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Alligator Bioscience

Annual Report Jan 22, 2025

3138_10-k_2025-01-22_f2790f5b-c65f-4a0a-b539-f58f97ae8d46.pdf

Annual Report

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Year-end report January – December 2024

Significant events during the quarter

  • Sharpened focus on mitazalimab and cost-reduction program to maximize Alligator's long-term value creation
  • Announcement of rights issue of units of approximately SEK 280 million, and raised bridge loans; subsequently approved following the quarter at EGM on 13 January 2025
  • Sale of future financial commitments for two bispecific antibodies to Orion Corporation

Other events during the quarter

  • Announcement of exercise of warrants series TO 9; Alligator to receive approximately 0.8 MSEK before issue costs
  • First patient dosed with out-licensed drug candidate HLX22/ AC101 in Helius Biotech Phase 3 clinical trial
  • Conversion of series C shares into ordinary shares for delivery to participants in incentive program from 2021
  • Presentation at SITC annual meeting of positive clinical and biomarker results for mitazalimab from OPTIMIZE-1
  • Presentation at SITC annual meeting of positive interim Phase 1 data for drug candidate ALG.APV-527, confirms antibody meets important trial endpoints
  • Nomination Committee appointed in respect of AGM 2025

"The strategic decisions made during the year and our progress in the clinic position us well for 2025. We now look forward to the 24-month follow-up in OPTIMIZE-1, which awaits us in the first quarter."

Financial information

MSEK, unless otherwise stated 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Net sales 41.8 11.7 57.8 58.1
Operating profit/loss -60.1 -70.4 -229.1 -249.0
Profit/loss for the period -55.4 -69.8 -233.9 -248.6
Cash flow for the period 17.1 -7.1 -1.2 -30.2
Cash and cash equivalents 64.3 66.1 64.3 66.1
Earnings per share before and after dilution, SEK -0.07 -0.11 -0.32 -0.55

CEO comments

Throughout 2024, Alligator has made notable progress with promising clinical results and has made strategic financial decisions with a clear focus on future developments. This work positions us well for the coming year and for our commitment to deliver mitazalimab to patients suffering from metastatic pancreatic cancer.

"The strategic decisions made during the year and our progress in the clinic position us well for 2025. We now look forward to the 24-month follow-up in OPTIMIZE-1, which awaits us in the first quarter."

Clinical Progress and Strategic Focus

Updated clinical and biomarker results from our Phase 2 trial in pancreatic cancer were presented at SITC 2024 in November. These data further confirm the mechanism of action for mitazalimab and have reinforced our confidence in our lead candidate as a potentially practice-changing treatment for metastatic pancreatic cancer. Mitazalimab has shown signficant survival benefits in the OPTIMIZE-1, with a median overall survival (OS) of 14.9 months, and a near doubling of the 18-month OS rate to 36.2%, compared to 18.6% reported with standard-of-care1 .

As part of the ongoing Phase 3 preparations, we held a productive meeting with the US FDA in December. Their feedback confirms that our manufacturing process is Phase 3 ready, thus significantly reducing the risk of the program. We are now looking forward to key interactions with regulatory authorities, notably the upcoming end of Phase 2 meeting for OPTIMIZE-1, and coming data readouts, where we anticipate the 24-month follow-up from the trial during the first quarter of 2025. We are confident that mitazalimab will continue to deliver exceptional results, and that these data and regulatory interactions will add to the momentum in our dialogues with global and regional pharma companies.

We also presented additional encouraging data at SITC in November for our bispecific antibody ALG.APV-527, co-developed with Aptevo Therapeutics. The candidate has consistently shown favorable safety and biological activity, and with the Phase 1 dose escalation trial approaching its final stages, we now assess the next steps for further clinical development.

During the quarter, we also reported on the first patient dosed in Henlius Biotech's Phase 3 trial with the out-licensed antibody HLX22/AC101 in HER2-positive advanced gastric cancer. The progress demonstrates Henlius' commitment to the program and bodes well for the completion of Henlius' ongoing Phase 2 trial with the candidate, which will trigger a milestone payment to Alligator.

Strategic Operational Decisions

During Q4 we made strategic decisions to optimize our operations and focus our resources. The sale of future financial commitments for two bispecific antibodies to Orion Corporation has provided us with non-dilutive income. Our cost reduction program announced in December is expected to save at least SEK 65 million annually, ensuring we maximize long-term value creation. As we part with a majority of our exceptional collegues, I am confident they will continue to be valuable contributors to other innovative organizations. Their commitment to Alligator strengthens our determination to ensure that mitazalimab reaches the patients as soon as possible.

To support our plans, Alligator has during the quarter secured bridge loans and are carrying out a rights issue of approximately SEK 280 million; a decision approved at the EGM on January 13, 2025. The proceeds will be used with a clear focus on mitazalimab. Participating in this rights issue offers a significant potential financial upside. The structure is designed to capture the expected value inflection points during 2025, including a licensing deal for mitazalimab.

Looking Ahead

As we move forward, we have sharpened our focus on securing a strategic partnership for mitazalimab and advancing it through Phase 3 trials.

We remain committed to delivering innovative treatments that improve the lives of cancer patients worldwide. With our dedicated streamlined team, our progress this year and our well-designed drug candidates we are on track to achieve our strategic goals. Thank you for your continued support and trust.

Søren Bregenholt CEO Alligator Bioscience AB (publ)

  1. Conroy et al., N Engl J Med 2011; DOI: 10.1056/NEJMoa1011923

Performance measures

Group

Note 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Result (KSEK)
Net sales 5 41,779 11,738 57,767 58,107
Operating profit/loss -60,089 -70,386 -229,141 -248,983
Profit/loss for the period -55,415 -69,830 -233,890 -248,586
R&D costs -54,284 -71,108 -205,311 -264,585
R&D costs as a percentage of operating costs, % 86% 85% 82% 85%
Capital (KSEK)
Cash and cash equivalents at end of period 64,310 66,118 64,310 66,118
Cash flow from operating activities -33,732 -54,498 -212,426 -189,286
Cash flow for the period 17,116 -7,085 -1,154 -30,184
Equity at the end of the period -130,588 11,855 -130,588 11,855
Equity ratio at the end of the period, % -125% 10% -125% 10%
Info per share (SEK)
Average number of shares 758,086,953 657,954,290 734,278,406 448,489,815
Earnings per share after dilution* -0.07 -0.11 -0.32 -0.55
Equity per share after dilution* -0.17 0.02 -0.17 0.02
Personnel
Number of employees at end of period 46 58 46 58
Average number of employees 47 59 52 56
Average number of employees employed within R&D 38 50 43 46

* Effect from dilution is not considered when result is negative and warrants where the strike price is higher than the closing share price is not considered.

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

Operating costs distributed by function, Parent Company

Operating costs (excl. write-downs), rolling 12 months and Liquidity (MSEK), Group

Market overview

Cancer's impact is widespread, affecting patients and their loved ones. As cancer diagnoses continue to rise globally, the demand for more effective treatments is increasing. Alligator is developing drug candidates that strike the right balance between effectiveness and tolerability. These drugs can be used alongside standard cancer treatments to address hard-to-treat cancers, potentially offering a cure.

Alligator is positioned as a leader in the immuno-oncology industry, either developing first-in-class or best-in-class antibodies targeting highly relevant immune activation pathways. We are convinced of the safety and efficacy benefits of combination treatments and our antibodies are designed with features that make them complementary to existing cancer therapies. This gives our antibodies a unique position of potentially being a part of tomorrow's combination therapies for the treatment of cancer.

The oncology market

The high societal costs of cancer care are a direct result of a rise in cancer cases, coupled to an increased longevity, which increases the likelihood of developing cancer. Improved awareness, screening, and diagnostic accuracy also results in more cancers being detected, more often, and at an earlier stage, which improves the probability of treatment success.

In 2022, sales of oncology drugs amounted to USD 265 billion, an increase of more than USD 100 billion from 5 years earlier.1 The oncology drug market is expected to more than double by 2028 to USD 542 billion, accounting for approximately 40% of the total drug market.1 A surge of new and innovative treatment methods is expected to emerge in the marketplace, and Alligator believes that immunotherapies will play a central role in these treatment options for cancer.

The immuno-oncology market

Immuno-oncology is a form of cancer therapy that aims to stimulate the immune system to attack tumors. 64 of the antibody-based drugs approved in Europe and/or the United States are in oncology, including several major immuno-oncology brands such as Keytruda® (Merck), Opdivo® (BMS), Tecentriq® (Roche) and Yervoy® (BMS).1

There have been major advances in immuno-oncology in recent years and the immunotherapy drug market is expected to grow rapidly in the years ahead.1 The average cost of treatment with existing immunotherapies is high. For example, the list price of Keytruda® is about USD 15,000 per patient, per month in the US.2 Although the cost of immunotherapies is high, the loss of patent exclusivity of earlier generation drugs helps keep costs under control and allows more patients to be treated with the latest generation of products.

The pancreatic cancer market

Urban China

Pancreatic cancer is one of the most challenging cancers to treat and has one of the lowest five-year survival rates of any cancer. Approximately 300,000 people in the 16 major markets* are diagnosed with pancreatic cancer each year.1 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.1

*) 16 main markets include: Australia, Brazil, Canada, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, UK, US, Today's pancreatic cancer market, dominated by chemotherapies, is approximately USD 2 billion, and is expected to increase to approximately USD 5.4 billion by 2029.1 The pancreatic cancer market is expected to increase significantly with the approval of novel innovative immunotherapies such as mitazalimab.

Cancer treatment market trends

Alligator believes that the need and demand for novel immunotherapy drugs will increase along with the global demand for new and more effective oncology therapies. The main market trends identified by the company include:

  • A global rise in annual cancer diagnosis
  • A growing number of applications for immunotherapy
  • An increased need for safe and effective combination therapies
  • An improved access to innovative medicines
  • An increased expenditure and investment in immunotherapy drug development

References

    1. Database GlobalData (Pharma Intelligence Center Drug Sales), February 2023.
    1. www.keytruda.com/financial-support/, February 2023

Operations

Alligator's overall objective is to establish the Company as one of the world's leading innovators in immuno-oncology by effectively developing tumor-directed immunotherapies with unique properties that allow patients to live longer and better lives. Building on its unique position within the CD40 field and its differentiating antibody engineering technologies, Alligator strives to develop the Company's drug candidates through so-called proof-of-concept in Phase 2 clinical studies or further and thereby make them attractive to Big Pharma for in-licensing, further development and commercialization.

The Company believes that for a company like Alligator, economic value is mainly created by out-licensing drug candidates at clinical study stage. Final Phase 3 clinical development as well as marketing and sales is foreseen to primarily be undertaken by the Company's partners.

Alligator's organization

In December 2024 Alligator announced a sharpening of its primary focus on lead asset mitazalimab, and in connection with this an adjustment of the size of its organization and scope of operations. The continued workforce of approximately 15 FTEs now focus on late-stage development. Limited research activities, primarily related to mitazalimab, will be covered by remaining internal and external resources.

Technology platform

Alligator has developed tumor-directed immunotherapies with a focus on active therapies that provide long-lasting tumor-specific immunity. The technologies form the basis for all drug candidates in the Company. The Company's technologies and know-how also provide additional value-creating opportunities through potential collaboration and licensing agreements with third parties.

Preclinical development strategy

The preclinical studies that have been carried out in the Company have evaluated the safety and toxicity of the antibodies and increased the Company's understanding of the mechanism of action in more complex systems. The latter is crucial for the design of clinical studies. Preclinical studies are required for permission to commence clinical studies, and something that the Company transfers to external parties in the event of a need for additional activities.

Manufacturing

Alligator entrusts the production of clinical trial materials to Contract Development and Manufacturing Organizations (CDMOs), an approach that enables the Company to leverage specialized expertise and advanced technology, and ensures both efficient and high-quality development processes.

Clinical development strategy

Alligator has the expertise and capacity to design and conduct clinical studies up to and including clinical proof-of-concept in Phase 2. The Company also has the medical and regulatory expertise and ability to analyze clinical data in preparation for late-phase clinical studies. The operational aspects of the clinical development process have been contracted to Clinical Research Organizations (CROs), which also makes it possible to conduct clinical studies in several different countries.

Business development strategy

Alligator conducts business development to generate non-dilutive income for the shareholders through out-licensing of antibodies and drug candidates, mainly in the preclinical or clinical phase, or further development through collaboration.

How Alligator promotes sustainability

We believe our commitment to sustainability, transparency and diversity drives our immuno-oncology innovation. From sustainable operations to fostering an inclusive culture, we are working towards our common goal of delivering best-in-class treatments for patients with hard-to-treat cancers.

Sustainable operations meeting high standards

Alligator is deeply committed to corporate responsibility and sustainability, integrating these principles into our daily operations. We strive to exceed established requirements in ecological, social, and economic sustainability. Our efforts include monitoring and reducing our environmental footprint, updating travel policies for reduced CO2 emissions, and integrating ESG and DEI objectives into our corporate goals.

Contributing to global sustainable development

Aligned with the United Nations' Sustainable Development Goals, we actively contribute to goals 3, 5 and 8, focused on good health and well-being, gender equality, and decent work and economic growth. As a company developing immuno-oncology drugs, we prioritize patient health, foster an inclusive and diverse workplace, and uphold fair working conditions essential for innovation and growth.

Transparency and engagement with stakeholders

Alligator values transparency and actively engages with stakeholders. Through our website, social media channels, and press releases, we provide up-to-date information tailored to various levels of expertise. Our commitment to corporate responsibility is evident through our Nasdaq ESG Transparency Partner certification and our dedication to providing clear governance.

Fostering a supportive work environment

At Alligator, we cultivate an environment where dedicated employees thrive. Our clinical-stage biotechnology company attracts leading expertise by offering growth opportunities, academic recognition, and a supportive team spirit. With a focus on diversity and inclusion, we aim to create equal opportunities for all employees, as reflected in our rankings on equality reports and diversity indices.

Core values and internal career development

Our organizational culture is guided by four core values: collaboration, curiosity, trust, and accountability. These values shape how we operate and interact to achieve our vision. We prioritize internal career development, offering opportunities for employees to grow within the company. Our commitment to diversity, equity, and inclusion is embedded in our DEI policy, fostering innovation in a psychologically safe environment.

By maintaining high standards of sustainability, engaging with stakeholders transparently, fostering a supportive work environment, and prioritizing diversity and inclusion, Alligator continues to drive innovation and success in immuno-oncology.

Project portfolio

Alligator's main focus is with lead candidate mitazalimab. The project portfolio further contains ATOR-4066, a pre-clinical program developed using Alligator's proprietary technology platform Neo-X-Prime® – as well as several programs developed in collaboration with partners.

Mitazalimab

Mitazalimab was developed using Alligator's proprietary technology platforms. In preclinical experimental models, mitazalimab has been shown to induce a potent tumor-targeted immune response, and to provide long-lasting tumor immunity against multiple types of cancer. The preclinical experiments also demonstrated that mitazalimab acts synergistically with other cancer therapies such as chemotherapy, checkpoint inhibitors, and cancer vaccines. Preclinical data also demonstrated that mitazalimab is effective in chemotherapy-resistant cancer cells.

A Phase 1 study with mitazalimab conducted by Janssen Biotech Inc., including 95 patients, showed signs of efficacy, proof-of-mechanism, as well as a manageable safety profile.

OPTIMIZE-1 – A highly promising Phase 2 trial

In the third quarter of 2021, the first patient was dosed in OPTIMIZE-1, a Phase 2 study designed to further assess the efficacy and safety of mitazalimab in combination with standardof-care chemotherapy, mFOLFIRINOX, for the treatment of first-line metastatic pancreatic cancer. The single arm, open-label, multi-center study is performed at clinical sites in Belgium, France and Spain, and has evaluated the efficacy of mitazalimab at the 900 µg/kg dose in 57 patients in total. The chemotherapy cocktail used, mFOLFIRI-NOX, kills tumor cells leading to increased release of tumor antigens. This, together with the activation of CD40 by mitazalimab leads to improved presentation of tumor antigens, and the consequent induction of T cell-dependent antitumor responses.

Project status: Phase 3 preparations ongoing

In July, Alligator announced the completion of enrollment for the additional cohort with 450 µg/kg of mitazalimab in combination with mFOLFIRINOX. This was a request from US FDA prior to entering Phase 3, and marks an important step in preparing for the candidate's continued clinical development. In December 2024, Alligator held a Type-C meeting with the US FDA. Their feedback reinforced a robust manufacturing strategy, an important milestone to ensure Phase 3 readiness.

Top-line results from OPTIMIZE-1 were announced in January 2024, nine months earlier than originally planned, which were followed by an 18-months survival follow-up in June, demonstrating an increase in ORR to 42.1% (40.4%) and in median Overall Survival (mOS) to 14.9 months (14.3 months) in the entire patient population. The Duration of Response was an unprecedented 12.6 months. These strong data are noteworthy, especially in the light of an ORR of 31.6% reported with FOLFIRINOX in a similar patient population and the 11.1 months of mOS demonstrated by FOLFIRINOX over a decade ago1 and confirmed by the 11.1 months demonstrated by NALIRIFOX in 20232 .

External interest

During 2024, mitazalimab data has been presented at leading medical conferences such as the AACR and ASCO Annual Meetings, as well as at ESMO GI.

In June 2024, results from the OPTIMIZE-1 trial were published in the renowned scientific journal The Lancet Oncology. Alligator views this as a testament to the great interest in mitazalimab's potential in pancreatic cancer.

Alligator receives much interest from the scientific community and continuously engages in discussions with investigators expressing interest in mitazalimab, and other assets. This strategic approach is in line with our commitment to fostering collaborations and transparent communication within the industry and academia. In May 2024, the Company announced an Investigator-Initiated Trial with mitazalimab, conducted by Moore's Cancer Center at UC San Diego.

Regulatory and intellectual property achievements

During 2023, Alligator received Orphan Drug Designation for mitazalimab in pancreatic cancer from the US Food and Drug Administration (FDA) and Orphan Designation from the European Medicines Agency (EMA). These orphan designations confer significant regulatory and financial benefits, including marketing exclusivity upon approval, giving mitazalimab stronger commercial protection in the two key markets of the US and EU.

Alligator also strengthened the mitazalimab Intellectual Property position in 2023 with a new patent granted by the European Patent Office covering mitazalimab's composition of matter until 2038. This new patent provides vital further protection for Alligator's lead asset in Europe and is a significant addition to the mitazalimab patent portfolio, which now stands at 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia and more. Protecting its intellectual property is a key pillar of Alligator's business strategy and provides a strong foundation for its drug development program and partnering discussions.

In April 2023, the FDA cleared Alligator's Investigational New Drug (IND) application for the OPTIMIZE-2 Phase 2 trial to evaluate mitazalimab in urothelial carcinoma, which will hedge the medical risk and maximize the long-term value of mitazalimab.

ATOR-4066

Innovative integration for enhanced therapeutic potential

ATOR-4066 is a bispecific antibody developed using our technology platform Neo-X-Prime®. This platform integrates Alligator's expertise in immuno-oncology and CD40 targeted therapies with our bispecific antibody format, RUBY®. The approach involves antibodies binding to both CD40 and molecules preferentially expressed on tumor cells, which not only activates dendritic cells directed at tumors but also links circulating tumor material to dendritic cells. This linkage educates and activates tumor neoantigenspecific T cells, resulting in superior anti-tumor activity. Besides CD40, ATOR-4066 binds CEACAM5, a tumor-associated antigen found predominantly in colorectal, gastric and pancreatic cancers.

Single-agent complete responses in preclinical tumor models

Preclinical data supporting ATOR-4066's mechanism of action and potent anti-tumor effects, as well as the potential of the Neo-X-Prime® platform, has been presented at various scientific meetings and in scientific articles, recently in April 2024 at the AACR Annual Meeting. These presentations collectively demonstrate ATOR-4066's ability to reshape the immune microenvironment and activate tumor-infiltrating immune cells has shown to lead to single-agent complete responses in translational tumor models. This affirm its potential as a promising drug candidate, supporting further development towards clinical trials.

Continued advancement and patent milestone

During the year, Alligator has strengthened the preclinical ATOR-4066 data package and prepared for its clinical development. In early 2024, the first US patent for ATOR-4066, providing protection for methods of treating cancer and/or tumors using a bispecific antibody comprising the binding regions of the 4066 molecule.

ALG.APV-527

A collaboration to pioneer bispecific therapy for solid tumors

ALG.APV-527, a bispecific antibody targeting 4-1BB and 5T4, is specifically designed for the treatment of metastatic solid tumors. In 2017, Aptevo Therapeutics and Alligator signed a co-development agreement, resulting in both companies equally owning and financing the asset's development. The original molecules involved in the tumor-binding function and the immunomodulatory function of the candidate were developed using Alligator's patented ALLIGATOR-GOLD® antibody library. Aptevo's ADAPTIR™ technology platform further improved the bispecific molecule, combining tumor-binding and immunomodulatory functions within the same molecule. This design allows ALG.APV-527 to selectively target tumors and stimulate antitumor-specific immune cells present within the tumor microenvironment.

Clinical progress and preliminary results

In February 2023, the first patient was dosed in the multi-center, dose-escalation trial for ALG.APV-527, evaluating the candidate in treatment of solid tumors expressing the tumor-associated antigen 5T4. The trial is currently more than 50% enrolled, and initial results reported in February 2024 indicate an overall well-tolerated candidate, with biomarker analyses confirming biological activity.

In September 2024, results from the Phase 1 monotherapy study were presented at the European Society of Medical Oncology conference and demonstrated that 60% of evaluable patients with solid tumors achieved stable disease. Additional data was presented at the SITC annual meeting in November, which confirmed that important trial endpoints had been met.

Recognition in the scientific community

Preclinical data highlighting the potential of ALG.APV-527 has been presented at conferences and published in the scientific journal Molecular Cancer Therapeutics in November 2022. The publication showcased favorable preclinical efficacy and safety data of ALG.APV-527 compared to first-generation 4-1BB antibodies.

Collaborations and Out-Licensing Agreements

Orion Corporation

Strategic partnership for bispecific cancer therapeutics

In 2021, Alligator forged a research collaboration and license agreement with Orion Corporation, a leading global pharmaceutical company headquartered in Finland. The primary objective of this collaboration is to explore novel bispecific antibody cancer therapeutics targeting immuno-oncology targets. The agreement encompasses an option to develop three bispecific antibodies, with a notable milestone achieved in January 2023 when Orion exercised its option to commence a second program within the collaboration, and later in April.

In December 2024, Alligator announced the sale of future financial commitments for two bispecific antibodies to Orion Corporation, and that no further development activities would be conducted under the agreement.

Biotheus

Expanding reach: Alligator's partnership with Biotheus

In 2019, Alligator finalized an agreement with the Chinese company Biotheus, granting Biotheus the Chinese rights (including Greater China, Hong Kong, Taiwan, and Macao) to an antibody from the ALLIGATOR-GOLD® antibody library. The agreement stipulates that Alligator is entitled to total initial upfront payments, along with milestone and option payments potentially totaling USD 142 million. To date, Alligator has received upfront payments amounting to approximately SEK 10 million.

AC101/HLX22

Clinical project developed by Shanghai Henlius

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. Shanghai Henlius has initiated two clinical trials:

  • A Phase 1 single-center, open-label, dose-escalation clinical trial to evaluate the safety and the tolerability of AC101/HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care. The trial, completed in 2021, enrolled 11 patients, and has not yet published its conclusions.
  • A Phase 2 multi-center randomized, double-blinded clinical trial to evaluate the clinical efficacy and safety of AC101/HLX22 as first-line therapy in HER2+ locally advanced or metastatic gastric cancer. The study aims to enroll 150 patients, with an estimated study completion in 2024.

In May, 2024, Henlius Biotech received an FDA-clearance on their IND-application for a Phase 3 trial with HLX22 (AC101) in Gastric Cancer.

Potential revenue share and milestones in project

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.

The Alligator Share

Number of shares and stock option programs

The total number of outstanding shares in the Company is 758,989,086 of which 758,209,917 are ordinary shares with one vote per share and 779,169 are series C shares with one-tenth of a vote per share. The number of votes in the Company amounts to 758,287,833 votes.

The Extraordinary General Meeting on 14 March 2024 resolved to carry out a rights issue and to reduce the share capital within the aggregate SEK 41,642,741.648 from SEK 42,169,864.96 to SEK 527,123.312. This reduction means that the quota value per share was reduced from SEK 0.064 to SEK 0.0008. During the Rights Issue in April 2024, 100,084,946 units were subscribed for, comprised of one ordinary share and one warrant, TO 9.

One warrant series TO 9 entitled the holder to subscribe for one new ordinary share in the Company at an exercise price corresponding to 90 percent of the volume-weighted average price of the Company's share on Nasdaq Stockholm during the period from and including November 4, 2024, up to and including November 29, 2024, however not less than the quota value of the share.

In total, 1 498 157 ordinary shares were subscribed for in December 2024. Proceeds of SEK 0.8 million was received on 30 December 2024 but the ordinary shares was registered in January 2025.

The Alligator share in brief 31 December 2024

Listed on: Nasdaq Stockholm Small Cap
Number of shares: 758,209,917 ordinary shares and 779,169 C shares
Approximately 3,514,310
Average turnover per day: (preceding quarter: approx. 2,043,374)
Number of shareholders: 11,891 (preceding quarter: approx. 11,909)
SEK 189 million
Market capitalization: (preceding quarter: approx. SEK 933 million)
Ticker: ATORX
ISIN: SE0000767188

Swedish and foreign ownership

Largest Shareholders, 31 December 2024 No of Shares %
Koncentra Holding AB
(Part of Allegro Investment Fund) 249,948,629 33.0
Roxette Photo SA 64,899,291 8.6
Magnus Petersson 21,010,002 2.8
Avanza Pension 18,998,815 2.5
Johan Zetterstedt 18,500,000 2.4
Harri Salminen 10,000,000 1.3
Lars Spånberg 9,641,572 1.3
Nordnet Pensionsförsäkring 5,836,863 0.8
Zetterstedt Holding AB 5,750,000 0.8
Pearla Gem Ltd 5,023,112 0.7
Other shareholders 348,601,633 46.0
Total number of shares 758,209,917 100.0

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).

The Alligator Share cont.

Share-based incentive programs

Alligator has issued warrants under three warrant programs which includes employees in Alligator as well as three warrant programs including certain board members.

Warrant program LTI 2022 I

The annual general meeting held on 5 May 2022 resolved to implement a warrant program for employees under which a total of 3,700,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. In June 2023, 1,073,000 unallocated warrants were cancelled. Of the original number of warrants, 2,627,000 warrants remain. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. In connection with transfers of warrants, the subsidiary has entered into agreements with the participants which entail a right for the subsidiary to, considering customary so-called "good and bad leaver" conditions, repurchase warrants in the event the participant's employment or assignment in the Alligator terminates or if the participant wants to transfer the warrants. After recalculation due to completed rights issues during 2023 and 2024 (further recalculation will occur as a result of the Rights Issue in February 2025), each warrant in the program entitles to subscription of 1.38 new ordinary shares in the Alligator at a subscription price amounting to SEK 2.46 per share. The warrants can be exercised during the period from and including 1 June 2025 up to and including 30 June 2025. As of 31 December 2024, participants in the program hold a total of 2,298,666 warrants, while the remaining 328,334 warrants are held by the subsidiary. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 3,172,159 new ordinary shares will be issued, corresponding to a dilution of approximately 0.42 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

Warrant program LTI 2022 II

The annual general meeting held on 5 May 2022 furthermore resolved to implement a warrant program for certain board members under which a total of 600,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. In June 2023, 100,000 unallocated warrants were cancelled. Of the original number of warrants, 500,000 warrants remain. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. After recalculation due to completed rights issues during 2023 and 2024 (further recalculation will occur as a result of the Rights Issue in February 2025), each warrant in the program entitles to subscription of 1.38 new ordinary shares in the Alligator at a subscription price amounting to SEK 2.46 per share. The warrants can be exercised during the period from and including 1 June 2025 up to and including 30 June 2025. As of 31 December 2024, the participants in the program hold all outstanding 500,000 warrants. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 690,000 new ordinary shares will be issued, corresponding to a dilution of approximately 0.09 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

Warrant program LTI 2023 I

The annual general meeting held on 26 May 2023 resolved to implement a warrant program for employees under which a total of 8,955,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. In connection with transfers of warrants, the subsidiary has entered into agreements with the participants which entail a right for the subsidiary to, considering customary so-called "good and bad leaver" conditions, repurchase warrants in the event the participant's employment or assignment in the Alligator terminates or if the participant wants to transfer the warrants. After recalculation due to a completed rights issue during 2024 (further recalculation will occur as a result of the Rights Issue in February 2025), each warrant in the program entitles to subscription of 1.05 new ordinary shares in the Alligator at a subscription price amounting to SEK 1.01 per share. The warrants can be exercised during the period from and including 1 June 2026 up to and including 30 June 2026. As of 31 December 2024, participants in the program hold a total of 4,888,333 warrants, while the remaining 4,066,667 warrants are held by the subsidiary. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 5,132,750 new ordinary shares will be issued, corresponding to a dilution of approximately 0.67 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

The Alligator Share cont.

Warrant program LTI 2023 II

The annual general meeting held on 26 May 2023 furthermore resolved to implement a warrant program for certain board members under which a total of 1,440,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. After recalculation due to a completed rights issue during 2024 (further recalculation will occur as a result of the Rights Issue in February 2025), each warrant in the program entitles to subscription of 1.05 new ordinary shares in the Alligator at a subscription price amounting to SEK 1.01 per share. The warrants can be exercised during the period from and including 1 June 2026 up to and including 30 June 2026. As of 31 Decemer 2024, the participants in the program hold all 1,440,000 outstanding warrants. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 1,512,000 new ordinary shares will be issued, corresponding to a dilution of approximately 0.20 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

Warrant program LTI 2024 I

The annual general meeting held on 7 May 2024 resolved to implement a warrant program for employees under which a total of 5,915,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. In connection with transfers of warrants, the subsidiary has entered into agreements with the participants which entail a right for the subsidiary to, considering customary so-called "good and bad leaver" conditions, repurchase warrants in the event the participant's employment or assignment in the Alligator terminates or if the participant wants to transfer the warrants. Recalculation will occur as a result of the Rights Issue in February 2025. Each warrant in the program entitles to subscription of one new ordinary share in the Alligator at a subscription price amounting to SEK 1.69 per share. The warrants can be exercised during the period from and including 1 June 2027 up to and including 30 June 2027. As of 31 December 2024, participants in the program hold a total of 2,554,166 warrants, while the remaining 3,360,834 warrants are held by the subsidiary. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 2,554,166 new ordinary shares will be issued, corresponding to a dilution of approximately 0.34 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

Warrant program LTI 2024 II

The annual general meeting held on 7 May 2024 furthermore resolved to implement a warrant program for certain board members under which a total of 640,000 warrants have been issued free of charge to the Alligator's subsidiary A Bioscience Incentive AB for transfer to the participants in the warrant program. Transfer to the participants has been made in exchange for cash consideration corresponding to the market value of the warrant at the time of the transfer. Recalculation will occur as a result of the Rights Issue in February 2025. Each warrant in the program entitles to subscription of one new ordinary share in the Alligator at a subscription price amounting to SEK 1.69 per share. The warrants can be exercised during the period from and including 1 June 2027 up to and including 30 June 2027. As of 31 December 2024, participants in the program hold all outstanding 640,000 warrants. Upon full exercise of all warrants held by the participants in the program to subscribe for shares, a total of 640,000 new ordinary shares will be issued, corresponding to a dilution of approximately 0.08 per cent of the Alligator's ordinary shares as of 31 December 2024. The warrants are subject to customary recalculation conditions in connection with new issues etc.

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 46 (58). Of these, 15 (17) were men and 31 (41) were women. Of the total number of employees at the end of the quarter 37 (48) were employed within research and development.

Financial calendar

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

  • Annual report 2024: March 2025
  • Interim report January March 2025: 24 April 2025
  • Interim report January June 2025: 10 July 2025
  • Interim report January September 2025: 23 October 2025
  • Year-end report 2025: February 12, 2026

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 has transaction exposure from contracted payment flows in foreign currency. Most of the Group's transaction exposure is in USD, GBP and EUR. During 2024 a 5 % stronger/weaker SEK against the USD would have had a positive/negative effect on posttax profits and equity of approx. +/- SEK 4,524 thousand, against the EUR of approx. +/- SEK 3,350 thousand and against the GBP of approx. +/- SEK 888 thousand.

The Group's business risks, risk management and financial risks are described in detail in the Annual Report for 2023.

Conflicts in the world

Many wars and conflicts are raging around the world, resulting in enormous 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 Group's ability to finance clinical trials in the future. The conflict between Israel and Palestina has been going on for decades and has flared up many times over the years. Recently, the violence has escalated and caused enormous suffering. Some other countries around the world are also at war right now.

The Group has no direct business in, nor does it conduct any clinical studies in affected countries but sees that the Group will suffer from increased raw material and energy prices, which in turn 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 Group has ongoing work to ensure that the Group is well prepared to counter cyber-attacks and other types of intrusion.

Statement of financial position

The Group works continuously to secure the financing of the operation. This includes both business development for new partnering agreements, with an upfront payment upon signing, as well as other options. As the Group within the next 12 months has additional financing needs that have not yet been secured, the Board is continuously working on evaluating various financing options to ensure continued operation. The company has decided to carry out a rights issue of ordinary shares and warrants in February 2025. The rights issue is covered by subscription and guarantee commitments of up to approximately SEK 140 million. It is the Board´s assessment that the Group has good prospects of securing future financing, owever, the absence of assurance at the same time of submission of this report means that there is a significant uncertainty factor regarding the Group´s ability to continue operation.

The Board has noted that the equity is below half of the registered share capital. The Board has considered the provisions in Chap. 25 in the Swedish Companies Act and concluded that the Company has significant surplus values (in amongst others, the mitazalimab project) that with good margin restores the share capital.

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 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.

Proposed appropriation of profits

The Board proposes that Alligator Bioscience does not pay dividends for the financial year 2024.

Registered trademarks

FIND®, ALLIGATOR-GOLD®, RUBY® and Neo-X-Prime® 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

Johan Giléus, CFO Email: joha[email protected] Phone: +46 46 540 82 00

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 the corresponding period in 2023. 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

All amounts KSEK unless specified Note 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Operating income
Net sales 5 41,779 11,738 57,767 58,107
Other operating income 5 280 1,168 1,945 3,795
Total operating income 42,059 12,906 59,712 61,902
Operating costs
Other external costs -43,496 -58,398 -167,207 -218,792
Personnel costs -15,275 -22,157 -70,428 -79,377
Depreciation and impairment of tangible assets and intangible assets -41,817 -2,672 -48,729 -10,489
Other operatings expenses -1,560 -65 -2,489 -2,227
Total operating costs -102,148 -83,292 -288,853 -310,884
Operating profit/loss -60,089 -70,386 -229,141 -248,983
Financial items
Other interest income and similar income statement items 14,452 1,341 15,594 1,788
Interest expense and similar income statement items -9,778 -785 -20,343 -1,391
Net financial items 4,674 556 -4,749 397
Profit/loss before tax -55,415 -69,830 -233,890 -248,586
Tax on profit for the period 0 - - -
Profit for the period attributable to Parent Company shareholders -55,415 -69,830 -233,890 -248,586
Earnings per share
Earnings per share before and after dilution, SEK -0.07 -0.11 -0.32 -0.55

Consolidated

Statement of Comprehensive Income

2024 2023 2024 2023
All amounts KSEK Note Oct-Dec Oct-Dec Jan-Dec Jan-Dec
Profit/loss for the period -55,415 -69,830 -233,890 -248,586
Other comprehensive income - - - -
Comprehensive income for the period -55,415 -69,830 -233,890 -248,586

Net Sales

Sales for the period, as well as last year period, pertain primarily to the collaboration agreement with Orion Corporation.

Other operating income

Other operating income for the quarter comprises primarily of operational exchange gains.

Operating costs

The Group's costs are lower compared to the same period previous year and pertain mainly to costs related to mitazalimab's OPTIMIZE-1 study that had its peak patient recruitment last year. External costs for mitazalimab amounted to SEK 32,349 thousand (34,261) during the fourth quarter of the year. These costs are driven by phase 3-enabling activities, e.g. production of study material and costs for the ongoing OPTIMIZE-1 study. In addition to the cost for mitazalimab activities, the ongoing dose escalation study in ALG.APV-527, has cost-wise been at the same level as the corresponding period previous year. During the quarter Alligator has got access to new lab and office premises. Alligator has concluded that no further value of right of use assets exist as a result of the communicated restructuring of the operations and hence a complete write-down has been made with SEK 40,4 million to SEK 0 million. Significant estimates and judgments are described in Note 3 and Note 18 of the Annual report for 2023. Regarding the acquired participation in development project, the conditions for the project have improved and the probability that the drug candidate will achieve milestones and incur royalties have increased. Part of the previous impairment (SEK 9,917 thousand) has thus been reversed.

Net financial items

Pertains to unrealized exchange gains and losses as a result of liquidity positions in USD, EUR and GBP and for the period this year also interest due to the new bridge loan, the credit facility and financial gain related to the warrants (TO 9) issued in connection with the Right issue of units in April 2024.

Consolidated Statement of Financial Position

All amounts in KSEK Note 2024-12-31 2023-12-31
ASSETS
Fixed assets
Intangible assets
Participations in development projects 3 27,865 17,949
Softwares - 15
Tangible assets
Right of use assets 1,267 17,613
Equipment, machinery and computers 1,754 2,699
Financial assets
Other long term financial fixed assets 6 2,056 1,986
Total fixed assets 32,942 40,262
Current assets
Current receivables
Accounts receivable 6 518 2
Other receivables 6 3,842 4,521
Prepayments and accrued income 2,726 7,547
Other short-term financial assets 6 - -
Cash and cash equivalents 6 64,310 66,118
Total current assets 71,396 78,188
TOTAL ASSETS 104,338 118,450

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 (AC101/HLX22). 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 27,865 thousand (17,949). Significant estimates and judgments are described in Note 3 and Note 18 of the Annual report for 2023. Regarding the acquired participation in development project, the conditions for the project have improved and the probability that the drug candidate will achieve milestones and incur royalties have increased. Part of the previous impairment has thus been reversed.

Right of use assets

At the end of the period, right of use assets amounted to SEK 1,267 thousand (17,613). Right of use assets pertain to leases for offices and laboratories, machines and vehicles.

In June 2022 Alligator entered into a lease contract with Medicon Village for lab and office premises valid from December 2024 with a contract period of 5 years. The new contract has increased the right of use assets by approximately SEK 40.4 million based on the use of the contract period without extension, and replaces the current contract with Medicon Village regarding lab and office premises. Impairment of 100% of the right of use asset has been accounted for since the move to the new premises has been cancelled, due to the restructuring of the operations initiated by the Group.

Cash and cash equivalents

Consolidated cash and cash equivalents, which consist of bank balances, totaled SEK 63,310 thousand (66,118).

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.

Consolidated Statement of Financial Position

All amounts in KSEK Note 2024-12-31 2023-12-31
EQUITY AND LIABILITIES
Equity
Share capital 607 42,170
Paid in, non-registered new share issue 824 -
Other capital contributions 1,145,709 1,055,224
Retained earnings and profit/loss for the period -1,277,728 -1,085,539
Equity attributable to Parent Company shareholders -130,588 11,855
Non-current provisions and liabilities
Lease liabilities 6 33,475 7,516
Total non-current provisions and liabilities 33,475 7,516
Current liabilities
Accounts payable 6 3,952 21,273
Other liabilities 6 140,643 3,261
Lease liabilities 6 10,097 8,581
Accrued expenses and deferred income 6 46,759 65,964
Total current liabilities 201,451 99,079
TOTAL EQUITY AND LIABILITIES 104,338 118,450

Consolidated

Statement of Changes in Equity, in summary

All amounts in KSEK 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Opening balance -76,004 81,897 11,855 89,051
New capital issue - - 97,082 195,097
Paid in, non-registered new share issue 824 - 824 -
Issue costs -42 -163 -7,523 -24,142
Warrants 84 - 1,060 440
Effect of share-based payments personnel - 22 59 74
Repurchase of warrants -34 -73 -53 -82
Profit/loss for the period -55,415 -69,830 -246,779 -248,586
Closing balance -130,588 11,855 -143,477 11,855

EQUITY AND LIABILITIES Equity

Equity at the end of the period amounted to SEK -130,588 thousand (11,855), corresponding to an equity ratio of -125 (10)%. The total number of shares outstanding in the Company amounts to 758,989,086 of which 758,209,917 are ordinary shares and 779,169 are series C shares.

Equity per share before potential dilution

At the end of the period, equity per outstanding share amounted to SEK -0.17 (0.02), before dilution.

Lease liabilities and loans

Lease liabilities pertain to leases for lab and offices, machines and vehicles. At the end of the period long- and short-term lease liabilities amounted to SEK 43,572 thousand (16,097). In June 2022 Alligator entered into a lease contract with Medicon Village for lab and office premises valid from December 2024 with an contract period of 5 years. The new contract has increased the lease liabilities by approximately SEK 40 million, based on the contract period without extension, and replaces the current contract with Medicon Village regarding lab and office premises.

During the second quarter 2024, the Group entered into an agreement with Fenja Capital II A/S for a credit facility amounting to up to SEK 80 million. During the third quarter the remaining part of the credit facility was utilized, which strengthened the cash position by further SEK 30 million. According to the agreement, Fenja has the right to convert up to SEK 12 million of the borrowed amount into shares at a price of SEK 1.47 per share. The facility is accounted for as a "compound financial instrument" where a portion is recorded as a loan and another portion (the value of the right to convert parts of the loan) is accounted for as equity. The transaction costs associated with the facility have been capitalized and are amortized over the term of the loan as interest costs, however, without impacting cash flow. The value of the right to convert is handled in the same way and is accounted for as an interest cost without affecting cash flow. The short-term liabilities will increase during the term of the facility at a corresponding rate so that the liabilities amount to SEK 87,458 thousand at the end of the term.

In order to secure the Group's liquidity needs until the Rights issue is completed, the Group raised a bridge loan of SEK 55 million during the fourth quarter.

Accrued expenses and deferred income

At the end of the period, accrued expenses and deferred income amounted to SEK 46,759 thousand (65,964). Expenses pertains to accrued expenses for clinical activities, personnel and other expenses. Accrued costs lower 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 Phase 1 study for ALG. APV-527.

Consolidated Statement of Cash Flows

All amounts in KSEK 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Operating activities
Operating profit/loss -60,089 -70,386 -229,141 -248,983
Adjustments for items not generating cash flow
Depreciation and impairments 41,817 2,672 48,729 10,489
Effect from warrant program - 22 59 74
Other items, no impact on cash flow - - -70 -2
Interest received 170 1,374 1,429 1,883
Interest paid -124 -101 -4,041
Tax paid - - - -483
Cash flow from operating activities before changes in working capital -18,225 -66,420 -183,035 -237,021
Changes in working capital
Change in operating receivables 3,285 5,177 4,948 13,267
Change in operating liabilities -18,791 6,745 -34,339 34,468
Cash flow from operating activities -33,732 -54,498 -212,426 -189,286
Investing activities
Acquisition of tangible assets - - - -2,459
Cash flow from investing activities - - - -2,459
Financing activities
Amortization of leasing liabilities -2,150 -2,352 -8,286 -9,754
Loan 55,000 - 135,000 -
Set up fee -2,750 - -6,750 -
New share issue - - 97,082 195,097
Paid in, non-registered new share issue 824 - 824 -
Issue costs -42 -163 -7,523 -24,142
Warrants - - 977 440
Repurchase of warants -34 -73 -53 -82
Acquisition of other short term investments - - - -50,000
Divestment of other short term investments - 50,000 - 50,000
Cash flow from financing activities 50,848 47,413 211,272 161,561
Cash flow for the period 17,116 -7,085 -1,154 -30,184
Cash and cash equivalents at beginning of period 47,797 73,919 66,118 97,305
Exchange rate differences in cash and cash equivalents -602 -716 -653 -1,004
Cash and cash equivalents at end of period 64,310 66,118 64,310 66,118

Investments

No investments were made under the fourth quarter of 2024 (SEK 0 thousand). Investments during the year amount to SEK 0 thousand (2,459).

Cash flow for the period

Cash flow for the fourth quarter totaled SEK 17,116 thousand (-7,085). The bridge loan has had a positive effect of SEK 52,250 thousand on the cash flow during the period.

Parent Company Income Statement

All amounts in KSEK Note 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Operating income
Net sales 5 41,779 11,738 57,767 58,107
Other operating income 5 280 1,168 1,945 3,795
Total operating income 42,059 12,906 59,712 61,902
Operating costs
Other external costs -90,493 -60,792 -220,859 -228,487
Personnel costs -15,275 -22,157 -70,428 -79,377
Depreciation and impairment of tangible assets and intangible assets -227 -297 -961 -1,200
Other operatings expenses -1,560 -65 -2,489 -2,227
Total operating costs -107,556 -83,312 -294,737 -311,291
Operating profit/loss -65,496 -70,406 -235,025 -249,389
Results from financial items
Impairment of investments in subsidiaries 3 7,865 - 7,865 -
Result from other securities and receivables - - - -
Other interest income and similar income statement items 10,029 1,341 11,170 1,788
Interest expense and similar income statement items -8,207 -684 -15,458 -910
Net financial items 9,687 657 3,577 878
Profit/loss after financial items -55,809 -69,749 -231,448 -248,511
Appropriations
Group contribution received 446 354 446 354
Total appropriations 446 354 446 354
Result before tax -55,364 -69,395 -231,002 -248,158
Tax on profit for the year - - - -
Profit/loss for the period -55,364 -69,395 -231,002 -248,158

Parent Company Statement of Comprehensive Income

All amounts in KSEK 2024
Note
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Profit/loss for the period -55,364 -69,395 -231,002 -248,158
Other comprehensive income - - - -
Profit/loss for the year -55,364 -69,395 -231,002 -248,158

Parent Company Balance Sheet

All amounts in KSEK Note 2024-12-31 2023-12-31
ASSETS
Fixed assets
Intangible assets
Software - 15
Total intangible assets - 15
Tangible assets
Equipment, machinery and computers 1,754 2,699
Total tangible assets 1,754 2,699
Financial assets
Participations in Group companies 3 28,159 20,294
Other long term financial fixed assets 2,056 1,986
Total financial assets 30,215 22,280
Total fixed assets 31,969 24,995
Current assets
Current receivables
Accounts receivables 518 2
Receivables from Group companies 1,644 1,199
Other receivables 3,840 4,520
Prepayments and accrued income 4,336 9,961
Total current receivables 10,338 15,681
Other short-term investments - -
Cash and bank deposits 62,262 64,510
Total current assets 72,599 80,191
TOTAL ASSETS 104,568 105,186

Parent Company Balance Sheet

All amounts in KSEK
Note
2024-12-31 2023-12-31
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 607 42,170
Paid in, non-registered new share issue 824 -
Total restricted equity 1,431 42,170
Non-restricted equity
Share premium reserve 1,144,552 1,054,452
Retained earnings -1,040,678 -834,223
Profit/loss for the period -231,002 -248,158
Total non-restricted equity -127,128 -27,928
Total equity -125,697 14,241
Provisions
Other provisions 38,679 -
Total other provisions 38,679 -
Current liabilities
Accounts payable 3,952 21,273
Other liabilities 140,643 3,262
Accrued expenses and deferred income 46,991 66,410
Total current liabilities 191,586 90,944
TOTAL EQUITY AND LIABILITIES 104,568 105,186

EQUITY AND LIABILITIES Equity

The Board has noted that the equity is below half of the registered share capital. The Board has considered the provisions in Chap. 25 in the Swedish Companies Act and concluded that the Company has significant surplus values (in amongst others, the mitazalimab project) that with good margin restores the share capital.

Notes

Note 1 General information

This Year End 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 Year End 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 2023.

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 2023. Regarding the acquired participation in development project, the conditions for the project have improved and the probability that the drug candidate will achieve milestones and incur royalties have increased. Part of the previous impairment has thus been reversed.

Note 4 Segment reporting

The Group 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 Group comprises only one operating segment, which corresponds to the Group as a whole, and no separate segment reporting is consequently not provided.

Note 5 Consolidated Income

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

All amounts in KSEK 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Licensing income 41,779 - 47,591 11,500
Reimbursement for development work - 11,738 10,168 46,607
Other - - 7 -
Total 41,779 11,738 57,767 58,107

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

All amounts in KSEK 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Swedish government grants received 63 156 -44 1,144
Operational exchange rate gains 140 1,012 1,871 2,632
Other 77 - 117 18
Total 280 1,168 1,945 3,795

Note 6 Financial instruments

Cash and cash equivalents for the Group at December 31, 2024 consisted of bank balances amounting to SEK 64.310 thousand (66.118). For financial assets and liabilities, the reported value as below is considered a reasonable approximation of fair value.

All amounts in KSEK 2024-12-31 2023-12-31
Financial assets valued at amortized cost
Other long term financial fixed assets 2,056 1,986
Other short term investments - -
Accounts receivable 518 2
Other receivables 122 24
Liquid assets - bank accounts 64,310 66,118
Total financial assets 67,006 68,130
Financial liabilities valued at amortized cost
Long-term lease liabilities 33,475 7,516
Accounts payable 3,952 21,273
Short-term lease liabilities 10,097 8,581
Other short-term liabilities 137,237 -
Accrued expenses 42,896 61,474
Total financial liabilities 227,656 98,844

Note 7 Related party transactions

In order to secure the Group's liquidity needs until the Rights issue 2024 was completed, the Group raised in February 2024 bridge loans of approximately SEK 58.8 millions from Koncentra and Roxette Photo SA. A compensation for the loans, an arrangement fee of 5 per cent and an annual interest rate of 8 per cent from disbursement of the loans have been paid. The subscription undertakings that Koncentra and Roxette Photo SA provided were fulfilled by offsetting the loans and accrued interests in the Rights issue in April 2024.

In connection with the Rights issue 2023, Alligator entered in March 2023 into an agreement on a top guarantee of MSEK 10 with Alligator's largest shareholder Koncentra, in which board member Staffan Enkrantz is chairman of the board of directors. Furthermore, Alligator entered in March 2023 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 per cent of the guaranteed amounts was paid for the bottom guarantee, and of 14 per cent of the guaranteed amount for the top guarantees. The guarantee compensation was paid in June 2023 after the Swedish Companies Registration Office registered the Rights issue.

In addition to the above, the Group has not carried out any other related party transactions during 2024 or during the previous year. All transactions with related parties have been carried out at arm's length.

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.

Alternative Performance Measures

All amounts KSEK unless specified 2024
Oct-Dec
2023
Oct-Dec
2024
Jan-Dec
2023
Jan-Dec
Profit/loss for the period -55,415 -69,830 -233,890 -248,586
Average number of shares before dilution 758,086,953 657,954,290 734,278,406 448,489,815
Earnings per share before dilution, SEK -0.07 -0.11 -0.32 -0.55
Average number of shares after dilution 758,086,953 657,954,290 734,278,406 448,489,815
Earnings per share after dilution, SEK -0.07 -0.11 -0.32 -0.55
Operating costs -102,148 -83,292 -288,853 -310,884
Impairment of tangible assets and intangible assets -39,062 - -39,062 -
Operating costs excluding impairments -63,086 -83,292 -249,791 -310,884
Reduce of administrative expenses 6,047 9,513 34,814 35,810
Reduce of depreciation 2,755 2,672 9,667 10,489
Research and development costs -54,284 -71,108 -205,311 -264,585
R&D costs / Operating costs excluding impairments % 86% 85% 82% 85%
Equity -130,588 11,855 -130,588 11,855
Average number of shares before dilution 758,209,917 657,954,290 758,209,917 657,954,290
Equity per share before dilution, SEK -0.17 0.02 -0.17 0.02
Average number of shares after dilution 758,209,917 657,954,290 758,209,917 657,954,290
Equity per share after dilution, SEK -0.17 0.02 -0.17 0.02
Equity -130,588 11,855 -130,588 11,855
Total assets 104,338 118,450 104,338 118,450
Equity ratio, % -125% 10% -125% 10%
Cash and cash equivalents 64,310 66,118 64,310 66,118
Cash and cash equivalents at end of period 64 310 66 118 64 310 66 118

For definitions, see the section "Financial definitions" on page 24.

Alligator presents certain financial performance measures in this report, including measures that are not defined under IFRS. The Group believes that these performance measures are an important complement because they allow for a better evaluation of the Group's financial 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 Group'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 Group's costs relate to R&D.

The Group 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 Group monitors performance indicators such as equity ratio and equity per share in order to assess the Group'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.

The declaration of the Board of Directors and the CEO

Anders Ekblom

Hans-Peter Ostler

Staffan Encrantz

Denise Goode Karin Nordbladh

Lund, January 22, 2025

Eva Sjökvist Saers Anders Ekblom Hans-Peter Ostler

Chairman of the Board Vice chairman of the Board

Eva Sjökvist Saers Staffan Encrantz Board member Board member

Board member Board member

Denise Goode Karin Nordbladh Employee representative

Søren Bregenholt CEO

Søren Bregenholt

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