Inovio Pharmaceuticals (INO) 2025 Conference Transcript

Inovio Pharmaceuticals (INO) 2025 Conference Summary Company Overview - Inovio Pharmaceuticals is on track to potentially have the first DNA immunotherapy approved in the US, differentiating itself from mRNA therapies with unique stability and delivery systems [1][2] Key Differentiators of DNA Medicines - DNA medicines are more stable than mRNA and do not require lipid nanoparticles for delivery, allowing for easier distribution without ultra-cold storage [3][4] - DNA therapies generate robust T cell responses, particularly CD8 T cells, while mRNA is more effective at producing high levels of neutralizing antibodies [3][4] - The DNA platform avoids issues related to pre-existing anti-vector immunity and flu-like adverse events commonly associated with mRNA and viral vector therapies [3][4] Clinical Data and Safety Profile - Approximately 19,000 administrations have been conducted across 6,000 subjects, showing mild tolerability with no significant differentiation from placebo adverse events [8] - The manufacturing cost of DNA medicines varies based on scale, with a focus on reducing costs for vaccine indications [9][10] RRP (Recurrent Respiratory Papillomatosis) Indication - RRP is a rare disease caused by HPV types 6 and 11, leading to wart-like growths in the respiratory tract, significantly affecting patients' quality of life [13][14] - Current standard treatment involves repeated surgeries, which can lead to permanent vocal cord damage and high economic costs [14][15] - The estimated prevalence of RRP is likely higher than the previously reported 14,000 active patients, with HPV vaccination rates remaining stagnant [16][17] BLA Submission Timeline - Inovio plans to commence rolling submission for the Biologics License Application (BLA) by mid-2025, pending completion of device testing [18][19] - A manufacturing issue related to a disposable component was identified and resolved, allowing for progress towards BLA submission [20][21] Phase 1/2 Study Results - The Phase 1/2 study showed a statistically significant reduction in surgeries from a median of four to one, with 72% of patients experiencing a 50% or greater reduction in surgeries [25][28] - Long-term data indicates continued clinical improvement, with 86% of patients showing significant improvement over a median follow-up of 2.8 years [28][29] Confirmatory Trial Design - The FDA has requested a placebo-controlled confirmatory trial to validate efficacy, with plans to expand the clinical trial site base to over 20 sites [33][35] - The trial will include a representative patient population with varying disease severity and HPV types [34] dMAb Technology - Inovio's dMAb platform demonstrated the ability to produce monoclonal antibodies against COVID-19, showing sustained production without generating anti-drug antibodies [43][44] - The technology has potential applications in protein replacement therapies, expanding its therapeutic scope [44][45] Future Programs and Financial Position - Inovio is focusing resources on advancing INO-3107 for RRP while also discussing future developments for INO-312 for oropharyngeal cancer [45][46] - The company reported a cash position of $94.1 million, providing a runway into Q1 2026 [49]