INOVIO PHARMACEUTICALS, INC. Q1 FY2025 earnings call

• Jacqui Shea stated Inovio remains on track to submit the BLA for INO-3107, aiming to start rolling submission mid-2025, complete in H2 2025, get file acceptance by end 2025, with a potential PDUFA date in mid-2026 if priority review is received. Resolved manufacturing issue with CELLECTRA device, initiated DV testing. Published clinical and immunology data from Phase 1/2 trial in Nature Communications, awaiting publication of longer-term data. Active at scientific conferences.
• Mike Sumner discussed progress on BLA for INO-3107, completed non-device module drafting, initiated DV testing. Completed Phase 1/2 trial RRP-001 showed statistically significant reduction in surgeries, RRP-002 showed clinical benefit continued beyond 1 year. Upcoming COSM presentation with data on surgery counts and peer-reviewed publication to follow. Plan to deploy medical science liaison team this quarter.
• Steve Egge highlighted market opportunity for INO-3107 in RRP, a rare HPV-related disease with no approved therapeutic options. 3107 offers significant clinical benefit, favorable safety profile, patient-centric regimen. Market research supports potential as preferred product. Refining go-to-market model and building commercial organization.
• Jacqui Shea talked about DMAb technology, which leverages DNA medicine platform to create DNA plasmids encoding monoclonal antibodies. Interim clinical data from Phase 1 proof-of-concept trial for COVID-19 showed durable in-vivo antibody production, well-tolerated, no serious adverse events. Potential broad application beyond monoclonal antibodies.

Inovio's operating expenses for the first quarter of 2025 dropped to $25.1 million from $31.5 million in the first quarter of 2024, a 20% decrease. The net loss for the first quarter of 2025 was $19.7 million or $0.51 per share basic and dilutive, compared to a net loss of $30.5 million or $1.31 per share in the first quarter of 2024. Cash, cash equivalents, and short-term investments finished the first quarter of 2025 at $68.4 million, down from $94.1 million as of December 31, 2024. The cash runway is estimated to take the company into the first quarter of 2026, with an operational net cash burn estimate of approximately $22 million for the second quarter of 2025.

• Aim to begin rolling submission of BLA for INO-3107 in mid-2025, complete submission in H2 2025, receive file acceptance by end 2025, with potential PDUFA date in mid-2026 if priority review is granted.
• Cash runway is estimated to last into the first quarter of 2026, with an operational net cash burn estimate of approximately $22 million for the second quarter of 2025.

Q: Can you give additional detail on the COSM presentation coming up?

A: Mike Sumner said they'll focus on surgery counts and will have a little more color, with a peer-reviewed publication available soon. Jacqui Shea noted COSM is the primary meeting for otolaryngologists treating RRP.

Q: How many MSLs plan to onboard and update on epidemiology?

A: Jacqui Shea said 14,000 is old data and they're researching, Steve Egge added RRP has no diagnostic code making it hard to get exact numbers but they think 14,000 is an underrepresentation. Mike Sumner said they haven't guided on MSL team size yet.

Q: Expectation for surgery sparing claim in label for 3107 and registration in other geographies?

A: Jacqui Shea said FDA recognizes reduction in surgeries, too early to predict terminology. For other geographies, confirmatory trial is placebo control, European regulators expect placebo control data, and they're aligned with European regulators on trial design.

Q: Initial indication for DMAb technology?

A: Jacqui Shea said they haven't disclosed specific indications but the technology is versatile for various applications including enzyme replacement therapies.

Q: Priority review for 3107 and adding data to filing?

A: Mike Sumner said they have a solid rationale for priority review based on product difference. Jacqui Shea said clinical modules are ready with strengthened data from RRP-002.

Q: Pricing for 3107 and funding for next steps?

A: Steve Egge said payers felt pricing around $360,000 per year for initial treatment is appropriate. In US, they plan to bring 3107 to market themselves; ex-US open to partnering.

Q: Baseline characteristics for confirmatory trial patients and HPV genotype impact?

A: Mike Sumner said phase 1/2 trial had 60% HPV6, 30% HPV11, and co-infected patients, and confirmatory trial will recruit representative population.