AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Alligator Bioscience

Earnings Release Apr 25, 2023

3138_10-q_2023-04-25_aeff8258-efc8-40c9-a7a3-8d1032986a91.pdf

Earnings Release

Open in Viewer

Opens in native device viewer

Financial Results and Business Update

"The first quarter of 2023 was extremely busy, with significant progress made on the clinical development of Alligator's pipeline, as well as on the business front. We reported outstanding data for mitazalimab, and additional data on progress free survival is expected in Q2 2023. That is just one of the important milestones ahead, and we at Alligator are all looking forward to sharing more about our progress in the coming months."

Søren Bregenholt

CEO Alligator Bioscience AB (publ)

Significant events: January – March 2023

Expansion of the immuno-oncology research collaboration and license agreement with Orion

Alligator and Orion initiated a second program under their collaboration and license agreement aiming to develop a bispecific antibody with potential applications in solid tumors.

Positive interim results from mitazalimab OPTIMIZE-1 Phase 2 trial in pancreatic cancer

Alligator announced a 52.5% Objective Response Rate in interim efficacy analysis of mitazalimab combined with mFOLFIRINOX in 1st line metastatic pancreatic cancer.

First patient dosed with ALG.APV-527 in Phase 1 Clinical Trial

Phase 1 study evaluating ALG.APV-527 in patients with solid tumors expressing the tumor-associated antigen 5T4 began.

Alligator presented at the European Bispecific & Multispecific Antibody Congress

Presentation on the obligate mechanism of action for bi-/ multispecific antibodies and the de-risking of current and future efforts.

New Chief Technology Officer announced

Laura von Schantz promoted to CTO to oversee Alligator's discovery pipeline and antibody technology development activities.

Key Opinion Leader interview on mitazalimab and the positive interim results from the OPTIMIZE-1 Phase 2 trial in pancreatic cancer

Interview with OPTIMIZE-1 Principal Investigator Jean-Luc Van Laethem from Erasmus Hospital.

Change of Employee representative on Board of Directors

Tova Landström replaced Laura von Schantz as employee representative on Board of Directors.

Announcement of Rights Issue

Alligator announced it intends to carry out a 91 percent secured rights issue of units of approximately SEK 199 million.

Significant events after the period

IND for OPTIMIZE-2 cleared by FDA

FDA authorization to initiate mitazalimab OPTIMIZE-2 phase 2 trial in urothelial carcinoma.

OPTIMIZE-1 fully recruited

Completion of patient enrolment in mitazalimab OPTIMIZE-1 phase 2 trial in pancreatic cancer and confirmation of timeline for top-line data in Q1 2024.

Rights Issue approved at EGM

The Extraordinary General Meeting on April 24, 2023 resolved to approve the rights issue of approximatly SEK 199 million, in accordance with the Board of Directors proposal. The subscription period in the rights issue runs from April 28 to May 12, 2023.

Financial summary

Figures in brackets refer to the outcome for the corresponding period in the preceding year.

January – March 2023

  • Net sales, SEK 9.6 million (5.4)
  • Operating profit/loss, SEK -62.2 million (-43.0)
  • Profit/loss for the period, SEK -62.5 million (-43.1)
  • Earnings per share before and after dilution, SEK -0.28 (-0.20)
  • Cash flow for the period, SEK -52.2 million (-43.8)
  • Cash and cash equivalents, SEK 44.8 million (97.3)

CEO Comments

Alligator Bioscience continues to make significant clinical progress with the OPTIMIZE-1 trial of our lead drug candidate mitazalimab. Key efficacy data are expected in the next few months following the outstanding interim results we announced at the start of the quarter, which showed the great potential our CD40 agonist has as a first line combination therapy for pancreatic cancer.

The highly encouraging 52% Objective Response Rate that we reported in January 2023 strongly suggests that mitazalimab in combination with chemotherapy offers significant clinical benefit for pancreatic cancer patients over standard of care. Since releasing those results, the Alligator team has continued working diligently, and on April 12 we announced that the enrolment of OPTIMIZE-1, had been completed, thereby significantly derisking the program. We now focus on progressing their treatment and follow-up as we advance towards the next milestone in the study, the first interim Progression Free Survival data due in mid-2023. We remain on track to report full top-line data in the beginning of Q1 2024.

The progress we are making with the OPTIMIZE-1 trial further underlines our firm belief in mitazalimab's clinical and commercial potential and we are now raising additional funding to allow us to complete the Phase 2 trial, prepare mitazalimab for Phase 3 clinical development and step up our manufacturing investments. Our preferential rights issue announced in March will spare us from the current financial market volatility and provide sufficient cash runway for us to deliver our next major inflection points on mitazalimab, including the full topline data, which we believe will significantly increase Alligator's value and offers the best path forward for our company, investors and patients.

We anticipate initiating discussions with regulators on mitazalimab's accelerated development and route to market in the US and Europe in the second half of this year. The upcoming interim PFS data will be used along with the ORR as a basis for the discussions. These data are also being utilized in our ongoing preparatory work on OPTIMIZE-2, our second Phase 2 clinical study with mitazalimab, which represents a welcome broadening of the asset's clinical development. Beginning of April we announced FDA's clearance of our Investigational New Drug application for OPTIMIZE-2 allowing us to initiate the study, which we expect to happen in H1 2024, or earlier if operationally feasible.

In other clinical developments this quarter, we dosed the first patient in our joint Phase 1 trial of ALG.APV-527, which we are co-developing with Aptevo Therapeutics. The initiation of this Phase 1 trial is an important milestone in the development of ALG.APV-527 and further underlines the strength of our collaboration with Aptevo. We place great importance on the value of our partnerships, which provide Alligator with external validations of our technology platforms along with opportunities to generate income, manage risk and maximize shareholder value over the long term.

A good example of this is our research collaboration and license agreement with Orion Corporation, which was expanded this quarter to include the development of a new bispecific antibody. The agreement not only makes Alligator eligible for development, regulatory approval, and sales milestone payments worth more than 300 million euros but is also a testament to the power of our scientific and technological capabilities.

We further strengthened those capabilities this quarter with the appointment of Laura von Schantz as our new Chief Technology Officer. Laura has a deep knowledge of the company having been with us since 2014 and she is the natural choice to oversee the technical aspects of our drive to advance and expand our best-inclass pipeline.

It has been a highly rewarding few months for Alligator in which we have taken significant steps both in the clinic and in the creation of new value for our shareholders and partners. I look forward to updating you on our progress again soon.

Søren Bregenholt CEO Alligator Bioscience AB (publ)

Performance measures Group

Note 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Result (KSEK)
Net sales 5 9,593 5,356 35,696
Operating profit/loss -62,191 -43,023 -192,789
Profit/loss for the period -62,543 -43,076 -193,403
R&D costs -60,092 -38,056 -186,945
R&D costs as a percentage of operating costs excl. Impairments, % 83% 78% 81%
Capital (KSEK)
Cash and cash equivalents at end of period 44,837 234,448 97,305
Cash flow from operating activities -49,233 -44,628 -172,607
Cash flow for the period -52,241 -43,770 -180,875
Equity at the end of the period 26,526 238,508 89,051
Equity ratio at the end of the period, % 22% 81% 53%
Info per share (SEK)
Average number of shares 220,584,878 220,584,878 220,584,878
Earnings per share after dilution* -0.28 -0.20 -0.88
Equity per share after dilution* 0.12 1.08 0.40
Personnel
Number of employees at end of period 58 48 53
Average number of employees 56 47 50

* Effect from dilution is not considered when result is negative and options where call rate is higher than closing rate is not considered.

Average number of employees employed within R&D 47 39 41

For definitions and calculations, see the sections later in this report.

Operating costs distributed by function, Parent Company

Operating costs, rolling 12 months and Liquidity (MSEK), Group

Operations

Alligator Bioscience is a clinical-stage biotech company developing tumor-directed best-inclass antibodies for hard-to-treat cancers. Our drug candidates have the potential to meet key needs in immuno-oncology by increasing the quantity and quality of tumor-specific T cells within the tumor and, at the same time, remodeling the tumor microenvironment and making the tumor more inflamed providing the immune system with better access to the tumor. Alligator's highest standards on the safety and efficacy of its drug candidates increase their potential to be combined with current standard therapies, which is key to improving clinical benefits in oncology today.

In the first quarter of 2023, the Company has reported significant advancements with its drug candidates. Our technology platforms and pharmaceutical research continue to build longterm value and attract interest from potential partners. To drive competitive and time-efficient development, some specific parts of Alligator's programs are conducted in collaboration with other biotechnology companies, contract laboratories, and leading international research institutions. In addition, our clinical studies are carried out in collaboration with leading specialist physicians and CROs with expertise in oncology clinical development. In summary, the Company has all the necessary expertise to pursue successful projects from concept to clinical development. This has been demonstrated by the OPTIMIZE-1 interim results showing the great potential of our lead drug candidate mitazalimab in pancreatic cancer.

Alligator's Organization

Alligator's research and development organization is divided into five units: Discovery, CMC (Chemistry, Manufacturing & Control), Non-Clinical Development, Medical Science and Clinical Operations. Members of all these functions collaborate crossfunctionally in project teams. The Discovery unit is responsible for early-stage research projects up until a drug candidate has been identified. This normally includes the development and evaluation of treatment concepts, the evaluation of potential drug candidates and early-stage confirmation of efficacy. The CMC unit develops manufacturing processes and is responsible for clinical trial material manufacturing. The Non-Clinical Development unit is responsible for pre-clinical evaluation of safety and efficacy of our molecules, including preparation of the data packages required for clinical trial applications. The Medical Science unit, led by our Chief Medical Officer, is responsible for designing all the clinical and regulatory development plans required to show that Alligator's products are safe and effective. The Clinical Operations unit is responsible for timely and excellent implementation of the clinical studies. Alligator will continue to build and shape the organization to match and support its strategy and objectives.

Several Proprietary Technologies

Alligator's technology platforms—FIND® (protein optimization technology), ALLIGATOR-FABTM, and ALLIGATOR-GOLD® (antibody libraries)—are used for the discovery and development of novel drug candidates. These platforms enable efficient generation of novel drug candidates with high potential.

In addition, the Company has bispecific antibody formats for the development of new dual-action antibodies. With the most recent antibody format, RUBYTM, Alligator can generate bispecific molecules from any two antibodies, with excellent properties in terms of stability and yield. The format eliminates the need for further optimization, enabling Alligator to quickly move drug candidates from preclinical research to clinical development.

Our 3rd generation proprietary platform technology aims at a more personalized immunotherapy, using CD40-antibodies that instruct the immune system to recognize and attack cancer cells, based on the tumor mutations unique to the individual patient. These antibodies contain one part that binds to tumors and tumor particles and another part that binds to dendritic cells through the CD40 molecule. This interaction between tumor particles and dendritic cells eventually results in a very efficient education and activation of tumor-specific T cells, that subsequently can recognize and destroy the tumor cells.

Business Model that Creates Value Across the Development Chain

The Company's business model is based on proprietary drug development. To maximize the value of the portfolio, the Company intends to bring molecules from drug discovery and preclinical studies to Proof-of-Concept in human clinical Phase 2 trials and beyond. To generate income, limit portfolio risk, and maximize long-term value creation, the Company seeks strategic global and regional partnerships for certain programs and technologies.

Immuno Oncology Market Overview

Cancer touches all our lives, either directly or through its effect on family and loved ones. With the continued rise of cancer diagnoses around the world, the need for more effective treatments also grows. Alligator's drug candidates are designed with an optimal efficacytolerability balance to meet the need for therapies that can safely be combined with current standard cancer treatments, to treat, or possibly even cure, cancers.

Oncology Market Trends

In 2020, 19.3 million new cancer cases were diagnosed globally, with the number expected to rise to 30.2 million by 2040,1 and the oncology drug market is expected to account for approximately 40% of the total drug market by 2028.2 A surge of new and innovative treatment methods is expected to emerge in the marketplace, and immunotherapies will play an important role in these treatment options for cancer.

Alligator believes that the demand for novel immunotherapy drugs will increase along with the global demand for new and more effective oncology therapies.

Immuno-oncology

Most tumors contain immune cells with the potential to attack and destroy cancer cells, and possibly eradicate the entire tumor itself. Cancer cells often activate immunosuppressive strategies to inhibit these types of attacks. Immunotherapies provide several different opportunities to help the immune system defend the body against the cancer. Such strategies could educate the immune system to better identify tumor cells or enhance the capabilities of the immune system to attack the tumor with full force.

Alligator's innovative assets and technologies target key immunooncology molecules to educate and activate the immune system to selectively attack tumors without affecting the rest of the body, a core concept that separates us from other competitors in the industry. The main benefit of tumor-directed treatment is the ability to effectively attack the tumor while minimizing the adverse effects caused by stimulating the whole immune system. This allows our candidates to work synergistically with current chemotherapy regimens and other immunotherapeutic drugs in hard-to-treat, metastatic solid tumors.

Our lead asset mitazalimab is in a clinical Phase 2 study for the treatment of metastatic pancreatic tumors, a tumor type that is one of the hardest cancers to treat and has one of the lowest five-year survival rates.

Approximately 300,000 people in the 16 major markets* are diagnosed with pancreatic cancer each year. Although surgery is the best treatment, only 15-20% of those diagnosed can be treated by surgery, while the remaining 85% are left with very few treatment options available to them, with chemotherapy regimens being the standard of care.2

We develop our pipeline programs, from Discovery Phase through clinical Phase 2, with an excellent efficacy-tolerability balance in mind, either alone or in collaboration with partners. These collaborations provide an opportunity of income, and an external validation of our platform, building on our confidence that our candidates will provide meaningful treatment options for people with hard-to-treat cancer, as stand-alone or combination therapies.

1 International Agency for Research on Cancer (IARC), Data version: 2020, April 2023. 2 Database GlobalData (Pharma Intelligence Center – Drug Sales), February 2023.

*) 16 main markets include: Australia, Brazil, Canada, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, UK, US, Urban China.

PIPELINE PROJECTS

Pipeline Projects – Internal Programs

Alligator's competitive project portfolio consists of the two clinical-stage assets, mitazalimab and ATOR-1017, and ATOR-4066, a pre-clinical program developed using Alligator's proprietary technology platform Neo-X-PrimeTM – as well as several programs developed in collaboration with partners.

Mitazalimab

Alligator's most advanced drug candidate mitazalimab, a potential game changer in the treatment of solid tumors, entered a Phase 2 clinical trial in pancreatic cancer, with the first patient dosed in the OPTIMIZE-1 study in Q3 2021. This clinical trial is

designed to evaluate the safety and efficacy of mitazalimab in combination with mFOLFIRINOX, the most efficacious standard of care chemotherapy for the treatment of advanced pancreatic cancer.

The clinical trial has been designed on the principal that mFOLFIRINOX efficiently kills tumor cells, leading to an increased release of tumor antigens which, when mFOLFIRINOX is used as standalone therapy, only triggers minimal immune response, leading to limited overall efficacy. The use of mitazalimab in combination with mFOLFIRINOX allows for activation of CD40, a receptor on dendritic cells, leading to significantly improved tumor antigen-presentation and subsequent activation of tumor-specific T cells that attack the cancer. The combination of mitazalimab with mFOLFIRINOX is therefore expected to significantly boost the immune response secondary to the release of tumor antigens, hence triggering a powerful attack on the solid tumors.

Mitazalimab has previously undergone two Phase 1 clinical trials, one conducted by Alligator, and one conducted by Janssen Biotech Inc., both of which showed strong evidence of efficacy and proof-of-mechanism, as well as a manageable safety profile.

In Q1 2022, Alligator announced that mitazalimab was safe and tolerable in combination with mFOLFIRINOX and that 900 µg/ kg, was selected as the Recommended Phase 2 Dose (RP2D), with the Phase 2 enrolment subsequently initiated at sites in Europe. As a consequence of the accelerated recruitment during 2022, the company announced that the full Phase 2 data would become available in Q1 2024, 9 months earlier than initially expected. In early January 2023, the interim efficacy readout for OPTIMIZE-1 was published, showing an Objective Response Rate (ORR) exceeding 50% in 23 evaluable patients, and a disease control rate of more than 90%. These results were further put into context with current treatment options in a webinar hosted by Alligator, featuring CMO Sumeet Ambarkhane and Principal Investigator of OPTIMIZE-1, Prof. Jean-Luc van Laethem.

The full enrolment of OPTIMIZE-1 was announced on April 12, reconfirming that full topline data are expected in the beginning of Q1 2024. The completion of enrolment significantly reduce the operational risk in OPTIMIZE-1 and the mitazalimab development program in general.

On April 3 Alligator announced that FDA had cleared the IND for OPTIMIZE-2, a phase 2 study assessing the safety and efficacy of an immunotherapeutic combination of mitazalimab (CD40 mAb) and a PD-1 inhibitor, in adult patients with histologically confirmed urothelial carcinoma, and who have progressed following prior treatment with PD-(L)1 therapy. Alligator expects to initiate OPTMIZE-2, during H1 2024 or earlier if operationally feasible.

ATOR-4066

ATOR-4066 is a bispecific antibody created to elicit powerful, tumor-specific immune effects, developed using Alligator's technology platform, Neo-X-PrimeTM. In Neo-X-Prime, we combine Alligator's expertise in immuno-oncology and CD40 targeted therapies with our state of the art technology platform and our bispecific antibody format RUBY™. The concept builds on bispecific antibodies

simultaneously binding to CD40 and to molecules preferentially expressed on tumor cells. In addition to a tumor directed activation of dendritic cells, this will also promote physical linkage of circulating tumor material to dendritic cells. This linking of tumor material with the dendritic cells results in education and activation of tumor neoantigen-specific T cells and induces superior anti-tumor immunity.

ATOR-4066 is a tumor directed bispecific antibody that binds to CD40 and carcinoembryonic antigen (CEACAM5), a tumorassociated antigen that is preferentially expressed in certain cancer types such as colorectal, gastric and pancreatic cancer. During the year, the preclinical data package supporting the mode of action of ATOR-4066 and its potent anti-tumor effect in in vivo models has been presented at several scientific meetings and in November a scientific article was published in the peerreviewed Journal for Immunotherapy of Cancer, highlighting the potential of ATOR-4066 and the Neo-X-Prime platform. In April we presented a poster at the 2023 AACR Annual Meeting. Taken together, the presented data show the ability of ATOR-4066 to remodel the immune microenvironment and activate tumorinfiltrating immune cells in primary human tumors expressing CEA, demonstrating the promise of this new candidate drug and strongly supporting further development towards the clinic.

Efforts to further strengthen the preclinical data package supporting ATOR-4066 and preparations for clinical development are ongoing.

ATOR-1017

ATOR-1017 is Alligator's second most advanced program and is in the final stages of a Phase 1 dose-escalation study. The study is designed to assess the safety and tolerability of ATOR-1017 in patients with advanced, solid cancers, and to establish a recommended Phase 2 dose for future studies.

ATOR-1017 is a 4-1BB agonist with a unique profile, most importantly through its ability to enhance the immune activating effect in tumors. This creates opportunities for a powerful, tumordirected immune activation, which can increase the therapeutic effect and reduce adverse side effects for patients.

Alligator presented a poster at the SITC Annual Meeting in November, highlighting new results from the Phase 1 first-inhuman clinical trial of ATOR-1017, showing it to be safe and well tolerated at doses up to 900 mg, with an excellent clinical profile as a potential best-in-class asset. These data warrant further development of ATOR-1017 in combination with other therapeutic approaches in solid tumors and Alligator is now seeking a partner to support this.

ALG-APV-527

ALG.APV-527 is a bispecific antibody targeting 4-1BB and 5T4, designed for the treatment of metastatic solid tumors. In 2017, Aptevo Therapeutics and Alligator Bioscience AB signed a codevelopment agreement. Under the agreement, both companies will equally own and finance the development.

The original molecules involved in the tumor-binding function and the immunomodulatory function of ALG.APV-527 were developed using Alligator's patented ALLIGATOR-GOLD® antibody library. The bispecific molecule was further developed and improved with Aptevo's technology platform ADAPTIR™. By combining a tumor-binding function with an immunomodulatory function in the same molecule, the drug candidate selectively targets the tumor and stimulates the antitumor-specific immune cells that are present in the tumor.

A publication in a peer-reviewed journal Molecular Cancer Therapeutics highlighting ALG.APV-527 preclinical data was published in November 2022. The data demonstrates a favorable preclinical efficacy and safety profile of ALG.APV-527 compared to a first generation 4-1BB antibody. In September 2022, the companies Investigational New Drug (IND) application received a "may proceed" notification from the US Food and Drug Administration (FDA), and in February 2023 the first patient was dosed in the Phase 1 clinical study to evaluate ALG.APV-527 in the treatment of solid tumors expressing the tumor-associated antigen 5T4. The study is being conducted in the US.

Collaborations and Out-Licensing Agreements

Orion Corporation

In 2021, Alligator entered a research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland. The aim of the collaboration is to discover new bispecific antibody cancer therapeutics against immuno-oncology targets. The agreement covers an option to develop three bispecific antibodies. In January 2023 we announced that Orion had exercised its option to initiate a second program within the agreement.

Under the agreement, Alligator will employ its proprietary phage display libraries and its RUBY™ bispecific platform. During the initial research period of the collaboration, Alligator will receive an upfront payment and reimbursement of research costs and other fees.

As part of the agreement, Alligator is eligible for development, approval, and sales milestone payments of up to EUR 313 million. Should Orion exercise its option to continue development and commercialization of the resulting product candidates, Alligator will be eligible to receive additional royalty payments.

MacroGenics, Inc.

In 2021, Alligator entered a joint research collaboration with US-based MacroGenics, Inc., a Nasdaq-listed biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The research collaboration utilizes Alligator's proprietary myeloid engaging Neo-X-Prime™ platform to develop bispecific antibodies against two undisclosed targets.

Under the joint research collaboration agreement, which covers activities from candidate drug generation up until INDenabling studies, each company will be responsible for its own costs. The parties may continue further development of the resulting bispecific molecule under a separate co-development collaboration and licensing agreement.

AC101/HLX22

Through its subsidiary Atlas Therapeutics AB, Alligator holds a participating interest in the clinical Biosynergy (AC101/HLX22) project, run by the listed Korean company AbClon. The drug candidate is now being further developed by the Chinese company Shanghai Henlius, which increased its rights to encompass a global license for development and commercialization in 2018. The phase 2 study had the first patient dosed in Q3 2021, and the estimated primary completion date for the study is April 2023. In 2022, an IND application has been approved for a second Phase 2 trial in China with AC101/HLX22 in gastric cancer.

Alligator incurs no cost for this project and is entitled to 35% of AbClon's revenue from out-licensing to Shanghai Henlius. In previous financial years, Alligator received two milestone payments totaling USD 3 million in conjunction with regional and global out-licensing.

Biotheus

In 2019, an agreement was concluded with Chinese company Biotheus, where Biotheus obtained the Chinese rights (Greater China, Hong Kong, Taiwan and Macao) to an antibody from the ALLIGATOR-GOLD® antibody library. The agreement gives Alligator the right to total initial upfront payments, as well as milestone and option payments of potentially USD 142 million. To date, Alligator has received upfront payments of SEK ~10 million.

The Alligator Share

Number of shares, stock option program and share saving program

The total number of outstanding shares in the Company at the end of the quarter was 221,534,728 (220,584,878), of which 220,584,878 are ordinary shares with one vote per share and 949,850 (0) are series C shares with one-tenth of a vote per share. The total number of votes in the company amounts to 220,679,863 votes.

Share saving program LTI 2021

At the annual general meeting 2021 it was resolved to implement a long-term incentive program by way of a performance-based share saving program for employees in the company ("LTI 2021"). For each ordinary share acquired by the participant on Nasdaq Stockholm, so called saving shares, the participant has a right to receive so called matching shares. In addition, given that a requirement related to the development of the company's share price from the day of the annual general meeting 2021 up until 30 September 2024 has been achieved, the participant has a right to receive further shares in the company free of charge, so called performance shares. After recalculation due to a completed rights issue in 2021, each saving share entitles to 1.0947 matching shares. The thresholds for the receipt of one, two or four performance shares per saving share amounts to SEK 15.74 for receipt of one performance share, SEK 31.65 for receipt of two performance shares and SEK 52.89 for receipt of four performance shares.

The maximum number of ordinary shares that can be issued in relation to LTI 2021 amount to 882,896, whereby 671,812 for the deliverance of matching shares and performance shares to participants and 211,084 to hedge payments of future social security contributions, which corresponds to a dilution of approximately 0.4 per cent of the company's share capital and votes.

Warrant programs, LTI 2022 I/II

At the annual general meeting 2022 it was resolved to implement a long-term incentive program by way of a warrant program for employees in the company ("LTI 2022-I"). In case all warrants issued within the warrant program LTI 2022-I are utilized for subscription of new ordinary shares, a total of 3,700,000 new ordinary shares will be issued, which corresponds to a dilution of approximately 1.65 per cent of the company's ordinary shares after full dilution.

The annual general meeting 2022 also resolved to adopt a warrants program for certain board members of the company, (LTI 2022- II"). In case all warrants issued within this program are utilized for subscription of new ordinary shares, a total of 600,000 new ordinary shares will be issued, which corresponds to a dilution of approximately 0.27 per cent of the company's ordinary shares after full dilution.

Each warrant in LTI 2022-I/II entitle to subscription of one ordinary share in the company. Subscription of shares by virtue of the warrants may be effected as from 1 June 2025 up to and including 30 June 2025. The subscription price per share for above warrant programs, was calculated to SEK 3,38 which corresponds to 200 per cent of the volume weighted average price during 10 trading days immediately after the annual general meeting 2022. All warrants have been transferred to the participants at fair market value.

In case the existing share saving program as well as both warrant programs are exercised in full, a total of 5,182,896 new shares will be issued, which corresponds to a total dilution of approximately 2,3 percent.

The Alligator share in brief March 31, 2023

Listed on: Nasdaq Stockholm Small Cap
221,534,728
Number of shares: (220,584,878 ordinary shares och 949,850 C shares)
Average turnover per Approximately 730,000
day: (preceding quarter: approx. 133,000)
Number of shareholders: 9,582 (preceding quarter: approx. 8,500)
SEK 159 million
Market capitalization: (preceding quarter: approx .SEK 342 million)
Ticker: ATORX
ISIN: SE0000767188

Swedish and foreign ownership

Largest Shareholders, Mar 31, 2023 No of Shares %
Koncentra Holding AB
(Part of Allegro Investment Fund). 55,643,092 25.2
Roxette Photo NV 18,413,950 8.3
Lars Spånberg 9,641,572 4.4
Avanza Pension 6,458,544 2.9
Magnus Petersson 6,455,297 2.9
Mikael Lönn 4,326,547 2.0
Fjärde AP-fonden 4,000,000 1.8
Öhman Fonder 3,786,791 1.7
Johan Zetterstedt 3,000,000 1.4
Johnson & Johnson Innovation LLC 2,740,919 1.2
Other shareholders 106,118,166 48.1
Total number of shares 220,584,878 100.0

The Company's owner structure is updated regularly on the Company's website: www.alligatorbioscience.com

Source: Modular Finance AB. Compiled and processed data from various sources, including Euroclear, Morningstar and the Swedish Financial Supervisory Authority (Finansinspektionen).

Other information

Review

This report has not been reviewed by the Company's auditor.

Employees

The number of employees in the Group at the end of the quarter was 58 (53). Of these, 18 (16) were men and 40 (37) were women. Of the total number of employees at the end of the quarter 49 (44) were employed within research and development.

Future report dates

Alligator intends to publish its financial reports according to the following:

  • Q2 Interim Report: July 13, 2023
  • Q3 Interim Report: October 26, 2023
  • Year-end Report 2023: February, 2024

Risks and uncertainties

During the course of its business operations, the Group is exposed to various financial risks, such as market risk (comprising foreign exchange risk, interest-rate risk and price risk), credit risk and liquidity risk. The aim of the Group's overall risk management is to achieve minimal adverse effects in terms of earnings and financial position. The Group's business risks, risk management and financial risks are described in detail in the Annual report for 2022.

The impact of Covid-19 on the Group's risks

The Covid-19 pandemic has affected the way we work, but we do not foresee any negative long-term effects on our operations due to the pandemic.

The impact of the war in Ukraine on the Group's risks

The situation in Ukraine is foremost a humanitarian tragedy that is causing great human suffering. The Russian invasion of Ukraine has worsened the political security situation in the rest of the world and created great uncertainty in the financial markets, which may affect the company's ability to finance clinical trials in the future. The company has no direct business in, nor does it conduct any clinical studies in Ukraine or Russia, but see a risk that the company eventually will suffer from increased raw material and energy prices, which will translate into increased prices for goods and services.

Cyber security

Cyber attacks have become a significant threat in society and for Alligator Bioscience, which is dependent on IT support in its daily operations. The company has ongoing work to ensure that the company is well prepared to counter cyber-attacks and other types of intrusion.

Statement of financial position

The Company works continuously to secure the financing of the operation. This include both business development for new partnering agreements, with an upfront payment upon signing, as well as other options. Alligator has resolved to carry out a 91 percent guaranteed rights issue of units of approximately SEK 199 million. Following the Company´s rights issue in April - May 2023, the Company's assessment is that the financial resources are sufficient for the ongoing operations the coming 12 months. More information on the rights issue is available on the Alligator website.

Forward-looking information

Even though the board and management believe the expectations in this report are justified, no guarantees can be given that they will turn out to be correct. Accordingly, the actual outcome may differ significantly from the assumptions stated in the forwardlooking information depending on, among other factors, changes in the economy or market, changes in legal or regulatory demands, political decisions and changes in exchange rates.

Parent Company

Both Group management functions and all operating activities are

carried out in the Parent Company. For additional details, refer to the information provided for the Group since the subsidiaries do not conduct their own operations.

Notes to the reader

Figures in brackets refer to the outcome for the corresponding period in the preceding year for figures related to the income statement and cash flow. For figures related to the financial position and personnel, figures in brackets refer to December 31, 2022. Unless otherwise stated, all amounts stated are rounded correctly, which may mean that some totals do not tally exactly. "Dollar" means US dollars unless otherwise stated.

Registered trademarks

FIND® and ALLIGATOR-GOLD® are Alligator Bioscience AB proprietary trademarks which are registered in Sweden and other countries.

For further information, please contact:

Søren Bregenholt, CEO Email: [email protected] Phone: +46 46 540 82 00

Marie Svensson, CFO Email: [email protected] Phone: +46 46 540 82 03

Guillaume van Renterghem, LifeSci Advisors, Investor Relations Email: [email protected]

Alligator Bioscience AB (publ) 556597-8201

Medicon Village, Scheelevägen 2 223 81 Lund, Sweden Phone: +46 46 540 82 00 www.alligatorbioscience.com

Financial statements

Unless otherwise stated in this Year-end report, numbers refer to the Group. Due to the nature of the business, there can be large fluctuations in revenue which are not seasonal or regular but are mainly linked to when milestones generating a payment are reached in out-licensed research projects. Like revenue, expenses can also fluctuate between periods. Among other factors, this fluctuation in expenses is influenced by the current phase of the various projects since certain phases generate higher costs. Figures in brackets refer to the outcome for the corresponding period in the preceding year for figures related to the income statement and cash flow. For figures related to the financial position and personnel, figures in brackets refer to December 31, 2022. Unless stated otherwise, all amounts are in SEK thousand (KSEK). All amounts stated are rounded, which may mean that some totals do not tally exactly.

Consolidated Income Statement

Net Sales

Sales for the period, as well as for the same period prior year, pertain primarily to the collaboration and licence agreement with Orion Corporation. In December 2022, Alligator Bioscience and Orion Corporation announced the initiation of a second program within their agreement.

Other operating income

Other operating income for the quarter comprises primarily of exchange gains in the company's operations.

Operating costs

The company's costs are higher compared to the same period previous year, and pertain mainly to costs related to Mitazalimab's OPTIMIZE-1 study and ALG.APV 527. External costs for mitazalimab amounted to SEK 28,763 thousand (14,470) during the first quarter of the year and the increased costs are mainly related to the increased number of patients in the study. In September 2022, an IND (Investigational New Drug) -application for ALG. APV 527 was approved, which enables the initiation of clinical studies which generates higher costs. First patient in ALG.APV 527 was dosed in February 2023. The personnel costs in the first quarter are higher than last year due to an increased number of employees.

Net financial items

Pertains to unrealized exchange gains and losses as a result of liquidity positions in USD, EUR and GBP.

All amounts KSEK unless specified Note 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Operating income
Net sales 5 9,593 5,356 35,696
Other operating income 5 834 200 1,439
Total operating income 10,427 5,555 37,135
Operating costs
Other external costs -51,467 -30,146 -147,725
Personnel costs -18,339 -15,396 -68,836
Depreciation of tangible assets and intangible assets -2,470 -2,747 -11,767
Other operatings expenses -342 -289 -1,597
Total operating costs -72,618 -48,578 -229,925
Operating profit/loss -62,191 -43,023 -192,789
Financial items
Other interest income and similar income statement items -86 55 32
Interest expense and similar income statement items -267 -108 -646
Net financial items -353 -54 -614
Profit/loss before tax -62,543 -43,076 -193,403
Tax on profit for the period - - -
Profit for the period attributable to Parent Company share
holders
-62,543 -43,076 -193,403
Earnings per share
Earnings per share before and after dilution, SEK -0.28 -0.20 -0.88

Consolidated Statement of Comprehensive Income

All amounts KSEK Note 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Profit/loss for the period -62,543 -43,076 -193,403
Other comprehensive income - - -
Comprehensive income for the period -62,543 -43,076 -193,403

Consolidated Statement of Financial Position

ASSETS

Participations in development projects

The Group's participations in development projects refers to cooperation with the South Korean company AbClon Inc. for the Biosynergy project. Biosynergy is outlicensed to the Chinese company Shanghai Henlius, which is now further developing the drug candidate. At the end of the period, participations in development projects amounted to SEK 17,949 thousand (17,949).

Right of use assets

At the end of the period, right of use assets amounted to SEK 24,736 thousand (25,550). Right of use assets pertain to leases for offices and laboratories, machines and vehicles.

In June 2022 Alligator entered into a lease agreement with Medicon Village for office premises valid from October 2024 with an agreement period of 5 years. The new agreement is estimated to increase the right of use assets by SEK 42,281 thousand, based on the use of the agreement period without extension, and replaces the current agreement with Medicon Village regarding office premises.

Cash and cash equivalents

Consolidated cash and cash equivalents, which consist of bank balances, totaled SEK 44,837 thousand (97,305).

The Group plans to use its liquidity for operating activities. A portion of the Group's liquidity is invested in USD, EUR and GBP foreign currency accounts. In accordance with the Group's Financial Policy, inflows of foreign currencies exceeding the expected requirements for the coming 18 months are to be converted to SEK at the time of payment. Besides this, no further hedging has taken place.

All amounts in KSEK Note 2023-03-31 2022-03-31 2022-12-31
ASSETS

Fixed assets Intangible assets

Participations in development projects 3 17,949 17,949 17,949
Patents - 10 -
Softwares 42 168 70

Tangible assets

Improvements in leased premises - 456 -
Right of use assets 24,736 23,154 25,550
Equipment, machinery and computers 1,581 3,450 1,386

Financial assets

Other long term financial fixed assets 6 1,815 - 1,815
Total fixed assets 46,123 45,188 46,770

Current assets

Current receivables

Total current assets 75,938 249,832 122,814
Cash and cash equivalents 6 44,837 234,448 97,305
Prepayments and accrued income 13,375 5,357 7,942
Other receivables 6 4,729 5,070 3,636
Accounts receivable 6 12,996 4,957 13,930
TOTAL ASSETS 122,061 295,020 169,584

Consolidated Statement of Financial Position

EQUITY AND LIABILITIES

Equity

Equity at the end of the period amounted to SEK 26,526 thousand (89,051), corresponding to an equity ratio of 22 (53) %. Alligator inteds to carry out a 91% secured rights issue of units of approximately SEK 199 million. The Rights Issue comprises a maximum of 441,169,756 units where each unit consists of one ordinary share and one warrant of series TO 6 free of charge. The subscription price is SEK 0.45 per unit, corresponding to SEK 0.45 per new share, which, assuming that the rights Issue is fully subscribed, results in the company receiving gross issue proceeds of approximately SEK 199 million.

The total number of outstanding shares in Alligator Bioscience AB amounts to 221,534,728 shares, of which 220,584,878 are ordinary shares with one vote per share and 949,850 are series C shares with one-tenth of a vote per share. The number of votes in the company amounts to 220,679,863 votes.

Equity per share before and after dilution

At the end of the period, equity per outstanding share amounted to SEK 0.12 (0,41), before and after dilution. Since the subscription price for issued options has not been reached, these are not taken into account (not "in-themoney"). C shares are not taken into account either.

Lease liabilities and loans

Lease liabilities pertain to leases for offices and laboratories, machines and vehicles. At the end of the period long- and short-term lease liabilities amounted to SEK 23,323 thousand (24,502).

In June 2022 Alligator entered into a lease agreement with Medicon Village for office premises valid from October 2024 with an agreement period of 5 years. The new agreement is estimated to increase the lease liabilities by SEK 42,281 thousand, based on the use of the agreement period without extension, and replaces the current agreement with Medicon Village regarding office premises.

Accrued expenses and deferred income

At the end of the period, accrued expenses and deferred income amounted to SEK 60,270 thousand (39,655). Expenses pertain to accrued expenses for clinical activities, personnel and other expenses. Accrued costs are higher compared to the same period last year and are primarily related to accrued patient costs for mitazalimab's OPTIMIZE-1 study and costs related to the initiation of clinical studies for ALG.APV-527.

All amounts in KSEK Note 2023-03-31 2022-03-31 2022-12-31
EQUITY AND LIABILITIES

Equity

Share capital 88,614 88,614 88,614
Other capital contributions 911,894 911,118 911,901
Retained earnings and profit/loss for the period -973,982 -761,223 -911,463
Equity attributable to Parent Company shareholders 26,526 238,509 89,051
Non-current provisions and liabilities
Lease liabilities 6 13,942 15,181 16,003
Total non-current provisions and liabilities 13,942 15,181 16,003
Current liabilities
Accounts payable 6 10,266 3,134 13,343
Other liabilities 1,676 1,274 3,032
Lease liabilities 6 9,380 7,225 8,499
Accrued expenses and deferred income 6 60,270 29,698 39,655
Total current liabilities 81,593 41,331 64,529
TOTAL EQUITY AND LIABILITIES 122,061 295,020 169,584

Consolidated Statement of Changes in Equity, in summary

All amounts in KSEK 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Opening balance 89,051 282,273 282,273
New capital issue - 380 380
Transaction costs - -713 -343
Treasury shares - -380 -380
Warrants - - 426
Effect of share-based payments personnel 25 26 99
Repurchase of warrants -7 - -
Profit/loss for the period -62,543 -43,077 -193,403
Closing balance 26,526 238,508 89,051

Consolidated Statement of Cash Flows

Investments

Investments during the quarter and the year consisted of laboratory equipment SEK 472 (440) thousand.

Cash flow for the period

Cash flow for the quarter totaled SEK -52,241 thousand (-43,770) and relates mainly to costs from operating activities.

Operating activities
Operating profit/loss -62,191 -43,023 -192,789
Adjustments for items not generating cash flow
Depreciation and impairments 2,470 2,747 11,767
Effect from warrant program 25 26 99
Other items, no impact on cash flow -1 141 -19
Interest received 10 - -
Interest paid -135 -123 -646
Tax paid - - -
Cash flow from operating activities before changes in working capital -59,823 -40,231 -181,588

Changes in working capital

Change in operating receivables -5,592 2,990 -5,859
Change in operating liabilities 16,182 -7,387 14,840
Cash flow from operating activities -49,233 -44,628 -172,607

Investing activities

Acquisition of tangible assets -472 -68 -440
Cash flow from investing activities -472 -68 -440

Financing activities

Amortization of leasing liabilities -2,529 1,717 -7,806
Amortization of installment purchase - -78 -104
New share issue - - 380
Transaction costs - -333 -343
Warrants - - 426
Repurchase of warants -7 - -
Purchase of treasury shares - -380 -380
Cash flow from financing activities -2,536 926 -7,827
Cash flow for the period -52,241 -43,770 -180,874
Cash and cash equivalents at beginning of period 97,305 278,148 278,148
Exchange rate differences in cash and cash equivalents -227 69 32
Cash and cash equivalents at end of period 44,837 234,448 97,305

Parent Company Income Statement

Note 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
5 9,593 5,356 35,696
5 834 200 1,439
10,427 5,555 37,135

Operating costs

Operating profit/loss -62,317 -43,117 -193,248
Total operating costs -72,744 -48,672 -230,383
Other operatings expenses -342 -289 -1,597
Depreciation and impairment of tangible assets and intangible assets -305 -1,165 -4,165
Personnel costs -18,339 -15,396 -68,836
Other external costs -53,758 -31,822 -155,785

Results from financial items

Other interest income and similar income statement items -86 55 35
Interest expense and similar income statement items -132 11 -4
Net financial items -217 66 31
Profit/loss after financial items -62,534 -43,051 -193,217

Appropriations

Group contribution received - - 407
Total appropriations - - 407
Result before tax -62,534 -43,051 -192,810
Tax on profit for the year - - -
Profit/loss for the period -62,534 -43,051 -192,810

Parent Company Statement of Comprehensive Income

All amounts in KSEK Note 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Profit/loss for the period -62,534 -43,051 -192,810
Other comprehensive income - - -
Profit/loss for the year -62,534 -43,051 -192,810

Parent Company Balance Sheet

All amounts in KSEK Note 2023-03-31 2022-03-31 2022-12-31
ASSETS

Fixed assets

Intangible assets

Patents - 10 -
Software 42 168 70
Total intangible assets 42 178 70

Tangible assets

Improvements in leased premises - 456 -
Equipment, machinery and computers 1,581 3,450 1,386
Total tangible assets 1,581 3,906 1,386

Financial assets

Participations in Group companies 3 20,294 20,294 20,294
Other long term financial fixed assets 1,815 - 1,815
Total financial assets 22,109 20,294 22,109
Total fixed assets 23,732 24,379 23,565

Current assets

Current receivables
Accounts receivables 12,996 4,957 13,930
Receivables from Group companies 845 438 845
Other receivables 4,728 5,070 3,636
Prepayments and accrued income 15,789 7,178 10,037
Total current receivables 34,358 17,644 28,447
Cash and bank deposits 43,588 233,590 96,046
Total current assets 77,946 251,233 124,494
TOTAL ASSETS 101,678 275,612 148,059

Parent Company Balance Sheet

All amounts in KSEK Note 2023-03-31 2022-03-31 2022-12-31
EQUITY AND LIABILITIES

Equity

Restricted equity

Share capital 88,614 88,614 88,614
Total restricted equity 88,614 88,614 88,614

Non-restricted equity

Total equity 28,859 240,686 91,369
Total non-restricted equity -59,754 152,072 2,755
Profit/loss for the period -62,534 -43,051 -192,810
Retained earnings -908,708 -715,995 -715,923
Share premium reserve 911,488 911,118 911,488

Non-current provisions and liabilities

Total non-current provisions and liabilities - 40 -
Other long-term liabilities - 40 -

Current liabilities

Accounts payable 10,266 3,134 13,343
Other liabilities 1,676 1,235 3,032
Accrued expenses and deferred income 60,876 30,517 40,314
Total current liabilities 72,818 34,886 56,690
TOTAL EQUITY AND LIABILITIES 101,678 275,612 148,059

Notes

Note 1 General information

This Interim report covers the Swedish Parent Company Alligator Bioscience AB (publ), corporate registration number 556597-8201, and its subsidiaries Atlas Therapeutics AB, corporate registration number 556815-2424, and A Bioscience Incentive AB, corporate registration number 559056-3663. Group's business operations are mainly carried out in the Parent Company.

The Parent Company is a Swedish public limited liability company registered and domiciled in the Municipality of Lund. The office is located at Medicon Village, SE-223 81 Lund.

Note 2 Accounting policies

This Interim report for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting and applicable regulations in the Swedish Annual Accounts Act (ÅRL). The interim report for the Parent Company has been prepared in accordance with the Swedish Annual Accounts Act (ÅRL) and the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities.

The accounting policies and calculation methods used in this report are the same as those described in the Annual report for 2022.

Note 3 Effects of changed estimates and judgments

Significant estimates and judgments are described in Note 3 and Note 18 of the Annual report for 2022. There have been no changes to the company's estimates and judgments since the Annual report for 2022 was prepared.

Note 4 Segment reporting

The company conducts only one business activity, namely research and development in the field of immunotherapy, and the chief operating decision-maker is thus only responsible for regularly making decisions on and allocating resources to one entity. Accordingly, the company comprises only one operating segment, which corresponds to the Group as a whole, and no separate segment reporting is provided.

Note 5 Consolidated Income

A breakdown of the Group's revenue regarding license revenue as follows:

All amounts in KSEK 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Reimbursement for development work 9,593 5,356 35,696
Total 9,593 5,356 35,696

A breakdown of the Group's other operating income is as follows:

All amounts in KSEK 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Swedish government grants received 216 1 305
Insurance compensation - 6 6
Operational exchange rate gains 600 193 1,103
Other 18 - 25
Total 834 200 1,440

Note 6 Financial instruments

Cash and cash equivalents for the Group at March 31, 2023 consisted of bank balances amounting to SEK 44,837 thousand (97,305). For financial assets and liabilities, the reported value as below is considered a reasonable approximation of fair value.

All amounts in KSEK 2023-03-31 2022-03-31 2022-12-31

Financial assets valued at amortized cost

Other long term financial fixed assets 1,815 - 1,815
Accounts receivable 12,996 4,957 13,930
Other receivables 12 950 -
Liquid assets - bank accounts 44,837 234,448 97,305
Total financial assets 59,661 240,355 113,050

Financial liabilities valued at amortized cost

Long-term lease liabilities 13,942 15,181 16,003
Accounts payable 10,266 3,134 13,343
Short-term lease liabilities 9,380 7,225 8,499
Other short-term liabilities - 40 -
Accrued expenses 56,536 26,248 36,072
Total financial liabilities 90,125 51,827 73,917

Note 7 Related party transactions

In connection with the rights Issue, Alligator has in March 2023 entered into an agreement on a top guarantee of MSEK 10 with the Company's largest shareholder Koncentra, in which company board member Staffan Enkrantz is chairman of the board of directors. Furthermore, Alligator has in March 2023 entered into an agreement of a top guarantee of MSEK 0.5 and a bottom guarantee of MSEK 0.5 with board member Hans- Peter Ostler. For the guarantee commitments, cash compensation of 11% of the guaranteed amounts is paid for the bottom guarantee, and of 13% of the guaranteed amount for the top guarantees. The guarantee compensation shall be paid no later than 5 banking days after the Swedish Companies Registration Office has registered the rights Issue.

In addition to the above, the company has not carried out any other related party transactions during the first quarter 2023 or during the previous year.

Financial definitions

Equity per share after dilution

Equity divided by the total number of shares at the end of the period and any outstanding options where the Company's share price on the reporting date is at least equal to the conversion price of the option.

Equity per share before dilution

Equity divided by the number of shares at the end of the period.

R&D costs

The Company's direct costs for research and development. Refers to costs for personnel, materials and external services.

R&D costs as a percentage of operating costs excluding impairments

R&D costs as a percentage of operating costs excluding impairments.

Average number of shares before and after dilution

Average number of outstanding shares during the period. The number of shares after dilution also takes account of outstanding options where the Company's share price on the reporting date is at least equal to the conversion price of the option.

Average number of employees

Average number of employees at the beginning and end of the period.

Average number of employees within R&D

Average number of employees within the Company's R&D departments at the beginning and end of the period.

Cash flow from operating activities

Cash flow before investing and financing activities.

Cash and cash equivalents, including securities

Cash and cash equivalents consists of bank balances, interest funds and publicly traded corporate bonds.

Cash flow for the period

Net change in cash and cash equivalents excluding the impact of unrealized foreign exchange gains and losses.

Earnings per share before and after dilution

Earnings divided by the weighted average number of shares during the period before and after dilution respectively. If the result is negative, the number of shares before dilution is also used for the calculation after dilution.

Operating costs excluding impairments

Other external costs, personnel costs and depreciation (excluding impairments of tangible and intangible assets).

Operating profit/loss Profit/loss before financial items and taxes.

Equity ratio Equity as a percentage of total assets.

Total assets Total of the Company's assets.

Calculation of Performance Measures

Alligator presents certain financial performance measures in this report, including measures that are not defined under IFRS. The Company believes that these performance measures are an important complement because they allow for a better evaluation of the Company's economic trends. These financial performance measures should not be viewed in isolation or be considered to replace the performance indicators that have been prepared in accordance with IFRS. In addition, such performance measures as Alligator has defined them should not be compared with other performance measures with similar names used by other companies. This is because the above-mentioned performance measures are not always defined in the same manner, and other companies may calculate them differently to Alligator.

To the right is shown the calculation of key figures, for the mandatory earnings per share according to IFRS and also for performance measures that are not defined under IFRS or where the calculation is not shown in another table in this report.

The Company's business operation is to conduct research and development which is why "R&D costs/Operating costs excluding impairment in percent" is an essential indicator as a measure of efficiency, and how much of the Company's costs relate to R&D.

The Company does not have a steady flow of income, with income generated irregularly in connection with the signing of license agreements and achievement of milestones. Therefore, the Company monitors performance indicators such as equity ratio and equity per share in order to assess the Company's solvency and financial stability. These are monitored along with the cash position and the various measures of cash flows shown in the consolidated statement of cash flow.

All amounts KSEK unless specified 2023
Jan-Mar
2022
Jan-Mar
2022
Jan-Dec
Profit/loss for the period -62,543 -43,076 -193,403
Average number of shares before dilution 220,584,878 220,584,878 220,584,878
Earnings per share before dilution, SEK -0.28 -0.20 -0.88
Average number of shares after dilution 220,584,878 220,584,878 220,584,878
Earnings per share after dilution, SEK -0.28 -0.20 -0.88
Operating costs -72,618 -48,578 -229,925
Operating costs excluding impairments -72,618 -48,578 -229,925
Reduce of administrative expenses 17,374 7,775 31,213
Reduce of depreciation 2,470 2,747 11,767
Research and development costs -60,092 -38,056 -186,945
R&D costs / Operating costs excluding impairments % 83% 78% 81%
Equity 26,526 238,508 89,051
Average number of shares before dilution
Equity per share before dilution, SEK
220,584,878
0.12
220,584,878
1.08
220,584,878
0.40
Average number of shares after dilution 220,584,878 220,584,878 220,584,878
Equity per share after dilution, SEK 0.12 1.08 0.40
Equity 26,526 238,508 89,051
Total assets 122,061 295,020 169,584
Equity ratio, % 22% 81% 53%
Cash and cash equivalents at end of period 44,837 234,448 97,305

For definitions, see the section "Financial definitions" on page 22.

The declaration of the Board of Directors and the CEO

Anders Ekblom

Hans-Peter Ostler

Eva Sjökvist Saers

Graham Dixon

Lund, April 25, 2023

Anders Ekblom Hans-Peter Ostler

Chairman of the Board Vice chairman of the Board

Veronica Wallin

Staffan Encrantz Denise Goode

Tova Landström

Eva Sjökvist Saers Graham Dixon Board member Board member

Board member Board member

Veronica Wallin Staffan Encrantz

Board member Board member

Søren Bregenholt CEO

Denise Goode Tova Landström Employee representative

Søren Bregenholt

Glossary

Agonist. A compound which binds to a receptor and stimulates its activity.

Antigen. Substance which triggers a reaction in the immune system, such as a bacteria or virus.

Antibody. Proteins used by the body's immune defenses to detect and identify xenobiotic material.

Bispecific antibodies. Antibody-based products which bind to two different targets and thus have dual functions.

Cancer. A disease in which cells divide in an uncontrolled manner and invade neighboring tissue. Cancer can also spread (metastasize) to other parts of the body through the blood and the lymphatic system.

Checkpoint inhibitor. An antibody with the ability to break the immune system's tolerance to something dangerous, for example a cancer tumor. Immune-inhibiting signals can be blocked through binding to a specific receptor such as CTLA-4 or PD-1.

Clinical study. The examination of healthy volunteers or patients to study the safety and efficacy of a potential drug or treatment method.

CRO (Clinical Research Organization). Company specialized in performing contract research and clinical studies on behalf of other pharma or biotech companies.

CTA (Clinical Trial Authorization). Application to start clinical trials in humans which is submitted to a regulatory authority.

CTLA-4 (Cytotoxic T-lymphocyte-Associated protein-4). An immuneinhibiting molecule expressed in and on the surface of T cells, primarily regulatory T cells.

Dendritic cell. A type of cell which detects xenobiotic substances. A key role of dendritic cells is their ability to stimulate T cells in the immune system.

Discovery. This research phase usually encompasses the development and evaluation of treatment concepts, the evaluation of potential drug candidates, and early efficacy studies.

Disease control rate (DCR). Proportion of patients with objective response or stabilization of disease.

Drug candidate. A specific compound usually designated before or during the preclinical phase. The drug candidate is the compound that is then studied in humans in clinical studies.

EMA. The European Medicines Agency.

Experimental model. A model of a disease or other injury to resemble a similar condition in humans.

FDA. The US Food and Drug Administration.

GMP (Good Manufacturing Practice). Quality assurance methodology designed to ensure that products are manufactured in a standardized manner, such that quality requirements are satisfied.

Immuno-oncology. Field of oncology in which cancer is treated by activating the immune system.

INN (International Nonproprietary Name). Generic name on a drug substance. The INN is selected by the World Health Organization (WHO) since 1953.

Lead. A potential drug candidate which binds to the actual target molecule/s.

Ligand. Binds to a receptor. Could be a drug, hormone or a transmitter substance.

Lymphocyte. A type of white blood cells.

Macrophages. A type of white blood cell of the immune system that engulfs and digests cellular debris and foreign materia such as bacteria.

Milestone payment. Financial consideration received in the course of a project/program when a specified objective is reached.

Mitazalimab. Generic name (INN) for ADC-1013.

Monospecific antibodies. Antibody-based product which bind only to one target, such as a receptor.

NK cells. NK cells (Natural Killer) are lymphocytes with the ability to activate several different cells in the immune system, such as macrophages.

Oncology. Term for the field of medicine concerned with the diagnosis, prevention and treatment of tumor diseases.

Objective Response Rate (ORR) Assessment of the tumor burden after a given treatment in patients with solid tumors. Important parameter to demonstrate the efficacy of a treatment and serves as a primary or secondary end-point in clinical trials.

Patent. Exclusive rights to a discovery or invention.

PD-1 (Programmed Death-1). Immune-inhibiting receptor on the surface of certain cells, for example tumor cells.

PD-L1 (Programmed Death-Ligand-1). The ligand that binds to PD-1, helping the cancer evade the body's immune defense.

Phase 1,2 and 3. The various stages of studies on the efficacy of a pharmaceutical in humans. See also "clinical study." Phase 1 examines the safety

on healthy human subjects, Phase 2 examines efficacy in patients with the relevant disease and Phase 3 is a large-scale study that verifies previously achieved results. In the development of new pharmaceuticals, different doses are trialed and safety is evaluated in patients with relevant disease. Phase 2 is often divided into Phase 2a and Phase 2b. In Phase 2a, which is open, different doses of the pharmaceutical are tested without comparison against placebo and focusing on safety and the pharmaceutical's metabolism in the body. Phase 2b is 'blind', and tests the efficacy of selected dose(es) against placebo.

Pharmacokinetics. The study of the turnover of substances in the body, for example how the amount of the substance is changed by absorption, distribution, metabolism and excretion.

Pharmacology. The study of how substances interact with living organisms to bring about a functional change.

Preclinical. The stage of drug development before the drug candidate is tested in humans. It includes the final optimization of the drug candidate, the production of materials for future clinical studies and the compilation of a data package for an application to start clinical studies.

Proof of concept studies. Studies carried out to provide support for dosages and administration paths in subsequent clinical studies.

R&D. Research & Development

Receptor. A receptor on a cell which picks up chemical signals.

RECIST. Response Evaluation Criteria in Solid Tumors - simple and pragmatic methodology to evaluate the activity and efficacy of new cancer therapeutics in solid tumors, using validated and consistent criteria to assess changes in tumor burden.

Sponsor. The person, company, institution or organization responsible for initiating, organizing or financing a clinical study.

T cell. A type of white blood cell which is important to the specific immune defense.

Tumor-associated antigen (TAA). A protein expressed to a much higher degree on the surface of tumor cells than healthy cells.

Tumor cell. A cell that divides relentlessly.

Tumor necrotic factor receptor superfamily (TNFR-SF). A group of immune-modulating target proteins related to the tumor necrosis factor protein. The name 'tumor necrosis factor' was derived from the fact that the first function detected for the protein was its ability to kill some types of tumor cells, though it was later discovered to have an immune-regulatory function.

Talk to a Data Expert

Have a question? We'll get back to you promptly.