Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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]

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]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

– 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 ...