Immunic Inc (NASDAQ:IMUX) said it is entering a pivotal period for its multiple sclerosis program after securing up to $400 million in new financing and advancing its lead drug into late-stage development, with key data expected by the end of 2026.
The biotechnology company’s oral candidate, vidofludimus calcium (IMU-838), is currently being evaluated in the twin phase 3 ENSURE-1 and ENSURE-2 trials in relapsing multiple sclerosis (RMS).
Top-line results from the studies are anticipated by year-end 2026, a major catalyst that could pave the way for a planned US New Drug Application submission in mid-2027 and a targeted potential approval in 2028.
To support those milestones, Immunic in February completed an oversubscribed private placement of up to $400 million in gross proceeds, including $200 million upfront. The transaction was led by existing investor BVF Partners L.P. and included participation from a group of new and current institutional backers.
CEO Daniel Vitt said the financing positions the company to transition into a fully integrated commercial-stage organization and to fund operations through the anticipated ENSURE data readout and NDA submission. “This financing is truly a pivotal milestone for Immunic and positions us to confidently transition into a fully integrated commercial-stage company,” Vitt told shareholders in a statement.
Beyond relapsing MS, Immunic plans to broaden vidofludimus calcium’s development into primary progressive multiple sclerosis (PPMS). Following phase 2 CALLIPER data showing reductions in 24-week confirmed disability progression and statistically significant confirmed disability improvement in progressive MS patients, the company expects to initiate a confirmatory phase 3 program in PPMS later this year.
Additional CALLIPER data were presented earlier this month at the ACTRIMS Forum, highlighting effects on antiviral immune responses linked to Epstein-Barr virus and MRI markers of acute and chronic inflammation—findings the company says further support the drug’s potential to address underlying drivers of disease progression.
Immunic believes vidofludimus calcium’s dual mechanism could differentiate it from currently available oral RMS therapies by addressing both relapse-associated worsening and progression independent of relapse activity.
As it prepares for potential commercialization, the company is also reshaping its leadership and board. Simona Skerjanec, former global head of neuroscience and rare diseases at Roche, has been elevated to interim chairperson. Thor Nagel of BVF Partners has joined the board, and Immunic has launched a search for a new chief executive officer with commercial expertise in multiple sclerosis. Vitt is expected to transition into a senior executive role focused on scientific strategy while remaining on the board.
Financially, Immunic ended 2025 with $15.5 million in cash and cash equivalents. Including roughly $187 million in net proceeds from the February 2026 financing, the company expects to fund operations into late 2027, covering its key phase 3 readouts and regulatory filing plans.
In addition to vidofludimus calcium, Immunic said it continues preparations for further clinical testing of IMU-856, contingent on additional financing or partnering, as it advances its broader pipeline in neurologic and gastrointestinal diseases.