Inovio Targets BLA Submission, FDA Approval by Year-End 2025 Amid Positive 3107 Trial Results

Inovio Pharmaceuticals aims to submit a Biologics License Application (BLA) for INO-3107 by year-end 2025 and target FDA file acceptance by the same time. The company's primary focus is on the ongoing progress of strategic priorities, with a continued emphasis on surgery reduction as demonstrated by the 3107 data showing sustained results.

Inovio Pharmaceuticals (INO) has set its sights on a significant milestone in the development of its DNA medicine, INO-3107. The company aims to submit a Biologics License Application (BLA) for INO-3107 by the end of 2025 and secure FDA file acceptance by the same timeframe. This strategic move is part of the company's broader focus on reducing the number of surgeries required for patients with recurrent respiratory papillomatosis (RRP).

During the Q2 2025 earnings call, Jacqueline E. Shea, CEO of Inovio, announced that the company has completed the design verification (DV) testing of its CELLECTRA 5PSP device. This milestone allows Inovio to move forward with key regulatory milestones for the INO-3107 program. Shea emphasized the company's intent to seek a priority review, which could lead to a Prescription Drug User Fee Act (PDUFA) date around mid-2026.

The company's progress is backed by recent publications of clinical data, including Phase I/II results in Nature Communications and a long-term efficacy study in The Laryngoscope. These publications form core elements of the BLA submission. The long-term efficacy study, published in The Laryngoscope, demonstrated that INO-3107 resulted in a sustained reduction in the number of surgeries needed to control RRP. The overall response rate (ORR) improved to 86% at the end of the second 12-month period (Year 2) compared to 72% observed at the end of the initial 12-month Phase 1/2 trial (Year 1). The mean number of surgeries patients needed to control their RRP continued to drop from 4.1 surgeries per year prior to receiving INO-3107 to 1.7 for Year 1 and 0.9 for Year 2 [2].

Inovio is also preparing for the commercial launch of INO-3107 and actively pursuing partnerships for its DPROT platform. The company's market research indicates that both patients and providers find INO-3107's efficacy, tolerability, and treatment simplicity compelling. Steven Egge, Chief Commercial Officer, reported progress in distribution and channel strategy, including signing a contract with a 3PL provider and negotiating contracts with specialty pharmacy and patient hub partners.

From a financial perspective, Inovio's operating expenses dropped from $33.3 million in the second quarter of 2024 to $23.1 million in the second quarter of 2025, representing a 31% decrease. The company's net loss for the second quarter of 2025 also decreased by 27% to $23.5 million from $32.2 million in the second quarter of 2024. Cash, cash equivalents, and short-term investments totaled $47.5 million at quarter-end, excluding $22.5 million from a July 2025 public offering. The company projects an operational net cash burn estimate of approximately $22 million for Q3 2025.

Management maintained confidence in meeting regulatory and commercial objectives, positioning INO-3107 as a potential new standard of care for RRP. The company's strategic focus continues to center on 3107, with incremental progress in device verification, regulatory milestones, and publication of long-term efficacy data.

References:
[1] https://seekingalpha.com/news/4484419-inovio-aims-for-bla-submission-and-fda-file-acceptance-by-year-end-2025-as-3107-data-shows
[2] https://www.biospace.com/press-releases/data-published-in-the-laryngoscope-shows-ino-3107-resulted-in-long-term-surgery-reduction-in-recurrent-respiratory-papillomatosis-rrp