Immunic secured US$400 million to conclude phase 3 MS program and prepare for launch
A late-week surprise from Munich-based Immunic, Inc. (listed on Nasdaq as IMUX): the company has launched a follow-on private placement of up to US$400 million and expects to close the financing later this month. At the same time, the biotech is pressing ahead with its transformation in preparation for the potential commercialisation of its lead asset. Current CEO Daniel Vitt will step back once a successor with proven market-launch expertise has been appointed.
The Gräfelfing-headquartered (near Munich) company announced the Nasdaq private placement of up to US$400 million at market terms under Nasdaq rules. The financing is led by existing investor BVF Partners L.P., with additional institutional investors participating.
Proceeds are intended to support Immunic’s transition from an R&D-driven organisation to a fully commercial-stage company. The immediate priority is completion of the ongoing Phase III ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS). Top-line data are expected by the end of 2026, with a US regulatory filing planned for mid-2027. In parallel, Immunic is building up its medical and commercial infrastructure ahead of a potential launch. A Phase III programme in primary progressive multiple sclerosis (PPMS) is also scheduled to begin later this year.
According to the company, vidofludimus calcium combines selective DHODH inhibition with activation of the transcription factor Nurr1, aiming to address both inflammatory and neurodegenerative mechanisms.
A long drug history with a happy end?
The strategic shift is accompanied by changes at the board level. Co-founder and CEO Daniel Vitt will relinquish day-to-day leadership once a successor with MS commercialisation experience has been found. Vitt will then be moving into a more science-focused executive role. Simona Skerjanec, formerly Head of Neuroscience and Rare Diseases at Roche, has been appointed interim Chair of the Board. Former Chairman Duane Nash remains on the board, and Thor Nagel of BVF Partners joins as a new member. Further board adjustments are planned to align governance with the company’s commercial ambitions.
The first US$200 million tranche will be raised via pre-funded warrants, with a further US$200 million potentially available upon exercise of additional warrants. Closing is expected in February 2026.
Investors are now awaiting the next set of clinical data, particularly as earlier subgroup analyses had raised some questions, which were answered at that time by choosing a debatable primary endpoint. The substantial financing underscores continued confidence in the programme, but regulatory approval remains to be secured.
Sanofi