Immunic Presents New Phase 2 CALLIPER Data, Secures $400M for Vidofludimus Calcium
Immunic presented new Phase 2 CALLIPER data at CMSC 2026 showing vidofludimus calcium's favorable effects in progressive MS, including a novel unified disability endpoint. The company also secured $400M in private placement to fund Phase 3 ENSURE studies and commercial preparations.
Immunic, Inc. (Nasdaq: IMUX) has presented additional data from its Phase 2 CALLIPER trial evaluating vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, while also securing up to $400 million in financing to support late-stage development and commercial preparations.
The company announced one late-breaking and two additional posters at the CMSC meeting. The late-breaking poster introduced a novel unified endpoint called Confirmed Disability Change (CDC), designed to capture both confirmed disability worsening (CDW) and confirmed disability improvement (CDI) within a single statistical framework. Three complementary statistical approaches — ordinal categorical analysis, time-to-event modeling, and Markov state change modeling — were applied post-hoc to data from the Phase 2 CALLIPER trial. Across these models, results consistently favored vidofludimus calcium over placebo. The findings suggest the CDC approach may provide a more complete view of disability trajectories in PMS than conventional one-direction analyses, particularly for evaluating possible neuroprotective effects.
A second poster presented patient-reported outcomes from the CALLIPER trial, including measures of severity of depressive thoughts (Patient Health Questionnaire-9, PHQ-9) and overall treatment satisfaction, collected over up to 120 weeks. Analyses showed that changes in PHQ-9 scores were similar between vidofludimus calcium and placebo across all assessed timepoints, indicating no negative impact on mood.
Vidofludimus calcium is an orally administered investigational small molecule designed as a first-in-class therapy that targets both neuroprotection via Nurr1 activation and inflammation reduction through selective dihydroorotate dehydrogenase (DHODH) inhibition.
Separately, Immunic announced an oversubscribed private placement of up to $400 million, led by existing investor BVF Partners and joined by Avidity Partners, OrbiMed, Trails Edge Capital Partners, TCGX, Vivo Capital, and other institutional investors. Under the terms, the company issued 229.1 million pre-funded warrants at $0.873 per warrant, yielding upfront proceeds of $200 million. Investors also received warrants for up to an additional 229.1 million shares at the same price for the remaining $200 million, expiring on the earlier of 30 days following public release of Phase 3 ENSURE data or February 17, 2031.
The company will use the proceeds to complete its ongoing Phase 3 ENSURE studies of vidofludimus calcium in relapsing multiple sclerosis, with top-line results anticipated by the end of 2026. Immunic aims to submit a new drug application in the U.S. by mid-2027 and targets regulatory approval in 2028. Plans also include launching a Phase 3 clinical program in primary progressive multiple sclerosis later this year, estimated to require approximately three-and-a-half to four years to complete.
The company is expanding medical and commercial teams in preparation for potential commercialization. As part of a planned transition, the board will begin searching for a new CEO with MS commercial expertise, while the current CEO transitions to a new executive role focused on scientific strategy and portfolio advancement.