EQS-News

Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update

Issuer: Immunic AG / Key word(s): Quarter Results/Quarterly / Interim Statement Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update 08.05.2024 / 12:30 CET/CEST The issuer is solely responsible for the content of this announcement. Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update

 – Substantially Bolstered Balance Sheet Through a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche –

 – Received Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis; Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States –

– Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain Underway –

 – Webcast to be Held Today, May 8, 2024, at 8:00 am ET –

NEW YORK, May 8, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update.

“During the first quarter and subsequent period, we have continued to advance both the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and the twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially groundbreaking, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Just last month, we hosted a Multiple Sclerosis (MS) R&D Day, highlighting the latest developments in the MS landscape as well as our highly encouraging preclinical and clinical data supporting the neuroprotective potential and reduced disability-worsening associated with vidofludimus calcium, which represent important distinctions compared to currently available MS therapies. We also shared our strong belief that vidofludimus calcium could elevate today’s standard of care by providing a holistic solution for the full spectrum of MS patients, given that it is designed to selectively manage all three components of smoldering MS with its neuroprotective, anti-inflammatory and antiviral effects. Importantly, the clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with PMS and non-relapsing secondary progressive multiple sclerosis (SPMS), which was observed in the recent interim analysis from our phase 2 CALLIPER trial, is significant, and, if this separation is also evident in the top-line CALLIPER data expected in April of next year, we may also be able to position vidofludimus calcium as the first oral treatment option for non-relapsing SPMS. Additionally, as it relates to our phase 3 ENSURE program, we expect to read-out the first of the ENSURE trials in the second quarter of 2026 and anticipate reading out the second ENSURE trial in the second half of 2026.”