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Biotech Stock News Bite - Immunic, Inc. (Nasdaq: IMUX) Year End 2023 Financial Results and Provides Corporate Update


February 22, 2024 ( Newswire) ( Biotech Stock News Bites - 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 fourth quarter and year ended December 31, 2023, and provided a corporate update.

"Immunic made remarkable progress throughout 2023, and these achievements were punctuated by the successful three-tranche private placement of up to $240 million, which we announced last month. Our ability to execute this transaction, with a group of top-tier, existing and new investors, we believe affirms the enormous value inherent in our two advanced clinical programs" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.

"During the fourth quarter, we reported an interim biomarker analysis from our phase 2 CALLIPER trial of our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium. The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). Notably, this effect was observed across all subpopulations, including advanced secondary progressive multiple sclerosis (SPMS), which we believe is a segment of very high unmet need in multiple sclerosis (MS). Further, if the top-line CALLIPER data, expected in April 2025, continues to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment option for advanced SPMS. This eagerly anticipated data is fully funded by the first $80 million tranche of our recent financing, which extended our cash runway into the third quarter of 2025. An interim futility analysis for our phase 3 ENSURE program is expected late this year, and the read-out of the first of the ENSURE trials is anticipated in the second quarter of 2026. If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of MS, based on its combined neuroprotective, anti-inflammatory, and antiviral effects. It is important to note that we continue to build on the multiple layers of patent protection around vidofludimus and its salt and free acid forms. In November, we were granted two fundamental new patents in the United States covering the specific dose strength used in clinical trials for the treatment of relapsing multiple sclerosis (RMS), as well as the dosing regimens associated with the treatment of MS. As a result, our extensive patent portfolio now provides protection into 2041 in the United States, unless extended further."

Dr. Vitt continued, "During the fourth quarter, we presented the previously reported positive results from our phase 1b clinical trial of our second key clinical program, IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, at two prestigious medical conferences. The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture, rather than the traditional immunomodulatory approaches used in many gastrointestinal indications, today. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD) and are considering additional clinical applications in other gastrointestinal disorders."

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