INOVIO Highlights Anticipated 2025 Milestones and 2024 Key Accomplishments

Core Insights - INOVIO anticipates 2025 to be a transformational year, focusing on becoming a commercial-stage company and advancing DNA medicines for rare diseases [2][4] - The company plans to submit a biologics license application (BLA) for INO-3107 by mid-2025, aiming for priority review from the FDA [4][6] Anticipated Milestones for 2025 - Submission of BLA to the FDA for INO-3107, which could be the first DNA medicine approved in the U.S. for recurrent respiratory papillomatosis (RRP) [4][6] - Resolution of manufacturing issues expected by February 2025, followed by retesting of the CELLECTRA® device [4] - Initiation of a confirmatory trial at approximately 20 U.S. academic centers, enrolling around 100 patients [4][6] - Submission of a redosing study protocol to the FDA based on recent durability data [4] - Presentation and publication of recent clinical trial data in a peer-reviewed journal [4] Key Accomplishments from 2024 - Reported that 50% of RRP patients treated with INO-3107 achieved a complete response after two years, an increase from 28% in the first year [4][6] - 95% of patients maintained or enhanced their overall response rate after two years [4] - New immunology data demonstrated INO-3107's ability to induce T cell responses against HPV-6 and HPV-11 [4] - No serious adverse events were reported in the Phase 1/2 trial, with most adverse events being mild [4][6] Emerging Pipeline - INO-3112 is set to undergo a Phase 3 trial in collaboration with Coherus BioSciences, focusing on HPV16/18-positive oropharyngeal squamous cell carcinoma [5][6] - INO-4201 is being developed as a potential booster to ERVEBO® with Phase 2 trial protocols to be finalized [5][6] - Ongoing Phase 1 trial for a DNA encoded monoclonal antibody targeting SARS-CoV-2, with first clinical data expected in Q1 2025 [5][6] Corporate Developments - Strengthened balance sheet with over $60 million in net proceeds from equity offerings in 2024 [6] - Appointment of Steven Egge as Chief Commercial Officer, bringing extensive experience in HPV-related diseases and commercial product launches [6][7]