Immunic secures $400M to support late-stage MS trials - ICYMI

Immunic Inc (NASDAQ:IMUX) earlier this week outlined however a recently secured up to $400 cardinal backstage placement is acceptable to enactment completion of late-stage trials and hole the institution for a imaginable commercialized motorboat of vidofludimus calcium successful aggregate sclerosis.

Speaking to Proactive, CEO Dr Daniel Vitt described the financing arsenic “a transformative transaction for the company,” noting that $200 cardinal has already been received, with the remainder disposable successful a 2nd tranche.

He said the rise equips the institution with the flexibility required to modulation into a commercial-stage enactment arsenic it approaches a pivotal information milestone.

The superior near-term catalyst is the Phase 3 ENSURE programme successful relapsing aggregate sclerosis (RMS), comprising 2 duplicate studies. Vitt confirmed that an interim investigation conducted successful 2024 resulted successful the Independent Data Monitoring Committee recommending the trials proceed arsenic planned.

Topline information from the four-year, 2,200-patient programme is expected astatine the extremity of the year.

Proactive: Hello, you're watching Proactive. I'm joined by Immunic CEO Dr Daniel Vitt. Daniel, precise bully to talk with you. Immunic precocious closed an up to $400 cardinal backstage placement financing, with $200 cardinal received immediately. Can you locomotion america done the details of the transaction, please?

Dr Daniel Vitt: It was a large transaction and a transformative transaction for the company. As you know, the institution is approaching Phase 3 readout and starting the preparations for commercialized motorboat of vidofludimus calcium. This rise equips the institution with the close financing and the flexibility to hole a cleanable modulation into a commercial-stage company.

With the caller superior from the archetypal tranche, the institution is good funded beyond the Phase 3 ENSURE readouts and imaginable NDA filing successful RMS. Can you update america connected currency scope and what the financing covers?

The afloat financing, which would see the 2nd tranche, would screen much oregon little everything. The astir important priorities are to implicit the Phase 3 studies successful relapsing MS astatine the extremity of the twelvemonth and to hole the NDA submission successful the mediate of adjacent year. In parallel, the institution present has the quality to footwear disconnected the Phase 3 survey successful superior progressive MS, addressing an country of precocious unmet aesculapian need. Considering the challenges and failures of different drugs successful that space, this opens a wide abstraction for vidofludimus calcium. It is an important measurement for the company.

You mentioned the important Phase 3 ENSURE readout coming up astatine the extremity of the year. Can you punctual america of the survey details and what investors volition spot erstwhile topline information is reported?

The institution has 2 ongoing Phase 3 duplicate studies. An interim investigation was conducted successful 2024, and the IDMC gave the greenish airy to proceed arsenic planned. The topline information is expected astatine the extremity of the year.