Inovio Pharmaceuticals (INO) Piper Sandler 37th Annual Healthcare Conference summary

Disease background and treatment landscape

• Recurrent respiratory papillomatosis (RRP) is a rare, serious disease caused by HPV 6 and 11, leading to wart-like growths in the airways, impacting speech, swallowing, and breathing, with risk of malignancy if spread to the lungs.

• Standard care involves repeated surgeries, often resulting in permanent vocal cord damage and significant patient burden.

INO-3107 product profile and clinical data

• INO-3107 is a DNA medicine delivered via electroporation, producing antigens to stimulate cytotoxic T cells targeting HPV-infected cells.

• Clinical data showed a median reduction from four to one surgery per year, with 28% of patients requiring no surgeries in the first year and 50% in the second year.

• Redosing is feasible and may further improve outcomes, with plans for a redosing program post-approval.

• BLA submission was completed in October, with potential FDA acceptance and PDUFA date expected by mid-next year.

Competitive landscape and market strategy

• Main competitor PRGN-2012 uses a gorilla adenoviral vector, requiring additional surgeries during treatment and has a higher side effect profile.

• PRGN-2012 is priced at $115,000 per dose, totaling $460,000 for a full regimen, excluding extra procedures.

• RRP affects about 14,000 active cases in the U.S., with new cases annually; market penetration by competitors is expected to be low in the first year.

• Product profile research indicates strong physician and patient preference for INO-3107 due to efficacy, tolerability, and ease of administration.