PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) reported second quarter 2025 financial results and outlined key milestones in its effort to bring INO-3107, a DNA medicine candidate for recurrent respiratory papillomatosis (RRP), closer to market approval.
The company confirmed it remains on track to submit a Biologics License Application (BLA) for INO-3107 in the second half of 2025, targeting U.S. Food and Drug Administration (FDA) file acceptance before year end. Design verification testing for INOVIO’s CELLECTRA® 5PSP delivery device, required for the BLA, has been completed. INOVIO has requested rolling submission under the FDA’s Breakthrough Therapy designation, which would allow the agency to begin reviewing clinical and non-clinical data while device-related documentation is finalized.
“We believe that INO-3107 could become the preferred treatment option for RRP patients and their physicians,” said Dr. Jacqueline Shea, INOVIO’s president and chief executive officer. “With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end.”
The company also completed a successful FDA inspection as sponsor of its Phase 1/2 trial and is preparing a confirmatory, placebo-controlled trial involving 100 patients across 20 U.S. sites. A retrospective study published in The Laryngoscope showed that INO-3107 significantly reduced the number of surgeries required for RRP patients, with efficacy improving in the second and third years after treatment. No serious safety issues were identified.
Beyond INO-3107, INOVIO presented data on next-generation DNA-based therapeutics at the Orphan Drug Summit, including early findings from its DNA-encoded monoclonal antibody program for COVID-19 and its DNA-encoded protein technology aimed at sustained protein expression.
On the financial side, INOVIO narrowed its quarterly net loss to $23.5 million, or $0.61 per share, compared with a loss of $32.2 million, or $1.19 per share, in the same period last year. Research and development expenses fell to $14.5 million from $23.1 million, reflecting reduced costs tied to INO-3107. General and administrative expenses also declined, from $10.2 million to $8.6 million.
The company reported $47.5 million in cash, cash equivalents, and short-term investments as of June 30, excluding $22.5 million raised in a July public offering. INOVIO projects its resources will fund operations into the second quarter of 2026, assuming a third-quarter operational cash burn of approximately $22 million.
INOVIO plans to showcase additional data from INO-3107 and other pipeline programs at several global scientific conferences this fall, including the American Academy of Otolaryngology, the World Vaccine Congress Europe, and the International Papillomavirus Society Conference.
If approved, INO-3107 could be launched in 2026, positioning the company to enter the market with what it views as a potentially transformative therapy for patients with RRP.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.