INOVIO Accelerates Towards PDUFA Target Date for INO-3107 Amidst Strong Commercial Preparations

In a move that underscores its commitment to advancing novel DNA medicines, INOVIO, a biotechnology company dedicated to developing innovative solutions for life-threatening diseases, announced on its fourth quarter and full year 2025 financial results conference call that it remains focused on securing approval for INO-3107, its lead candidate for adults with recurrent respiratory papillomatosis (RRP).

With the FDA having accepted its BLA for review under the Accelerated Approval Program in December last year, INOVIO now finds itself racing towards the October 30th PDUFA target date. While the company awaits a meeting with the FDA to discuss eligibility for this accelerated program, it continues to advance commercial preparations and optimize resources towards achieving U.S. approval.

"These are very exciting times for INOVIO," said Dr. Jackie Shea, President and CEO of the company, on the conference call. "We strongly believe that INO-3107 does fulfill the criteria for review under the Accelerated Approval Program by meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatments." The FDA has agreed to meet with INOVIO to discuss this issue, and the company is awaiting a meeting date.

In preparation for the PDUFA target date, INOVIO has taken steps to further conserve its financial resources. This includes rescoping projects and activities that do not directly support the advancement of INO-3107 towards U.S. approval and eliminating roles that don't contribute to this primary goal. As a result, the company's estimated cash runway has been extended into the fourth quarter of this year.

While resources are primarily directed towards advancing its lead candidate, INOVIO is also leveraging partnerships to advance other promising candidates in its pipeline. A recent collaboration with the Dana-Farber Cancer Institute and Akeso to evaluate INO-5412 in combination with a novel PD-1/CTLA-4 bispecific antibody checkpoint inhibitor is one such example of this strategy.

The company's focus on securing approval for INO-3107 reflects its commitment to delivering innovative solutions for life-threatening diseases. As Dr. Shea emphasized, the upcoming meeting with the FDA will be crucial in determining whether INO-3107 meets the necessary criteria for accelerated approval.