Clinical Trials and Pipeline Updates - The phase 3 ENSURE program for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS) received a positive interim futility analysis, confirming the trials are not futile and should continue as planned without sample size adjustments [1][2] - Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) is expected in April 2025 [2][4] - The company is preparing for phase 2 clinical testing of IMU-856 in celiac disease, contingent on financing, licensing, or partnering [4] - Vidofludimus calcium demonstrated potential neuroprotective effects in PMS through Nurr1 activation, supported by interim data from the CALLIPER trial [2] - IMU-856 showed positive effects in phase 1b trials for celiac disease, including gut architecture protection, symptom improvement, biomarker response, and nutrient absorption enhancement [2] Financial Performance - Research and Development (R&D) expenses for Q3 2024 were $21.4 million, a $1.6 million increase from Q3 2023, driven by higher external development costs for vidofludimus calcium and IMU-856 [5] - For the nine months ended September 30, 2024, R&D expenses decreased by $5.5 million to $58.4 million, primarily due to deprioritizing the izumerogant program [6] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2024, up $0.6 million from Q3 2023, mainly due to higher personnel costs [7] - Net loss for Q3 2024 was $24.4 million, or $0.24 per share, compared to a net loss of $22.8 million, or $0.51 per share, in Q3 2023 [13] - Cash and cash equivalents as of September 30, 2024, were $59.1 million, expected to fund operations into Q3 2025 [15] Corporate and Strategic Developments - The company presented key data on vidofludimus calcium at the 40th Congress of ECTRIMS, highlighting its therapeutic potential in MS [3] - Immunic hosted an MS R&D Day in New York, featuring discussions on vidofludimus calcium's potential to become a leading treatment for relapsing and progressive MS [3] - The company appointed Simona Skerjanec to the Board of Directors and Jason Tardio as Chief Operating Officer and President to support the potential launch of vidofludimus calcium [3] - Immunic is exploring financing, licensing, or partnering opportunities to fund the IMU-856 clinical program [2] Market and Industry Context - Vidofludimus calcium combines neuroprotective, anti-inflammatory, and antiviral effects, positioning it as a unique treatment option for MS [2][17] - IMU-856 targets SIRT6, aiming to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in various gastrointestinal disorders [17] - The company's pipeline focuses on orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, addressing significant unmet medical needs [17]

Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [4] - 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 [4] - Vidofludimus calcium has demonstrated therapeutic activity in phase 2 trials for relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis [4] - Other development programs include IMU-856, targeting Sirtuin 6 (SIRT6) for gastrointestinal diseases, and IMU-381, a next-generation molecule in preclinical testing [4] Upcoming Events - Immunic will release its financial results for Q3 2024 on November 7, 2024, before the U.S. financial markets open [1] - A webcast will follow at 8:00 am ET on the same day, with registration available in advance [2] - An archived replay of the webcast will be accessible approximately one hour after completion on Immunic's website [3]

NEW YORK, Oct. 29, 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 participation in the following industry, scientific and investor conferences in November: November 4-6: BIO-Europe. Members of Immunic's management, business development and investor relations teams will participate in partnering activities at this conference in Stockholm ...

Group 1 - The company specializes in medium and small-cap markets while also providing updates on blue-chip companies, commodities, and broader investment stories [2] - Proactive delivers news and unique insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [2] - The company has a strong focus on technology adoption, utilizing automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [2] Group 2 - Proactive's news team operates from key finance and investing hubs globally, including London, New York, Toronto, Vancouver, Sydney, and Perth [1] - The company aims to provide fast, accessible, informative, and actionable business and finance news content to a global investment audience [1] - Proactive's content is produced independently by experienced and qualified teams of news journalists [1]

Core Insights - The Independent Data Monitoring Committee (IDMC) confirmed that the predetermined futility criteria for the phase 3 ENSURE program have not been met, allowing the trials to continue as planned [1][2] - The ENSURE program is expected to be completed in 2026, with the trials evaluating the efficacy of vidofludimus calcium for treating relapsing multiple sclerosis (RMS) [1][3] Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases, with its lead asset being vidofludimus calcium (IMU-838) [5][6] - Vidofludimus calcium is designed as a next-generation treatment option for multiple sclerosis and has shown a favorable pharmacokinetic, safety, and tolerability profile in over 1,800 individuals [5][6] Clinical Trial Details - The ENSURE program consists of two identical multicenter, randomized, double-blind phase 3 trials (ENSURE-1 and ENSURE-2), each enrolling approximately 1,050 adult patients with active RMS across more than 100 sites in over 15 countries [3] - The primary endpoint for both trials is the time to first relapse, assessed over a period of up to 72 weeks, with key secondary endpoints including disability progression and changes in brain volume [3] Future Milestones - The next clinical milestone for vidofludimus calcium is the topline readout of the phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), expected to be released in April of the following year [2]

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, The ...

– Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes – – Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue Reduction in Multiple Sclerosis Patients – – Preclinical Data Showed Improved Neuronal ...

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, The ...

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, The ...

NEW YORK, Aug. 28, 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 company will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following scientific and investor conferences in September: September 10: Immunic's MS R&D Day. Management of Immunic, including Daniel Vitt, Ph.D., Chief Execut ...