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].

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Core Insights - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [2] Group 1: Company Overview - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for relapsing and progressive multiple sclerosis, showing therapeutic activity in patients with relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis [2] - 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) [2] - IMU-856 targets Sirtuin 6 (SIRT6) to restore intestinal barrier function and regenerate bowel epithelium, with plans for a phase 2 clinical trial for gastrointestinal diseases like celiac disease [2] - IMU-381 is a next-generation molecule in preclinical testing aimed at addressing gastrointestinal diseases [2] Group 2: Upcoming Events - Immunic will participate in the BIO International Convention 2024 from June 3-6, where Jessica Breu will present a company overview on June 4 at 11:00 am PDT [1] - The presentation will be accessible on Immunic's website, with an archived replay available post-conference [1] - Immunic's management will engage in partnering activities at the BIO International Convention [1] - Additionally, Immunic will participate in the Pharmaceutical Contract Management Group (PCMG) Assembly 2024 from June 5-7, with Werner Gladdines participating in a panel discussion on June 6 at 12:05 pm CEST [4]

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]

Immunic THERAPEUTICS Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, risks relating to strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management. Risks and uncertainties that may cause actual results to differ materially ...

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, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Delaware 56-2358443 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36201 I ...