is approved, clinical study development may proceed.

The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the

provisions of the CTR.

Medicines used in clinical trials must be manufactured in accordance with Good Manufacturing Practice, or GMP. Other national and

EU-wide regulatory requirements may also apply.

Marketing Authorization

In order to market our product candidates in the EU and many other foreign jurisdictions, we must obtain separate regulatory

approvals. More concretely, in the EU, medicinal products can only be commercialized after obtaining a marketing authorization, or

MA. To obtain regulatory approval of a product candidate under EU regulatory systems, we must submit a MA application, or MAA.

The process for doing this depends, among other things, on the nature of the medicinal product. There are two main types of MA.

—“Centralized MAs” are issued by the European Commission through the centralized procedure, based on the opinion of the

Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and are valid

throughout the entire territory of the EU. The centralized procedure is mandatory for certain types of products, such as (i)

medicinal products derived from biotechnological processes, (ii) designated orphan medicinal products, (iii) advanced-therapy

medicinal products, or ATMPs (i.e. gene-therapy, somatic cell-therapy or tissue-engineered medicines) and (iv) medicinal

products containing a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases,

diabetes, or autoimmune diseases and other immune dysfunctions and viral diseases. The centralized procedure is optional for

products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic,

scientific or technical innovation or which are in the interest of public health in the EU. Under the centralized procedure the

maximum timeframe for the evaluation of a MAA by the EMA is 210 days, excluding clock stops. In exceptional cases, the CHMP

might perform an accelerated review of a MAA in no more than 150 days (not including clock stops).

—“National MAs” are issued by the competent authorities of the EU member states, only cover their respective territory, and are

available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been

authorized for marketing in an EU member state, this national MA can be recognized in other member states through the mutual

recognition procedure. If the product has not received a national MA in any member state at the time of application, it can be

approved simultaneously in various member states through the decentralized procedure. Under the decentralized procedure an

identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which

is selected by the applicant as the reference member state, or RMS. The competent authority of the RMS prepares a draft

assessment report, a draft summary of the product characteristics, or SmPC, and a draft of the labeling and package leaflet,

which are sent to the other Member States (referred to as the concerned member states, or CMSs) for their approval. If the CMSs

raise no objections, based on a potential serious risk to public health, to the assessment, SmPC, labeling, or packaging proposed

by the RMS, the product is subsequently granted a national MA in all the member states (i.e., in the RMS and the CMSs).

Under the above described procedures, before granting the MA, the EMA or the competent authorities of the EU member states

make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and

efficacy. MAs have an initial duration of five years. After these five years, the authorization may be renewed on the basis of a

reevaluation of the risk-benefit balance.

Furthermore, MA may also be granted “under exceptional circumstances” when the applicant can show that it is unable to provide

comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and

subject to specific procedures being introduced. This may arise in particular when the intended indications are very rare and, in the

present state of scientific knowledge, it is not possible to provide comprehensive information, or when generating data may be

contrary to generally accepted ethical principles. This MA is reserved to medicinal products to be approved for severe diseases or

unmet medical needs and the applicant does not hold the complete data set legally required for the grant of a MA. The applicant

does not have to provide the missing data and will never have to. Although the MA “under exceptional circumstances” is granted

definitively, the risk-benefit balance of the medicinal product is reviewed annually and the MA is withdrawn in case the risk-benefit

ratio is no longer favorable.

Data and Marketing Exclusivity

In the EU, innovative medicinal products (including both small molecules and biological medicinal products) generally receive eight

years of data exclusivity and an additional two years of market exclusivity upon MA. The data exclusivity period, if granted, prevents

generic or biosimilar applicants from referencing the innovator’s pre-clinical and clinical trial data contained in the dossier of the

reference product when applying for a generic or biosimilar MA, for a period of eight years from the date on which the reference

product was first authorized in the EU. During the additional two-year period of market exclusivity, a generic or biosimilar MA can be

submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed until the expiration of

the market exclusivity period. The overall ten-year period can be extended to a maximum of 11 years if, during the first eight years of

those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific

evaluation prior to their authorization, are determined to bring a significant clinical benefit in comparison with currently approved

therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical

or biological entity, and products may not qualify for data exclusivity.

In the EU, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product

but that do not meet the definition of a generic medicinal product, for example, because of differences in raw materials or

manufacturing processes. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines

from the EMA detail the type of quantity of supplementary data to be provided for different types of biological product. There are

no such guidelines for complex biological products, such as gene or cell therapy medicinal products, and so it is unlikely that

biosimilars of those products will currently be approved in the EU. However, guidance from the EMA states that they will be

considered in the future in light of the scientific knowledge and regulatory experience gained at the time.

Orphan Medicinal Products

The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the United States. A

medicinal product can be designated as an orphan if its sponsor can establish that: (1) the product is intended for the diagnosis,

prevention or treatment of life-threatening or chronically debilitating conditions, (2) either (a) such condition affects no more than 5

in 10,000 persons in the EU when the application is made, or (b) where it is unlikely that the marketing of the medicine would

generate sufficient return in the EU to justify the necessary investment in its development, and (3) there exists no satisfactory method

of diagnosis, prevention or treatment of the condition that have been authorized in the EU or, if such a method exists, the product in

question would be of significant benefit to those affected by the condition.

Orphan designation must be requested before submitting an MAA. In the EU, orphan designation entitles a party to incentives such

as reduction of fees or fee waivers, protocol assistance and access to the centralized procedure. Upon grant of a MA, orphan

medicinal products are entitled to ten years of market exclusivity for the approved indication, which means that the competent

authorities cannot accept another MAA, or grant a MA, or accept an application to extend a MA for a similar medicinal product for

the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal

products that have also complied with an agreed Pediatric Investigation Plan, or PIP. No extension to any supplementary protection

certificate can be granted on the basis of pediatric studies for orphan indications.

This period may be reduced to six years if, at the end of the fifth year, it is established that the orphan designation criteria are no

longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity or

where the prevalence of the condition has increased above the threshold. Additionally, MA may only be granted to a “similar

medicinal product” for the same indication at any time, if (i) the holder of the MA for the original orphan medicinal product consents

to a second orphan medicinal product application, (ii) the holder of the MA for the original orphan medicinal product cannot supply

sufficient quantities of the orphan medicinal product, or (iii) the second applicant can establish that its medicinal product, although

similar, is safer, more effective or otherwise clinically superior to the authorized orphan medicinal product. A “similar medicinal

product” is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan

medicinal product, and which is intended for the same therapeutic indication. Orphan designation does not convey any advantage

in, or shorten the duration of, the regulatory review and approval process.

European Pediatric Development

In the EU, MAAs for new medicinal products have to include the results of studies conducted in the pediatric population, in

compliance with a PIP, with the EMA’s Pediatric Committee, or PDCO. The PIP sets out the timing and measures proposed to

generate data to support a pediatric indication of the product candidate for which MA is being sought. The PDCO can grant a

deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the

efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO

when this data is not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or

condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant

therapeutic benefit over existing treatments for pediatric patients. Once the MA is obtained in all the EU member states and study

results are included in the product information, even where such results are negative, the product is eligible for six months’

supplementary protection certificate extension (if any is in effect at the time of approval) or, in the case of orphan medicinal

products, a two year extension of the orphan market exclusivity is granted.

Controlled Substances

Controlled substances are not regulated at EU level and the EU legislation does not establish different classes of narcotic or

psychotropic substances. However, the United Nations, or UN, Single Convention on Narcotic Drugs of 1961 and the UN

Convention on Psychotropic Substances of 1971, or the UN Conventions, codify internationally applicable control measures to

ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes. The individual EU member

states are all signatories to these UN Conventions. All signatories have a dual obligation to ensure that these substances are

available for medical purposes and to protect populations against abuse and dependence.

The UN Conventions regulate narcotic drugs and psychotropic substances as Schedule I, II, III, IV substances with Schedule II

substances presenting the lowest relative risk of abuse among such substances and Schedule I and IV substances considered to

present the highest risk of abuse.

The UN Conventions require signatories to require all persons manufacturing, trading (including exporting and importing) or

distributing controlled substances to obtain a license from the relevant authority. Each individual export or import of a controlled

substance must also be subject to an authorization. Before the relevant authority can issue an export authorization for a particular

shipment, the exporter must provide the authority with a copy of the import authorization issued by the relevant authority of the

importing country. Implementation of the obligations provided in the UN Conventions and additional requirements are regulated at

national level and requirements may vary from one member state to another.

Post-Approval requirements

Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory

oversight by the EMA, the European Commission and/or the competent regulatory authorities of the member states. The holder of

a MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, or

QPPV, who is responsible for the establishment and maintenance oversight of that system, and oversees the safety profiles of

medicinal products and any emerging safety concerns. Key obligations include expedited reporting of suspected serious adverse

reactions and submission of periodic safety update reports, or PSURs.

All new MAA must include a risk management plan, or RMP, describing the risk management system that the company will put in

place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also

impose specific obligations as a condition of the MA. Such risk-minimization measures or post-authorization obligations may include

additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization

safety studies.

The advertising and promotion of medicinal products is also subject to laws concerning promotion of medicinal products,

interactions with physicians, misleading and comparative advertising and unfair commercial practices. All advertising and

promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all

off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines is also prohibited in the EU. Although

general requirements for advertising and promotion of medicinal products are established under EU directives, the details are

governed by regulations in each member state and can differ from one country to another.

Much like the Anti-Kickback Statue prohibition in the United States, the provision of benefits or advantages to physicians to induce

or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also

prohibited in the EU. The provision of benefits or advantages to induce or reward improper performance generally is usually

governed by national EU member states anti-bribery laws. Infringement of these laws could result in substantial fines and

imprisonment.

Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements with physicians often

must be the subject of prior notification and/or approval by the physician’s employer, his or her competent professional organization

and/or the regulatory authorities of the individual EU member states. These requirements are provided in national laws, industry

codes or professional codes of conduct, applicable in the EU member states.

Failure to comply with EU and member state laws that apply to the conduct of clinical trials, manufacturing approval, MA of

medicinal products and marketing of such products, both before and after grant of the MA, manufacturing of pharmaceutical

products, statutory health insurance, bribery and anti-corruption or with other applicable regulatory requirements may result in

administrative, civil or criminal penalties. These penalties could include delays or refusal to authorize the conduct of clinical trials, or

to grant MA, product withdrawals and recalls, product seizures, suspension, withdrawal or variation of the MA, total or partial

suspension of production, distribution, manufacturing or clinical trials, operating restrictions, injunctions, suspension of licenses,

fines and criminal penalties.

The aforementioned EU rules are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member

states plus Norway, Liechtenstein and Iceland.

Regulation of Combination Products in the European Union

The EU regulates medical devices and medicinal products separately, through different legislative instruments, and the applicable

requirements will vary depending on the type of drug-device combination product. EU guidance has been published to help

manufacturers select the right regulatory framework.

Drug-delivery products intended to administer a medicinal product where the medicinal product and the device form a single

integral product are regulated as medicinal products in the EU. The EMA is responsible for evaluating the quality, safety and efficacy

of MAAs submitted through the centralized procedure, including the safety and performance of the medical device in relation to its

use with the medicinal product. The EMA or the EU member state national competent authority will assess the product in

accordance with the rules for medicinal products described above but the device part must comply with Regulation (EU) No

2017/745, or the EU Medical Devices Regulation (including the general safety and performance requirements provided in Annex I).

MAA must include—where available—the results of the assessment of the conformity of the device part with the EU Medical Devices

Regulation contained in the manufacturer’s EU declaration of conformity of the device or the relevant certificate issued by a notified

body. If the MAA does not include the results of the conformity assessment and where for the conformity assessment of the device,

if used separately, the involvement of a notified body is required, the competent authority must require the applicant to provide a

notified body opinion on the conformity of the device.

By contrast, in case of drug-delivery products intended to administer a medicinal product where the device and the medicinal

product do not form a single integral product (but are e.g. co-packaged), the medicinal product is regulated in accordance with the

rules for medicinal products described above while the device part is regulated as a medical device and will have to comply with all

the requirements set forth by the EU Medical Devices Regulation.

The characteristics of non-integral devices used for the administration of medicinal products may impact the quality, safety and

efficacy profile of the medicinal products. To the extent that administration devices are co-packaged with the medicinal product or,

in exceptional cases, where the use of a specific type of administration device is specifically provided for in the product information

of the medicinal product, additional information may need to be provided in the MAA for the medicinal product on the

characteristics of the medical device(s) that may impact on the quality, safety and/or efficacy of the medicinal product.

The requirements regarding quality documentation for medicinal products when used with a medical device, including single

integral products, co-packaged and referenced products, are outlined in the EMA guideline of July 22, 2021, which became

applicable as of January 1, 2022.

The aforementioned EU rules are generally applicable in the EEA

Regulation of Medical Devices in the European Union

In the EU, until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the EU Medical Devices

Directive which has been repealed and replaced by the EU Medical Devices Regulation. Our Founded Entities' medical devices

current certificates have been granted under the EU Medical Devices Directive whose regime is described below. In accordance with

the EU Medical Devices Regulation’s extended transitional provisions, both (i) devices lawfully placed on the market pursuant to the

EU Medical Devices Directive prior to May 26, 2021, and (ii) legacy devices lawfully placed on the EU market after May 26, 2021 in

accordance with the EU Medical Devices Regulation transitional provisions may generally continue to be made available on the

market or put into service, provided that the requirements of the transitional provisions are fulfilled. However, even in this case,

manufacturers must comply with a number of new or reinforced requirements set forth in the EU Medical Devices Regulation with

regard to registration of economic operators and of devices, post-market surveillance and vigilance requirements. Pursuing

marketing of medical devices in the EU will notably require that our devices be certified under the new regime set forth in the EU

Medical Devices Regulation.

In the EU, there is currently no premarket government review of medical devices. However, the EU requires that, all medical devices

placed on the market in the EU must meet the safety and performance requirements laid down in Annex I to the Medical Devices

Regulation, including the requirement that a medical device must be designed and manufactured in such a way that during normal

conditions of use, it is suitable for its intended purpose. Medical devices must be safe and effective and must not compromise the

clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any

risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are

compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. The

European Commission has adopted various standards applicable to medical devices. These include standards governing common

requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical

devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these

standards is viewed as the easiest way to satisfy the essential requirements as a practical matter as it creates a rebuttable

presumption that the device satisfies that general safety and performance requirement.

Compliance with the general safety and performance requirements of the Medical Devices Regulation is a prerequisite for European

conformity marking, or CE mark, without which medical devices cannot be marketed or sold in the EU. To demonstrate compliance

with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation, medical device

manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk)

classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the general safety and

performance must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the

products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended

performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and

acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and

safety of the device are supported by suitable evidence. Except for low-risk medical devices (Class I non-sterile, non-measuring

devices), where the manufacturer can self-assess the conformity of its products with the general safety and performance

requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the

intervention of a notified body. Notified bodies are independent organizations designated by EU member states to assess the

conformity of devices before being placed on the market. A notified body would typically audit and examine a product’s technical

dossiers and the manufacturer’s quality system (the notified body must presume that quality systems which implement the relevant

harmonized standards – which is ISO 13485:2016 for Medical Devices Quality Management Systems – conform to these

requirements). If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the

notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The

manufacturer may then apply the European Conformity, or CE mark, to the device, which allows the device to be placed on the

market throughout the EU.

Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify

continued compliance with the applicable requirements. In particular, there will be a new audit by the notified body before it will

renew the relevant certificate(s).

The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market,

manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting

identification information to the electronic system (Eudamed), unless they have already registered. The information to be submitted

by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons

responsible for regulatory compliance. The new Regulation also requires that before placing a device, other than a custom-made

device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the

unique device identifier, or UDI, database. These new requirements aim at ensuring better identification and traceability of the

devices. Each device – and as applicable, each package – will have a UDI composed of two parts: a device identifier, or UDI-DI,

specific to a device, and a production identifier, or UDI-PI, to identify the unit producing the device. Manufacturers are also notably

responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date. Certain

obligations for registration in Eudamed will become applicable on May 28, 2026 (for the four first modules related to (i) economic

actor,(ii) UDI/devices registrations, (iii) notified bodies and certificates, and (iv) market surveillance

for the four first modules related to (i) economic actor,(ii) UDI/devices registrations, (iii) notified bodies and certificates, and (iv)

market surveillance). Until Eudamed is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to

apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in

particular, information regarding registration of devices and economic operators.

All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system which

has been reinforced by the EU Medical Devices Regulation. Under this system, serious incidents and Field Safety Corrective Actions,

or FSCAs, must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through

Eudamed – once functional – and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states,

other actors such as the economic operators in the supply chain will also be informed. Until Eudamed is fully functional, the

corresponding provisions of the EU Medical Devices Directive continue to apply. Manufacturers are required to take FSCAs, which

are defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with

the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration in the

characteristics or performance of a device on the market (e.g., inadequacy in the information supplied by the manufacturer,

undesirable side-effect), which, directly or indirectly, might lead to either the death or serious deterioration of the health of a

patient, user, or other persons, or to a serious public health threat. An FSCA may include the recall, modification, exchange,

destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its

customers and/or to the end users of the device through Field Safety Notices. For similar serious incidents that occur with the same

device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common

and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.

The advertising and promotion of medical devices are subject to some general principles set forth in EU legislation. According to

the EU Medical Devices Regulation, only devices that are CE marked may be marketed and advertised in the EU in accordance with

their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on

unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and

contain general rules (for example, requiring that advertisements are evidenced, balanced and not misleading). Specific

requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices,

which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may

impose limitations on promotional activities with healthcare professionals.

In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies,

suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with regulatory

requirements (as applicable) could require time and resources to respond to the regulatory authorities’ observations and to

implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement

powers and, if such issues cannot be resolved to their satisfaction, can take a variety of actions, including untitled or warning letters,

fines, consent decrees, injunctions or civil or criminal penalties.

The aforementioned EU rules are generally applicable in the EEA.

Regulation of In Vitro Diagnostic Medical Devices in the European Union

The EU regulatory landscape concerning in vitro diagnostic medical devices, or IVD MDs, recently evolved. On April 5, 2017

Regulation (EU) 2017/746 of the European Parliament and of the Council on IVD MDs and repealing Directive 98/79/EC and

Commission Decision 2010/227/EU, or the IVDR, was adopted to establish a modernized and more robust EU legislative framework,

with the aim of ensuring better protection of public health and patient safety. This aims at reducing the risk of discrepancies in

interpretation across the different European markets.

The IVDR became applicable on May 26, 2022. Following subsequent legislative changes, European institutions adopted a

“progressive” roll-out of the IVDR to prevent disruption in the supply of in vitro diagnostic medical devices. Therefore, the IVDR

applies since May 26, 2022, but there is a tiered system extending the grace period for many devices (depending on their risk

classification) before they have to be fully compliant with the regulation. However, even in this case, manufacturers must comply with

a number of new or reinforced requirements set forth in the EU IVDR. The IVDR among other things:

—strengthens the rules on placing devices on the market and reinforce surveillance once they are available;

—establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of

devices placed on the market;

—establishes explicit provisions on importers’ and distributors’ obligations and responsibilities;

—imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the

requirements of the new regulation;

—improves the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a

unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through

the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;

—sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive

information on products available in the EU; and

—strengthens rules for the assessment of certain high-risk devices that may have to undergo an additional check by experts before

they are placed on the market.

The aforementioned EU rules are generally applicable in the EEA.

Regulation of Companion Diagnostics in the European Union

In the EU, IVD MDs were regulated by the EU IVDD, which regulated the placing on the market, the CE marking, the essential

requirements, the conformity assessment procedures, the registration obligations for manufactures and devices as well as the

vigilance procedure. IVD MDs had to comply with the requirements provided for in the EU IVDD, and with further requirements

implemented at national level (as the case may be).

The regulation of companion diagnostics is subject to further requirements since the IVDR became applicable on May 26, 2022 but

there is a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be

fully compliant with the Regulation. The IVDR introduced a new classification system for companion diagnostics which are now

specifically defined as diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients

that are suitable or unsuitable for treatment. Companion diagnostics will have to undergo a conformity assessment by a notified

body. Before it can issue an EU certificate, the notified body must seek a scientific opinion from the EMA on the suitability of the

companion diagnostic to the medicinal product concerned if the medicinal product falls exclusively within the scope of the

centralized procedure for the authorization of medicines, or the medicinal product is already authorized through the centralized

procedure, or a MAA for the medicinal product has been submitted through the centralized procedure. For other substances, the

notified body can seek the opinion from a national competent authorities or the EMA.

Brexit and the Regulatory Framework in the United Kingdom

Since the end of the Brexit transition period on January 1, 2021, and the implementation of the Windsor Framework on January 1,

2025, the United Kingdom, or UK, has not generally been directly subject to EU laws with respect to medicinal products.

Since January 1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, has been the UK’s standalone

medicines and medical devices regulator. As a result of the Northern Ireland Protocol, different rules applied in Northern Ireland

than in Great Britain, or GB (England, Scotland and Wales); broadly, Northern Ireland continued to follow the EU regulatory regime.

However, on January 1, 2025, an arrangement called the “Windsor Agreement” came into effect and reintegrated Northern Ireland

under the regulatory authority of the MHRA with respect to medicinal products. The Windsor Framework removes EU licensing

processes, and EU labelling and serialization requirements in relation to Northern Ireland, and introduces a UK-wide licensing

process for medicinal products.

It The EU laws that have been transposed into UK law through secondary legislation remain applicable in the UK; however, new

legislation such as the (EU) CTR is not generally applicable in the UK. Whilst the EU-UK Trade and Cooperation Agreement, or TCA,

includes the mutual recognition of GMP inspections of manufacturing facilities for medicinal products and GMP documents issued,

it does not contain wholesale mutual recognition of UK and EU pharmaceutical regulations and product standards.

The UK regulatory framework in relation to clinical trials is derived from pre-existing EU legislation (as implemented into UK law,

through secondary legislation). In April 2025, the UK government adopted the Medicines for Human Use (Clinical Trials)

Amendment Regulations. The amendment, which will take full effect from April 2026, aims to provide a more flexible regime to

make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical

trials more patient-centered.

MAs in the UK are governed by the UK’s Human Medicines Regulations 2012. In order to use the centralized procedure to obtain an

MA that will be valid throughout the EEA, companies must be established in the EEA. Therefore, since Brexit, companies

established in the UK can no longer use the EU centralized procedure and instead an EEA entity must hold any centralized MAs. In

order to obtain a UK MA to commercialize products in the UK, an applicant must be established in the UK and must follow one of

the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures. Applications are

governed by the UK’s Human Medicines Regulations 2012, and are made electronically through the MHRA Submissions Portal. The

MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will

benefit patients, including a 150-day assessment and a rolling review procedure. In addition, an international recognition procedure,

or IRP, has applied since January 1, 2024, whereby the MHRA will have regard to decisions on the approval of MAs made by the

EMA and certain other regulators when determining an application for a new UK MA. Pursuant to the IRP, the MHRA will take into

account the expertise and decision-making of trusted regulatory partners (i.e. the regulators in Australia, Canada, Switzerland,

Singapore, Japan, the U.S. and the EU). The MHRA will conduct a targeted assessment of IRP applications but retain the authority to

reject applications if the evidence provided is considered insufficiently robust. The IRP allows medicinal products approved by such

trusted regulatory partners that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update an MA in the

UK. Applications should be decided within a maximum of 60 days if there are no major objections identified that cannot be resolved

within such 60-day period and the approval from the trusted regulatory partner selected has been granted within the previous 2

years or if there are such major objections identified or such approval has not been granted within the previous 2 years within 110

days. Applicants can submit initial MAAs to the IRP but the procedure can also be used throughout the lifecycle of a product for

post-authorization procedures including line extensions, variations and renewals. In the UK, the initial duration of an MA is five years

and following renewal will be valid for an unlimited period unless the MHRA decides on justified grounds relating to

pharmacovigilance, to proceed with only one additional 5-year renewal. Any authorization which is not followed by the actual

placing of the medicinal product on the market in the UK within 3 years shall cease to be in force.

There is no pre-MA orphan designation in the UK. The MHRA reviews applications from companies for orphan designation in

parallel to the corresponding MAA. The criteria are essentially the same, but have been tailored for the market, i.e., the prevalence

of the condition in the UK, rather than the EU, must not be more than five in 10,000. Should an orphan designation be granted, the

period of market exclusivity will be set from the date of first approval of the product in the UK.

With respect to medical devices (including IVD MDs), the TCA does not specifically refer to them but does provide for cooperation

and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and

measures, standardization related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For

medical devices that are locally manufactured but use components from other countries, the “rules of origin” criteria will need to be

reviewed. The rules for placing medical devices on the Northern Ireland market will differ from those in GB.

All medical devices must be registered with the MHRA, and since January 1, 2022, manufacturers based outside the UK have been

required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.

Furthermore, on June 16, 2025, an amendment to the UK’s Medical Devices Regulations 2002, or UK MDR, became applicable

which aims to clarify and strengthen the post-market surveillance requirements for medical devices in GB. This amendment also aims

to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and

support the entire health system in better protecting patients. In addition, the MHRA launched a consultation between November

14, 2024 and January 5, 2025 on proposals to update the pre-market requirements for medical devices in GB, covering four topics,

namely: (1) a new international reliance scheme to enable swifter market access for certain devices that have already been approved

in a comparable regulator country; (2) the UK Conformity Assessed, or UKCA, mark and, in particular, proposals to remove the

requirement to place such UKCA marking on devices; (3) conformity assessment procedures for in vitro diagnostic devices; and (4)

maintaining in UK law certain pieces of “assimilated” EU law . This consultation builds on the MHRA’s previous consultation between

September and November 2021, and the UK government’s response to that consultation which was published on June 26, 2022. On

July 22, 2025, the MHRA published a response to the consultation confirming that it will incorporate feedback to this consultation

into new legislation on pre-market requirements for medical devices in GB. A draft of the new legislation is expected to be

published this year and aims to enable greater international collaboration and practices, with more patient-centered, proportionate

requirements for medical devices which are responsive to technological advances. Under the UK MDR, in order to be lawfully placed

on the GB market, class I (non-sterile, non-measuring or non-re-useable) medical devices need to be “UKCA” self-certified, and

other medical devices need to be “UKCA” certified by a UK approved body. However, certain medical devices in compliance with:

(1) the EU Medical Devices Directive can continue to be placed on the GB market until the sooner of certificate expiration or June

30, 2028; or (2) the EU Medical Devices Regulation can continue to be placed on the GB market until June 30, 2030.

Similarly, under the UK MDR, in order to be lawfully placed on the GB market, class A (non-sterile) IVD MDs need to be “UKCA” self

certified, and other IVDs need to be “UKCA” certified by a UK approved body. However, certain IVD MDs in compliance with: (1)

the EU IVDD can continue to be placed on the GB market until the sooner of certificate expiration or June 30, 2030; or (2) the EU

IVDR can continue to be placed on the GB market until June 30, 2030. On February 16, 2026, the MHRA launched a targeted

consultation on proposals for recognizing such devices in GB, which will run until April 10, 2026. In particular, the consultation

includes a proposal to extend the recognition of EU Medical Devices Regulation-compliant medical devices and EU IVDR-compliant

IVD MDs in GB indefinitely.

Under the terms of the Northern Ireland Protocol, Northern Ireland follows EU rules on medical devices and devices marketed in

Northern Ireland require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified

body, in which case a CE mark is required before placing the device on the market in the EU or Northern Ireland. Alternatively, if a

UK notified body conducts such assessment, a ‘UKNI’ mark and a CE mark are applied and the device may only be placed on the

market in Northern Ireland and not the EU.

Under the UK’s Misuse of Drugs Act 1971, class A drugs are considered to be the most potentially harmful, and have the highest

level of control exerted over them. Similarly, Schedule 1 of the UK’s Misuse of Drugs Regulations 2001 lists those drugs to which the

most restrictive controls apply: they are considered to have no legitimate or medicinal use, and can only be imported, exported,

produced, supplied and the like under a license issued by the UK government’s Home Office.

Rest of the World Regulation

For other countries outside of the EU, the UK and the United States, such as countries in Eastern Europe, Latin America or Asia, the

requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country.

Additionally, the clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements

and the ethical principles that have their origin in the Declaration of Helsinki.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or

withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Additional Laws and Regulations Governing International Operations

Our operations are subject to global anti-corruption laws, including the UK Bribery Act 2020 (“Bribery Act”), the US Foreign Corrupt

Practices Act ("FCPA"), and other applicable laws which generally prohibit us, our employees, and intermediaries acting on our

behalf from corruptly authorizing, promising, offering, or providing, directly or indirectly, anything of value, to government officials

or other persons to obtain or retain business or gain some other business advantage. The Bribery Act also prohibits: (i)

“commercial” bribery of private parties, in addition to bribery involving domestic or foreign officials; (ii) the acceptance of bribes, as

well as the giving of bribes; and (iii) “facilitation payments”, meaning generally low-level payments designed to secure or expedite

routine governmental actions or other conduct that persons are already under obligations to perform. The Bribery Act also creates

an offense applicable to corporate entities for failure to prevent bribery by our employees, officers, directors, and other third parties

acting on our behalf, to which the only defense is to maintain “adequate procedures” designed to prevent such acts of bribery.

Compliance with global anti-corruption laws presents particular challenges in the pharmaceutical industry, because, in many

countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. We

have policies and procedures designed to promote compliance with anti-corruption laws and may need to dedicate additional

resources as our operations expand around the world.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing

with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data

relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources

to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product

candidates outside of the United States, which could limit our growth potential and increase our development costs.

The failure to comply with laws governing international business practices may result in investigations, substantial civil and criminal

fines and penalties, collateral litigation, suspension or debarment from government contracting, and other sanctions.

Healthcare Laws and Regulation

Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous

regulatory authorities in the United States in addition to the FDA, including the Centers for Medicare & Medicaid Services, or CMS,

the Office of Inspector General and Office for Civil Rights, other divisions of the Department of Health and Human Services, or HHS,

the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade

Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local

governments.

Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products and other

medical items and services. Arrangements with providers, consultants, third-party payors and customers are subject to broadly

applicable fraud and abuse, anti-kickback, false claims laws, reporting of payments to physicians and teaching hospitals and patient

privacy laws and regulations and other healthcare laws and regulations that may constrain our business and/or financial

arrangements. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

—the federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party

acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration (including any kickback, bribe or

certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, or in return for, that is intended to induce or reward

referrals, including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made

under a federal healthcare program, such as Medicare or Medicaid. A person or entity need not have actual knowledge of the

federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;

—the federal civil and criminal false claims laws, including the civil False Claims Act, or FCA, which prohibit individuals or entities

from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or

approval that are false, fictitious or fraudulent; knowingly making, using or causing to be made or used, a false statement or

record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or

knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal

government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government

payors if they are deemed to “cause” the submission of false or fraudulent claims. The government may assert that a claim

including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim

for purposes of the FCA. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the

federal government alleging violations of the FCA and to share in any monetary recovery.

—the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration

to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s

selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program,

unless an exception applies;

—the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes civil and criminal liability for,

among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit

program or knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any

materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the

federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to

violate it in order to have committed a violation;

—the federal transparency requirements known as the federal Physician Payments Sunshine Act, which requires certain

manufacturers of drugs, devices, biologics and medical supplies to report annually to CMS information related to payments and

other transfers of value made by that entity to physicians (defined to include doctors, dentists, optometrists, podiatrists and

chiropractors), certain non-physician practitioners such as physician assistants and nurse practitioners, and teaching hospitals, as

well as ownership and investment interests held by the physicians described above and their immediate family members;

—federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that

potentially harm consumers;

—federal price reporting laws, which require manufacturers to calculate and report complex pricing metrics to government

programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved products;

—analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare

items or services that are reimbursed by non-governmental third-party payors, including private insurers; and

—some state laws require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the

relevant compliance guidance promulgated by the federal government in addition to requiring manufacturers to report

information related to payments to physicians and other healthcare providers, marketing expenditures, and pricing information.

Certain state and local laws require the registration of pharmaceutical sales and medical representatives.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, in the event we

obtain regulatory approval for any one of our products, it is possible that some of our business activities could be subject to

challenge and may not comply under one or more of such laws, regulations, and guidance. Law enforcement authorities are

increasingly focused on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these

laws. Violations of these laws can subject us to administrative, civil and criminal penalties, damages, fines, disgorgement, the

exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm, and the

curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a

corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Efforts to ensure that

our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare

laws and regulations will involve substantial costs.

Moreover, analogous state and foreign laws and regulations may be broader in scope than the provisions described above and may

apply regardless of payor. These laws and regulations may differ from one another in significant ways, thus further complicating

compliance efforts. For instance, in the EU, many EU member states have adopted specific anti-gift statutes that further limit

commercial practices for medicinal products and MDs, in particular vis-à-vis healthcare professionals and organizations. Additionally,

there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or

entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency

requirements (often on an annual basis), similar to the requirements in the United States, on pharmaceutical companies. Certain

countries also mandate implementation of commercial compliance programs, or require disclosure of marketing expenditures and

pricing information.

Coverage and Reimbursement

In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers

performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.

Thus, even if a product candidate is approved, sales of the product will depend, in part, on the extent to which third-party payors,

including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and

managed care organizations, provide coverage, and establish adequate reimbursement levels for, the product. In the United States,

no uniform policy of coverage and reimbursement for drug and other medical products exists among third-party payors. Although

CMS determines whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors

tend to follow CMS to a substantial degree, coverage and reimbursement for drug and other medical products can differ

significantly from payor to payor. The process for determining whether a third-party payor will provide coverage for a product may

be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is

approved. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing the

cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage

to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a

particular indication.

In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct

expensive pharmacoeconomic or other studies in order to demonstrate the medical necessity and cost-effectiveness of the product,

in addition to the costs required to obtain FDA or other comparable regulatory approvals. Additionally, companies may also need to

provide discounts to purchasers, private health plans or government healthcare programs. Nonetheless, product candidates may

not be considered medically necessary or cost effective. A decision by a third-party payor not to cover a product could reduce

physician utilization once the product is approved and have a material adverse effect on sales, our operations and financial

condition. Additionally, a third-party payor’s decision to provide coverage for a product does not imply that an adequate

reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that

other payors will also provide coverage and reimbursement for the product, and the level of coverage and reimbursement can differ

significantly from payor to payor. Factors payors consider in determining reimbursement are based on whether the product is:

—a covered benefit under its health plan;

—safe, effective and medically necessary;

—appropriate for the specific patient;

—cost-effective; and

—neither experimental nor investigational.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private

payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower

prices than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with

predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that

reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of

reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the

government, such as average sales price, or ASP, and best price. Penalties may apply in some cases when such metrics are not

submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by

government healthcare programs.

In addition, in many foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The

requirements governing drug pricing and reimbursement vary widely from country to country. In the EU, governments influence the

price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that

fund a large part of the cost of those products to consumers. Member states are free to restrict the range of pharmaceutical

products for which their national health insurance systems provide reimbursement, and to control the prices and reimbursement

levels of pharmaceutical products for human use. Some jurisdictions operate positive and negative list systems under which

products may only be marketed once a reimbursement price has been agreed to by the government. Member states may approve a

specific price or level of reimbursement for the pharmaceutical product, or alternatively adopt a system of direct or indirect controls

on the profitability of the company responsible for placing the pharmaceutical product on the market, including volume-based

arrangements, caps and reference pricing mechanisms. To obtain reimbursement or pricing approval, some of these countries may

require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available

therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will

allow favorable reimbursement and pricing arrangements for any of our products. The downward pressure on health care costs has

become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some

countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.

The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products

have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including

price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and

cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could

further limit a company’s revenue generated from the sale of any approved products. Coverage policies and third-party payor

reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more

products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement

rates may be implemented in the future.

Healthcare Reform

In the United States and some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and

regulatory changes and proposed changes regarding the healthcare system directed at broadening the availability of healthcare,

improving the quality of healthcare, and containing or lowering the cost of healthcare. For example, in March 2010, the U.S.

Congress enacted the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation

Act, or collectively the ACA which, among other things, included changes to the coverage and payment for products under

government health care programs. The ACA included provisions of importance to our potential product candidates that:

—created an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and

biologic products, apportioned among these entities according to their market share in certain government healthcare programs;

—expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain

individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid

rebate liability;

—expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both

branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting

Medicaid drug rebates on outpatient prescription drug prices;

—addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are

calculated for drugs that are inhaled, infused, instilled, implanted or injected;

—expanded the types of entities eligible for the 340B drug discount program; and

—created a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical

effectiveness research, along with funding for such research.

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of

the ACA.

On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states

without specifically ruling on the constitutionality of the ACA.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011, the

Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers, which went

into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032 unless

additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which,

among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer

treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from

three to five years. More recently, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated

the statutory Medicaid drug rebate cap, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average

manufacturer price.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS

may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened

governmental scrutiny over the manner in which manufacturers set prices for their commercial products, which has resulted in

several Congressional inquiries and proposed and enacted state and federal legislation designed to, among other things, bring

more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform

government program reimbursement methodologies for pharmaceutical products. On August 16, 2022, the Inflation Reduction Act

of 2022, or IRA, was into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations

with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first

due in 2023), and replaces the Part D coverage gap discount program with a new manufacturer discounting program (which began

in 2025). The IRA permits the Secretary of the Department of Health and Human Services to implement many of these provisions

through guidance, as opposed to regulation, for the initial years. CMS has published the negotiated prices for the initial ten drugs,

which went into effect in 2026, and the subsequent 15 drugs, which will be first effective in 2027, along with the next 15 drugs that

will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges. For

that and other reasons, it is currently unclear how the IRA will be effectuated.

In addition, the One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the

Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services

covered by Medicaid, which could adversely affect our ability to generate revenue, attain profitability or commercialize seralutinib.

Furthermore, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether

and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical

industry and on our ability to receive adequate revenues for seralutinib. On the one hand, President Trump has threatened to

impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing,

which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers

have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump

administration is pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations

in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models

under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of

their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. Imposing a rebate in

the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical

market, and while the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be

significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.

pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of

considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that

negatively affect the pharmaceutical industry.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations

designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on

certain product access and marketing cost disclosure, drug price reporting and other transparency measures, and, in some cases,

designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-

called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states. In

addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what

pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

Furthermore, there has been increased interest by third-party payors and governmental authorities in reference pricing systems and

publication of discounts and list prices. It is difficult to predict the future legislative landscape in healthcare and the effect on our

business, results of operations, financial condition and prospects. However, we expect that additional state and federal healthcare

reform measures will be adopted in the future.

Outside the United States, ensuring coverage and adequate payment for a product also involves challenges. Pricing of prescription

pharmaceuticals is subject to government control in many countries. In the EU, pricing negotiations with government authorities can

extend well beyond the receipt of regulatory approval for a product and may require a clinical trial that compares the cost-

effectiveness of a product to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in

commercialization.

Health Technology Assessment, or HTA, of medicinal products in the EU is an essential element of the pricing and reimbursement

decision-making process in a number of EU member states. The outcome of HTA has a direct impact on the pricing and

reimbursement status granted to the medicinal product. A negative HTA by a leading and recognized HTA body concerning a

medicinal product could undermine the prospects to obtain reimbursement for such product not only in the EU member state in

which the negative assessment was issued, but also in other EU member states

In 2011, Directive 2011/24/EU was adopted at the EU level. This Directive establishes a voluntary network of national authorities or

bodies responsible for HTA in the individual EU member states. The network facilitates and supports the exchange of scientific

information concerning HTAs. Further to this, on December 13, 2021, Regulation No 2021/2282 on HTA, amending Directive

2011/24/EU, was adopted. The Regulation entered into force in January 2022 and has been applicable since January 2025, with

phased implementation based on the type of product, i.e. oncology and advanced therapy medicinal products as of 2025, certain

high-risk medical devices as of 2026, orphan medicinal products as of 2028, and all other medicinal products by 2030. The

Regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal

products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical

assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the

EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest

potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification

of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.

Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of

health technologies, and making decisions on pricing and reimbursement.

Data Privacy and Security Laws

Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and

security of health-related and other personal information, and could apply now or in the future to our operations or the operations

of our partners. In the United States, numerous federal and state laws and regulations, including data breach notification laws,

health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure,

and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of

personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving,

may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to

significant civil and/or criminal penalties and restrictions on data processing.

Foreign Private Issuer Status

We report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private

issuer status. As long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of

the Exchange Act that are applicable to U.S. domestic public companies, including:

—the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security

registered under the Exchange Act;

—sections of the Exchange Act that impose liability for insiders who profit from trades made in a short period of time;

—the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited

financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events; and

—Regulation FD, which regulates selective disclosures of material information by issuers.


ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS

You should read the following discussion and analysis, including those portions incorporated herein by reference, together with our

consolidated financial statements, including the notes thereto, included elsewhere in this annual report on Form 20-F. Some of the

information contained in this discussion and analysis or incorporated herein, including information with respect to our plans and

strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result

of many factors, including those factors set forth in the “Risk Factors” section incorporated herein by reference, our actual results

could differ materially from the results described in or implied by these forward-looking statements.

Our audited consolidated financial statements as of and for the years ended December 31, 2025, 2024 and 2023 have been

prepared in accordance with IFRS Accounting Standards as issued by the IASB.

The following discussion contains references to the consolidated financial statements of PureTech Health plc and its consolidated

subsidiaries, or the Company or the Group. These financial statements consolidate the Company’s subsidiaries and include the

Company’s interest in associates and investments held at fair value. Subsidiaries are those entities over which the Company

maintains control. Associates are those entities in which the Company does not have control for financial accounting purposes but

maintains significant influence over the financial and operating policies. Where we have neither control nor significant influence for

financial accounting purposes, we recognize our holding in such entity as an investment at fair value. For purposes of our

consolidated financial statements, each of our Founded Entities are considered to be either a “subsidiary” or an “associate”

depending on whether PureTech Health plc controls or maintains significant influence over the financial and operating policies of

the respective entity at the respective period end date. For additional information regarding the accounting treatment of these

entities, see "Note 1. Material Accounting Policies" to our audited consolidated financial statements included elsewhere in this

annual report on Form 20-F.

A. OPERATING RESULTS

The information (including tabular data) set forth or referenced under the heading “Key Performance Indicators—2025” on page 20

of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by

reference.

2025 Compared with 2024

The information (including tabular data) set forth or referenced under the heading “Financial Review” on pages 67 to 80 of

PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by

reference.

2024 Compared with 2023

This information is set forth under Item 5. A. "Operating Results" of PureTech's annual report on Form 20-F for the year ended

December 31, 2024.

The information (including tabular data) set forth or referenced under the heading “Risk Management” on pages 59 to 64 of

PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by

reference.

B. LIQUIDITY AND CAPITAL RESOURCES

The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein:

"Viability" on pages 65 to 66 and "Financial Review—Cash Flow and Liquidity" on page 68 of PureTech's "Annual Report and

Accounts 2025" included as exhibit 15.1 to this annual report on Form 20-F and “Notes to the Consolidated Financial Statements—

Note 20. Subsidiary Notes Payable”, “Notes to the Consolidated Financial Statements—Note 23. Leases and subleases”, “Notes to

the Consolidated Financial Statements—Note 24. Capital and Financial Risk Management” and “Notes to the Consolidated

Financial Statements—Note 25. Commitments and Contingencies”, in each case of our audited consolidated financial statements

included elsewhere in this annual report on Form 20-F.

Under various license and collaboration agreements we are required to make milestone payments upon successful completion and

achievement of certain intellectual property, clinical, regulatory and sales milestones. We will also be required to make royalty

payments in connection with the sale of products developed under these agreements, if and when such sales occur. As of December

31, 2025, these milestone events have not yet occurred and therefore the Company does not have a present obligation to make the

related payments in respect of the licenses. We believe that the occurrence of many of these milestones is remote at this time. As of

December 31, 2025 payments in respect of developmental milestones that are dependent on events that are outside the control of

the Company but are reasonably possible to occur amounted to approximately $7.1 million. These milestone amounts represent an

aggregate of multiple milestone payments depending on different milestone events in multiple agreements. The probability that all

such milestone events will occur in the aggregate is remote. We are not able to predict when and if such milestone events will occur.

Payments made to license IP represent the acquisition cost of intangible assets. For more information, see "Note 14. Intangible

Assets" to our audited consolidated financial statements included elsewhere in this annual report on Form 20-F.

We present the preferred shares issued by our subsidiaries to third parties as liabilities in our Consolidated Statement of Financial

Position. Such preferred shares are redeemable only upon liquidation or deemed liquidation (as defined in the subsidiaries'

incorporation documents) of the respective subsidiaries. We are unable to predict when and if such liquidation or deemed

liquidation events will occur, and therefore when and if such shares will be redeemed, if at all.

As of December 31, 2025, our off-balance sheet arrangements consist of outstanding standby letters of credit. We have no other off-

balance sheet arrangements that have had, or are reasonably likely to have, a material current or future effect on our consolidated

financial statements or changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or

capital resources. See “Note 15. Other Financial Assets” to our audited consolidated financial statements included elsewhere in this

annual report on Form 20-F.

We consider the Group's working capital to be sufficient for its present requirements.

C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.

The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein:

"Overview - Giving Life To Science" on page 1 and “ESG Report - Patients—Bioethics: R&D” on page 32 of PureTech’s “Annual

Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F and "Notes to the Consolidated Financial

Statements - Note 4. Segment Information" of our consolidated financial statements included elsewhere in this annual report on

Form 20-F.

D. TREND INFORMATION

Other than as disclosed elsewhere in this annual report on Form 20-F, we are not aware of any trends, uncertainties, demands,

commitments or events for the period from January 1, 2025 to the present time that are reasonably likely to have a material adverse

effect on our net revenue, income, profitability, liquidity or capital resources, or that would cause the disclosed financial information

to be not necessarily indicative of future operating results or financial condition.

E. CRITICAL ACCOUNTING ESTIMATES

The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein

"Notes to the Consolidated Financial Statements – Note 1. Material Accounting Policies" of our consolidated financial statements

included elsewhere in this annual report on Form 20-F.


ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. DIRECTORS AND SENIOR MANAGEMENT

The information (including tabular data) set forth under the heading “Board of Directors” on pages 82 to 83, “Management team”

on page 84 and "Directors’ Report for the year ended December 31, 2025” on pages 92 to 97 in each case of PureTech’s “Annual

Report and Accounts 2025" included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

B. COMPENSATION

The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:

“Directors’ Report for the year ended December 31, 2025” on pages 92 to 97, “Directors’ Remuneration Report for the year ended

December 31, 2025” on pages 102 to 109, “Directors’ Remuneration Policy” on pages 106 to 109, “Annual Report on Remuneration”

on pages 110 to 121, in each case of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report

on Form 20-F and “Notes to the Consolidated Financial Statements—Note 10 Share-based Payments” of our audited consolidated

financial statements included elsewhere in this annual report. References to the term audited within the "Annual Report on

Remuneration" are not incorporated by reference within this Form 20-F.

C. BOARD PRACTICES

The information (including graphs and tabular data) set forth under the headings "Board of Directors" on pages 82 to 83 “The

Board” on pages 85 to 89, “Report of the Nomination Committee” on page 98, “Report of the Audit Committee” on pages 99 to

101, and "Directors' Remuneration Report for the year ended December 31, 2025" on pages 102 to 109 in each case of PureTech’s

“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

D. EMPLOYEES

The information (including tabular data) set forth under the heading “ESG Report— People” on pages 34 to 38 of PureTech’s

“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

E. SHARE OWNERSHIP

The information (including graphs and tabular data) set forth under the headings “Directors’ Report for the year ended December

31, 2025” on pages 92 to 97 and “Annual Report on Remuneration” on pages 110 to 121, in each case of PureTech’s “Annual Report

and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference. For information

regarding the share ownership of our directors and executive officers, see Item 7.A - "Major Shareholders". References to the term

audited within the "Annual Report on Remuneration" are not incorporated by reference within this Form 20-F.

F. DISCLOSURE OF REGISTRANT'S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION

None.

1 Consists of 41,011,890 shares beneficially held. The address for Invesco Ltd. is c/o Invesco Ltd.,1331 Spring Street NW, Suite 2500, Atlanta, GA 30309.

2 Consists of 15,476,552 shares beneficially held. The address for Citigroup Inc. is 388 Greenwich Street, New York, NY 10013.

3 Consists of 13,899,145 shares beneficially held. The address for Lansdowne Partners Limited is c/o 15 Davies Street, London W1K 3AG, United Kingdom.

4 Consists of 11,636,089 shares beneficially held. The address for Tang Capital Management, LLC is 4747 Executive Drive, Suite 210, San Diego, CA 92121.

5 Consists of 10,763,123 shares beneficially held. The address for Briarwood Chase Management LLC is 1350 Avenue of the Americas, Suite 3005, New York, NY 10019

6 Consists of 9,554,140 shares beneficially held. The address for Recordati S.p.A. is c/o Via Civitali, 1, 20148 Milano, Italy.

7 . Consists of an aggregate of 8,637,138 shares beneficially held. The address for Baillie Gifford & Co. is c/o Calton Square, 1 Greenside Row, Edinburgh EH1 3AN, United Kingdom.

8 Consists of an aggregate of 114,612 shares beneficially held.

9 Consists of an aggregate of 163,081 shares beneficially held.

10 Consists of an aggregate of 79,239 shares beneficially held.

11 Consists of an aggregate of 1,382,432 shares beneficially held, split between (i) 1,303,076 shares held by the John L LaMattina Revocable Trust and (ii) 79,356 shares held by the LaMattina

Charitable Trust.

12 Consists of an aggregate of 2,820,056 ordinary shares split between shares held by Dr. Langer directly, shares held jointly with his spouse, and those held by a family trust.

13 Consists of an aggregate of 109,021 shares beneficially held.


ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. MAJOR SHAREHOLDERS

The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of April 10, 2026 by:

—each of our directors;

—each of our executive officers; and

—each person, or group of affiliated persons, who is known by us to beneficially own more than 3 percent of our outstanding

ordinary shares.

The column entitled “Percentage of Shares Beneficially Owned” is based on a total of 243,418,190 ordinary shares outstanding as

of April 10, 2026.

Beneficial ownership is determined in accordance with the rules and regulations of the SEC and includes voting or investment power

with respect to our ordinary shares. Ordinary shares subject to options that are currently exercisable or exercisable within 60 days

after April 10, 2026 are considered outstanding and beneficially owned by the person holding the options for the purpose of

calculating the percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other

person. Except as otherwise noted, the persons and entities in this table have sole voting and investment power with respect to all

of the ordinary shares beneficially owned by them, subject to community property laws, where applicable. Except as otherwise set

forth below, the address of the beneficial owner is c/o PureTech Health, 6 Tide Street, Suite 400, Boston, Massachusetts 02210. The

information in the table below is based on information known to us or ascertained by us from public filings made by the

shareholders. We have also set forth below information known to us regarding any significant change in the percentage ownership

of our ordinary shares by any major shareholders during the past three years. The major shareholders listed below do not have

voting rights with respect to their ordinary shares that are different from the voting rights of other holders of our ordinary shares.


NAME OF BENEFICIAL OWNER	PERCENTAGE OF SHARES BENEFICIALLY OWNED
3 Percent Shareholders
Invesco Ltd.1	16.9%
Citigroup Inc. 2	6.4%
Lansdowne Partners Limited3	5.7%
Tang Capital Management, LLC4	4.8%
Briarwood Chase Management LLC55	4.4%
Recordati S.p.A Pharmaceutical Company66	3.9%
Baillie Gifford & Co7	3.6%

Executive Officers and Directors
Robert Lyne8	*
Sharon Barber-Lui.9	*
Michele Holcomb, Ph.D.10	*
John LaMattina, Ph.D.11	*
Robert Langer, Sc.D.12	1.2%
Kiran Mazumdar-Shaw.13	*

*Represents beneficial ownership of less than 1 percent of our outstanding ordinary shares.

We are not aware that the Company is directly owned or controlled by another corporation, any foreign government or any other

natural or legal person(s) severally or jointly. We are not aware of any arrangement, the operation of which may result in a change of

control of the Company.

The number of record holders in the United States is not representative of the number of beneficial holders nor is it representative

of where such beneficial holders are resident since many of these ordinary shares were held by brokers or other nominees. As of

April 10, 2026, assuming that all of our ordinary shares represented by ADSs are held by residents of the United States, we estimate

that approximately 30% of our outstanding ordinary shares were held in the United States by approximately 52 holders of record.

The information (including graphs and tabular data) set forth under the headings “Directors’ Report for the year ended December

31, 2025—Substantial Shareholders” on page 92 and “Annual Report on Remuneration” on pages 110 to 121, in each case of

PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by

reference.

Change in Ownership of Major Shareholders

To our knowledge, other than as disclosed in the table above, our other filings with the SEC, public disclosure, including without

limitation Schedule 13 filings, and this annual report, there has been no significant change in the percentage ownership held by any

major shareholder since January 1, 2023.

B. RELATED PARTY TRANSACTIONS

The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:

headings “Directors’ Report for the year ended December 31, 2025—Related party transactions” on page 94, “Highlights of the

Year – 2025” on page 1, "A Diversified Portfolio Positioned for Significant Upside" on page 9 and "Founded Entities" on pages 10

to 19, in each case of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F

and “Notes to the Consolidated Financial Statements—Note 26. Related Parties Transactions” of our audited consolidated financial

statements included elsewhere in this annual report. For information regarding transactions with our Founded Entities, see Item

10.C - "Material Contracts."

C. INTERESTS OF EXPERTS AND COUNSEL

Not applicable.


ITEM 8.	FINANCIAL INFORMATION

A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION

Consolidated Financial Statements

Please see the information below under the heading Item 18—“Financial Statements.”

Dividend Distribution Policy

We have never declared or paid any dividends on our ordinary shares, though we may consider doing so in the future depending on

the progression of our business. Under English law, we may only pay dividends if our accumulated realized profits, which have not

been previously distributed or capitalized, exceed our accumulated realized losses, so far as such losses have not been previously

written off in a reduction or reorganization of capital. Therefore, we must have sufficient distributable profits before issuing a

dividend. Distributable profits are determined at the holding company level and not on a consolidated basis. Subject to such

restrictions and to any restrictions set out in the Articles of Association, declaration and payment of cash dividends in the future, if

any, will be at the discretion of our Board of Directors (the "Board") (and in the case of final dividends, must be approved by our

shareholders), and will depend upon such factors as results of operations, capital requirements, contractual restrictions, our overall

financial condition or applicable laws and any other factors deemed relevant by the Board.

Legal Proceedings

As of December 31, 2025, we were not party to any material legal matters or claims, except as noted below. In the future, we may

become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate

would have a material adverse impact on our financial position, results of operations or cash flows. In March 2024, a complaint was

filed against the Company alleging breach of contract with respect to certain payments alleged to be owed to a previous employee

of a Company subsidiary based on purported terms of a contract between such individual and the Company. During the year ended

December 31, 2025, a settlement was reached, and payments in the amounts of $850 and $89 were made in June and July 2025.

B. SIGNIFICANT CHANGES

Except as otherwise disclosed in this annual report on Form 20-F and in the “Notes to the Consolidated Financial Statements—Note

28. Subsequent Events”, no significant change has occurred since the date of the most recent financial statements included

elsewhere in this annual report on Form 20-F.


ITEM 10.	ADDITIONAL INFORMATION

A. SHARE CAPITAL

Not applicable.

B. MEMORANDUM AND ARTICLES OF ASSOCIATION

Objects

Section 31 of the Companies Act 2006 provides that the objects of a company are unrestricted unless any restrictions are set out in

the articles. There are no such restrictions in our Articles of Association ("Articles") and our objects are therefore unrestricted.

A copy of our Articles is attached as Exhibit 1.1 to this annual report on Form 20-F. The information called for by this Item is set forth

in Exhibit 2.3 to our annual report on Form 20-F for the year ended December 31, 2025.

C. MATERIAL CONTRACTS

Except as otherwise set forth below or as otherwise disclosed in this report, we are not currently, and have not been in the last two

years, party to any material contract, other than contracts entered into in the ordinary course of business.

The Company asked shareholders to approve a resolution to adopt a new PureTech Health plc Performance Share Plan, or PSP, at

the Company’s Annual General Meeting (“AGM”) on June 13, 2023, to help better manage the potential dilution from equity

incentives, a critically important part of our overall compensation program. The new PSP proposal passed with support from 96.8%

of the shares voted at the AGM. Following the AGM, a new forward-looking limit of 10% of the issued share capital over the next 5

years was instituted for all new awards. Any forfeitures, cancellations, or withholdings from shares granted under the prior

extinguished limit of the prior PSP are not eligible to be re-granted at any time under the new limit contained in the new PSP. As

part of the change and the implementation of the new PSP, the Company removed the separate “5% in 10 years” dilution limit

applicable to awards granted to senior employees such as Executive Directors, to ensure we have full flexibility in operating the new

PSP going forward.

On August 10, 2018, we entered into a Lease Agreement with RBK I Tenant, LLC for certain premises of approximately 50,858

rentable square feet of space at 6 Tide Street, Boston, MA 02210. The lease commenced on April 26, 2019 for an initial term

consisting of ten years and three months and there is an option to extend for two consecutive periods of five years each.

We have executed agreements with the members of the Board substantially in the form of our Form of Deed of Indemnity.

We entered into an Asset Purchase Agreement by and between Auspex Pharmaceuticals, Inc. and PureTech Health LLC, dated July

15, 2019, pursuant to which Auspex assigned and transferred all patent claims, inventory, technology, contracts and related rights

relating to LYT-100 to us. As consideration, we paid an upfront payment, which we do not deem material. In addition, Auspex is

eligible to receive milestone payments of approximately $84 million in the aggregate depending upon specified developmental,

regulatory and commercial achievements. In addition, for ten years following the first commercial sale of any commercialized

product containing LYT-100, Auspex is eligible to receive low to middle single-digit royalties on the worldwide net sales of such

product.

We entered into a Royalty Agreement with Follica, Incorporated, dated July 23, 2013, pursuant to which Follica agreed to pay us a

two percent royalty on net sales by Follica or its sublicensees of (i) products involving skin disruption using any mechanical, energy or

chemical based approaches, applying compounds to the skin, or any other approaches to the treatment of hair follicles or other

dermatological disorders commercialized by Follica, (ii) processes involving such products, or (iii) services which use or incorporate

any such product or process. In the event that Follica sublicenses the rights to any of these products, processes or services, Follica

will be obligated to pay us low teen royalties on any income received from the sublicensee. Either party may terminate this

agreement upon an uncured material breach by the other party. To date, we have not received any royalty payments pursuant to

this agreement. We do not direct or control the development and commercialization of the intellectual property licensed pursuant

to this agreement.

We entered into an Exclusive Patent License Agreement with Karuna, dated March 4, 2011, pursuant to which we granted Karuna an

exclusive license to patent rights relating to combinations of a muscarinic activator with a muscarinic inhibitor for the treatment of

central nervous system disorders. Karuna agreed to make milestone payments to us of up to an aggregate of $10 million upon the

achievement of specified development and regulatory milestones. In addition, for the term of this agreement Karuna is obligated to

pay us low single-digit running royalties on the worldwide net sales of any commercialized product covered by the licenses granted

under this agreement. In the event that Karuna sublicenses any of the patent rights granted under this agreement, Karuna will be

obligated to pay us royalties within the range of 15 percent to 25 percent on any income received from the sublicensee, excluding

royalties. Karuna may terminate this agreement for any reason with proper prior notice to us, provided that it would lose its rights to

the underlying patents as a result. Either party may terminate this agreement upon an uncured material breach by the other party.

We do not direct or control the development and commercialization of the intellectual property licensed pursuant to this

agreement. The acquisition of Karuna by Bristol Meyers Squibb (NYSE: BMY), which closed on March 18, 2024 (the “Karuna

Acquisition”), had no impact on our rights or obligations under the Exclusive Patent License Agreement with Karuna, which remains

in full force and effect.

We entered into a Research and License Agreement with New York University, or NYU, on March 6, 2017, pursuant to which NYU

granted to us an exclusive worldwide license to patents relating to certain therapeutic candidates, including LYT-200. In connection

with this agreement, we are required to pay an annual license fee in addition to milestone payments upon the achievement of

certain clinical and commercial milestones, both of which we deem immaterial. Additionally, for the term of this agreement, we are

obligated to make low single digit royalty payments on the net sales of any commercialized product covered by the license granted

under the agreement. In the event that we sublicense any of the patent rights granted under the Research and License Agreement,

we will be obligated to pay NYU a low teen percentage of any royalties received by such sublicensee, provided that such payments

are capped at a low single digit of net sales of any commercialized product by such sublicensee.

Gelesis Promissory Note and Convertible Notes

On July 25, 2022, GLS issued a short-term promissory note in the aggregate principal amount of $15.0 million (the “Promissory

Note”) to us for a cash purchase price of $15.0 million as part of a series of promissory notes issued by GLS. On July 27, 2022, the

Promissory Note was amended and restated to revise certain provisions contained therein.

On February 21, 2023, we entered into a Note and Warrant Purchase Agreement (the “NPA”) with GLS, Gelesis (together with GLS,

the “Notes Issuers”), Gelesis 2012, Inc. and Gelesis, LLC, as guarantors of the Convertible Notes, pursuant to which, for a cash

purchase price of $5.0 million, (i) the Notes Issuers issued a short-term secured convertible note in the aggregate principal amount

of $5.0 million (the “Convertible Notes” and such initial issuance, the “Initial Notes”) to us and (ii) GLS issued warrants to purchase

23,688,047 shares of common stock of GLS (the “Warrants”) to us. The Convertible Notes are guaranteed by the domestic

subsidiaries of Gelesis and are secured by a first-priority lien on any and all assets of GLS, including without limitation, intellectual

property, regulatory filings and product approvals, clearances and marks worldwide (other than the equity interests in Gelesis S.r.l.

and assets held by Gelesis S.r.l.) and a pledge of the 100% of the equity interests of Gelesis and the domestic subsidiaries of the

Notes Issuers. The Convertible Notes bear interest at a rate of 12% per annum, and were originally scheduled to mature on July 31,

2023, unless earlier converted or extended as described below. The Convertible Notes are not convertible, and the Warrants are not

exercisable, until GLS receives stockholder approval of the issuance of the shares of common stock underlying the Convertible Note

and the Warrants (the “Stockholder Approval”) in accordance with the terms thereof. Upon receipt of Stockholder Approval, (i) the

Convertible Notes shall be convertible at our option into a number of shares of common stock equal to (x) the outstanding principal

amount of such Note plus accrued and unpaid interest divided by (y) the Conversion Price (as defined in the Convertible Note) and

(ii) the Warrants will become exercisable for a purchase price of $0.2744 per share.

In addition, pursuant to the NPA, we agreed, upon the request of the Notes Issuers, to purchase from the Notes Issuers an

additional $5.0 million principal amount of the Convertible Notes (the “Additional Notes”), and to purchase from GLS additional

Warrants, representing warrant coverage of 170% of the principal amount of the Additional Notes, subject to certain conditions.

On May 1, 2023, (i) the Notes Issuers issued to us, for a cash purchase price of $2.0 million, an Additional Note in the aggregate

principal amount of $2.0 million, and (ii) GLS issued to us a warrant to purchase 192,307,692 shares of Common Stock of GLS.

On May 26, 2023, (i) the Notes Issuers issued to us, for a cash purchase price of $0.35 million, an Additional Note in the aggregate

principal amount of $0.35 million, and (ii) GLS used to us a warrant to purchase 43,133,803 shares of Common Stock of GLS.

On June 12, 2023, the Notes Issuers issued to us, for a cash purchase price of $3.0 million, an Additional Note in the aggregate

principal amount of $3.0 million.

On June 28, 2023, we entered into Amendment No. 3 to the NPA with the Notes Issuers and certain of its subsidiaries, which

extended the maturity date of the Convertible Notes issued pursuant to the NPA to March 31, 2024, unless earlier converted or

redeemed.

On September 20, 2023, the Notes Issuers issued to us, for a cash purchase price of $1.5 million, an Additional Note in the

aggregate principal amount of $1.5 million.

The aggregate principal amount of Convertible Notes issued under the NPA was $11.85 million.

Gelesis Merger Agreement

On June 12, 2023, PureTech Health LLC and Caviar Merger Sub LLC, a Delaware limited liability company and a wholly-owned

subsidiary of PureTech Health LLC (“Merger Sub”), entered into an agreement (hereinafter the "Merger Agreement"), with GLS

pursuant to which GLS was to merge with and into Merger Sub, with Merger Sub continuing as the surviving company (the

“Surviving Company”, and such merger, the “Merger”). If the Merger had been completed, we would have acquired all issued and

outstanding shares of common stock of GLS not otherwise held by us, and GLS would have become our indirect wholly-owned

subsidiary. In connection with the execution and delivery of the Merger Agreement, PureTech Health LLC entered into a Voting and

Support Agreement (the “Voting and Support Agreement”) with GLS.

Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each share

of common stock of GLS issued and outstanding immediately prior to the Effective Time would have been cancelled and converted

into the right to receive $0.05664 per share in cash, without interest.

On October 12, 2023, we delivered a notice of termination to GLS in accordance with the Merger Agreement, terminating the

Merger Agreement pursuant to Section 8.2(a) of the Merger Agreement. As a result of the termination of the Merger Agreement,

the Voting and Support Agreement was terminated in accordance with its terms.

Gelesis Bankruptcy Filing

On October 30, 2023, GLS, together with its U. S. subsidiaries, Gelesis, Inc., and Gelesis, LLC, ceased operations and filed a

voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Code in the United States Bankruptcy

Court for the District of Delaware Case No. 23-11787. Subsequently, the Chapter 7 Trustee of GLS entered into a sale of

substantially all assets to an affiliate of Theras Group S.r.l., T-Investments S.r.l., and Andromeda Energy S.r.l. for a purchase price of

$15.0 million. The transaction closed on July 16, 2024 pursuant to a Section 363 sale process in the U.S. Bankruptcy Court for the

District of Delaware. As of December 31, 2025, a plan of distribution for the proceeds from this sale of substantially all assets has not

been filed by the Chapter 7 Trustee of GLS.

Royalty Pharma Royalty Purchase Agreement

On March 22, 2023, we entered into a Royalty Purchase Agreement (the “Royalty Pharma Agreement”) with Royalty Pharma

Investments 2019 ICAV (“Royalty Pharma”), pursuant to which Royalty Pharma acquired an interest in our royalty in Karuna’s KarXT

for aggregate payments to us of up to $500.0 million. Pursuant to the Royalty Pharma Agreement, Royalty Pharma will receive 100%

of the royalty payments that we had a right to receive from Karuna until Royalty Pharma receives $60.0 million in such royalty

payments during a calendar year, after which Royalty Pharma will receive 33% and we will receive 67% of such royalty payments for

such calendar year. We received an upfront payment of $100.0 million from Royalty Pharma upon closing and are eligible to receive

up to $400.0 million in additional payments upon the achievement of certain regulatory and commercial milestones related to KarXT.

The Karuna Acquisition had no impact on our rights or obligations under the Royalty Pharma Agreement with Karuna, which remains

in full force and effect.

Vedanta Note Purchase Agreement

On April 24, 2023, we entered into a Secured Convertible Promissory Note Purchase Agreement with Vedanta and other investors

pursuant to which we purchased a secured convertible promissory note (the “Vedanta Note”) from Vedanta in the principal amount

of $5.0 million. On August 5, 2025, the Vedanta Notes were converted to equity as part of a recapitalization and qualified equity

financing of Vedanta.

Seaport Therapeutics Asset Transfer Agreement and Transition Services Agreement

On April 8, 2024, in connection with the launch of our Founded Entity, Seaport Therapeutics, Inc. (“Seaport”), which we founded on

April 1, 2024, we entered into an Asset Transfer Agreement, by and among Seaport, PureTech Health LLC (“PureTech Health”) and

PureTech LYT, Inc. (“PureTech LYT”) pursuant to which PureTech Health and PureTech LYT agreed to transfer and assign to Seaport

all assets, rights and properties existing as of the closing date (the “Seaport Closing Date”) related to the Glyph Technology or

Products (as defined in the Asset Transfer Agreement) (together, the “Transferred Assets”) subject to the conditions set forth

therein. In consideration of the asset transfer, Seaport issued to PureTech LYT shares of Seaport Series A-1 Preferred Stock and

shares of Seaport common stock on the Seaport Closing Date. Following the Seaport Closing Date, PureTech is entitled to receive

certain tiered royalty payments in respect of annual net sales of Glyph Products at specified rates ranging from 3% to 5% during the

Royalty Term (as defined in the Asset Transfer Agreement). In addition, PureTech is entitled to receive from Seaport certain

milestone payments upon achievement of certain specified milestones, certain sublicense income, and certain other amounts as set

forth in the Asset Transfer Agreement. Seaport has the exclusive right to develop products utilizing the Glyph technology for CNS

applications and may also develop products for non-CNS applications. PureTech retains certain rights to develop products utilizing

the Glyph technology for non-CNS applications to the extent Seaport is not developing products in such applications.

In connection with entry into the Asset Transfer Agreement, we entered into a Transition Services Agreement with Seaport pursuant

to which we will provide to Seaport certain services relating to the orderly transition and continued operation of the Transferred

Assets on a transitional basis for one year following the Seaport Closing Date (unless extended by mutual agreement of the parties

or the earlier termination of all services provided under the Transition Services Agreement) in consideration of Seaport’s payment of

all fees associated with the transitioned services. Subsequently, the term of the Transition Services Agreement was extended to 18

months following the Seaport Closing Date.

Seaport Stock Purchase Agreements

On April 8, 2024, in connection with the launch of Seaport, we entered into a Series A-2 Preferred Stock Purchase Agreement with

Seaport and other investors party thereto pursuant to which we agreed to purchase an aggregate of 8,421,052 shares of Seaport’s

Series A-2 Preferred Stock at a purchase price of $3.80 per share and agreed to purchase, if requested by Seaport, up to a specified

amount of Series B Preferred Stock in Seaport’s next qualified preferred stock financing.

On October 18, 2024, we entered into a Series B Preferred Stock Purchase Agreement with Seaport and other investors party

thereto pursuant to which we agreed to purchase an aggregate of 3,031,578 shares of Seaport’s Series B Preferred Stock at a

purchase price of $4.75 per share.

Voting and Investors’ Rights Agreements

We are party to voting and investors’ rights agreements with certain of our Founded Entities as described below:

—Pursuant to an Amended and Restated Investors’ Rights Agreement, as amended, between Vedanta and certain of its investors,

dated February 3, 2026, we are entitled to customary rights, including rights related to information, inspection, pre-emption, and

registration. The execution of this agreement replaced and terminated the previous Amended and Restated Investors' Rights

Agreement dated August 5, 2025, which had provided PureTech with certain rights.

—Pursuant to an Amended and Restated Voting Agreement between Sonde and certain of its investors, dated May 25, 2022, we

are entitled to designate one director to Sonde’s board of directors for so long as PureTech Health LLC and its affiliates continue

to hold at least 1,000,000 shares of Sonde’s Series A-2 preferred stock. The execution of this agreement replaced and terminated

the previous Voting Agreement dated April 9, 2019, which had provided us with equivalent rights.

—Pursuant to a Voting Agreement between Entrega and certain of its investors, dated December 18, 2017, we are entitled to

designate four directors to Entrega’s board of directors.

—Pursuant to an Amended and Restated Voting Agreement between Seaport and certain investors, dated October 18, 2024, we

are entitled to designate two directors to Seaport’s board of directors so long as we and our affiliates beneficially own an

aggregate of at least 10,000,000 shares of the Series A-1 Preferred Stock of Seaport. The agreement also provides for drag-along

rights with respect to certain sales of Seaport's capital stock. The execution of this agreement replaced and terminated the

previous Voting Agreement dated April 8, 2024, which had provided us with similar rights.

Agreements with Founded Entities Restricting Sale of Shares in Connection with an Underwritten Offering

We are party to agreements containing market stand-off provisions with certain of our Founded Entities that restrict our ability to sell

shares of such Founded Entities for 180 days (or for a period of time as specified below) after their initial public offerings or initial

public listing through a business combination, or an underwritten offering, as follows:

—Amended and Restated Investors’ Rights Agreement between Vedanta, as amended, and the investor parties named therein,

dated March 1, 2023, the execution of which replaced and terminated the previous Amended and Restated Investors' Rights

Agreement dated July 15, 2021, which had contained an equivalent restriction;

—Investors’ Rights Agreement between Entrega and the investor parties named therein, dated December 18, 2017;

—Amended and Restated Investors’ Rights Agreement between Sonde and the investor parties named therein, dated May 25,

2022, the execution of which replaced and terminated the previous Investors' Rights Agreement dated April 9, 2019, which had

contained an equivalent restriction;

—Amended and Restated Registration and Stockholders Rights Agreement dated January 13, 2022 between CPSR and the

stockholder parties named therein, the execution of which terminated the Ninth Amended and Restated Stockholders

Agreement between Gelesis and the stockholder parties named therein, dated December 5, 2019, which had contained an

equivalent restriction; and

—The Backstop Agreement between CPSR and us, among others, dated December 30, 2021, which provides that certain shares

acquired thereunder are subject to a 180-day market stand off provision.

Other Shareholder Rights Agreements

We have certain registration rights provisions in agreements with our Founded Entities as follows:

—Amended and Restated Investors’ Rights Agreement between Vedanta, as amended, and the investor parties named therein,

dated February 3, 2026, the execution of which replaced and terminated the previous Amended and Restated Investors' Rights

Agreement dated August 5, 2025, which had provided us with similar rights;

—Investors’ Rights Agreement between Entrega and the investor parties named therein, dated December 18, 2017;

—Amended and Restated Investors’ Rights Agreement between Sonde and the investor parties named therein, dated May 25,

2022, the execution of which replaced and terminated the previous Investors' Rights Agreement dated April 9, 2019, which had

provided us with similar rights ;

—Amended and Restated Registration and Stockholders Rights Agreement dated January 13, 2022 between CPSR and the

stockholder parties named therein, the execution of which terminated the Ninth Amended and Restated Stockholders

Agreement between Gelesis and the stockholder parties named therein, dated December 5, 2019,which had provided us with

similar rights;

—The Backstop Agreement between CPSR and us, among others, dated December 30, 2021;

—Subscription Agreement between CPSR and the investor parties thereto dated July 19, 2021;

and

—Amended and Restated Investors’ Rights Agreement between Seaport and the investor parties thereto, dated October 18, 2024,

the execution of which replaced and terminated the previous Amended and Restated Investors' Rights Agreement dated April 8,

2024, which had provided us with similar rights. The Amended and Restated Investors' Rights Agreement grants us a preemptive

right to purchase our pro rata share of new securities that Seaport may propose to sell and issue, subject to certain exceptions.

We also have the right, following the completion of an initial public offering, to demand that Seaport file a registration statement

or request that our shares be covered by a registration statement that Seaport is filing in certain circumstances. The agreement

also provides us with certain information and inspection rights, which rights terminate upon an initial public offering or certain

liquidation events.

We have certain preemptive rights of first refusal with respect to transfers of shares by other holders pursuant to the following

agreements:

—Fifth Amended and Restated Right of First Refusal and Co-Sale Agreement, dated July 19, 2019, by and among Follica,

Incorporated and the investors and key holders party thereto;

—Amended and Restated Right of First Refusal and Co-Sale Agreement, dated May 25, 2022, by and between Sonde Health, Inc.

and the investors and key holders party thereto, the execution of which replaced and terminated the previous Right of First

Refusal and Co-Sale Agreement dated April 9, 2019, which had provided us with similar rights;

—Right of First Refusal and Co-Sale Agreement, dated December 18, 2017, by and between Entrega, Inc. and the investors and key

holders party thereto; and

—Amended and Restated Right of First Refusal and Co-Sale Agreement, dated October 18, 2024, by and between Seaport

Therapeutics, Inc. and the investors and key holders party thereto, the execution of which replaced and terminated the previous

Right of First Refusal and Co-Sale Agreement dated April 8, 2024, which had provided us with similar rights. The Amended and

Restated Right of First Refusal and Co-Sale Agreement grants us and certain other investors the right of first refusal to purchase

and co-sale rights with respect to certain transfers.

D. EXCHANGE CONTROLS

Other than certain economic sanctions which may be in place from time to time, there are currently no UK laws, decrees or other

regulations restricting the import or export of capital or affecting the remittance of dividends or other payment to holders of

ordinary shares who are non-residents of the United Kingdom. Similarly, other than certain economic sanctions which may be in

force from time to time, there are no limitations relating only to nonresidents of the United Kingdom under English law or the

Company's articles of association on the right to be a holder of, and to vote in respect of, the ordinary shares.

E. TAXATION

Certain United Kingdom Tax Considerations

The following is a general summary of certain U.K. tax considerations relating to the ownership and disposal of an ordinary share or

ADS and does not address all possible tax consequences relating to an investment in an ordinary share or ADS. It is based on U.K.

tax law and generally published HM Revenue & Customs, or HMRC, practice (which may not be binding on HMRC) as of the date of

this annual report on Form 20-F, both of which are subject to change, possibly with retrospective effect.

Save as provided otherwise, this summary applies only to a person who is the absolute beneficial owner of an ordinary share or ADS

and who is resident (and, in the case of an individual, domiciled) in the United Kingdom for tax purposes and who is not resident for

tax purposes in any other jurisdiction and does not have a permanent establishment or fixed base in any other jurisdiction with which

the holding of an ordinary share or ADS is connected (“U.K. Holders”). A person (a) who is not resident (or, if resident, is not

domiciled) in the United Kingdom for tax purposes, including an individual and company who trades in the United Kingdom through

a branch, agency or permanent establishment in the United Kingdom to which an ordinary share or ADS is attributable, or (b) who is

resident or otherwise subject to tax in a jurisdiction outside the United Kingdom, is recommended to seek the advice of professional

advisors in relation to their taxation obligations.

This summary is for general information only and is not intended to be, nor should it be considered to be, legal or tax advice to any

particular investor. It does not address all of the tax considerations that may be relevant to specific investors in light of their

particular circumstances or to investors subject to special treatment under U.K. tax law. In particular:

—this summary only applies to an absolute beneficial owner of an ordinary share or ADS and any dividend paid in respect of the

ordinary share where the dividend is regarded for U.K. tax purposes as that person’s own income (and not the income of some

other person);

—this summary: (a) only addresses the principal U.K. tax consequences for an investor who holds an ordinary share or ADS as a

capital asset, (b) does not address the tax consequences that may be relevant to certain special classes of investor such as a

dealer, broker or trader in shares or securities and any other person who holds an ordinary share or ADS otherwise than as an

investment, (c) does not address the tax consequences for a holder that is a financial institution, insurance company, collective

investment scheme, pension scheme, charity or tax-exempt organization, (d) assumes that a holder is not an officer or employee

of the company (nor of any related company) and has not (and is not deemed to have) acquired the an ordinary share or ADS by

virtue of an office or employment, and (e) assumes that a holder does not control or hold (and is not deemed to control or hold),

either alone or together with one or more associated or connected persons, directly or indirectly (including through the holding

of an ordinary share or ADS), an interest of 10 percent or more in the issued share capital (or in any class thereof), voting power,

rights to profits or capital of the company, and is not otherwise connected with the company.

This summary further assumes that a holder of an ordinary share or ADS is the beneficial owner of the underlying ordinary share for

U.K. direct tax purposes.

POTENTIAL INVESTORS IN THE ORDINARY SHARES OR ADSs SHOULD SATISFY THEMSELVES PRIOR TO INVESTING AS TO THE

OVERALL TAX CONSEQUENCES, INCLUDING, SPECIFICALLY, THE CONSEQUENCES UNDER U.K. TAX LAW AND HMRC

PRACTICE OF THE ACQUISITION, OWNERSHIP AND DISPOSAL OF THE ORDINARY SHARES OR ADSs, IN THEIR OWN

PARTICULAR CIRCUMSTANCES BY CONSULTING THEIR TAX ADVISERS.

Taxation of Dividends

Withholding Tax

A dividend payment in respect of an ordinary share may be made without withholding or deduction for or on account of U.K. tax.

Income Tax

A dividend received by individual U.K. Holders may, depending on his or her particular circumstances, be subject to U.K. income tax

on the gross amount of the dividend paid.

An individual holder of an ordinary share or ADS who is not a U.K. Holder will not be chargeable to U.K. income tax on a dividend

paid by the company, unless such holder carries on (whether solely or in partnership) a trade, profession or vocation in the United

Kingdom through a permanent establishment in the United Kingdom to which the ordinary share or ADS is attributable. In these

circumstances, such holder may, depending on his or her individual circumstances, be chargeable to U.K. income tax on a dividend

received from the company.

All dividends received by a UK Holder from the Company or from other sources will form part of the UK Holder’s total income for UK

income tax purposes and will constitute the top slice of that income. The rate of U.K. income tax that is chargeable on dividends

received in the tax year 2026/2027 by (i) an additional rate taxpayer is 39.35 percent, (ii) a higher rate taxpayer is 35.75 percent, and

(iii) a basic rate taxpayer is 10.75 percent. A nil rate of income tax will apply to the first £500 of taxable dividend income received by

an individual U.K. Holder in a tax year.

Corporation Tax

A U.K. Holder within the charge to U.K. corporation tax may be entitled to exemption from U.K. corporation tax in respect of

dividend payments, provided the dividends qualify for exemption (which is likely) and certain conditions are met (including anti-

avoidance conditions). If the conditions for the exemption are not satisfied, or such U.K. Holder elects for an otherwise exempt

dividend to be taxable, U.K. corporation tax will be chargeable on the gross amount of a dividend. If potential investors are in any

doubt as to their position, they should consult their own professional advisers.

A corporate holder of an ordinary share or ADS that is not a U.K. Holder will not be subject to U.K. corporation tax on a dividend

received from the company, unless it carries on a trade in the United Kingdom through a permanent establishment to which the

ordinary share or ADS is attributable. In these circumstances, such holder may, depending on its individual circumstances and if the

exemption from U.K. corporation tax discussed above does not apply, be chargeable to U.K. corporation tax on dividends received

from the company.

Taxation of Disposals

U.K. Holders

A disposal or deemed disposal of an ordinary share or ADS by an individual U.K. Holder may, depending on his or her individual

circumstances, give rise to a chargeable gain or to an allowable loss for the purpose of U.K. capital gains tax. The principal factors

that will determine the capital gains tax position on a disposal of an ordinary share or ADS are the extent to which the holder

realizes any other capital gains in the tax year in which the disposal is made, the extent to which the holder has incurred capital

losses in that or any earlier tax year and the level of the annual exemption for tax-free gains in that tax year (the “annual

exemption”). The annual exemption for the 2026/2027 tax year is £3,000. If, after all allowable deductions, an individual U.K. Holder’s

total taxable income for the year exceeds the basic rate income tax limit, a taxable capital gain accruing on a disposal of an ordinary

share or an ADS is taxed at the rate of 24 percent. In other cases, a taxable capital gain accruing on a disposal of an ordinary share

or ADS may be taxed at the rate of 18 percent save to the extent that any capital gains exceed the unused basic rate tax band. In

that case, the rate currently applicable to the excess would be 24 percent.

An individual U.K. Holder who ceases to be resident in the United Kingdom (or who fails to be regarded as resident in a territory

outside the United Kingdom for the purposes of double taxation relief) for a period of five tax years or less than five years and who

disposes of an ordinary share or ADS during that period of temporary non-residence may be liable to U.K. capital gains tax on a

chargeable gain accruing on such disposal on his or her return to the United Kingdom (or upon ceasing to be regarded as resident

outside the United Kingdom for the purposes of double taxation relief) (subject to available exemptions or reliefs).

A disposal (or deemed disposal) of an ordinary share or ADS by a corporate U.K. Holder may give rise to a chargeable gain or an

allowable loss for the purpose of U.K. corporation tax. Any gain or loss in respect of currency fluctuations over the period of holding

an ordinary share or an ADS are also brought into account on a disposal.

Non-U.K. Holders

An individual holder who is not a U.K. Holder should not normally be liable to U.K. capital gains tax on capital gains realized on the

disposal of an ordinary share or ADS unless such holder carries on (whether solely or in partnership) a trade, profession or vocation

in the United Kingdom through a permanent establishment in the United Kingdom to which the ordinary share or ADS is

attributable. In these circumstances, such holder may, depending on his or her individual circumstances, be chargeable to U.K.

capital gains tax on chargeable gains arising from a disposal of his or her ordinary share or ADS.

A corporate holder of an ordinary share or ADS that is not a U.K. Holder will not be liable for U.K. corporation tax on chargeable

gains realized on the disposal of an ordinary share or ADS unless: (i) it carries on a trade in the United Kingdom through a

permanent establishment to which the ordinary share or ADS is attributable; or (ii) the corporate holder is disposing of an interest in

a company and that disposal is of an asset that derives 75 percent or more of its gross asset value from UK land and that holder has

a substantial indirect interest in UK land (broadly at least 25 percent at any time during the previous two years). In these

circumstances, a disposal (or deemed disposal) of an ordinary share or ADS by such holder may give rise to a chargeable gain or an

allowable loss for the purposes of U.K. corporation tax.

Inheritance Tax

If, for the purposes of the Double Taxation Relief (Taxes on Estates of Deceased Persons and on Gifts) Treaty United States of

America Order 1979 (S1 1979/1454) between the United States and the United Kingdom, an individual holder is domiciled at the

time of their death or at the time of a transfer made during their lifetime in the United States and is not a national of the United

Kingdom, any ordinary share or ADS beneficially owned by that holder should not generally be subject to U.K. inheritance tax,

provided that any applicable U.S. federal gift or estate tax liability is paid, except where (i) the ordinary share or ADS is part of the

business property of a U.K. permanent establishment or pertain to a U.K. fixed base used for the performance of independent

personal services; or (ii) the ordinary share or ADS is comprised in a settlement unless, at the time the settlement was made, the

settlor was domiciled in the United States and not a national of the U.K. (in which case no charge to U.K. inheritance tax should

apply).

Stamp Duty and Stamp Duty Reserve Tax

The stamp duty and stamp duty reserve tax, or SDRT, treatment of the issue, transfer and agreement to transfer an ordinary share

outside a depositary receipt system or a clearance service are discussed in the paragraphs under “General” below. The stamp duty

and SDRT treatment of such transactions in relation to such systems are discussed in the paragraphs under “Depositary Receipt

Systems and Clearance Services” below. The discussion below relates to the holders of our ordinary shares or ADSs wherever

resident, however it should be noted that special rules may apply to certain persons such as market makers, brokers, dealers or

intermediaries.

General

Issue of Ordinary Shares or ADSs

The issue of an ordinary share or ADS does not give rise to a stamp duty or SDRT liability.

Transfer of Ordinary Shares

A transfer of an ordinary share will generally be subject to stamp duty at the rate of 0.5 percent of the consideration given for the

transfer (rounded up to the next £5). An exemption from stamp duty is available on an instrument transferring an ordinary share

where the amount or value of the consideration is £1,000 or less, and it is certified on the instrument that the transaction effected

does not form part of a larger transaction or series of transactions in respect of which the aggregate amount or value of the

consideration exceeds £1,000. The purchaser normally pays the stamp duty.

An unconditional agreement to transfer an ordinary share will normally give rise to a charge to SDRT at the rate of 0.5 percent of the

amount or value of the consideration payable for the transfer. SDRT is, in general, payable by the purchaser. If a duly stamped

transfer completing an agreement to transfer is produced within six years of the date on which the agreement is made (or, if the

agreement is conditional, the date on which the agreement becomes unconditional) any SDRT already paid is generally repayable,

normally with interest, and any SDRT charge yet to be paid is cancelled.

Transfer of ADSs

No stamp duty will, in practice, be payable on a written instrument transferring an ADS or on an unconditional agreement to transfer

an ADS provided the instrument of transfer or the unconditional agreement to transfer is executed and remains at all times outside

the UK. Where these conditions are not met, the transfer of, or agreement to transfer, an ADS could, depending on the

circumstances, attract a charge to U.K. stamp duty at the rate of 0.5 percent of the value of the consideration. No SDRT will be

payable in respect of an agreement to transfer an ADS.

Depositary Receipt Systems and Clearance Services

No SDRT or stamp duty is payable when shares are issued to a clearance service or depositary receipt system.

Where an ordinary share or ADS is otherwise transferred (i) to, or to a nominee or an agent for, a person whose business is or

includes the provision of clearance services or (ii) to, or to a nominee or an agent for a person whose business is or includes issuing

depositary receipts, stamp duty or SDRT will generally be payable at the higher rate of 1.5 percent of the amount or value of the

consideration given or, in certain circumstances, the value of the shares.

With effect from January1,2024, the Finance Act 2024 introduced new legislation containing exemptions to the 1.5% stamp duty and

SDRT charges on the transfer of shares into clearance services or depositary receipt issuers. These exemptions from the 1.5%

charges include exemptions for (i) transfers of shares into clearance services or depositary receipt issuers where such transfers are in

the course of a capital-raising arrangement (being arrangements pursuant to which securities are issued by a company for the

purpose of raising new capital), and (ii) transfers of shares into clearance services or depositary receipt issuers where such transfers

are in the course of arrangements for the first listing of the shares of a company on a recognized stock exchange and where such

arrangements do not affect the beneficial ownership of the shares, or instruments which effect such transfers.

Shareholders who hold their shares in certificated form should take note that future transfers of such shares into a clearance service

or to a depositary receipt issuer may not benefit from these exemptions and may be subject to a 1.5% charge.

Accordingly, specific professional advice should be sought in relation to the application of the 1.5% stamp duty or SDRT charge.

There is an exception from the 1.5 percent charge on the transfer to, or to a nominee or agent for, a clearance service where the

clearance service has made and maintained an election under section 97A(1) of the Finance Act 1986, which has been approved by

HM Revenue & Customs. It is understood that HM Revenue & Customs regards the facilities of DTC as a clearance service for these

purposes and we are not aware of any section 97A election having been made by the DTC.

Any liability for stamp duty or SDRT in respect of a transfer into a clearance service or depositary receipt system, or in respect of a

transfer within such a service, which does arise will strictly be accountable by the clearance service or depositary receipt system

operator or their nominee, as the case may be, but will, in practice, be borne by the participants in the clearance service or

depositary receipt system.

Repurchase of Ordinary Shares

U.K. stamp duty will generally be due at a rate of 0.5% of the consideration paid (rounded up to the next £5.00) on a repurchase by

the company of its ordinary shares.

Taxation in the United States

The following discussion is a summary of the material U.S. federal income tax consequences to U.S. Holders and Non-U.S. Holders,

each as defined below, of the acquisition, ownership and disposition of our ordinary shares or ADSs, but does not purport to be a

comprehensive discussion of all the tax considerations that may be relevant to a decision to purchase our ordinary shares or ADSs.

The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local or non-U.S. tax laws, are not

discussed. This discussion is based on current provisions of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), U.S.

Treasury Regulations promulgated thereunder, published rulings and administrative pronouncements of the U.S. Internal Revenue

Service (the "IRS"), and judicial decisions, in each case as available on the date of this annual report on Form 20-F. All of the

foregoing are subject to change, which change could apply retroactively and could affect the tax consequences described below.

We have not, and will not, seek a ruling from the IRS with regard to the U.S. federal income tax treatment of an investment in our

ordinary shares or ADSs, and there can be no assurance the IRS or a court will agree with the discussion below. This discussion is

limited to U.S. Holders and Non-U.S. Holders of our ordinary shares or ADSs. This discussion addresses only the U.S. federal income

tax considerations for holders that our ordinary shares or ADSs as capital assets within the meaning of Section 1221 of the Code

(generally, property held for investment). This discussion does not address all U.S. federal income tax matters that may be relevant

to a particular holder, including the impact of the Medicare contribution tax on net investment income and the alternative minimum

tax. Each prospective investor should consult a professional tax advisor with respect to the tax consequences of the acquisition,

ownership or disposition of our ordinary shares or ADSs. In addition, this discussion does not address tax considerations applicable

to a holder of our ordinary shares or ADSs that may be subject to special tax rules including, without limitation, the following:

—U.S. expatriates and former citizens or long-term residents of the United States;

—banks or other financial institutions;

—insurance companies;

—dealers or traders in securities, currencies, or notional principal contracts;

—tax-exempt entities, including an “individual retirement account” or “Roth IRA” retirement plan;

—regulated investment companies or real estate investment trusts;

—“qualified foreign pension funds,” or entities wholly owned by a “qualified foreign pension fund”;

—persons who have elected to mark securities to market;

—tax-exempt organizations or governmental organizations;

—persons that hold our ordinary shares as part of a hedge, straddle, conversion, constructive sale or similar transaction involving

more than one position;

—partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors

therein);

—"controlled foreign corporations," "foreign controlled foreign corporations," "passive foreign investment companies," and

corporations that accumulate earnings to avoid U.S. federal income tax;

—persons who acquired our ordinary shares or ADSs as compensation for the performance of services;

—“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by

qualified foreign pension funds;

—holders that own (or are deemed to own) 10 percent or more of our ordinary shares or ADSs, by vote or value; and

—U.S. Holders that have a “functional currency” other than the U.S. dollar.

If an entity treated as a partnership or other pass-through entity for U.S. federal income tax purposes holds our ordinary shares or

ADSs, the tax treatment of a partner in the partnership will generally depend upon the status of the partner, the activities of the

partnership and certain determinations made at the partner level. A partner in a partnership or other pass-through entity that hold

our ordinary shares or ADSs should consult his, her or its tax advisor regarding the tax consequences of acquiring, holding and

disposing of our ordinary shares or ADSs through a partnership or other pass-through entity, as applicable.

For the purposes of this discussion, a “U.S. Holder” is a beneficial owner of our ordinary shares or ADSs that is (or is treated as), for

U.S. federal income tax purposes:

—an individual who is either a citizen or resident of the United States;

—a corporation created or organized in or under the laws of the United States, any state of the United States or the District of

Columbia;

—an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or

—a trust, if (1) a court within the United States is able to exercise primary supervision over its administration and one or more

"United States persons" (within the meaning of Section 7701(a)(3) of the Code) have the authority to control all of the substantial

decisions of such trust or (2) such trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a

United States person for U.S. federal income tax purposes.

For purposes of this discussion, a "Non-U.S. Holder" is a beneficial owner of our ordinary shares or ADSs that is not a U.S. Holder.

THIS DISCUSSION IS NOT TAX ADVICE. PERSONS CONSIDERING AN INVESTMENT IN ORDINARY SHARES OR ADSs SHOULD

CONSULT THEIR TAX ADVISORS AS TO THE PARTICULAR TAX CONSEQUENCES APPLICABLE TO THEM RELATING TO THE

ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR ORDINARY SHARES OR ADSs, INCLUDING THE APPLICABILITY OF U.S.

FEDERAL, STATE AND LOCAL TAX LAWS, ANY NON-U.S. TAX LAWS AND ANY INCOME TAX TREATY.

Ownership of ADSs

For U.S. federal income tax purposes, a holder of ADSs generally will be treated as the owner of the ordinary shares represented by

such ADSs. Gain or loss will generally not be recognized on account of exchanges of ordinary shares for ADSs, or of ADSs for

ordinary shares. References to ordinary shares in the discussion below are deemed to include ADSs, unless context otherwise

requires.

Treatment of the Company as a Domestic Corporation for U.S. Federal Income Tax Purposes

Even though we are incorporated under the laws of England and Wales, due to the circumstances of its formation and the

application of Section 7874 of the Code, the Company is treated as a U.S. domestic corporation for U.S. federal income tax

purposes. This has implications for all shareholders; we are subject to U.S. federal income tax as if we were a U.S. corporation, and

distributions made by us are generally treated as U.S.-source as described below and generally subject to U.S. dividend withholding

tax to the extent treated as a dividend, as described below.

U.S. Holders

Distributions

As described in the section entitled “Dividend Distribution Policy,” we have never declared or paid any dividends on our ordinary

shares or ADSs, though we may consider doing so in the future depending on the progression of our business. If we do make

distributions of cash or property on our ordinary shares or ADSs (or engage in any transactions treated as distributions for U.S.

federal income tax purposes), such distributions will be treated as U.S.-source dividends includible in the gross income of a U.S.

Holder as ordinary income to the extent of our current and accumulated earnings and profits, as determined under U.S. federal

income tax principles. To the extent the amount of a distribution exceeds tour current and accumulated earnings and profits, the

distribution will be treated first as a non-taxable return of capital to the extent of a U.S. Holder’s adjusted tax basis in the ordinary

shares or ADSs and thereafter as gain from the sale of such ordinary shares or ADSs. Subject to applicable limitations and

requirements, dividends received on the ordinary shares or ADSs generally should be eligible for the “dividends received

deduction” available to corporate shareholders. A dividend paid by us to a non-corporate U.S. Holder generally will be eligible for

preferential rates if certain holding period requirements are met.

The U.S. dollar value of any distribution made by us in foreign currency will be calculated by reference to the exchange rate in effect

on the date of the U.S. Holder’s actual or constructive receipt of such distribution, regardless of whether the foreign currency is in

fact converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on such date of receipt, the U.S. Holder

generally will not recognize foreign currency gain or loss on such conversion. If the foreign currency is not converted into U.S. dollars

on the date of receipt, such U.S. Holder will have a basis in the foreign currency equal to its U.S. dollar value on the date of receipt.

Any gain or loss on a subsequent conversion or other taxable disposition of the foreign currency generally will be U.S.-source

ordinary income or loss to such U.S. Holder.

Sale or Other Taxable Disposition

A U.S. Holder will recognize gain or loss for U.S. federal income tax purposes upon a sale or other taxable disposition of its ordinary

shares or ADSs in an amount equal to the difference between the amount realized from such sale or disposition and the U.S.

Holder’s adjusted tax basis in the ordinary shares or ADSs. A U.S. Holder’s adjusted tax basis in the ordinary shares or ADSs

generally will be the U.S. Holder’s cost for such ordinary shares or ADSs. Any such gain or loss generally will be U.S.-source capital

gain or loss and will be long-term capital gain or loss if, on the date of sale or disposition, such U.S. Holder held the ordinary shares

or ADSs for more than one year. Long-term capital gains derived by non-corporate U.S. Holders are eligible for taxation at reduced

rates. The deductibility of capital losses is subject to significant limitations.

Information Reporting And Backup Withholding

Payments of distributions on or proceeds arising from the sale or other taxable disposition of ordinary shares or ADSs generally will

be subject to information reporting, and they may be subject to backup withholding, if a U.S. Holder (i) fails to furnish such U.S.

Holder’s correct U.S. taxpayer identification number (generally on IRS Form W-9), (ii) furnishes an incorrect U.S. taxpayer

identification number, (iii) is notified by the IRS that such U.S. Holder has previously failed to properly report items subject to backup

withholding, or (iv) fails to certify under penalty of perjury that such U.S. Holder has furnished its correct U.S. taxpayer identification

number and that the IRS has not notified such U.S. Holder that it is subject to backup withholding.

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund

or a credit against a U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.

Non-U.S. Holders

Distributions

As described in the section entitled “Dividend Distribution Policy,” we have never declared or paid any dividends on our ordinary

shares or ADSs, though we may consider doing so in the future depending on the progression of our business. If we do make

distributions of cash or property on our ordinary shares or ADSs (or engage in any transactions treated as distributions for U.S.

federal income tax purposes), such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid of

our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Amounts not treated as

dividends for U.S. federal income tax purposes will constitute a return of capital and first be applied against and reduce a Non-U.S.

Holder’s adjusted tax basis in its ordinary shares or ADSs, but not below zero. Any excess will be treated as capital gain and will be

treated as described below under “—Sale or Other Taxable Disposition.”

Subject to the discussion below on effectively connected income, dividends paid to a Non-U.S. Holder will be subject to U.S. federal

withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax

treaty, provided the Non-U.S. Holder furnishes a valid IRS Form W-8BEN or W-8BEN-E (or other applicable documentation)

certifying qualification for the lower treaty rate). A Non-U.S. Holder that does not timely furnish the required documentation, but

that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for

refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable

income tax treaty.

If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the

United States (and, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the

United States to which such dividends are attributable), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax

described above. To claim the exemption, the Non-U.S. Holder must furnish to the applicable withholding agent a valid IRS Form

W-8ECI, certifying that the dividends are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the

United States.

Any such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular rates. A

Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an

applicable income tax treaty) on such effectively connected dividends, as adjusted for certain items. Non-U.S. Holders should

consult their tax advisors regarding any applicable tax treaties that may provide for different rules.

Sale or Other Taxable Disposition

A Non-U.S. Holder will not be subject to U.S. federal income tax on any gain realized upon the sale or other taxable disposition of

our ordinary shares or ADSs unless:

—the gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if

required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the United States to

which such gain is attributable);

—the Non-U.S. Holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of

the disposition and certain other requirements are met; or

—our ordinary shares or ADSs constitutes U.S. real property interests (“USRPI”) by reason of our status as a U.S. real property

holding corporation (“USRPHC”) for U.S. federal income tax purposes.

Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular

rates. A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate

specified by an applicable income tax treaty) on such effectively connected gain, as adjusted for certain items.

A Non-U.S. Holder described in the second bullet point above will be subject to U.S. federal income tax at a rate of 30% (or such

lower rate specified by an applicable income tax treaty) on gain realized upon the sale or other taxable disposition of our ordinary

shares or ADSs, which may be offset by U.S. source capital losses of the Non-U.S. Holder (even though the individual is not

considered a resident of the United States), provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with

respect to such losses.

With respect to the third bullet point above, we believe we currently are not, and do not anticipate becoming, a USRPHC. Because

the determination of whether we are a USRPHC depends, however, on the fair market value of our USRPIs relative to the fair market

value of our non-U.S. real property interests and our other business assets, there can be no assurance we currently are not a

USRPHC or will not become one in the future. Even if we are or were to become a USRPHC, gain arising from the sale or other

taxable disposition of our ordinary shares or ADSs by a Non-U.S. Holder will not be subject to U.S. federal income tax if our ordinary

shares or ADSs is “regularly traded,” as defined by applicable U.S. Treasury Regulations, on an established securities market and

such Non-U.S. Holder owned, actually and constructively, 5% or less of our ordinary shares or ADSs throughout the shorter of the

five-year period ending on the date of the sale or other taxable disposition or the Non-U.S. Holder’s holding period.

Non-U.S. Holders should consult their tax advisors regarding potentially applicable income tax treaties that may provide for different

rules.

Information Reporting and Backup Withholding

Payments of dividends on our ordinary shares or ADSs will not be subject to backup withholding, provided the applicable

withholding agent does not have actual knowledge or reason to know the holder is a United States person and the holder either

certifies its non-U.S. status, such as by furnishing a valid IRS Form W-8BEN, W-8BEN-E, or W-8ECI, or otherwise establishes an

exemption. However, information returns are required to be filed with the IRS in connection with any distributions on our ordinary

shares or ADSs paid to the Non-U.S. Holder, regardless of whether such distributions constitute dividends or whether any tax was

actually withheld. In addition, proceeds of the sale or other taxable disposition of our ordinary shares or ADSs within the United

States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information

reporting if the applicable withholding agent receives the certification described above and does not have actual knowledge or

reason to know that such holder is a United States person or the holder otherwise establishes an exemption. Proceeds of a

disposition of our ordinary shares or ADSs conducted through a non-U.S. office of a non-U.S. broker generally will not be subject to

backup withholding or information reporting.

Copies of information returns that are filed with the IRS may also be made available under the provisions of an applicable treaty or

agreement to the tax authorities of the country in which the Non-U.S. Holder resides or is established.

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund

or a credit against a Non-U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the

IRS.

Additional Withholding Tax on Payments Made to Foreign Accounts

Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as the Foreign

Account Tax Compliance Act, or "FATCA") on certain types of payments made to non-U.S. financial institutions and certain other

non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on, or (subject to the proposed U.S. Treasury

Regulations discussed below) gross proceeds from the sale or other disposition of, our ordinary shares or ADSs paid to a “foreign

financial institution” or a “non-financial foreign entity” (each as defined in the Code), unless (1) the foreign financial institution

undertakes certain diligence and reporting obligations, (2) the non-financial foreign entity either certifies it does not have any

“substantial United States owners” (as defined in the Code) or furnishes identifying information regarding each substantial United

States owner, or (3) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these

rules. If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in (1) above, it must

enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertake to identify

accounts held by certain “specified United States persons” or “United States owned foreign entities” (each as defined in the Code),

annually report certain information about such accounts, and withhold 30% on certain payments to non-compliant foreign financial

institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental

agreement with the United States governing FATCA may be subject to different rules.

Under the applicable U.S. Treasury Regulations and administrative guidance, withholding under FATCA generally applies to

payments of dividends on our ordinary shares or ADSs. While withholding under FATCA would have applied also to payments of

gross proceeds from the sale or other disposition of stock on or after January 1, 2019, proposed U.S. Treasury Regulations eliminate

FATCA withholding on payments of gross proceeds entirely. Taxpayers generally may rely on these proposed U.S. Treasury

Regulations until final U.S. Treasury Regulations are issued.

F. DIVIDENDS AND PAYING AGENTS

Not applicable.

G. STATEMENT BY EXPERTS

Not applicable.

H. DOCUMENTS ON DISPLAY

We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to make certain filings with the

SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains a website at http://www.sec.gov from

which filings may be accessed.

We also make available on our website, free of charge, our annual reports on Form 20-F and the text of our reports on Form 6-K,

including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are

electronically filed with or furnished to the SEC. Our website address is www.puretechhealth.com. The information contained on our

website is not incorporated by reference into this annual report on Form 20-F.

I. SUBSIDIARY INFORMATION

Not applicable.

J. ANNUAL REPORT TO SECURITY HOLDERS

Not applicable.


ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

A. DEBT SECURITIES

Not applicable.

B. WARRANTS AND RIGHTS

Not applicable.

C. OTHER SECURITIES

Not applicable.

D. AMERICAN DEPOSITARY SHARES

Our ADSs are registered with Citibank, N.A., as depositary . Each ADS represents ten ordinary shares (or a right to receive ten

ordinary shares) deposited with Citibank, N.A. (London), as custodian for the depositary in the United Kingdom. Citibank’s

depositary offices are located at 388 Greenwich Street, New York, New York, 10013. ADSs represent ownership interests in securities

that are on deposit with the depositary bank. ADSs may be represented by certificates that are commonly known as “American

Depositary Receipts” or “ADRs.” The depositary bank typically appoints a custodian to safekeep the securities on deposit. In this

case, the custodian is Citibank, N.A.—London Branch, located at Citigroup Centre Canary Wharf, London E14 5LB D.

A deposit agreement among us, the depositary, ADS holders and beneficial owners of ADSs issued thereunder sets out ADS holder

rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. A copy of

the deposit agreement is incorporated by reference as exhibit 2.1 to this annual report on Form 20-F.

Fees and Charges

As an ADS holder, you will be required to pay the following fees under the terms of the deposit agreement:


SERVICE		FEES
— Issuance of ADSs (e.g., an issuance of ADS upon a deposit of ordinary shares, upon a change in the ADS(s)-to-ordinary share(s) ratio, or for any other reason), excluding ADS issuances as a result of distributions of ordinary shares)		Up to U.S.$0.05 per ADS issued

—Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property, upon a change in the ADS(s)-to-ordinary share(s) ratio, or for any other reason)		Up to U.S.$0.05 per ADS cancelled

—Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)		Up to U.S.$0.05 per ADS held


—Distribution of ADSs pursuant to (i) share dividends or other free share distributions, or (ii) exercise of rights to purchase additional ADSs		Up to U.S.$0.05 per ADS held

—Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)		Up to U.S.$0.05 per ADS held

—ADS Services		Up to U.S.$0.05 per ADS held on the applicable record date(s) established by the depositary bank

—Registration of ADS transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other reason)		Up to U.S.$0.05 per ADS (or fraction thereof) transferred

—Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of partial entitlement ADSs for full entitlement ADSs, or upon conversion of restricted ADSs (each as defined in the deposit agreement) into freely transferable ADSs, and vice versa).		Up to U.S.$0.05 per ADS (or fraction thereof) converted

As an ADS holder you will also be responsible to pay certain charges such as:

—taxes (including applicable interest and penalties) and other governmental charges;

—the registration fees as may from time to time be in effect for the registration of ordinary shares on the share register and

applicable to transfers of ordinary shares to or from the name of the custodian, the depositary bank or any nominees upon the

making of deposits and withdrawals, respectively;

—certain cable, telex and facsimile transmission and delivery expenses;

—the fees, expenses, spreads, taxes and other charges of the depositary bank and/or service providers (which may be a division,

branch or affiliate of the depositary bank) in the conversion of foreign currency;

—the reasonable and customary out-of-pocket expenses incurred by the depositary bank in connection with compliance with

exchange control regulations and other regulatory requirements applicable to ordinary shares, ADSs and ADRs; and

—the fees, charges, costs and expenses incurred by the depositary bank, the custodian, or any nominee in connection with the ADR

program.

ADS fees and charges for (i) the issuance of ADSs, and (ii) the cancellation of ADSs are charged to the person for whom the ADSs

are issued (in the case of ADS issuances) and to the person for whom ADSs are cancelled (in the case of ADS cancellations). In the

case of ADSs issued by the depositary bank into DTC, the ADS issuance and cancellation fees and charges may be deducted from

distributions made through DTC, and may be charged to the DTC participant(s) receiving the ADSs being issued or the DTC

participant(s) holding the ADSs being cancelled, as the case may be, on behalf of the beneficial owner(s) and will be charged by the

DTC participant(s) to the account of the applicable beneficial owner(s) in accordance with the procedures and practices of the DTC

participants as in effect at the time. ADS fees and charges in respect of distributions and the ADS service fee are charged to the

holders as of the applicable ADS record date. In the case of distributions of cash, the amount of the applicable ADS fees and

charges is deducted from the funds being distributed. In the case of (i) distributions other than cash and (ii) the ADS service fee,

holders as of the ADS record date will be invoiced for the amount of the ADS fees and charges and such ADS fees and charges may

be deducted from distributions made to holders of ADSs. For ADSs held through DTC, the ADS fees and charges for distributions

other than cash and the ADS service fee may be deducted from distributions made through DTC, and may be charged to the DTC

participants in accordance with the procedures and practices prescribed by DTC and the DTC participants in turn charge the

amount of such ADS fees and charges to the beneficial owners for whom they hold ADSs. In the case of (i) registration of ADS

transfers, the ADS transfer fee will be payable by the ADS Holder whose ADSs are being transferred or by the person to whom the

ADSs are transferred, and (ii) conversion of ADSs of one series for ADSs of another series, the ADS conversion fee will be payable by

the Holder whose ADSs are converted or by the person to whom the converted ADSs are delivered.

In the event of refusal to pay the depositary bank fees, the depositary bank may, under the terms of the deposit agreement, refuse

the requested service until payment is received or may set off the amount of the depositary bank fees from any distribution to be

made to the ADS holder. Certain depositary fees and charges (such as the ADS services fee) may become payable shortly after the

purchase of ADSs. Note that the fees and charges you may be required to pay may vary over time and may be changed by us and by

the depositary bank. You will receive prior notice of such changes. The depositary bank may reimburse us for certain expenses

incurred by us in respect of the ADR program, by making available a portion of the ADS fees charged in respect of the ADR program

or otherwise, upon such terms and conditions as we and the depositary bank agree from time to time.


ITEM 15.	CONTROLS AND PROCEDURES

A. Disclosure Controls and Procedures

Disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act, are designed to

ensure that information required to be disclosed by us in the reports that are filed or submitted under the Securities Exchange Act

of 1934, as amended, is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and

forms, and that such information is accumulated and communicated to the management of the Group, including our Chief Executive

Officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Because of its inherent

limitations, disclosure controls and procedures can provide only reasonable assurance of achieving their control objectives. Our

management, with the participation of our Chief Executive Officer and principal financial officer, has evaluated the effectiveness of

the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b) as of December 31,

2025. Based on such evaluation, our Chief Executive Officer and principal financial officer have concluded that, as of December 31,

2025, our disclosure controls and procedures were effective at the reasonable assurance level.

B. Management’s Annual Report on Internal Control Over Financial Reporting

In accordance with the requirements of section 404 of Sarbanes-Oxley, the following report is provided by management in respect

of the Group’s internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)):

—Management is responsible for establishing and maintaining adequate internal control over financial reporting for the Group.

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of

financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted

accounting principles;

—Management, including our Chief Executive Officer and principal financial officer, conducted an evaluation of the effectiveness of

Group's internal control over financial reporting based on criteria established in Internal Control - Integrated Framework (2013)

issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO);

—Based on their assessment under these criteria, our management has concluded that as of December 31, 2025, the Group's

internal control over financial reporting was effective.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,

projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because

of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

C. Attestation Report of the Registered Public Accounting Firm

The effectiveness of the Group's internal control over financial reporting as of December 31, 2025 has been audited by

PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Item

18 - "Financial Statements".

D. Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) that occurred

during the period covered by this annual report on Form 20-F that have materially affected, or are reasonably likely to materially

affect, the Group's internal control over financial reporting.


ITEM 16.	RESERVED


ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT

Our Board of Directors has determined that Sharon Barber-Lui, independent director (under the standards set forth in Nasdaq Stock

Market Rule 5605(a)(2) and Rule 10A-3 under the Exchange Act) and member of our audit committee, is an audit committee financial

expert as defined in Item 16A of Form 20-F under the Exchange Act.


ITEM 16B.	CODE OF ETHICS

Our Board of Directors has adopted a written Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics

applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal

accounting officer or controller, or persons performing similar functions. A current copy of the code is posted on the investor

relations section of our website, which is located at www.puretechhealth.com.The information contained on, or that can be accessed

through, our website is not and shall not be deemed to be part of this annual report on Form 20-F. Our Code of Business Conduct

and Ethics is intended to meet the definition of “code of ethics” under Item 16B of Form 20-F under the Exchange Act. We will

disclose on our website any amendment to, or waiver from, a provision of our Code of Business Conduct and Ethics that applies to

our directors or executive officers to the extent required under the rules of the SEC or Nasdaq. We granted no waivers under our

Code of Business Conduct and Ethics in 2025.


ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES

The following table sets forth the aggregate fees billed to us for professional services rendered by PricewaterhouseCoopers LLP in

2024 and 2025.


For the years ending December 31,	2025 $000s	2024 $000s
Audit fees	2,572	2,843
Audit-related fees	—	—
Tax fees	—	—
All other fees*	6	6
Total	2,578	2,848

*”All other fees” represents non-audit fees in connection with access to the PricewaterhouseCoopers LLP on-line accounting research and disclosure database.

The information set forth or referenced under the heading “Report of the Audit Committee” on pages 99 to 101 of PureTech’s

“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as well as pre-

approves and reviews the audit and non-audit services to be performed by the independent auditor. In accordance with this policy,

all services performed by and fees paid to PricewaterhouseCoopers LLP were approved by the Audit Committee.


ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

Not applicable.


ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

None.


ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT

Not applicable.


ITEM 16G.	CORPORATE GOVERNANCE

We qualify as a foreign private issuer (as such term is defined in Rule 3b-4 under the Exchange Act). The Listing Rules of the Nasdaq

Stock Market include certain accommodations in the corporate governance requirements that allow foreign private issuers to follow

“home country” corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq

Stock Market. We rely on the certain exemptions for foreign private issuers and follow United Kingdom corporate governance

practices in lieu of the Nasdaq corporate governance rules.

A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by U.S.

domestic companies under the Nasdaq corporate governance rules is set forth below.

The information (including tabular data) set forth or referenced under the headings “Directors’ Report for the year ended

31 December 2025—Compliance with the UK Corporate Governance Code” (first paragraph only) on page 93 of PureTech’s “Annual

Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.

The Sarbanes-Oxley Act of 2002, as well as related rules subsequently implemented by the SEC, requires foreign private issuers,

including our company, to comply with various corporate governance practices. In addition, Nasdaq rules provide that foreign

private issuers may follow home country practice in lieu of the Nasdaq corporate governance standards, subject to certain

exceptions and except to the extent that such exemptions would be contrary to U.S. federal securities laws. The home country

practices followed by our company in lieu of Nasdaq rules are described below:

—We do not follow Nasdaq’s quorum requirements applicable to meetings of shareholders. Such quorum requirements are not

required under U.K. law. In accordance with generally accepted business practice, our articles of association provide alternative

quorum requirements that are generally applicable to meetings of shareholders.

—We do not follow Nasdaq’s requirements that independent directors have regularly scheduled meetings at which only

independent directors are present. Under U.K. law the independent directors may choose to meet in executive session at their

discretion.

—We do not follow Nasdaq’s requirements to seek shareholder approval for the implementation of certain equity compensation

plans, the issuances of ordinary shares under such plans, or in connection with certain private placements of equity securities. In

accordance with U.K. law, we are not required to seek shareholder approval to allot ordinary shares in connection with applicable

employee equity compensation plans. We will follow U.K. law with respect to any requirement to obtain shareholder approval

prior to any private placements of equity securities.

—We do not follow Nasdaq’s requirements with respect to review and approval of related party transactions. We will follow U.K.

law with respect to any requirements regarding review and approval of related party transactions.

Other than as discussed above, we intend to comply with the rules generally applicable to U.S. domestic companies listed on

Nasdaq. We may in the future, however, decide to use other foreign private issuer exemptions with respect to some or all of the

other Nasdaq rules. Following our home country governance practices may provide less protection than is accorded to investors

under Nasdaq rules applicable to domestic issuers.

We intend to take all actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate

governance requirements of the Sarbanes-Oxley Act of 2002, the rules adopted by the SEC and Nasdaq’s listing standards.

Because we are a foreign private issuer, our directors and senior management are not subject to short-swing profit liability under

Section 16 of the Exchange Act. They are, however, subject to the obligations to file public reports of their share ownership and

trading activities under Section 16 of the Exchange Act, subject to any available exemption, and report changes in share ownership

under Section 13 of the Exchange Act and related SEC rules.


ITEM 16H.	MINE SAFETY DISCLOSURE

Not applicable.

ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

ITEM 16J. INSIDER TRADING POLICIES

Our Board of Directors has adopted a Securities Dealing Code, which applies to all of our directors, officers, employees and other

covered persons, governing the purchase, sale, and other dispositions of our securities. We believe our Securities Dealing Code is

reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us.

A copy of our Securities Dealing Code is filed as Exhibit 11.1 to this annual report on Form 20-F.

ITEM 16K. CYBERSECURITY DISCLOSURE

We have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity,

and availability of our critical systems and information.

We design and assess our program based on the National Institute of Standards and Technology Cybersecurity Framework (NIST

CSF). This does not imply that we meet any particular technical standards, specifications, or requirements, only that we use the NIST

CSF as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.

Our cybersecurity risk management program is integrated into our overall risk management program, and shares common

methodologies, reporting channels and governance processes that apply across the risk management program to other legal,

compliance, strategic, operational, and financial risk areas.

Key elements of our cybersecurity risk management program include but are not limited to the following:

—risk assessments designed to help identify material risks from cybersecurity threats to our critical systems and information;

—a security team principally responsible for managing (1) our cybersecurity risk assessment processes, (2) our security controls, and

(3) our response to cybersecurity incidents;

—the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security processes;

—cybersecurity awareness training of our employees, including incident response personnel, and senior management, including

phishing training courses designed to educate users on detecting malicious emails;

—a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents;

—use of a Digital Forensics and Incident Response team provided by our external IT service provider as needed; and

—an internal risk management process for key service providers based on our assessment of their criticality to our operations and

respective risk profile.

We have not identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have

materially affected us, including our operations, business strategy, results of operations, or financial condition. We face risks from

cybersecurity threat that, if realized, are reasonably likely to materially affect us, including our operations, business strategy, results

of operations, or financial conditions. For more information, see the section titled “Risk Factor— Cyberattacks or other failures in our

telecommunications or information technology systems, or those of our collaborators, contract research organizations, third-party

logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant

disruption of our business operations.”

Cybersecurity Governance

Our Board considers cybersecurity risk as part of its risk oversight function and has delegated to the Audit Committee (Committee)

oversight of cybersecurity and other information technology risks. The Committee oversees management’s implementation of our

cybersecurity risk management program.

The Committee receives reports at least annually from management on our cybersecurity risks. In addition, management updates

the Committee,where it deems appropriate, regarding any cybersecurity incidents it considers to be significant or potentially

significant. The full Board also periodically receives briefings from management on our cyber risk management program. Board

members receive presentations on cybersecurity topics from our Vice President of IT, internal security staff or external experts as

part of the Board's continuing education on topics that impact public companies.

Our management team, including our Vice President of IT who serves as our Information Security Officer, has a combined 30+ years

of risk management experience and is responsible for assessing and managing our material risks from cybersecurity threats. Our

Vice President of IT brings 20+ years of experience, including serving as lead of all aspects of IT strategy at similar Boston-area

biopharma companies. Based on the Vice President of IT's extensive background, he counsels the management team on IT risks and

leads the overall function. The team has primary responsibility for our overall cybersecurity risk management program and

supervises both our internal cybersecurity personnel and our retained external cybersecurity consultants. Our management team’s

experience includes experience managing IT programs as well as various certifications, such as the Information Systems Security

Professional certification, and Certified Cloud Security Professionalism certification.

Our management team takes steps to stay informed about and monitor efforts to prevent, detect, mitigate, and remediate

cybersecurity risks and incidents through various means, which may include briefings from internal security personnel; threat

intelligence and other information obtained from governmental, public or private sources, including external consultants engaged

by us; and alerts and reports produced by security tools deployed in our information technology environment.


EXHIBIT NUMBER	DESCRIPTION OF EXHIBIT	INCORPORATION BY REFERENCE
		Schedule/Form	File Number	Exhibit	File Date
101.INS*	XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH*	Inline XBRL Taxonomy Extension Schema Document
101.CAL*	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*	Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

* Filed herewith.

**Furnished herewith.

*** Certain of the information included within Exhibit 15.1, which is provided pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, is incorporated by reference

in this annual report on Form 20-F, as specified elsewhere in this annual report on Form 20-F. With the exception of the items and pages so specified, the "Annual Report and Accounts

2024" is not deemed to be filed as part of this annual report on Form 20-F.

# Indicates a management contract or any compensatory plan, contract or arrangement.

† Portions of this exhibit (indicated by asterisks) have been omitted because either (A) they are both (i) not material and (ii) would likely cause competitive harm if publicly disclosed., or

(B) they are both (i) not material and (ii) the type of information that the Registrant customarily and actually treats as private or confidential, as applicable. The Registrant agrees to

furnish an unredacted copy of this exhibit to the Securities and Exchange Commission upon request.

+ Schedules and exhibits to this exhibit omitted. The Registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.

F-2

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of PureTech Health plc

Opinions on the Financial Statements and Internal Control over Financial Reporting

We have audited the accompanying consolidated statement of financial position of PureTech Health plc and its subsidiaries (the

"Company") as of December 31, 2025 and 2024, and the related consolidated statements of comprehensive income/(loss), of

changes in equity and of cash flows for each of the three years in the period ended December 31, 2025, including the related notes

(collectively referred to as the "consolidated financial statements"). We also have audited the Company's internal control over

financial reporting as of December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued

by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of

the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the

period ended December 31, 2025 in conformity with IFRS Accounting Standards as issued by the International Accounting Standards

Board. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of

December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.

Basis for Opinions

The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control

over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in

Management’s Annual Report on Internal Control Over Financial Reporting appearing under Item 15. Our responsibility is to express

opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based

on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)

(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and

the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the

audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement,

whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of

the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such

procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial

statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as

well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial

reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material

weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.

Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our

audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability

of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted

accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to

the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of

the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial

statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are

being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable

assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that

could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,

projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because

of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial

statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or

disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or

complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial

statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the

critical audit matter or on the accounts or disclosures to which it relates.

Valuation of the Company’s investment in the Convertible Preferred Shares of Seaport Therapeutics, Inc.

As described in Notes 5 and 19 to the consolidated financial statements, the Company has an investment in Seaport Therapeutics,

Inc. (“Seaport”) through its ownership of Seaport’s Series A-1, A-2 and B convertible preferred shares (the “Preferred Shares”)

measured at a fair value of $236 million as of December 31, 2025. The fair value of the Preferred Shares is determined by

management using a valuation model that utilizes both the market backsolve and probability weighted expected return method.

The valuation of this investment is categorized as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs,

which have a significant effect on the valuation. The significant assumptions used by management in the valuation include the equity

value of Seaport and the probability of Seaport entering into an initial public offering.

F-3

The principal considerations for our determination that performing procedures relating to the valuation of the Company’s

investment in the Preferred Shares of Seaport is a critical audit matter are (i) the significant judgment by management when

developing the fair value estimate of the Preferred Shares; (ii) a high degree of auditor judgment, subjectivity and effort in

performing procedures and evaluating audit evidence related to management’s significant assumptions related to the equity value

of Seaport and the probability of Seaport entering into an initial public offering; and (iii) the audit effort involved the use of

professionals with specialized skill and knowledge.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall

opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the

valuation of the Preferred Shares of Seaport, including controls over the method, significant assumptions, and underlying data.

These procedures also included, among others (i) testing management’s process for determining the fair value of the Preferred

Shares; (ii) evaluating the appropriateness of the valuation method; (iii) testing the completeness and accuracy of the underlying

data used in the valuation method; and (iv) evaluating the reasonableness of the significant assumptions used by management

related to the equity value of Seaport and the probability of Seaport entering into an initial public offering. Evaluating

management’s assumption related to the probability of Seaport entering into an initial public offering involved evaluating whether

the assumption used by management was reasonable considering the consistency with internal and external market data.

Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the market backsolve

and probability-weighted expected return method and (ii) the reasonableness of the equity value assumption.

/s/ PricewaterhouseCoopers LLP

Boston, Massachusetts

April 29, 2026

We have served as the Company’s auditor since 2023.

F-4

Consolidated Statement of Comprehensive Income/(Loss)

For the years ended December 31


	Note	2025 $000s	2024 $000s	2023 $000s
Contract revenue	3	4,659	4,315	750
Grant revenue	3	—	513	2,580
Total revenue		4,659	4,828	3,330
Operating expenses:
General and administrative expenses	9	(46,618)	(71,469)	(53,295)
Research and development expenses	9	(56,567)	(69,454)	(96,235)
Operating income/(loss)		(98,527)	(136,095)	(146,199)
Other income/(expense):
Gain/(loss) on deconsolidation of subsidiary	8	—	151,808	61,787
Gain/(loss) on investments held at fair value	5	38,485	(2,398)	77,945
Realized gain/(loss) on sale of investments	5	375	151	(122)
Gain/(loss) on investments in notes from associates	7	(3,628)	13,131	(27,630)
Other income/(expense)		1,331	961	(908)
Other income/(expense)		36,564	163,652	111,072
Finance income/(costs):
Finance income	11	13,048	22,669	16,012
Finance costs – contractual	11	(1,876)	(1,731)	(3,424)
Finance income/(costs) – fair value accounting	11	—	(8,108)	2,650
Finance costs – non-cash interest expense related to sale of future royalties	11, 18	(43,908)	(8,058)	(10,159)
Net finance income/(costs)		(32,735)	4,773	5,078
Share of net income/(loss) of associates accounted for using the equity method	6	(17,928)	(8,754)	(6,055)
Gain/(loss) on dilution of ownership interest in associates	6	1,699	199	—
Income/(loss) before taxes		(110,927)	23,774	(36,103)
Tax benefit/(expense)	27	842	4,008	(30,525)
Income/(loss) for the year		(110,084)	27,782	(66,628)
Other comprehensive income/(loss):
Items that are or may be reclassified as profit or loss
Equity-accounted associates – share of other comprehensive income/(loss)		—	—	92
Total other comprehensive income/(loss)		—	—	92
Total comprehensive income/(loss) for the year		(110,084)	27,782	(66,535)
Income/(loss) attributable to:
Owners of the Group		(109,739)	53,510	(65,697)
Non-controlling interests		(345)	(25,728)	(931)
		(110,084)	27,782	(66,628)
Comprehensive income/(loss) attributable to:
Owners of the Group		(109,739)	53,510	(65,604)
Non-controlling interests		(345)	(25,728)	(931)
		(110,084)	27,782	(66,535)
		$	$	$
Earnings/(loss) per share:
Basic earnings/(loss) per share	12	(0.46)	0.21	(0.24)
Diluted earnings/(loss) per share	12	(0.46)	0.21	(0.24)

The accompanying notes are an integral part of these financial statements.

F-5

Consolidated Statement of Financial Position

As of December 31,


	Note	2025 $000s	2024 $000s
Assets
Non-current assets
Property and equipment, net	13	5,202	7,069
Right of use asset, net	23	6,297	8,061
Intangible assets, net	14	601	601
Investments held at fair value	5	217,426	191,426
Investment in associates – equity method	6	—	2,397
Investment in notes from associates, non-current	7	—	6,350
Other non-current assets		165	475
Total non-current assets		229,692	216,379
Current assets
Trade and other receivables	24	1,758	1,522
Income tax receivable		6,372	—
Prepaid expenses		6,576	4,404
Other financial assets	15	1,596	1,642
Investment in notes from associates, current	7	11,417	11,381
Short-term investments	24	24,829	86,666
Cash and cash equivalents	24	252,470	280,641
Total current assets		305,018	386,256
Total assets		534,710	602,635
Equity and liabilities
Equity
Share capital		4,860	4,860
Share premium		290,262	290,262
Treasury stock		(41,154)	(46,864)
Merger reserve		138,506	138,506
Translation reserve		182	182
Other reserve	16	(3,352)	(4,726)
Retained earnings/(Accumulated deficit)		(77,231)	32,486
Equity attributable to the owners of the Group		312,073	414,707
Non-controlling interests	21	(6,397)	(6,774)
Total equity		305,676	407,933
Non-current liabilities
Sale of future royalties liability, non-current	18	170,422	136,782
Lease liability, non-current	23	11,087	14,671
Liability for share-based awards	10	1,217	1,861
Total non-current liabilities		182,726	153,314
Current liabilities
Lease liability, current	23	3,584	3,579
Trade and other payables	22	23,185	27,020
Sale of future royalties liability, current	18	13,247	6,435
Tax liability, current	27	1,208	75
Notes payable	20	4,916	4,111
Preferred share liability	17, 19	169	169
Total current liabilities		46,309	41,388
Total liabilities		229,034	194,702
Total equity and liabilities		534,710	602,635

Please refer to the accompanying Notes to the consolidated financial information. Registered number: 09582467.

The Consolidated Financial Statements were approved by the Board of Directors and authorized for issuance on April 29, 2026 and

signed on its behalf by:

Robert Lyne

Chief Executive Officer

April 29, 2026

The accompanying notes are an integral part of these financial statements.

F-6

Consolidated Statement of Changes in Equity

For the years ended December 31


		Share Capital			Treasury Shares
	Note	Shares	Amount $000s	Share premium $000s	Shares	Amount $000s	Merger reserve $000s	Translation reserve $000s	Other reserve $000s	Retained earnings/ (accumulated deficit) $000s	Total Parent equity $000s	Non- controlling interests $000s	Total Equity $000s
Balance January 1, 2023		289,161,653	5,455	289,624	(10,595,347)	(26,492)	138,506	89	(14,478)	149,516	542,220	5,369	547,589
Net income/(loss)		—	—	—	—	—	—	—	—	(65,697)	(65,697)	(931)	(66,628)
Other comprehensive income/(loss), net		—	—	—	—	—	—	92	—	—	92	—	92
Total comprehensive income/(loss)		—	—	—	—	—	—	92	—	(65,697)	(65,604)	(931)	(66,535)
Deconsolidation of Subsidiary	8	—	—	—	—	—	—	—	—	—	—	(9,085)	(9,085)
Exercise of stock options	10	306,506	6	638	239,226	530	—	—	(22)	—	1,153	—	1,153
Purchase of Treasury stock	16	—	—	—	(7,683,526)	(19,650)	—	—	—	—	(19,650)	—	(19,650)
Equity-settled share- based awards	10	—	—	—	—	—	—	—	3,348	—	3,348	277	3,625
Expiration of share options in subsidiary	10	—	—	—	—	—	—	—	1,458	—	1,458	(1,458)	—
Settlement of restricted stock units		—	—	—	425,219	986	—	—	156	—	1,142	—	1,142
Other		—	—	—	—	—	—	—	—	—	—	(6)	(6)
Balance December 31, 2023		289,468,159	5,461	290,262	(17,614,428)	(44,626)	138,506	182	(9,538)	83,820	464,066	(5,835)	458,232
Net income/(loss)		—	—	—	—	—	—	—	—	53,510	53,510	(25,728)	27,782
Total comprehensive income/(loss)		—	—	—	—	—	—	—	—	53,510	53,510	(25,728)	27,782
Deconsolidation of Subsidiary	8	—	—	—	—	—	—	—	—	—	—	7,430	7,430
Exercise of stock options	10	—	—	—	412,729	1,041	—	—	(146)	—	895	—	895
Repurchase and cancellation of ordinary shares from Tender Offer	16	(31,540,670)	(600)	—	—	—	—	—	600	(104,844)	(104,844)	—	(104,844)
Purchase of Treasury stock	16	—	—	—	(1,903,990)	(4,791)	—	—	—	—	(4,791)	—	(4,791)
Equity-settled share- based awards expense	10	—	—	—	—	—	—	—	4,569	—	4,569	17,372	21,941
Settlement of restricted stock units	10	—	—	—	599,512	1,512	—	—	(211)	—	1,301	—	1,301
Expiration of share options in subsidiary		—	—	—	—	—	—	—	1	—	1	(1)	—
Other		—	—	—	—	—	—	—	—	—	—	(12)	(12)
Balance December 31, 2024		257,927,489	4,860	290,262	(18,506,177)	(46,864)	138,506	182	(4,726)	32,486	414,707	(6,774)	407,933
Net income/(loss)		—	—	—	—	—	—	—	—	(109,739)	(109,739)	(345)	(110,084)
Total comprehensive income/(loss)		—	—	—	—	—	—	—	—	(109,739)	(109,739)	(345)	(110,084)
Exercise of stock options	10	—	—	—	65,000	164	—	—	(58)	—	106	—	106
Equity-settled share- based awards expense	10	—	—	—	—	—	—	—	6,338	—	6,338	758	7,095
Settlement of restricted stock units	10	—	—	—	2,197,726	5,544	—	—	(4,942)	—	603	—	603
Expiration of share options in subsidiary		—	—	—	—	—	—	—	36	—	36	(36)	—
Other		—	—	—	—	1	—	—	—	22	23	—	23
Balance December 31, 2025		257,927,489	4,860	290,262	(16,243,451)	(41,154)	138,506	182	(3,352)	(77,231)	312,073	(6,397)	305,676

The accompanying notes are an integral part of these financial statements.

F-7

Consolidated Statement of Cash Flows

For the years ended December 31


	Note	2025 $000s	2024 $000s	2023 $000s
Cash flows from operating activities:
Income/(loss) for the year		(110,084)	27,782	(66,628)
Adjustments to reconcile income/(loss) for the period to net cash used in operating activities:
Non-cash items:
Depreciation and amortization		3,348	3,571	4,933
Share-based compensation expense	10	8,222	22,850	4,415
(Gain)/loss on investment held at fair value	5	(38,485)	2,398	(77,945)
Realized (gain)/loss on sale of investments	5	(375)	(151)	265
Gain on dilution of ownership interest in associates	6	(1,699)	(199)	—
Gain on deconsolidation of subsidiary	8	—	(151,808)	(61,787)
Share of net (gain)/loss of associates accounted for using the equity method	6	17,928	8,754	6,055
(Gain)/loss on investments in notes from associates	7	3,628	(13,131)	27,630
(Gain)/loss on disposal of assets		(93)	14	318
Impairment of fixed assets		112	226	1,260
Income taxes expense/(benefit)	27	(842)	(4,008)	30,525
Finance (income)/costs, net	11	32,735	(4,773)	(5,078)
Changes in operating assets and liabilities:
Trade and other receivables		(236)	629	9,750
Prepaid expenses and other financial assets		(1,862)	(1,262)	2,834
Deferred revenue		—	—	(283)
Trade and other payables	22	(1,025)	(9,695)	3,844
Other		—	92	1,374
Income taxes paid		(5,503)	(37,913)	(150)
Interest received		13,621	23,547	14,454
Interest paid		(4,521)	(1,295)	(1,701)
Net cash provided by (used in) operating activities		(85,131)	(134,369)	(105,917)
Cash flows from investing activities:
Purchase of property and equipment	13	(6)	(11)	(70)
Proceeds from sale of property and equipment		269	255	865
Purchases of intangible assets		—	—	(175)
Investment in preferred shares held at fair value	5, 17	(888)	(14,400)	—
Sale of investments held at fair value	5	2,753	298,109	33,309
Investment in convertible notes from associates	7	(150)	—	(16,850)
Short-term note to associate		—	(660)	—
Repayment of short-term note from associate		—	660	—
Cash derecognized upon loss of control over subsidiary	8	—	(91,570)	(13,784)
Purchases of short-term investments		(84,049)	(308,942)	(178,860)
Proceeds from maturity of short-term investments		145,310	357,447	244,556
Other		50	—	—
Net cash provided by (used in) investing activities		63,288	240,888	68,991
Cash flows from financing activities:
Receipts from Royalty Purchase Agreement	18	—	25,000	100,000
Issuance of subsidiary preferred shares	17	—	68,100	—
Payment of lease liability	23	(3,579)	(3,394)	(3,338)
Exercise of stock options		106	895	1,153
Repurchase of ordinary shares from Tender Offer, including associated costs	16	(2,053)	(102,768)	—
Payments of withholding taxes in connection with stock-based awards		(801)	—	—
Purchase of treasury stock	16	—	(4,791)	(19,650)
Other		—	—	(23)
Net cash provided by (used in) financing activities		(6,328)	(16,958)	78,141
Net increase (decrease) in cash and cash equivalents		(28,171)	89,560	41,215
Cash and cash equivalents at beginning of year		280,641	191,081	149,866
Cash and cash equivalents at end of year		252,470	280,641	191,081
Supplemental disclosure of non-cash investment and financing activities:
Purchase of intangible assets not yet paid in cash		—	—	25
Cost associated with Tender Offer not yet paid in cash		—	2,076	—
Settlement of restricted stock units through issuance of equity		1,404	1,301	1,142
Conversion of note receivable from associate into preferred shares		2,836	—	—

The accompanying notes are an integral part of these financial statements.

F-8


Notes to the Consolidated Financial Statements (Amounts in thousands, except share and per share data, or exercise price and conversion price)


1.	Material Accounting Policies

Description of Business

PureTech Health plc (the “Parent”) is a public company incorporated, domiciled and registered in the United Kingdom (“UK”). The

registered number is 09582467 and the registered address is 13th Floor, One Angel Court, London, EC2R 7HJ, United Kingdom.

The Parent and its subsidiaries are together referred to as the “Group”.

The accounting policies set out below have, unless otherwise stated, been applied consistently to all periods presented in these

group financial statements.

Basis of Presentation

The consolidated financial statements of the Group (the "Consolidated Financial Statements") are presented as of December 31,

2025 and 2024, and for the years ended December 31, 2025, 2024 and 2023. The Consolidated Financial Statements have been

approved by the Directors on April 29, 2026, and are prepared in accordance with IFRS Accounting Standards as issued by the the

International Accounting Standards Board ("IASB").

For presentation of the Consolidated Statement of Comprehensive Income/(Loss), the Group uses a classification based on the

function of expenses, rather than based on their nature, as it is more representative of the format used for internal reporting and

management purposes and is consistent with international practice.

Certain amounts in the Consolidated Financial Statements and accompanying notes may not add due to rounding. All percentages

have been calculated using unrounded amounts.

Basis of Measurement

The Consolidated Financial Statements are prepared on the historical cost basis except that the following assets and liabilities are

stated at their fair value: investments held at fair value, investments in notes from associates and preferred share liabilities.

Use of Judgments and Estimates

In preparing the Consolidated Financial Statements, management has made judgments, estimates and assumptions that affect the

application of the Group’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results

may differ from these estimates. Estimates and underlying assumptions are reviewed on an on-going basis.

Significant estimation is applied in determining the following:

—Financial instruments (see Note 19. Financial Instruments): In accordance with IFRS 9, Financial Instruments ("IFRS 9"), the Group

carries certain financial assets and financial liabilities at fair value, with changes in fair value through profit and loss ("FVTPL").

Valuation of the aforementioned financial instruments includes determining the appropriate valuation methodology and making

certain estimates such as the equity value of an entity and the probability of entering into an initial public offering.

Significant judgement is also applied in determining the following:

—Whether financial instruments should be classified as liability or equity (see Note 17. Subsidiary Preferred Shares). The judgement

includes an assessment of whether the financial instruments include contractual obligations of the Group to deliver cash or other

financial assets or to exchange financial assets or financial liabilities with another party, and whether those obligations could be

settled by the Group exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments.

Further information about these critical judgments and estimates is included below under Financial Instruments.

—Whether the power to control investees exists (see Note 5. Investments Held at Fair Value, Note 6. Investments in Associates and

Note 8. Gain/(loss) on Deconsolidation of Subsidiary and accounting policy with regard to Subsidiaries below). The judgement

includes an assessment of whether the Group has (i) power over the investee; (ii) exposure, or rights, to variable returns from its

involvement with the investee; and (iii) the ability to use its power over the investee to affect the amount of its own returns. The

Group considers among others its voting shares, shareholder agreements, ability to appoint board members, representation on

the board, rights to appoint management, de facto control, and investee dependence on the Group. If the power to control the

investee exists, it consolidates the financial statements of such investee in the Consolidated Financial Statements of the Group.

Upon issuance of new shares in an investee and/or a change in any shareholders or governance agreements, the Group

reassesses its ability to control the investee based on the revised voting interest, revised board composition and revised

subsidiary governance and management structure. When such new circumstances result in the Group losing its power to control

the investee, the investee is deconsolidated.

—Whether the Group has significant influence over financial and operating policies of investees in order to determine if the Group

should account for its investment as an associate based on IAS 28 Investments in Associates and Joint Ventures ("IAS 28") or a

financial instrument based on IFRS 9 (refer to Note 5. Investments Held at Fair Value and Note 6. Investments in Associates). This

judgement includes, among others, an assessment whether the Group has representation on the board of directors of the

investee, whether the Group participates in the policy making processes of the investee, whether there is any interchange of

managerial personnel, whether there is any essential technical information provided to the investee and if there are any

transactions between the Group and the investee.

F-9


1.	Material Accounting Policies continued

—Upon determining that the Group does have significant influence over the financial and operating policies of an investee, if the

Group holds more than a single instrument issued by its equity-accounted investee, judgement is required to determine whether

the additional instrument forms part of the investment in the associate, which is accounted for under IAS 28 and scoped out of

IFRS 9, or it is a separate financial instrument that falls in the scope of IFRS 9. This judgement includes an assessment of the

characteristics of the financial instrument of the investee held by the Group and whether such financial instrument provides

access to returns underlying an ownership interest.

—When the Group has other investments in an equity accounted investee that are not accounted for under IAS 28, judgement is

required in determining if such investments constitute long-term interests ("LTI") for the purposes of IAS 28. This determination is

based on the individual facts and circumstances and characteristics of each investment, but is driven, among other factors, by the

intention and likelihood to settle the instrument through redemption or repayment in the foreseeable future, and whether or not

the investment is likely to be converted to common stock or other equity instruments. After considering the individual facts and

circumstances of the Group’s investment in its associate's preferred stock in the manner described above, including the long-

term nature of such investment, the ability of the Group to convert its preferred stock investment to an investment in common

shares and the likelihood of such conversion, the Group concluded that such investment was considered a long-term interest.

—In determining the appropriate accounting treatment for the Royalty Purchase Agreement during 2023, management applied

significant judgement (refer to Note 18. Sale of Future Royalties Liability).

As of December 31, 2025, the Group had cash and cash equivalents of $252,470 and short-term investments of $24,829. Considering

the Group’s financial position as of December 31, 2025, and its principal risks and opportunities, the Group prepared a going

concern analysis covering a period of at least the twelve-month period from the date of signing the Consolidated Financial

Statements ("the going concern period") utilizing realistic scenarios and applying a severe but plausible downside scenario. Even

under the downside scenario, the analysis demonstrates the Group continues to maintain sufficient liquidity headroom and

continues to comply with all financial obligations. The Board of Directors believe the Group and the Parent is adequately resourced

to continue in operational existence for at least the twelve-month period from the date of signing the Consolidated Financial

Statements. Accordingly, the Board of Directors considered it appropriate to adopt the going concern basis of accounting in

preparing the Consolidated Financial Statements and the PureTech Health plc Financial Statements.

Basis of consolidation

The Consolidated Financial Statements as of December 31, 2025 and 2024, and for each of the years ended December 31, 2025,

2024 and 2023, comprise PureTech Health plc and its consolidated subsidiaries. Intra-group balances and transactions, and any

unrealized income and expenses arising from intra-group transactions, are eliminated.

Subsidiaries

As used in these financial statements, the term subsidiaries refers to entities that are controlled by the Group. Under applicable

accounting rules, the Group controls an entity when it is exposed to, or has the rights to, variable returns from its involvement with

the entity and has the ability to affect those returns through its power over the entity. In assessing control, the Group takes into

consideration potential voting rights, board representation, shareholders' agreements, ability to appoint board of directors and

management, de facto control and other related factors. The financial statements of subsidiaries are included in the Consolidated

Financial Statements from the date that control commences until the date that control ceases. Losses applicable to the non-

controlling interests ("NCI") in a subsidiary are allocated to the non-controlling interests even if doing so causes the non-controlling

interests to have a deficit balance.

A list of all current and former subsidiaries organized with respect to classification as of December 31, 2025, and the Group’s total

voting percentage, based on outstanding voting common and preferred shares as of December 31, 2025, 2024 and 2023, is outlined

below. All current subsidiaries are domiciled within the United States and conduct business activities solely within the United States.

F-10


1.	Material Accounting Policies continued


	Voting percentage at December 31, through the holdings in
	2025		2024		2023
Subsidiary	Common	Preferred	Common	Preferred	Common	Preferred
Subsidiary operating companies
Gallop Oncology, Inc. (Indirectly Held through PureTech LYT) 1, 2	100.0	—	100.0	—	N/A	N/A
Entrega, Inc. (indirectly held through Enlight)2	—	77.3	—	77.3	—	77.3
PureTech LYT, Inc. (formerly Ariya Therapeutics, Inc.)2	—	100.0	—	100.0	—	100.0
PureTech LYT 100, Inc.2	—	100.0	—	100.0	—	100.0
PureTech Management, Inc.3	100.0	—	100.0	—	100.0	—
PureTech Health LLC3	100.0	—	100.0	—	100.0	—
Deconsolidated former subsidiary operating companies
Sonde Health, Inc.2, 4, 6	—	40.2	—	40.2	—	40.2
Akili Interactive Labs, Inc.2, 5, 6	—	—	—	—	14.6	—
Gelesis, Inc. 2, 8	—	—	—	—	—	—
Seaport Therapeutics, Inc. 1, 2, 4, 6	0.8	42.1	0.8	42.1	N/A	N/A
SPTX, Inc. (held Indirectly through Seaport) 1, 2, 4, 6	0.8	42.1	0.8	42.1	N/A	N/A
Karuna Therapeutics, Inc.2, 5 , 6	—	—	—	—	2.3	—
Vedanta Biosciences, Inc.2, 4, 6	0.2	4.8	—	46.9	—	47.0
Vedanta Biosciences Securities Corp. (indirectly held through Vedanta)2, 4, 6	0.2	4.8	—	46.9	—	47.0
Vor Biopharma Inc.2, 5, 6	—	—	2.1	—	3.9	—
Non-trading holding companies
Endra Holdings, LLC (held indirectly through Enlight)2	86.0	—	86.0	—	86.0	—
Ensof Holdings, LLC (held indirectly through Enlight)2, 7	—	—	—	—	86.0	—
PureTech Securities Corp.2	100.0	—	100.0	—	100.0	—
PureTech Securities II Corp.2	100.0	—	100.0	—	100.0	—
Inactive subsidiaries
Alivio Therapeutics, Inc.2	—	100.0	—	100.0	—	100.0
Appeering, Inc.2, 7	—	—	—	—	—	100.0
Commense Inc.2, 7	—	—	—	—	—	99.1
Enlight Biosciences, LLC2	86.0	—	86.0	—	86.0	—
Ensof Biosystems, Inc. (held indirectly through Enlight)2, 7	—	—	—	—	57.7	28.3
Follica, LLC 2	28.7	56.7	28.7	56.7	28.7	56.7
Knode Inc. (indirectly held through Enlight)2, 7	—	—	—	—	—	86.0
Libra Biosciences, Inc.2, 7	—	—	—	—	—	100.0
Mandara Sciences, LLC2, 7	—	—	—	—	98.3	—
Tal Medical, LLC.2, 7	—	—	—	—	—	100.0

1In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics and Gallop Oncology) to advance certain programs from the Wholly-Owned programs segment.

2Registered address is Corporation Trust Center, 1209 Orange St., Wilmington, DE 19801, USA.

3Registered address is 2711 Centerville Rd., Suite 400, Wilmington, DE 19808, USA.

4On October 18, 2024, the Group lost control over Seaport. On March 1, 2023, the Group lost control over Vedanta. On May 25, 2022, the Group lost control over Sonde. Seaport,

Vedanta and Sonde were deconsolidated from the Group’s financial statements, resulting in only the profits and losses generated by these entities through the deconsolidation date

being included in the Group’s Consolidated Statement of Comprehensive Income/(Loss). See Notes 8. Gain/(loss) on Deconsolidation of Subsidiary, 5. Investments Held at Fair Value

and 6. Investments in Associates for further details about the accounting for the investments in these entities subsequent to deconsolidation.

5The Group's investments in Akili and Karuna were disposed of in 2024. The Group's investments in Vor were disposed of in 2025.

6See Notes 5. Investments Held at Fair Value for additional discussion on the Group's investment held in these entities.

7Inactive subsidiary dissolved in November 2024.

8On October 30, 2023, Gelesis ceased operations and filed a voluntary petition for relief under the United States bankruptcy code.

Change in Subsidiary Ownership and Loss of Control

Changes in the Group’s interest in a subsidiary that do not result in a loss of control are accounted for as equity transactions.

Where the Group loses control of a subsidiary, the assets and liabilities are derecognized along with any related non-controlling

interest. Any interest retained in the former subsidiary is measured at fair value when control is lost. Any resulting gain or loss is

recognized as profit or loss in the Consolidated Statement of Comprehensive Income/(Loss).

F-11


1.	Material Accounting Policies continued

Associates

As used in the Consolidated Financial Statements, the term associates are those entities in which the Group has no control but

maintains significant influence over the financial and operating policies. Significant influence is presumed to exist when the Group

holds between 20 and 50 percent of the voting power of an entity, unless it can be clearly demonstrated that this is not the case. The

Group evaluates if it maintains significant influence over associates by assessing if the Group has the power to participate in the

financial and operating policy decisions of the associate.

Application of the Equity Method to Associates

Associates are accounted for using the equity method (equity accounted investees) and are initially recognized at cost, or if

recognized upon deconsolidation, they are initially recorded at fair value at the date of deconsolidation. The Consolidated Financial

Statements include the Group’s share of the total comprehensive income or loss of equity accounted investees, from the date that

significant influence commences until the date that significant influence ceases.

To the extent the Group holds interests in associates that are not providing access to returns underlying ownership interests, the

instrument is accounted for in accordance with IFRS 9 as investments held at fair value.

When the Group’s share of losses exceeds its equity method investment in the investee, losses are applied against long-term

interests, which are investments accounted for under IFRS 9. Investments are determined to be long-term interests when they are

long-term in nature and in substance they form part of the Group's net investment in that associate. This determination is impacted

by many factors, among others, whether settlement by the investee through redemption or repayment is planned or likely in the

foreseeable future, whether the investment can be converted and/or is likely to be converted to common stock or other equity

instrument and other factors regarding the nature of the investment. Whilst this assessment is dependent on many specific facts and

circumstances of each investment, typically conversion features whereby the investment is likely to convert to common stock or other

equity instruments would point to the investment being a long-term interest. Similarly, where the investment is not planned or likely

to be settled through redemption or repayment in the foreseeable future, this would indicate that the investment is a long-term

interest. When the net investment in the associate, which includes the Group’s investments in other long-term interests, is reduced

to nil, recognition of further losses is discontinued except to the extent that the Group has incurred legal or constructive obligations

or made payments on behalf of an investee.

The Group has adopted the amendments to IAS 28 that addresses the dual application of IAS 28 and IFRS 9 when equity method

losses are applied against long-term interests. The amendments provide the annual sequence in which both standards are to be

applied in such a case. The Group has applied the equity method losses to the long-term interests presented as part of Investments

held at fair value subsequent to remeasuring such investments to their fair value at the balance sheet date.

Sale of Future Royalties Liability

The Group accounts for the sale of future royalties liability as a financial liability, as it continues to hold the rights under the royalty

bearing licensing agreement and has a contractual obligation to deliver cash to an investor for a portion of the royalty it receives.

Interest on the sale of future royalties liability is recognized using the effective interest rate over the life of the related royalty stream.

The sale of future royalties liability and the related interest expense are based on the Group’s current estimates of future royalties

expected to be paid over the life of the arrangement. Forecasts are updated periodically as new data is obtained. Any increases,

decreases or a shift in timing of estimated cash flows require the Group to re-calculate the amortized cost of the sale of future

royalties liability as the present value of the estimated future contractual cash flows that are discounted at the liability’s original

effective interest rate. The adjustment is recognized immediately in profit or loss as income or expense.

Financial Instruments

Classification

The Group classifies its financial assets in the following measurement categories:

—Those to be measured subsequently at fair value either through other comprehensive income "FVOCI", or through profit or loss

"FVTPL", and

—Those to be measured at amortized cost.

The classification depends on the Group’s business model for managing the financial assets and the contractual terms of the cash flows.

For assets measured at fair value, gains and losses are recorded in profit or loss.

Measurement

At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at FVTPL,

transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets that are

carried at FVTPL are expensed.

Impairment

The Group assesses on a forward-looking basis the expected credit losses associated with its debt instruments carried at amortized

cost. For trade receivables, the Group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses

to be recognized from initial recognition of the receivables.

Financial Assets

The Group’s financial assets consist of cash and cash equivalents, investments in debt securities, trade and other receivables,

investments in notes from associates, restricted cash deposits and investments in equity securities. The Group’s financial assets are

virtually all classified into the following categories: investments held at fair value, investments in notes from associates, trade and

other receivables, short-term investments and cash and cash equivalents. The Group determines the classification of financial assets

at initial recognition depending on the purpose for which the financial assets were acquired.

F-12


1.	Material Accounting Policies continued

Investments held at fair value are investments in equity instruments. Such investments consist of the Group's minority interest

holdings where the Group has no significant influence or preferred share investments that are not providing access to returns

underlying ownership interests and are categorized as debt instruments that are presented at fair value through profit and loss

because the amounts receivable do not represent solely payments of principal and interest. These financial assets are initially

measured at fair value and subsequently re-measured at fair value at each reporting date. The Group has elected to record the

changes in fair values for the financial assets falling under this category through profit and loss. Please refer to Note 5. Investments

Held at Fair Value.

Changes in the fair value of financial assets at FVTPL are recognized in other income/(expense) in the Consolidated Statement of

Comprehensive Income/(Loss) as applicable.

The investments in notes from associates, since their contractual terms do not consist solely of cash flow payments of principal and

interest on the principal amount outstanding, are initially and subsequently measured at fair value, with changes in fair value

recognized through profit and loss.

Cash and cash equivalents consist of demand deposits with banks and other financial institutions and highly liquid instruments with

original maturities of three months or less at the date of purchase. Cash and cash equivalents are carried at cost, which

approximates their fair value.

Short-term investments consist of short-term US treasury bills that are held to maturity. The contractual terms consist solely of

payment of the principal and interest and the Group's business model is to hold the treasury bills to maturity. As such, such short-

term investments are recorded at amortized cost. As of the balance sheet date, amortized cost approximated the fair value of such

short-term investments.

Trade and other receivables are non-derivative financial assets with fixed and determinable payments that are not quoted on active

markets. These financial assets are carried at the amounts expected to be received less any expected lifetime losses. Such losses are

determined taking into account previous experience, credit rating and economic stability of counterparty and economic conditions.

When a trade receivable is determined to be uncollectible, it is written off against the available provision. As of the balance sheet

date, the Group did not record any such expected lifetime losses related to the outstanding trade and other receivable balances.

Trade and other receivables are included in current assets, unless maturities are greater than 12 months after the end of the

reporting period.

Financial Liabilities

The Group’s financial liabilities primarily consist of trade and other payables, and preferred shares.

The majority of the Group’s subsidiaries have preferred shares and certain notes payable with embedded derivatives, which are

classified as current liabilities. When the Group has preferred shares and notes with embedded derivatives that qualify for

bifurcation, the Group has elected to account for the entire instrument as FVTPL after determining under IFRS 9 that the instrument

qualifies to be accounted for under such FVTPL method.

The Group derecognizes a financial liability when its contractual obligations are discharged, cancelled or expire.

Equity Instruments Issued by the Group

Financial instruments issued by the Group are treated as equity only to the extent that they meet the following two conditions,

in accordance with IAS 32:

1They include no contractual obligations upon the Group to deliver cash or other financial assets or to exchange financial assets

or financial liabilities with another party under conditions that are potentially unfavorable to the Group; and

2Where the instrument will or may be settled in the Group’s own equity instruments, it is either a non-derivative that includes no

obligation to deliver a variable number of the Group’s own equity instruments or is a derivative that will be settled by the Group

exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments.

To the extent that this definition is not met, the financial instrument is classified as a financial liability. Where the instrument so

classified takes the legal form of the Group’s own shares, the amounts presented in the Group's shareholders' equity exclude

amounts in relation to those shares.

Changes in the fair value of liabilities at FVTPL are recognized in net finance income/(costs) in the Consolidated Statement of

Comprehensive Income/(Loss) as applicable.

IFRS 15, Revenue from Contracts with Customers

The standard establishes a five-step principle-based approach for revenue recognition and is based on the concept of recognizing

an amount that reflects the consideration for performance obligations only when they are satisfied, and the control of goods or

services is transferred.

The majority of the Group’s contract revenue is generated from licenses and services, some of which are part of collaboration

arrangements.

Management reviewed contracts where the Group received consideration in order to determine whether or not they should be

accounted for in accordance with IFRS 15. To date, the Group has entered into transactions that generate revenue and meet the

scope of either IFRS 15 or IAS 20 Accounting for Government Grants. Contract revenue is recognized at either a point-in-time or

over time, depending on the nature of the performance obligations.

F-13


1.	Material Accounting Policies continued

The Group accounts for agreements that meet the definition of IFRS 15 by applying the following five step model:

—Identify the contract(s) with a customer – A contract with a customer exists when (i) the Group enters into an enforceable contract

with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the payment

terms related to those goods or services, (ii) the contract has commercial substance and, (iii) the Group determines that collection

of substantially all consideration for goods or services that are transferred is probable based on the customer’s intent and ability

to pay the promised consideration.

—Identify the performance obligations in the contract – Performance obligations promised in a contract are identified based on the

goods or services that will be transferred to the customer that are both capable of being distinct, whereby the customer can

benefit from the good or service either on its own or together with other resources that are readily available from third parties or

from the Group, and are distinct in the context of the contract, whereby the transfer of the goods or services is separately

identifiable from other promises in the contract.

—Determine the transaction price – The transaction price is determined based on the consideration to which the Group will be

entitled in exchange for transferring goods or services to the customer. To the extent the transaction price includes variable

consideration, the Group estimates the amount of variable consideration that should be included in the transaction price utilizing

either the expected value method or the most likely amount method depending on the nature of the variable consideration.

Variable consideration is included in the transaction price if, in the Group’s judgement, it is probable that a significant future

reversal of cumulative revenue under the contract will not occur.

—Allocate the transaction price to the performance obligations in the contract – If the contract contains a single performance

obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple

performance obligations require an allocation of the transaction price to each performance obligation based on a relative

standalone selling price basis.

—Recognize revenue when (or as) the Group satisfies a performance obligation – The Group satisfies performance obligations

either over time or at a point in time as discussed in further detail below. Revenue is recognized at the time the related

performance obligation is satisfied by transferring a promised good or service to a customer.

Revenue generated from services agreements (typically where licenses and related services were combined into one performance

obligation) is determined to be recognized over time when it can be determined that the services meet one of the following: (a) the

customer simultaneously receives and consumes the benefits provided by the entity’s performance as the entity performs; (b) the

entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced; or (c) the entity’s

performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for

performance completed to date.

It was determined that the Group has contracts that meet criteria (a), since the customer simultaneously receives and consumes the

benefits provided by the Group’s performance as the Group performs. Therefore, revenue is recognized over time using the input

method based on costs incurred to date as compared to total contract costs. The Group believes that in research and development

service type agreements using costs incurred to date represents the most faithful depiction of the entity’s performance towards

complete satisfaction of a performance obligation.

Revenue from licenses that are not part of a combined performance obligation are recognized at a point in time. Such licenses relate

to intellectual property that has significant stand-alone functionality and as such represent a right to use the entity's intellectual

property as it exists at the point in time at which the license is granted.

Royalty revenue received in respect of licensing agreements when the license of intellectual property is the predominant item in the

arrangement is recognized as the related third-party sales in the licensee occur.

Amounts that are receivable or have been received per contractual terms but have not been recognized as revenue since

performance has not yet occurred or has not yet been completed are recorded as deferred revenue. The Group classifies as non-

current deferred revenue amounts received for which performance is expected to occur beyond one year or one operating cycle.

Grant Revenue

The Group recognizes grants from governmental agencies as grant revenue in the Consolidated Statement of Comprehensive

Income/(Loss), gross of the expenditures that were related to obtaining the grant, when there is reasonable assurance that the

Group will comply with the conditions within the grant agreement and there is reasonable assurance that payments under the grants

will be received. The Group evaluates the conditions of each grant as of each reporting date to ensure that the Group has

reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant payment will be

received as a result of meeting the necessary conditions.

The Group submits qualifying expenses for reimbursement after the Group has incurred the research and development expense.

The Group records an unbilled receivable upon incurring such expenses. In cases in which the grant revenue is received prior to the

expenses being incurred or recognized, the amounts received are deferred until the related expense is incurred and/or recognized.

Grant revenue is recognized in the Consolidated Statement of Comprehensive Income/(Loss) at the time in which the Group

recognizes the related reimbursable expense for which the grant is intended to compensate.

Functional and Presentation Currency

The Consolidated Financial Statements are presented in United States dollars (“US dollars”). The functional currency of all members

of the Group is the U.S. dollar. The Group's share in foreign exchange differences in associates were reported in other

comprehensive income/(loss).

F-14


1.	Material Accounting Policies continued

Foreign Currency

Transactions in foreign currencies are translated to the respective functional currencies of Group entities at the foreign exchange rate

ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are

retranslated to the functional currency at the foreign exchange rate ruling at that date. Foreign exchange differences arising on

remeasurement are recognized in the Consolidated Statement of Comprehensive Income/(Loss). Non-monetary assets and liabilities

that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.

Share Capital

Ordinary shares are classified as equity. The Group's equity is comprised of share capital, share premium, merger reserve, other

reserve, translation reserve, and retained earnings/accumulated deficit.

Treasury Shares

Treasury shares acquired as a result of repurchasing shares are recognized at cost and are deducted from shareholders' equity.

No gain or loss is recognized in profit and loss for the purchase, sale, re-issue or cancellation of the Group's own equity shares.

The nominal value related to shares that are repurchased and cancelled are reduced from share capital and transferred to a capital

redemption reserve.

Property and Equipment

Property and equipment is stated at cost less accumulated depreciation and any accumulated impairment losses. Cost includes

expenditures that are directly attributable to the acquisition of the asset. Assets under construction represent leasehold improvements

and machinery and equipment to be used in operations or research and development activities. When parts of an item of property and

equipment have different useful lives, they are accounted for as separate items (major components) of property and equipment.

Depreciation is calculated using the straight-line method over the estimated useful life of the related asset:


Laboratory and manufacturing equipment	2-8 years
Furniture and fixtures	7 years
Computer equipment and software	1-5 years
Leasehold improvements	5-10 years, or the remaining term of the lease, if shorter

Depreciation methods, useful lives and residual values are reviewed at each balance sheet date.

Intangible Assets

Intangible assets, which include purchased patents and licenses with finite useful lives, are carried at historical cost less accumulated

amortization, if amortization has commenced. Intangible assets with finite lives are amortized from the time they are available for

their intended use. Amortization is calculated using the straight-line method to allocate the costs of patents and licenses over their

estimated useful lives.

Research and development intangible assets, which are still under development and have accordingly not yet obtained marketing

approval, are presented as In-Process Research and Development (IPR&D). The cost of IPR&D represents upfront payments as well

as additional contingent payments based on development, regulatory and sales milestones related to certain license agreement

where the Group licenses IP from a third party. These milestones are capitalized as the milestone is triggered. See Note 25.

Commitments and Contingencies. IPR&D is not amortized since it is not yet available for its intended use, but it is evaluated for

potential impairment on an annual basis or more frequently when facts and circumstances warrant.

Impairment of Non-Financial Assets

The Group reviews the carrying amounts of its property and equipment and intangible assets at each reporting date to determine

whether there are indicators of impairment. If any such indicators of impairment exist, then an asset’s recoverable amount is

estimated. The recoverable amount is the higher of an asset’s fair value less cost of disposal and value in use.

The Group’s IPR&D intangible assets are not yet available for their intended use. As such, they are tested for impairment at least annually.

An impairment loss is recognized when an asset’s carrying amount exceeds its recoverable amount. For the purposes of impairment

testing, assets are grouped at the lowest levels for which there are largely independent cash flows. If a non-financial asset instrument

is impaired, an impairment loss is recognized in the Consolidated Statement of Comprehensive Income/(Loss).

Investments in associates are considered impaired if, and only if, objective evidence indicates that one or more events, which

occurred after the initial recognition, have had an impact on the future cash flows from the net investment and that impact can be

reliably estimated. If an impairment exists, the Group measures an impairment by comparing the carrying value of the net

investment in the associate to its recoverable amount and recording any excess as an impairment loss.

Employee Benefits

Short-Term Employee Benefits

Short-term employee benefit obligations are measured on an undiscounted basis and expensed as the related service is provided.

A liability is recognized for the amount expected to be paid if the Group has a present legal or constructive obligation due to past

service provided by the employee, and the obligation can be estimated reliably.

Defined Contribution Plans

A defined contribution plan is a post-employment benefit plan under which an entity pays fixed contributions into a separate entity

and has no legal or constructive obligation to pay further amounts. Obligations for contributions to defined contribution plans are

recognized as an employee benefit expense in the periods during which related services are rendered by employees.

F-15


1.	Material Accounting Policies continued

Share-based Payments

Share-based payment arrangements, in which the Group receives goods or services as consideration for its own equity instruments, are

accounted for as equity-settled share-based payment transactions (except certain restricted stock units – see below) in accordance with

IFRS 2. The grant date fair value of employee share-based payment awards is recognized as an expense with a corresponding increase

in equity over the requisite service period related to the awards. The amount recognized as an expense is adjusted to reflect the actual

number of awards for which the related service and non-market performance conditions are expected to be met, such that the amount

ultimately recognized as an expense is based on the number of awards that do meet the related service and non-market performance

conditions at the vesting date. For share-based payment awards with market conditions, the grant date fair value is measured to reflect

such conditions and there is no true-up for differences between expected and actual outcomes.

Certain restricted stock units are treated as liability settled awards as the Group has a historical practice of settling these awards in

cash. Such awards are remeasured at every reporting date until settlement date and are recognized as compensation expense over

the requisite service period. Differences in remeasurement are recognized in profit and loss. The cumulative cost that will ultimately

be recognized in respect of these awards will equal to the amount at settlement.

The fair value of the awards is measured using option pricing models and other appropriate models, which take into account the

terms and conditions of the awards granted.

Development Costs

Expenditures on research activities are recognized as incurred in the Consolidated Statement of Comprehensive Income/(Loss). In

accordance with IAS 38, development costs are capitalized only if the expenditure can be measured reliably, the product or process is

technically and commercially feasible, future economic benefits are probable, the Group can demonstrate its ability to use or sell the

intangible asset, the Group intends to and has sufficient resources to complete development and to use or sell the asset, and it is able to

measure reliably the expenditure attributable to the intangible asset during its development. The point at which technical feasibility is

determined to have been reached is, generally, when regulatory approval has been received where applicable. Management determines

that commercial viability has been reached when a clear market and pricing point have been identified, which may coincide with

achieving meaningful recurring sales. Otherwise, the development expenditure is recognized as incurred in the Consolidated Statement

of Comprehensive Income/(Loss). As of the balance sheet date, the Group has not capitalized any development costs.

Provisions

A provision is recognized in the Consolidated Statement of Financial Position when the Group has a present legal or constructive

obligation due to a past event that can be reliably measured, and it is probable that an outflow of economic benefits will be

required to settle the obligation. Provisions are determined by discounting the expected future cash flows at a pre-tax rate that

reflects risks specific to the liability.

Leases

The Group’s leases are virtually all leases of real estate for use in operations. The Group includes options that are reasonably certain to

be exercised as part of the determination of the lease term. The group determines if an arrangement is a lease at inception of the

contract in accordance with guidance detailed in IFRS 16. Right-of-use ("ROU") assets represent the Group’s right to use an underlying

asset for the lease term and lease liabilities represent the Group's obligation to make lease payments arising from the lease. Operating

lease ROU assets and lease liabilities are recognized at commencement date based on the present value of the lease payments over

the lease term. As most of the Group's leases do not provide an implicit rate, the Group used its estimated incremental borrowing rate,

based on information available at commencement date, in determining the present value of future payments.

The Group has elected to account for lease payments as an expense on a straight-line basis over the life of the lease for:

—Leases with a term of 12 months or less and containing no purchase options; and

—Leases where the underlying asset has a value of less than $5,000.

The right-of-use asset is depreciated on a straight-line basis and the related lease liability gives rise to an interest charge.

Finance Income and Finance Costs

Finance income consists of interest income on funds invested in money market funds and U.S. treasuries. Finance income is

recognized as it is earned. Finance costs consist mainly of loan, notes and lease liability interest expenses, interest expense due to

accretion of and adjustment to sale of future royalties liability as well as the changes in the fair value of financial liabilities carried at

FVTPL (such changes can consist of finance income when the fair value of such financial liabilities decrease).

Taxation

Tax on the profit or loss for the year comprises current and deferred income tax. In accordance with IAS 12, tax is recognized in the

Consolidated Statement of Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity.

Current income tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or

substantially enacted at the reporting date, and any adjustment to tax payable in respect of previous years.

Deferred tax is recognized due to temporary differences between the carrying amounts of assets and liabilities for financial reporting

purposes and the amounts used for taxation purposes. Deferred tax assets are recognized for unused tax losses, unused tax credits

and deductible temporary differences to the extent that it is probable that future taxable profits will be available against which they

can be used. Deferred tax assets with respect to investments in associates are recognized only to the extent that it is probable the

temporary difference will reverse in the foreseeable future and taxable profit will be available against which the temporary difference

can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable

that the related tax benefit will be realized.

F-16


1.	Material Accounting Policies continued

Deferred tax is measured at the tax rates that are expected to be applied to temporary differences when they reverse, using tax

rates enacted or substantively enacted at the reporting date.

Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current

tax liabilities and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on

either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.

Fair Value Measurements

The Group’s accounting policies require that certain financial assets and certain financial liabilities be measured at their fair value.

The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure

fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. Fair values are

categorized into different levels in a fair value hierarchy based on the inputs used in the valuation techniques as follows:

—Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.

—Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly

(i.e. as prices) or indirectly (i.e. derived from prices).

—Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs).

The Group recognizes transfers between levels of the fair value hierarchy at the end of the reporting period during which the change

has occurred.

The carrying amount of cash and cash equivalents, accounts receivable, restricted cash, deposits, accounts payable, accrued

expenses and other current liabilities in the Group’s Consolidated Statement of Financial Position approximates their fair value

because of the short maturities of these instruments.

Operating Segments

Operating segments are reported in a manner that is consistent with the internal reporting provided to the chief operating decision

maker (“CODM”). The CODM reviews discrete financial information for the operating segments in order to assess their performance

and is responsible for making decisions about resources allocated to the segments. The CODM has been identified as the Group’s

Board of Directors.


2.	New Standards and Interpretations

The Group has applied the IFRS Interpretations Committee ("Committee")'s agenda decision published by the International

Accounting Standards Board in July 2024, for the first time for its reporting period ended December 31, 2025. This Committee

agenda decision clarifies certain requirements for disclosure of revenue and expenses for reporting segments under IFRS 8,

Operating Segments. The adoption of this Committee agenda decision did not have any impact on the amounts recognized or

disclosed in prior and current periods.

In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements was issued to achieve comparability of the financial

performance of similar entities. The standard, which replaces IAS 1 Presentation of Financial Statements, impacts the presentation of

primary financial statements and notes, including the statement of earnings where companies will be required to present separate

categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category.

The standard will also require management-defined performance measures to be explained and included in a separate note within

the consolidated financial statements. The standard is effective for annual reporting periods beginning on or after January 1, 2027,

including interim financial statements, and requires retrospective application. The Group is currently assessing the impact of the

new standard.

In May 2024, Amendments to IFRS 9 and IFRS 7, Targeted Improvements to Financial Instruments Standards, was issued to clarify the

date of recognition and derecognition of some financial assets and liabilities, with a new exception for some financial liabilities

settled through an electronic cash transfer system; clarify and add further guidance for assessing whether a financial asset meets the

solely payments of principal and interest (SPPI) criterion; add new disclosures for certain instruments with contractual terms that can

change cash flows (such as some instruments with features linked to the achievement of environment, social and governance (ESG)

targets); and update the disclosures for equity instruments designated at fair value through other comprehensive income (FVOCI).

The standard is effective for annual reporting periods beginning on or after January 1, 2026, including interim financial statements,

and requires prospective application. The Group does not expect these amendments to have a material impact on the Group's

Consolidated Financial Statements.

On July 18, 2024, IASB issued five standards as a result of IASB’s annual improvements project. IASB uses the annual improvements

process to make necessary, but non-urgent, amendments to IFRS Accounting Standards that will not be included as part of another

major project. The amended standards are: IFRS 1 – First-time Adoption of International Financial Reporting Standards, IFRS 7 and

its accompanying Guidance on implementing IFRS 7, IFRS 9, IFRS 10 – Consolidated Financial Statements and IAS 7 – Statement of

Cash Flows. The effective date for adoption of these amendments is annual reporting periods beginning on or after January 1, 2026,

and early adoption is permitted. The Group does not expect these amendments to have a material impact on the Group's

Consolidated Financial Statements.

F-17


3.	Revenue

Revenue recorded in the Consolidated Statement of Comprehensive Income/(Loss) consists of the following:


For the years ended December 31,	2025 $	2024 $	2023 $
Contract revenue	4,659	4,315	750
Grant revenue	—	513	2,580
Total revenue	4,659	4,828	3,330

All amounts recorded in contract revenue were generated in the United States.

During the years ended December 31, 2025, and 2024 the Group recognized $4,659 and $315, respectively in royalty revenue

pursuant to a license agreement executed in 2011 with Karuna Therapeutics, Inc. ("Karuna"). Under the terms of the license

agreement, Karuna and its acquirer Bristol Myers Squibb ("BMS") pays the Group a royalty that amounts to 3% of annual net sales

of Cobenfy.

During the year ended December 31, 2024, the Group achieved and received a $4,000 milestone payment from BMS following the

approval by the U.S. Food and Drug Administration ("FDA") to market KarXT as Cobenfy, pursuant to the license agreement

discussed above. This milestone payment was recognized as contract revenue during the year ended December 31, 2024.

The Group’s contract related to contract revenue for the year ended December 31, 2023 was determined to have a single

performance obligation which consisted of a deliverable of research and development services. For such contract, revenue was

recognized over time based on the input method which the Group believes is a faithful depiction of the transfer of goods and

services. Progress was measured based on costs incurred to date as compared to total projected costs. Payments for such contract

were primarily made up-front on a periodic basis.

Disaggregated Revenue

The Group disaggregates contract revenue in a manner that depicts how the nature, amount, timing, and uncertainty of revenue and

cash flows are affected by economic factors. The Group disaggregates revenue based on contract revenue or grant revenue, and

further disaggregates contract revenue based on the transfer of control of the underlying performance obligations.


Timing of contract revenue recognition for the years ended December 31,	2025 $	2024 $	2023 $
Transferred at a point in time	4,659	4,315	—
Transferred over time	—	—	750
	4,659	4,315	750


Customers over 10% of revenue	2025 $	2024 $	2023 $
Customer A	—	—	750
Customer B	4,659	4,315	—
	4,659	4,315	750

Accounts receivable represent rights to consideration in exchange for services that have been transferred by the Group, when

payment is unconditional and only the passage of time is required before payment is due. Accounts receivable do not bear interest

and are recorded at the invoiced amount. Accounts receivable are included within trade and other receivables on the Consolidated

Statement of Financial Position. The accounts receivable related to contract revenue were $1,517 and $868 as of December 31, 2025

and 2024, respectively.

F-18


4.	Segment Information

Basis for Segmentation

The Directors are the Group’s chief operating decision-makers. The Group’s operating segments are determined based on the

financial information provided to the Board of Directors periodically for the purposes of allocating resources and assessing

performance. The Group has determined each of its Wholly-Owned programs represents an operating segment and the Group has

aggregated each of these operating segments into one reportable segment, the Wholly-Owned segment. Each of the Group’s

Controlled Founded Entities represents an operating segment. The Group aggregates each Controlled Founded Entity operating

segment into one reportable segment, the Controlled Founded Entities segment. The aggregation is based on the high level of

operational and financial similarities of the operating segments. For the Group’s entities that do not meet the definition of an

operating segment, the Group presents this information in the Parent Company and Other column in its segment footnote to

reconcile the information in this footnote to the Consolidated Financial Statements. Substantially all of the Group’s revenue and

profit generating activities are generated within the United States and, accordingly, no geographical disclosures are provided.

Following is the description of the Group's reportable segments:

Wholly-Owned Segment

The Wholly-Owned segment is advancing Wholly-Owned programs which are focused on treatments for patients with devastating

diseases. The Wholly-Owned segment is comprised of the technologies that are wholly-owned and will be advanced through

with either the Group's funding or non-dilutive sources of financing. The operational management of the Wholly-Owned segment

is conducted by the PureTech Health team, which is responsible for the strategy, business development, and research

and development.

Controlled Founded Entities Segment

The Controlled Founded Entities segment is comprised of the Group’s consolidated operational subsidiaries as of December 31,

2025 that either have, or have plans to hire, independent management teams and currently have already raised third-party dilutive

capital. These subsidiaries have active research and development programs and have an equity or debt investment partner, who

will provide additional industry knowledge and access to networks, as well as additional funding to continue the pursued growth

of the entity.

The Group’s entities that were determined not to meet the definition of an operating segment are included in the Parent Company

and Other column to reconcile the information in this footnote to the Consolidated Financial Statements. This column captures

activities not directly attributable to the Group's operating segments and includes the activities of the Parent, corporate support

functions, certain research and development support functions that are not directly attributable to a strategic business segment as

well as the elimination of intercompany transactions. This column also captures the operating results for the deconsolidated entities

through the date of deconsolidation (e.g. Seaport in 2024, and Vedanta in 2023) and accounting for the Group's holdings in

Founded Entities for which control has been lost, which primarily represent: the activity associated with deconsolidating an entity

when the Group no longer controls the entity, the gain or loss on the Group's investments accounted for at fair value (e.g. the

Group's ownership stakes in Seaport, Vedanta, and Sonde) and the Group's net income or loss of associates accounted for using

the equity method.

The term "Founded Entities" refers to entities which the Group incorporated and announced the incorporation as a Founded Entity

externally. It includes certain of the Group’s wholly-owned subsidiaries which have been announced by the Group as Founded

Entities, Controlled Founded Entities and deconsolidated Founded Entities.

Changes within the Reportable Segments

There was no change to the reportable segments in 2025 or 2024, except for the changes to the composition of the reportable

segments as described below.

In August 2025, the Group announced a new Founded Entity, Celea Therapeutics ("Celea") to advance our deupirfenidone (LYT-100)

program if external funding is secured. The financial results of this program, which is currently housed within PureTech LYT 100, Inc.

were included in the Wholly-Owned segment as of and for the year ended December 31, 2025. Upon raising dilutive third-party

financing, the financial results of this program will be included in the Controlled Founded Entities segment or Parent and Other

column depending on if the Group maintains control over this entity.

In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics "Seaport" and Gallop Oncology "Gallop") to

advance certain programs from the Wholly-Owned segment. The financial results of these programs were included in the Wholly-

Owned segment as of and for the year ended December 31, 2023.

Seaport was deconsolidated on October 18, 2024 upon the completion of its Series B preferred share financing. The financial results

of Seaport through the date of deconsolidation are included within the Parent Company and Other column as of December 31,

2024. It is impracticable for the Group to recast its segment results for the year ended December 31, 2023 as the cost to develop

the information would be excessive. However, as Seaport is a pre-commercial, clinical-stage biopharmaceutical company, it

primarily performs research and development activities. Seaport incurred direct research and development expenses of $8,843 for

the year ended December 31, 2023, which are included in the Wholly-Owned segment. Seaport incurred direct research and

development expenses of $5,061 for the year ended December 31, 2024, prior to its deconsolidation from the Group’s Consolidated

Financial Statements.

As Gallop has not raised dilutive third-party financing as of December 31, 2025, the financial results of Gallop were included in the

Wholly-Owned segment as of and for the years ended December 31, 2025 and 2024.

As of December 31, 2024, Alivio was dormant and did not meet the definition of operating segment. Therefore, the financial results

of Alivio were removed from the Wholly-Owned segment and are included in the Parent Company and Other column. The

corresponding information for 2023 has been restated to include Alivio in the Parent Company and Other column so that the

segment disclosures are presented on a comparable basis.

F-20


4.	Segment Information continued


	For the year ended December 31, 2024
	Wholly-Owned Segment $	Controlled Founded Entities Segment $	Parent Company and Other $	Consolidated $
Contract revenue	—	—	4,315	4,315
Grant revenue	513	—	—	513
Total revenue	513	—	4,315	4,828
General and administrative expenses	(8,888)	(173)	(62,408)	(71,469)
Research and development expenses	(56,849)	(672)	(11,933)	(69,454)
Total operating expenses	(65,737)	(845)	(74,341)	(140,923)
Operating income/(loss)	(65,224)	(845)	(70,026)	(136,095)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain on deconsolidation				151,808
Gain/(loss) on investment held at fair value				(2,398)
Realized gain/(loss) on sale of investments				151
Gain/(loss) on investment in notes from associates				13,131
Other income/(expense)				961
Total other income/(expense)				163,652
Net finance income/(costs)				4,773
Share of net income/(loss) of associates accounted for using the equity method				(8,754)
Gain on dilution of ownership interest in associate				199
Income/(loss) before taxes				23,774
	As of December 31, 2024
Available Funds
Cash and cash equivalents	9,062	432	271,148	280,641
Short-term Investments	—	—	86,666	86,666
Consolidated cash, cash equivalents and short-term investments	9,062	432	357,814	367,307


	For the year ended December 31, 2023
	Wholly-Owned Segment $	Controlled Founded Entities Segment $	Parent Company and Other $	Consolidated $
Contract revenue	—	750	—	750
Grant revenue	270	—	2,310	2,580
Total revenue	270	750	2,310	3,330
General and administrative expenses	(13,203)	(562)	(39,530)	(53,295)
Research and development expenses	(87,069)	(672)	(8,494)	(96,235)
Total operating expenses	(100,272)	(1,233)	(48,024)	(149,530)
Operating income/(loss)	(100,002)	(483)	(45,714)	(146,199)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain on deconsolidation				61,787
Gain/(loss) on investment held at fair value				77,945
Realized gain/(loss) on sale of investments				(122)
Gain/(loss) on investment in notes from associates				(27,630)
Other income/(expense)				(908)
Total other income/(expense)				111,072
Net finance income/(costs)				5,078
Share of net income/(loss) of associates accounted for using the equity method				(6,055)
Income/(loss) before taxes				(36,103)

F-21


5.	Investments Held at Fair Value

Investments held at fair value include both unlisted and listed securities held by the Group. These investments, which include

interests in Seaport, Vedanta and Sonde along with other insignificant investments as of December 31, 2025, are initially measured

at fair value, and are subsequently re-measured at fair value at each reporting date with changes in fair value recorded through

profit and loss. See Note 19. Financial Instruments for information regarding the valuation of these instruments. Activities related to

such investments during the periods are shown below:


	Balance under IFRS 9	Equity method loss recorded against LTI	Carrying Amount
Investments held at fair value	$	$	$
Balance as of January 1, 2024	317,841		317,841
Sale of Karuna shares	(292,672)		(292,672)
Investment in Seaport preferred shares - Seaport deconsolidation	179,248		179,248
Sale of Akili shares	(5,437)		(5,437)
Gain realized on sale of Karuna shares	151		151
Gain/(loss) – changes in fair value through profit and loss	(2,398)		(2,398)
Equity method losses recorded against LTI, net		(5,307)	(5,307)
Balance as of December 31, 2024	196,733	(5,307)	191,426
Sale of Vor Shares	(2,753)		(2,753)
Gain realized on sale of Vor shares	375		375
Investment in Vedanta preferred shares	888		888
Conversion of Vedanta note to preferred shares	2,836		2,836
Gain/(loss) – changes in fair value through profit and loss	38,485		38,485
Equity method losses recorded against LTI, net		(13,831)	(13,831)
Balance as of December 31, 2025	236,564	(19,138)	217,426

Seaport

On October 18, 2024, Seaport Therapeutics, Inc. ("Seaport") completed a Series B preferred share financing, which resulted in the

Group’s voting interest being below 50% and the Group losing control over Seaport Board of Directors. Consequently, the Group

no longer had the power to direct the relevant Seaport activities. As a result, Seaport was deconsolidated on this date and its results

of operations are included in the Consolidated Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on

Deconsolidation of Subsidiary. Following deconsolidation, the Group still has significant influence in Seaport through its voting

interest in Seaport and its remaining representation on Seaport's Board of Directors. Upon deconsolidation, the Group owns

950,000 of common stock, 40,000,000 of Series A-1 preferred stock, 8,421,052 of Series A-2 preferred stock, and 3,031,578 of Series B

preferred stock. The common shares are subject to IAS 28 Investments in Associates and Joint Ventures due to the significant

influence the Group retained and are accounted for under the equity method. See Note 6. Investments in Associates. The Group's

preferred shares do not provide their shareholders with access to returns associated with a residual equity interest and as such, are

accounted for under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the

preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the

amounts receivable do not represent solely payments of principal and interest. As of December 31, 2025 and 2024, these preferred

shares had a fair value of $236,003 and $177,288, respectively.

The fair value of the preferred shares is determined by management using a valuation model that utilizes both the market backsolve

and probability-weighted expected return methods. The valuation of the investment is categorized as Level 3 in the fair value

hierarchy due to the use of significant unobservable inputs, which have a significant effect on the valuation. The significant

assumptions in the valuation include the estimated equity value of Seaport and the probability of Seaport entering into an initial

public offering. See Note 19. Financial Instruments for valuation of these preferred shares.

During the year ended December 31, 2025 and 2024, the Group recognized a gain of $58,715 and a loss of $1,960 for the changes in

the fair value of the investment in Seaport that was included in gain/(loss) on investments held at fair value within the Consolidated

Statement of Comprehensive Income/(Loss). For the year ended December 31, 2025, the increase in fair value of $58,715 was

reduced by $19,138, which represented the excess equity method losses from the Group's investment in Seaport common stock.

The recognition of the $19,138 loss against the investment in Seaport's Preferred A-1, A-2 and B shares occurred because the

Group’s share of equity method losses from applying the equity method of accounting to its investment in Seaport’s common shares

was greater than its equity method investment balance and because the Group’s investment in Seaport’s Preferred A-1, A-2 and B

shares represents a long-term interest ("LTI"). The $19,138 loss was included in share of net income/(loss) of associates accounted

for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss) as it represented a portion of the

Group’s share of equity method losses from applying the equity method of accounting.

F-22


5.	Investments Held at Fair Value continued

Vedanta

2023

On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of

financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of

Directors and the Group lost control over the Vedanta Board of Directors and the power to direct the relevant Vedanta activities.

Consequently, Vedanta was deconsolidated on March 1, 2023 and its results of operations were included in the Consolidated

Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary.

Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its

remaining representation on Vedanta's Board of Directors.

2025

On August 5, 2025, Vedanta completed a recapitalization of its capital structure. Vedanta issued new Series A convertible preferred

shares to investors. The Group invested $888 in exchange for 1,477,692 shares of Series A convertible preferred stock. In addition,

as part of the recapitalization, the Group’s secured convertible promissory note in the principal amount of $5,000 was converted into

10,129,586 shares of Vedanta Series A-1 convertible preferred shares and the Group’s existing investment in Vedanta’s convertible

preferred shares was converted into 577,851 shares of Vedanta common stock. Following Vedanta's recapitalization, the Group's

ownership interest was reduced to 5.1% and, thus, the Group no longer has significant influence over Vedanta's relevant activities.

The Group's investments in Vedanta convertible preferred shares prior to or after the 2025 recapitalization do not provide it with

access to returns associated with a residual equity interest, and, as such, are accounted for under IFRS 9 as investments held at fair

value with changes in fair value recorded in profit and loss. Under IFRS 9, the preferred share investments are categorized as debt

instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely

payments of principal and interest. The Group's investments in Vedanta common stock is accounted for at fair value under IFRS 9 as

investments held at fair value with changes in fair value recorded in profit and loss.

During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $14,335, $2,990, and $6,303,

respectively, for the changes in the fair value of the investment in Vedanta that were included in gain/(loss) on investments held at

fair value within the Consolidated Statement of Comprehensive Income/(Loss). The fair value of the Group’s investment in Vedanta

was $553 and $11,163 as of December 31, 2025 and 2024, respectively.

Sonde

On May 25, 2022, Sonde completed a Series B preferred share financing, which resulted in the Group losing control over Sonde and

the deconsolidation of Sonde.

Following deconsolidation, the Group still has significant influence in Sonde through its 48.2% voting interest in Sonde and its

remaining representation on Sonde's Board of Directors. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares

have the same terms as common stock and provide their shareholders with access to returns associated with a residual equity

ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method. See Note 6.

Investments in Associates. The convertible Preferred A-2 and B shares do not provide their shareholders with access to returns

associated with a residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value with changes

in fair value recorded in profit and loss. Under IFRS 9, the A-2 and B preferred share investments are categorized as debt instruments

that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of

principal and interest.

The Group’s investment in Sonde’s Preferred A-2 and B shares represents a LTI. When the Group’s share of equity method losses

from applying the equity method of accounting to its investment in Sonde’s Preferred A-1 shares is greater than its equity method

investment balance, the additional loss is applied to the LTI. In accordance with IAS 28, IFRS 9 should be applied independently

ignoring any prior equity method loss absorption. The prior year excess equity method losses absorbed by the LTI should be

reversed if the LTI's fair value decreases.

During the year ended December 31, 2023, the Group recognized a loss of $994 for the changes in the fair value of the investment in

Sonde that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive

Income/(Loss).

As of December 31, 2024, the fair value of the Group’s investment in Sonde Preferred A-2 and B shares was $5,307 prior to applying

the excess equity method losses from the investment in Sonde Preferred A-1 shares. After the excess equity method losses were

applied, the balance of the investment in Sonde Preferred A-2 and B shares was $0. During the year ended December 31, 2024, the

Group recognized a loss of $5,102 for the changes in the fair value of its investment in Sonde's Preferred A-2 and B shares that was

included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). In

addition, the Group also recognized a loss of $5,307 on its investment in Sonde’s Preferred A-2 and B shares because the Group’s

share of equity method losses was greater than its equity method investment balance. The additional loss was included in share of

net income/(loss) of associates accounted for using the equity method within the Consolidated Statement of Comprehensive

Income/(Loss).

F-23


5.	Investments Held at Fair Value continued

As of December 31, 2025, the fair value of the Group's investment in Sonde Preferred A-2 and B shares was $0, a fair value reduction of

$5,307 from December 31, 2024. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year

ended December 31, 2025, the Group recognized the decrease in fair value within gain/(loss) on investments held at fair value in the

Consolidated Statement of Comprehensive Income/(Loss) and reversed $5,307 of equity method loss that had reduced the fair value of

Sonde’s Preferred A-2 and B shares in the prior year. The reversal of $5,307 was included in the Group’s share of net income/(loss) of

associates accounted for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss).

Vor

Vor was deconsolidated in February 2019 after its initial public offering.

As of December 31, 2024, the Group held 2,671,800 shares of Vor common stock with fair value of $2,966. On June 26, 2025, the

Group sold its remaining shares of Vor common stock at $1.03 per share for aggregate proceeds of $2,753 before income tax. As a

result of this transaction, the Group recognized a gain of $375 which was included in realized gain/(loss) on sale of investments within

the Consolidated Statement of Comprehensive Income/(Loss). Therefore, the Group no longer holds any ownership interest in Vor.

During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $588, $3,046, and $11,756, respectively,

for the changes in the fair value of the investment that were included in gain/(loss) on investments held at fair value within the

Consolidated Statement of Comprehensive Income/(Loss).

Karuna

Karuna was deconsolidated in March 2019. During 2019, Karuna completed its initial public offering and the Group lost its significant

influence in Karuna. The shares held in Karuna were accounted for as an investment held at fair value under IFRS 9.

2023

During the twelve months ended December 31, 2023, the Group sold 167,579 shares of Karuna common stock with aggregate

proceeds of $33,309, net of transaction fees. As of December 31, 2023, the Group held 886,885 shares, or 2.3%, of the total

outstanding Karuna common stock with a fair value of $280,708.

2024

In March 2024, Karuna common shares were acquired by Bristol Myers Squibb for $330 per share in accordance with the terms of

a definitive merger agreement signed in December 2023. As a result of this transaction, the Group received total proceeds of

$292,672 before income tax in exchange for its holding of 886,885 shares of Karuna common stock. As a result, the Group no longer

holds any ownership interest in Karuna.

During the years ended December 31, 2024 and 2023, the Group recognized gains of $11,813 and $107,079, respectively, for the

changes in the fair value of the Karuna investment that were included in gain/(loss) on investments held at fair value within the

Consolidated Statement of Comprehensive Income/(Loss).

Akili

Akili was deconsolidated in 2018. At the time of deconsolidation, the Group did not hold common shares in Akili and the preferred

shares it held did not have equity-like features. Therefore, the preferred shares held by the Group fell under the guidance of IFRS 9

and were treated as a financial asset held at fair value and changes to the fair value of the preferred shares were recorded through

the Consolidated Statement of Comprehensive Income/(Loss), in accordance with IFRS 9.

On July 2, 2024, Akili was acquired by Virtual Therapeutics, and the Group received total proceeds of $5,437 before income taxes

in exchange for its holding of 12,527,476 shares of Akili common stock. As a result, the Group no longer holds any ownership interest

in Akili.

During the years ended December 31, 2024 and 2023, the Group recognized losses of $985, and $8,681, respectively, for the

changes in the fair value of the investment in Akili that were included in gain/(loss) on investments held at fair value within the

Consolidated Statement of Comprehensive Income/(Loss).

Gelesis

Gelesis was deconsolidated in July 2019. On January 13, 2022, Gelesis completed its business combination with Capstar Special

Purpose Acquisition Corp ("Capstar"). Gelesis became a wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis

Holdings, Inc., which began trading on the New York Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the

Group had significant influence over Gelesis, the investment in Gelesis common shares was accounted for under the equity method.

Please refer to Note 6. Investments in Associates for information regarding the Group's investment in Gelesis as an associate.

In February and May 2023, as part of Gelesis' issuance of senior secured promissory notes to the Group, Gelesis also issued to the

Group (i) warrants to purchase 23,688,047 shares of Gelesis common stock with an exercise price of $0.2744 per share (ii) warrants

to purchase 192,307,692 shares of Gelesis common stock with an exercise price of $0.0182 per share and (iii) warrants to purchase

43,133,803 shares of Gelesis common stock with an exercise price of $0.0142 per share. These warrants expire five years after

issuance and are collectively referred to as the Gelesis 2023 Warrants.

The Gelesis 2023 Warrants were recorded at their initial fair value of $1,121 and then subsequently re-measured to fair value with

changes in fair value recorded through profit and loss.

As Gelesis ceased operations in October 2023, the fair value of the Gelesis 2023 Warrants was written down to $0 as of December

31, 2023. During the year ended December 31, 2023, the Group recognized a loss of $1,264 related to the change in the fair value

of these warrants that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of

Comprehensive Income/(Loss).

F-24


6.	Investments in Associates

Gelesis (Boston, MA)

Gelesis was founded by the Group and was deconsolidated from the Group’s financial statements as of July 1, 2019. On January 13,

2022, Gelesis completed its business combination with Capstar Special Purpose Acquisition Corp ("Capstar"). Gelesis became a

wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis Holdings, Inc., which began trading on the New York

Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the Group had significant influence over Gelesis through its

voting interest in Gelesis and representation on Gelesis' Board of Directors, the investment in Gelesis common shares was

accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures.

During the year ended December 31, 2023, the Group entered into agreements with Gelesis to purchase senior secured convertible

promissory notes and warrants for shares of Gelesis common stock (see Note 7. Investment in Notes from Associates). The warrants

to purchase shares of Gelesis common stock represented potential voting rights to the Group and it was therefore necessary to

consider whether they were substantive. If these potential voting rights were substantive and the Group had the practical ability to

exercise the rights and take control of greater than 50% of Gelesis common stock, the Group would be required to consolidate

Gelesis under the accounting standards.

In February 2023, the Group obtained warrants to purchase 23,688,047 shares of Gelesis common stock (the “February Warrants”) at

an exercise price of $0.2744 per share. The exercise of the February Warrants was subject to the approval of the Gelesis stockholders

until May 1, 2023. On May 1, 2023, stockholder approval was no longer required for the Group to exercise the February Warrants.

The potential voting rights associated with the February Warrants were not substantive as the exercise price of the February

Warrants was at a significant premium to the fair value of the Gelesis common stock.

In May 2023, the Group obtained warrants to purchase 235,441,495 shares of Gelesis common stock (the “May Warrants”). The May

Warrants were exercisable at the option of the Group and had an exercise price of either $0.0182 or $0.0142. The May Warrants were

substantive as the Group would have benefited from exercising such warrants since their exercise price was at the money or at an

insignificant premium over the fair value of the Gelesis common stock. However, that benefit from exercising the May Warrants only

existed for a short period of time because in June 2023, the potential voting rights associated with the May Warrants were impacted

by the terms and conditions of a merger agreement that the Group signed with Gelesis on June 12, 2023 (the "Merger Agreement")

and were no longer substantive.

On October 12, 2023, the Group terminated the Merger Agreement with Gelesis as certain closing conditions were not satisfied. In

October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the

United States Bankruptcy Code. A Chapter 7 trustee has been appointed by the Bankruptcy Court who has control over the assets

and liabilities of Gelesis, effectively eliminating the authority and powers of the Board of Directors of Gelesis and its executive

officers to act on behalf of Gelesis. The assets of Gelesis are in liquidation and Gelesis no longer has any officers or employees. The

Group ceased accounting for Gelesis as an equity method investment as it no longer has significant influence over Gelesis.

During the year ended December 31, 2023, the Group recorded $4,910 as its share in the losses of Gelesis, and the Group’s balance

in this equity method investment was reduced to $0.

Sonde (Boston, MA)

Following the deconsolidation of Sonde in May 2022, the Group has significant influence in Sonde through its voting interest in

Sonde and its remaining representation on Sonde's Board of Directors. The Group's voting interest at the date of deconsolidation

was 48.2% and remained at 40.2% subsequently. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares, in

substance, have the same terms as common stock and as such, provide their shareholders with access to returns associated with a

residual equity ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method.

The Preferred A-2 and B shares, however, do not provide their shareholders with access to returns associated with a residual equity

interest and as such, are accounted for under IFRS 9, as investments held at fair value.

During the years ended December 31, 2025, 2024, and 2023, the Group recorded income of $5,307, loss of $8,492 and loss of $1,052,

respectively, related to Sonde's equity method of accounting.

As of December 31, 2023, the equity method investment in Sonde had a balance of $3,185. The Group’s share in Sonde’s losses in

2024 exceeded the Group’s equity method investment in Sonde. As a result, the Group's equity method investment in Sonde was

reduced to $0 as of December 31, 2024. Since the Group’s investment in Sonde’s Preferred A-2 and B shares represents a long-term

interest, the Group recognized additional equity method losses, totaling $5,307, against its investment in Sonde's Preferred A-2 and

B shares (See Note 5. Investments Held at Fair Value), reducing the balance of the preferred share investment to $0 as of December

31, 2024.

During the year ended December 31, 2025, the Group recorded income of $5,307 within its share of net income/(loss) of associates

accounted for using the equity method in the Consolidated Statement of Comprehensive Income/(Loss). This amount represents the

reversal of previously recognized equity method losses that were applied against the Group’s Sonde’s Preferred A-2 and B

investment. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year ended

December 31, 2025, the Group reversed the excess equity method losses that had been applied in prior periods to reduce the fair

value of the Group’s investment in Sonde’s Preferred A-2 and B shares. See Note 5. Investments Held at Fair Value.

Since the Group did not incur legal or constructive obligations or made payments on behalf of Sonde, the Group stopped

recognizing additional equity method losses since 2024. As of December 31, 2025 and 2024, unrecognized equity method losses

amounted to $1,651 and $14,447.

F-25


6.	Investments in Associates continued

Seaport (Boston, MA)

On October 18, 2024, Seaport completed a Series B preferred share financing. As a result of this financing, the Group's voting

interest was reduced below 50%, and the Group no longer controls Seaport's Board of Directors. Consequently, the Group lost

control over Seaport, and as such, ceased to consolidate Seaport on the date the round of financing was completed. See Note 8.

Gain/(loss) on Deconsolidation of Subsidiary.

Following deconsolidation, the Group still has significant influence in Seaport through its voting interest and its remaining

representation on Seaport's Board of Directors. The Group's voting interest as of the date of deconsolidation was 43.0% and

remained at 42.9% subsequently. The Group holds both common shares and preferred shares in Seaport. The common shares are

subject to IAS 28 Investments in Associates and Joint Ventures due to the Group's retained significant influence and are accounted

for under the equity method. The preferred shares do not provide their shareholders with access to returns associated with a

residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value.

The fair value of the common shares on the date of deconsolidation amounted to $2,461, which was the initial value of the equity

method investment in Seaport. When applying the equity method, the Group records its share of the losses in Seaport based on its

common share equity interest in Seaport, which was 12.4% and 13.1% as of December 31, 2025 and 2024, respectively.

During the year ended December 31, 2024, the Group recorded a loss of $262 related to Seaport’s equity method of accounting and

a gain of $199 for the dilution of ownership interest. As of December 31, 2024, the Seaport equity method investment had a balance

of $2,397.

During the year ended December 31, 2025, the Group’s share in Seaport’s losses amounted to $23,234 which exceeded the balance

of Group’s equity method investment in Seaport. The Group recorded a loss of $4,096 related to Seaport’s equity method of

accounting and a gain of $1,699 for the dilution of ownership interest. As a result, the Group's equity method investment in Seaport

was reduced to $0 as of December 31, 2025. Since the Group’s investment in Seaport Preferred A-1, A-2 and B shares represents a

long-term interest, the Group recognized additional equity method losses, totaling $19,138 against the fair value of Seaport

Preferred A-1, A-2, and B shares. See Note 5. Investments Held at Fair Value.

The following table provides summarized financial information for Seaport, the Group’s material associate for the years ended

December 31, 2025 and December 31, 2024. The information disclosed reflects the amounts presented in the financial statements of

Seaport and not the Group’s share of those amounts. The amounts have been amended to reflect adjustments made by the Group

when using the equity method, including fair value adjustments and modifications for differences in accounting policies.


	As of December 31, 2025	As of December 31, 2024
Summarized statement of financial position	$	$
Current assets	222,944	310,151
Non-current assets	25,688	5,632
Current liabilities	(12,633)	(11,149)
Non-current liabilities	(564,576)	(460,996)
Equity awards issued to third parties	(12,425)	(2,042)
Other	(301)	—
Net assets/(liabilities)	(341,302)	(158,405)

Reconciliation to carrying amounts:
Opening net assets/(liabilities)	(158,405)	(156,414)
Profit/(loss) for the period	(182,897)	(1,991)
Closing net assets/(liabilities)	(341,302)	(158,405)

Group's share in %	12.4%	13.1%
Group's share of net assets (net deficit)	(42,300)	(20,764)
Unrecognized goodwill and intangibles	23,162	23,162
Equity method losses recorded against long-term interests	(19,138)	—
Carrying amount of Investment in associates	—	2,397
	For the year ended December 31,
Statement of comprehensive income/(loss)	2025	2024
Profit/(loss) from continuing operations (100%)	(182,897)	(1,991)
Profit/(loss) for the year	(182,897)	(1,991)
Total comprehensive income/(loss)	(182,897)	(1,991)
Group's share in gain (net losses)	(23,234)	(262)

F-27


7.	Investment in Notes from Associates

Sonde

In July 2025, Sonde closed a bridge financing in the form of convertible promissory notes with its existing investors for total

proceeds of $1,200, of which the Group invested $150. The notes are categorized as debt instruments that are presented at fair

value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. As of

December 31, 2025, the Group wrote down the convertible note to $0 and recognized a loss of $150 for the year ended December

31, 2025, which was included in gain/(loss) on investments in notes from associates in the Consolidated Statement of

Comprehensive Income/(Loss).

Gelesis

On July 27, 2022, the Group, as a lender, entered into an unsecured promissory note (the "Junior Note") with Gelesis, as a borrower,

in the amount of $15,000. The Junior Note bears an annual interest rate of 15% per annum. The maturity date of the Junior Note is

the earlier of December 31, 2023 or five business days following the consummation of a qualified financing by Gelesis. Based on the

terms of the Junior Note, due to the option to convert to a variable amount of shares at the time of default, the Junior Note is

required to be measured at fair value with changes in fair value recorded through profit and loss.

During the year ended December 31, 2023, the Group entered into multiple agreements with Gelesis to purchase senior secured

convertible promissory notes (the "Senior Notes") and warrants for share of Gelesis common stock for a total consideration of

$11,850. The Senior Notes are secured by a first-priority lien on substantially all assets of Gelesis and the guarantors (other than the

equity interests in, and assets held by Gelesis s.r.l., a subsidiary of Gelesis, and certain other exceptions). The initial fair value of the

Senior Notes and warrants was determined to be $10,729 and $1,121, respectively. The Senior Notes represent debt instruments

that are presented at fair value through profit and loss as the amounts receivable do not represent solely payments of principal and

interest as the Senior Notes are convertible into Gelesis common stock.

In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of

the United States Bankruptcy Code. Therefore, the Group determined that the fair value of the Junior Note and the Senior Notes

with the warrants was $0 as of December 31, 2023.

In June 2024, the Bankruptcy Court approved an executed agreement for a third party to acquire the remaining net assets of Gelesis

for $15,000. As the only senior secured creditor, the Group is expected to receive a majority of the proceeds from this sale after

deduction of Bankruptcy Court related legal and administrative costs. As of December 31, 2025 and 2024, these notes were

determined to have a fair value of $11,417 and $11,381, respectively.

For the years ended December 31, 2025, 2024 and 2023, the Group recorded a gain of $36, a gain of $11,381 and a loss of $27,230,

respectively, for the changes in the fair value of these notes, which were included in gain/(loss) on investments in notes from

associates in the Consolidated Statement of Comprehensive Income/(Loss).

F-28


7.	Investment in Notes from Associates continued

Vedanta

On April 24, 2023, Vedanta closed the second tranche of its convertible debt for additional proceeds of $18,000, of which $5,000

were invested by the Group. The convertible debt carried an interest rate of 9% per annum. The debt had various conversion

triggers, and the conversion price was established at the lower of 80% of the equity price of the last financing round, or a certain

pre-money valuation cap established in the agreement. If the convertible debt was not earlier converted or repaid, the entire

outstanding amount of the convertible debt should be due and payable upon the earliest to occur of (a) the later of (x) November 1,

2025 and (y) the date which was sixty (60) days after all amounts owed under, or in connection with, the loan Vedanta received from a

certain investor had been paid in full, or (b) the consummation of a Deemed Liquidation Event (as defined in Vedanta’s Amended

and Restated Certificate of Incorporation).

On August 5, 2025, Vedanta completed a recapitalization of its capital structure. See Note 5. Investments Held at Fair Value. The

secured convertible promissory note held by the Group in the principal amount of $5,000 with a fair value of $2,836 was converted

into 10,129,586 shares of Series A-1 preferred stock. As a result, the convertible promissory note is no longer outstanding as of

December 31, 2025.

Due to the terms of the convertible debt, the investment in such convertible debt was measured at fair value with changes in the fair

value recorded through profit and loss. As of December 31, 2024, the Vedanta convertible debt was determined to have a fair value

of $6,350. During the years ended December 31, 2025, 2024 and 2023, the Group recorded a loss of $3,514, a gain of $1,750 and a

loss of $400, respectively, for the changes in the fair value of the Vedanta convertible debt, which were included in gain/(loss) on

investments in notes from associates in the Consolidated Statement of Comprehensive Income/(Loss).

The following is the activity in respect of investments in notes from associates during the period. The fair value of the notes from

associates of $11,417 and $17,731 as of December 31, 2025 and December 31, 2024, respectively, is determined using unobservable

Level 3 inputs. See Note 19. Financial Instruments for additional information.


Investment in notes from associates	$
Balance as of January 1, 2024	4,600
Changes in the fair value of the notes	13,131
Balance as of December 31, 2024	17,731
Investment in Sonde convertible note	150
Conversion of Vedanta note to preferred shares	(2,836)
Changes in the fair value of the notes	(3,628)
Balance as of December 31, 2025	11,417
Investment in notes from associates, current	11,417
Investment in notes from associates, non-current	—

F-29


8.	Gain/(loss) on Deconsolidation of Subsidiary

Upon the Group losing control over a subsidiary, the assets and liabilities of the subsidiary are derecognized along with any related

non-controlling interest. Any interest that the Group retains in the former subsidiary is measured at fair value when control is lost.

Any resulting gain or loss is included in gain/(loss) on deconsolidation of subsidiary in the Consolidated Statement of

Comprehensive Income/(Loss).

Vedanta

On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of

financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of

Directors, and the Group lost control over the Vedanta Board of Directors, which is the governance body that has the power to

direct the relevant activities of Vedanta. Consequently, Vedanta was deconsolidated on March 1, 2023 from the Group’s

Consolidated Financial Statements. The results of Vedanta’s operations are included in the Group’s Consolidated Financial

Statements through the date of deconsolidation.

Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its

remaining representation on Vedanta's Board of Directors. The convertible preferred shares in Vedanta the Group holds do not

provide their holders with access to returns associated with a residual equity interest, and as such, are accounted for under IFRS 9,

Financial Instruments, as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the

Group’s preferred share investment is categorized as a debt instrument that is presented at fair value through profit and loss

because the amounts receivable do not represent solely payments of principal and interest.

Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Vedanta and

recorded its aforementioned investment in Vedanta at fair value. The deconsolidation resulted in a gain of $61,787. As of the date

of deconsolidation, the investment in Vedanta convertible preferred shares held at fair value amounted to $20,456.

As of December 31, 2025 and December 31, 2024, the Group’s investment in Vedanta convertible preferred shares was held at fair

value of $553 and $11,163, respectively, and categorized as Level 3 in the fair value hierarchy.

Seaport

On October 18, 2024, Seaport completed a Series B preferred share financing and amended its Voting Agreement to grant the

Series B preferred stockholders’ representation on Seaport’s Board of Directors. As a result of the Series B preferred share financing

and the amendments to the Voting Agreement, the Group's voting interest was reduced below 50%, and the Group no longer

controls Seaport’s Board of Directors, which is the governance body that has the power to direct the relevant activities of Seaport.

Therefore, the Group concluded that it lost control over Seaport, and Seaport was deconsolidated on October 18, 2024 from the

Group’s Consolidated Financial Statements. The results of Seaport’s operations are included in the Group’s Consolidated Financial

Statements through the date of deconsolidation.

Following deconsolidation, the Group has significant influence over Seaport through its voting interest in Seaport and its remaining

representation on Seaport’s Board of Directors. The Group holds Preferred A-1, A-2 and B shares in addition to common shares. The

common shares are accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures.

The Preferred A-1, A-2 and B shares do not provide their shareholders with access to returns associated with a residual equity

interest, and, as such, are accounted for under IFRS 9, Financial Instruments, as investments held at fair value with changes in fair

value recorded in profit and loss. Under IFRS 9, the A-1, A-2 and B preferred share investments are categorized as debt instruments

that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of

principal and interest.

Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Seaport and

recorded its aforementioned investment in Seaport at fair value. The deconsolidation resulted in a gain of $151,808.

As of December 31, 2025 and December 31, 2024, the Group’s investment in Seaport’s convertible preferred shares was held at fair

value of $236,003 and $177,288, respectively, and categorized as Level 3 in the fair value hierarchy. The significant unobservable inputs

used in the fair value measurement of the Group’s investment in the convertible preferred shares of Seaport and the sensitivity of the

fair value measurement to changes to these significant unobservable inputs are disclosed in Note 19. Financial Instruments.

F-31


9.	Operating Expenses

Total operating expenses were as follows:


For the years ended December 31,	2025 $	2024 $	2023 $
General and administrative	46,618	71,469	53,295
Research and development	56,567	69,454	96,235
Total operating expenses	103,185	140,923	149,530

The average number of persons employed by the Group during the year, analyzed by category, was as follows:


For the years ended December 31,	2025	2024	2023
General and administrative	35	39	40
Research and development	27	41	56
Total	62	80	96

The aggregate payroll costs of these persons were as follows:


	2025 $	2024 $	2023 $
For the years ended December 31,	2025 $	2024 $	2023 $
General and administrative	22,616	40,559	24,586
Research and development	10,824	15,023	21,102
Total	33,440	55,581	45,688

Detailed operating expenses were as follows:


	2025 $	2024 $	2023 $
For the years ended December 31,	2025 $	2024 $	2023 $
Salaries and wages	22,475	29,032	37,084
Healthcare and other benefits	1,707	2,203	2,599
Payroll taxes	1,035	1,496	1,590
Share-based payments	8,222	22,850	4,415
Total payroll costs	33,440	55,581	45,688
Amortization	1,764	1,764	1,979
Depreciation	1,585	1,807	2,955
Total amortization and depreciation expenses	3,348	3,571	4,933
Other general and administrative expenses	20,653	27,491	25,180
Other research and development expenses	45,743	54,280	73,729
Total other operating expenses	66,397	81,771	98,909
Total operating expenses	103,185	140,923	149,530

Please refer to Note 10 Share-based Payments for further disclosures related to share-based payments and Note 26. Related Parties

Transactions for management’s remuneration disclosures.

F-32


10.	Share-based Payments

Share-based payments include stock options and restricted stock units (“RSUs”). Expense for stock options and time-based RSUs is

recognized based on the grant date fair value of these awards. Performance-based RSUs to executives are treated as liability awards

and the related expense is recognized based on reporting date fair value up until settlement date.

Share-based Payment Expense

The Group's share-based payment expense for the years ended December 31, 2025, 2024 and 2023, was $8,222, $22,850, and

$4,415, respectively. The following table provides the classification of the Group’s consolidated share-based payment expense as

reflected in the Consolidated Statement of Income/(Loss):


Year ended December 31,	2025 $	2024 $	2023 $
General and administrative	6,893	21,993	3,185
Research and development	1,329	857	1,230
Total	8,222	22,850	4,415

The Performance Share Plan

In June 2015, the Group adopted the Performance Stock Plan (the “2015 PSP”). Under the 2015 PSP and subsequent amendments,

awards of ordinary shares may be made to the Directors, senior managers and employees, and other individuals providing services

to the Group up to a maximum authorized amount of 10% of the total ordinary shares outstanding.

In June 2023, the Group adopted a new Performance Stock Plan (the "2023 PSP") that has the same terms as the 2015 PSP but

instituted for all new awards a limit of 10% of the total ordinary shares outstanding over a five-year period.

The awards granted under these plans have various vesting terms over a period of service between one and four years, provided the

recipient remains continuously engaged as a service provider. The options awards expire 10 years from the grant date.

The share-based awards granted under these plans are generally equity-settled (see cash settlements below). As of December 31,

2025, the Group has issued 32,199,101 units of share-based awards under these plans.

RSUs

During the twelve months ended December 31, 2025 and 2024, the Group granted the following RSUs to certain non-executive

Directors, executives and employees:


Year ended December 31,	2025	2024
Time-based RSUs	4,855,916	4,388,116
Performance-based RSUs	1,494,919	1,822,151
Total RSUs	6,350,835	6,210,267

RSU activity for the years ended December 31, 2025, 2024 and 2023 is detailed as follows:


	Number of Shares/Units	Weighted Average Grant Date Fair Value (GBP) (*)
Outstanding (Non-vested) at January 1, 2023	6,090,780	1.74
RSUs Granted in Period	3,679,669	1.28
Vested	(716,029)	2.00
Forfeited	(1,880,274)	1.94
Outstanding (Non-vested) at December 31, 2023	7,174,146	1.10
RSUs Granted in Period	6,210,267	1.63
Vested	(1,347,729)	1.71
Forfeited	(3,057,962)	1.75
Outstanding (Non-vested) at December 31, 2024	8,978,722	1.29
RSUs Granted in Period	6,350,835	1.14
Vested	(3,184,023)	1.62
Forfeited	(2,757,344)	1.39
Outstanding (Non-vested) at December 31, 2025	9,388,190	1.20

*For liability awards - based on fair value at reporting date or settlement date.

Each RSU entitles the holder to one ordinary share on vesting and the RSU awards are generally based on a vesting schedule over a

one to three-year requisite service period in which the Group recognizes compensation expense for the RSUs. Following vesting,

each recipient will be required to make a payment of one pence per ordinary share on settlement of the RSUs.

RSUs granted to the non-executive directors and employees are time-based and equity-settled. The grant date fair value on such

RSUs is recognized over the vesting term.

F-33


10.	Share-based Payments continued

RSUs granted to executives are performance-based and vesting of such RSUs is subject to the satisfaction of both performance and

market conditions. The performance condition is based on the achievement of the Group's strategic targets. The market conditions

are based on the achievement of the absolute total shareholder return (“TSR”), TSR as compared to the FTSE 250 Index, and TSR as

compared to the MSCI Europe Health Care Index. The RSU award performance criteria have changed over time as the criteria are

continually evaluated by the Group’s Remuneration Committee.

The Group recognizes the estimated fair value of performance-based awards with non-market conditions as share-based compensation

expense over the performance period based upon its determination of whether it is probable that the performance targets will be

achieved. The Group assesses the probability of achieving the performance targets at each reporting period. Cumulative adjustments,

if any, are recorded to reflect subsequent changes in the estimated outcome of performance-related conditions.

The fair value of the performance-based awards with market conditions is based on the Monte Carlo simulation analysis utilizing

a Geometric Brownian Motion process with 100,000 simulations to value those shares. The model considers share price volatility,

risk-free rate and other covariance of comparable public companies and other market data to predict distribution of relative

share performance.

The RSUs to executives are treated as liability awards as the Group has a historical practice of settling these awards in cash, and as

such adjusted to fair value at every reporting date until settlement with changes in fair value recorded in earnings as share-based

compensation expense.

The Group recorded $5,713, $4,388, and $827, respectively, for the years ended December 31, 2025, 2024 and 2023 in respect of all

restricted stock units, of which $1,127, $909, and $402, respectively, were in respect of liability settled share-based awards.

As of December 31, 2025, the carrying amount of the RSU liability awards was $3,044 with $1,827 current and $1,217 non-current, out

of which $1,827 related to awards that have met all their performance and market conditions and were settled in March 2026. As of

December 31, 2024, the carrying amount of the RSU liability awards was $3,736 with $1,875 current and $1,861 non-current, out of

which $1,875 related to awards that met all their performance and market conditions and were settled in February 2025.

Stock Options

Stock option activity for the years ended December 31, 2025, 2024 and 2023, is detailed as follows:


	Number of Options	Wtd Average Exercise Price (GBP)	Wtd Average of remaining contractual term (in years)	Wtd Average Stock Price at Exercise (GBP)
Outstanding at January 1, 2023	17,793,881	2.31	8.03
Granted	3,120,975	2.22
Exercised	(534,034)	1.71		2.46
Forfeited and expired	(3,424,232)	2.40
Options Exercisable at December 31, 2023	9,065,830	2.19	6.01
Outstanding at December 31, 2023	16,956,590	2.29	7.20
Granted	2,665,875	1.87
Exercised	(412,729)	1.73		2.20
Forfeited and expired	(4,725,746)	2.24
Options Exercisable at December 31, 2024	9,534,400	2.33	4.45
Outstanding at December 31, 2024	14,483,990	2.25	5.87
Granted	381,000	1.24
Exercised	(65,000)	1.20		1.39
Forfeited and expired	(2,388,931)	2.41
Options Exercisable at December 31, 2025	9,690,271	2.28	4.87
Outstanding at December 31, 2025	12,411,059	2.19	5.62

The fair value of the stock options awarded by the Group was estimated on the grant date using the Black-Scholes option valuation

model, considering the terms and conditions upon which options were granted, with the following weighted-average assumptions:


At December 31,	2025	2024	2023
Expected volatility	45.18%	44.76%	43.69%
Expected term (in years)	6.16	6.16	6.16
Risk-free interest rate	3.81%	4.31%	4.04%
Expected dividend yield	—	—	—
Exercise price (GBP)	1.24	1.87	2.22
Underlying stock price (GBP)	1.24	1.87	2.22

Expected volatility is based on the Group’s historical volatility results.

These assumptions resulted in an estimated weighted-average grant-date fair value per share of stock options granted during the

years ended December 31, 2025, 2024 and 2023 of $0.80, $1.18 and $1.37, respectively.

F-34


10.	Share-based Payments continued

The Group incurred share-based payment expense for the stock options of $1,751, $1,092 and $3,310 for the years ended

December 31, 2025, 2024 and 2023, respectively.

For shares outstanding as of December 31, 2025, the range of exercise prices is detailed as follows:


Range of Exercise Prices (GBP)	Options Outstanding	Wtd Average Exercise Price (GBP)	Wtd Average of remaining contractual term (in years)
0.01	89,845	—	3.75
1.00 to 2.00	5,627,230	1.62	5.73
2.00 to 3.00	4,100,484	2.25	6.49
3.00 to 4.00	2,593,500	3.40	4.07
Total	12,411,059	2.19	5.62

Subsidiary Plans

For the years ended December 31, 2025, 2024 and 2023, the subsidiaries incurred share-based payment expense of $758, $17,372

and $277, respectively.

For the year ended December 31, 2025, Gallop recognized share-based payment expense of $758. The share-based payment

expense for the year ended December 31, 2025 is related to 6,309,087 shares of restricted stock issued to Gallop executives under

the Gallop 2025 Stock Option and Grant Plan (the “Gallop Plan”) approved by the Gallop Board of Directors in September 2025.

These awards vest over 25 months and have weighted average grant date fair value of $0.46. As of December 31, 2025, all of these

awards were unvested and outstanding.

The share-based payment expense for the year ended December 31, 2024 is primarily related to awards granted under the Seaport

2024 Equity Incentive Plan (the "Seaport Plan") approved by the Seaport Board of Directors in 2024. Seaport was deconsolidated from

the Group's Consolidated Financial Statements as of October 18, 2024. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary.

The options granted under the Seaport Plan are equity settled and expire 10 years from the grant date. Typically, the awards vest in

four years but vesting conditions can vary based on the discretion of Seaport’s Board of Directors. The estimated grant date fair

value of the equity awards is recognized as an expense over the awards’ vesting periods. See tables below for Seaport option-

related activities.

Before its deconsolidation on October 18, 2024, Seaport granted 7,200,000 shares of restricted stock awards and restricted stock

units to certain officers and directors, of which 6,227,778 shares were fully vested as of the deconsolidation date. The fair value of

these awards was measured on the date of grant at the estimated fair value of the Seaport common stock using the market

backsolve and probability adjusted expected return model. See Note 19. Financial Instruments. The weighted average fair value of

these awards was $0.97. As the substantial majority of these awards were fully vested as of the deconsolidation date, the stock-

based compensation expense for these awards was recognized in the Group’s Consolidated Statement of Comprehensive Income/

(Loss) for the year ended December 31, 2024.

Seaport also granted options to its employees, officers and directors in 2024. The fair value of the stock options awarded by Seaport

was estimated on the grant date using the Black-Scholes option valuation model. The weighted average fair value of these awards

was $0.92 and the weighted average exercise prices for the options was $1.28.

A summary of stock option activity by number of shares in these subsidiaries is presented in the following table:


	Outstanding as of January 1, 2025	Granted During the Year	Exercised During the Year	Expired During the Year	Forfeited During the Year	Deconsolidation During the Year	Outstanding as of December 31, 2025
Entrega	334,500	—	—	(87,500)	—	—	247,000


	Outstanding as of January 1, 2024	Granted During the Year	Exercised During the Year	Expired During the Year	Forfeited During the Year	Deconsolidation During the Year	Outstanding as of December 31, 2024
Entrega	344,500	—	—	(5,000)	(5,000)	—	334,500
Seaport	—	22,429,780	—	—	(29,018)	(22,400,762)	—


	Outstanding as of January 1, 2023	Granted During the Year	Exercised During the Year	Expired During the Year	Forfeited During the Year	Deconsolidation During the Year	Outstanding as of December 31, 2023
Entrega	344,500	—	—	—	—	—	344,500
Follica	2,776,120	—	—	(2,170,547)	(605,573)	—	—
Vedanta	1,824,576	—	—	(1,313)	(29,607)	(1,793,656)	—

F-36


12.	Earnings/(Loss) per Share

Basic earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary

shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares.

Diluted earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary

shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares, plus the weighted average

number of ordinary shares that would be issued at conversion of all the dilutive potential ordinary shares into ordinary shares.

Dilutive effects arise from equity-settled shares from the Group's share-based plans.

For the years ended December 31, 2025 and 2023, the Group incurred a net loss, and therefore, all outstanding potential securities

were considered anti-dilutive. The amount of potential securities that were excluded from the diluted calculation in 2025 and 2023

amounted to 1,117,792 and 1,509,900 shares, respectively.

Earnings/(Loss) Attributable to Owners of the Group:


	2025		2024		2023
	Basic $	Diluted $	Basic $	Diluted $	Basic $	Diluted $
Income/(loss) for the year, attributable to the owners of the Group	(109,739)	(109,739)	53,510	53,510	(65,697)	(65,697)

Weighted-Average Number of Ordinary Shares:


	2025		2024		2023
	Basic	Diluted	Basic	Diluted	Basic	Diluted
Issued ordinary shares at January 1,	239,421,312	239,421,312	271,853,731	271,853,731	278,566,306	278,566,306
Effect of shares issued & treasury shares purchased	1,366,273	1,366,273	(17,397,423)	(17,397,423)	(2,263,773)	(2,263,773)
Effect of dilutive shares	—	—	—	1,571,612	—	—
Weighted average number of ordinary shares at December 31,	240,787,585	240,787,585	254,456,308	256,027,920	276,302,533	276,302,533

Earnings/(Loss) per Share:


	2025		2024		2023
	Basic $	Diluted $	Basic $	Diluted $	Basic $	Diluted $
Basic and diluted earnings/(loss) per share	(0.46)	(0.46)	0.21	0.21	(0.24)	(0.24)

F-37


13.	Property and Equipment


Cost	Laboratory and Manufacturing Equipment $	Furniture and Fixtures $	Computer Equipment and Software $	Leasehold Improvements $	Construction in process $	Total $
Balance as of January 1, 2024	5,363	1,072	917	15,165	1	22,518
Additions, net of transfers	246	—	11	—	—	256
Disposals	(2,215)	—	(387)	—	(1)	(2,602)
Deconsolidation of subsidiaries	(246)	—	(11)	—	—	(256)
Balance as of December 31, 2024	3,148	1,072	530	15,165	—	19,916
Additions, net of transfers	—	6	—	—	—	6
Disposals	(1,313)	—	(266)	—	—	(1,578)
Balance as of December 31, 2025	1,836	1,078	264	15,165	—	18,343


Accumulated depreciation and impairment loss	Laboratory and Manufacturing Equipment $	Furniture and Fixtures $	Computer Equipment and Software $	Leasehold Improvements $	Construction in process $	Total $
Balance as of January 1, 2024	(4,142)	(698)	(894)	(7,248)	—	(12,982)
Depreciation	(139)	(153)	(13)	(1,503)	—	(1,807)
Disposals/Impairment	1,485	—	376	—	—	1,861
Deconsolidation of subsidiaries	81	—	—	—	—	81
Balance as of December 31, 2024	(2,715)	(851)	(530)	(8,751)	—	(12,847)
Depreciation	—	(154)	—	(1,431)	—	(1,585)
Disposals/Impairment	1,025	—	266	—	—	1,291
Balance as of December 31, 2025	(1,691)	(1,005)	(264)	(10,181)	—	(13,141)


Property and Equipment, net	Laboratory and Manufacturing Equipment $	Furniture and Fixtures $	Computer Equipment and Software $	Leasehold Improvements $	Construction in process $	Total $
Balance as of December 31, 2024	433	221	—	6,414	—	7,069
Balance as of December 31, 2025	145	74	—	4,983	—	5,202

Depreciation of property and equipment is included in the general and administrative expenses and research and development

expenses in the Consolidated Statement of Comprehensive Income/(Loss). The Group recorded depreciation expense of $1,585,

$1,807 and $2,955 for the years ended December 31, 2025, 2024 and 2023, respectively.

F-39


16.	Equity

Total equity for the Group as of December 31, 2025, and 2024, was as follows:


	December 31, 2025 $	December 31, 2024 $
Equity	December 31, 2025 $	December 31, 2024 $
Share capital, £0.01 par value, issued and paid 257,927,489, as of December 31, 2025 and 2024	4,860	4,860
Share premium	290,262	290,262
Treasury shares, 16,243,451 and 18,506,177 as of December 31, 2025 and 2024, respectively	(41,154)	(46,864)
Merger reserve	138,506	138,506
Translation reserve	182	182
Other reserves	(3,352)	(4,726)
Retained earnings/(accumulated deficit)	(77,231)	32,486
Equity attributable to owners of the Group	312,073	414,707
Non-controlling interests	(6,397)	(6,774)
Total equity	305,676	407,933

Shareholders are entitled to vote on all matters submitted to shareholders for a vote. Each ordinary share is entitled to one vote and

is entitled to receive dividends when and if declared by the Group’s Directors.

On June 18, 2015, the Group acquired the entire issued share capital of PureTech LLC in return for 159,648,387 ordinary shares. This

was accounted for as a common control transaction at cost. It was deemed that the share capital was issued in line with movements

in share capital as shown prior to the transaction taking place. In addition, the merger reserve records amounts previously recorded

as share premium.

Other reserves comprise the cumulative credit to share-based payment reserves corresponding to share-based payment expenses

recognized through Consolidated Statement of Comprehensive Income/(Loss), settlements of vested stock awards as well as other

additions that flow directly through equity such as the excess or deficit from changes in ownership of subsidiaries while control is

maintained by the Group.

On May 9, 2022, the Group announced the commencement of a $50,000 share repurchase program (the "Program") of its ordinary

shares of one pence each. The Group executed the Program in two equal tranches. It entered into an irrevocable non-discretionary

instruction with Jefferies International Limited (“Jefferies”) in relation to the purchase by Jefferies of the ordinary shares for an

aggregate consideration (excluding expenses) of no greater than $25,000 for each tranche and the simultaneous on-sale of such

ordinary shares by Jefferies to the Group, subject to certain volume and price restrictions.

In February 2024, the Group completed the Program and has repurchased an aggregate of 20,182,863 ordinary shares under the

Program. These shares have been held as treasury shares and are being used to settle the vesting of restricted stock units or

exercise of stock options.

In March 2024, the Group announced a proposed capital return of $100,000 to its shareholders by way of a tender offer (the "Tender

Offer"). The proposed Tender Offer was approved by shareholders at the Annual General Meeting of Stockholders held on June 6,

2024, to acquire a maximum number of 33,500,000 ordinary shares (including ordinary shares represented by American Depository

Shares (''ADSs'')) for a fixed price of 250 pence per ordinary share (equivalent to £25.00 per ADS) for a maximum aggregate amount

of $100,000 excluding expenses.

The Tender Offer was completed on June 24, 2024. The Group repurchased 31,540,670 ordinary shares under the Tender Offer.

Following such repurchase, the Group cancelled these shares repurchased. As a result of the cancellation, the nominal value of

$600 related to the cancelled shares was reduced from share capital and transferred to a capital redemption reserve, increasing

the capital redemption reserve balance to $600 which was included within other reserves in the Consolidated Statement of

Changes in Equity.

As of December 31, 2025 and December 31, 2024, the Group’s issued share capital was 257,927,489 shares, including 16,243,451

shares and 18,506,177 shares repurchased under the share repurchase program, and were held by the Group in treasury,

respectively. The Group does not have a limited amount of authorized share capital.

F-40


17.	Subsidiary Preferred Shares

Preferred shares issued by subsidiaries often contain redemption and conversion features that are assessed under IFRS 9 in

conjunction with the host preferred share instrument. This balance represents subsidiary preferred shares issued to third parties.

The subsidiary preferred shares are redeemable upon the occurrence of a contingent event, other than full liquidation of the

subsidiaries, that is not considered to be within the control of the subsidiaries. Therefore, these subsidiary preferred shares are

classified as liabilities. These liabilities are measured at fair value through profit and loss. The preferred shares are convertible into

ordinary shares of the subsidiaries at the option of the holders and are mandatorily convertible into ordinary shares under certain

circumstances. Under certain scenarios, the number of ordinary shares receivable on conversion will change and therefore, the

number of shares that will be issued is not fixed. As such, the conversion feature is considered to be an embedded derivative that

normally would require bifurcation. However, since the subsidiary preferred share liability is measured at fair value through profit and

loss, as mentioned above, no bifurcation is required.

The preferred shares are entitled to vote with holders of common shares on an as converted basis.

In April 2024, Seaport closed a Series A-2 preferred share financing with aggregate proceeds of $100,100 of which $68,100 was from

outside investors and $32,000 was from the Group. The $68,100 received from the outside investors was recorded as a subsidiary

preferred share liability within the Group’s balance sheet. In October 2024, Seaport closed a Series B preferred share financing with

aggregate proceeds of $226,000 of which $211,600 was from outside investors and $14,400 was from the Group. As a result of the

Series B preferred share financing, the Group lost control of Seaport, and the Group derecognized the assets, liabilities and non-

controlling interest in respect of Seaport from its Consolidated Financial Statements. See Note 8. Gain/(loss) on Deconsolidation of

Subsidiary. As such, the balance of subsidiary preferred share liability in Seaport was reduced to $0 upon deconsolidation.

The fair value of all subsidiary preferred shares as of December 31, 2025 and December 31, 2024 was $169.

As is customary, in the event of any voluntary or involuntary liquidation, dissolution or winding up of a subsidiary, the holders of

outstanding subsidiary preferred shares shall be entitled to be paid out of the assets of the subsidiary available for distribution to

shareholders and before any payment shall be made to holders of ordinary shares. A merger, acquisition, sale of voting control or

other transaction of a subsidiary in which the shareholders of the subsidiary immediately before the transaction do not own a

majority of the outstanding shares of the surviving company shall be deemed to be a liquidation event. Additionally, a sale, lease,

transfer or other disposition of all or substantially all of the assets of the subsidiary shall also be deemed a liquidation event.

As of December 31, 2025 and December 31, 2024, the minimum liquidation preference reflecting the amounts that would be

payable to the subsidiary preferred holders upon a liquidation event of the subsidiaries, is as follows:


	2025 $	2024 $
Balance as of December 31,	2025 $	2024 $
Entrega	2,216	2,216
Follica	6,405	6,405
Total minimum liquidation preference	8,621	8,621

For the years ended December 31, 2025 and 2024, the Group recognized the following changes in the value of subsidiary

preferred shares:


	2025 $	2024 $
	2025 $	2024 $
Balance as of January 1,	169	169
Issuance of Seaport preferred shares – financing cash flow	—	68,100
Increase in value of preferred shares measured at fair value – finance income	—	8,108
Deconsolidation of subsidiary - (Seaport)	—	(76,208)
Balance as of December 31,	169	169

F-41


18.	Sale of Future Royalties Liability

On March 4, 2011, the Group entered into a license agreement (the “License Agreement”) with Karuna, according to which the

Group granted Karuna an exclusive license to research, develop and sell KarXT in exchange for a royalty on annual net sales,

development and regulatory milestones and a fixed portion of sublicensing income, if any.

On March 22, 2023, the Group signed an agreement with Royalty Pharma (the "Royalty Purchase Agreement"), according to which

the Group sold Royalty Pharma a partial right to receive royalty payments from Karuna in respect of net sales of KarXT, if and when

received. According to the Royalty Purchase Agreement, all royalties due to the Group under the License Agreement will be paid to

Royalty Pharma up to an annual royalties threshold of $60,000, while all royalties above such annual threshold in a given year will be

split 33% to Royalty Pharma and 67% to the Group. Under the terms of the Royalty Purchase Agreement, the Group received a non-

refundable initial payment of $100,000 at the execution of the Royalty Purchase Agreement and is eligible to receive additional

payments in the aggregate of up to an additional $400,000 based on the achievement of certain regulatory and commercial

milestones.

The Group continues to hold the rights under the License Agreement and has a contractual obligation to deliver cash to Royalty

Pharma for a portion of the royalties it receives. Therefore, the Group will continue to account for any royalties and milestones due

to the Group under the License Agreement as revenue in its Consolidated Statement of Comprehensive Income/(Loss) and record

the proceeds from the Royalty Purchase Agreement as a financial liability on its Consolidated Statement of Financial Position. In

determining the appropriate accounting treatment for the Royalty Purchase Agreement, management applied significant judgment.

The acquisition of Karuna by Bristol Myers Squibb ("BMS"), which closed on March 18, 2024, had no impact on the Group's rights or

obligations under the License Agreement or the Royalty Purchase Agreement, each of which remains in full force and effect.

In order to determine the amortized cost of the sale of future royalties liability, management is required to estimate the total amount

of future receipts from and payments to Royalty Pharma under the Royalty Purchase Agreement over the life of the agreement. The

$100,000 liability, recorded at execution of the Royalty Purchase Agreement, is accreted to the total of these receipts and payments

as interest expense over the life of the Royalty Purchase Agreement. These estimates contain assumptions that impact both the

amortized cost of the liability and the interest expense that are recognized in each reporting period.

Additional proceeds received from Royalty Pharma increase the Group’s financial liability. As royalty payments are made to Royalty

Pharma, the balance of the liability is effectively repaid over the life of the Royalty Purchase Agreement. The estimated timing and

amount of royalty payments to and proceeds from Royalty Pharma are likely to change over the life of the Royalty Purchase

Agreement. A significant increase or decrease in estimated royalty payments, or a significant shift in the timing of cash flows, will

materially impact the sale of future royalties liability, interest expense and the time period for repayment. The Group periodically

assesses the expected payments to, or proceeds from, Royalty Pharma. Any such changes in amount or timing of cash flows requires

the Group to re-calculate the amortized cost of the sale of future royalties liability as the present value of the estimated future cash

flows from the Royalty Purchase Agreement that are discounted at the liability’s original effective interest rate. The adjustment is

recognized immediately in profit or loss as income or expense.

On October 1, 2024, the Group received $25,000 from Royalty Pharma upon the FDA's approval for BMS to market KarXT as

Cobenfy. The Group paid Royalty Pharma $3,456 in 2025 for the royalties received from BMS for the sales of Cobenfy from the fourth

quarter of 2024 through the third quarter of 2025. For the year ended December 31, 2025, the Group recognized $4,659 royalty

revenue from BMS’ sale of Cobenfy. The royalties for the fourth quarter of 2025 was paid to Royalty Pharma in February 2026.

The following shows the activity in respect of the sale of future royalties liability:


	Sale of future royalties liability $
Balance as of January 1, 2024	110,159
Payment from Royalty Pharma – regulatory milestone	25,000
Non-cash interest expense recognized	8,058
Balance as of December 31, 2024	143,217
Payments to Royalty Pharma	(3,456)
Non-cash interest expense recognized	43,908
Balance as of December 31, 2025	183,669
Sale of future royalties liability, current	13,247
Sale of future royalties liability, non-current	170,422

F-42


19.	Financial Instruments

The Group’s financial instruments consist of financial assets in the form of convertible notes, investment in shares, and financial

liabilities, including notes and preferred shares. Many of these financial instruments are presented at fair value, with changes in fair

value recorded through profit and loss.

Fair Value Process

For financial instruments measured at fair value under IFRS 9, the change in the fair value is reflected through profit and loss. Using

the guidance in IFRS 13, the total business enterprise value and allocable equity of each entity being valued can be determined

using a market backsolve approach through a recent arm’s length financing round (or a future probable arm's length transaction),

market/asset probability-weighted expected return method ("PWERM") approach, discounted cash flow approach, or hybrid

approaches. The approaches, in order of strongest fair value evidence, are detailed as follows:


Valuation Method	Description
Market – Backsolve	The market backsolve approach benchmarks the original issue price (OIP) of the company’s latest funding transaction as current value.
Market/Asset – PWERM	Under a PWERM, the company value is based upon the probability-weighted present value of expected future investment returns, considering each of the possible future outcomes available to the enterprise. Possible future outcomes can include IPO scenarios, potential SPAC transactions, merger and acquisition transactions as well as other similar exit transactions of the investee.
Income Based – DCF	The income approach is used to estimate fair value based on the income streams, such as cash flows or earnings, that an asset or business can be expected to generate.

At each measurement date, investments held at fair value (that are not publicly traded) as well as the fair value of subsidiary

preferred share liability, including embedded conversion rights that are not bifurcated, were determined using the following

allocation methods: option pricing model (“OPM”), PWERM, or hybrid allocation framework. The methods are detailed as follows:


Allocation Method	Description
OPM	The OPM model treats preferred stock as call options on the enterprise’s equity value, with exercise prices based on the liquidation preferences of the preferred stock.
PWERM	Under a PWERM, share value is based upon the probability-weighted present value of expected future investment returns, considering each of the possible future outcomes available to the enterprise, as well as the rights of each share class.
Hybrid	The hybrid method is a combination of the PWERM and OPM. Under the hybrid method, multiple liquidity scenarios are weighted based on the probability of the scenario's occurrence, similar to the PWERM, while also utilizing the OPM to estimate the allocation of value in one or more of the scenarios.

Valuation policies and procedures are regularly monitored by the Group. Fair value measurements, including those categorized

within Level 3, are prepared and reviewed for reasonableness and compliance with the fair value measurements guidance under

IFRS accounting standards. The Group measures fair value using the following fair value hierarchy that reflects the significance of the

inputs used in making the measurements:


Fair Value Hierarchy Level	Description
Level 1	Inputs that are quoted market prices (unadjusted) in active markets for identical instruments.
Level 2	Inputs other than quoted prices included within Level 1 that are observable either directly (i.e. as prices) or indirectly (i.e. derived from prices).
Level 3	Inputs that are unobservable. This category includes all instruments for which the valuation technique includes inputs not based on observable data and the unobservable inputs have a significant effect on the instruments' valuation.

Whilst the Group considers the methodologies and assumptions adopted in fair value measurements as supportable and

reasonable, because of the inherent uncertainty of valuation, those estimated values may differ significantly from the values that

would have been used had a ready market for the investment existed.

F-43


19.	Financial Instruments continued

Subsidiary Preferred Share Liability

As of December 31, 2025 and December 31, 2024, the fair value of subsidiary preferred share liability was $169 and $169,

respectively. See Note 17. Subsidiary Preferred Shares for the changes in the Group’s subsidiary preferred share liability

measured at fair value, which are categorized as Level 3 in the fair value hierarchy. The changes in fair value of subsidiary preferred

share liability are recorded in finance income/(costs) – fair value accounting in the Consolidated Statement of Comprehensive

Income/(Loss).

Investments Held at Fair Value

The Group has immaterial investments in listed entities on an active exchange, and as such, the fair value of these investments

as of December 31, 2025 was calculated utilizing the quoted common share price, which is categorized as Level 1 in the fair value

hierarchy.

Seaport, Vedanta and Sonde

As of December 31, 2025, the Group accounted for the following investments under IFRS 9 as investments held at fair value with

changes in fair value through profit and loss: Seaport preferred shares, Vedanta preferred shares, and Sonde preferred A-2 and B

shares. The valuations of the aforementioned investments are categorized as Level 3 in the fair value hierarchy due to the use of

significant unobservable inputs to value such assets. During the year ended December 31, 2025, the Group recorded such

investments at fair value and recognized a gain of $39,074 for the changes in fair value of the investments.

The following table summarizes the changes in all the Group’s investments held at fair value categorized as Level 3 in the fair

value hierarchy:


Level 3 Investments held at fair value	Balance under IFRS 9 $	Equity method loss recorded against LTI $	Carrying Amount $
Balance as of January 1, 2024	24,872	—	24,872
Deconsolidation of Seaport - new investment in Seaport preferred shares	179,248	—	179,248
Gain/(loss) on changes in fair value	(10,361)	—	(10,361)
Equity method loss recorded against LTI	—	(5,307)	(5,307)
Balance as of December 31, 2024	193,758	(5,307)	188,452
Investment in Vedanta preferred shares	888	—	888
Conversion of Vedanta note to preferred shares	2,836	—	2,836
Gain/(loss) on changes in fair value	39,074	—	39,074
Equity method loss recorded against LTI, net	—	(13,831)	(13,831)
Balance as of December 31, 2025	236,557	(19,138)	217,419

The changes in fair value of investments held at fair value are recorded in gain/(loss) on investments held at fair value in the

Consolidated Statement of Comprehensive Income/(Loss).

As of December 31, 2025, the Group’s material investment held at fair value categorized as Level 3 in the fair value hierarchy

included the preferred shares of Seaport with fair value of $236,003. The significant unobservable inputs used at December 31, 2025

in the fair value measurement of this investment and the sensitivity of the fair value measurement to changes in these significant

unobservable inputs are summarized in the table below.


As of December 31, 2025	Investment Measured through Market Backsolve & PWERM
Unobservable Inputs	Input Value	Sensitivity Range	Fair Value Increase/ (Decrease) $
Equity Value	689,748	-10%	(24,667)
		+10%	24,634
Probability of entering into an initial public offering ("IPO")*	50%	-10%	(5,270)
		+10%	5,270

*Assumed the IPO event occurs on June 30, 2026.

The unobservable inputs outlined within the table above were used to determine the fair value of our investment in the convertible

preferred shares of a private company as of December 31, 2025. Whilst the Group considers the methodologies and assumptions

used in the fair value measurement to be supportable and reasonable based on a number of factors, including stage of

development for underlying programs and market conditions, because of the inherent uncertainties associated with the valuation,

the estimated value may differ significantly from the values that would have been used had a ready market for the investment

existed. The fair value measurement of our investment in the convertible preferred shares will be updated at each reporting date.

F-44


19.	Financial Instruments continued

Investments in Notes from Associates

As of December 31, 2025 and 2024, the investment in notes from associates was $11,417 and $17,731, respectively. The balance as

of December 31, 2025 represents the fair value of convertible promissory notes issued by Gelesis with a principal value of $26,850.

The balance as of December 31, 2024 represents the fair value of the aforementioned convertible debt issued by Gelesis as well as

the convertible promissory note issued by Vedanta with a principal value of $5,000. The Vedanta convertible note was converted into

shares of Vedanta Series A-1 preferred stock in August 2025. See Note 5. Investments Held at Fair Value. As a result, the Vedanta

convertible promissory note is no longer outstanding.

During the year ended December 31, 2025, the Group recorded a loss of $3,628 for the changes in fair value of the notes from

associates in the gain/(loss) on investments in notes from associates within the Consolidated Statement of Comprehensive Income/

(Loss). The loss was primarily driven by a decrease of $3,514 in the fair value of the Vedanta convertible note prior to its conversion.

In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of

the United States Bankruptcy Code. Therefore, the Group determined the fair value of the convertible promissory notes issued by

Gelesis to be $0 as of December 31, 2023. In June 2024, the Bankruptcy Court approved an executed agreement for a third party to

acquire the remaining net assets of Gelesis for $15,000. As the only senior secured creditor, the Group is expected to receive a

majority of the proceeds from this sale after deduction of legal and administrative costs incurred by the Bankruptcy Court. As of

December 31, 2025 and 2024, these notes were determined to have a fair value of $11,417 and $11,381, respectively.

The convertible debt issued by Vedanta was valued at the conversion date using a probability-weighted backsolve approach.

Fair Value Measurement and Classification

The fair value of financial instruments by category as of December 31, 2025 and 2024:


	2025
	Carrying Amount		Fair Value
	Financial Assets $	Financial Liabilities $	Level 1 $	Level 2 $	Level 3 $	Total $
Financial assets1:
Money Markets2	97,447	—	97,447	—	—	97,447
Investment in notes from associates	11,417	—	—	—	11,417	11,417
Investments held at fair value3	217,426	—	7	—	217,419	217,426
Total financial assets	326,290	—	97,454	—	228,836	326,290
Financial liabilities:
Subsidiary preferred shares	—	169	—	—	169	169
Share-based liability awards	—	3,044	—	—	3,044	3,044
Total financial liabilities	—	3,213	—	—	3,213	3,213

1.Excluded from the table above are short-term investments of $24,829 and cash equivalent of $124,538 that are classified at amortized cost as of December 31, 2025. The cost of these

short-term investments and cash equivalent approximates current fair value.

2.Included within cash and cash equivalents.

3.The carrying amount of $217,419 reflects the fair value of $236,557 as of December 31, 2025, net of $19,138 in equity method loss allocated to the long-term interest.


	2024
	Carrying Amount		Fair Value
	Financial Assets $	Financial Liabilities $	Level 1 $	Level 2 $	Level 3 $	Total $
Financial assets1:
Money Markets2	181,716	—	181,716	—	—	181,716
Investment in notes from associates	17,731	—	—	—	17,731	17,731
Investments held at fair value3	191,426	—	2,974	—	188,452	191,426
Total financial assets	390,873	—	184,690	—	206,183	390,873
Financial liabilities:
Subsidiary preferred shares	—	169	—	—	169	169
Share-based liability awards	—	3,736	—	—	3,736	3,736
Total financial liabilities	—	3,905	—	—	3,905	3,905

1.Excluded from the table above are short-term investments of $86,666 and cash equivalent of $62,179 that are classified at amortized cost as of December 31, 2024. The cost of these

short-term investments and cash equivalent approximates current fair value.

2.Included within cash and cash equivalents.

3.The carrying amount of $188,452 reflects the fair value of $193,758 as of December 31, 2024, net of $5,307 in equity method loss allocated to the long-term interest.

F-45


20.	Subsidiary Notes Payable

The subsidiary notes payable was comprised of loans as of December 31, 2025 and 2024 with a balance of $4,916 and $4,111,

respectively. It also included convertible notes of $260 as of December 31, 2023. These instruments do not contain embedded

derivatives, and therefore, are held at amortized cost.

Loans

In October 2010, Follica entered into a loan and security agreement with Lighthouse Capital Partners VI, L.P. The loan is secured by

Follica’s assets, including Follica’s intellectual property and bears interest at a rate of 5.0% in the interest only period and 12.0% in

the repayment period.

Convertible Notes

The activities of the convertible notes were as follows:


	Knode $	Appeering $	Total $
	Knode $	Appeering $	Total $
Balance as of January 1, 2023	99	149	248
Accrued interest on convertible notes - finance costs	5	8	13
Balance as of December 31, 2023	104	156	260
Accrued interest on convertible notes - finance costs	5	7	12
Forgiveness of debt – entity dissolution – finance income	(109)	(164)	(273)
Balance as of December 31, 2024	—	—	—

In November 2024, the Group dissolved Knode and Appeering as they were no longer operational entities. As a result, the principal

and interest on these notes outstanding were written off in full as of the dissolution date.


21.	Non-Controlling Interest

As of December 31, 2025 and 2024, non-controlling interests included Entrega and Follica. Ownership interests of the non-

controlling interests in these entities as of December 31, 2025 were 11.7%, and 19.9%, respectively. There was no change from

December 31, 2024, in the ownership interests of the non-controlling interests in these two entities. Non-controlling interests

include the amounts recorded for subsidiary stock awards. See Note 10 Share-based Payments.

For the year ended December 31, 2024, Seaport issued 950,000 shares of fully vested common stock to the Group and 3,450,000

shares of common stock to certain officers and directors, of which 2,455,555 shares were fully vested before Seaport's

deconsolidation from the Group's Consolidated Financial Statements on October 18, 2024. Ownership interest of non-controlling

interests was 61.3% immediately before Seaport's deconsolidation.

During the year ended December 31, 2023, Vedanta Biosciences, Inc was deconsolidated. See Note 8. Gain/(loss) on

Deconsolidation of Subsidiary.

F-47


23.	Leases and subleases continued


	Total lease liability
	2025 $	2024 $
	2025 $	2024 $
Balance as of January 1,	18,250	21,644
Cash paid for rent - principal - financing cash flow	(3,579)	(3,394)
Cash paid for rent - interest - operating cash flow	(1,065)	(1,295)
Interest expense	1,065	1,295
Balance as of December 31,	14,671	18,250

Depreciation of the right-of-use assets, which virtually all consist of leased real estate, is included in the general and administrative

expenses and research and development expenses line items in the Consolidated Statement of Comprehensive Income/(Loss).

The Group recorded depreciation expense of $1,764, $1,764 and $1,979 for the years ended December 31, 2025, 2024 and

2023, respectively.

The following table details the short-term and long-term portion of the lease liability as of December 31, 2025 and 2024:


	Total lease liability
	2025 $	2024 $
	2025 $	2024 $
Short-term portion of lease liability	3,584	3,579
Long-term portion of lease liability	11,087	14,671
Total lease liability	14,671	18,250

The following table details the future maturities of the lease liability, showing the undiscounted lease payments to be paid after the

reporting date:


	2025 $
	2025 $
Less than one year	4,419
One to two years	4,551
Two to three years	4,687
Three to four years	2,796
Four to five years	—
More than five years	—
Total undiscounted lease maturities	16,452
Interest	1,781
Total lease liability	14,671

During the year ended December 31, 2019, the Group entered into a lease agreement for certain premises consisting of 50,858

rentable square feet of space located at 6 Tide Street, Boston, Massachusetts. The lease commenced on April 26, 2019 for an initial

term consisting of ten years and three months, and there is an option to extend the lease for two consecutive periods of five years

each. The Group assessed at the lease commencement date whether it was reasonably certain to exercise the extension options,

and deemed such options were not reasonably certain to be exercised. The Group will reassess whether it is reasonably certain to

exercise the options only if there is a significant event or significant change in circumstances within its control.

On June 26, 2019, the Group executed a sublease agreement with Gelesis. The lease is for 9,446 rentable square feet located on the

sixth floor of the Group’s former office at 501 Boylston Street, Boston, Massachusetts. The sublease expired on August 31, 2025, and

was determined to be a finance lease. Gelesis ceased operations and filed for bankruptcy on October 30, 2023. As a result, the

Group wrote off its receivable in the lease of $1,266 in 2023.

On January 23, 2023, the Group executed a sublease agreement with Allonnia, LLC (“Allonnia”). The sublease was initially for

approximately 11,000 rentable square feet located on the third floor of the 6 Tide Street building where the Group’s offices are

currently located. Allonnia obtained possession of the premises on February 17, 2023 with a rent commencement date of May 17,

2023. The annual lease fee was $1,111 per year. The lease term was for two years from the rent commencement date, and Allonnia

had the option to extend the sublease. In February 2024, Allonnia extended the lease term through May 31, 2026. The annual lease

fee increased to $1,279 per year. In May 2025, Allonnia extended the lease term through June 26, 2027. The average annual lease

fee increased to $1,384 per year. The sublease was determined to be an operating lease, and as such, the total lease payments

under the sublease agreement are recognized over the lease term on a straight-line basis.

Rental income recognized by the Group during the year ended December 31, 2025, 2024, and 2023 was $1,238, $1,053, and

$781 respectively, which was included in the other income/(expense) line item in the Consolidated Statement of Comprehensive

Income/(Loss).

F-48


24.	Capital and Financial Risk Management

Capital Risk Management

The Group's capital and financial risk management policy is to maintain a strong capital base to support its strategic priorities,

maintain investor, creditor and market confidence as well as sustain the future development of the business. The Group’s objectives

when managing capital are to safeguard its ability to continue as a going concern, to provide returns for shareholders and benefits

for other stakeholders, and to maintain an optimal capital structure to reduce the cost of capital. To maintain or adjust the capital

structure, the Group may issue new shares or incur new debt. The Group has no material externally imposed capital requirements.

The Group’s share capital is set out in Note 16. Equity.

Management continuously monitors the level of capital deployed and available for deployment in the Wholly-Owned programs

segment and at Founded Entities. The Directors seek to maintain a balance between the higher returns that might be possible with

higher levels of deployed capital and the advantages and security afforded by a sound capital position.

The Group’s Directors have overall responsibility for the establishment and oversight of the Group's capital and risk management

framework. The Group is exposed to certain risks through its normal course of operations. The Group’s main objective in using

financial instruments is to promote the development and commercialization of intellectual property through the raising and investing

of funds for this purpose. The nature, amount and timing of investments are determined by planned future investment activity. Due

to the nature of activities and with the aim to maintain the investors’ funds as secure and protected, the Group’s policy is to hold any

excess funds in highly liquid and readily available financial instruments and maintain minimal exposure to other financial risks.

The Group has exposure to the following risks arising from financial instruments:

Credit Risk

Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to meet its contractual

obligations. Financial instruments that potentially subject the Group to concentrations of credit risk consist principally of cash and

cash equivalents, short-term investments, and trade and other receivables. The Group held the following balances:


	2025 $	2024 $
Balance as of December 31,	2025 $	2024 $
Cash and cash equivalents	252,470	280,641
Short-term investments	24,829	86,666
Trade and other receivables	1,758	1,522
Total	279,057	368,828

The Group invests its excess cash in U.S. Treasury Bills (presented as short-term investments), and money market accounts, which the

Group believes are of high credit quality. Further, the Group's cash and cash equivalents and short-term investments are held at

diverse, investment-grade financial institutions.

The Group assesses the credit quality of customers on an ongoing basis. The credit quality of financial assets is assessed by

historical and recent payment history, counterparty financial position, and reference to credit ratings (if available) or to historical

information about counterparty default rates. The Group does not have expected credit losses due to the high credit quality or

healthy financial conditions of these counterparties. As of December 31, 2025 and 2024, none of the trade and other receivables

were impaired.

Liquidity Risk

Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations associated with its financial liabilities that

are settled by delivering cash or another financial asset. The Group actively manages its liquidity risk by closely monitoring the

maturity of its financial assets and liabilities and projected cash flows from operations, under both normal and stressed conditions,

without incurring unacceptable losses or risking damage to the Group’s reputation. Due to the nature of these financial liabilities,

the funds are available on demand to provide optimal financial flexibility.

The table below summarizes the maturity profile of the Group’s financial liabilities, including subsidiary preferred shares that have

customary liquidation preferences, as of December 31, 2025 and 2024, based on contractual undiscounted payments:


Balance as of December 31,	2025
Balance as of December 31,	Carrying Amount $	Within Three Months $	Three to Twelve Months $	One to Five Years $	Total $ (*)
Subsidiary notes payable (Note 20)	4,916	4,916	—	—	4,916
Trade and other payables (Note 22)	23,185	23,185	—	—	23,185
Tax liability (Note 27)	1,208	—	1,208	—	1,208
Subsidiary preferred shares (Note 17)1	169	169	—	—	169
Total	29,477	28,269	1,208	—	29,477

F-49


24.	Capital and Financial Risk Management continued


Balance as of December 31,	2024
Balance as of December 31,	Carrying Amount $	Within Three Months $	Three to Twelve Months $	One to Five Years $	Total $ (*)
Subsidiary notes payable (Note 20)	4,111	4,111	—	—	4,111
Trade and other payables (Note 22)	27,020	27,020	—	—	27,020
Tax liability (Note 27)	75	75	—	—	75
Subsidiary preferred shares (Note 17)1	169	169	—	—	169
Total	31,375	31,375	—	—	31,375

1Redeemable only upon a liquidation or deemed liquidation event, as defined in the applicable shareholder documents.

*Does not include payments in respect of lease obligations nor payments on sale of future royalties liability. For the contractual future payments related to lease obligations, see Note

23. Leases and subleases. For contractual future payments related to sale of future royalties, see Note 18. Sale of Future Royalties Liability.

Interest Rate Sensitivity

As of December 31, 2025, the Group had cash and cash equivalents of $252,470, and short-term investments of $24,829. The Group's

exposure to interest rate sensitivity is impacted by changes in the underlying U.K. and U.S. bank interest rates. The Group has not

entered into investments for trading or speculative purposes. Due to the conservative nature of the Group's investment portfolio,

which is predicated on capital preservation and investments in short duration, high-quality U.S. Treasury Bills and related money

market accounts, a change in interest rates would not have a material effect on the fair market value of the Group's portfolio, and

therefore, the Group does not expect operating results or cash flows to be significantly affected by changes in market interest rates.

Controlled Founded Entity Investments

The Group maintains investments in certain Controlled Founded Entities. The Group’s investments in Controlled Founded Entities

are eliminated as intercompany transactions upon financial consolidation. The Group is, however, exposed to a subsidiary preferred

share liability owing to the terms of existing preferred shares and the ownership of Controlled Founded Entities preferred shares by

third parties. As discussed in Note 17. Subsidiary Preferred Shares, certain of the Group’s subsidiaries have issued preferred shares

that include the right to receive a payment in the event of any voluntary or involuntary liquidation, dissolution or winding up of a

subsidiary, including in the event of "deemed liquidation" as defined in the incorporation documents of the entities, which shall be

paid out of the assets of the subsidiary available for distribution to shareholders, and before any payment shall be made to holders

of ordinary shares. The liability of preferred shares is maintained at fair value through profit and loss and was insignificant as of

December 31, 2025. The Group’s cash position supports the business activities of the Controlled Founded Entities. Accordingly, the

Group views exposure to the third party subsidiary preferred share liability as low.

Deconsolidated Founded Entity Investments

The Group maintains certain debt or equity holdings in Founded Entities that are deconsolidated. These holdings are deemed

either as investments carried at fair value under IFRS 9 with changes in fair value recorded through profit and loss or as associates

accounted for under IAS 28 using the equity method. The Group's exposure to investments held at fair value and investments in

notes from associates was $217,426 and $11,417, respectively, as of December 31, 2025, and the Group may or may not be able to

realize the value in the future. Accordingly, the Group views the risk as high. The Group’s exposure to investments in associates is

limited to the carrying amount of the investment in an associate. The Group is not exposed to further contractual obligations or

contingent liabilities beyond the value of the initial investments. As of December 31, 2025, the investments in associates include

Sonde and Seaport, and the carrying amounts of the investments under the equity method were $0. Accordingly, the Group views

the risk as low.

Equity Price Risk

As of December 31, 2024, the Group held 2,671,800 common shares of Vor with a fair value of $2,966. These common shares were

sold in 2025. As of December 31, 2025, the Group held immaterial investments in listed entities on an active exchange. As such, the

Group views the exposure to equity price risk as low.

Foreign Exchange Risk

The Group maintains Consolidated Financial Statements in the Group's functional currency, which is the U.S. dollar. Monetary assets

and liabilities denominated in currencies other than the functional currency are translated into the functional currency at exchange

rates prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into

the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign

currency transactions are included in the determination of net income/(loss) for the respective periods. Such foreign currency gains

or losses were not material for all reported periods.

The Group does not currently engage in currency hedging activities since its foreign currency risk is limited, but the Group may

begin to do so in the future if and when its foreign currency risk exposure changes.

F-50


25.	Commitments and Contingencies

The Group is a party to certain licensing agreements where the Group is licensing IP from third parties. In consideration for such

licenses, the Group has made upfront payments and may be required to make additional contingent payments based on

developmental and sales milestones and/or royalties on future sales. As of December 31, 2025, certain milestone events have not yet

occurred, and therefore, the Group does not have a present obligation to make the related payments in respect of the licenses.

Such milestones are dependent on events that are outside of the control of the Group, and many of these milestone events are

remote of occurring. Payments in respect of developmental milestones that are dependent on events that are outside the control of

the Group but are reasonably possible to occur amounted to approximately $7,121 and $7,121, respectively, as of December 31,

2025 and December 31, 2024. These milestone amounts represent an aggregate of multiple milestone payments depending on

different milestone events in multiple agreements. The probability that all such milestone events will occur in the aggregate is

remote. Payments made to license IP represent the acquisition cost of intangible assets.

The Group is a party to arrangements with contract manufacturing and contract research organizations, whereby the counterparty

provides the Group with research and/or manufacturing services. As of December 31, 2025 and December 31, 2024, the

noncancellable commitments in respect of such contracts amounted to approximately $4,308 and $8,395, respectively.

In March 2024, a complaint was filed in Massachusetts District Court against the Group alleging breach of contract with respect to

certain payments alleged to be owed to a previous employee of a Group's subsidiary based on purported terms of a contract

between such individual and the Group. As of December 31, 2024, the Group recognized a provision of $900, which represented

management's best estimate of the expected settlement related to the financial obligation associated with the lawsuit, considering

the likelihood of settlement. During the year ended December 31, 2025, a settlement was reached, and payments in the amounts of

$850 and $89 were made in June 2025 and July 2025, respectively.

The Group is involved from time-to-time in various legal proceedings arising in the normal course of business. Although the

outcomes of these legal proceedings are inherently difficult to predict, the Group does not expect the resolution of such legal

proceedings to have a material adverse effect on its financial position or results of operations. The Group did not book any

provisions and did not identify any contingent liabilities requiring disclosure for any legal proceedings in the years ended December

31, 2025 and 2024.


26.	Related Parties Transactions

Related Party Subleases

During 2019, the Group executed a sublease agreement with a related party, Gelesis. During 2023, the sublease receivable was

written down to $0 as Gelesis ceased operations and filed for bankruptcy. The Group recorded $23 of interest income with respect

to the sublease during the year ended December 31, 2023, which is presented within finance income in the Consolidated Statement

of Comprehensive Income/(Loss).

Key Management Personnel Compensation

Key management includes executive directors and members of the executive management team of the Group (not including non-

executive directors and not including subsidiary directors). The key management personnel compensation of the Group was as

follows for the years ended December 31:


	2025 $	2024 $	2023 $
For the years ended December 31,	2025 $	2024 $	2023 $
Short-term employee benefits	3,918	5,166	9,714
Post-employment benefits	76	61	41
Termination benefits	408	395	417
Share-based payment expense	2,174	2,540	599
Total	6,576	8,161	10,772

Short-term employee benefits include salaries, health care and other non-cash benefits. Post-employment benefits include 401K

contributions from the Group. Termination benefits include severance pay. Share-based payments are generally subject to vesting

terms over future periods. See Note 10 Share-based Payments. As of December 31, 2025 and 2024, the payable due to the key

management employees was $1,613, and $1,509, respectively.

In addition, the Group incurred remuneration expense for non-executive directors in the amounts of $673, $670 and $475 for the

years ended December 31, 2025, 2024 and 2023, respectively. Also, the Group incurred $574, $501 and $373 of share-based

compensation expense for such non-executive directors for the years ended December 31, 2025, 2024 and 2023, respectively.

During 2025, the Group entered into an agreement with a contract research, development, and manufacturing organization whose

board chairperson is also a non-executive director of the Group. As of December 31, 2025, $210 was included in the Consolidated

Statement of Financial Position as an accounts payable to this related party, of which $58 was expensed during the year in

connection with this related party agreement.

During the years ended December 31, 2025, 2024 and 2023, the Group incurred $46, $34, and $46 respectively, of expenses from

other related parties.

Convertible Notes Issued to Directors

During the year ended December 31, 2024, the Group dissolved an inactive subsidiary, which held a convertible note issued

to a related party. As a result of the entity's dissolution, the convertible note's outstanding balance on the day of dissolution

was written down to $0 and a gain of $108 was recorded and included in finance income/ (costs) within the Consolidated Statement

of Comprehensive Income/(Loss).

F-51


26.	Related Parties Transactions continued

Directors’ and Senior Managers’ Shareholdings and Share Incentive Awards

The Directors and senior managers hold beneficial interests in shares in the following businesses as of December 31, 2025:


	Business name (share class)	Number of shares held as of December 31, 2025	Number of options held as of December 31, 2025	Number of RSUs held as of December 31, 2025	Ownership interest¹
Directors:
Dr Robert Langer	Entrega (Common)	250,000	82,500	—	4.35%
Dr John LaMattina	Vedanta Biosciences (Common)	2,500	427,416	—	0.15%
	Seaport Therapeutics (Preferred B)2	21,052	—	—	0.01%
Michele Holcomb	Seaport Therapeutics (Preferred B)	21,052	—	—	0.01%
Sharon Barber-Lui	Seaport Therapeutics (Preferred B)	21,052	—	—	0.01%
Kiran Mazumdar-Shaw	Seaport Therapeutics (Preferred B)3	21,052	—	—	0.01%
Senior Managers:
Eric Elenko	Seaport Therapeutics (Common)	950,000	—	—	0.63%

1Ownership interests as of December 31, 2025 are calculated on a diluted basis, including issued and outstanding shares, warrants and options (and written commitments to issue

options) but excluding unallocated shares authorized to be issued pursuant to equity incentive plans.

2Dr. John and Ms. Mary LaMattina hold 21,052 Series B preferred shares of Seaport Therapeutics.

3 Shares owned through Glentec International.

Directors and senior managers hold 7,522,370 ordinary shares and 3.1% voting rights of the Group as of December 31, 2025. This

amount excludes options to purchase 422,221 ordinary shares. This amount also excludes 2,535,651 shares, which are issuable based

on the terms of performance-based RSU awards granted to certain senior managers covering the financial years from 2023 to 2027,

and 2,180,815 shares of time-based RSUs to senior managers, which vest primarily over 3 years. Such shares will be issued to such

senior managers in future periods provided that performance and/or service conditions are met, and certain of the shares will be

withheld for payment of customary withholding taxes. This amount also excludes 469,720 shares, which are issuable to non-executive

directors immediately prior to the Group's 2026 Annual General Meeting of Stockholders, based on the terms of the RSU awards

granted to non-executive directors in 2025.

During the year ended December 31, 2024, certain officers and directors participated in the Tender Offer. See Note 16. Equity for

details on the program. Consequently, the Group repurchased a total of 767,533 ordinary shares at 250 pence per ordinary share

from these related parties.

Other

See Note 7. Investment in Notes from Associates for details on the notes issued by Gelesis, Sonde, and Vedanta to the Group.

As of December 31, 2025, and 2024 the Group had receivables outstanding from Seaport in the amounts of $7, and $408,

respectively.


27.	Taxation

Tax on the profit or loss for the year comprises current and deferred income tax. Tax is recognized in the Consolidated Statement of

Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity.

For the years ended December 31, 2025, 2024 and 2023, the Group filed a consolidated U.S. federal income tax return that included

all subsidiaries in which the Group owned greater than 80% of the vote and value. For the years ended December 31, 2025, 2024

and 2023, the Group filed certain consolidated state income tax returns which included all subsidiaries in which the Group owned

greater than 50% of the vote and value. The remaining subsidiaries file separate U.S. tax returns.

F-52


27.	Taxation continued

Amounts recognized in Consolidated Statement of Comprehensive Income/(Loss):


	2025 $	2024 $	2023 $
For the year ended December 31,	2025 $	2024 $	2023 $
Income/(loss) for the year	(110,084)	27,782	(66,628)
Income tax expense/(benefit)	(842)	(4,008)	30,525
Income/(loss) before taxes	(110,927)	23,774	(36,103)

Recognized Income Tax Expense/(Benefit):


	2025 $	2024 $	2023 $
For the year ended December 31,	2025 $	2024 $	2023 $
Federal - current	874	35,310	(2,246)
State - current	1,018	13,144	(46)
Total current income tax expense/(benefit)	1,892	48,454	(2,292)
Federal - deferred	(2,734)	(46,442)	29,294
State - deferred	—	(6,020)	3,523
Total deferred income tax expense/(benefit)	(2,734)	(52,462)	32,817
Total income tax expense/(benefit), recognized	(842)	(4,008)	30,525

The income tax expense/(benefit) was $(842), $(4,008) and $30,525 for the tax years ended December 31, 2025, 2024 and 2023,

respectively.

The income tax benefit recognized in 2025 was primarily due to capital loss generated on the sale of the Vor Biopharma investment

and general business tax credits, partially offset by the recognition of a reserve for uncertain tax positions related to a state audit.

The income tax benefit recognized in 2024 was primarily attributable to the recognition of a deferred tax asset, which was generated

in 2024 from the sale of the Group’s investment in Akili common stock. This deferred tax asset was used to offset income generated

from the sale of the Group’s investment in Karuna common shares, partially offset with state income tax expense.

Reconciliation of Effective Tax Rate

The Group is primarily subject to taxation in the U.S. A reconciliation of the U.S. federal statutory tax rate to the effective tax rate

is as follows:


	2025		2024		2023
For the year ended December 31,	$	%	$	%	$	%
US federal statutory rate	(23,295)	21.00	4,994	21.00	(7,573)	21.00
State taxes, net of federal effect	(5,664)	5.11	1,026	4.32	(3,974)	11.01
Tax credits	(1,772)	1.60	(2,517)	(10.59)	(9,167)	25.39
Stock-based compensation	777	(0.70)	2,123	8.93	589	(1.63)
Finance income/(costs) – fair value accounting	769	(0.69)	1,640	6.90	(556)	1.54
Loss with respect to associate for which no deferred tax asset is recognized	639	(0.58)	210	0.88	249	(0.69)
Revaluation of deferred due to rate change	(271)	0.24	(3,419)	(14.38)	—	—
Nondeductible compensation	505	(0.46)	1,534	6.45	872	(2.42)
Recognition of deferred tax assets and tax benefits not previously recognized	(962)	0.87	(12,396)	(52.14)	(433)	1.20
Unrecognized deferred tax asset	—	—	—	—	83,984	(232.63)
Deconsolidation of subsidiary	—	—	3,863	16.25	(17,506)	48.49
Cancellation of Debt Income	—	—	(987)	(4.15)	—	—
Current year losses and credits for which no deferred tax asset is recognized	27,288	(24.60)	—	—	—	—
Uncertain tax positions	1,208	(1.09)	—	—	—	—
Other	(66)	0.06	755	3.16	1,321	(3.65)
Worthless stock deduction	—	—	(833)	(3.50)	(17,281)	47.87
	(842)	0.76	(4,008)	(16.86)	30,525	(84.52)

The Group is also subject to taxation in the UK, but to date, no taxable income has been generated in the UK. Changes in corporate

tax rates can change both the current tax expense (benefit) as well as the deferred tax expense (benefit).

F-53


27.	Taxation continued

Deferred Tax Assets and Liabilities

Deferred tax assets have been recognized in the U.S. jurisdiction in respect of the following items:


	2025 $	2024 $
For the year ended December 31,	2025 $	2024 $
Operating tax losses	33,810	2,621
Tax credits	272	238
Share-based payments	5,989	6,206
Capitalized research & development expenditures	40,696	48,904
Lease liability	3,912	4,851
Sale of future royalties	53,321	42,406
Deferred tax assets	137,999	105,226
Investments held at fair value	(31,289)	(23,565)
Right of use assets	(1,679)	(2,143)
Property and equipment, net	(796)	(1,235)
Investment in associates	—	(637)
Other temporary differences	(2,198)	(1,900)
Deferred tax liabilities	(35,962)	(29,480)
Deferred tax assets (liabilities), net	102,037	75,746
Deferred tax assets (liabilities), net, not recognized	102,037	75,746

As of December 31, 2025, the Group does not have sufficient taxable temporary differences; has a history of losses; and does not

believe it is probable future profits will be available to support the recognition of its deferred tax assets. The unrecognized deferred

tax assets of $102,037 are primarily related to capitalized research & development expenditures, net operating loss carryforwards

and deferred tax asset related to the sale of future royalties to Royalty Pharma.

Unrecognized Deferred Tax Assets

Deferred tax assets have not been recognized in respect of the following carryforward losses, credits and temporary differences,

because it is not probable that future taxable profit will be available against which the Group can use the benefits therefrom.


	2025 $		2024 $
For the year ended December 31,	2025 $		2024 $
For the year ended December 31,	Gross Amount	Tax Effected	Gross Amount	Tax Effected
Deductible temporary difference	254,843	67,955	274,227	72,887
Tax losses*	123,691	33,810	7,815	2,621
Tax credits	272	272	238	238
Total	378,806	102,037	282,280	75,746

*The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for

details on gross state tax net operating losses carryforwards.

Tax Losses and Tax Credits Carryforwards

Tax losses and tax credits for which no deferred tax asset was recognized are presented below:


Balance as of December 31,	2025 $		2024 $
	2025 $		2024 $
	Gross Amount	Tax Effected	Gross Amount	Tax Effected
Tax losses expiring:
Within 10 years	2,382	593	1,537	416
More than 10 years	2,440	7,604	3,285	729
Available Indefinitely	118,870	25,613	2,993	1,476
Total*	123,691	33,810	7,815	2,621
Tax credits expiring:
Within 10 years	91	91	44	44
More than 10 years	181	181	194	194
Available indefinitely	—	—	—	—
Total	272	272	238	238

*The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for

details on gross state tax net operating losses carryforwards.

F-54


27.	Taxation continued

The Group had U.S. federal net operating losses carry forwards (“NOLs”) of $123,691, $7,815 and $13,681 as of December 31, 2025,

2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire through 2037 with the exception

of $118,870, which is not subject to expiration, and can be utilized up to 80% of annual taxable income. The Group had U.S. federal

research and development tax credits of approximately $272, $238 and $1,396 as of December 31, 2025, 2024 and 2023, respectively,

which are available to offset future taxes that expire at various dates through 2044. A portion of these federal NOLs and credits can

only be used to offset the profits from the Group’s subsidiaries who file separate federal tax returns. These NOLs and credits are

subject to review and possible adjustment by the Internal Revenue Service.

The Group had state net operating losses carry forwards (“NOLs”) of approximately $376,066, $125,322 and $111,446 for the years

ended December 31, 2025, 2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire at

various dates beginning in 2030. These NOLs are subject to review and possible adjustment by state taxing authority.

Utilization of the NOLs and research and development credit carryforwards may be subject to a substantial annual limitation under

Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could

occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that

can be utilized annually to offset future taxable income and tax, respectively. The Group has performed a Section 382 analysis

through December 31, 2025. The results of this analysis concluded that certain net operating losses were subject to limitation under

Section 382 of the Internal Revenue Code. None of the Group’s net operating losses, which are subject to a Section 382 limitation,

has been recognized in the financial statements.

Tax Balances

The tax related balances presented in the Consolidated Statement of Financial Position are as follows:


For the year ended December 31,	2025 $	2024 $

Income tax receivable – current	6,372	—
Tax liability – current	(1,208)	(75)

Uncertain Tax Positions

The Group has recorded an uncertain tax position reserve of approximately $1,208 as of December 31, 2025, inclusive of interest

and penalties, related to a state audit. U.S. corporations are routinely subject to audit by federal and state tax authorities in the

normal course of business.


28.	Subsequent Events

The Group has evaluated subsequent events after December 31, 2025, up to the date of issuance, April 29, 2026, of the

Consolidated Financial Statements, and has not identified any recordable or disclosable events not otherwise reported in these

Consolidated Financial Statements or notes thereto.


EXHIBIT NUMBER	DESCRIPTION OF EXHIBIT	INCORPORATION BY REFERENCE
		Schedule/Form	File Number	Exhibit	File Date
1.1	Articles of Association of the Registrant	20FR12B	001-39670	3.1	10/27/2020
2.1	Deposit Agreement dated as of November 11, 2020, by and among the Registrant, Citibank N.A. and the holders of beneficial holders of American Depository Shares thereunder	20-F	001-39670	2.1	4/15/2021
2.2	Form of American Depository Receipt (included in Exhibit 2.1)
2.3	Description of Registrant’s Securities	20-F	001-39670	2.3	4/26/2022
4.1#	2015 Performance Share Plan	20FR12B	001-39670	10.1	10/27/2020
4.2#	2023 Performance Share Plan	20-F	001-39670	4.2	4/25/2024
4.3#	Form of Incentive Stock Option Deed of Agreement under the Performance Share Plan	20FR12B	001-39670	10.2	10/27/2020
4.4#	Form of Nonstatutory Stock Option Deed of Agreement under the Performance Share Plan	20FR12B	001-39670	10.3	10/27/2020
4.5#	Form of Restricted Share Units Agreement under the Performance Share Plan	20FR12B	001-39670	10.4	10/27/2020
4.6	Lease Agreement, dated as of August 10, 2018, by and between the Registrant and RBK I TENANT, LLC	20FR12B	001-39670	10.5	10/27/2020
4.7#	Form of Deed of Indemnity between the Registrant and each of its directors and executive officers	20FR12B	001-39670	10.6	10/27/2020
4.8†	Asset Purchase Agreement, dated July 15, 2019, by and between Auspex Pharmaceuticals, Inc. and PureTech Health LLC	20FR12B	001-39670	10.7	10/27/2020
4.9†	Royalty Agreement, dated as of July 23, 2013, by and between PureTech Ventures LLC and Follica, Incorporated	20FR12B	001-39670	10.8	10/27/2020
4.10	Royalty and Sublicense Income Agreement, dated as of December 18, 2009, as amended on June 28, 2012, by and between PureTech Ventures LLC, Gelesis, Inc. and Gelesis LP	20FR12B	001-39670	10.9	10/27/2020
4.11†	Exclusive Patent License Agreement, dated as of March 4, 2011, as amended on February 1, 2013 and February 25, 2015, by and between PureTech Ventures LLC and Karuna Pharmaceuticals, Inc.	20FR12B	001-39670	10.10	10/27/2020
4.12†	Ninth Amended and Restated Registration Rights Agreement, dated December 5, 2019, between Gelesis, Inc. and the stockholders party thereto	20FR12B	001-39670	10.12	10/27/2020
4.13†	Fifth Amended and Restated Right of First Refusal and Co-Sale Agreement, dated July 19, 2019, by and among Follica, Incorporated and the investors and key holders party thereto	20FR12B	001-39670	10.18	10/27/2020
4.14†	Amended and Restated Investors’ Rights Agreement, dated June 30, 2020, by and between Vor Biopharma Inc. and the investors party thereto	20FR12B	001-39670	10.21	10/27/2020
4.15†	Amended and Restated Voting Agreement, dated May 25, 2022, by and among Sonde Health, Inc. and the stockholders party thereto	20-F	001-39670	4.15	4/25/2024
4.16†	Amended and Restated Investors' Rights Agreement, dated May 25, 2022, by and among Sonde Health, Inc. and the investors party thereto	20-F	001-39670	4.16	4/25/2024
4.17†	Amended and Restated Right of First Refusal and Co-Sale Agreement, dated May 25, 2022, by and among Sonde Health, Inc. and the investors and key holders party thereto	20-F	001-39670	4.17	4/25/2024
4.18†	Voting Agreement, dated December 18, 2017, between Entrega, Inc. and the stockholders party thereto	20FR12B	001-39670	10.26	10/27/2020
4.19†	Investors’ Rights Agreement, dated December 18, 2017, by and between Entrega, Inc. and the investors party thereto	20FR12B	001-39670	10.27	10/27/2020


EXHIBIT NUMBER	DESCRIPTION OF EXHIBIT	INCORPORATION BY REFERENCE
		Schedule/Form	File Number	Exhibit	File Date
4.20†	Right of First Refusal and Co-Sale Agreement, dated December 18, 2017, by and between Entrega, Inc. and the investors and key holders party thereto	20FR12B	001-39670	10.28	10/27/2020
4.21†	Research and License Agreement, dated March 6, 2017, as amended on April 23, 2018, August 6, 2018, May 31, 2019, and July 22, 2020 between PureTech LYT, Inc. and New York University	20FR12B	001-39670	10.29	10/27/2020
4.22+	Amended and Restated Registration and Stockholder Rights Agreement, dated January 13, 2022, by and among Gelesis Holdings, Inc. and the stockholders party thereto	8-K	001-39362	10.2	1/20/2022
4.23†	Amended and Restated Investors' Rights Agreement, dated March 1, 2023 by and among Vedanta Biosciences, Inc. and the investors and noteholders party thereto	20-F	001-39670	4.25	4/25/2024
4.24	Form of Subscription Agreement	S-4	333-258693	10.2	8/10/2021
4.25	Form of Promissory Note of Gelesis Holdings, Inc.	8-K	001-39362	10.1	7/29/2022
4.26+	Note and Warrant Purchase Agreement, dated as of February 21, 2023, by and among Gelesis Holdings, Inc., Gelesis, Inc., Gelesis 2012, Inc., Gelesis LLC and PureTech Health LLC	8-K	001-39362	10.1	2/23/2023
4.27†+	Royalty Purchase Agreement, dated as of March 22, 2023, by and between PureTech Health LLC and Royalty Pharma Investments 2019 ICAV	20-F	001-39670	4.36	04/25/2024
4.28	Form of Secured Subordinated Convertible Promissory Note of Vedanta Biosciences, Inc.	20-F	001-39670	4.37	4/25/2024
4.29+	Asset Transfer Agreement, dated April 8, 2024, by and among Seaport Therapeutics Inc., PureTech Health LLC, and PureTech LYT Inc.	S-1/A 1	333-294976	10.14	4/27/2026
4.30+	Amended and Restated Investors’ Rights Agreement, by and between the Registrant and certain of its stockholders, dated as of October 18, 2024.	S-1/A 1	333-294976	4.2	4/27/2026
8.1	Subsidiaries of PureTech Health plc	20FR12B	001-39670	21.1	10/27/2020
11.1	Securities Dealing Code	20-F	001-39670	11.1	4/30/2025
12.1*	Certification by the Principal Executive and Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
13.1**	Certification of Principal Executive and Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes- Oxley Act of 2002.
15.1***	Annual Report and Accounts 2025
97.1	Policy for Recovery of Erroneously Awarded Compensation	20-F	001-39670	97.1	4/25/2024
99.1*	Seaport Therapeutics, Inc. and subsidiaries Consolidated Financial Statements as of December 31, 2025 and 2024, for the period from October 18, 2024 to December 31, 2024 and for the years ended December 31, 2025 and 2024



		PURETECH HEALTH PLC

By:		/s/ Robert Lyne
		Name: Robert Lyne
		Title: Chief Executive Officer


	2024 $	2023 $
Assets, Liabilities and non-controlling interests in deconsolidated subsidiary	Seaport	Vedanta
Cash and cash equivalents	(91,570)	(13,784)
Trade and other receivables	(220)	(702)
Prepaid assets	(1,309)	(3,516)
Property and equipment, net	(175)	(8,092)
Right of use asset, net	—	(2,477)
Trade and other payables	6,102	15,078
Trade and other payables due to PureTech	3,370	139
Deferred revenue	—	1,902
Lease liabilities (including current portion)	—	4,146
Long-term loan (including current portion)	—	15,446
Subsidiary preferred shares and warrants	76,208	24,568
Other assets and liabilities, net	(475)	(462)
Sub-total (net assets)/liabilities	(8,070)	32,246
Derecognize carrying value of non-controlling interest	(7,430)	9,085
Recognize investment retained in deconsolidated subsidiary at fair value*	167,308	20,456
Calculated gain on deconsolidation	151,808	61,787


		Page
	PART I	1

ITEM 1.	IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS	1
ITEM 2.	OFFER STATISTICS AND EXPECTED TIMETABLE	2
ITEM 3.	KEY INFORMATION	3
ITEM 4.	INFORMATION ON THE COMPANY	4
ITEM 4A.	UNRESOLVED STAFF COMMENTS	28
ITEM 5.	OPERATING AND FINANCIAL REVIEW AND PROSPECTS	29
ITEM 6.	DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES	31
ITEM 7.	MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS	32
ITEM 8.	FINANCIAL INFORMATION	34
ITEM 9.	THE OFFER AND LISTING	35
ITEM 10.	ADDITIONAL INFORMATION	36
ITEM 11.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	47
ITEM 12.	DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES	48

	PART II	50

ITEM 13.	DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES	50
ITEM 14.	MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS	51
ITEM 15.	CONTROLS AND PROCEDURES	52
ITEM 16.	RESERVED	53
ITEM 16A.	AUDIT COMMITTEE FINANCIAL EXPERT	53
ITEM 16B.	CODE OF ETHICS	53
ITEM 16C.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	53
ITEM 16D.	EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES	53
ITEM 16E.	PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS	54
ITEM 16F.	CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT	54
ITEM 16G.	CORPORATE GOVERNANCE	54
ITEM 16H.	MINE SAFETY DISCLOSURE	54
ITEM 16I.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	54
ITEM 16J	INSIDER TRADING POLICIES	54
ITEM 16K	CYBERSECURITY DISCLOSURE	55

	PART III	56

ITEM 17.	FINANCIAL STATEMENTS	56
ITEM 18.	FINANCIAL STATEMENTS	57
ITEM 19.	EXHIBITS	58



	Page
Consolidated Financial Statements as of and for the Years Ended December 31, 2025, 2024, and 2023
Report of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm (PCAOB ID 238)	F-2
Consolidated Statement of Comprehensive Income/(Loss) for the Years Ended December 31, 2025, 2024 and 2023	F-4
Consolidated Statement of Financial Position as of December 31, 2025 and 2024	F-5
Consolidated Statement of Changes in Equity for the Years Ended December 31, 2025, 2024 and 2023	F-6
Consolidated Statement of Cash Flows for the Years Ended December 31, 2025, 2024 and 2023	F-7
Notes to the Consolidated Financial Statements	F-8


	For the year ended December 31, 2025
	Wholly-Owned Segment $	Controlled Founded Entities Segment $	Parent Company and Other $	Consolidated $
Contract revenue	—	—	4,659	4,659
Total revenue	—	—	4,659	4,659
General and administrative expenses	(11,401)	(120)	(35,097)	(46,618)
Research and development expenses	(55,900)	(701)	34	(56,567)
Total operating expenses	(67,301)	(821)	(35,063)	(103,185)
Operating income/(loss)	(67,301)	(821)	(30,405)	(98,527)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain/(loss) on investment held at fair value				38,485
Realized gain/(loss) on sale of investments				375
Gain/(loss) on investment in notes from associates				(3,628)
Other income/(expense)				1,331
Total other income/(expense)				36,564
Net finance income/(costs)				(32,735)
Share of net income/(loss) of associates accounted for using the equity method				(17,928)
Gain on dilution of ownership interest in associate				1,699
Income/(loss) before taxes				(110,927)
	As of December 31, 2025
Available Funds
Cash and cash equivalents	6,361	116	245,993	252,470
Short-term Investments	—	—	24,829	24,829
Consolidated cash, cash equivalents and short-term investments	6,361	116	270,822	277,299


Outstanding and exercisable at December 31, 2025	Number of options	Weighted- average exercise price $	Weighted- average contractual life outstanding	Exercise Price Range $
Entrega	247,000	1.85	2.41	0.02-2.36


Cost	Licenses $
Balance as of January 1, 2024	906
Write-off	(80)
Deconsolidation of subsidiary	(225)
Balance as of December 31, 2024	601
Balance as of December 31, 2025	601


	Non-Controlling Interest $
Balance as of January 1, 2023	5,369
Share of comprehensive income/(loss)	(931)
Equity settled share-based payments	277
Expiration of share options in subsidiary	(1,458)
Deconsolidation of subsidiary (Vedanta)	(9,085)
Other	(6)
Balance as of December 31, 2023	(5,835)
Share of comprehensive income/(loss)	(25,728)
Equity settled share-based payments	17,372
Deconsolidation of subsidiary (Seaport)	7,430
Other	(13)
Balance as of December 31, 2024	(6,774)
Share of comprehensive income/(loss)	(345)
Equity settled share-based payments - See Note 10. Share-based Payments	758
Expiration of share options in subsidiary	(36)
Balance as of December 31, 2025	(6,397)