Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [1] - The company's lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for relapsing and progressive multiple sclerosis, respectively [1] - Vidofludimus calcium has demonstrated therapeutic activity in phase 2 trials for relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis [1] Product Pipeline - Vidofludimus calcium acts as a first-in-class nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects and additional anti-inflammatory and anti-viral effects by inhibiting dihydroorotate dehydrogenase (DHODH) [1] - IMU-856 targets Sirtuin 6 (SIRT6) to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in gastrointestinal diseases such as celiac disease and inflammatory bowel disease [1] - IMU-381 is a next-generation molecule in preclinical testing aimed at addressing gastrointestinal diseases [1] Upcoming Conferences - Immunic will participate in the American Academy of Neurology (AAN) 2025 Annual Meeting from April 5-9, 2025, in San Diego, California, with management and medical teams available at booth 2233 [3] - At the German Biotech Days 2025 on April 9-10, 2025, Chief Scientific Officer Hella Kohlhof will present on vidofludimus calcium, highlighting its dual benefits of neuroprotection and relapse prevention [3] - The presentation will be part of a symposium titled "All Grown Up? Mature Biotech Companies Present their Progress" on April 9, 2025 [3]

Financial Performance - Immunic has an accumulated deficit of approximately $511.4 million as of December 31, 2024, and $410.9 million as of December 31, 2023, with operating losses incurred each year since inception in 2016[28]. - The company incurred net losses of $100.5 million and $93.6 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $511.4 million as of December 31, 2024[160]. - The company has not generated any revenue from its current product candidates to date[165]. - The company anticipates continued significant and increasing losses for the foreseeable future[164]. - The independent auditor's report raises substantial doubt about the company's ability to continue as a "going concern" due to ongoing losses and negative cash flows[174]. - The company has consumed substantial cash resources since inception, indicating a high dependency on external funding for ongoing operations[169]. - The company has raised net cash of approximately $430.9 million from private and public offerings since inception, with cash and cash equivalents of approximately $35.7 million as of December 31, 2024[30]. - The company used net cash of $84.8 million and $70.8 million in operating activities for the years ended December 31, 2024, and December 31, 2023, respectively, primarily related to the development of current product candidates[169]. Clinical Trials and Development - The ongoing Phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and the Phase 2 CALLIPER clinical trial in progressive multiple sclerosis (PMS) are critical to the company's development pipeline[32]. - Positive interim data from the CALLIPER trial was announced on October 9, 2023, showing biomarker evidence of vidofludimus calcium's neuroprotective potential[18]. - The first patient was enrolled in a Phase 2 clinical trial of vidofludimus calcium for Post COVID Syndrome on September 4, 2024, sponsored by Goethe University Frankfurt[45]. - A positive interim analysis of the Phase 3 ENSURE program for vidofludimus calcium confirmed that predetermined futility criteria were not met, allowing the trials to continue without changes[48]. - The Phase 3 ENSURE program aims to enroll approximately 1,050 adult patients with active RMS across more than 100 sites in over 15 countries, with a primary endpoint of time to first relapse up to 72 weeks[86]. - The Phase 2 EMPhASIS trial of vidofludimus calcium demonstrated a 62% reduction in cumulative unique active MRI lesions at the 45 mg dose and a 70% reduction at the 30 mg dose compared to placebo[77]. - In the ongoing open-label extension phase of the EMPhASIS trial, 97.6% of patients were free from confirmed disability worsening after 48 weeks of treatment with vidofludimus calcium[81]. - The company has an ongoing Phase 3 clinical program for vidofludimus calcium in RMS, requiring two successful Phase 3 trials for marketing approval[105]. - The Phase 2 CALLIPER trial for vidofludimus calcium in PMS completed enrollment in August 2023, with top-line data expected in April 2025[90]. - The CALLIPER trial enrolled 467 patients across more than 70 sites, focusing on the annualized rate of percent brain volume change as the primary endpoint[93]. Product Candidates - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[21]. - The company is preparing for Phase 2 clinical testing of IMU-856 in patients with ongoing active celiac disease, contingent on financing[21]. - The company has selected IMU-381 as a development candidate for gastrointestinal diseases, currently in preclinical testing[22]. - IMU-856 is being developed as a treatment for gastrointestinal diseases, targeting the restoration of intestinal barrier function[112]. - Celiac disease affects approximately 1 in 100 people globally, with an estimated two million diagnosed in the United States alone[115]. - IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease pathophysiology, including protection of gut architecture and improvement of symptoms[125]. - The Phase 1 clinical trial of IMU-856 was found to be safe and well-tolerated, with no serious adverse events reported across all dose levels[120][122]. - The Phase 1b trial enrolled 43 patients, with doses of 80 mg or 160 mg of IMU-856 administered once daily over 28 days[124]. - IMU-856's formulation has been improved for Phase 2 clinical testing, enhancing stability and robustness[128]. - A patent covering the composition of IMU-856 is granted in the US and other jurisdictions, expected to provide protection until at least 2038[130]. Regulatory and Market Considerations - The FDA cleared the Investigational New Drug application for the Phase 3 ENSURE program on July 1, 2021, based on the promising results from the Phase 2 trial[85]. - The ongoing clinical trials are expected to provide a straightforward path towards potential regulatory approval of vidofludimus calcium in RMS[85]. - The marketing approval process for product candidates is lengthy and unpredictable, with no guarantee of success[181]. - The company may face delays and increased costs in clinical trials due to geopolitical factors, such as the invasion of Ukraine by Russia, which has disrupted clinical development programs[186]. - The approval process in foreign markets may require additional testing and compliance with varying regulatory requirements, which could delay commercialization[214]. - The company intends to market approved product candidates internationally, necessitating separate regulatory approvals in each market[214]. - Approved products will be subject to extensive ongoing regulatory requirements, which may lead to significant additional expenses and potential penalties for non-compliance[210]. - The FDA may require a Risk Evaluation and Mitigation Strategy for approved product candidates, which could include costly post-approval studies and safety monitoring[210]. Operational Challenges - Clinical trials have been delayed due to the ongoing military action by Russia in Ukraine, affecting over 60 planned sites[159]. - The company has limited marketing and sales experience, which may hinder revenue generation upon regulatory approval[157]. - The company may require additional funding sooner than planned, which could lead to dilution of stockholder equity or impose operational restrictions[170]. - The company has faced disruptions in operations due to disease outbreaks, epidemics, and pandemics, impacting clinical trial activities[156]. - The company has not completed all clinical trials required for the approval of its current product candidates, which may face delays or terminations due to various factors[187]. - Patient enrollment is critical for clinical trials and can be influenced by the size and nature of the patient population, eligibility criteria, and competing trials[188]. - The company is responsible for ensuring compliance with regulatory requirements during clinical trials, but cannot guarantee that clinical investigators will maintain such compliance[189]. - Delays or terminations of clinical trials can harm the commercial prospects of product candidates and increase costs, jeopardizing revenue generation[190]. - The company may face difficulties in enrolling patients for clinical trials due to the limited number of patients with the diseases being studied[207]. - The planned clinical trials may face challenges in identifying and enrolling eligible patients due to perceived risks and competing therapies, potentially delaying timelines for regulatory approval[208].

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 has a strong emphasis on technology adoption 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]

Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [2] - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for relapsing and progressive multiple sclerosis, respectively [2] - Vidofludimus calcium has demonstrated therapeutic activity in phase 2 trials for relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis [2] - Other programs include IMU-856, targeting Sirtuin 6 (SIRT6) for gastrointestinal diseases, and IMU-381, currently in preclinical testing for gastrointestinal conditions [2] Upcoming Events - Immunic will participate in the 34th Annual Meeting of the Society for Virology from March 4-7, 2025, with two abstracts accepted for presentation [4] - The presentations will cover topics related to antiviral activity and will be accessible on Immunic's website [4] - Daniel Vitt, CEO of Immunic, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on March 12, 2025 [4]

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]