Inovio Pharmaceuticals (NasdaqCM:INO) FY Conference Transcript

Inovio Pharmaceuticals FY Conference Summary Company Overview - Company: Inovio Pharmaceuticals (NasdaqCM: INO) - Focus: Developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases [4][5] - Lead Candidate: INO-3107, targeting recurrent respiratory papillomatosis (RRP) caused by HPV 6 and 11 [4][5] Regulatory Updates - BLA Acceptance: INO-3107's Biologics License Application (BLA) accepted for review by the FDA under the Accelerated Approval Program with a PDUFA target date of October 30, 2026 [5][19] - Designations: Received Orphan Drug designation and Breakthrough Therapy designation from the FDA and Orphan Drug designation in the EU [5] - Regulatory Challenges: Disappointment over not receiving priority review; FDA indicated inadequate information for Accelerated Approval eligibility [19][20] Market Opportunity - RRP Prevalence: Approximately 14,000 active cases in the U.S., with potential underestimation of market opportunity [12][39] - Surgery Burden: Patients may require hundreds of surgeries over a lifetime, leading to significant unmet needs [12][13] - Competitor Pricing: Competitor's treatment priced at approximately $115K per dose, indicating a lucrative market for RRP treatments [39] Product Profile and Efficacy - Efficacy Data: INO-3107 shows a 50%-100% reduction in surgeries after treatment, with 72% in year 1 improving to 86% in year 2; 28% of patients required no surgeries in year 1, increasing to 50% in year 2 [14][15] - Safety Profile: Well-tolerated with transient injection site reactions; no treatment discontinuations reported [15] - Administration: Office-based administration with no need for ultra-cold chain storage, making it easier for healthcare professionals [16] Clinical Pipeline - Future Trials: Plans to initiate Phase III trial for INO-3112 and Phase II trial for INO-5401 in glioblastoma; advancing DPROT platform candidates from preclinical to Phase I [17][41] - dMAb Technology: Exciting early-stage technology with potential to unlock further applications of DNA medicines [6][41] Immunogenicity and Redosing Strategy - Comparison with Adenoviral Approaches: INO-3107 avoids generating immune responses against viral vectors, allowing for multiple redosing without the risk of neutralizing antibodies [35][36][38] - Redosing Plans: Potential annual redosing strategy post-approval to maintain cytotoxic T-cell responses [38] Upcoming Milestones - PDUFA Date: Focus on the upcoming PDUFA date in October 2026; awaiting FDA meeting to discuss preliminary comments [17][43] - Market Research: Ongoing research to support launch strategy and address unmet needs in the RRP community [39][40] Conclusion - Inovio Pharmaceuticals is positioned to address significant unmet needs in the RRP market with its lead candidate INO-3107, supported by promising efficacy and safety data. The company is actively engaging with regulatory bodies to navigate the approval process while also advancing its broader clinical pipeline.