• Recurrent respiratory papillomatosis (RRP) is a rare HPV-related disease of the respiratory tract with significant unmet need
• INO-3107 previously received Orphan Drug and Breakthrough Therapy designations; BLA submitted under FDA's Accelerated Approval program
• Expect to receive file acceptance by year end 2025 with potential PDUFA date in mid-2026 if request for priority review granted

INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, announced that it has completed the rolling submission of its Biologics License Application (BLA) for its DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults.

INOVIO submitted the BLA under the FDA's Accelerated Approval program and has requested a priority review, which if granted, is expected to be completed within six months following the 60-day filing period. If approved, INO-3107 would be INOVIO's first commercial product and the first DNA medicine available in the United States.

"The potential to have a meaningful new treatment for RRP brings me so much hope for the RRP community, which has been desperate for relief from the risks and costs of repeated surgery," said Kim McClellan, President of the RRP Foundation. "Every patient deserves a therapy that works for them and I believe we are now one step closer to surgery being a last resort for the treatment of this disease."

"This is a pivotal moment in our efforts to deliver on the promise of INO-3107, an innovative DNA immunotherapy candidate that has the potential to become a paradigm-shifting treatment option for RRP," said Dr. Michael Sumner, Chief Medical Officer of INOVIO. "I'd like to thank the patients and physicians who participated in the INO-3107 clinical trial, as well as our internal team for their tremendous effort in completing INOVIO's first BLA submission. We look forward to continued communication and collaboration with the FDA during the review process and will be focused on finalizing our preparations for a potential commercial launch in 2026."