Core Insights - Immunic, Inc. presented data on its lead asset, vidofludimus calcium, at the ACTRIMS Forum 2025, highlighting its potential as a treatment for multiple sclerosis [1][2] - The company expects top-line data from the Phase 2 CALLIPER trial in progressive multiple sclerosis to be released in April 2025, which will provide insights into the drug's effects on a non-active patient population [2][4] Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [1][10] - Vidofludimus calcium is currently in Phase 3 and Phase 2 clinical trials for relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in previous trials [10] Drug Mechanism and Research Findings - Vidofludimus calcium acts as a selective immune modulator by activating the neuroprotective transcription factor Nurr1, which is associated with direct neuroprotective effects [9] - The drug also selectively inhibits dihydroorotate dehydrogenase (DHODH), impacting overactive immune cells and providing anti-inflammatory and anti-viral effects [9] - Preclinical studies indicate that vidofludimus calcium reduces neuronal loss and injury by decreasing microglial activation, suggesting its neuroprotective potential [4][9] Presentation Details - Two poster presentations at the ACTRIMS Forum will cover the baseline characteristics of patients in the CALLIPER trial and the neuroprotective function of vidofludimus calcium [8][9] - The first poster will analyze patient characteristics across major clinical trials in progressive multiple sclerosis, while the second will present evidence of the drug's neuroprotective effects [8][9]

Core Insights - Immunic Inc's drug candidate IMU-856 shows potential as an oral treatment for obesity by significantly increasing endogenous GLP-1 levels in a dose-dependent manner [1][10] Company Developments - The latest data indicates that IMU-856, initially studied for celiac disease, has additional pharmacological activity impacting GLP-1 levels [2][8] - In a Phase 1b clinical trial, patients treated with the highest dose of 160 mg showed a 250% increase in GLP-1 levels after four weeks [4][8] - Preclinical studies in rats demonstrated a significant reduction in weight gain, with the high-dose group experiencing a 40% lower weight gain compared to placebo [6][7] Industry Context - The global obesity treatment market is projected to reach $170 billion, highlighting the demand for effective treatment options [10] - Current obesity treatments primarily consist of injectable incretin mimetics, indicating a market opportunity for oral alternatives like IMU-856 [9][10]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a strong presence in key finance and investing hubs with bureaus and studios located in London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - IMU-856 shows potential as an oral treatment option for weight management, demonstrating a dose-dependent increase in GLP-1 levels and reduction in body weight gain and food consumption [1][2][3] Clinical Trial Findings - A post hoc analysis from a phase 1b clinical trial in celiac disease patients revealed a statistically significant increase in GLP-1 levels, with a dose-dependent increase of up to 250% compared to placebo [2][3] - The trial involved a small patient population, with 11 in the placebo group and 13 each in the 80 mg and 160 mg IMU-856 groups [2] - Preclinical studies indicated a reduction in body weight gain by up to 40% in a dose-dependent manner, linked to decreased food intake [2][3] Mechanism of Action - IMU-856 targets SIRT6, a protein involved in intestinal barrier function and regeneration, which may enhance the function of enteroendocrine cells that produce GLP-1 [2][7] - The compound has shown positive results in histology, disease symptoms, biomarkers, and nutrient absorption in celiac disease patients [7] Market Potential - The obesity treatment market is projected to exceed $170 billion globally by 2031, indicating significant commercial potential for IMU-856 if further clinical trials confirm its efficacy [3] Company Overview - Immunic, Inc. is focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, with IMU-856 as a key candidate [8]

Immunic (IMUX) FY 2025 Conference February 12, 2025 01:20 PM ET Company Participants Jason Tardio - President & COODaniel Vitt - CEO & Director Conference Call Participants Andreas Argyrides - Managing Director & Senior Analyst - Biotechnology Andreas Argyrides Good. Great. Good afternoon, everyone, and welcome to Oppenheimer's thirty fifth Annual Healthcare Life Science Conference. My name is Andreas Zargaridis. I'm one of the senior biotech analysts at Oppenheimer. And today, I have the pleasure to be joi ...

Core Insights - Immunic, Inc. is actively participating in several investor and scientific conferences throughout February 2025, showcasing its commitment to engaging with stakeholders and presenting its clinical developments [1][2][4] Conference Participation - February 10-11: Immunic's CEO, Daniel Vitt, will engage in one-on-one meetings at the BIO CEO & Investor Conference in New York [2] - February 11-12: Dr. Vitt will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference, with a webcast available on Immunic's website [2] - February 19-22: Immunic's team will attend the 19th Congress of ECCO in Berlin, presenting two abstracts on IMU-856, an orally available small molecule modulator targeting Sirtuin 6 [2][4] - February 25-27: Dr. Hella Kohlhof will present on vidofludimus calcium (IMU-838) at the 7th Neuroimmunology Drug Development Summit in Boston [2][4] - February 27 - March 1: Immunic will participate in the ACTRIMS Forum 2025 in West Palm Beach, Florida, with two abstracts accepted for poster presentations [2][3] Product Development - Immunic's lead asset, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for relapsing and progressive multiple sclerosis, showing therapeutic activity in previous trials [4] - IMU-856 is designed to restore intestinal barrier function and is preparing for a phase 2 clinical trial, targeting gastrointestinal diseases [4] - IMU-381 is in preclinical testing, aimed at addressing gastrointestinal disease needs [4] Presentation Details - At the ECCO Congress, two presentations will focus on IMU-856: one on its effects from a Phase 1 clinical study and another on its preclinical characterization [2] - The presentation on vidofludimus calcium will highlight its dual role in neuroprotection and relapse prevention in multiple sclerosis [2]

Core Insights - Immunic Inc is advancing its novel therapy vidofludimus calcium, with significant milestones achieved in 2024, including a positive interim analysis of the ENSURE trials for relapsing multiple sclerosis and anticipation of results from the CALLIPER progressive MS study in April 2025 [1][5][7] Company Overview - Immunic is focused on a differentiated pipeline, strong leadership, and patient-centric priorities, with vidofludimus calcium having the potential to transform the multiple sclerosis treatment landscape [4] - The company has also been working on its second clinical program, IMU-856, targeting Sirtuin 6 for gastrointestinal conditions [2][4] Recent Developments - In 2024, Immunic achieved a positive interim analysis in its Phase 3 ENSURE program for relapsing forms of multiple sclerosis, with the independent data monitoring committee recommending the continuation of trials [5][6] - The company has expanded its scientific and medical presence through publications and presentations, enhancing visibility in the multiple sclerosis space [6] Financial Position - Immunic secured a three-tranche private placement totaling $240 million, which strengthens its financial base for ongoing and future projects [6] Future Outlook - 2025 is expected to be pivotal for Immunic, with the CALLIPER study's top-line results anticipated in April, focusing on vidofludimus calcium in progressive multiple sclerosis [7] - The company will continue advancing the ENSURE 1 and ENSURE 2 Phase 3 trials for relapsing multiple sclerosis, with enrollment progressing well [7] Product Differentiation - Vidofludimus calcium features a dual mechanism that addresses both neuroinflammation and neurodegeneration, making it suitable for both relapsing and progressive MS [8] - It is a selective DHODH inhibitor with proven anti-inflammatory effects and neuroprotective properties, showing strong results in interim analyses, including reductions in neural filament light levels, a biomarker for neurodegeneration [9] - Unlike other oral therapies, vidofludimus calcium has no black box warnings, indicating a favorable safety profile, and could potentially be the first oral therapy approved for both relapsing and progressive MS [9]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April – – Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 – – Strengthened Management Team and Board of Directors with Key Hires – – Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 202 ...

 NEW YORK, Nov. 26, 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 that Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a fireside chat on Thursday, December 5, 2024, at 11:30 am ET, during the Piper Sandler 36th Annual Healthcare Conference, taking place December 3-5, 2024, in New York.Dr. Vitt, Glenn Whaley ...