Immunic Secures $400 Million Private Placement to Fund MS Trials and Commercial Transition

Immunic announced an oversubscribed private placement of up to $400 million to complete Phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a Phase 3 trial in primary progressive MS, and transition into a commercial organization.

Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, announced on February 13, 2026 the pricing of a private placement with gross proceeds of up to USD 400 million priced at the market under Nasdaq rules. The financing includes upfront proceeds of USD 200 million, with potential for up to USD 200 million in additional proceeds.

The financing was led by existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors.

The proceeds of this financing are expected to support Immunic's strategic transition from a research and development (R&D)-focused company into a fully integrated commercial entity. In the coming months, the company will prioritize completion of the ongoing phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple sclerosis (RMS). Top-line data continues to be expected by the end of 2026. Subsequently, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. In parallel, Immunic will work on the preparations for the potential commercialization of vidofludimus calcium, including the pre-commercial ramp-up and expansion of the medical and commercial teams.

Immunic is working towards initiation of a phase 3 clinical program in primary progressive multiple sclerosis (PPMS), which is expected later this year and estimated to take approximately 3.5 to 4 years to complete.

With these pivotal programs underway, Immunic is positioning itself to become a leading innovator in next‑generation oral therapies for relapsing and progressive forms of multiple sclerosis (MS). Vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through nuclear receptor-related 1 (Nurr1) activation, while reducing new inflammatory damage via selective dihydroorotate dehydrogenase (DHODH) inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses.

Immunic's Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board of Directors will begin a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition to a new senior executive role focused on strengthening the company's scientific strategy and driving portfolio advancement. He will continue to support the organization in this capacity and as a member of the Board of Directors.

Concurrent with the transaction, Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, who joined Immunic's Board of Directors in July 2024, has been elevated to interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, will remain a member of the Board of Directors. Additionally, Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board of Directors.

The Board of Directors intends to explore and evaluate further refreshment in order to better align its future composition with Immunic's strategic goals and objectives. As part of this refreshment, the Board expects that two new directors will replace existing directors at or prior to Immunic's upcoming annual meeting with a third director expected to be replaced at or prior to Immunic's 2027 annual meeting.

Dr. Vitt stated that the proceeds from the initial closing are expected to provide sufficient runway through submission of an NDA in the United States in mid-2027 and to start preparations for the potential launch of vidofludimus calcium in RMS, as well as initiation of a phase 3 clinical program in PPMS.

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References

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