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Egetis Therapeutics

Interim / Quarterly Report Aug 22, 2024

3152_ir_2024-08-22_5450fb02-b44a-4c7b-be39-131c6c43f619.pdf

Interim / Quarterly Report

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Financial overview

2024
Apr-Jun
2023
Apr- un
2024
an-Jun
2023
an-Jun
2023
an-Dec
Net revenue, MSEK 13.9 5.9 25.9 12.7 57.6
Result after tax, MSEK -71.9 -79.5 -146.9 -154.4 -326.9
Cash flow, MSEK -57.1 -64.8 -113.1 51.0 180.4
Cash, MSEK 192.6 179.2 192.6 179.2 303.3
Equity ratio, % 62 90 62 90 72
Earnings per share, SEK -0.2 -0.3 -0.5 -0.6 -1.3
Earnings per share after dilution, SEK -0.2 -0.3 -0.5 -0.6 -1.3
Average number of employees 33 26 32 23 27

Comments from the CFO

The last few months have been eventful for Egetis. We are pleased by the important recommendations from the European Thyroid Association (ETA) to use tiratricol as long-term therapy for all patients with MCT8 deficiency. We are also looking forward to the new survival data which will be presented at the ETA Annual Meeting in September.

While Triac Trial II did not meet the

neurodevelopmental endpoints in the studied subpopulation, it confirmed the well-tolerated safety profile seen in previous clinical studies, despite higher dosing per kg body weight compared to previous studies.

Tiratricol (Emcitate®) treatment in patients with MCT8 deficiency is associated with three times lower risk of mortality

Treatment with the investigational drug tiratricol (Emcitate®) in pediatric and adult patients with MCT8 deficiency is associated with an approximately three times lower risk of mortality compared to MCT8 deficiency patients not treated with tiratricol. These new encouraging data are presented in an Abstract by Dr Floor van der Most, and co-authors, Erasmus Medical Center, Rotterdam, The Netherlands, published ahead of the 46th Annual Meeting of the European Thyroid Association, to be held in Athens, Greece, on September 7-10, 2024.

European Thyroid Association recommended tiratricol as long-term therapy for all patients with MCT8 deficiency in new guidelines

Early July, The European Thyroid Association (ETA) published new guidelines recommending the use of tiratricol as long-term therapy for all patients with MCT8 deficiency, and for certain patients with Resistance to Thyroid Hormone (RTH)-beta, as further outlined in the guidelines.

These inaugural 2024 European Thyroid Association Guidelines on diagnosis and management of genetic disorders of thyroid hormone transport, metabolism and action were commissioned by the Executive Committee of the ETA and developed by an independent team of experts.

Egetis marketing authorisation application in the EU for tiratricol for the treatment of MCT8 deficiency

On October 26, 2023, the European Medicines Agency (EMA) validated the Marketing Authorisation Application (MAA) for tiratricol for the treatment of MCT8 deficiency. This started the formal review of the MAA dossier by the Committee for Medicinal Products for Human Use (CHMP) at the EMA. The Company submitted responses on August 15, 2024, to the Day 120 List of Questions from the EMA.

Egetis continues to work towards increased disease awareness of MCT8 deficiency and its impact on patients, caregivers and the healthcare system MCT8 deficiency is an ultra-rare genetic disease first described in 2004, and there are currently no approved therapies for this disease. Consequently, the general awareness of the disease and the diagnosis are very low, even among specialist physicians, and a large portion of patients remain misdiagnosed. Our medical affairs activities are focused on improving awareness of the disease and its diagnosis, by participation and dialogues at scientific conferences, partnering with genetic testing companies, engaging with Key Opinion Leaders, advisory committees, and interactions with patient groups.

In 2024 Egetis has so far participated at 17 scientific conferences relevant to MCT8 deficiency. More information about MCT8 deficiency is available at www.mct8deficiency.com.

Three new clinical study sites have been added to the ReTRIACt study, which is pivotal in the USA Following an agreement with the FDA, Egetis is conducting a pivotal, randomized, placebo-controlled study (ReTRIACt) in at least 16 evaluable patients with MCT8 deficiency to verify the results from previous clinical trials and publications regarding the normalization of thyroid hormone T3 levels, to support the submission of a New Drug Application (NDA) in the USA.

The first patients were included in the ReTRIACt study in July 2023, at Erasmus Medical Center in Rotterdam, The Netherlands, and Children's Hospital of Philadelphia, USA. During late 2023 and early 2024 two additional hospitals were included in the study: Addenbrooke's Hospital in Cambridge, UK, and Saint Louis University Hospital in St. Louis, Missouri, USA. To increase the recruitment capacity in the ReTRIACt study we have opened three additional clinical study sites in the USA: one each in Texas, Georgia and North Carolina. So far, 13 patients have been included, whereof 6 patients have completed the study, and Egetis estimates that 2 patients will be randomized

and a further 6 to commence screening during the next 6 weeks.

As previously communicated, we will update the market as soon as recruitment is closed. At that time, we will also provide information on when to expect topline results and when we plan to submit the NDA application.

More information about the ReTRIACt study is available on clinicaltrials.gov under the code NCT05579327.

Triac Trial II with tiratricol

Triac Trial II is an international, open-label, multicenter study in young patients (<30 months old) with MCT8 deficiency with 22 patients included. The study is conducted in Europe and the USA and examined the neurodevelopmental effects of early intervention with tiratricol, as well as the effect on clinical and biochemical aspects of thyrotoxicosis. Patients were initially treated with tiratricol for 96 weeks and will be followed for an additional two years. Top-line results from the study, after 96 weeks of treatment, were announced on June 19, 2024. The trial did not meet its primary endpoints, which were assessed by changes in the Gross Motor Function Measure (GMFM)-88 total score and the Bayley Scales for Infant and toddler Development (BSID)-III Gross Motor Skill domain, compared to natural history scores from the Triac Trial I. Among key secondary endpoints, total serum thyroid hormone T3 concentrations were reduced significantly and durably in all patients, thereby verifying tiratricol's ability to alleviate thyrotoxicosis in MCT8 deficiency patients. As agreed with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the Triac Trial II study is complementary to the already demonstrated treatment effects on T3 concentrations and chronic thyrotoxicosis in patients of all ages, which the already submitted and validated marketing authorization application for Emcitate® (tiratricol) for the treatment of MCT8 deficiency in the EU is based on

The trial confirmed the well-tolerated safety profile seen in previous clinical studies, despite higher dosing per kg body weight compared to previous studies. The design of the Triac Trial II study is available on clinicaltrials.gov under the code NCT02396459.

Egetis awarded Promising Innovative Medicine designation in the UK for tiratricol (Emcitate®) for treatment of MCT8 deficiency

A Promising Innovative Medicine Designation (PIM) designation is a recognition of tiratricol as a promising candidate drug in the UK for the treatment of patients with MCT8 deficiency. MCT8 deficiency is a debilitating condition, and we are delighted that the MHRA has recognized the potential of Emcitate® (tiratricol) for patients living with this disease. This is testament to our commitment to supporting patients with MCT8 deficiency in the UK.

Managed access program for tiratricol

There is continued significant and growing interest from physicians worldwide in treating patients with MCT8 deficiency with tiratricol, which is already being prescribed as part of Managed Access Programs to patients in over 25 countries. Currently approximately 220 patients are being treated with tiratricol, and more patients are gaining access to treatment. At the request of the FDA, Egetis has implemented an Expanded Access Program (EAP) in the USA. Currently, 8 sites are open to enroll patients in the EAP and an additional 10 hospitals are in the process of joining the program. The EAP program for tiratricol facilitates physicians in accessing the medication for their MCT8 deficiency patients who are ineligible for a clinical trial until the product receives market authorization. The program is also important for patients in the ReTRIACt study so that they can continue treatment with tiratricol after completing the study.

Cash

We report cash of approximately SEK 193 million as of June 30, 2024. In addition, we have access to debt financing totaling EUR 15 million, which will be available provided that the Company meets certain conditions, including those related to the Phase III ReTRIACt study for tiratricol.

Outlook

2024 is a year marked by several important milestones for Egetis. Our team continues to focus on delivering four key priorities.:

    1. Complete the ReTRIACt study, which is pivotal in the USA, as soon as possible;
    1. Potential positive opinion from EMA for tiratricol for MCT8 deficiency;
    1. Preparatory launch activities in Europe;
    1. Preparing the NDA for tiratricol in the USA.

Nicklas Westerholm, CEO

About Egetis Therapeutics

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.

The Company's lead drug candidate tiratricol (Emcitate®) is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) tiratricol has shown highly significant and clinically relevant results on serum thyroid hormone T3 concentrations and secondary clinical endpoints. Egetis submitted a marketing authorisation application (MAA) for tiratricol to the European Medicines Agency (EMA) in October 2023 and responded to EMA's Day 120 List of Questions on August 13, 2024.

After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled pivotal study in 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. As previously communicated, the Company will update the market as soon as recruitment closes, and at that time, the Company will also provide information on

when to expect topline results and when the Company plans to submit the NDA application.

Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor.

The drug candidate Aladote® (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The study start has been postponed until tiratricol marketing authorization submissions for MCT8 deficiency have been completed. Aladote has been granted ODD in the US and in the EU.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com

Pipeline overview

About Emcitate

Emcitate is Egetis' lead drug candidate in clinical development and is being developed as a treatment of monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley Syndrome (AHDS), a rare genetic disease that affects 1 in 70,000 men with high unmet medical need with no approved treatment.

Thyroid hormones are crucial for the development and metabolic state of virtually all tissues. Thyroid hormone transport across the plasma membrane is required for the hormones' metabolism and intracellular action and is facilitated by thyroid hormone transporters, including MCT8. Mutations in the gene for MCT8 cause MCT8 deficiency. The gene is located on the X chromosome and mainly affects men.

The resulting dysfunction of MCT8 leads to impaired transport of thyroid hormone into certain cells and across the blood-brain-barrier and disruption of normal thyroid hormone regulation. Patients with MCT8 deficiency therefore have low concentrations of thyroid hormone in the central nervous system, which signals that the body should produce more thyroid hormone. This leads to increased levels of active thyroid hormone T3 in peripheral tissues, also called thyrotoxicosis. This leads to a complex pattern of symptoms with neurological developmental delay and intellectual disability, accompanied by severely elevated circulating thyroid hormone concentrations

which are toxic for tissues including the heart, muscle, liver and kidney and results in symptoms such as failure to thrive, cardiovascular stress, insomnia and muscle wasting.

Most patients will never develop the ability to walk or even sit independently. At present there is no approved therapy available for the treatment of MCT8 deficiency.

Emcitate was granted Orphan Drug Designation for MCT8 deficiency in the EU in 2017 and the US in 2019. Emcitate received US Rare Paediatric. Disease Designation (RPDD) in 2020. Upon approval of the NDA, sponsors holding a RPDD and meeting the criteria specified can apply to receive a Priority Review Voucher (PRV). A PRV provides accelerated FDA review of a subsequent new drug application for any drug candidate, in any indication, shortening time to market in the US. The voucher may also be sold or transferred to another sponsor. During the last few years PRVs have been sold for around \$100 million.

A Phase IIb clinical trial (Triac Trial I) in MCT8 deficiency has been completed which showed significant and clinically relevant treatment effects on key aspects of the disease. In October 2021, data from long-term treatment in patients with MCT8 deficiency up to 6 years, with Emcitate was published in the Journal of Clinical Endocrinology & Metabolism. The data comes from an investigator-initiated real-life cohort study at 33 sites conducted by the Erasmus

Medical Center, Rotterdam, The Netherlands, where the efficacy and safety of Emcitate was investigated in 67 patients with MCT8 deficiency.

Based on the new long-term data in 2021, Egetis had further interactions with the regulatory agencies in the US and Europe. In December 2021, the EMA concluded that the clinical data from the Triac Trial I, together with the published data from long-term treatment, is sufficient for a regulatory submission of a Marketing Authorisation Application (MAA) to the EMA for the treatment of MCT8 deficiency and Egetis has successfully completed the submission on October 9, 2023. The average review time for MAAs is generally 13-14 months.

FDA acknowledges that a treatment effect on T3 levels and the manifestations of chronic thyrotoxicosis in MCT8- deficiency could provide a basis for marketing approval also in the US. Egetis is conducting a randomized study in 16 evaluable patients for up to 30 days to verify the T3 results, seen in previous clinical trials and publications. The design of this study (ReTRIACt) is available on clinicaltrials.gov under the code NCT055793. It is well established that the T3 levels in untreated MCT8 patients are significantly elevated, and we have previously shown that Emcitate is able to normalize these levels rapidly and durably. So far 13 patients have been included, whereof 6 patients have completed the randomized phase. Recruitment will continue until at least 16 patients have completed the randomized phase. As previously communicated, the Company will update the market as soon as recruitment closes. At that time, the Company will also inform when to expect topline results and when the Company plans to submit the NDA application.

The Triac Trial II study included 22 young boys with MCT8 deficiency (<30 months old) and investigated the neurodevelopmental effects of early intervention with tiratricol. Top-line results were published in June-2024. The trial did not meet its primary endpoints, which were assessed by changes in the Gross Motor Function Measure (GMFM)-88 total score and the Bayley Scales for Infant and toddler Development (BSID)-III Gross Motor Skill domain, compared to natural history scores from the Triac Trial I. Among key secondary endpoints, total serum thyroid hormone T3 concentrations were reduced significantly and durably in all patients, thereby verifying tiratricol's ability to alleviate thyrotoxicosis in MCT8 deficiency patients.

The trial confirmed the well-tolerated safety profile seen in previous clinical studies, despite higher dosing per kg body weight compared to previous studies.

Emcitate is already supplied to approximately 220 patients in Managed Access Programs, following individual regulatory approvals from national regulatory agencies in over 25 countries, The most recent program to open is the EAP in the USA, requested by the FDA. Managed Access Programs allow early access to a medicine prior to regulatory marketing approval, granted to pharmaceuticals under development for conditions with high unmet medical needs and where no available treatment alternatives exist

Emcitate has been granted orphan drug designation (ODD) for RTH-β in the USA and the EU. RTH-β is an additional indication, without overlap in patient populations, to the previously obtained ODD for MCT8 deficiency. The ODD for RTH-β is a direct result of Egetis' work to extend the indications for the Emcitate program to related but distinct conditions.

About Aladote

Aladote is a first-in-class drug candidate with the potential to reduce the risk of acute liver failure associated with paracetamol/acetaminophen poisoning. Aladote has shown a beneficial effect in relevant preclinical models, even in the time window when N-acetylcysteine (NAC) treatment no longer is effective (>8 hours). A proof of principle study in patients with paracetamol poisoning to prevent acute liver injury has been successfully completed. The study results provide preliminary evidence of the safety and tolerability of the combination of Aladote and NAC. Further, the results indicate that Aladote may reduce acute liver injury in this patient population.

Aladote has been granted Orphan Drug Designation (ODD) in the US and EU.

Paracetamol/acetaminophen is the most used drug in the world for the treatment of fever and pain, but

also one of the most overdosed drugs – intentionally or unintentionally. Paracetamol overdose is one of the most common methods in suicide attempts. When excessive amounts of paracetamol are metabolized in the liver, the harmful metabolite N-acetyl-p-benzoquinone imine (NAPQI) is formed, which can cause acute liver failure. The current standard of care for paracetamol poisoning, NAC, is effective if the patient receives medical care within eight hours of ingestion.

A pivotal Phase IIb/III study, Albatross, will be targeting patients with increased risk of liver injury, who arrive late at hospital, more than eight hours after a paracetamol overdose, for which current standard of care, NAC, is substantially less effective. The study has been parked until after Emcitate marketing authorization submissions for MCT8 deficiency have been completed.

Financial Information

Half-year report January - June 2024

Revenue and results

Revenue

Revenue amounted to MSEK 13.9 (5.9) during the quarter and MSEK 25.9 (12.7) for the period. Revenue consisted of 'Managed Access Program' Emcitate revenue of MSEK 13.9 (5.9) for the quarter and MSEK 25.9 (12.7) for the period. The increase in revenue during the quarter stems from increased demand for Emcitate, adjusted reimbursement levels and regional variations in orders.

Costs of goods

Cost of goods sold amounted to MSEK -3.1 (-1.3) for the quarter and MSEK-5.6 (-3.6) for the period and is entirely attributable to Emcitate. The increase in the quarter is due to increased volumes of Emcitate.

Operating expenses

Total operating expenses amounted to MSEK -86.0 (-84.9) for the quarter and MSEK -164.1 (-164.3) for the period.

Research and development expenses

Research and development expenses amounted to MSEK -40.1 (-42.8) for the quarter and MSEK -72.9 (-87.5) for the period. At the beginning of the corresponding period last year several cost items within R&D, such as costs related to production of Emcitate and preclinical activities, coincided.

Marketing and sales expenses

During the quarter, marketing and sales expenses amounted to MSEK -24.3 (-18.3) and for the period MSEK -46.8 (-35.8). The increase in costs compared to the same period of the previous year primarily stems from the expansion of the workforce and increased activity in preparation for the planned commercialization of Emcitate.

Administrative expenses

Administrative expenses amounted to MSEK -21.7 (-22.7) during the quarter and MSEK-43.2 (-39.6) during the period. The increase in costs during the quarter and period was mainly attributable to preparatory work within the corporate functions for the planned launch of Emcitate and increased costs for the employee stock option program (ESOP), which will continue to vary to some extent with the development of the stock price but has no impact on cash flow. The recognized costs for the ESOP were MSEK 1.6 for the period.

Other operating income and other operating expenses

Other operating income amounted to MSEK 2.0 (0.3) for the quarter and MSEK4.0 (1.0) for the period, and other operating expenses amounted to MSEK -2.0 (-1.4) for the quarter and MSEK -5.1 (-2.5) for the period. The change in other operating income and other operating expenses is primarily explained by currency exchange rate fluctuations related to operating receivables and liabilities.

Financial items – net

The net financial result amounted to MSEK 3.3 (0.8) for the quarter and MSEK-3.1 (0.8) for the period. The change compared to the same quarter and period previous year mainly consists of interest expenses related to the Company's loan financing, and revaluation of the lender's convertible right. The revaluation of the convertible right has no impact on cash flow and will continue to fluctuate with development of the stock price.

Tax

The total reported tax for the quarter amounted to MSEK 0.0 (-) and for the period MSEK 0.0 (-) and relates to the tax result in Egetis' subsidiary in the USA.

Result for the period

The result for the quarter amounted to MSEK-71.9 (-79.5) and MSEK-146.9 (-154.4) for the period. Earnings per share amounted to SEK -0.2 (-0.3) for the quarter and SEK -0.5 (-0.6) for the period, both before and after dilution.

Financial position

Cash

Cash as of June 30, 2024, amounted to MSEK 192.6 (179.2).

Cash flow

Cash flow from operating activities amounted to MSEK -56.4 (-64.2) for the quarter and MSEK -111.8 (-143.6) for the period. Cash flow for the quarter amounted to MSEK -57.1 (-64.8) and for the period MSEK -113.1 (51.0). Cash flow from operating activities is driven by costs related to the ongoing clinical trials and preparations for the planned commercialization of Emcitate.

The cash flow from investing activities amounted to MSEK - (-0.0) during the quarter and MSEK - (0.0) during the period. Cash flow from financing activities amounted to MSEK -0.6 (-0.6) during the quarter and MSEK -1.3 (194.7) during the period and primarily relates to leasing costs. In the corresponding period previous year, a capital markets transaction was conducted.

Equity and equity ratio

Equity amounted to MSEK 401.5 (550.9) as of June 30, 2024. Equity per average number of shares amounted to SEK 1.4 (2.3) for the period. The Company's solvency was 62 (90) %.

Debts and receivables

Long-term liabilities amounted to MSEK 95.9 (5.8) as of June 30, 2024. These consist of long-term loans of MSEK 57.3 (-), convertible loans and convertible right

of MSEK 32.2 (-), liabilities for leasehold rights MSEK 1.6 (3.3), deferred tax liability on leasehold rights MSEK 0.8 (-), and provisions for social charges related to the stock option programs of MSEK4.1 (2.5). Short-term liabilities amounted to MSEK 149.2 (52.1) and consisted mostly of other short-term and accrued liabilities of MSEK 95.8 (30.9), short-term portion of loans MSEK 19.5 (-), and accounts payable MSEK 33.8 (21.2). The increase in accrued liabilities is due to provisions for discounts determined annually. The provisions are estimated by the Company based on standard industry practices, with final adjustment to be made after agreement with authorities upon the Emcitate market approval.

Investments in tangible and intangible assets

Intangible fixed assets amounted to MSEK 408.6 (409.7) as of June 30, 2024. No significant investments have been classified as tangible fixed assets during the period.

Shares

The number of shares in the company amounted to 292,571,459 as of June 30, 2024. The number of shareholders amounted to 8,120 as of June 30, 2024. The top 10 largest shareholders held 64.5% of the share capital. Egetis Therapeutics' shares are listed on the main list of Nasdaq Stockholm.

Stock option plan and warrant programs Information regarding existing incentive programs

For information about current and previous employee stock option programs please see note 8.

Employees

Number of employees amounted to 34 (28) individuals as of June 30, 2024, comprising 21 women and 13 men (17 women and 11 men).

Parent company

The parent company's revenue for the quarter amounted to MSEK 25.8 (22.7) and MSEK 49.1 (42.2) for the period. Revenue for the period consisted of billing for intra-group services from the parent company to the subsidiary companies RTTI AB and Egetis Therapeutics US Inc. totalling MSEK 30.6 (19.9), and re billing of costs for Emcitate to RTTI AB totalling MSEK 18.5 (22.3). The revenue increase for the period mainly pertains to re-billing of administrative services within the organization.

Operating expenses amounted to MSEK -42.3 (-38.4) for the quarter and MSEK -84.4 (-74.2) for the period. The parent company's result for the quarter amounted to MSEK -72.5 (-94.8) and MSEK -124.0 (-131.1) for the period.

Financial fixed assets amounted to MSEK435.7 (434.1). Long-term loan liabilities amounted to MSEK 57.3 (-), convertible loans and convertible option to MSEK 32.2 (-), and other long-term liabilities to MSEK 4.1 (-2.5).

MSEK 2024 2023 2024 2023 2023
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Revenue 13.9 5.9 25.9 12.7 57.6
Costs of goods -3.1 -1.3 -5.6 -3.6 -11.0
Gross profit 10.7 4.6 20.3 9.1 46.6
Research and Development -40.1 -42.8 -72.9 -87.5 -194.0
Marketing and sales -24.3 -18.3 -46.8 -35.8 -86.6
Administrative expenses -21.7 -22.7 -43.2 -39.6 -86.2
Other operating income 2.0 0.3 4.0 1.0 8.9
Other operating expense -2.0 -1.4 -5.1 -2.5 -13.4
Operating expenses -86.0 -84.9 -164.1 -164.3 -371.4
Operating result -75.2 -80.3 -143.8 -155.2 -324.8
Financial items
Finance income 03 0.8 22 0.9 4.9
Finance expense -5.1 0.0 -10.0 -0.1 -4.2
Revaluation of convertible right 8.1 4.7 -2.7
Sum financial items 3.3 0.8 -3.1 0.8 -2.0
Results after financial net -71.9 -79.5 -146.9 -154.4 -326.8
Group contribution received
13x 0.0 0.0 -0.1
Results after tax -71.9 -79.5 -146.9 -154.4 -326.9
Share Data
Number of outstanding shares at the end of period 292,571,459 249,589,128 292,571,459 249,589,128 292,571,459
Average number of outstanding shares during period 292,571,459 249,589,128 292,571,459 244,561,504 256,752,282
Average number of shares during period, after dilution 300,556,495 255,537,608 298,993,082 249,612,356 260,011,478
Earnings per share (SEK) -0.2 -0.3 -0.5 -0.6 -1.3
Earnings per share after dilution (SEK) -0.2 -0.3 -0.5 -0.6 -1.3
Equity per average number of outstanding shares 1.4 22 1.4 23 21
1.4 22 1.4 2.3 2.1
Equity per average number of shares, after dilution
MSEK 2024 2023 2024 2023 2023
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Net loss for the period -71.9 -79.5 -146.9 -154.4 -326.9
Translation exchange rate differences 0.0 0.2 0.1 0.2 -0.1
Comprehensive income for the period -71.9 -79.3 -146.7 -154.2 -327.0
MSEK 30/06/2024 30/06/2023 31/12/2023
ASSETS
Non-current assets
Research and development costs 404.8 404.8 404.8
Licenses 3.8 4.9 4.3
Right-of-use assets 3.8 5.4 4.3
Deferred tax asset 0.8 - -
Equipment 0.0 0.1 0.1
Financial non-current assets 0.8 0.8 0.8
Total non-current assets 414.1 416.0 414.3
Current assets
Inventories 1.0 0.1 0.7
Accounts receivables
Other receivables 20.9 4.2 28.2
13.1 6.6 8.2
Prepaid expenses and accrued income 4.9 2.6 5.5
Cash and bank balance 192.6 179.2 303.3
Total current assets 232.5 192.7 345.9
Total assets 646.6 608.8 760.2
MSEK 30/06/2024 30/06/2023 31/12/2023
Equity
Share capital 15.4 13.1 15.4
Other capital contributions 1,780.0 1,622.6 1,780.0
Reserves 19.4 9.1 16.7
Accumulated loss including net loss -1,413.3 -1,093.9 -1,266.5
Total equity 401.5 550.9 545.6
Non-current liabilities
Borrowing 89.4 - 103.4
Deferred tax liability 0.8 - -
Other non-current liabilities 1.6 3.3 2.2
Provisions 4.1 2.5 5.1
Total non-current liabilities 95.9 5.8 110.8
Current liabilities
Accounts payable 33.8 21.2 28.7
Current tax liabilities - - 0.1
Borrowing 19.5 - 5.2
Other liabilities 10.1 8.1 6.8
Accrued expenses and deferred income 85.7 22.8 63.0
Total current liabilities 149.2 52.1 103.9
Total equity and liabilities 646.6 608.8 760.2
MSEK 2024 2023 2024 2023 2023
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
OPERATING ACTIVITIES
Result after financial net -71.9 -79.5 -146.9 -154.4 -326.8
Adjustments for non-cash items -7.9 -0.3 1.5 3.3 17.7
Tax paid 0.0 0.0
Cash flow from operating activities before -79.8 -79.8 -145.4 -151.1 -309.3
changes in working capital
Cash flow from changes in working capital
Increase/decrease in operating receivables -5.8 2.1 2.7 6.1 -22.9
Increase/decrease in operating liabilities 29.1 13.6 30.9 1.3 53.8
Cash flow from changes in working capital 23.3 15.6 33.6 7.5 30.9
Cash flow from operating activities -56.4 -64.2 -111.8 -143.6 -278.4
INVESTING ACTIVITIES
Acquisition of subsidiaries, net cash required
Investment in financial assets 0.0 0.0
Purchase of property, plant and equipment 0.0 0.0
Cash flow from investing activities 0.0 0.0 0.0
FINANCING ACTIVITIES
New share issue 210.0 381.9
Cost new share issue -14.0 -26.3
Proceeds from borrowings 108.8
Repayment of loans -3.0
Repayment of leases -0.6 -0.6 -1.3 -1.3 -2.6
Cash flow from financing activities -0.6 -0.6 -1.3 194.7 458.9
Cash flow for the period -57.1 -64.8 -113.1 51.0 180.4
Balance at beginning of period 251.8 243.5 303.3 127.7 127.7
Change in cash -57.1 -64.8 -113.1 51.0 180.4
Exchange rate difference in cash -2.1 0.5 2.3 0.4 -4.8
CASH BALANCE AT THE END OF THE PERIOD 192.6 179.2 192.6 179.2 303.3
MSEK Share capital Other capital Accumulated loss incl.
contributions net results for the period
Other reserves Total equity
Opening balance 01/01/2024 15.4 1 780,0 -1 266.5 16,7 545,6
Comprehensive income for the period -146,7 -146.7
Transactions with shareholders
Issued warrants 3.4 3,4
Costs due to share-based payments of employee stock option plan -0.7 -0,7
Closing balance 30/06/2024 15,4 1 780,0 -1 413,3 19,4 401,5
Opening balance 01/01/2023 11,3 1 428.4 -939.6 6.1 506,2
Share issue 4,1 377,8 381,9
Costs, share issue -26.3 -26.3
Comprehensive income for the period -327.0 -327,0
Transactions with shareholders
Issued warrants 3.4 3.4
Costs due to share-based payments of employee stock option plan 7,2 7,2
Closing balance 31/12/2023 15.4 1 780,0 -1 266,5 16,7 545,6
2024 2023 2023
Jan-Jun Jan-Jun Jan-Dec
Equity, MSEK 401.5 550.9 545.6
Equity ratio, % 62 90 72
Number of outstanding shares at the end of the period 292,571,459 249,589,128 292,571,459
Average number of outstanding shares during the period 292,571,459 244,561,504 256,752,282
Average number of shares during the period after dilution 298,993,082 249,612,356 260,011,478
Share Data, SEK
Earnings per share -0.5 -0.6 -1.3
Earnings per share after dilution -0.5 -0.6 -1.3
Cash flow from operating activities per average number of outstanding shares -0.4 -0.6 -1.1
Equity per average number of outstanding shares 1.4 2.3 2.1
Equity per average number of shares after dilution 1.4 2.3 2.1
Dividend - - -
Average number of employees 32 23 27

*Effect from dilution is not considered when result is negative.

MSEK 2024 2023 2024 2023 2023
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Jan-Dec
Revenue 25.8 22.7 49.1 42.2 93.6
Costs of goods - - - - -
Gross profit 25.8 22.7 49.1 42.2 93.6
Research and Development -12.8 -11.9 -23.5 -24.6 -56.3
Marketing and sales -9.4 -7.5 -19.9 -16.0 -38.4
Administrative expenses -19.9 -18.7 -40.6 -33.3 -78.1
Other operating income 0.2 0.0 0.3 0.1 4.5
Other operating expense -0.5 -0.2 -0.7 -0.4 -4.4
Operating expenses -42.3 -38.4 -84.4 -74.2 -172.7
Operating result -16.6 -15.6 -35.3 -32.0 -79.2
Financial items
Finance income 0.1 0.9 0.5 0.9 4.8
Finance expense -4.1 0.0 -8.9 0.0 -3.9
Revaluation of convertible right 8.1 - 4.7 - -2.7
Sum financial items 4.1 0.9 -3.7 0.9 -1.8
Results after financial net -12.5 -14.8 -39.0 -31.1 -80.9
Group contribution received/ given -60.0 -80.0 -85.0 -100.0 -245.0
Tax - - - - -
Results after tax -72.5 -94.8 -124.0 -131.1 -325.9
MSEK 30/06/2024 30/06/2023 31/12/2023
ASSETS
Non-current assets
Equipment 0.0 0.1 0.1
Financial non-current assets 435.7 434.1 435.0
Total non-current assets 435.8 434.2 435.0
Current assets
Receivables from Group companies 1.0 0.5 0.5
Other receivables 0.1 0.5 0.0
Prepaid expenses and accrued income 5.4 4.4 9.3
Cash and bank balance 155.3 161.7 271.6
Total current assets 161.8 167.1 281.5
Total assets 597.6 601.3 716.5
MSEK 30/06/2024 30/06/2023 31/12/2023
Equity
Restricted Equity
Share capital 15.4 13.1 15.4
Non-restricted equity
Share premium reserve 505.0 673.5 830.9
Reserves
Net loss for the period
19.4 9.0 16.7
Total equity -124.0
415.7
-131.1
564.5
-325.9
537.1
Non-current liabilities
Borrowing 89.4 - 103.4
Provisions
Total non-current liabilities
4.1
93.5
2.5
2.5
5.1
108.6
Current liabilities
Liabilities to group company
Accounts payable 41.8
11.3
14.1
5.2
38.1
5.5
Borrowing 19.5 - 5.2
Other liabilities 7.7 5.6 4.3
Accrued expenses and deferred income 7.9 9.4 17.7
Total current liabilities 88.4 34.3 70.9
Total equity and liabilities 597.6 601.3 716.5

Notes

Note 1 - Accounting principles

Egetis applies International Financial Reporting Standards (IFRS) as adopted by the EU. This report is prepared in accordance with IAS 34 Interim Financial Reporting and the Annual Accounts Act and should be read together with the Egetis consolidated financial statements for the year ended December 31, 2023. The interim report does not include all disclosures that would otherwise be required in a complete set of financial statements. Applied accounting principles and calculation methods are the same as in the latest annual report for 2023. Some amendments to existing standards became applicable from January 1, 2024, however none of these have a material impact on the consolidated financial statements or accounting policies. The parent company and the Group's accounting currency is SEK. All the numbers in this interim report are, if nothing else is stated, presented in million SEK.

The preparation of interim reports requires certain critical accounting estimates to be made. Furthermore, company management is required to make assessments when applying accounting principles. See the Group's accounting principles in the annual report 2023 regarding more information on estimates and assessments.

Parent company

The parent company Egetis Therapeutics AB (publ) prepares financial reports in accordance with the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities and the Swedish Annual Accounts Act. The parent company applies the exception from application of IFRS 16 Leases.

Operating risks

All business operations involve risk. Risks may be company specific or due to events in the external environment and may affect a certain industry or market. The group is, among others, exposed to the following operational and financial risks.

Operational risks:

Pharmaceutical development, Manufacturing, Regulatory, Commercialization, Competition and Market Acceptance and Intellectual property.

Financial risks:

Foreign currency, Need of working capital, General market risk, Credit and Interest rate risks.

A more detailed description of the Group's risk exposure is included in Egetis 2023 Annual Report, Risks and Risk Management section and Note 3. There are no major changes in the Group's risk exposure in 2024 compared with 2023.

External risk factors

Egetis Therapeutics is dependent on the efficient and uninterrupted operation of various IT systems to run its business. A significant breakdown or other disruption in the IT systems (for example as a result of a virus attack or network congestion attacks) can affect the ability to conduct business in general and can lead to delays and increased costs in the Company's research and development work.

There is a risk that the Company, as a result of such as viral pandemics, will not succeed in recruiting participants for its clinical studies, either because participants do not want, or due to restrictions should not, visit hospitals to avoid infection. There is also a risk that new variants of different microorganisms will lead to lockdowns in Sweden or in other countries, which could mean that the Company or its partners cannot conduct research and development work according to the existing clinical development plan. There is also a risk that caregivers need

to allocate resources to meet the effects of different pandemics, which can lead to limited resources to participate in the Company's clinical trials.

Continued and/or escalating tension between Russia and Ukraine led to Russia's full-scale military invasion of Ukraine and current inflationary situation in the society could have a significant negative impact on the global macroeconomic situation and the Swedish economy. It could result in the Company or its partners not being able to conduct R&D efforts according to plan.

A more detailed description of the Group's risk exposure is included in Egetis 2023 Annual Report, Risks and Risk Management section and Note 3. There are no major changes in the Group's risk exposure in 2024 compared with 2023.

Note 2 - Additional information

Other information in accordance with IAS 34.16A are found on the pages before the income statement and statement of comprehensive income. For information on earnings, cash flow and financial position, see page 9. For events after the period, see page 1.

Note 3 - Transition from cost-based income statement to functional based income statement

As of January 1, 2024, the group has transitioned from a cost-based income statement to a function-based income statement. The transition has been carried out to align the income statement with the internal review process by the Company's management. Furthermore, the function-based income statement is motivated by alignment to a format commonly used by the industrial peer group.

The below tables illustrate the income statements resulting from the transition, from a cost based to function-based income statement. Group 01/04/2023--30/06/2023

Cost based Costs of
sales of
goods Project costs
Other
external
costs
Employee
costs
Depreciation
and
impairment
Other
operating
expenses
Function
based
Revenue
Revenue
Costs of goods sold
5.9
0.0
-1.3 5.9 Total revenue
-1.3 Costs of goods sold
5.9 -1.3 0.0 0.0 0.0 0.0 0.0 4.6 Gross profit
Operating expenses
Costs of sales of goods
Project costs
-1.3
-41.5
1.3 41.5 0.0
0.0
Other external costs
Employee costs
-25.5
-15.8
25.5 15.8 0.0
0.0
Depreciation and impairment
Other operating expenses
-0.9
-1.1
0.9 0.0
1.1
0.0
0.0
-325
-9.1
-6.3
-5.8
-3.9
-3.4
-42.8 Research and Development
-18.3 Marketing and sales
0.1 -13.4 -8.4 -0.9 0.3
-1.4
-22.7 Administrative expenses
0.3 Other operating income
-1.4 Other operating expense
Operating results -80.3 0.0 0.0 0.0 0.0 0.0 0.0 -80.3 Operating result
Financial items Financial items
Interest income and similar items
Interest expense and similar items
Revaluation of convertible right
0.8
0.0
0 8 Finance income
0.0 Finance expense
- Revaluation of convertible right
Sum financial items
Results after financial net
0.8
-79.5
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.8 Sum financial items
-79.5 Results after financial net
Tax 0 0 0 0 0 0 Tax
-
Net loss for the period -79.5 0.0 0.0 0.0 0.0 0.0 0.0 -79.5 Results after tax
Cost based Costs of
sales of
goods Project costs Other
external
Costs
Employee
costs
Depreciation
and
impairment
Other
operating
expenses
Function
based
Revenue
Revenue
Costs of goods sold
12.7
0.0
-3.6 12.7 Total revenue
-3.6 Costs of goods sold
12.7 -3.6 0.0 0.0 0.0 0.0 0.0 9.1 Gross profit
Operating expenses
Costs of sales of goods
Project costs
-3.6
-89 4
3.6 89.4 0.0
0.0
Other external costs
Employee costs
-40.4
-31.2
-1.8
40.4 31.2 1.8 0.0
0.0
0.0
Depreciation and impairment
Other operating expenses
-1.5 -71.0 -7.1 -9.4 1.5 0.0
-87.5 Research and Development
-18.5
0.0
-10.9
-22.3
-6.3
-15.5
-1.8 -35.8 Marketing and sales
-39.6 Administrative expenses
1.0
-25
1.0 Other operating income
-2.5 Other operating expense
Operating results -155.2 0.0 0.0 0.0 0.0 0.0 0.0 -155.2 Operating result
Financial items Financial items
Interest income and similar items
Interest expense and similar items
Revaluation of convertible right
0.9
-0.1
0.9 Finance income
-0.1 Hinance expense
Revaluation of convertible right
Sum financial items
Results after financial net
0.8
-1154.4
0.8 Sum financial items
-154.4 Results after financial net
Tax - Tax
Net loss for the period -154.4 0.0 0.0 0.0 0.0 0.0 0.0 -154.4 Results after tax
Costs of
sales of
Other
external
Employee Depreciation
and
Other
operating
Function
Revenue Cost based goods Project costs costs costs impairment expenses based
Revenue 57.6 57.6 Total revenue
Costs of goods sold 0.0 -11.0 -11.0 Costs of goods sold
57.6 -11.0 0.0 0.0 0.0 0.0 0.0 46.6 Gross profit
Operating expenses
Costs of sales of goods -11.0 11.0 0.0
Project costs -193.5 193.5 0.0
Other external costs -85.8 85.8 0.0
Employee costs -84.0 84.0 0.0
Depreciation and impairment -3.6 3.6 0.0
Other operating expenses -4.6 4.6 0.0
-194.0 Research and Development
-157.0
-36.5
-19.3
-21.1
-17.7
-28.9
-86.6 Marketing and sales
0.0 -45.3 -37.3 -3.6 0.0 -86.2 Administrative expenses
8.9 8.9 Other operating income
-13.4 -13.4 Other operating expense
Operating results -324 8 0.0 0.0 0.0 0.0 0.0 0.0 -324.8 Operating result
Financial items Financial items
Interest income and similar items 4.9 4.9 Finance income
Interest expense and similar items -4 2 -4.2 Finance expense
Revaluation of convertible right -2.7 -2.7 Revaluation of convertible right
Sum financial items -2.0 2.0 Sum financial items
Results after financial net -326 8 -326.8 Results after financial net
Tax -0.1 -0.1 Tax
Net loss for the period -326.9 0.0 0.0 0.0 0.0 0.0 0.0 -326.9 Results after tax
Parent 01/04/2023--30/06/2023 Costs of Other Depreciation Other
Employee and operating
sales of external Function
Cost based goods Project costs costs Costs impairment expenses based
Revenue
Revenue 22.8 -0.1 22.7 Total revenue
Costs of goods sold 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Costs of goods sold
22.8 0.0 0.0 0.0 0.0 0.0 -0.1 22.7 Gross profit
Operating expenses
Costs of sales of goods
Project costs -12.3 12.3 0.0
Other external costs -11.6 11.6 0.0
Employee costs -14.3 14.3 0.0
Depreciation and impairment 0.0 0.0 0.0 0.0
Other operating expenses -0.2 0.2 0.0
-8.3 0.2 -3.8 -11.9 Research and Development
-3.2 -1.2 -3.2 -7.5 Marketing and sales
-0.8 -10.7 -7.3 0.0 0.1 -18.7 Administrative expenses
0.0 0.0 Other operating income
Operating results -15.7 0.0 0.0 0.0 0.0 0.0 -0.2
0.0
-0.2 Other operating expense
-15.7 Operating result
Financial items Financial items
Interest income and similar items 0.9 0.9 Finance income
Interest expense and similar items 0.0 0.0 Finance expense
Sum financial items
Results after financial net
0.9
-14.8
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.9 Sum financial items
-14.8 Results after financial net
Appropriations -80.0 -80.0 Appropriations
lax
Net loss for the period
-94.8 0.0 0.0 0.0 0.0 0.0 0.0 - Tax
-94.8 Results after tax

|--|

Costs of
sales of
Other
external
Employee Depreciation
and
Other
operating
Function
Cost based goods Project costs costs costs impairment expenses based
Revenue
Revenue 42.3 -0.1 42.2 Total revenue
Costs of goods sold 0.0 0.0 Costs of goods sold
42.3 0.0 0.0 0.0 0.0 0.0 -0.1 42.2 Gross profit
Operating expenses
Costs of sales of goods 0.0 0.0
Project costs -23.6 23.6 0.0
Other external costs -20.6 20.6 0.0
Employee costs -29.7 29.7 0.0
Depreciation and impairment 0.0 0.0 0.0
Other operating expenses -0.4 0.4 0.0
-14.6 -0.7 -9.4 -24.6 Research and Development
-8.0 -1.4 -6.6 -16.0 Marketing and sales
-1.0 -18.6 -13.7 0.0 -33.3 Administrative expenses
0.1 0.1 Other operating income
-0.4 -0.4 Other operating expense
Operating results -32.0 0.0 0.0 0.0 0.0 0.0 0.0 -32.0 Operating result
Financial items Financial items
Interest income and similar items 0.9 0.9 Finance income
Interest expense and similar items 0.0 0.0 Finance expense
Revaluation of convertible right 0.0 Revaluation of convertible
Sum financial items 0.9 0.9 Sum financial items
Results after financial net -31.1 -31.1 Results after financial net
Appropriations -100.0 -100.0 Appropriations
Tax - Tax
Net loss for the period -131.1 0.0 0.0 0.0 0.0 0.0 0.0 -131.1 Results after tax

Parent 01/01/2023--31/12/2023

Costs of
sales of
Other
external
Employee Depreciation
and
Other
operating
Function
Cost based goods Project costs costs costs impairment expenses based
Revenue
Revenue 98.1 -4.5 93.6 Total revenue
Costs of goods sold 0.0 0.0 0.0 Costs of goods sold
98.1 0.0 0.0 0.0 0.0 0.0 -4.5 93.6 Gross profit
Operating expenses
Costs of sales of goods 0.0 0.0 0.0
Project costs -55.2 55.2 0.0
Other external costs -43.7 43.7 0.0
Employee costs -73.9 73.9 0.0
Depreciation and impairment -0.1 0.1 0.0
Other operating expenses -4.4 4 4 0.0
-36.9 -1.8 -17.6 -56.3 Research and Development
-16.9 -22 -19.3 -38.4 Marketing and sales
-1.4 -39.7 -37.0 -0.1 -78.1 Administrative expenses
4.5 4.5 Other operating income
-4.4 -4.4 Other operating expense
Operating results -79.2 0.0 0.0 0.0 0.0 0.0 0.0 -79.2 Operating result
Financial items Financial items
Interest income and similar items 4.8 4.8 Finance income
Interest expense and similar items -3.9 -3.9 Hinance expense
Revaluation of convertible right -2.7 -2.7 Revaluation of convertible right
Sum financial items -1.8 -1.8 Sum financial items
Results after financial net -80.9 -80.9 Results after financial net
Appropriations -245.0 -245.0 Appropriations
Tax 0.0 0.0 Tax
Net loss for the period -325.9 0.0 0.0 0.0 0.0 0.0 0.0 -325.9 Results after tax

Note 4 - Segments

The Group applies segment reporting with mainly two independent development areas, Emcitate and Aladote. The highest executive decision-maker in the Company allocates the Company's resources between these two R&D projects. The Aladote project has been parked since June 2023. Revenue for Emcitate is attributable to the 'Managed Access Program' use of the drug candidate.

Revenue and expenses attributable to Emcitate and Aladote are reported below.

2024
Apr-Jun
MSEK Emcitate Aladote Common Sum
Revenue 13.9 13.9
Costs of sales of goods -3.1 -3.1
Project costs -36.7 -0.8 -37.5
Other -48.4 -48.4
Operating results -25.9 -0.8 -48.4 -75.2
Net financial items 3.3
Pretax profit -71.9
2023
Apr-Jun
MSEK Emcitate Aladote Common Sum
Revenue 5.9 5.9
Costs of sales of goods -1.3 -1.3
Project costs -41.0 -0.6 -41.5
Other -43.3 -43.3
Operating results -36.4 -0.6 -43.3 -80.3
Net financial items 0.8
Pretax profit -79.5
2024
Jan-Jun
MSEK Emcitate Aladote Common Sum
Revenue 25.9 25.9
Costs of sales of goods -5.6 -5.6
Project costs -67.0 -0.9 -68.0
Other -96.7 -96.2
Operating results -46.8 -0.9 -96.2 -143.8
Net financial items -3.1
Pretax profit -146.9
2023
Jan-Jun
MSEK Emcitate Aladote Common Sum
Revenue 12.7 0.0 12.7
Costs of sales of goods -3.6 -3.6
Project costs -88.1 -1.3 0.0 -89.4
Other -74.9 -74.9
Operating results -79.0 -1.3 -74.9 -155.2
Net financial items 0.8
Pretax profit -154.4

14.5

43.1

2023
Jan-Dec
MSEK Emcitate Aladote Common Sum
Revenue 57.6 0.0 57.6
Costs of sales of goods -11.0 -11.0
Project costs -189.4 -4.1 0.0 -193.5
Other -177 9 -177.9
Operating results -142.9 -4.1 -177.9 -324.8
Net financial items -2.0
Pretax profit -326.8

Turnover by type of revenue 2024 2023 2024 2023 2023 MSEK Apr-Jun Jan-Jun Jan-Jun Jan-Dec Apr-Jun License sales Sales of goods 13.9 5.9 25.9 12.7 Total 13.9 5.9 25.9 12.7 57.6

Note 5 - Contingent liabilities

Egetis has a contractual obligation to pay the former owners of Rare Thyroid Therapeutics International AB and Erasmus Medical Center, in the event of future sales of Emcitate, the equivalent of 3% and 10% of the net sales of the product. In addition, former owners have the right to a one-time payment equal to 50% of the net proceeds in the event of a future sale of the U.S. Rare Pediatric Disease Priority Review Voucher (PRV).

Note 6 - Related party transactions

Peder Walbergand Elisabeth Svanberg havebeen providing consultancy services to the company, invoicing MSEK 0.3 and 0.1 respectively (1.0 and 0.0) during the period.

Note 7 - Borrowing

MSEK 30/06/2024 30/06/2023 31/12/2023
Convertible loan (Excluding convertible right) -25.2 -23.5
Convertible right -6.9 -11.1
Borrowing - Non-current -57.3 -68.8
Borrowing - Current -19.5 -5.2
Total -109.0 - -108.6

Loan

During the fourth quarter 2023, a combined financing was carried out, consisting of a directed share issue of approximately SEK 172 million and a debt financing of about SEK 290 million, aimed at funding the ongoing development towards the application for the first approved treatment for MCT8 deficiency patients. The debt financing in Euros is divided into two parts, 10 million euros ("Tranche A") and 15 million euros ("Tranche B"). Tranche B will be made available provided that the Company meets certain conditions, including those related to the phase III study (ReTRIACt) for Emcitate. The interest rate for the tranches is based on the ECB's base rate (MRO) plus a margin. An interestrate discount will be applied upon FDA approval of Emcitate.

Tranche A was utilized on November 30, 2023 and matures on April 1, 2027. Tranche B is available for utilization until September 30, 2024 and matures on December 1, 2027.

Warrants

As part of the Debt Financing, the lender will also receive warrants entitling them to subscribe for shares in the Company. The total number of warrants to be issued to the lender will depend on the utilization of Tranche A and Tranche B. Upon full utilization of Tranche B, the lender will be entitled to 1,090,977 warrants and 1,636,464 warrants, respectively. This is equivalent to 0.9 percent of the total number of shares in the Company on a fully diluted basis. The exercise price for the warrants is 4.26 SEK. The warrants will be subject to customary recalculation terms and shall be exercisable prior to the tenth anniversary of the grant date. In connection with the utilization of Tranche A, 1,090,977 warrants were issued with an estimated market value of 3.4 million SEK, which is reported as an increase in the equity of the parent company and the group.

Convertible Loan

A portion of Tranche A is a convertible loan of 3 million euros, which can be converted into shares in the Company at a conversion rate of approximately 0.5133 euros per share. Repayment of the convertible loan shall be made no later than April 1, 2027, unless conversion occurs before then. The convertible loan, which grants a right but not an obligation to convert the loan into shares, is denominated in euros and, as indicated in note 1, the criteria for accounting for the convertible as an equity instrument are not met. Therefore, the conversion option is classified as a derivative and is remeasured continuously at fair value through the income statement. This remeasurement has no impact on cash flows.

Note 8 - Employee Stock Option Plan

Egetis implements stock option plans for employees (ESOP) and key consultants. The options are granted to participants free of charge. The options have a three-year vesting period from the grant date, provided, with

customary exceptions, that the participant is still employed by/providing services to Egetis. Once the options are vested, they can be exercised within a one-year period or a six-months period dependent on the terms of the respective ESOP. Each vested option entitles the holder to acquire one share in Egetis at a predetermined price, unless recalculation based on the terms and conditions has not been applied. The options have been valued at each grant date according to the Black-Scholes valuation model. For further information, see Note 11 in the Annual Report 2023.

During the second quarter, ESOP 2020/2024 with 2,800,000 outstanding options forfeited and a new ESOP of 7,968,600 options was allotted. The CEO and the rest of the management team (ten individuals) were granted 1,630,600 and 4,674,600 employee stock options, respectively.

During the second quarter of 2024, the average share price exceeded the exercise price of the ESOP-2022 why a dilution impactis reported in the number of shares after dilution. However, as earnings per share are negative, no dilution is reported in the key ratio earnings per share after dilution. As of June 30, 2024, the company has four ESOPs outstanding. Full utilization of the granted employee stock options and the lender warrants would increase the number of shares in the company by 28,996,736.

Changes in outstanding employee stock options and warrants to lenders during the first six months 2024

2024/2027 Option plan Option plan
2023 2026
2022 2026 2021/2025 to lender Option plan Option plan Warrants Total number of
outstanding
options
Number of outstanding options 01/01/2024 8,491,276 7,109,272 4,850,000 1,090,977 21,541,525
Number of granted options during the period 7,968,600 7,968,600
Number of forfeited options during the period -218,978 -238.411 -150,000 -607,389
Number of outstanding options 6/30/2024 7,968,600 8,272,298 6,870,861 4,700,000 1,090,977 28,902,736
Corresponding number of shares after
recalculation 6/30/2024
7,968,600 8,272,298 6,870,861 4,794,000 1,090,977 28,996,736

Note 9 -Key ratios definitions

Ratios that have been calculated according to IFRS

Earnings per share. Net income divided by average number of shares before dilution.

Number of shares at end of period. The number of outstanding shares before dilution at the end of the period. Number of shares after dilution. The number of issued shares after dilution effect of potential shares at end of period.

Average number of shares during the period. Average number of outstanding shares before dilution for the period.

Average number of shares during the period after dilution. Average number of issued shares after dilution effect of potential shares.

Project costs Refer to external costs that are directly attributable to the Group's costs regarch and development of drug candidates.

Ratios that have not been calculated in accordance with IFRS The company defines the below ratios as follows.

Equity ratio, % The period's closing equity divided by the period's closing balance sheet. The Company uses the alternate Equity ratio as it shows the proportion of total assets represented by shareholders' equity and has been included to allow investors to assess the Company's capital structure.

Cash flow from operations per share. Cash flow from operating activities divided by the average number of shares outstanding at the end of the period. The Company uses the alternate key figure Cash flow from operations per share because the Company believes that the key ratio gives investors a better understanding of the Company's cash flow in relation to its number of shares adjusted for changes in the number of shares outstanding during the period.

Equity per share. Equity divided by number of shares outstanding at the end of the period. Outstanding stock options and warrants are only considered if they are "in the money". The Company uses the alternate key ratio equity per share because the Company believes that the key ratio gives investors a better understanding of the historical return per share adjusted for changes in the number of shares outstanding during the period.

2024 2023 2023
Jan-Jun an-Jun an-Dec
A Equity, MSEK 401,5 550.9 545,6
B Balance sheet total, MSEK 646,6 608,8 760,2
A/B Equity ratio % 62 90 72
A Net result, MSEK -146,7 -154,2 -327,0
B Equity, MSEK 401,5 550,9 545,6
A/B Return on equity, % neg. neg. neg.
A Cash flow from operating activities, MSEK -111,8 -143,6 -278,4
B Average number of outstanding shares during the period, kSEK 292 571 244 562 256 752
A/B Cash flow from operating activities per shares, SEK -0.4 -0.6 -1.1
A Equity, MSEK 401,5 550.9 545,6
B Average number of outstanding shares during the period, kSEK 292 571 244 562 256 752
A/B Equity per average number of shares before dilution, SEK 1.4 2.3 2.1
A Equity, MSEK 401,5 550,9 545,6
B Average number of shares at the end of the period after dilution, kSEK 298 993 244 562 256 752
A/B Equity per average number of shares after dilution, SEK 1.4 2.3 2.1

Number of employees (average). The average number of employees at the end of each period.

Other information

Next reports

Interim report January 1- September 30: November 8, 2024 Full year results January 1- December 31: February 26, 2025 Interim report January 1- March 31: April 30, 2025

This report, and further information is available on the website, www.egetis.com This report has not been reviewed by the Company's auditor. This is a translation of the Swedish interim report.

For further information, please contact:

Nicklas Westerholm, CEO [email protected] Yilmaz Mahshid, CFO [email protected]

Karl Hård, VP Investor Relations and Business Development [email protected]

This information is such information as Egetis Therapeutics AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on August 22, 2024, at 7.00 am (CEST).

Egetis Therapeutics AB (publ) Klara Norra kyrkogata 26, 111 22 Stockholm, Sweden Org.nr. 556706-6724 Phone: +46(0)8-679 72 10 www.egetis.com

Analysts who follow Egetis Therapeutics

ABGSC: Alexander Krämer Bryan, Garnier & Co: Oscar Haffen Lamm Carnegie: Arvid Necander Handelsbanken: Mattias Häggblom & Rickard Anderkrans Nordea: Patrik Ling Pareto Securities: Chien-Hsun Lee Redeye: Fredrik Thor Rx Securities: Joseph Hedden

EGETIS

THミRAPEUTICS

Certification

This Half year report for January-June 2024 provides a true and fair overview of the parent's and group's business activities, financial position, and results of operations, and describes significant risks and uncertainties to which the companies in the group are exposed.

Stockholm, August 22, 2024

Mats Blom Thomas Lönngren
Chairman of the board Board member
Gunilla Osswald Elisabeth Svanberg
Board member Board member
Peder Walberg Behshad Sheldon
Board member Board member

Nicklas Westerholm

CEO

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