Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Core Viewpoint - Immunic Inc reported positive data from the phase 2 EMPhASIS trial of vidofludimus calcium for relapsing-remitting multiple sclerosis (RRMS), indicating a low rate of confirmed disability worsening in treated patients, which supports the drug's potential neuroprotective effects [2][4]. Group 1: Trial Results - The EMPhASIS trial demonstrated a significant reduction in inflammatory lesions on MRI, with 30 mg and 45 mg doses showing reductions of 76% and 78% respectively [4]. - The trial also indicated initial signs of neuroprotection, with a reduction in disability progression by more than 50% [4][5]. - A total of 268 patients were randomized, with 254 entering the open-label extension phase, and 182 remaining on active treatment as of January, highlighting the drug's safety and tolerability [3]. Group 2: Importance of Disability Worsening - Confirmed disability worsening (CDW) is a critical concern for MS patients, as it relates to their independence over time, measured by the EDSS disability score [6]. - The data from the EMPhASIS trial suggests that vidofludimus calcium may address the unmet need to slow down disability progression independent of relapse activity [6]. Group 3: Future Development Plans - Based on the EMPhASIS data, Immunic plans to conduct two phase 3 studies (ENSURE studies) in relapsing MS, with 1,122 patients enrolled, expected to read out by the end of next year [7]. - The studies will also assess the long-term neuroprotective effects as a secondary endpoint, which is crucial for the drug's positioning [8]. - The CALLIPER phase 2 study confirmed a 24% reduction in overall CDW and a 32% reduction in the primary progressive MS subgroup for patients treated with 45 mg, reinforcing the drug's potential efficacy [10].

Core Insights - Immunic, Inc. reported long-term data from the phase 2 EMPhASIS trial of vidofludimus calcium, showing 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW at week 144 [1][3] - The drug demonstrated a favorable safety and tolerability profile, with no new safety signals emerging during treatment durations of up to 5.5 years [1][3] Group 1: Clinical Trial Data - The phase 2 EMPhASIS trial included 268 patients with relapsing-remitting multiple sclerosis (RRMS), achieving both primary and key secondary endpoints with high statistical significance [4] - A total of 29 CDW events were confirmed at 12 weeks, with 44.8% associated with relapse-associated worsening (RAW) and 13.8% with progression independent of relapse activity (PIRA) [3] - The open-label extension (OLE) period provided approximately 952 treatment years of data, reinforcing the drug's safety and tolerability [2][3] Group 2: Drug Mechanism and Potential - Vidofludimus calcium is a first-in-class nuclear receptor-related 1 (Nurr1) activator, combining neuroprotective, anti-inflammatory, and anti-viral effects [6][7] - The drug has shown therapeutic activity in both relapsing-remitting and progressive multiple sclerosis patients, significantly reducing brain lesions and confirmed disability worsening [6][7] - The ongoing phase 3 clinical trials aim to further evaluate the drug's efficacy and safety, with top-line data expected by the end of 2026 [7]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - The article discusses potential investment opportunities in IMUX, indicating a possible long position in the stock within the next 72 hours [1]. Group 1 - The analyst has no current stock or derivative positions in the companies mentioned but may initiate a beneficial long position [1]. - The article expresses the author's own opinions and is not influenced by compensation from any company [1]. - There is no business relationship with any company whose stock is mentioned in the article [1].

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Summary of Immunic (IMUX) Conference Call Company Overview - **Company**: Immunic (IMUX) - **Focus**: Clinical stage company developing oral treatments for chronic inflammation and autoimmune diseases, particularly multiple sclerosis (MS) [2][3] Key Points on Multiple Sclerosis (MS) Treatment - **Market Opportunity**: Immunic targets a significant commercial opportunity with peak sales potential estimated between $3 billion to $7 billion across various forms of MS [3][9] - **Pipeline**: - **Beta Frutimous Calcium**: In phase three for relapsing MS (RMS) and recently completed phase two for progressive MS (PMS) [3][9] - **IMU 856**: Targeting gastrointestinal diseases, specifically celiac disease [4][26] Beta Frutimous Calcium - **Mechanism of Action**: - Acts as a potent inhibitor of DHODH, reducing inflammation and preventing neurodegeneration [4][5] - Activates NurOwn, a nuclear receptor that protects neurons from cell death [5][10] - **Clinical Data**: - Phase two study (EMPHASIS) showed a 76% reduction in active lesions and a 94.2% rate of patients free from confirmed disability worsening after two years [12][13] - Phase two study (CALIPER) demonstrated a 24% reduction in confirmed disability worsening overall, with 33% in primary progressive MS (PPMS) patients [19][20] - Notably effective in patients without active inflammation, showing a 34% reduction in disability worsening [22][24] Unmet Medical Need - **Current Treatments**: Only one drug approved for primary progressive MS, highlighting a significant unmet need in the market [16][15] - **Patient Population**: Approximately 1.2 million eligible patients for MS treatment globally, with many not currently receiving therapy [8][16] Key Points on IMU 856 - **Mechanism**: A selective modulator targeting epithelial regeneration in the gut, potentially applicable to various gastrointestinal disorders [26][28] - **Clinical Data**: - Phase one study showed a significant increase in GLP-1 levels (up to 250%) in celiac disease patients, indicating potential for managing weight gain and gut health [31][32] - Demonstrated protection of gut villi and improved nutrient absorption in a short-term study [35][36] Safety and Tolerability - **Beta Frutimous Calcium**: Favorable safety profile with no new safety findings reported, making it an attractive option for newly diagnosed MS patients [23][14] - **IMU 856**: Safety and tolerability assessed in clinical studies, with promising results [30][34] Future Outlook - **Next Steps**: Anticipation of top-line data from phase three studies by the end of 2026, with potential NDA submission in 2027 if results are positive [25][37] - **Market Positioning**: Immunic aims to position Beta Frutimous Calcium as a unique oral treatment option for all forms of MS, addressing both relapsing and progressive forms [37]

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 focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and 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 completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][3] - Additional data from the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) supports the positive results previously released, highlighting the neuroprotective potential of vidofludimus calcium [1][4] Group 1: ENSURE Trials - The ENSURE program consists of two identical multicenter, randomized, double-blind Phase 3 trials aimed at evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients [2] - A total of 1,121 patients were enrolled in ENSURE-1 and 1,100 patients in ENSURE-2, with the primary endpoint being the time to first relapse over 72 weeks [2] - Secondary endpoints include time to confirmed disability worsening, volume of new T2 lesions, and MRI-based endpoints [2] Group 2: CALLIPER Trial Data - In the Phase 2 CALLIPER trial, vidofludimus calcium demonstrated a 24% reduction in the hazard ratio for 24-week confirmed disability worsening (24wCDW) compared to placebo [5] - The drug showed a 33% reduction in 24wCDW in primary progressive multiple sclerosis (PPMS) patients, a 19% reduction in non-active secondary progressive multiple sclerosis (naSPMS), and a 34% reduction in active secondary progressive multiple sclerosis (aSPMS) [5] - For patients without evidence of gadolinium-enhancing lesions at baseline, vidofludimus calcium reduced 24wCDW by 34% compared to placebo [5][6] Group 3: Vidofludimus Calcium Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [7] - The drug acts as a selective immune modulator, activating the neuroprotective transcription factor Nurr1 and inhibiting dihydroorotate dehydrogenase (DHODH) to provide neuroprotective, anti-inflammatory, and anti-viral effects [7] - The drug has been tested in approximately 2,700 individuals, showing an attractive pharmacokinetic, safety, and tolerability profile [7]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]