AwesomeCapital: Inovio aims for INO-3107 submission by mid-2025, addressing key manufacturing issues

Wednesday, March 19, 2025

CEO Jacqui Shea highlighted that Inovio remains committed to transforming into a commercial-stage company, with a primary focus on advancing INO-3107, a DNA medicine for recurrent respiratory papillomatosis (RRP). Shea confirmed that manufacturing issues with the CELLECTRA device have been resolved, and the company is preparing for FDA-required device verification testing. A BLA submission is targeted for mid-2025 under a rolling process, with a goal to complete submission by the end of the year.
Peter Kies, CFO, emphasized financial discipline, highlighting a reduction in quarterly operating expenses to $20.5 million and full-year expenses down to $112.6 million in 2024. Kies noted that the company has $94.1 million in cash and projects its cash runway to extend into the first quarter of 2026.
Mike Sumner, Chief Medical Officer, detailed new clinical durability data for INO-3107, showing reductions in the need for surgeries in years two and three after treatment. The mean number of surgeries reduced from 4.1 per year pre-treatment to 0.9 by year three.
Steve Egge, Chief Commercial Officer, discussed the market potential for INO-3107, noting its potential to become the preferred non-surgical treatment for RRP due to its efficacy and tolerability profile.

Inovio plans to begin submitting the BLA for INO-3107 in mid-2025, with a goal of achieving FDA acceptance for filing by year-end 2025. Priority review will also be requested.
Preparations for a Phase 3 confirmatory trial are underway, involving approximately 20 major U.S. medical centers. The trial will enroll patients who have undergone at least two surgeries in the previous year.
The company is also advancing next-generation DNA medicine technology, including DNA-encoded monoclonal antibodies (DMAbs) and DNA protein replacement candidates (DPROT).

The company reported a net loss of $19.4 million for Q4 2024, narrowing from previous quarters, and $107.3 million for the full year. Per-share loss was $0.65 for the quarter and $3.95 for the year.
Operating expenses declined significantly year-over-year, reflecting cost control measures.
Cash, cash equivalents, and short-term investments stood at $94.1 million at the end of 2024, down from $145.3 million at the end of 2023.

Roy Buchanan, Citizens JMP, inquired about the BLA submission timeline for INO-3107. Mike Sumner confirmed that no additional FDA meetings are required, and rolling submission is planned for mid-2025.
Analysts raised questions on the durability of the DMAb technology. Jacqui Shea stated that in vivo antibody production remained stable for up to 72 weeks in a Phase 1 trial.
Sudan Loganathan, Stephens, asked about pricing strategies for INO-3107. Steve Egge noted that pricing is expected to align with rare disease treatments.

Analysts generally displayed a neutral to slightly positive sentiment, focusing on the resolution of manufacturing issues and the BLA submission timeline. Questions were specific and sought clarity on operational and strategic matters.
Management maintained a confident tone throughout, particularly on the progress of INO-3107 and its potential market impact. Shea emphasized the company’s ability to resolve challenges and meet milestones.

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