Immunic Inc (NASDAQ:IMUX) earlier this week outlined how a newly secured up to $400 million private placement is set to support completion of late-stage trials and prepare the company for a potential commercial launch of vidofludimus calcium in multiple sclerosis.
Speaking to Proactive, CEO Dr Daniel Vitt described the financing as “a transformative transaction for the company,” noting that $200 million has already been received, with the remainder available in a second tranche.
He said the raise equips the company with the flexibility required to transition into a commercial-stage organization as it approaches a pivotal data milestone.
The primary near-term catalyst is the Phase 3 ENSURE program in relapsing multiple sclerosis (RMS), comprising two twin studies. Vitt confirmed that an interim analysis conducted in 2024 resulted in the Independent Data Monitoring Committee recommending the trials continue as planned.
Topline data from the four-year, 2,200-patient program is expected at the end of the year.
Proactive: Hello, you’re watching Proactive. I’m joined by Immunic CEO Dr Daniel Vitt. Daniel, very good to speak with you. Immunic recently closed an up to $400 million private placement financing, with $200 million received immediately. Can you walk us through the details of the transaction, please?
Dr Daniel Vitt: It was a great transaction and a transformative transaction for the company. As you know, the company is approaching Phase 3 readout and starting the preparations for commercial launch of vidofludimus calcium. This raise equips the company with the right financing and the flexibility to prepare a perfect transition into a commercial-stage company.
With the fresh capital from the first tranche, the company is well funded beyond the Phase 3 ENSURE readouts and potential NDA filing in RMS. Can you update us on cash reach and what the financing covers?
The full financing, which would include the second tranche, would cover more or less everything. The most important priorities are to complete the Phase 3 studies in relapsing MS at the end of the year and to prepare the NDA submission in the middle of next year. In parallel, the company now has the ability to kick off the Phase 3 study in primary progressive MS, addressing an area of high unmet medical need. Considering the challenges and failures of other drugs in that space, this opens a wide space for vidofludimus calcium. It is an important step for the company.
You mentioned the important Phase 3 ENSURE readout coming up at the end of the year. Can you remind us of the study details and what investors will see when topline data is reported?
The company has two ongoing Phase 3 twin studies. An interim analysis was conducted in 2024, and the IDMC gave the green light to continue as planned. The topline data is expected at the end of the year.