Alligator Bioscience

• FDA feedback validates the clinical development strategy and Phase 3 design
• FDA feedback confirms that the toxicology package is adequate for the BLA submission
• Regulatory feedback significantly reduces program risk and Company remains on track for Phase 3 initiation during 2025

Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces the successful completion of its End of Phase 2 (EOP2) interaction with the US Food and Drug Administration (FDA), further strengthening the prospect of initiating Phase 3 in 2025 with mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX.

The EOP2 meeting with the FDA provided positive feedback and alignment on the non-clinical and clinical data packages to support the Biologics License Application (BLA), including the Phase 3 trial design, thus reinforcing earlier regulatory guidance from the Paul Ehrlich Institute (PEI) of Germany in July 2024. Additionally, a recent Type C Chemistry, Manufacturing, and Controls (CMC) interaction with the FDA in December 2024 confirmed that the completed and planned CMC work through early 2025 is Phase 3-enabling.

Alligator expanded patient recruitment during 2024 in the ongoing OPTIMIZE-1 study by enrolling an additional 15 patients at the 450 µg/kg dose level as per guidance received from the FDA in December 2023. Results from this cohort, along with a 24-month follow-up on the 900 µg/kg dose group, are expected during Q1 2025. Alligator updated the FDA on this activity, and no new information emerged affecting the Phase 3 dose selection.

“The successful outcome of our End-of-Phase 2 FDA interaction marks a critical milestone in our development program,” said Søren Bregenholt, CEO of Alligator Bioscience. " With clear regulatory alignment on our Phase 3 trial and robust CMC progress, mitazalimab is well-positioned for Phase 3 initiation during 2025. We remain committed to addressing the unmet medical need of patients with metastatic pancreatic cancer.”