Core Insights - Immunic, Inc. (NASDAQ:IMUX) has experienced a significant share price increase of 24.10% over the past five days as of January 9, 2026, following a review of its 2025 performance and upcoming milestones [2] Group 1: Company Performance and Milestones - The company has completed enrollment in the Phase 3 ENSURE-1 and ENSURE-2 trials for vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (RMS), with 1,121 and 1,100 patients enrolled across over 100 sites in 15 countries [3] - A synchronized top-line readout is anticipated by the end of 2026 to evaluate the therapy's potential in modifying disease progression [3] - Long-term Phase 2 EMPhASIS data confirmed durable disability protection in relapsing-remitting MS (RRMS), with over 92% of patients remaining free of 24-week confirmed disability worsening after up to 5.5 years [4] Group 2: Clinical Trial Results - The Phase 2 CALLIPER trial in progressive MS demonstrated statistically significant reductions in 24-week confirmed disability worsening (24wCDW), indicating neuroprotective effects independent of inflammation [5] Group 3: Product Development and Financing - Management discussed IMU-856, a small molecule modulator targeting Sirtuin 6 (SIRT6), which has shown promising early clinical and preclinical signals for gastrointestinal barrier restoration and weight management [6] - The company plans to expand its oral immunology portfolio, supported by strong financing in 2025, including a $65 million public offering to advance its programs [6] Group 4: Company Focus - Immunic, Inc. is dedicated to developing selective oral immunology therapies aimed at chronic inflammatory and autoimmune diseases, including multiple sclerosis, ulcerative colitis, and Crohn's disease [7]

Core Insights - Immunic Inc's CEO highlighted significant milestones in 2025, particularly the phase 2 CALLIPER study, which showed a 31% reduction in confirmed disability worsening in progressive multiple sclerosis (MS) patients and a 34% reduction in those without baseline gadolinium lesions, indicating a potential neuroprotective effect of vidofludimus calcium [1][5] Clinical Developments - The CALLIPER study results suggest that vidofludimus calcium can address both inflammatory and non-inflammatory processes driving disability progression in MS, benefiting patients with relapsing forms of the disease [6] - Long-term data from the EMPhASIS study indicated that 92.3% of relapsing-remitting MS patients remained free of 12-week confirmed disability worsening after 144 weeks, with only 13.8% of events being independent of relapses, supporting the drug's efficacy [2][7] Patent and Strategic Positioning - Immunic has strengthened its patent position for vidofludimus calcium, potentially securing exclusivity until 2041 in key markets, which provides a significant competitive advantage [3][8] - Early findings on IMU-856 in celiac disease showed increases in natural GLP-1 levels, suggesting potential applications in gut health and weight management [3][8] Future Outlook - Enrollment in the phase 3 ENSURE trials is complete, with top-line data expected by the end of 2026, which is crucial for FDA submission and potential market launch [9][10] - The company is preparing for a New Drug Application (NDA) submission and aims for a commercial launch in 2028, contingent on FDA approval [11]

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Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][2][6] - Phase 2 CALLIPER data demonstrated that vidofludimus calcium significantly reduced 24-week confirmed disability worsening (CDW) and increased 24-week confirmed disability improvement (CDI) across progressive multiple sclerosis (PMS) and its subtypes, highlighting the drug's neuroprotective mechanism [1][2][6] - Long-term open-label data from the Phase 2 EMPhASIS trial showed low rates of confirmed disability worsening events in patients with relapsing-remitting multiple sclerosis (RRMS), indicating favorable long-term safety and tolerability [1][2][6] - The company received a U.S. patent for dose strengths of vidofludimus calcium in PMS, extending intellectual property protection until 2041 [1][2][6] Vidofludimus Calcium Highlights - Enrollment completed for ENSURE-1 with 1,121 patients and ENSURE-2 with 1,100 patients across over 100 sites in 15 countries [6] - Positive results from the CALLIPER trial showed statistically significant improvements in 24wCDI and reductions in thalamic atrophy and new or enlarging T2 lesion volume compared to placebo [6] - At week 144 of the EMPhASIS trial, 92.3% of patients remained free of 12wCDW and 92.7% free of 24wCDW, with no new safety signals reported [6] IMU-856 Highlights - IMU-856 demonstrated a dose-dependent increase in endogenous glucagon-like peptide-1 (GLP-1) levels and a reduction in body weight gain in preclinical testing, indicating potential for weight management [6] - The company is preparing for further clinical testing of IMU-856, contingent on financing, licensing, or partnering [6] Corporate Developments - Immunic closed a $5.1 million registered direct offering and an oversubscribed $65 million underwritten public offering [6] - The company will host one-on-one meetings at the 44th Annual J.P. Morgan Healthcare Conference in January 2026 [5]

Core Insights - Immunic Inc emphasizes the long-term clinical potential of its lead compound, vidofludimus calcium, in treating multiple sclerosis (MS), focusing on disease progression rather than just symptom relief [1][5]. Group 1: Importance of Long-term Focus - The fear of losing independence due to MS is significant for patients, as the disease often affects young adults at critical life stages [2]. - Long-term disease progression is crucial to understand, as MS is a chronic autoimmune disease that impacts patients' lives over decades [4]. - Focusing on long-term progression allows for better treatment options that help patients maintain independence and improve quality of life [9]. Group 2: Clinical Outcomes and Research - Vidofludimus calcium shows promise in protecting nerve cells and reducing nerve damage, with clinical studies indicating it can slow down disease progression [5][7]. - The compound has demonstrated the ability to delay and halt progression in some patients, with some even experiencing improvements in abilities [6]. - Long-term data suggests that vidofludimus calcium can reduce the risk of confirmed disability worsening, addressing underlying processes of long-term disability in MS [7]. Group 3: Future of MS Research - Progress in understanding the biology and pathophysiology of MS provides hope for developing better protective approaches for neurological function and quality of life [10]. - The work of Immunic is aimed at enabling individuals with MS to maintain independence and lead fulfilling lives for as long as possible [11].

Summary of Immunic Therapeutics Conference Call Company Overview - **Company**: Immunic Therapeutics - **Focus**: Transforming the Multiple Sclerosis (MS) market with innovative treatments, particularly through the development of vidofludimus calcium [2][3] Key Points and Arguments Clinical Trials and Data - **Phase 3 Studies**: Two significant Phase 3 studies in relapsing MS are expected to yield data in the next year [2] - **CALLIPER Study**: Positive results from the Phase 2 study in progressive MS, showing a 34% reduction in disability worsening, which is the best result reported in any clinical trial to date [3][4] - **Statistical Significance**: Achieved statistical significance in disability score changes after 60 weeks, with a P value of 0.01 after 120 weeks [4] Mechanism of Action - **Neuroprotective Effect**: Vidofludimus calcium activates nuclear receptors, providing a direct neuroprotective effect, which is unique compared to other MS treatments that are primarily immunosuppressive [8][9] - **Hazard Ratio**: In the primary progressive MS population, the hazard ratio for improvement was reported at 2.8, indicating a threefold higher likelihood of benefit compared to placebo [4] Market Position and Competitive Landscape - **Oral Disease-Modifying Therapy Segment**: Vidofludimus calcium aims to compete in the oral therapy segment, which currently represents 40% of total prescriptions for MS [12] - **Differentiation**: The drug is expected to have a unique mechanistic advantage by addressing both relapse-associated worsening and progression independent of relapse activity [13][14] - **Safety Profile**: Vidofludimus calcium is anticipated to have a better safety and tolerability profile compared to existing oral therapies, which have serious safety concerns [14] Target Patient Segments - **Newly Diagnosed Patients**: Positioned as a first-choice option for newly diagnosed patients due to its safety and tolerability [15] - **Switching from Other Therapies**: Expected to be a logical switch for patients experiencing safety concerns with existing therapies, particularly those coming off anti-CD20 therapies [16][17] - **Market Opportunity**: Estimated market opportunity in the U.S. for patients switching from anti-CD20 therapies is between $500 million and $1 billion [17] Financial and Strategic Considerations - **Funding**: Recent capital raise of $65 million, with potential for an additional $65 million through cash warrants [21] - **Partnerships**: Ongoing discussions regarding potential partnerships to support clinical development and commercialization strategies [23][24] - **Commercial Strategy**: Aiming to build a commercial plan similar to successful small biotech companies, focusing on the unique value proposition of vidofludimus calcium [24] Other Programs - **IMU-856**: Demonstrated proof of concept in celiac disease, restoring the epithelial layer in the gut wall and showing functional improvements [25][26] - **Prioritization**: Current priority remains on executing the MS program while being prepared to advance other programs as funding allows [26] Additional Important Insights - **Market Growth**: The MS market is projected to grow from $23 billion to $30 billion, indicating ample space for multiple products [19] - **Regulatory Considerations**: Anticipation of regulatory focus on 24-week confirmed disability worsening as a pivotal endpoint for future studies [7] This summary encapsulates the critical insights from the conference call, highlighting Immunic Therapeutics' strategic direction, clinical advancements, and market positioning in the MS treatment landscape.

Core Insights - Immunic, Inc. is a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases [3] - The company will participate in the 8th Annual Evercore ISI Healthcare Conference, with CEO Daniel Vitt scheduled for a fireside chat on December 4, 2025 [1][2] Company Overview - Immunic's lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [3] - Vidofludimus calcium acts as a first-in-class nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects and anti-inflammatory properties by inhibiting dihydroorotate dehydrogenase (DHODH) [3] - The company is also developing IMU-856, targeting Sirtuin 6 (SIRT6) to restore intestinal barrier function, with potential applications in various gastrointestinal diseases [3] - IMU-381 is in preclinical testing as a next-generation molecule for gastrointestinal diseases [3]

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the company's advancements in its oral MS treatment, vidofludimus calcium, during the third quarter and at the 2025 ECTRIMS conference, showcasing significant clinical study data [1][5]. Clinical Study Results - The CALLIPER study demonstrated a statistically significant effect on confirmed disability improvement in patients, indicating the treatment's efficacy [2][6]. - In the EMPhASIS phase 2 open-label extension trial, 92.3% of patients remained free of 12-week confirmed disability worsening after 144 weeks, showcasing the drug's durability and favorable safety profile [3][7]. Upcoming Trials and Goals - The ENSURE phase 3 trials in relapsing MS are set to provide topline data in 2026, with the primary endpoint focusing on time to first relapse, which is crucial for drug approval [4][10]. - Secondary endpoints aim to confirm the drug's neuroprotective potential, consistent with findings from previous studies [11][12]. Intellectual Property and Market Position - Recently granted US patents enhance the commercial protection for vidofludimus calcium in both relapsing and progressive MS, potentially extending market exclusivity beyond 2041 [4][13]. Future Milestones - The most significant upcoming milestone is the phase 3 data readout from the ENSURE studies at the end of next year, which is expected to be pivotal for the company and MS patients [14].

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Financial Performance - Net loss for Q3 2025 was approximately $25.6 million, or $0.13 per share, compared to a net loss of approximately $24.4 million, or $0.24 per share, in Q3 2024[11]. - The net loss for Q3 2025 was $25,579,000, compared to a net loss of $24,368,000 in Q3 2024, indicating a 5% increase in losses year-over-year[15]. - Other Income for the nine months ended September 30, 2025, was $1.2 million, compared to a loss of $1.1 million for the same period in 2024[8]. - Interest Income for Q3 2025 was $0.4 million, a decrease from $0.8 million in Q3 2024, primarily due to a lower average cash balance[6]. - The company reported interest income of $419,000 for Q3 2025, down from $776,000 in Q3 2024, a decrease of 46%[15]. Cash and Liquidity - Cash and Cash Equivalents as of September 30, 2025, were $35.1 million, insufficient to fund operations for at least 12 months without raising additional capital[11]. - Cash and cash equivalents as of September 30, 2025, were $35,132,000, slightly down from $35,668,000 as of December 31, 2024[17]. - Total current liabilities increased to $30,079,000 as of September 30, 2025, from $22,175,000 as of December 31, 2024, marking a 35% increase[17]. Research and Development - Vidofludimus calcium demonstrated statistically significant 24-week confirmed disability improvement in progressive multiple sclerosis, with consistent signals for slowing disability progression across subgroups[2]. - Long-term data from the phase 2 EMPhASIS trial showed a cumulative exposure of approximately 952 treatment years with an annualized discontinuation rate of only ~6.4%[5]. - Research and development expenses for the nine months ended September 30, 2025, were $62,914,000, up from $58,429,000 in the same period of 2024, representing a 7% increase[15]. - Research and Development (R&D) expenses for Q3 2025 were $20.0 million, a decrease of $1.4 million compared to Q3 2024[6]. Operating Expenses - General and Administrative (G&A) expenses for Q3 2025 were $6.0 million, an increase of $1.6 million compared to Q3 2024[6]. - Total operating expenses for Q3 2025 were $25,993,000, compared to $25,726,000 in Q3 2024, reflecting a slight increase of 1%[15]. Assets and Deficits - The accumulated deficit as of September 30, 2025, was $589,271,000, compared to $511,399,000 at the end of 2024, reflecting a 15% increase[17]. - Total assets as of September 30, 2025, were $40,704,000, slightly down from $40,868,000 as of December 31, 2024[17]. - The weighted-average common shares outstanding for Q3 2025 were 193,897,764, compared to 101,272,580 in Q3 2024[15]. Future Outlook - Top-line data from the twin phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis is expected by the end of 2026[7]. - The company received a Notice of Allowance for a key patent covering dose strengths of vidofludimus calcium, expected to provide protection into 2041[3]. - The company has not provided specific guidance for future revenue or operational milestones in the current release[12].