INOVIO Pharmaceuticals Reports Q4 and Full Year 2025 Financial Results

Inovio Pharmaceuticals Inc. (NASDAQ: INO), a biotechnology company dedicated to developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, has released its financial results for the fourth quarter and full year ended December 31, 2025. Notably, the company is on the brink of a significant milestone, with its Biologics License Application (BLA) for INO-3107 currently under review by the FDA.

Dr. Jacqueline Shea, President and CEO of INOVIO, expressed optimism regarding the company's future, emphasizing the commitment to advancing INO-3107 for patients suffering from recurrent respiratory papillomatosis (RRP). "Our top priority is advancing INO-3107, and to do so, optimizing and extending our financial resources towards our target PDUFA date of October 30, 2026," she stated.

In December 2025, INOVIO's BLA for INO-3107 was accepted by the FDA for review under the accelerated approval program. However, a standard 10-month review has been granted instead of the requested priority review. The FDA raised concerns regarding the adequacy of information provided to justify eligibility for accelerated approval, but INOVIO remains confident that INO-3107 meets the necessary criteria and addresses a significant unmet medical need.

The company has made notable progress in clinical research, evidenced by the publication of results from its Phase 1/2 trial (RRP-001) in *Nature Communications*. The study demonstrated that INO-3107 induced new populations of T cells, which were associated with meaningful clinical benefits, including a reduction in the need for surgical interventions. Additionally, a retrospective study (RRP-002) published in *The Laryngoscope* highlighted the long-term safety and efficacy of INO-3107, reporting continued patient improvement beyond the initial trial period.

To prepare for commercialization, INOVIO is advancing its market research, pricing strategy, and go-to-market model. The company has begun establishing partnerships with logistics providers, specialty distributors, and pharmacies to facilitate the launch of INO-3107.

Inovio has also forged a clinical trial collaboration with Akeso Inc. to evaluate INO-5412, a combination therapy with cadonilimab for glioblastoma multiforme (GBM). This partnership is part of the INSIGhT trial, aimed at finding innovative treatments for GBM.

Furthermore, INOVIO is actively enrolling patients in the GBM-001 Phase 1/2 trial, which combines INO-5401 and INO-9012 with Regeneron's PD-1 checkpoint inhibitor, Libtayo®. Collaborations with academic institutions, such as the Basser Center at the University of Pennsylvania, are also ongoing, exploring the potential of INO-5401 in preventing cancer in individuals with BRCA mutations.

Inovio reported a decrease in both research and development (R&D) and general and administrative (G&A) expenses. R&D expenses amounted to $10.3 million for Q4 and $54.2 million for the year, a decline from $12.9 million and $75.6 million in 2024. G&A expenses were $7.2 million for Q4 and $32.7 million for the full year, down from $7.6 million and $37 million in 2024.

The company's net loss for Q4 was $3.8 million, translating to $0.06 per basic share and ($0.26) per diluted share. For the entire year, the net loss stood at $84.9 million, or ($1.81) per share, significantly improved from a loss of $107.3 million in 2024. Notably, the fourth-quarter results included a $21.2 million non-cash gain related to fair value adjustments of warrant liabilities.

As of December 31, 2025, INOVIO's cash, cash equivalents, and short-term investments totaled $58.5 million, a decrease from $94.1 million the previous year. The company estimates its cash reserves will support operations into the fourth quarter of 2026, with an operational net cash burn expected at approximately $22 million for Q1 2026.

With a firm focus on advancing INO-3107 towards its PDUFA target date, INOVIO Pharmaceuticals is strategically positioning itself for potential commercialization. The company is committed to leveraging partnerships and optimizing resources to support its innovative pipeline while maintaining financial discipline.

As INOVIO moves forward, stakeholders and investors will be keenly watching for updates, particularly regarding potential FDA discussions on accelerated approval and the outcomes of ongoing clinical trials. The coming months are poised to be critical for INOVIO as it navigates the complexities of drug development and market entry.