Inovio Pharmaceuticals Shareholders Back Board as INO-3107 FDA Review Advances

Key Points

• Shareholders approved all proposals at Inovio’s 2026 annual meeting, including the election of eight directors, executive compensation, and the ratification of Ernst & Young as auditor.
• Inovio said the FDA has completed its mid-cycle review of INO-3107 with no new major issues, and the company is heading toward a Q3 late-cycle review ahead of the Oct. 30, 2026 PDUFA date.
• The company is counting on INO-3107 to address recurrent respiratory papillomatosis, citing trial data showing fewer surgeries and enough cash to fund operations into Q1 2027.

Inovio Pharmaceuticals NASDAQ: INO shareholders approved all proposals presented at the company’s 2026 annual meeting, including the election of eight directors and the ratification of Ernst & Young LLP as the company’s independent registered public accounting firm for the year ending Dec. 31, 2026.

Simon X. Benito, chairman of Inovio’s board of directors, presided over the virtual meeting. Rob Crotty, Inovio’s general counsel, corporate secretary and chief compliance officer, said a quorum was present based on a preliminary count of shares represented by proxy.

The board nominees elected were Simon Benito, Roger D. Dansey, Ann C. Miller, Jacqueline Shea, Jay Shepard, David B. Weiner, Wendy Yarno and Lota Zoth. Shareholders also approved, on a non-binding advisory basis, the compensation of Inovio’s named executive officers, and approved an amendment and restatement of the company’s amended and restated 2023 Omnibus Incentive Plan.

Crotty said the company expects to report preliminary voting results, or final results if available, in a Form 8-K filing with the Securities and Exchange Commission within four days after the meeting.

Inovio Highlights INO-3107 Regulatory Progress

Following the formal portion of the meeting, Dr. Jackie Shea, Inovio’s chief executive officer, provided an update on the company’s progress and priorities. Shea said Inovio’s work in 2025 culminated with the U.S. Food and Drug Administration’s acceptance of its first Biologics License Application for INO-3107 under the Accelerated Approval Program.

INO-3107 is Inovio’s lead DNA immunotherapy candidate in development for the treatment of recurrent respiratory papillomatosis, or RRP. Shea said the target Prescription Drug User Fee Act date for the application is Oct. 30, 2026, and that the company is focused on the potential approval and commercial launch of what would be Inovio’s first product.

Shea said the FDA has completed its standard mid-cycle review of the BLA, with “no new significant issues being raised,” and has scheduled the late-cycle review for the third quarter. She also said the FDA reiterated its intent to schedule an informal meeting to discuss a potential review issue raised in the file acceptance letter related to INO-3107’s eligibility under the Accelerated Approval pathway.

“We have indicated to the agency that we are eager to discuss this with them as we believe that 3107 meets the requirements for Accelerated Approval eligibility,” Shea said.

Company Cites Unmet Need in RRP

Shea described RRP as a rare HPV-related disease estimated to affect approximately 14,000 people in the U.S. based on available epidemiological data. The disease is characterized by persistent wart-like growths called papilloma that primarily grow on the vocal cords and in the respiratory tract.

Shea said surgery remains the standard of care and that patients can undergo numerous surgeries to manage the disease. She said there is now an improved immunotherapy on the market, but added that it “doesn’t work for every patient” and includes additional surgery as part of its dosing protocol.

According to Shea, Inovio designed INO-3107 with the goal of reducing surgeries. She said the company believes the candidate could become a preferred treatment option for RRP based on efficacy and tolerability results observed to date, as well as a patient-focused treatment regimen that does not require surgery during the dosing window.

Shea said Inovio completed a Phase 1/2 open-label trial of INO-3107 in patients who required at least two surgeries in the previous year, along with a retrospective trial to assess longer-term treatment effects. She said the trials showed a statistically significant reduction in surgeries in the first 12 months following treatment, with clinical benefit continuing into the second year. She added that half of patients required no surgery in year two.

Shea said Inovio believes INO-3107 meets FDA criteria for Accelerated Approval based on its potential to provide meaningful therapeutic benefit over existing treatments and address remaining unmet need among patients.

Pipeline Partnerships and Research Updates

While Inovio is directing most of its resources toward INO-3107, Shea said the company is continuing to advance other pipeline candidates through partnerships.

She highlighted a collaboration announced in February with Akeso to evaluate Inovio’s immuno-oncology candidate INO-5401 in combination with Akeso’s dual checkpoint inhibitor as a potential treatment for glioblastoma. Shea said the study will be part of a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute.

Shea also discussed Inovio’s work with The Wistar Institute, AstraZeneca and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania to advance DNA-encoded monoclonal antibody technology. She said a Phase 1 proof-of-concept trial published in Nature Medicine in October demonstrated the technology’s ability to produce monoclonal antibodies within the human body.

Shea said Inovio’s DNA-encoded protein technology builds on that research and is aimed at enabling additional types of proteins to be made within the body to treat diseases caused by missing or defective proteins. She noted that Inovio has presented preclinical work on factor VIII production for hemophilia A and is seeking partnerships for rare disease targets including Fabry disease and hypophosphatasia.

Financial Position

Shea said financial discipline remains central to Inovio’s strategy as it focuses resources on advancing INO-3107. She said the company reduced total operating spend for 2025 by 23% compared with 2024, and that operating expenses declined 13% in the first quarter of 2026 compared with the first quarter of 2025.

Inovio ended the first quarter of 2026 with $37.7 million in cash, cash equivalents and short-term investments. Shea said the company also completed a public equity offering in April 2026 that provided net proceeds of approximately $16 million. Based on current operating plans, she said Inovio estimates its cash runway extends into the first quarter of 2027.

Shea concluded by saying the company is focused on upcoming milestones, including the potential approval and launch of INO-3107 and the opportunity to introduce what she described as the first DNA medicine in the United States.

About Inovio Pharmaceuticals NASDAQ: INO

Inovio Pharmaceuticals is a biotechnology company focused on the discovery, development and commercialization of DNA-based immunotherapies and vaccines aimed at treating and preventing infectious diseases and cancers. The company leverages proprietary technologies to design synthetic DNA sequences that encode antigens capable of eliciting targeted immune responses. Inovio's business activities span early research through clinical development, with a primary emphasis on advancing candidates against viral pathogens such as SARS-CoV-2, human papillomavirus (HPV), HIV, Ebola, Zika and other emerging threats.

Central to Inovio's platform is its SynCon® technology, which constructs optimized DNA plasmids for broad antigen coverage, and the Cellectra® electroporation device, designed to enhance cellular uptake and expression of DNA vaccines.

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