Update on INO-3017 FDA Review and RRPF Advocacy

On December 29, 2025, INOVIO announced that the U.S. Food and Drug Administration (FDA) had accepted the Company’s Biologics License Application (BLA) for INO-3017 as a potential treatment for adults with RRP. The review classification designated by the FDA is Standard and the Prescription Drug User Fee Act (PDUFA) target action date is currently set for October 30, 2026.

The BLA submission was made and accepted for review under the FDA’s accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue, its preliminary conclusion that the Company had not submitted adequate information to justify eligibility for the accelerated approval pathway. What this means is that the FDA accepted the file for review under the accelerated approval program, but they may change their decision during the review process. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program.

The Recurrent Respiratory Papillomatosis Foundation (RRPF) agrees with INOVIO’s belief that INO-3017 does meet the eligibility criteria for the Accelerated Approval program and represents the most appropriate and timely pathway toward approval for patients facing

this rare and serious disease. RRPF has formally offered its assistance to INOVIO in upcoming discussions with the FDA to advocate for continued access to the accelerated approval pathway.

“The unmet need of the RRP community is our number one focus. Every surgery matters for patients, and we’re aligned with the RRPF’s mission for every patient to have a non-surgical treatment option that works for them.”

— Dr. Jacqueline Shea, Chief Executive Officer, INOVIO

RRPF remains steadfast in its commitment to advocating for the RRP community and ensuring that patient voices are heard throughout the regulatory process. Thank you for your continued support and partnership in advancing meaningful treatments for RRP.