– 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 /PRNewswire/ -- 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." "We are well capitalized to execute on our upcoming MS milestones, following our successful January 2024, three-tranche private placement of up to $240 million, with a group of top-tier new and existing investors, which we believe reflects the enormous potential of our clinical programs. In addition to strengthening our capital position, we also continued to build on the several layers of patents, currently protecting vidofludimus calcium into 2041 in the United States, with the United States Patent and Trademark Office's (USPTO) Notice of Allowance last month for our fourth patent application covering a key composition-of-matter of a specific polymorph of vidofludimus calcium and related production of the material." Dr. Vitt concluded, "Our second program, IMU-856, an orally available, systemically acting small molecule modulator that targets Sirtuin 6 ("SIRT6"), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, also shows great promise. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. In particular, the data from our phase 1b clinical trial in celiac disease patients during periods of gluten-free diet and gluten challenge demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. We are currently preparing clinical phase 2 testing of IMU-856 in patients with ongoing active celiac disease (OACD) despite gluten-free diet, while also exploring the possibility of additional clinical uses in other gastrointestinal conditions." First Quarter 2024 and Subsequent Highlights April 2024: Hosted an MS R&D Day, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium. March 2024: Received Notice of Allowance from the USPTO for patent application 16/981,122 entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. February 2024: Presented data from the company's phase 2 CALLIPER and CALVID-1 clinical trials of vidofludimus calcium, in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. January 2024: Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors. These included lead investor BVF Partners, alongside Avidity Partners, Janus Henderson Investors, Soleus Capital, RTW Investments and Adage Capital Partners. The initial tranche successfully closed on January 8, 2024, with Immunic securing $80 million in gross proceeds. Clinical Development Programs Vidofludimus calcium in MS: Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025. An interim futility analysis of the ENSURE program is expected in late 2024. The read-out of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the second ENSURE trial in the second half of 2026. IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856 in OACD patients despite gluten-free diet. Financial and Operating Results Research and Development (R&D) Expenses were $18.7 million for the three months ended March 31, 2024, as compared to $22.9 million for the three months ended March 31, 2023. The $4.2 million decrease reflects (i) a decrease of $2.4 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer and (ii) a $2.5 million decrease in external development costs related to the vidofludimus calcium and IMU-856 programs. The decreases were partially offset by a $0.7 million increase in personnel costs, $0.3 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount. General and Administrative (G&A) Expenses were $5.1 million for the three months ended March 31, 2024, as compared to $4.2 million for the same period ended March 31, 2023. The $0.9 million increase was primarily due to (i) a $0.8 million increase in personnel expense in general and administrative, $0.5 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount and (ii) $0.1 million in legal and consultancy expenses. Interest Income was $1.2 million for the three months ended March 31, 2024, as compared to $0.8 million for the same period ended March 31, 2023. The $0.4 million increase was due to higher interest rates. The Change in Fair Value of the Tranche Rights of $4.8 million for the three months ended March 31, 2024 was a non-cash charge related to the change in value of the tranche rights associated with the ...