Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP)
Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored trial
Current cash, cash equivalents, and short-term investments anticipated to fund operations into first quarter 2027, beyond the target PDUFA date
PLYMOUTH MEETING, Pa., May 13, 2026 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the first quarter ended March 31, 2026 and provided an update on recent company developments.
"We remain focused on advancing INO-3107 toward its target PDUFA date to ensure that every RRP patient has access to therapeutic options that work for them to reduce the need for surgery. We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease, and that INO-3107 has the potential to become the preferred product by patients and their physicians, if approved, based on clinical results, tolerability data and the simplicity of its patient-centric treatment regimen that does not require additional surgeries during the dosing window," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "While the BLA for INO-3107 is under active review, we continue to advance our commercial readiness plans in anticipation of a 2026 approval, as well as leverage the power of partnerships to advance other promising candidates in our pipeline."
Operational Highlights
INO-3107, Recurrent Respiratory Papillomatosis (RRP)INO-3107 is INOVIO's lead product candidate. It has been developed as a potential treatment for RRP, a rare and debilitating disease of the respiratory tract caused by infection with HPV-6 and/or HPV-11. In December 2025, the FDA accepted for review the company's BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026. Since then, the BLA has been under active review by the FDA, including the recent completion of the mid-cycle review meeting. INOVIO is focused on advancing INO-3107 through the regulatory process and working with the FDA as they complete their review of the BLA, including addressing the potential review issue they noted in their file acceptance letter regarding eligibility for review under the accelerated approval program. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. As a part of communications about the mid-cycle review, the FDA has reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program.
INOVIO continues to engage with the RRP community, including presenting data from our Phase 1/2 trial of INO-3107 at the Combined Otolaryngology Spring Meeting (COSM), the premier educational and technology forum for the specialists who treat RRP. INOVIO will also be presenting at the upcoming American Society of Clinical Oncology (ASCO) Annual Conference.
In anticipation of a potential approval in 2026, INOVIO continues to advance commercial readiness plans, including incorporating key learnings from the launch of a competitor's recently approved RRP product. INOVIO believes INO-3107 has a positively differentiated product profile. INOVIO plans to commercialize INO-3107 itself in the U.S., with the support of a contract sales organization, and has engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.
INO-5412In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. This novel combination builds on INOVIO's previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.
Next-Generation DNA Medicine CandidatesINOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several recent scientific conferences. Based on positive preclinical data on Factor VIII production for Hemophilia A, INOVIO is developing additional DPROT indications in the rare disease space, including Fabry disease and Hypophosphatasia (HPP), and is in discussions with potential partners to accelerate development of this promising platform.
General CorporateINOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $16.0 million.
First Quarter 2026 Financial Results
Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026 decreased to $14.1 million from $16.1 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower expensed inventory, among other variances.
General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended March 31, 2026 from $9.0 million for the same period in 2025.
Total Operating Expenses: Total operating expenses decreased to $21.9 million for the three months ended March 31, 2026 from $25.1 million for the same period in 2025.
Net Loss: INOVIO's net loss for the three months ended March 31, 2026 was $19.7 million, or $0.28 per basic and diluted share, compared to a net loss of $19.7 million, or $0.51 per basic and diluted share, for the three months ended March 31, 2025.
Cash, Cash Equivalents and Short-term Investments: As of March 31, 2026, cash, cash equivalents and short-term investments were $37.7 million (excluding net proceeds from the April 2026 offering of $16.0 million), compared to $58.5 million as of December 31, 2025.
Cash GuidanceINOVIO estimates that ...
