Alligator Bioscience (ATORX) Q1 2025 earnings summary

Executive summary

• Significant progress with mitazalimab in first-line metastatic pancreatic cancer, including 24-month follow-up data showing a 29.4% survival rate and median OS of 14.9 months, with FDA alignment on Phase 3 trial design targeting initiation in H2 2025 pending partnership.

• Top-line data from a backfill cohort supports 900 micrograms as the recommended phase III dose for mitazalimab.

• Successful regulatory interactions and FDA End-of-Phase 2 meeting have minimized program risk and support a clear path to approval.

• Cost reduction program ahead of plan, with restructuring to conclude in late Q2 2025, expected to lower OpEx and support strategic focus on mitazalimab.

• New Chief Medical Officer, Dr. Tom Moore, appointed, bringing extensive oncology drug development experience.

Financial highlights

• Rights issue in February raised SEK 153 million gross, with proceeds used for loan repayments and operational funding.

• Net sales for Q1 2025 were SEK 7.0 million, down from SEK 57.8 million in Q1 2024 due to the end of the Orion collaboration.

• Operating loss improved to SEK -43.7 million from SEK -59.6 million year-over-year; net loss for the period was SEK -8.3 million.

• Liquidity funds of SEK 28.9 million at quarter-end.

• R&D costs accounted for 83% of operating costs in Q1 2025.

Outlook and guidance

• Phase III clinical program for mitazalimab targeted to start by end of 2025, pending partnership.

• Cost-reduction program ahead of plan, with restructuring to conclude in late Q2 2025, expected to lower burn rate.

• Cash runway expected to last until end of 2025, assuming prudent warrant exercise; funding for 2025 is contingent on successful warrant subscriptions.

• Focused discussions ongoing with global pharma and biotech companies for mitazalimab partnership, with high likelihood of agreement in 2025.

• No significant cash allocation to pipeline assets 4066 and 527 until non-dilutive income is secured.