Inovio Pharmaceuticals(US:INO) Prnewswire·2025-11-10 21:05Core Insights - INOVIO has completed the rolling submission of its Biologics License Application (BLA) for its lead candidate INO-3107, aimed at treating Recurrent Respiratory Papillomatosis (RRP) in adults, under the FDA's accelerated approval program [2][3][6] - The company is preparing for a potential commercial launch of INO-3107 in mid-2026, which would mark its first commercial product and the first DNA medicine available in the United States [3][6] - Recent data from clinical trials indicate that INO-3107 significantly reduces the need for surgeries in patients, with 81% of patients experiencing a reduction in surgeries at Year 1 and 91% at Year 2 post-treatment [7][5] Operational Highlights - INOVIO is conducting a confirmatory trial for INO-3107, expected to enroll patients during the BLA review period at approximately 20 sites across the United States [4] - The company has published proof-of-concept data on its next-generation DNA-Encoded Monoclonal Antibody (DMAb) technology in Nature Medicine, showcasing its potential as a long-acting alternative to traditional therapies [8][6] - INOVIO's DPROT program is set to present promising preclinical data at the World Federation of Hemophilia Global Forum, focusing on in vivo therapeutic protein production [9] Financial Performance - For Q3 2025, INOVIO reported a net loss of $45.5 million, an increase from a net loss of $25.2 million in Q3 2024, primarily due to a non-cash loss on fair value adjustment related to warrant liabilities [13][20] - Research and Development (R&D) expenses decreased to $13.3 million from $18.7 million year-over-year, while General and Administrative (G&A) expenses also saw a decline to $7.9 million from $8.6 million [13][20] - As of September 30, 2025, INOVIO had cash, cash equivalents, and short-term investments totaling $50.8 million, down from $94.1 million at the end of 2024, with an estimated operational net cash burn of approximately $22 million for Q4 2025 [12][13]