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• Regulatory Progress for INO3107

  • The BLA for INO3107, Inovio's lead candidate for recurrent respiratory papillomatosis (RRP), remains on track for the October 30, 2026 PDUFA target date.
  • The FDA has completed all scheduled pre-licensure inspections (covering clinical operations, manufacturing, in-house testing, and the delivery device facility), with only one minor observation, which Inovio has addressed and is submitting a response for.
  • The FDA granted an informal clinical meeting in July 2026, where Inovio presented the full totality of INO3107's safety and efficacy data to support its eligibility for accelerated approval. Representatives from the RRP Foundation and an RRP specialist also joined to emphasize the significant unmet need in this patient population.
  • The FDA did not share preliminary conclusions on accelerated approval eligibility during the meeting, but noted feedback on the confirmatory trial design will be provided soon; label negotiations are expected to start in September 2026. If approved, INO3107 will receive 7 years of orphan drug exclusivity.

• Commercial Preparation for Potential INO3107 Launch

  • Inovio has completed all core launch preparation work and is moving to implementation. Cineos Health, a rare disease commercialization specialist, will serve as the contract sales organization for the US launch.
  • Inovio highlights multiple competitive advantages for INO3107 over the existing approved treatment Papiimios: it does not require additional scoping surgery during the dosing window (unlike Papiimios, which requires surgery before doses 3 and 4, with 83% of Papiimios trial patients needing at least one MRD surgery during dosing), it is not impacted by pre-existing neutralizing antibodies or an immunosuppressive tumor microenvironment, and it does not require ultra-cold chain storage, enabling broader use across care settings.
  • A medical science liaison team is being initiated to drive scientific engagement with healthcare providers. A full patient support program and payer access strategy is in development.

• Pipeline and Platform Progress

  • Partner ApolloBio announced positive top-line Phase 3 results for VGX3100 (for HPV16/18 positive cervical dysplasia) in Greater China, meeting the primary endpoint of lesion regression and viral clearance with a favorable safety profile. ApolloBio will use this data to submit for regulatory approval in China, and the results further validate Inovio's DNA medicine platform for HPV-related diseases.
  • Promising preclinical data for the company's next-generation DNA-encoded protein (DPoP) platform targeting Factor VIII for Hemophilia A was presented at multiple major scientific conferences in Q2 2026. Two new rare disease targets have been added to the platform: Fabry disease and hypophosphatasia. Inovio is currently in discussions with potential partners to advance DPoP candidates.

• Financial Updates

  • Inovio completed an underwritten public equity offering in late July 2026, generating approximately $18.3 million in net proceeds to support INO3107 development and launch preparation.
  • As of June 30, 2026, Inovio held $36.7 million in cash, equivalents, and short-term investments. With the addition of the July offering proceeds, the company expects its cash runway to extend into late Q1 2027, covering all pre-launch and launch costs for INO3107 if approved.

• Cash runway is projected to extend into late first quarter 2027, including all planned pre-launch inventory build, launch marketing spend, and operational costs through a potential INO3107 launch after the October 30, 2026 PDUFA date.
  • Estimated operational net cash burn for Q3 2026 is approximately $18 million.
  • The BLA review for INO3107 remains on track to meet the October 30, 2026 PDUFA target date.
  • Label negotiations for INO3107 are expected to begin in September 2026 if the review progresses as planned.
  • No additional capital raising is required prior to the PDUFA date, based on current spending projections.

Inovio did not break out financial performance for multiple distinct product segments in this call. The company is a clinical-stage biotech with no approved products generating revenue as of Q2 2026. Aggregate Q2 2026 operating expenses were $18.6 million, a 19% decrease from $23.1 million in Q2 2025. Year-to-date operating expenses for the first six months of 2026 were 16% lower than the same period in 2025. Net loss for Q2 2026 was $16 million, or $0.07 per basic/dilutive share, compared to a net loss of $23.5 million, or $0.61 per basic/dilutive share, in Q2 2025. The reduction in net loss was driven by a $13.9 million non-cash gain on fair value adjustment for warrant liabilities.

• Forward-looking statements regarding INO3107 approval, launch, and future performance are subject to material risks, and actual results could differ materially from management's current expectations, as detailed in Inovio's SEC filings.
  • The FDA has not yet issued a conclusion on INO3107's eligibility for accelerated approval, which was identified as a potential review issue in the December 2025 BLA acceptance letter, so approval is not guaranteed.
  • Cash runway projections are based on current spending assumptions and do not include any future capital raising; if spending exceeds projections, the company may need to raise additional capital earlier than planned.
  • Fluctuations in Inovio's share price can cause significant volatility in reported net income/loss due to fair value adjustments for warrant liabilities.

Q: Can you provide more detail on the informal FDA meeting for INO3107, and did the FDA raise any new efficacy, safety, or CMC questions? / A: The meeting gave Inovio the opportunity to present the full set of existing efficacy and safety data for INO3107 that the FDA had already received via prior submissions. The FDA did not disagree with Inovio's presentation of the data, and raised no new questions about efficacy, safety, or CMC. FDA also declined to share any preliminary conclusion on INO3107's accelerated approval eligibility because the BLA remains under active review.

Q: Is there any update on the design of the INO3107 confirmatory trial, including patient population, endpoint, and planned start after approval? / A: Inovio had already submitted the confirmatory trial protocol to the FDA, and is still awaiting the agency's feedback and comments. The FDA noted during the informal meeting that this feedback would be forthcoming, and Inovio will align on trial start expectations with the FDA once comments are received.

Q: Should investors expect another capital raise before the PDUFA date, or is current funding enough to bridge through launch? / A: The current cash position, including the $18.3 million in net proceeds from the July 2026 equity offering, is sufficient to fund the company through late Q1 2027, which covers the anticipated INO3107 launch after the October 2026 PDUFA. No additional capital raise is planned before PDUFA based on current projections.

Q: Are pre-launch costs like inventory build and marketing spend already included in the cash runway projection for late Q1 2027? / A: Yes, all pre-launch inventory build and launch marketing spend for the fourth quarter of 2026 and first quarter of 2027 are already baked into the cash runway projection.