Core Viewpoint - Immunic, Inc. is actively participating in several scientific and investor conferences in October 2025 to present data on its clinical pipeline, particularly focusing on its orally administered therapies for chronic inflammatory and autoimmune diseases [1][2][3]. Conference Participation - Immunic's R&D team will present data on IMU-856 at the United European Gastroenterology Week (UEGW) in Berlin, Germany, from October 4-7, 2025, highlighting its positive effects on gut hormone levels in celiac disease patients [2]. - At the 17th International Congress of the International Society of Neuroimmunology (ISNI) in Chiba, Japan, from October 5-8, 2025, Immunic will present data on its lead asset, vidofludimus calcium (IMU-838), which exhibits signs of neuroprotection in preclinical models [2][3]. - Immunic's CEO and CFO will participate in the Roth's 4th Annual Healthcare Opportunities Conference in New York on October 9, 2025, discussing the next wave of innovation in underserved indications [2]. - A virtual fireside chat with Immunic's leadership will take place on October 23, 2025, as part of H.C. Wainwright's HCW @ Home event [2]. Clinical Development Programs - Vidofludimus calcium (IMU-838) is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. It has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [3]. - IMU-856 targets SIRT6 to restore intestinal barrier function and may be applicable in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3]. - IMU-381, currently in preclinical testing, is a next-generation molecule aimed at addressing gastrointestinal disease needs [3].

Core Insights - Immunic Inc is developing vidofludimus calcium, a first-in-class oral medication aimed at treating multiple sclerosis (MS) by addressing both inflammatory flares and neurodegeneration [2][22] - The drug combines two mechanisms: inhibition of the enzyme DHODH to reduce relapses and MRI lesions, and activation of the Nurr1 protein to protect neurons from degeneration [3][9] Drug Mechanism - Vidofludimus calcium targets inflammation by inhibiting DHODH, which helps reduce hyperactivated immune cells responsible for relapses and inflammatory brain lesions [6][7] - The neuroprotective aspect involves activating Nurr1, which is linked to nerve survival and the regulation of microglia, the guardians of the central nervous system [8][9] Clinical Trials and Efficacy - In the EMPhASIS Phase 2 trial, vidofludimus calcium demonstrated a 71%-78% reduction in certain lesion measures over 24 weeks and a significant reduction in disability worsening [10][11] - The CALLIPER Phase 2 study showed a 24% reduction in the risk of confirmed disability worsening in the overall population, with a 31% reduction in primary progressive MS patients [12][13] Market Potential - The fully de-risked market for vidofludimus calcium is estimated to be between $3 billion and $7 billion, indicating significant commercial potential [20] - The company raised $65 million in an oversubscribed funding round, reinforcing investor confidence [20] Future Developments - Two global Phase 3 trials, ENSURE-1 and ENSURE-2, have completed enrollment, with results expected by the end of 2026 [14][19] - The company is engaging with regulators to discuss the potential for a Phase 3 study, particularly in primary progressive MS [20][22]

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 has a presence in key finance and investing hubs with offices in London, New York, Toronto, Vancouver, Sydney, and Perth [2][3] Group 2 - The company utilizes technology to enhance workflows and has adopted automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [4][5] - Proactive's editorial operations produce approximately 50,000 pieces of news and feature articles annually [1]

Core Insights - Immunic, Inc. presented significant data on vidofludimus calcium at the ECTRIMS Congress, highlighting its potential to improve disability in progressive multiple sclerosis (PMS) patients [1][2] - The CALLIPER trial demonstrated a statistically significant reduction in confirmed disability worsening (24wCDW) and improvement (24wCDI) in the overall PMS population, with a notable two-fold probability over placebo [2][4] - Long-term data from the EMPhASIS trial showed high rates of patients remaining free of confirmed disability worsening, indicating favorable safety and tolerability [1][9] Group 1: CALLIPER Trial Findings - Vidofludimus calcium reduced the risk of 24wCDW by 23.8% in the overall PMS population and by 33.7% in patients without gadolinium-enhancing lesions [4][7] - The treatment demonstrated consistent trends in reducing disability progression across various outcomes and subgroups, supporting its neuroprotective potential [5][7] - The results from the CALLIPER trial were selected for the 'Best of ECTRIMS 2025' slide deck, underscoring their significance [2][10] Group 2: EMPhASIS Trial Insights - In the EMPhASIS trial, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW) and 92.7% remained free of 24-week confirmed disability worsening (24wCDW) at week 144 [9][13] - The trial indicated low discontinuation rates and a favorable long-term safety profile, with no new safety signals observed [9][13] - Cumulative data from up to 5.5 years of treatment reinforced the drug's tolerability and safety [9][13] Group 3: Mechanism and Future Potential - Vidofludimus calcium acts as a Nurr1 activator, which may represent a novel mechanism to prevent neurodegeneration in MS [2][5] - The drug's unique dual mode of action combines neuroprotective, anti-inflammatory, and anti-viral effects, positioning it as a potential differentiated oral therapy in the multi-billion-dollar MS market [2][15] - The company is advancing vidofludimus calcium into phase 3 studies for PMS, with top-line data from ongoing trials expected by the end of 2026 [2][16]

Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing their offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing significant growth and expansion in their coverage [1]

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's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Immunic, Inc. has received a Notice of Allowance for a new patent related to vidofludimus calcium, which is aimed at treating progressive multiple sclerosis (PMS) and is expected to provide protection until 2041, with potential extensions [1][2] Group 1: Patent and Intellectual Property - The newly allowed patent covers dose strengths of vidofludimus calcium ranging from 10 mg to 45 mg for treating PMS, including primary and secondary progressive forms [1] - Immunic's intellectual property strategy includes multiple granted patents in the U.S. and Europe, covering various aspects of vidofludimus calcium, including composition-of-matter and dosing regimens [2] - A pending application could extend patent protection for vidofludimus calcium up to 2044 if granted, with additional undisclosed applications in process to strengthen exclusivity [2] Group 2: Clinical Development and Efficacy - Vidofludimus calcium has shown neuroprotective potential in clinical trials, delaying confirmed disability worsening and reducing brain volume loss in patients with PMS [2][3] - The drug is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [4] - To date, vidofludimus calcium has been tested in approximately 2,700 individuals, demonstrating a favorable pharmacokinetic, safety, and tolerability profile [3]

Summary of Immunic, Inc. Conference Call Company Overview - **Company Name**: Immunic, Inc. - **Ticker**: IMUX - **Industry**: Biotechnology - **Focus**: Developing small molecule therapies for chronic inflammatory and autoimmune diseases [1][2] Core Products - **IMU-856**: - Phase II-ready asset targeting SIRT6 to regenerate gut wall and barrier function in gastrointestinal diseases. - Proof-of-concept data in celiac disease showing a dose-dependent increase in endogenous GLP-1 [2][3]. - **Vidofludimus Calcium**: - Phase III molecule for relapsing forms of multiple sclerosis (MS). - Addresses both neuroinflammation and neurodegeneration, which are critical in MS progression [3][5]. Unmet Need in Multiple Sclerosis - MS leads to significant physical and cognitive disabilities. - Current therapies primarily address neuroinflammation but do not halt chronic disability accumulation. - Vidofludimus calcium aims to provide neuroprotective benefits alongside anti-inflammatory effects [3][4][5]. Mechanism of Action - **Dual Mechanistic Approach**: - Inhibits dihydroorotate dehydrogenase (DHODH) to reduce inflammation. - Activates nuclear receptor-related protein 1 (NRR-1) for neuroprotection [5][6]. - **Epstein-Barr Virus**: - Vidofludimus calcium may prevent reactivation of this virus, which is linked to MS symptoms [6][7]. Clinical Data - **Phase II EMPhASIS Study**: - 268 patients; significant reduction in cumulative active lesions (76%) and gadolinium-enhanced lesions (80%) at week 24 with 30 mg dose [11]. - Confirmed disability worsening was 1.6% for vidofludimus calcium vs. 3.7% for placebo, indicating over 50% benefit [11][12]. - Long-term follow-up showed less than 8% of patients reported confirmed disability worsening at week 144 [12]. - Significant reductions in serum neurofilament light chain, a biomarker for disability worsening [13]. - **Safety Profile**: - Low discontinuation rates (2.8%) compared to other therapies (e.g., Aubagio at 20%) [14]. - No increased risk of serious infections or hepatotoxicity observed [14]. Ongoing Studies - **ENSURE I and ENSURE II**: - Phase III studies fully enrolled with over 1,100 patients each, focusing on time to first relapse [16]. - Expected top-line data in late 2026 [16]. - **CALIBRATE Study**: - Exploratory Phase II study for progressive MS, showing a 31% reduction in disability worsening for primary progressive MS [17][18]. Market Opportunity - **Market Size**: - MS market valued at $23 billion, projected to grow to $30 billion [20]. - Vidofludimus calcium could capture a significant share as the first oral disease-modifying therapy for both relapsing and progressive MS [20][21]. - **Potential Revenue**: - Estimated $1 billion to $2 billion opportunity in relapsing MS and over $2 billion in progressive MS if successful [21]. Conclusion - Vidofludimus calcium represents a transformative opportunity in the MS market with its dual mechanism of action and favorable safety profile. - The company anticipates significant commercial potential if ongoing studies confirm its efficacy [21][22].

Company Overview - Immunic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases[5] - The company's lead drug candidate, Vidofludimus Calcium, has a peak sales potential of $3-7 billion in Multiple Sclerosis (MS)[5] - As of June 30, 2025, Immunic had a cash balance of $55.3 million[5] Clinical Pipeline - Vidofludimus Calcium's Phase 2 EMPhASIS trial in Relapsing-Remitting Multiple Sclerosis (RRMS) was successfully completed, showing a reduction in disability worsening[6] - The CALLIPER trial for Progressive Multiple Sclerosis (PMS) with Vidofludimus Calcium also showed substantial reductions in disability worsening[6] - Top-line data for the ENSURE trials (ENSURE-1 and ENSURE-2) in Relapsing Multiple Sclerosis (RMS) are expected by the end of 2026[6] Vidofludimus Calcium Efficacy - The EMPhASIS trial showed a 78% reduction in cumulative unique active (CUA) lesions and a 74% reduction in Gadolinium-enhancing (Gd+) lesions with the 45mg dose compared to placebo[44] - In the CALLIPER trial, Vidofludimus Calcium demonstrated a 24% risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population[94] - A 34% reduction of 24wCDW was observed in patients without baseline inflammatory lesions in the CALLIPER trial[95] Market Opportunity - The Multiple Sclerosis (MS) market is large and growing, with many brands generating over $1 billion in global annual sales in 2024[100] - The MS therapies market is currently a $20 billion market growing at 4% year-over-year[101] - Vidofludimus Calcium has a potential peak sales of $1-2 billion for Relapsing MS (RMS), $1-2 billion for non-active Secondary Progressive MS (naSPMS), and $2-3 billion for Primary Progressive MS (PPMS)[108]

Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [6] - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for treating relapsing multiple sclerosis, with top-line data expected by the end of 2026 [6] - Vidofludimus calcium has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [6] Upcoming Conferences - Immunic will participate in several investor and scientific conferences in September 2025, including the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, where company executives will present an overview and hold one-on-one meetings [1] - The company will also attend the Leerink Partners Biopharma Summit from September 17-19, and the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 24-26, where data on vidofludimus calcium will be presented [5] Presentation Details - At ECTRIMS, Immunic will present data on vidofludimus calcium, including an oral presentation and four poster presentations, one of which is a late-breaking poster [5] - Key presentations will include efficacy and safety data from the Phase 2 CALLIPER Trial for progressive multiple sclerosis, with specific sessions scheduled for September 24, 2025 [5][6]