Inovio Pharmaceuticals (NASDAQ:INO) management used the company’s fourth-quarter and full-year 2025 earnings call to detail progress on its first biologics license application (BLA), ongoing launch preparations, and cost-cutting actions intended to extend cash runway as the FDA reviews INO-3107 for recurrent respiratory papillomatosis (RRP).
INO-3107 BLA under FDA review with October PDUFA date
President and CEO Dr. Jackie Shea said the FDA is currently reviewing Inovio’s BLA for INO-3107, a potential treatment for adults with RRP. She noted the FDA accepted the filing for review under the Accelerated Approval Program with a standard 10-month review timeline and a Prescription Drug User Fee Act (PDUFA) target date of October 30, 2026.
Chief Medical Officer Dr. Mike Sumner said Inovio believes INO-3107 meets accelerated approval criteria by addressing an unmet medical need and providing a meaningful therapeutic benefit over existing treatments. Sumner said the company submitted an “assessment aid” to the FDA in February to reiterate and expand its rationale and is awaiting the agency’s scheduling of a meeting to discuss eligibility. Meanwhile, Sumner said the BLA remains under active review and the company has been responding to routine FDA information requests.
Company argues differentiation vs. existing therapy in RRP
Sumner said the regulatory landscape shifted after the “unexpected full approval” of PAPZIMEOS in August 2025. He said that under published FDA guidance, when there is already an approved product, accelerated approval eligibility depends on whether a candidate provides meaningful benefit over existing treatments and addresses remaining critical unmet need.
In support of Inovio’s position, Sumner highlighted multiple points the company believes differentiate INO-3107:
- Reduction in surgeries: Sumner said the majority of patients in Inovio’s trial experienced fewer surgeries after treatment, with most seeing a 50%–100% reduction versus the year prior. He said clinical benefit continued to improve in the second 12-month period post-treatment, with half of patients requiring zero surgeries during that time.
- Dosing window and safety profile: Sumner said efficacy was achieved without the “vast majority” of patients requiring surgery during the dosing window, which he described as a key advantage.
- Trial endpoint differences: Sumner contrasted Inovio’s approach—counting every surgery after day zero—with the PAPZIMEOS trial design, where surgeries during a 12-week dosing window were not counted against the efficacy endpoint. He also said PAPZIMEOS’ label includes a requirement for procedures to maintain minimal residual disease (MRD), and he cited the PAPZIMEOS single-site phase I/II trial as having a high proportion of complete responders who had at least one surgery during the dosing window.
- Mechanism of action and patient subsets: Sumner said PAPZIMEOS uses an adenoviral vector and that preexisting neutralizing antibodies may limit immune responses for some patients. He added that investigators identified immune factors in the papilloma microenvironment linked to lack of efficacy for PAPZIMEOS, while Inovio cited data published in Nature Communications indicating INO-3107’s efficacy was not impacted by the papilloma microenvironment.
On the call, management said there was no new clinical data expected to be submitted for the accelerated approval eligibility discussion, but reiterated that additional documentation had already been provided in the assessment aid.
Commercial launch preparations continue ahead of potential approval
Chief Commercial Officer Steve Egge emphasized the burden of RRP, describing surgery as the standard of care and noting that some patients can undergo hundreds of procedures over their lifetimes. Egge highlighted both medical risks—such as permanent damage to vocal cords and airways—and broader impacts including travel for specialized care, missed work, impaired communication, and psychological strain.
Egge said market research conducted by third-party providers supported management’s belief that INO-3107 could become a preferred option based on efficacy, tolerability, and a regimen that can be administered in a physician’s office without an ultra-cold chain requirement. He also said physicians responded favorably to data showing fewer surgeries and to tolerability, and he reiterated that INO-3107 does not require surgeries during the dosing window to maintain MRD.
Egge added that the RRP Foundation’s recently published position statement on managing adults with RRP recommends immunotherapy as a first-line treatment and notes that INO-3107, if approved, would be included as a first-line option.
On launch readiness, Egge said Inovio has completed targeting, segmentation, positioning work, and developed its pricing strategy. He also said the company has selected key commercial partners, including a third-party logistics provider, specialty distributor, specialty pharmacy, patient services hub, and its agency of record, while finalizing its go-to-market model and planning a commercial organization build-out.
Pipeline updates: GBM collaboration, dMAb/DPROT progress, and HPV-related oncology program
Beyond INO-3107, Shea said Inovio is leaning on partnerships to advance other programs while conserving internal resources. She highlighted an announced collaboration involving an “innovative phase II adaptive platform trial” sponsored by Dana-Farber Cancer Institute, in which Inovio will work with Akeso to evaluate INO-5412 in combination with Akeso’s PD-1/CTLA-4 bispecific antibody checkpoint inhibitor, cadonilimab. Management said the trial is planned to initiate in the second half of 2026.
Discussing the biological rationale, management referenced prior work combining INO-5401 plus IL-12 with a PD-1 inhibitor (Libtayo) and said adding CTLA-4 blockade could provide additional benefit through synergism between the checkpoint pathways. Management also said prior data showed benefits in both methylated and unmethylated MGMT populations, while noting that the INSIGhT platform is in the unmethylated group and may yield a quicker readout due to poorer prognosis.
Shea also pointed to platform progress in DNA-encoded monoclonal antibodies (dMAbs), citing phase I proof-of-concept data published in Nature Medicine showing durable production for up to 72 weeks without generating anti-drug antibodies, and said newer data demonstrate consistent production out to 96 weeks. She described DPROT as an effort to enable additional complex proteins to be produced in vivo, referencing preclinical data presented at the World Federation of Hemophilia Global Forum that included Factor VIII production and said the company is seeking partnerships for rare disease targets.
In Q&A, Shea also discussed INO-3112 (HPV16/18-positive head and neck cancer), noting a previously announced partnership with Coherus involving its PD-1 inhibitor LOQTORZI and a goal to start a phase III trial, but said the majority of resources are currently directed to INO-3107. Shea said the company would look to move other candidates forward if INO-3107 is approved and sufficient financial resources are available, and stressed the importance of partnerships.
2025 financial results and cash runway
Chief Financial Officer Peter Kies said the company is prioritizing spending to extend its cash runway toward a potential 2026 launch. Kies said Inovio reduced headcount by approximately 15% and continued to reduce spending, resulting in an estimated cash runway into the fourth quarter of 2026. He said the projection includes an estimated $22 million operational net cash burn for the first quarter of 2026, which he noted historically runs higher than other quarters, and does not include any future capital raising.
Inovio ended the fourth quarter of 2025 with $58.5 million in cash, cash equivalents, and short-term investments, compared with $94.1 million at December 31, 2024.
Kies said total operating expenses declined to $17.5 million in the fourth quarter of 2025 from $20.5 million in the fourth quarter of 2024. For the full year, operational expenses decreased 23% to $86.9 million in 2025 from $112.6 million in 2024.
Inovio reported net income of $3.8 million, or $0.06 per share, for the fourth quarter of 2025, which Kies said was primarily driven by a $21.2 million non-cash gain from a fair value adjustment related to warrant liability. For the full year of 2025, the company reported a net loss of $84.9 million, or $1.81 per share, basic and diluted.
In closing remarks, Shea said the company’s near-term strategic focus is advancing the INO-3107 BLA review and optimizing resources ahead of the October 30 PDUFA date, while continuing to progress other pipeline programs through partnerships where possible.
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.
