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].

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 ...

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]

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– Vidofludimus Calcium's Activation of Nurr1 Reduces Neuronal Loss and Injury Directly and Indirectly By Decreasing Microglial Activations in Preclinical Models –– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –NEW YORK, Feb. 26, 2025 /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 ...

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]

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, ...

– New Data Suggests that IMU-856 Could Be a Potential Oral Treatment Option for Weight Management; Program Is Phase 2 Ready –– Dose-Dependent Increase of Endogenous GLP-1 Levels Observed in Post Hoc Analysis of Patients From Phase 1b Clinical Trial in Celiac Disease –– Dose-Dependent Reduction of Body Weight Gain and Food Consumption Observed in Preclinical Study –– Webcast to be Held Today, February 20 at 8:00 am ET –NEW YORK, Feb. 20, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology comp ...

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]

Immunic Inc (NASDAQ:IMUX) chief operating officer Jason Tardio joined Proactive to discuss the company’s progress in advancing its novel therapy vidofludimus calcium. He discussed the significant milestones achieved in 2024, such as the positive interim analysis of the ENSURE trials in relapsing multiple sclerosis (MS) and the anticipation of the results from the CALLIPER progressive MS study in April 2025. Proactive: Hello, you're watching Proactive. I'm joined by Immunic chief operating officer Jason Tard ...