PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) reported third-quarter 2025 results and detailed a series of regulatory and clinical milestones that could reshape the company’s trajectory as it moves closer to launching its first commercial product.
The company completed the rolling Biologics License Application for INO-3107, its DNA immunotherapy for recurrent respiratory papillomatosis (RRP), and has requested priority review under the FDA’s accelerated approval pathway. A file-acceptance decision is expected by the end of 2025, positioning INOVIO for a potential mid-2026 approval and commercial launch.
CEO Dr. Jacqueline Shea said results from the Phase 1/2 program show the therapy’s ability to reduce reliance on repeated surgeries — the standard intervention for RRP — with most patients requiring fewer procedures through two years of follow-up. “As we work toward a potential approval, we are also advancing our next-generation DNA medicine candidates,” Shea noted, highlighting recent proof-of-concept data published in Nature Medicine and upcoming presentations on INOVIO’s DNA-encoded protein technology.
Advancing INO-3107 and Building Out Confirmatory Data
INO-3107 would be the first FDA-approved DNA medicine available in the United States. INOVIO is preparing a confirmatory trial expected to begin during the BLA review period at roughly 20 U.S. sites.
Newly published retrospective data in The Laryngoscope reinforce earlier findings:
- 81% of patients showed a reduction in surgeries at Year 1
- 91% showed continued benefit by Year 2
- Mean annual surgeries declined 78% compared with the year prior to treatment
Importantly, response rates were consistent regardless of viral load or papilloma subtype.
Next-Generation DNA Medicines Show Momentum
INOVIO’s DNA-Encoded Monoclonal Antibody (DMAb) technology achieved a significant milestone with first-in-human data demonstrating durable expression of complex proteins. The Phase 1 trial, led by The Wistar Institute with INOVIO and AstraZeneca, suggests the platform could offer a scalable alternative to conventional monoclonal antibody therapies. The company will present additional preclinical data from its DNA-encoded protein (DPROT) program at the upcoming World Federation of Hemophilia Global Forum.
Financial Results Reflect Focused Spending and Market Volatility
Third-quarter operating expenses fell sharply as INOVIO narrowed its focus on late-stage programs.
- R&D expenses declined to $13.3 million from $18.7 million a year earlier.
- G&A expenses decreased to $7.9 million from $8.6 million.
- Total operating expenses were $21.2 million, down from $27.3 million.
Despite tighter operations, the company reported a wider net loss of $45.5 million, driven largely by a $22.5 million non-cash fair-value adjustment related to warrant liabilities. Cash, cash equivalents, and short-term investments totaled $50.8 million at quarter-end, down from $94.1 million at year-end 2024.
INOVIO expects current resources to fund operations into the second quarter of 2026, excluding any future capital raises. The company ended September with 53.6 million common shares outstanding.
With its BLA now submitted and a potential approval next year, INOVIO enters 2026 with its lead program nearing the commercial finish line and a growing portfolio of next-generation DNA technologies beginning to show early clinical promise.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.