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Alligator Bioscience
Quarterly Report • May 6, 2024
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Quarterly Report
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Interim report January – March 2024
Significant events during the period
- • First U.S. Patent granted for Neo-X-Prime® bispecific antibody ATOR-4066.
- • Positive top-line results reported from OPTIMIZE-1 Phase 2 trial with mitazalimab in 1st line pancreatic cancer.
- • Alligator reported plans to adjust headcount by approximately 20-25%, a process finalized in March, which will result in annual savings of 20 MSEK.
- • Alligator resolved to carry out a rights issue of shares and warrants of approximately 150.9 MSEK, subject to approval by an Extraordinary Meeting. The decision was approved by the EGM on March 14.
- • Alligator and Aptevo Therapeutics reported positive interim data from their dose-escalation trial with candidate ALG.APV-527.
- • Publication of article in scientific journal "mAbs" highlighting Alligator's unique bispecific antibody format RUBY®.
Significant post-period events
- • Notice of Annual General Meeting on May 7, 2024.
- • Alligator held two presentations at the Annual Meeting for American Association of Cancer Research in San Diego, on candidates mitazalimab and ATOR-4066.
- • The Company's Rights Issue was subscribed to a total of approximately 71.0 per cent, corresponding to approximately 107.1 MSEK before deduction of issue costs.
- • Orion Corporation exercised development option under research collaboration and license agreement, triggering an undisclosed milestone payment to Alligator.
"We remain laser focused on securing a commercial partnership to accelerate mitazalimab's development and bring it to patients as fast as possible."
Financial information
| 2024 Jan–Mar |
2023 Jan–Mar |
|
|---|---|---|
| Net sales (KSEK) | 6,977 | 9,593 |
| Operating profit/loss (KSEK) | -59,636 | -62,191 |
| Profit/loss for the period (KSEK) | -62,752 | -62,543 |
| Cash and cash equivalents (KSEK) | 40,022 | 44,837 |
| Cash flow for the period (KSEK) | -26,160 | -52,241 |
| Earnings per share before and after dilution (SEK) | -0.10 | -0.28 |
PIPELINE PROJECTS
CEO comments
Alligator has advanced with purpose and confidence through the first quarter of this year, continuously delivering on our promises. We are efficiently progressing our drug candidates through their various stages of development while ensuring we remain financially disciplined to achieve all our next major inflection points in the most efficient manner for our patients and stakeholders.
"We remain laser focused on securing a commercial partnership to accelerate mitazalimab's development and bring it to patients as fast as possible."
Key priority: securing commercial partnership for mitazalimab
We remain laser focused on our key priority of securing a commercial partnership to drive mitazalimab through the last stage of development and bring it to patients as fast as possible. Our preparations for the Phase 3 evaluation of our lead asset in pancreatic cancer are fully underway with our teams working on all fronts to ensure a timely start to the registration study, which remains on track to be initiated in the first half of 2025 in collaboration with a commercial partner. We showcased mitazalimab in a presentation at the 2024 American Association for Cancer Research Annual Meeting in April in San Diego. The presentation highlighted the synergistic potential of mitazalimab and chemotherapy to achieve an improved antitumor response, further underlining the potential of mitazalimab combined with mFOLFIRINOX to deliver significant clinical benefit for pancreatic cancer patients over standard of care. This was confirmed by the outstanding top-line results from OPTIMIZE-1 announced in January, demonstrating most notably a median duration of response of 12.5 months, almost doubling that seen in previous trials. Even more important for further clinical development, patients and potential partners are the promising long-term benefits that were observed, a median Overall Survival of more than 14 months.
A second presentation at the AACR reinforced the strength of the Alligator's Neo-X-Prime® bispecific antibody platform, showing how ATOR-4066 allows the selective activation of CD40, opening the way to an even more targeted therapeutic approach than mitazalimab.
Positive interim data on ALG.APV-527
Beyond our CD40 assets, we are also continuing to develop our earlier clinical assets targeting 4-1BB. This quarter we reported positive interim data from the dose-escalation phase of the ALG.APV-527 Phase 1 study in solid tumors expressing the tumor antigen 5T4, which we are developing in collaboration with Aptevo Therapeutics. The preliminary results showed that ALG.APV-527 induces the expected biological effects, giving us confidence in the continuing development of the asset. The study is on track for a further readout in the second half of this year.
Further recognition of Alligator's technology in scientific community
Following up on the differentiated features of Alligator's platform, the RUBY® bispecific antibody format was featured in the peerreviewed journal "mAbs". The article highlighted how RUBY® allows for the rapid generation of bispecific antibodies (bsAbs) that fulfill key development criteria and mitigate many of the challenges associate with other bsAb formats. The data in this article are yet another demonstration of the power of Alligator's proprietary drug discovery engine to generate high quality therapeutic molecules with excellent potential in hard-to-treat cancers.
The importance of the RUBY® format is also highlighted by its use in our successful collaboration with Orion Corporation. On April 26, we announced that the collaboration had reached yet another milestone, with Orion exercising their option to select lead antibodies from our second discovery program, triggering a milestone payment to Alligator.
Investor support and financial milestones
Such scientific achievements could not be done without the support of our investors. As we need to pursue our quest for value creation, during Q1 we successfully raised an additional SEK 107.1 million to ensure our ability to progress our pipeline and create more value for our shareholders. The recent restructuring of our workforce is now complete allowing us to devote the necessary resources to advancing our key priorities while maximizing longterm value creation. Once again, we have a busy period ahead of us and I look forward to reporting on our progress in our next update.
Søren Bregenholt CEO Alligator Bioscience AB (publ)
Performance measures
Group
| Note | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|
|---|---|---|---|---|
| Result (KSEK) | ||||
| Net sales | 5 | 6,977 | 9,593 | 58,107 |
| Operating profit/loss | -59,636 | -62,191 | -248,983 | |
| Profit/loss for the period | -62,752 | -62,543 | -248,586 | |
| R&D costs | -54,817 | -60,092 | -264,585 | |
| R&D costs as a percentage of operating costs, % | 82% | 83% | 85% | |
| Capital (KSEK) | ||||
| Cash and cash equivalents at end of period | 40,022 | 44,837 | 66,118 | |
| Cash flow from operating activities | -82,792 | -49,233 | -189,286 | |
| Cash flow for the period | -26,160 | -52,241 | -30,184 | |
| Equity at the end of the period | -50,889 | 26,526 | 11,855 | |
| Equity ratio at the end of the period, % | -58% | 22% | 10% | |
| Info per share (SEK) | ||||
| Average number of shares | 657,954,290 | 220,584,878 | 448,489,815 | |
| Earnings per share after dilution* | -0.10 | -0.28 | -0.55 | |
| Equity per share after dilution* | -0.08 | 0.12 | 0.02 | |
| Personnel | ||||
| Number of employees at end of period | 55 | 58 | 58 | |
| Average number of employees | 55 | 56 | 56 | |
| Average number of employees employed within R&D | 46 | 47 | 46 |
* Effect from dilution is not considered when result is negative and options where call rate is higher than closing rate is not considered.
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
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
-
- Database GlobalData (Pharma Intelligence Center Drug Sales), February 2023.
-
- www.keytruda.com/financial-support/, February 2023
Operations
Our technology platforms and pharmaceutical research cultivate long-term value and attract interest from potential partners, and we ensure competitive, efficient development of our programs through collaborations with leading biotech firms, labs and research institutions. Our oncology expertise is further enhanced by conducting clinical trials alongside specialist physicians and CROs.
Alligator has had a strong start to 2024, reporting promising top line data for lead candidate mitazalimab in the trial OPTIMIZE-1—a phase 2 study that underscores the Company's in-house expertise and strategic partnerships in navigating projects from conception to clinical development.
Alligator's organization
Alligator's research and development organization is divided into five units: Discovery, Chemistry, Manufacturing & Control (CMC), Non-Clinical Development, Medical Science and Clinical Operations. Members of all these functions collaborate cross– functionally 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 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 trials. Alligator continues to build and shape the organization to match and support its strategy and objectives.
INTERNAL
Several proprietary technologies
Alligator's proprietary technologies and antibody libraries enable efficient generation of novel drug candidates with high therapeutic potential. A great recent addition to our technologies is RUBY®, an antibody format that allows Alligator to generate dual-action bispecific antibodies, with excellent properties in terms of stability and manufacturing yield. This eliminates the need for further optimization and enables rapid advancement to clinical development.
With our 3rd generation technology platform, Neo-X-Prime®, we aim at a more personalized immunotherapy, with bispecific antibodies binding to tumor and tumor particles and to dendritic cells through the CD40 molecule. The resulting interaction between the two targets leads to an efficient education and activation of tumor-specific T cells, that subsequently recognize and destroy the tumor cells.
Business model that creates value across the development chain
Alligator combines internal expertise in proprietary drug development with strategic partnerships, optimizing our portfolio's value by advancing lead molecules from preclinical studies through Phase 2 clinical trials and beyond.
Our technologies and partnerships enable us to create candidates with inherent value across the development chain, enabling income generation, risk mitigation and an enhanced long-term value.
Design of highly efficient antibodies through Alligator's propritetary technologies
are based on Alligator's proprietary format, RUBY®, conferring outstanding properties.
EXTERNAL
New projects New candidates are further developed, either in-house or through external collaborations.
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.
Alligator's project portfolio
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-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 enrolled 57 patients in total. The chemotherapy cocktail used, mFOLFIRINOX, 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: Positive top-line Phase 2 readout
Top-line results were announced in January 2024, nine months earlier than originally planned, and demonstrated an ORR of 40.4% and a median Overall Survival (mOS)* of 14.3 months in the entire patient population. 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 2023, mitazalimab data were presented at leading medical conferences such as the AACR Special Conference on Pancreatic Cancer, the International Cancer Immunotherapy Conference (CICON), the 3rd Annual Tumor Myeloid-Directed Therapies Summit and the ASCO Annual Meeting, and published in the scientific journal Cells. In April 2024, further mitazalimab data was presented in San Diego at the Annual Meeting for AACR, supporting the unique dosing regimen chosen for OPTIMIZE-1.
Alligator recieves 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, and we look forward to sharing significant milestones from these potential engagements with the market.
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 neoantigen-specific T cells, resulting in superior anti-tumor activity. Besides CD40, ATOR-4066 binds CEACAM5, a tumorassociated 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. 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
Alligator focus its efforts on activities to support the preclinical ATOR-4066 data package and preparing 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.
ATOR-1017
Enhancing immune activation with ATOR-1017
ATOR-1017, a 4-1BB agonist with a unique profile, most importantly by enhancing immune activation within tumors, presenting opportunities for potent, tumor-directed immune responses. This capability holds promise for increasing therapeutic efficacy while minimizing adverse effects in patients.
Clinical advancements and promising results
Findings from Alligator's Phase 1 dose-escalation study, successfully completed in September 2022, demonstrated the safety and tolerability of ATOR-1017 in patients with advanced solid cancers, and established its safety and tolerability at doses up to 900 mg/kg. The results were presented at scientific conferences, positioning it as a potential best-in-class asset. Subsequent data published in the journal Cancer Immunology, Immunotherapy in October 2023, revealed the potent activity of ATOR-1017, both in vitro and in vivo, as monotherapy and in combination with anti-PD-1 treatment. These results, coupled with the Phase 1 study outcomes, support further development of ATOR-1017 in patients with histologically confirmed, advanced, and/or refractory solid cancer.
Future development and partnership goals
Continued efforts are focused on securing a partnership to capitalize on these promising clinical foundations and advance ATOR-1017 to its next development milestone.
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 Bioscience AB 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.
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.
Key Terms and Milestones
Under this partnership, Alligator leverages its proprietary phage display libraries and RUBY® bispecific platform. Throughout the initial research phase, Alligator is eligible for upfront payments as well as reimbursement for research costs and associated fees. The agreement also outlines potential milestone payments totaling up to EUR 313 million tied to development, regulatory approval, and sales milestones.
Additionally, should Orion proceed with the development and commercialization of resulting product candidates, Alligator stands to receive additional royalty payments. Recent milestones include Orion's selection of bispecific lead antibodies on May 11, 2023, the achievement of Technical Feasibility in the second collaboration project on July 31, 2023, and selection of lead antibodies on April 26, 2024, all events triggering milestone payments to Alligator.
MacroGenics, Inc.
Strategic Partnership for Innovative Cancer Therapeutics
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 IND-enabling studies, each company is 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.
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.
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, stock option program and share saving program
The total number of outstanding shares in the Company is 658,904,140, of which 657,954,290 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 658,049,275 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 642,741.648 from SEK 42,169,864.96 to SEK 527,123.312. This reduction means that the quota value per share is reduced from SEK 0.064 to SEK 0.008. The Rights Issue comprise of a maximum of 140,990,205 units. One existing ordinary share in the Company on the record date entitles to three unit rights. Fourteen unit rights entitle to subscription of one unit to a subscription price of SEK 1.07. One unit consists of one ordinary share and one warrant, TO 9.
One warrant series TO 9 will entitle 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. The exercise period will run between December 4, 2024, to December 18, 2024.
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 the recalculation due to rights issues the maximum number of ordinary shares that can be issued in relation to LTI 2021 amounts to 1,382,514 whereby 1,051,981 for the deliverance of matching shares and performance shares to participants and 330,533 to hedge payments of future social security contributions, which corresponds to a dilution of approximately 0.21 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 and for certain board members ("LTI 2022-I", respectively "LTI 2022-II"). Each warrant in LTI 2022-I/II entitles 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. Due to rights issues the subscription price per share for above warrant programs, has been recalculated to SEK 2.57. In case all warrants held by participants are utilized for subscription of new ordinary shares, a total of 3,740,072 new ordinary shares will be issued, which corresponds to a dilution of approximately 0.6 per cent of the company's ordinary shares after full dilution. All warrants have been transferred to the participants at fair market value.
Warrant programs 2023/2023-II
At the annual general meeting 2023 it was resolved to implement another long-term incentive program by way of a warrant program for employees in the company and for certain board members ("Warrant program 2023", respectively "Warrant program 2023-II"). In case all warrants held by participants are utilized for subscription of new ordinary shares, a total of 8,015,000 new ordinary shares will be issued, which corresponds to a dilution of approximately 1.2 per cent of the company's ordinary shares after full dilution.
In case both the existing share saving program as well as the warrants held by particpants are exercised, a total of 13,137,586 ordinary shares will be issued, which corresponds to a total dilution of approximately 2.0 per cent of the company's ordinary shares.
The Alligator share in brief March 31, 2024
| Listed on: | Nasdaq Stockholm Small Cap |
|---|---|
| 658,904,140 | |
| Number of shares: | (657,954,290 ordinary shares och 949,850 C shares) |
| Average turnover per | Approximately 4,812,931 |
| day: | (preceding quarter: approx. 1,950,000 |
| Number of shareholders: 11,482 (preceding quarter: approx. 10,418) | |
| SEK 655 million | |
| Market capitalization: | (preceding quarter: approx .SEK 454 million) |
| Ticker: | ATORX |
| ISIN: | SE0000767188 |
Swedish and foreign ownership
| Largest Shareholders, March 31, 2024 | No of Shares | % |
|---|---|---|
| Koncentra Holding AB | ||
| (Part of Allegro Investment Fund) | 205,840,048 | 31.2 |
| Roxette Photo NV | 53,446,475 | 8.1 |
| Avanza Pension | 23,323,782 | 3.5 |
| Magnus Petersson | 19,124,338 | 3.1 |
| Nordnet Pensionförsäkring | 13,119,015 | 2.0 |
| Johan Zetterstedt | 11,187,161 | 1.7 |
| Lars Spånberg | 9,641,572 | 1.5 |
| Jonas Sjögren | 9,281,534 | 1.4 |
| Öhman Fonder | 6,530,782 | 1.0 |
| Harri Salminen | 5,000,000 | 0.8 |
| Other shareholders | 301,459,583 | 45.7 |
| Total number of shares | 657,954,290 100.0 |
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 55 (58). Of these, 16 (17) were men and 39 (41) were women. Of the total number of employees at the end of the quarter 46 (48) were employed within research and development. During the period, the Company's restructuring has been fully negotiated with the trade unions concerned, which means that the company's workforce will be reduced by approx. 20%. Costs for the staff reduction of SEK 1,848 thousand are expensed in the period.
Future report dates
Alligator intends to publish its financial reports according to the following:
- • January June 2024 interim report: 11 July, 2024
- • January September 2024 interim report: 24 October 2024
- • Year-end report 2024: February 2025
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 2023 a 5 % stronger/weaker SEK against the USD would have had a positive/negative effect on posttax profits and equity of approx. +/- SEK 3,520 thousand, against the EUR of approx. +/- SEK 2,688 thousand and a against the GBP of approx. +/- SEK 1,558 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 Company'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 company has no direct business in, nor does it conduct any clinical studies in affected countries but sees that the company 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 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 includes both business development for new partnering agreements, with an upfront payment upon signing, as well as other options. As the company 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. It is the Board´s assessment that the company has good prospects of securing future financing, for example, through a new share issue, however, the absence of assurance at the same time of submission of this report means that there is a significant uncertainty factor regarding the company´s ability to continue operation.
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, 2023. 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®, 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
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
Financial statements
Unless otherwise stated in this interim 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 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|
|---|---|---|---|---|---|
| Operating income | Net Sales | ||||
| Net sales | 5 | 6,977 | 9,593 | 58,107 | |
| Other operating income | 5 | 508 | 834 | 3,795 | |
| Total operating income | 7,486 | 10,427 | 61,902 | ||
| Operating costs | |||||
| Other external costs | -43,026 | -51,467 | -218,792 | operations. | |
| Personnel costs | -20,979 | -18,339 | -79,377 | ||
| Depreciation of tangible assets and intangible assets | -2,526 | -2,470 | -10,489 | ||
| Other operatings expenses | -591 | -342 | -2,227 | ||
| Total operating costs | -67,122 | -72,618 | -310,884 | ||
| Operating profit/loss | -59,636 | -62,191 | -248,983 | ||
| Financial items | |||||
| Other interest income and similar income statement items | 506 | -86 | 1,788 | ||
| Interest expense and similar income statement items | -3,621 | -267 | -1,391 | ||
| Net financial items | -3,115 | -353 | 397 | ||
| Profit/loss before tax | -62,752 | -62,543 | -248,586 | ||
| Tax on profit for the period | - | - | - | ||
| Profit for the period attributable to Parent Company shareholders | -62,752 | -62,543 | -248,586 | ||
| Earnings per share | |||||
| Earnings per share before and after dilution, SEK | -0.10 | -0.28 | -0.55 |
Consolidated
Statement of Comprehensive Income
| 2024 | 2023 | 2023 | ||
|---|---|---|---|---|
| All amounts KSEK | Note | Jan-Mar | Jan-Mar | Jan-Dec |
| Profit/loss for the period | -62,752 | -62,543 | -248,586 | |
| Other comprehensive income | - | - | - | |
| Comprehensive income for the period | -62,752 | -62,543 | -248,586 |
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 exchange gains in the company's operations.
Operating costs
The company'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 highest patient recruiment last year. External costs for mitazalimab amounted to SEK 23,799 thousand (28,763) during the first quarter of the year. These costs are driven by Phase 3 enabling activities as drug production, as well as 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 previous year period.
The personnel costs in the first quarter are higher than last year as the reusult has been charged with costs for staff reductions with SEK 1 848 thousand.
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 Brigde Loan.
Consolidated Statement of Financial Position
| All amounts in KSEK | Note | 2024-03-31 | 2023-03-31 | 2023-12-31 | |
|---|---|---|---|---|---|
| ASSETS | ASSETS | ||||
| Fixed assets Intangible assets |
|||||
| Participations in development projects | 3 | 17,949 | 17,949 | 17,949 | |
| Softwares | 10 | 42 | 15 | ||
| Tangible assets | |||||
| Right of use assets | 15,343 | 24,736 | 17,613 | ||
| Equipment, machinery and computers | 2,449 | 1,581 | 2,699 | ||
| Financial assets | |||||
| Other long term financial fixed assets | 6 | 2,063 | 1,815 | 1,986 | |
| Total fixed assets | 37,813 | 46,123 | 40,262 | ||
| Current assets | |||||
| Current receivables | |||||
| Accounts receivable | 6 | 756 | 12,996 | 2 | |
| Other receivables | 6 | 4,246 | 4,729 | 4,521 | |
| Prepayments and accrued income | 4,939 | 13,375 | 7,547 | ||
| Cash and cash equivalents | 6 | 40,022 | 44,837 | 66,118 | |
| Total current assets | 49,963 | 75,938 | 78,188 | ||
| TOTAL ASSETS | 87,776 | 122,061 | 118,450 |
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 17,949 thousand (17,949).
Right of use assets
At the end of the period, right of use assets amounted to SEK 15,343 thousand (24,736). 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 40,022 thousand (44,837).
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 | 2024-03-31 | 2023-03-31 | 2023-12-31 | |
|---|---|---|---|---|---|
| EQUITY AND LIABILITIES | EQUITY AND LIABILITIES | ||||
| Equity | Equity | ||||
| Share capital | 527 | 88,614 | 42,170 | ||
| Other capital contributions | 1,055,216 | 911,894 | 1,055,224 | ||
| Retained earnings and profit/loss for the period | -1,106,632 | -973,982 | -1,085,539 | ||
| Equity attributable to Parent Company shareholders | -50,889 | 26,526 | 11,855 | ||
| Non-current provisions and liabilities | |||||
| Lease liabilities | 6 | 5,384 | 13,942 | 7,516 | |
| Total non-current provisions and liabilities | 5,384 | 13,942 | 7,516 | ||
| Current liabilities | Lease liabilities and loans | ||||
| Accounts payable | 6 | 5,454 | 10,266 | 21,273 | |
| Other liabilities | 60,549 | 1,676 | 3,261 | ||
| Lease liabilities | 6 | 8,559 | 9,380 | 8,581 | |
| Accrued expenses and deferred income | 6 | 58,718 | 60,270 | 65,964 | |
| Total current liabilities | 133,281 | 81,593 | 99,079 | ||
| TOTAL EQUITY AND LIABILITIES | 87,776 | 122,061 | 118,450 |
Consolidated
Statement of Changes in Equity, in summary
| All amounts in KSEK | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|---|---|---|---|
| Opening balance | 11,855 | 89,051 | 89,051 |
| New capital issue | - | - | 195,097 |
| Transaction costs | - | - | -24,142 |
| Treasury shares | - | - | - |
| Warrants | - | - | 440 |
| Effect of share-based payments personnel | 17 | 25 | 74 |
| Repurchase of warrants | -8 | -7 | -82 |
| Profit/loss for the period | -62,752 | -62,543 | -24,8586 |
| Closing balance | -50,889 | 26,526 | 11,855 |
Equity
Equity at the end of the period amounted to SEK –50,889 thousand (26,526), corresponding to an equity ratio of -58 (22) %. The total number of shares outstanding in the company amounts to 658,904,140 of which 657,954,290 are ordinary shares and 949,850 are series C shares. The total number of votes in the company amounts to 658,049,275..
Equity per share before and after dilution
At the end of the period, equity per outstanding share amounted to SEK –0.08 (0.12), before and after dilution. Since the subscription price for issued options has not been reached, these are not taken into account (not "in-the-money"). 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 13,943 thousand (23,323). 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 58,718 thousand (60,270). Expenses pertains to accrued expenses for clinical activities, personnel and other expenses. Accrued costs at the same level as 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. SEK 1,848 thousand (0) of the accrued expenses related to personnel pertains to the restructuring of the Company.
Consolidated Statement of Cash Flows
| All amounts in KSEK | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|
|---|---|---|---|---|
| Operating activities | Investments | |||
| Operating profit/loss | -59,636 | -62,191 | -248,983 | |
| Adjustments for items not generating cash flow | ||||
| Depreciation and impairments | 2,526 | 2,470 | 10,489 | |
| Effect from warrant program | 17 | 25 | 74 | |
| Other items, no impact on cash flow | -78 | -1 | -2 | |
| Interest received | 506 | 10 | 1,883 | |
| Interest paid | -3,621 | -135 | -483 | |
| Cash flow from operating activities before changes in working capital | -60,287 | -59,823 | -237,021 | |
| Changes in working capital | ||||
| Change in operating receivables | 2,129 | -5,592 | 13,267 | |
| Change in operating liabilities | -24,634 | 16,182 | 34,468 | |
| Cash flow from operating activities | -82,792 | -49,233 | -189,286 | |
| Investing activities | ||||
| Acquisition of tangible assets | - | -472 | -2,459 | |
| Cash flow from investing activities | - | -472 | -2,459 | |
| Financing activities | ||||
| Amortization of leasing liabilities | -2,154 | -2,529 | -9,754 | |
| Loan | 58,793 | - | - | |
| New share issue | - | - | 195,097 | |
| Transaction costs | - | - | -24,142 | |
| Warrants | - | - | 440 | |
| Repurchase of warants | -8 | -7 | -82 | |
| Acquisition of other short term investments | - | - | -50,000 | |
| Divestment of other short term investments | - | - | 50,000 | |
| Cash flow from financing activities | 56,632 | -2,536 | 161,561 | |
| Cash flow for the period | -26,160 | -52,241 | -30,184 | |
| Cash and cash equivalents at beginning of period | 66,118 | 97,305 | 97,305 | |
| Exchange rate differences in cash and cash equivalents | 64 | -227 | -1,004 | |
| Cash and cash equivalents at end of period | 40,022 | 44,837 | 66,118 |
No investments were made under the first quarter of 2024 (472 thousand). Investments during the year amount to SEK 0 thousand (472).
Cash flow for the period
Cash flow for the first quarter totaled SEK -26,160 thousand (-52,241). In order to secure the Company's liquidity needs until the Rights Issue has been completed, the Company has in February 2024 raised bridge loans of a total of approximately SEK 58.8 million from Koncentra and Roxette Photo SA.
Parent Company Income Statement
| All amounts KSEK | Note | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|---|---|---|---|---|
| Operating income | ||||
| Net sales | 5 | 6,977 | 9,593 | 58,107 |
| Other operating income | 5 | 508 | 834 | 3,795 |
| Total operating income | 7,486 | 10,427 | 61,902 | |
| Operating costs | ||||
| Other external costs | -45,209 | -53,758 | -228,487 | |
| Personnel costs | -20,979 | -18,339 | -79,377 | |
| Depreciation and impairment of tangible assets and intangible assets | -256 | -305 | -1,200 | |
| Other operatings expenses | -591 | -342 | -2,227 | |
| Total operating costs | -67,035 | -72,744 | -311,291 | |
| Operating profit/loss | -59,550 | -62,317 | -249,389 | |
| Results from financial items | ||||
| Other interest income and similar income statement items | 506 | -86 | 1,788 | |
| Interest expense and similar income statement items | -3,534 | -132 | -910 | |
| Net financial items | -3,029 | -217 | 878 | |
| Profit/loss after financial items | -62,578 | -62,534 | -248,511 | |
| Appropriations | ||||
| Group contribution received | - | - | 354 | |
| Total appropriations | - | - | 354 | |
| Result before tax | -62,578 | -62,534 | -248,158 | |
| Tax on profit for the year | - | - | - | |
| Profit/loss for the period | -62,578 | -62,534 | -248,158 |
Parent Company Statement of Comprehensive Income
| 2024 | 2023 | 2023 | ||
|---|---|---|---|---|
| All amounts KSEK | Note | Jan-Mar | Jan-Mar | Jan-Dec |
| Profit/loss for the period | -62,578 | -62,534 | -248,158 | |
| Other comprehensive income | - | - | - | |
| Profit/loss for the period | -62,578 | -62,534 | -248,158 |
Parent Company Balance Sheet
| All amounts in KSEK Note |
2024-03-31 | 2023-03-31 | 2023-12-31 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible assets | |||
| Software | 10 | 42 | 15 |
| Total intangible assets | 10 | 42 | 15 |
| Tangible assets | |||
| Equipment, machinery and computers | 2,449 | 1,581 | 2,699 |
| Total tangible assets | 2,449 | 1,581 | 2,699 |
| Financial assets | |||
| Participations in Group companies 3 |
20,294 | 20,294 | 20,294 |
| Other long term financial fixed assets | 2,063 | 1,815 | 1,986 |
| Total financial assets | 22,357 | 22,109 | 22,280 |
| Total fixed assets | 24,815 | 23,732 | 24,995 |
| Current assets | |||
| Current receivables | |||
| Accounts receivables | 756 | 12,996 | 2 |
| Receivables from Group companies | 1,199 | 845 | 1,199 |
| Other receivables | 4,244 | 4,728 | 4,520 |
| Prepayments and accrued income | 7,352 | 15,789 | 9,961 |
| Total current receivables | 13,552 | 34,358 | 15,681 |
| Cash and bank deposits | 38,427 | 43,588 | 64,510 |
| Total current assets | 51,978 | 77,946 | 80,191 |
| TOTAL ASSETS | 76,793 | 101,678 | 105,186 |
EQUITY AND LIABILITIES
Equity
The board has noted that more than half of the booked registered equity is below half of the registered share capital. The company has considered the provisions in Chap. 25 in the Swedish Companies Act and concluded that the company has large un-booked values (in amongst others, the mitazalimab project) that with good margin restores the share capital. The rights issue in April will increase the equity with approx. SEK 107 million, before issue costs.
Parent Company Balance Sheet
| All amounts in KSEK Note |
2024-03-31 | 2023-03-31 | 2023-12-31 |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 527 | 88,614 | 42,170 |
| Total restricted equity | 527 | 88,614 | 42,170 |
| Non-restricted equity | |||
| Share premium reserve | 1,054,452 | 911,488 | 1,054,452 |
| Retained earnings | -1,040,721 | -908,708 | -834,223 |
| Profit/loss for the period | -62,578 | -62,534 | -248,158 |
| Total non-restricted equity | -48,847 | -59,754 | -27,928 |
| Total equity | -48,320 | 28,859 | 14,241 |
| Current liabilities | |||
| Accounts payable | 5,454 | 10,266 | 21,273 |
| Other liabilities | 60,549 | 1,676 | 3,262 |
| Accrued expenses and deferred income | 59,110 | 60,876 | 66,410 |
| Total current liabilities | 125,114 | 72,818 | 90,944 |
| TOTAL EQUITY AND LIABILITIES | 76,793 | 101,678 | 105,186 |
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 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. There have been no changes to the company's estimates and judgments since the Annual report for 2023 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 | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|---|---|---|---|
| Licensing income | - | - | 11,500 |
| Reimbursement for development work | 6,977 | 9,593 | 46,607 |
| Total | 6,977 | 9,593 | 58,107 |
A breakdown of the Group's other operating income is as follows:
| All amounts in KSEK | 2024 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|---|---|---|---|
| Swedish government grants received | 63 | 216 | 1,144 |
| Insurance compensation | - | - | - |
| Operational exchange rate gains | 405 | 600 | 2,632 |
| Other | 40 | 18 | 18 |
| Total | 508 | 834 | 3,795 |
Note 6 Financial instruments
Cash and cash equivalents for the Group at March 31, 2024 consisted of bank balances amounting to SEK 40,022 thousand (48,837). For financial assets and liabilities, the reported value as below is considered a reasonable approximation of fair value.
| All amounts in KSEK | 2024-03-31 | 2023-03-31 | 2023-12-31 |
|---|---|---|---|
| Financial assets valued at amortized cost | |||
| Other long term financial fixed assets | 2,063 | 1,815 | 1,986 |
| Accounts receivable | 756 | 12,996 | 2 |
| Other receivables | 17 | 12 | 24 |
| Liquid assets - bank accounts | 40,022 | 44,837 | 66,118 |
| Total financial assets | 42,859 | 59,661 | 68,130 |
| Financial liabilities valued at amortized cost | |||
| Long-term lease liabilities | 5,384 | 13,942 | 7,516 |
| Accounts payable | 5,454 | 10,266 | 21,273 |
| Short-term lease liabilities | 8,559 | 9,380 | 8,581 |
| Accrued expenses | 53,978 | 56,536 | 61,474 |
| Total financial liabilities | 73,375 | 90,125 | 98,844 |
Note 7 Related party transactions
In order to secure the Company's liquidity needs until the Rights Issue has been completed, the Company has in February 2024 raised bridge loans of a total of approximately MSEK 58.8 from Koncentra and Roxette Photo SA. As 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 will be paid. According to the bridge loans, the subscription undertakings that Koncentra and Roxette Photo SA have provided shall be fulfilled by offsetting against outstanding loan and accrued interest or, if the Rights Issue is not carried out, repaid in cash no later than 31 May 2024.
In connection with the rights Issue, Alligator entered in March 2023 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 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% of the guaranteed amounts was paid for the bottom guarantee, and of 14% 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 Company has not carried out any other related party transactions during the first quarter 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 Jan-Mar |
2023 Jan-Mar |
2023 Jan-Dec |
|---|---|---|---|
| Profit/loss for the period | -62,752 | -62,543 | -248,586 |
| Average number of shares before dilution | 657,954,290 | 220,584,878 | 448,489,815 |
| Earnings per share before dilution, SEK | -0.10 | -0.28 | -0.55 |
| Average number of shares after dilution | 657,954,290 | 220,584,878 | 448,489,815 |
| Earnings per share after dilution, SEK | -0.10 | -0.28 | -0.55 |
| Operating costs | -67,122 | -72,618 | -310,884 |
| Operating costs excluding impairments | -67,122 | -72,618 | -310,884 |
| Reduce of administrative expenses | 9,780 | 10,056 | 35,809 |
| Reduce of depreciation | 2,526 | 2,470 | 10,489 |
| Research and development costs | -54,817 | -60,092 | -264,585 |
| R&D costs / Operating costs excluding impairments % | 82% | 83% | 85% |
| Equity | -50,889 | 26,526 | 11,855 |
| Average number of shares before dilution | 657,954,290 | 220,584,878 | 657,954,290 |
| Equity per share before dilution, SEK | -0.08 | 0.12 | 0.02 |
| Average number of shares after dilution | 657,954,290 | 220,584,878 | 657,954,290 |
| Equity per share after dilution, SEK | -0.08 | 0.12 | 0.02 |
| Equity | -50,889 | 26,526 | 11,855 |
| Total assets | 87,776 | 122,061 | 118,450 |
| Equity ratio, % | -58% | 22% | 10% |
| Other short-term financial assets (interest funds) | - | - | - |
| Cash and cash equivalents | 40,022 | 44,837 | 66,118 |
| Cash and cash equivalents at end of period | 40,022 | 44,837 | 66,118 |
For definitions, see the section "Financial definitions" on page 22.
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.
The declaration of the Board of Directors and the CEO
Anders Ekblom
Hans-Peter Ostler
Graham Dixon
The Board and the CEO declare that this Interim report provides a true and fair overview of the Company and the Group's operations, positions and earnings and describes the material risks and uncertainty factors faced by the Parent Company and the companies within the Group.
Lund, May 6, 2024
Eva Sjökvist Saers Anders Ekblom Hans-Peter Ostler
Chairman of the Board Vice chairman of the Board
Veronica Wallin
Staffan Encrantz Denise Goode
Anette Sundstedt
Board member Board member
Veronica Wallin Staffan Encrantz
Board member Board member
Søren Bregenholt CEO
Denise Goode Anette Sundstedt 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.
