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]

Financial Data and Key Metrics Changes - The company is in advanced development with its lead asset, fibiflutimus calcium, and anticipates completion of Phase III studies next year [6] - The Phase II study for progressive multiple sclerosis is expected to read out in April, highlighting the potential of the drug [7] Business Line Data and Key Metrics Changes - Fibiflutimus calcium is being evaluated primarily for progressive and relapsing multiple sclerosis, with a focus on addressing unmet medical needs in these areas [3][7] - The company aims to differentiate its product by targeting both neuroinflammation and neurodegeneration, which is a unique approach in the current market [12][13] Market Data and Key Metrics Changes - The relapsing forms of multiple sclerosis represent a significant market opportunity, with approximately 900,000 patients diagnosed in major markets, yet only 500,000 currently on therapy [41] - The market for multiple sclerosis treatments is projected to grow from $23 billion to over $30 billion by the 2030s, indicating a robust opportunity for new entrants [48] Company Strategy and Development Direction - The company is focused on developing a dual mechanistic approach to treat multiple sclerosis, which includes neuroprotective benefits and anti-inflammatory effects [12][42] - There is ongoing interest from legacy MS companies and other neuroscience players in potential partnerships, given the differentiated profile of fibiflutimus calcium [48][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address both relapse-associated worsening and progression independent of relapse, which is a significant unmet need in the market [13][42] - The company believes that if the Phase II results are positive, it could lead to a substantial market share, as the drug would be suitable for all forms of MS [52] Other Important Information - The Phase II CALIPER trial is designed to demonstrate the immunoprotective potential of fibiflutimus calcium, with success defined by a protective effect on disability worsening [17][21] - The company is also exploring the potential of its drug in other indications beyond multiple sclerosis, such as celiac disease and inflammatory bowel disease [57] Q&A Session Summary Question: What is the expected outcome of the Phase II CALIPER trial? - Success is defined as a protective effect on clinical endpoints of disability worsening, with a target of at least a 15% improvement being considered significant [21][24] Question: How does fibiflutimus calcium compare to existing treatments for MS? - Currently, there is only one approved therapy for primary progressive MS, and no treatments for non-active secondary progressive MS, indicating a significant opportunity for fibiflutimus calcium [26][27] Question: What are the competitive dynamics in the MS treatment landscape? - Recent failures of BTK inhibitors in relapsing MS studies have created an open opportunity for fibiflutimus calcium, which is positioned to address both neuroinflammation and neurodegeneration [39][41]

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]

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– 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 ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients –NEW YORK, Nov. 13, 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 the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been publi ...