Inovio Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Remain on track to submit BLA for INO-3107 in the second half of 2025, with goal of file acceptance by year-end.
• Completed design verification (DV) testing of CELLECTRA 5PSP device, enabling progress on regulatory milestones.
• Requested rolling submission of BLA for INO-3107 using breakthrough therapy designation, aiming for priority review with potential PDUFA date mid-2026.
• Published Phase I/II clinical data in Nature Communications and retrospective study data on long-term efficacy in Laryngoscope.
• Continued commercial preparations, including market research and go-to-market plan refinement.
• Reduced operating expenses by 31% in Q2 2025 compared to Q2 2024, with net loss decreasing 27% in Q2 2025.

No traditional product segment breakdown with revenue contributions was provided. The focus was on the progress of the INO-3107 program, including regulatory and clinical advancements.

• On track to submit BLA in second half 2025, targeting file acceptance by year-end.
• Projected cash runway into Q2 2026 with an estimated net cash burn of ~$22M in Q3 2025.
• Plan to request priority review for BLA, which could lead to a 6-month review period and PDUFA date mid-2026.

• Actual events or results could differ materially from expectations due to various factors.
• Risks associated with regulatory processes, including potential delays or issues with BLA submission and review.
• Cash burn risks and potential impact of external factors on interactions with the FDA.

Q: From Ted Tenthoff from Piper Sandler, asking about advisory committee meeting prep.

A: Jacqueline E. Shea and Mike Sumner discussed that based on interactions with the FDA, there was low likelihood of an advisory committee meeting, as the risk-benefit of the data presented did not indicate a requirement for such a meeting.

Q: From Cheng Li from Oppenheimer, asking about DV testing completion and redosing strategy.

A: Jacqueline E. Shea stated they remained on track for BLA submission in the second half of 2025, with DV testing completed though it was complex involving external vendors. Michael Sumner mentioned plans for a redosing strategy, likely annual dosing, to maintain and enhance clinical benefit.

Q: From Sudan Loganathan from Stephens Inc., asking about median prior surgeries and confirmatory trial enrollment.

A: Michael Sumner noted patients in the study had a median of 4 prior surgeries, and the confirmatory trial aimed to enroll 100 patients across ~20 sites in the U.S., with confidence the trial would carry forward based on Phase I/II data.

Q: From Eduardo Martinez-Montes from H.C. Wainwright, asking about physician coverage and confirmatory trial design.

A: Steven Egge discussed there are 300-400 laryngologists treating most RRP patients, and Michael Sumner mentioned the confirmatory trial design aligned with FDA and European regulator feedback, targeting patients with 2 or more prior surgeries.

Q: From Roy Buchanan from Citizens, asking about time lines and FDA interactions.

A: Jacqueline E. Shea discussed time lines for rolling submission (requested in July, expecting feedback in August), updating IND for confirmatory trial, and aiming to complete BLA submission in second half 2025 with file acceptance by year-end. She also noted FDA interactions continued normally despite external volatility.