Immunic, Inc., a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases, reported a net loss of approximately $97.2 million for the fiscal year ending December 31, 2025, compared to a net loss of $100.5 million in 2024. The company has accumulated a deficit of approximately $608.6 million since its inception in 2016. Research and development expenses increased by 2% to $82.0 million, primarily due to higher external development costs associated with its lead product candidate, vidofludimus calcium (IMU-838), which is currently in Phase 3 clinical trials for relapsing multiple sclerosis (RMS). General and administrative expenses also rose by 18% to $21.2 million, reflecting increased personnel and legal costs.
Immunic's clinical development pipeline includes three key programs: vidofludimus calcium, which has shown promise in treating RMS and progressive multiple sclerosis (PMS); IMU-856, aimed at gastrointestinal diseases such as celiac disease; and IMU-381, which is in preclinical testing. The company completed enrollment for its Phase 3 ENSURE trials of vidofludimus calcium in June 2025, with top-line data expected by the end of 2026. Additionally, interim results from the Phase 2 CALLIPER trial indicated that vidofludimus calcium reduced the risk of disability worsening in PMS patients.
In February 2026, Immunic closed a private placement that raised approximately $187 million, which the company plans to use to fund ongoing clinical trials and operations. This funding is expected to support the company for more than twelve months. However, Immunic has not yet generated any revenue from product sales and does not anticipate doing so until it receives regulatory approval for its product candidates. The company is also facing challenges related to compliance with Nasdaq listing requirements, having been granted an extension until June 22, 2026, to regain compliance with the minimum bid price rule.
The company has made significant strategic changes, including appointing a new interim chairperson and initiating a search for a new CEO with commercial expertise in the MS space. Immunic's operational focus remains on advancing its clinical programs while managing its financial resources effectively. The company continues to face risks associated with the lengthy and uncertain nature of drug development, including potential delays in clinical trials and the need for additional funding to support its operations and development efforts.
About IMMUNIC, INC.
Immunic, Inc. is a biotechnology company focused on developing oral immunology therapies for chronic inflammatory and autoimmune diseases, primarily multiple sclerosis. Its pipeline includes small molecule drugs targeting neuroprotection, immune modulation, and gastrointestinal regeneration. The company aims to provide disease-modifying treatments with neuroprotective, anti-inflammatory, and antiviral effects, leveraging clinical trials and strategic collaborations to address high unmet medical needs in neurology and gastroenterology markets.
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