Immunic Announces Successful Private Placement Raising up to USD 400 Million

Immunic, a late-stage biotechnology company known for developing revolutionary oral therapies for conditions affecting the nervous system and gastrointestinal tract, is in the midst of a significant transformation. With the successful pricing of a private placement of up to USD 400 million, the company is poised to shift from a research and development-focused entity to a fully integrated commercial operation. This move is part of Immunic’s strategic plan to position itself as a leading provider of next-generation oral treatments for various forms of multiple sclerosis (MS).

The private placement, led by existing investors such as BVF Partners L.P. and a consortium of other financial backers, will provide upfront proceeds of USD 200 million, with the potential for an additional USD 200 million in the future. This financial boost sets the stage for Immunic to achieve several key milestones in its development pipeline. One primary focus is on completing the ongoing phase 3 ENSURE clinical trials of vidofludimus calcium, an investigational drug for relapsing MS. With top-line data expected by the end of 2026, the company plans to submit a New Drug Application in mid-2027 in the United States, aiming for potential regulatory approval in 2028.

In Addition to addressing relapsing MS, Immunic is also prepared to initiate a phase 3 clinical program for primary progressive MS. This program, anticipated to commence later this year, is projected to take approximately 3.5 to 4 years to conclude. The company’s novel oral therapy, vidofludimus calcium, operates based on a groundbreaking mechanism. By activating nuclear receptor-related 1 (Nurr1) and inhibiting dihydroorotate dehydrogenase (DHODH), the drug offers direct neuroprotective effects while diminishing new inflammatory damage. This dual-action approach has the potential to target the key biological drivers of disability progression in MS, distinguishing it from existing therapies that primarily tackle inflammatory relapses.

In tandem with this strategic shift, Immunic is making changes to its leadership team. Dr. Daniel Vitt, the company’s Co-Founder and Chief Executive Officer, will work alongside the Board of Directors to recruit a new CEO with significant commercial experience in the MS sector. Dr. Vitt intends to transition to a senior executive role focused on enhancing the company’s scientific vision and advancing its drug portfolio. Simona Skerjanec, who previously led the neuroscience and rare diseases division at Roche and has served on Immunic’s Board of Directors since 2024, has been appointed interim Chairperson. Drawing on her industry expertise, Skerjanec will guide the company in this crucial phase. Additionally, Thor Nagel, a Principal at BVF Partners L.P., will join the Board of Directors to offer further strategic insights.

In closing, Dr. Vitt expresses gratitude towards investors for their support and is optimistic about Immunic’s prospects moving forward. The company’s progression towards becoming a fully-fledged commercial entity marks a significant milestone, and Dr. Vitt is confident in the team’s ability to execute this transition successfully. With a renewed focus on scientific excellence and a robust portfolio of potential therapies, Immunic is well-positioned to make significant strides in the treatment landscape for MS and beyond.