Results & Analyst Call Summary

Conference date: May 13, 2026 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2026 (Q1, first quarter)

Forward-looking statements

Overview: INO-3107 for RRP PDUFA is October 30, 2026.

Basic data (GAAP):

Revenue was $0 thousand, flat sequentially from $0 thousand, and down from $65 million in the year-earlier quarter.

Net income was negative $20 million, down sequentially from $3.8 million, and flat from negative $20 million year-earlier.

EPS (earnings per share, diluted) was negative $0.28, down sequentially from $0.06, and up from negative $0.51 year-earlier.

Guidance:

Cash runway into Q1 2027.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "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. 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." If approved, INO-3107 would be Inovio's first commercial product and the first human DNA medicine available in the United States. However, would be second to the RRP market (after Precigen's Papzimeos); believes 3107 is the superior product based on the data [see slides for details]. But FDA raised possible issue with accelerated approval status.

The FDA accepted the BLA for INO-3107 for RRP (Recurrent Respiratory Papillomatosis) in Q4 2025, including the device component. PDUFA date is October 30, 2026. Must also start the Phase 3 trial. Pricing will be in line with rare disease pricing, feedback from payers is good. Will build field teams in 2026. Believes there are about 14 thousand active RRP cases in the U.S. and similar prevalence in the EU. Working towards applying for authorization in EU, which will require the Phase 3 data. In February updated the IND for the Phase 3 trial. Still in discussions with FDA about an accelerate approval program issue, since Inovio strongly believes that "INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments."

Described why 3107 will be the preferred treatment for RRP, even though competitor got FDA approval first. More tolerable, safe and effective. Regimen can be done in physician's office and no surgery or scoping required. Negotiating with payers and HCPs. Selected commercial partners for sales and distribution.

In March 2026, Inovio announced a 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). This will be part of a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care. The 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.

Emphasized progress in the DMAb (DNA-encoded monoclonal antibody) technology. Believes can address multiple diseases and is in discussion with potential partners for development.

In Q1 presented pre-clinical data from the DNA-encoded protein technology (DPROT) at the World Federation of Hemophilia Global Forum. Working on DPROT (DNA-encoded protein technology) for Factor VIII. Preclinical data was presented at the World Federation of Hemophilia Global Forum in November 2025. Is developing additional DPROT indications (Fabry, Hypophosphatasia) and is actively seeking partners to accelerate development of this promising program.

Inovio also has a variety of other vaccines in clinical or preclinical study. See the Inovio Pipeline for an overview.

Cash and equivalents balance ended at $38 million, down sequentially from $58 million. In Q2 2026 raised $16 million with a public equity offering. No debt, but $25 million in common stock warrant liabilities.

Q4 2024 R&D expense was $14 million. General and administrative expense was $8 million. Total operating expenses were $22 million. Operating profit negative $22 million. Interest $0.4 million. Change in fair value of stock warrant liability $4 million. Loss on investment 2$ million. Other expense $0.3 million.

Q&A selective summary:

Launch versus Papzimeos? We have a differentiated product. Overall market is at least 14,000 patients. They are likely to have reached less than 10% of the market if we get approval.

Main FDA issue? Mainly accelerated approval, meaningful therapeutic benefit, residual disease.

We have provided the FDA with additional analysis, but no new data.

Because RRP is a chronic viral illness, we believe our ability to redose gives an advantage over the competitor.

Are you still treating prior patients? Our Phase 1/2 trial had a 4 dose regimen. Follow up had no additional dosing. We have no planned data for redosing. We will discuss the redosing strategy with the FDA if we get approval.

Label on approval? Expect to have a similar label to the approved product. Our patient population had a good balance. Should have no restrictions.

Pricing? Rare disease pricing, which payers recognized. More closer to launch.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: