Inovio outlines mid-2026 launch for INO-3107 as BLA submission progresses

Earnings Call Insights: Inovio Pharmaceuticals (INO) Q3 2025

MANAGEMENT VIEW

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CEO Jacqueline Shea highlighted, “we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO-3107. This represents a milestone in our work to deliver on the promise of DNA medicine for the RRP community and is our first BLA submission, an important moment for Inovio as well.” Shea stated the company expects to receive FDA file acceptance by year-end and has requested a priority review, which could provide for a potential PDUFA date around mid-2026. She emphasized ongoing commercial preparations for a swift launch if approved, positioning 3107 as a preferred treatment due to clinical results, tolerability, and a patient-centric regimen. Shea also noted progress on next-generation DNA medicine candidates, including recent proof-of-concept data published in Nature Medicine for the DMAb technology and upcoming presentations for the DPROT platform.

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Chief Medical Officer Michael Sumner reported the BLA rolling submission was completed on October 30 and that the submission “clearly articulates the clinical efficacy of 3107 and demonstrates a tolerable safety profile in clinical trials to date.” Sumner explained the confirmatory trial plans are advancing, with the FDA requiring only trial initiation and enrollment before approval. He stressed, “the majority of patients experienced fewer surgeries with most experiencing a 50% to 100% reduction compared to the year before treatment.”

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Chief Commercial Officer Steven Egge noted, “A key advantage for 3107 is a positively differentiated product profile that I believe will appeal to laryngologists and to their RRP patients who are looking for an effective, well-tolerated treatment that minimizes exposure to the risks and costs of surgery, including during the treatment window.” Egge discussed advancements in launch preparations, including payer research, initial pricing strategy, and commercial organization build-out.

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CFO Peter Kies remarked, “Operating expenses dropped from $27.3 million in the third quarter of 2024 to $21.2 million in the third quarter of 2025, a 22% decrease.” Kies reported a net loss of $45.5 million or $0.87 per share, primarily due to a $22.5 million noncash loss on fair value adjustments related to warrant liabilities. Kies added, “We finished the quarter of 2025 with $50.8 million in cash, cash equivalents and short-term investments... We estimate our cash runway to take us into the second quarter of 2026.”

OUTLOOK

* Management anticipates FDA file acceptance of the BLA for INO-3107 by year-end and a potential PDUFA date in mid-2026, contingent on priority review. The company is preparing for pre-approval inspections and expects to have initiated the confirmatory trial before approval. There were no explicit changes to guidance from the previous quarter, though the focus has shifted to regulatory milestones and commercial launch readiness.

FINANCIAL RESULTS

* Kies reported a 22% reduction in operating expenses year-over-year to $21.2 million for Q3 2025. Net loss increased to $45.5 million or $0.87 per share, primarily driven by a noncash loss on warrant liabilities. The operational net loss from operations decreased 22% to $21.2 million, and loss from operations per share dropped 58% to $0.41. The company’s cash position was $50.8 million at quarter-end, projecting a cash runway into Q2 2026 with no additional capital raises included.

Q&A

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Edward Tenthoff, Piper Sandler: Asked about Papzimeos’ market launch and competitive impact. Shea confirmed Papzimeos became available for order as of October 21. Egge stated, “we would expect single-digit penetration into the prevalent population in that time period... the vast majority of the opportunity will remain. And like we've talked about previously, we do expect to have the preferred product profile in this space.”

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Jay Olson, Oppenheimer: Inquired about the expected label for 3107 versus Papzimeos and the impact of required surgeries. Sumner replied, “we do believe our data would justify a broad label similar to what Papzimeos received.” Shea added, “...the requirement for minimal residual disease surgeries that Precigen's treatment regimen requires, we do think that, that's going to be a really key differentiator.” Olson’s follow-up on the confirmatory study’s relevance to ex-U.S. filings was addressed by Sumner, who noted its value to European filings would depend on the final design.

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Felix Ampomah, Stephens: Asked about sales force readiness and cross-reactivity for patients switching from Papzimeos to 3107. Egge indicated plans for a similarly sized sales team as competitors, with MSLs and access teams preparing ahead of approval. Sumner stated, “no reason to suspect there would be any cross-reactivity issues for patients who have previously received Papzimeos to receive INO-3107.”

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Eduardo Martinez-Montes, H.C. Wainwright: Requested details on DMAb/DPROT expression levels and program prioritization. Shea described sustained in vivo antibody expression over 72 weeks with “a concentration in the blood of about of over 1 microgram per ml.” She added, “the majority of our resources are going towards 3107 at the moment... we're going to be looking to advance these programs once we get into the clinic through partnerships or once we have additional financial resources available.”

SENTIMENT ANALYSIS

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Analysts’ tone was generally positive, with questions focused on competitive positioning, label differentiation, and commercialization readiness. Skepticism was minimal, as reflected in the congratulatory prefaces and constructive follow-ups.

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Management maintained a confident and upbeat tone throughout, emphasizing regulatory milestones, product differentiation, and commercial readiness. Shea and Sumner both used language expressing belief in the product’s advantages and market opportunity. The tone in Q3 remained consistent with Q2, with management providing detailed responses and highlighting strengths.

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Compared to the previous quarter, the current tone was slightly more optimistic given the achievement of the BLA submission milestone and increased specificity regarding the launch timeline and commercial plans.

QUARTER-OVER-QUARTER COMPARISON

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The company progressed from preparing and finalizing the BLA submission in Q2 to completing the rolling submission in Q3.

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Management’s focus shifted from device testing and publication of long-term efficacy data to regulatory milestone achievements and commercial launch preparations for INO-3107.

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Analysts’ questions in Q3 centered on competitive dynamics, product label differentiation, and sales force strategy, while Q2 questions focused more on regulatory process, redosing strategy, and trial design.

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Key financial metrics continued their downward trend in operating expenses, while net loss variability increased due to noncash adjustments. Cash runway projections remained steady into Q2 2026.

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Management’s confidence grew as tangible regulatory progress was achieved, and there was more clarity on launch sequencing and competitive positioning.

RISKS AND CONCERNS

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Management highlighted the need to complete pre-approval inspections for manufacturing, finalize the confirmatory trial design, and secure FDA acceptance of the BLA for INO-3107.

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Market competition from Papzimeos was addressed, with management noting the majority of the prevalent population would remain untapped by mid-2026.

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Analysts asked about sales force scaling, label differentiation, and cross-reactivity, but no specific new risks were raised beyond those inherent in regulatory and commercial execution.

FINAL TAKEAWAY

Inovio’s management underscored the milestone achievement of completing the BLA rolling submission for INO-3107, with expectations for FDA file acceptance by year-end and a potential launch in mid-2026. The company continues to highlight the differentiated product profile and patient-centric advantages of 3107 over competitors, while maintaining cost discipline and preparing for commercial launch. Progress on next-generation DNA medicine platforms further supports Inovio’s broader innovation strategy as the company heads toward significant regulatory and commercial catalysts in the coming quarters.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/ino/earnings/transcripts]

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