INO-3107

May 13, 2026: INOVIO (NASDAQ: INO) reported Q1 2026 results and provided pipeline/regulatory updates. The FDA is actively reviewing the Biologics License Application (BLA) for INO-3107 for adults with recurrent respiratory papillomatosis (RRP) under the accelerated approval program; the target PDUFA date is October 30, 2026. The company said the FDA mid-cycle review meeting has been completed and that the agency noted a potential review issue in the file acceptance letter regarding eligibility for accelerated approval; the FDA intends to schedule an informal meeting to discuss preliminary commentary on that eligibility. INOVIO cited presentations of Phase 1/2 INO-3107 data at the Combined Otolaryngology Spring Meeting (COSM) and said it will also present at the upcoming ASCO Annual Conference. Commercial readiness activities are ongoing in anticipation of a potential 2026 approval and U.S. self-commercialization (with a contract sales organization and selected partners).

INO-5412: In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to study INO-5412 plus cadonilimab in glioblastoma within the INSIGhT Phase 2 adaptive platform trial sponsored by Dana-Farber.

Financial/cash runway: Cash, cash equivalents and short-term investments were $37.7M as of March 31, 2026 (excluding ~$16.0M net proceeds from an April 2026 equity offering). The company expects funding into Q1 2027, beyond the INO-3107 PDUFA date.