Inovio Pharmaceuticals FY Conference Summary Company Overview - **Company**: Inovio Pharmaceuticals (NasdaqCM: INO) - **Focus**: Development of innovative therapies for HPV-related diseases, particularly recurrent respiratory papillomatosis (RRP) and other cancers. Key Points Industry and Disease Context - **Recurrent Respiratory Papillomatosis (RRP)**: - A rare disease caused by HPV types 6 and 11, leading to wart-like growths in the airways, affecting speech, swallowing, and breathing [3][4] - Current treatment involves repeated surgeries, which can lead to permanent vocal cord damage after multiple procedures [4] Product Development - **INO-3107**: - A DNA medicine delivered via a proprietary CELLECTRA device using electroporation, avoiding lipid nanoparticles or viral vectors [7][8] - Mechanism: Produces antigens targeting HPV E6 and E7 oncoproteins, generating cytotoxic T cells to destroy infected cells [9] - Clinical data shows a significant reduction in surgeries: - Median surgeries decreased from four to one in the first year post-treatment [11] - 28% of patients required no surgeries in the first year, increasing to 50% in the second year [11] Regulatory Status - **BLA Submission**: - Rolling submission completed on October 30, 2025, with expectations for acceptance feedback by year-end and a proposed PDUFA date in mid-2026 [13] Competitive Landscape - **Comparison with Precigen's PRGN-2012**: - PRGN-2012 is a gorilla-based adenoviral product requiring additional surgeries during treatment, contrasting with INO-3107's patient-centric approach [15][18] - Precigen's pricing is $115,000 per dose, totaling $460,000 for a four-dose regimen, excluding additional surgical costs [20] Market Potential - **Epidemiology**: - Estimated 14,000 active RRP cases in the U.S., with new cases at approximately 1.8 per 100,000 annually [22] - Inovio anticipates capturing a significant market share despite Precigen's entry, projecting single-digit penetration for Precigen in the first year [22] Future Development - **Pipeline Candidates**: - INO-3112 targeting HPV-positive head and neck cancers, with plans for a phase three trial [28] - INO-5401 for glioblastoma, also moving towards a randomized control trial [29] In Vivo Protein Production Technology - **Innovative Approach**: - Inovio's technology allows for the endogenous production of proteins, demonstrated with monoclonal antibodies against SARS-CoV-2, showing sustained production over 72 weeks [33] - Focus on long-term therapeutic protein production, with ongoing preclinical candidates [34][35] Financial Position - **Cash Reserves**: - Ended Q3 with approximately $51 million, with additional funds raising total cash to around $70 million, potentially reaching $100 million with warrant exercises [36][37] - Funds expected to support operations through the PDUFA date and facilitate launch preparations [37] Conclusion - Inovio Pharmaceuticals is positioned for a significant market entry with INO-3107, backed by promising clinical data and a robust pipeline, while navigating a competitive landscape with a focus on patient-centric treatment options [38]

Core Insights - INOVIO has completed the rolling submission of its Biologics License Application (BLA) for its DNA immunotherapy candidate INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP) in adults [1][2] - The BLA was submitted under the FDA's Accelerated Approval program, with a request for priority review, which could lead to a decision within six months [2][4] - If approved, INO-3107 would be INOVIO's first commercial product and the first DNA medicine available in the United States [2] Company Overview - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases [8] - The company utilizes a proprietary DNA medicines platform that includes precisely designed DNA plasmids delivered by its investigational medical device, CELLECTRA [7] Product Details - INO-3107 is designed to elicit an antigen-specific T cell response against HPV-6 and HPV-11 proteins, potentially preventing or slowing the growth of new papillomas [3][4] - In a Phase 1/2 trial, 72% of participants experienced a 50-to-100% reduction in the number of surgeries required after one year of treatment, with this number increasing to 86% after two years [3][4] Market Context - RRP is a rare disease primarily caused by HPV-6 and HPV-11, characterized by wart-like growths in the respiratory tract, which can lead to severe complications [3][4] - The standard treatment involves surgery to remove papillomas, but they often regrow, highlighting the need for effective alternative therapies [3][4] Regulatory Status - INO-3107 has received Orphan Drug and Breakthrough Therapy designations from the FDA, facilitating its expedited review process [4][6] - The company anticipates receiving file acceptance by the end of 2025, with a potential Prescription Drug User Fee Act (PDUFA) date in mid-2026 if priority review is granted [4][6]

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]