• Mitazalimab meets OPTIMIZE-1 Phase 2 primary endpoint, demonstrating 40.4% Overall Response Rate and median Overall Survival of 14.3 months
• Results confirm benefit of mitazalimab in combination with mFOLFIRINOX in pancreatic cancer and compare favorably to the standard of care
• ATOR-4066 preclinical data presented at 2023 SITC Annual Meeting
• Alligator plans to restructure and reduce workforce by 20-25%, with expected annual costs savings of SEK 20 million

Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX)

"Over the last 12 months our OPTIMIZE-1 trial evaluating our lead asset mitazalimab in pancreatic cancer has delivered two sets of highly encouraging interim data as well as faster-than-expected patient recruitment leading to an accelerated top-line readout, nine months earlier than planned. The top-line data has now provided further indication of the potential of mitazalimab combined with chemotherapy to confer significant clinical benefit to pancreatic cancer patients over the standard of care. The OPTIMIZE-1 Phase 2 results are a worthy validation of the capabilities of our drug development program. We now need to remain laser focused on our objective to deliver outstanding returns to our stakeholders and to maximize the chances of developing innovative therapies in an ever more challenging Biotech environment. Unfortunately, this initiative will affect our most important asset, our colleagues who have strived professionally and diligently to allow Alligator to deliver on our mission. We could not be more grateful for the efforts and commitment to advance mitazalimab and our other innovative options for those who suffer from hard-to-treat cancers, and we remain committed to supporting those colleagues impacted by this initiative."

Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

• On October 11, the European Patent Office granted Alligator a new patent covering mitazalimab's composition of matter until 2038, including a potential supplementary term. The patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia and more.

ATOR-4066

• On November 3, Alligator presented a poster entitled "Combination treatment with ATOR-4066, a Neo-X-Prime® bispecific antibody targeting CD40 and CEACAM5, and anti-PD-1 reverses T cell exhaustion in vitro" at the 2023 SITC (Society for Immunotherapy of Cancer) Annual Meeting held in San Diego.

ATOR-1017

• On October 5, Alligator announced the publication of a scientific article entitled "ATOR-1017, an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1" in the journal Cancer Immunology, Immunotherapy.

Capital Markets Day

• On December 1, Alligator hosted a Capital Markets Day in which members of the Company's executive management team provided an overview of Alligator's strategy, its proprietary and partnered assets and its technology platforms. The in-person event was held in Stockholm and live streamed online.

Significant events after the end of the period:
Mitazalimab

• On January 29, Alligator announced positive top-line results from the OPTIMIZE-1 Phase 2 trial in pancreatic cancer, demonstrating that mitazalimab in combination with mFOLFIRINOX achieved a 40.4% Overall Response Rate (ORR), a median Duration of Response (DoR) of 12.5 months, and median Overall Survival (mOS) of 14.3 months, which compares favorably to the 11.1 months mOS demonstrated by FOLFIRINOX,[1] and more recently by NALIFIROX in the NAPOLI 3 Phase 3 trial.[2]
• Results indicate that mitazalimab in combination with mFOLFIRINOX has the potential to deliver significant clinical benefit for pancreatic cancer patients over standard of care alone.
• Alligator has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, the FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3-enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.

ATOR-4066

• On January 16, Alligator announced that the United States Patent and Trademark Office (USPTO) had issued a new patent entitled "Novel peptides" which provides protection for ATOR-4066 regarding methods of treating cancer and/or a tumor using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule.

Company

• Alligator plans to restructure and reduce the workforce with 20-25% to adjust the burn rate and secure its continued ability to invest in the development of mitazalimab and other key value drivers. When fully implemented, the restructuring is expected to reduce annual cost by approximately SEK 20 million.

 
Outlook into 2024
Alligator continues to advance its Phase 3-enabling activities for the further clinical evaluation of mitazalimab in pancreatic cancer. In addition, Alligator is intensifying its business development efforts to identify the right partner to bring mitazalimab to patients as fast as possible, leveraging its full commercial potential. With the OPTIMIZE-1 top-line data validating CD40 as a target, Alligator sees increased potential in its Neo-X-Prime® bispecific antibody ATOR-4066, and will continue efforts to further strengthen its supporting preclinical data package and prepare it for clinical development. Alligator is also expecting the preliminary Phase 1 readout for ALG.APV-527, a bispecific antibody with a tumor-directed 4-1BB agonistic effect being co-developed with Aptevo Therapeutics, in the first half of 2024.
 
FINANCIAL SUMMARY FOR Q4 2023 and FULL YEAR 2023
The financial summaries for the quarterly periods ending December 31st, 2023 and December 31st, 2022 are presented below.

 
The financial summaries for the full year periods ending December 31st, 2023 and December 31st, 2022 are presented below.

The full report is attached as a PDF, and is also available on the company’s website.
Alligator will host a conference call on Friday, February 9, 2024, at 2 p.m. CET/ 8 a.m. EST for investors, analysts and media, where CEO Søren Bregenholt, CFO Marie Svensson, and CMO Dr. Sumeet Ambarkhane will present and comment on the Year-end report 2023, which will be followed by a Q&A session. The call will be held in English and can be accessed through Alligator's channel on YouTube.

[1] N Engl J Med 2011 May 12;364(19):1817-25. DOI: 10.1056/NEJMoa1011923.
[2] Lancet 2023 Oct 7;402(10409):1272-1281; DOI: 10.1016/S0140-6736(23)01366-1