Inovio Pharmaceuticals (INO) FY Conference Transcript

Summary of Inovio Pharmaceuticals (INO) FY Conference Call - September 05, 2025 Company Overview - Inovio Pharmaceuticals is a clinical-stage biotech company focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases [2][3] - The company has a deep pipeline of therapeutic and vaccine candidates with multiple potential near and mid-term catalysts [2] Lead Program: INO-3107 - INO-3107 is aimed at treating recurrent respiratory papillomatosis (RRP), a rare HPV-related disease [3] - The FDA has granted breakthrough therapy and orphan drug designations for INO-3107, and the company is following an accelerated approval pathway [3] - The Biologics License Application (BLA) submission is expected in the second half of the year, with a goal for FDA acceptance by year-end [5][18] - INO-3107 is positioned to become the first DNA medicine approved in the U.S. [5] Clinical Trials and Efficacy - The Phase 1/2 trial (001) enrolled 32 patients who had required at least two surgical interventions in the prior year [11] - Results showed a statistically significant reduction in surgeries from a median of 4 prior to treatment to 1 at the end of 12 months [12] - In the follow-up trial (002), 28 of the original 32 patients were enrolled, showing continued improvement with a median follow-up of 2.8 years [12] - By the end of the second year, the mean number of surgeries reduced from 1.7 to 0.9, representing over 75% reduction compared to the year prior to treatment [15] Commercial Opportunity - There are an estimated 14,000 patients in the U.S. with RRP, with about 1.8 per 100,000 new cases annually [19] - INO-3107 is expected to be a preferred product due to its efficacy, tolerability, and patient-centric treatment approach [20] - The treatment can be administered in a doctor's office, making it convenient for both patients and healthcare providers [22] Pipeline and Future Developments - Inovio has additional clinical-stage candidates following INO-3107, including DMAP candidates that encode monoclonal antibodies [24][25] - The DMAP technology showed durable production of monoclonal antibodies with no serious adverse events reported [25][26] - The company is in discussions for potential collaborations to further develop its technologies [26] Key Takeaways - INO-3107 represents a significant advancement in treating RRP, addressing both the symptoms and underlying viral infection [19][20] - The company is on track for its BLA submission and is preparing for a commercial launch [18][22] - Inovio's innovative DNA medicine technology has the potential to transform treatment paradigms for various diseases [17][26]