PLYMOUTH MEETING, PA — INOVIO (Nasdaq: INO) reported its 2025 financial results and said the U.S. Food and Drug Administration is reviewing its lead drug candidate, INO-3107, for a rare respiratory disease, the company announced.
The FDA accepted the company’s biologics license application for INO-3107 in December under the accelerated approval program, with a target decision date of October 30, 2026.
The application is for the potential treatment of recurrent respiratory papillomatosis, a rare condition that can require repeated surgeries to manage.
The FDA noted in its acceptance letter that it may require additional information to determine whether the treatment qualifies for accelerated approval, according to the company.
INOVIO said it plans to meet with the agency to address the issue.
Clinical data from a Phase 1/2 trial published in Nature Communications showed the therapy generated immune responses associated with reduced need for surgery, the company said.
Additional long-term safety and clinical response data were published in The Laryngoscope, indicating continued improvement for many patients beyond one year.
INOVIO also reported progress in other pipeline programs, including a collaboration with Akeso Inc. to study a combination therapy for glioblastoma in a Phase 2 trial sponsored by Dana-Farber Cancer Institute.
The company said it continues enrolling patients in a separate Phase 1/2 trial for newly diagnosed glioblastoma.
Research on next-generation DNA-based therapies was also highlighted, including a Phase 1 study of DNA-encoded monoclonal antibodies published in Nature Medicine and preclinical data related to hemophilia presented at an international forum.
For the full year 2025, INOVIO reported research and development expenses of $54.2 million, down from $75.6 million in 2024.
General and administrative expenses totaled $32.7 million, compared with $37.0 million the prior year.
Total operating expenses were $86.9 million, down from $112.6 million in 2024.
The company reported a net loss of $84.9 million for the year, compared with a net loss of $107.3 million in 2024.
INOVIO reported net income of $3.8 million for the fourth quarter, primarily driven by a non-cash gain related to warrant liabilities.
As of December 31, 2025, the company reported $58.5 million in cash, cash equivalents, and short-term investments, down from $94.1 million a year earlier.
INOVIO said its current cash position is expected to fund operations into the fourth quarter of 2026.
The company said it is prioritizing spending and resources to support the development and potential commercialization of INO-3107.
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