Alligator Bioscience (ATORX) Q3 2024 earnings summary

Executive summary

• Mitazalimab remains the top priority, showing strong phase II results in first-line metastatic pancreatic cancer, with significant improvements in response durability and overall survival compared to standard chemotherapy regimens.

• Completed enrollment for the 450 µg/kg cohort in the mitazalimab Phase 2 OPTIMIZE-1 trial; Phase 3 initiation on track for H1 2025.

• The pipeline includes 4066 (CD40 bispecific) with promising preclinical data and ALG.APV-527 (bispecific antibody) in phase I, with positive interim data and top-line results expected Q1 2025.

• The company is preparing for a phase 3 trial, engaging with global pharma partners for potential licensing and development collaborations, and advancing commercial manufacturing.

• Ongoing efforts to secure a global partner for mitazalimab, with new interest following recent data releases.

Financial highlights

• Q3 2024 net sales were SEK 1.4 million, down from SEK 19.4 million in Q3 2023; YTD net sales SEK 16.0 million (YTD 2023: SEK 46.4 million).

• Operating loss for Q3 2024 was SEK -62.0 million (Q3 2023: SEK -52.7 million); YTD operating loss SEK -169.1 million (YTD 2023: SEK -178.6 million).

• Cash and cash equivalents at period end were SEK 47.8 million, with SEK 48 million reported after drawing the second tranche of the Fenja facility.

• Cash flow for Q3 2024 was SEK -29.5 million (Q3 2023: SEK -86.5 million).

• Operating costs are trending downward as clinical trial recruitment has ended, but phase 3 enabling activities are ongoing.

Outlook and guidance

• Phase 3 trial for mitazalimab is targeted to start in late H1 2025, pending final dose selection and regulatory discussions.

• 24-month follow-up data for the 900-microgram cohort and top-line data for the 450-microgram cohort are expected in mid-Q1 2025.

• Top-line Phase 1 data for ALG.APV-527 anticipated in Q1 2025.

• Approval for mitazalimab is anticipated by 2030, with potential for earlier interim approval.

• Warrants Series TO 9 subscription period in December 2024 expected to improve liquidity.