PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) narrowed its second-quarter net loss as the biotechnology company moved its lead drug candidate toward an Oct. 30 regulatory decision and raised additional capital to fund operations through a potential commercial launch.
The company reported a net loss of $6.0 million, or $0.07 per share, for the three months ended June 30, compared with a loss of $23.5 million, or $0.61 per share, a year earlier. The improvement was driven primarily by a $13.9 million non-cash gain tied to the fair-value adjustment of warrant liabilities.
Operating expenses fell 19% to $18.6 million from $23.1 million a year earlier. Research and development spending declined to $10.8 million from $14.5 million, while general and administrative expenses decreased to $7.8 million from $8.6 million.
INOVIO ended June with $36.7 million in cash, cash equivalents and short-term investments, down from $58.5 million at the end of 2025. That figure excludes approximately $18.3 million in net proceeds from an underwritten public equity offering completed in July.
The company expects those resources to fund operations into late in the first quarter of 2027, including through a potential launch of INO-3107 if the therapy receives regulatory approval. INOVIO projects an operational net cash burn of approximately $18 million in the third quarter.
The cash forecast does not assume additional capital-raising activities.
INO-3107, INOVIO’s treatment candidate for recurrent respiratory papillomatosis, or RRP, remains under U.S. Food and Drug Administration review through the accelerated approval program. The agency has set an Oct. 30 Prescription Drug User Fee Act target date.
The regulatory process has advanced through the late-cycle review meeting and all scheduled pre-licensure inspections. INOVIO also held an informal clinical meeting with the FDA to present data supporting the candidate’s safety and efficacy and its rationale for accelerated approval eligibility.
During that meeting, according to INOVIO, the FDA did not discuss a preliminary comment contained in its file-acceptance letter concerning accelerated approval eligibility. The agency indicated that feedback on the design of a confirmatory trial would be forthcoming.
INOVIO maintains that INO-3107 meets the criteria for accelerated approval by addressing an unmet clinical need and providing a meaningful therapeutic benefit over existing treatments. The FDA previously granted the candidate Orphan Drug and Breakthrough Therapy designations.
“As the FDA’s review of our BLA for INO-3107 continues to advance, we are pleased to have held the informal clinical meeting with the FDA, where we presented the totality of data supporting INO-3107’s safety and efficacy,” President and Chief Executive Officer Jacqueline Shea said.
With a regulatory decision approaching, INOVIO has begun building the infrastructure for a U.S. launch. The company engaged Syneos Health to recruit and deploy medical science liaisons and to serve as its contract sales organization.
INOVIO has also engaged or identified partners for logistics, specialty distribution, specialty pharmacy services, patient support and marketing.
Separately, ApolloBio, INOVIO’s partner for VGX-3100 in Greater China, reported positive topline results in May from a pivotal Phase 3 trial evaluating the investigational DNA immunotherapy for cervical dysplasia. The study met its predefined primary efficacy endpoint and showed what ApolloBio characterized as a favorable safety and tolerability profile.
ApolloBio plans to use the trial results to support a future application for regulatory approval in China. VGX-3100 targets diseases associated with high-risk human papillomavirus types 16 and 18.
INOVIO is also continuing work on its next-generation DNA-Encoded Monoclonal Antibody and DNA-Encoded Protein programs. The company presented preclinical data on Factor VIII production for hemophilia A at scientific conferences in May and June and is discussing potential partnerships to accelerate development.
The company is focusing potential additional DNA-Encoded Protein indications on rare diseases, including Fabry disease and hypophosphatasia.
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