INOVIO PHARMACEUTICALS, INC. Q3 FY2024 earnings call

• Advancing INO-3107: Recently announced immunology data supporting its mechanism of action, presented safety and efficacy data, had a positive pre-BLA meeting with the FDA, and is preparing for a BLA submission targeted for mid-2025. Addressed a manufacturing issue with the device's single-use component.
• Pipeline progress: Consulted with European regulators on INO-3112's Phase 3 trial design, INO-5401 has ongoing trials, an upcoming FDA meeting for INO-4201, and clinical data from DNA encoded monoclonal antibodies study expected by year-end.
• Financial discipline: Reduced operating expenses, ended Q3 2024 with $84.4 million in cash, cash equivalents, and short-term investments, and has a cash runway into Q3 2025.

No detailed breakdown of financial performance by product segments is provided in the transcript. The focus is on the INO-3107 program and pipeline progress.

• Targets BLA submission for INO-3107 in mid-2025 and expects non-device related BLA modules to be completed by the end of 2024.
• Cash runway projects into Q3 2025 with an estimated net cash burn of approximately $24 million for the fourth quarter of 2024.

• Manufacturing issue with the single-use component of the device, which needs to be resolved before BLA submission and Phase 3 trials.
• Regulatory approval challenges in regions like the EU, UK, Japan, and China, requiring placebo-controlled data and alignment with regulators.
• Competition from other products, which could impact the market uptake of INO-3107.
• Cash runway risk if additional capital raising is not undertaken.

Q: Regulatory updates for 3107 outside the US, timelines for filing in EU, UK, Japan, China?

A: Met with UK and EU regulators, needing placebo-controlled data for EU/UK; not yet reached out to Japan/China but are interested in progressing there.

Q: Physician feedback on immunology data, what physicians look for?

A: Compelling data supports the mechanism of action, ties in with clinical data, and key opinion leaders (KOLs) in the field have been impressed with the data.

Q: Steps to resolve the manufacturing issue for the device component?

A: Working closely with the existing manufacturer to implement the resolution for the single-use component issue; Phase 3 start for INO-3112 is dependent on resolving this device issue.

Q: Confirmatory trial design for 3107 and redosing plan?

A: Placebo-controlled study design, not including redosing initially; longer follow-up planned for better characterization of benefit.

Q: Timeline for confirmatory trial initiation and BLA submission for 3107?

A: Targeting mid-2025 for BLA submission, need to start the confirmatory trial ahead of the submission.

Q: Adverse events for 3107 and commercial strategy vs competition?

A: Adverse events are transient and resolve rapidly; the product has a well-differentiated profile based on data, with plans to engage health plans ahead of approval.

Q: Redosing approach for 3107?

A: Commence redosing in commercial patients post-launch.