Core Insights - INOVIO is advancing its lead product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP) and has initiated the rolling submission of its Biologics License Application (BLA), expected to be completed in the second half of 2025 with a goal for FDA acceptance by the end of 2025 [1][5]. Group 1: INO-3107 Presentations - INOVIO will present data on INO-3107 at several upcoming scientific conferences, including the American Academy of Otolaryngology Annual Meeting, World Vaccine Congress Europe, and the European Society for Medical Oncology Congress, showcasing its long-term efficacy and immune response in treating HPV-6/11 RRP [3][4][5]. - Specific presentations include topics such as "DNA Immunotherapy (INO-3107) Demonstrates a Durable Response for Treatment of HPV-6/11 Recurrent Respiratory Papillomatosis" and "Clinical Response to INO-3107 in RRP is Irrespective of Papilloma Microenvironment and Molecular Subtype" [3][4]. Group 2: Next-Generation DNA Medicine - INOVIO is also focusing on its next-generation DNA medicine technology, with presentations planned on a Phase 1 clinical trial of a DNA-encoded monoclonal antibody (DMAb) and new preclinical data on DNA-encoded protein technology (DPROT) for Hemophilia A [2][5]. - Upcoming presentations will cover the CELLECTRA® in vivo gene delivery platform and the transformational potential of DMAb technology in rare diseases [4][5]. Group 3: Company Overview - INOVIO is a biotechnology company dedicated to developing and commercializing DNA medicines aimed at treating HPV-related diseases, cancer, and infectious diseases, utilizing innovative technology to enhance the design and delivery of these medicines [6].

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]