PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) has released its financial results for the first quarter of 2025, alongside significant updates on its pipeline advancements, including the upcoming Biologics License Application (BLA) submission for INO-3107 and progress in its DNA-encoded monoclonal antibodies (DMAb) technology.
The company remains on track to begin rolling its BLA submission for INO-3107 as a treatment for recurrent respiratory papillomatosis (RRP) in mid-2025, with the goal of completing the process later in the year. INOVIO aims for FDA acceptance by year-end, paving the way for a potential mid-2026 approval under priority review. “We continue to focus our efforts and resources on bringing this important product candidate to patients eager for a non-surgical therapeutic option,” said Dr. Jacqueline Shea, President and CEO of INOVIO.
INO-3107 has shown promising results in clinical trials, with data published earlier this year in Nature Communications. The treatment demonstrated new T-cell production that traveled to airway tissue, reducing the need for surgical intervention. INOVIO’s ongoing market research underscores the product’s potential as a preferred non-surgical option for patients and providers.
The company also reported encouraging interim outcomes from a Phase 1 trial of its DMAb technology. The trial showed prolonged in vivo antibody production, with 100% of participants maintaining biologically relevant levels through week 72 and no signs of anti-drug antibodies, a common issue with other delivery platforms.
On the financial front, INOVIO reported a net loss of $19.7 million for the first quarter, an improvement from the $30.5 million loss in the same period last year. Operating expenses totaled $25.1 million, down from $31.5 million in Q1 2024, reflecting lower R&D and administrative costs. Cash, cash equivalents, and short-term investments stood at $68.4 million as of March 31, 2025, with the company expecting to fund operations into the first quarter of 2026.
Dr. Shea highlighted INOVIO’s progress across its pipeline, reaffirming the company’s commitment to innovation in DNA medicines. “Beyond INO-3107, we are excited about the promising data from our DMAb trial and the potential across our entire pipeline,” she said.
Looking ahead, INOVIO is well-positioned to advance its key programs, support its commercialization plans, and explore opportunities to enhance its DNA medicines portfolio, with FDA milestones on the horizon and ongoing progress in cutting-edge biotechnologies.
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