Inovio Pharmaceuticals (INO) investor relations material

Platform overview and technology

• Focused on DNA medicines for HPV-related diseases, cancer, and infectious diseases, leveraging a proprietary delivery system (CELLECTRA) for efficient plasmid DNA delivery and strong T-cell responses.

• CELLECTRA device enables rapid, tolerable administration with minimal adverse events and is regulated as a combination product in the U.S.; CE marked in the EU.

• DNA medicines platform is flexible, capable of producing various proteins for immune response or protein replacement.

Lead program: INO-3107 for RRP

• INO-3107 targets recurrent respiratory papillomatosis (RRP), a rare disease caused by HPV 6/11, with high unmet need due to reliance on repeated surgeries.

• Phase I/II trial enrolled patients with 2–8 surgeries in the prior year; 72% had a 50–100% reduction in surgeries in year one, increasing to 86% in year two.

• Safety profile showed mainly mild adverse events, with few systemic effects and no flu-like symptoms.

• Over 95% of RRP patients are HPV 6 or 11 positive, with HPV 6 being more common.

Regulatory and commercial outlook

• PDUFA date for INO-3107 is October 30; company expects to enter labeling discussions and confirm design of a 100-patient, placebo-controlled confirmatory trial.

• FDA review included additional data submissions and advocacy from patient groups; company awaits final decision.

• Commercial readiness includes partnerships with specialty distributors, Syneos Health for sales and MSL deployment, and a focused field force targeting 300–400 laryngologists in 100 centers.

• Ex-U.S. opportunity exists, with EMA likely requiring a placebo-controlled trial.