INO-3107

March 12, 2026: INOVIO (NASDAQ: INO) reported Q4/full-year 2025 results and outlined pipeline/regulatory catalysts. The FDA accepted the Biologics License Application for INO-3107 for adults with recurrent respiratory papillomatosis (RRP) for review under the Accelerated Approval Program, but set a standard 10‑month review (not priority) with a PDUFA target action date of October 30, 2026. In its filing acceptance letter, the FDA flagged a potential issue: a preliminary conclusion that the submission did not provide adequate information to justify eligibility for the accelerated approval pathway; a meeting to discuss eligibility is agreed but not yet scheduled. INOVIO cited Phase 1/2 RRP-001 immunologic/clinical results published in Nature Communications and long-term safety/response data from retrospective study RRP-002 in The Laryngoscope, noting most patients showed continued improvement beyond 12 months as measured by reduced surgeries.

GBM: INOVIO signed a clinical trial collaboration and supply agreement with Akeso to study INO-5412 (INO-5401+INO-9012) plus Akeso’s cadonilimab (PD‑1/CTLA‑4 bispecific) in the Dana-Farber–sponsored INSIGhT Phase 2 adaptive platform trial; GBM-001 Phase 1/2 dosing with INO-5401+INO-9012 plus Libtayo continues.

Platform: Phase 1 DMAb COVID-19 proof-of-concept published in Nature Medicine; Factor VIII DPROT preclinical data presented (Nov 2025) at the World Federation of Hemophilia Global Forum. Cash runway projected into Q4 2026.