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news.Immunic has announced an oversubscribed private placement of up to $400m, strengthening its move from an R&D-focused organisation into a commercial-stage entity.
The proceeds will be used for completing ongoing Phase III ENSURE trials for vidofludimus calcium in RMS. Credit: Gorodenkoff / Shutterstock.com.
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The placement was led by existing investor BVF Partners and joined by entities such as Avidity Partners, OrbiMed, Trails Edge Capital Partners, TCGX, Vivo Capital and other institutional investors.
The company will also use the proceeds for completing its ongoing Phase III ENSURE studies of vidofludimus calcium in relapsing multiple sclerosis (MS), with top-line results anticipated by the end of this year.
Immunic aims to submit a new drug application (NDA) in the US by mid-2027 and targets regulatory approval in 2028. Parallel efforts are focused on preparing for vidofludimus calcium’s potential commercialisation, including expanding medical and commercial teams.
Plans also include launching a Phase III clinical programme in primary progressive multiple sclerosis (PPMS) later this year. The company estimates this trial will require around three-and-a-half to four years to complete.
Vidofludimus calcium is designed as a first-in-class therapy that targets both neuroprotection via Nurr1 activation and inflammation reduction through selective dihydroorotate dehydrogenase (DHODH) inhibition.
Under the private placement terms, Immunic has agreed with select accredited investors to issue 229.1 million pre-funded warrants at $0.873 per warrant, yielding upfront proceeds of $200m.
Investors will also receive warrants for up to an additional 229.1 million shares (or pre-funded warrants) at the same price for the remaining $200m. These warrants are set to expire on the earlier of 30 days following public release of Phase III ENSURE data or on 17 February 2031.
Leerink Partners served as lead placement agent alongside B Riley Securities, Brookline Capital Markets, Guggenheim Securities, LifeSci Capital, Stifel and William Blair.
Immunic intends to use the net proceeds for operations and general purposes, funding activities into late 2027.
Immunic co-founder and CEO Dr Daniel Vitt said: “I would like to thank BVF and the other investors in the consortium for joining our journey towards potential regulatory approval of vidofludimus calcium.”
The board will begin searching for a new CEO with MS commercial expertise as Dr Vitt transitions to a new executive role focused on scientific strategy and portfolio advancement.
