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]

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].