– 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 ...

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 ...

– Webcast to be Held at 8:00 am ET on August 8, 2024 – NEW YORK, Aug. 1, 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 release its financial results for the second quarter ended June 30, 2024, including a corporate update, on Thursday, August 8, 2024, before the opening of the U.S. financial markets. A webcast wil ...

Core Viewpoint - Immunic Inc is developing vidofludimus calcium as a treatment for multiple sclerosis (MS), with promising results from clinical trials and ongoing Phase 3 studies expected to conclude in 2026 [2][8]. Company Overview - Immunic Inc's lead asset, vidofludimus calcium, targets both relapsing and progressive forms of MS, which affects approximately 1 million people in the US and 2.8 million globally [13][12]. - The drug has a dual mode of action, providing neuroprotection, anti-inflammatory, and antiviral properties [10][14]. Clinical Trials - Phase 2 studies of vidofludimus calcium involved over 200 relapsing MS patients, showing statistically significant efficacy and a clean safety profile, leading to the initiation of Phase 3 studies [8]. - The ENSURE program consists of two parallel studies recruiting around 2,000 patients, with completion expected in 2026 [8]. - The CALLIPER study, focusing on progressive MS, has fully recruited 467 patients, with top-line data anticipated in April 2025 [16]. Disease Understanding - MS is characterized as an immune-mediated demyelinating disease, where the immune system attacks the myelin coating of nerves, leading to severe disability without effective treatment [11]. - Relapsing MS accounts for 85% of cases, with defined relapses followed by periods of remission, although ongoing worsening can occur between relapses [5][12]. Health Insights - The discussion on brain health emphasizes the importance of lifestyle choices, including exercise and nutrition, which can positively impact brain function and overall health [9][17].

About this content Proactive financial news and online broadcast teams provide fast, accessible, informative and actionable business and finance news content to a global investment audience. All our content is produced independently by our experienced and qualified teams of news journalists. Use of technology About Oliver Haill Proactive news team spans the world's key finance and investing hubs with bureaus and studios in London, New York, Toronto, Vancouver, Sydney and Perth. Proactive has always been a f ...

NEW YORK, May 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 participation in the following industry and scientific conferences in June: June 3-6: BIO International Convention 2024. Jessica Breu, Vice President Investor Relations and Communications of Immunic, will present a company overview on Tuesday, June 4, 2024, at 11:00 am PDT ...

Financial Data and Key Metrics Changes - The company ended Q1 2024 with $97.3 million in cash and cash equivalents, which is expected to fund operations into the third quarter of 2025 [24] - R&D expenses decreased to $18.7 million in Q1 2024 from $22.9 million in Q1 2023, primarily due to reductions in clinical development costs [25] - G&A expenses increased to $5.1 million in Q1 2024 from $4.2 million in Q1 2023, mainly related to personnel expenses [26] - The net loss for Q1 2024 was approximately $29.6 million or $0.30 per share, compared to a net loss of approximately $2.3 million or $0.58 per share in Q1 2023 [29] Business Line Data and Key Metrics Changes - The company is advancing its Phase 2 CALLIPER trial in progressive multiple sclerosis and two Phase III ENSURE trials in relapsing multiple sclerosis [22] - Positive interim analysis data from the CALLIPER trial was presented, showing a clear separation of vidofludimus calcium from placebo in serum neurofilament light chain levels [10] Market Data and Key Metrics Changes - Interest income increased to $1.2 million in Q1 2024 from $0.8 million in Q1 2023, attributed to higher interest rates [20] Company Strategy and Development Direction - The company aims to elevate the standard of care for multiple sclerosis patients with vidofludimus calcium, which is designed to manage neuroprotective, anti-inflammatory, and antiviral effects [19] - The company is also preparing for Phase 2 clinical testing of IMU-856, targeting a broad range of gastrointestinal disorders [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of vidofludimus calcium based on strong clinical evidence and ongoing discussions with pharmaceutical companies for partnerships [22][23] - The company anticipates reporting top-line data from the Phase 2 CALLIPER trial in April 2025, which could be a significant value inflection point [30] Other Important Information - The company received a Notice of Allowance for a patent covering a specific polymorph of vidofludimus calcium, enhancing its intellectual property protection [16] - The extensive patent portfolio is expected to provide protection into at least 2041 in the U.S. and 2039 internationally [18] Q&A Session Summary Question: Impact on NfL observed in the CALLIPER study interim analysis - Management noted that the data was well-received by experts, highlighting a strong reduction in NfL levels compared to placebo [40] Question: Interim futility analysis for the ENSURE program - Management clarified that the futility analysis will provide feedback on whether to proceed as planned or suggest sample size adjustments, without revealing medical results [42][43] Question: Visibility on event rates across ENSURE trials - Management stated that current event rates on disability worsening are not available but the study is on track [46] Question: Measurement of neurofilament light chain and variability - Management confirmed the use of state-of-the-art Simoa technology for measuring NfL, aiming to minimize variability [63][66] Question: Life cycle management and additional IP for vidofludimus calcium - Management indicated ongoing work on additional intellectual property and research on Nurr1 activator compounds to extend the franchise [68][69]