Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in IMUX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...

Core Viewpoint - Immunic, Inc. has successfully closed a registered direct offering of 5,666,667 shares of common stock at a price of $0.90 per share, raising approximately $5.1 million in gross proceeds to fund clinical trials and operations [1][2]. Group 1: Offering Details - The offering was led by Aberdeen Investments and closed on April 10, 2025 [1]. - The gross proceeds from the offering were approximately $5.1 million before deducting commissions and offering expenses [2]. - Titan Partners Group acted as the sole placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund clinical trials, operations, and other general corporate purposes [2]. Group 3: Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [5]. - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for multiple sclerosis and has shown therapeutic activity in earlier trials [5]. - Other development programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, which is in preclinical testing [5].

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 YORK, April 9, 2025 /PRNewswire/ -- Immunic, Inc. ("Immunic" or the "Company") (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the pricing of a registered direct offering of 5,666,667 shares of its common stock at the market under Nasdaq rules at a price of $0.90 per share, led by Aberdeen Investments. All securities in the offering are being sold by Immunic. The gros ...

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]