Inovio Pharmaceuticals (NasdaqCM:INO) FY Conference Transcript

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]