Alligator Bioscience (ATORX) investor relations material

Clinical progress and data highlights

• Lead asset mitazalimab, a CD40 agonist, is advancing toward phase III for first-line metastatic pancreatic cancer, showing strong long-term survival benefits and a clear regulatory path in the US and Europe.

• Phase II data indicate mitazalimab triples two-year survival probability and does not add significant toxicity to chemotherapy, with median overall survival extended by about four months.

• Tumor reduction data show rare complete remissions and sustained treatment response beyond two years for some patients.

• Mechanistic studies confirm mitazalimab activates myeloid and T cells in tumors, correlating with improved survival outcomes.

• Phase III trial design has been agreed with regulators, and partnership negotiations are ongoing to initiate the study.

Market opportunity and strategic expansion

• Metastatic pancreatic cancer remains a high unmet need, with 85,000 annual cases in the US and EU and poor survival rates; mitazalimab targets an addressable population of 22,000 first-line patients.

• Investigator-initiated trials (IITs) are expanding mitazalimab’s clinical footprint in other oncology indications with minimal company expenditure, leveraging external grants.

• A randomized phase II IIT in biliary tract cancer will start next year, funded by a French government grant, with additional US-based IITs planned.

Pipeline and financial outlook

• ATOR-4066, a next-generation CD40 bispecific, is positioned as a future pipeline priority, offering broader immune activation and precision medicine potential, but is on hold due to financial constraints.

• HLX-22, out-licensed to Henlius, is in late-stage trials for gastric cancer and could generate SEK 150–400 million in annual royalties for the company starting late 2020s.

• Investor and pharma sentiment is improving, aligning with the completion of phase II and ongoing partnership discussions.