INO News & Events

Inovio announced that its partner for VGX-3100 in China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100, INOVIO's investigational DNA immunotherapy being developed as a potential treatment for cervical dysplasia. The trial successfully met its predefined primary efficacy endpoint and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future regulatory submission of VGX-3100 in China. "We believe these positive topline results for VGX-3100 reflect both the potential of our DNA medicine platform in HPV-related diseases and the power of partnerships to advance innovative DNA immunotherapies," said Dr. Jacqueline Shea, Inovio's President and CEO. "We look forward to these data being presented at upcoming international medical conferences and published in peer-reviewed publications. We also anticipate future updates from ApolloBio as they work towards filing for potential regulatory approval of VGX-3100 in China." According to the terms of the ApolloBio Agreement, INOVIO is entitled to receive up to an aggregate of $20M, less required income, withholding or other taxes, upon the achievement of specified milestones related to the regulatory approval of VGX-3100 in specified territories. In the event that VGX-3100 is approved for marketing, INOVIO will be entitled to receive royalty payments based on a tiered percentage of annual net sales.

Estimates current cash, cash equivalents and short-term investments balances sufficient into 1Q27, beyond the target PDUFA date for INO-3107. Reports Q1 revenue $0, consensus $250K. "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 CEO Jacqueline Shea. "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."