Inovio Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Completed rolling submission of BLA for INO-3107 on October 30, aiming for FDA file acceptance by year-end and potential PDUFA date mid-2026 if priority review granted. • Preparing for pre-approval inspections of manufacturing sites. • Aligned confirmatory trial plans, with FDA now only requiring initiating and enrolling patients prior to approval. • Progressing next-generation DNA medicine candidates: Proof-of-concept data on DMAb technology published in Nature Medicine; preclinical data on DPROT technology to be presented at World Federation of Hemophilia Global Forum. • Commercial preparations for INO-3107 launch, including market research, pricing strategy, and partner contracts. • Highlighting differences between INO-3107 and Papzimeos in terms of surgery reduction and treatment regimen.

No specific product segment financial performance data provided in the transcript.

• Expect BLA file acceptance by end of 2025. • Potential PDUFA date mid-2026 if priority review granted. • Cash runway estimated to last into second quarter of 2026, with projected net operational cash burn of approximately $22 million for Q4 2025.

• Actual events or results could differ materially from forward-looking statements. • Factors in SEC filings under Risk Factors that could cause differences. • Uncertainties around market acceptance, competition, and regulatory approvals.

Q: When it comes to Papzimeos, have they launched yet and impact of head start?

A: Yes, Papzimeos became available to order as of October 21. Inovio expects to be a fast follower with single-digit penetration into the prevalent population in the time period before its potential approval in mid-2026, and sees significant opportunity remaining as the majority of the prevalent population will be available when it enters the market.

Q: Similarity of labels and differentiator with Papzimeos?

A: INO-3107 has the potential for a broad label similar to Papzimeos, but a key differentiator is the lack of a requirement for minimal residual disease surgeries during the dosing window, which poses logistical and patient-related challenges for Papzimeos.

Q: Sales force preparedness post approval and cross-reactivity with Papzimeos?

A: Advancing launch preparations with medical science liaisons (MSLs) and an access team to engage in scientific exchange and work with payers pre-approval; no cross-reactivity issues expected for patients switching from Papzimeos to INO-3107, but patients would need to complete the entire INO-3107 treatment regimen.

Q: DMAb expression levels and prioritization of programs?

A: DMAb study showed sustained expression over 72 weeks with a concentration in the blood of over 1 microgram per ml; prioritizing programs like Factor VIII for DPROT technology, with plans to advance these once resources are available post-3107 launch.