[Company Update and Business Highlights](index=1&type=section&id=Company%20Update%20and%20Business%20Highlights) This section provides an overview of Immunic's recent clinical advancements and financial strengthening through successful fundraising efforts [Q2 2025 and Subsequent Corporate Highlights](index=1&type=section&id=Q2%202025%20and%20Subsequent%20Corporate%20Highlights) Immunic achieved significant clinical progress in Q2 2025 and beyond, including positive data for vidofludimus calcium in MS trials and strengthened its balance sheet through two financings - In April 2025, positive data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) patients were announced, showing a reduced relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo, with no new safety signals identified[5](index=5&type=chunk) - In April 2025, a **$5.1 million** registered direct offering was completed[5](index=5&type=chunk) - In May 2025, an oversubscribed **$65 million** underwritten public offering was completed, with the potential for the company to receive up to an additional **$130 million** if all Series A and Series B warrants are exercised for cash[5](index=5&type=chunk) - In June 2025, additional data from the Phase 2 CALLIPER trial were announced, further confirming the neuroprotective potential of vidofludimus calcium[8](index=8&type=chunk) - In June 2025, patient enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) patients was completed on schedule, with ENSURE-1 enrolling **1,121 patients** and ENSURE-2 enrolling **1,100 patients**[8](index=8&type=chunk) - In June 2025, long-term open-label extension (OLE) data from the Phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) patients were reported, showing that at Week 144, **92.3%** of patients had no 12-week confirmed disability worsening and **92.7%** had no 24-week confirmed disability worsening, demonstrating good long-term safety and tolerability[8](index=8&type=chunk) [CEO's Commentary on Clinical Progress](index=1&type=section&id=CEO's%20Commentary%20on%20Clinical%20Progress) CEO Dr. Daniel Vitt highlighted significant clinical progress for vidofludimus calcium (IMU-838) in MS treatment, including Phase 3 ENSURE trial enrollment and neuroprotective effects in Phase 2 CALLIPER, also noting IMU-856's potential in GI diseases and weight management - Vidofludimus calcium (IMU-838), an oral Nurr1 activator, is progressing in Phase 3 ENSURE trials for relapsing multiple sclerosis (RMS), with topline data expected by the end of **2026**[2](index=2&type=chunk) - The Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) showed a **23.8%** reduction in time to 24-week confirmed disability worsening (24wCDW) compared to placebo, with a **31.3%** reduction in the primary progressive multiple sclerosis (PPMS) subgroup and a **19.2%** reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup[2](index=2&type=chunk) - IMU-856, an oral SIRT6 modulator, shows potential in gastrointestinal diseases and weight management, with late-stage analysis of Phase 1b clinical trials indicating up to a **250%** increase in GLP-1 levels in fasting celiac disease patients compared to placebo[4](index=4&type=chunk) - The company is preparing for further clinical testing of IMU-856 and exploring potential financing, licensing, or partnership opportunities[4](index=4&type=chunk) [Anticipated Clinical Milestones](index=3&type=section&id=Anticipated%20Clinical%20Milestones) Immunic anticipates topline data for vidofludimus calcium in RMS Phase 3 ENSURE trials by late 2026 and plans further IMU-856 clinical testing pending financing, licensing, or collaboration - Topline data for vidofludimus calcium in the Phase 3 ENSURE-1 and ENSURE-2 twin trials for multiple sclerosis (MS) are expected by the end of **2026**[8](index=8&type=chunk) - Further clinical testing of IMU-856 is in preparation, contingent on financing, licensing, or collaboration[8](index=8&type=chunk) [Financial Performance Overview](index=3&type=section&id=Financial%20Performance%20Overview) This section provides a summary of Immunic's financial results for Q2 and H1 2025, detailing changes in expenses, income, net loss, and liquidity [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) R&D expenses increased in Q2 and H1 2025 compared to the prior year, primarily due to higher external development costs for vidofludimus calcium, partially offset by reduced IMU-856 project costs Research and Development Expenses (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $21,369 | $18,323 | +$3,046 | | Six Months Ended June 30 | $42,902 | $37,059 | +$5,843 | - The increase for the three-month period primarily reflects a **$2.6 million** increase in external development costs related to the vidofludimus calcium program and a **$0.6 million** increase in personnel expenses[6](index=6&type=chunk) - The increase for the six-month period primarily reflects a **$7.3 million** increase in external development costs related to the vidofludimus calcium program, partially offset by a **$1.5 million** decrease in external development costs related to the IMU-856 program[7](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) G&A expenses rose in Q2 and H1 2025 compared to the prior year, mainly due to increased personnel, legal, and consulting fees General and Administrative Expenses (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $5,714 | $4,491 | +$1,223 | | Six Months Ended June 30 | $11,006 | $9,636 | +$1,370 | - The increase for the three-month period was due to an **$0.8 million** increase in personnel expenses and a **$0.4 million** increase in legal and consulting fees[9](index=9&type=chunk) - The increase for the six-month period was due to a **$0.7 million** increase in personnel expenses, a **$0.5 million** increase in legal and consulting fees, and a **$0.2 million** increase in other cost categories[9](index=9&type=chunk) [Interest Income](index=3&type=section&id=Interest%20Income) Interest income significantly decreased in Q2 and H1 2025 compared to the prior year, primarily due to lower average cash balances Interest Income (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $241 | $998 | -$757 | | Six Months Ended June 30 | $424 | $2,185 | -$1,761 | - The decrease in interest income was due to lower average cash balances[9](index=9&type=chunk)[10](index=10&type=chunk) [Other Income (Expense)](index=4&type=section&id=Other%20Income%20(Expense)) Other income (expense) significantly increased in H1 2025, driven by a government grant and the absence of prior-year tranche right-related expenses, while Q2 saw a decrease Other Income (Expense) (in thousands of USD) | Period | 2025 | 2024 | Change | | :------------------- | :----- | :----- | :----- | | Three Months Ended June 30 | $22 | $436 | -$414 | | Six Months Ended June 30 | $1,191 | $(1,658) | +$2,849 | - The **$2.8 million** increase for the six-month period was primarily attributable to a **$1.0 million** grant income from the German Federal Ministry of Finance recognized in Q1 2025, and the absence of **$1.7 million** in transaction costs related to tranche rights from a January 2024 financing[11](index=11&type=chunk) - The change in fair value of tranche rights was **$0** for H1 2025, compared to a negative **$4.8 million** for H1 2024, as these tranche rights were reclassified to equity on March 4, 2024[13](index=13&type=chunk)[17](index=17&type=chunk) [Net Loss and EPS](index=4&type=section&id=Net%20Loss%20and%20EPS) Immunic reported increased net losses for Q2 and H1 2025 year-over-year, but basic and diluted net loss per share decreased due to a higher weighted-average number of common shares outstanding Net Loss and EPS (in thousands of USD, except per share amounts) | Period | Net Loss 2025 | Net Loss 2024 | Change | EPS 2025 | EPS 2024 | | :------------------- | :------------ | :------------ | :----- | :------- | :------- | | Three Months Ended June 30 | $(26,820) | $(21,380) | $(5,440) | $(0.20) | $(0.21) | | Six Months Ended June 30 | $(52,293) | $(50,964) | $(1,329) | $(0.45) | $(0.51) | - The weighted-average number of common shares outstanding significantly increased: **132,175,202 shares** for Q2 2025 compared to **101,272,580 shares** for the same period in 2024; and **116,844,985 shares** for H1 2025 compared to **99,607,158 shares** for the same period in 2024[11](index=11&type=chunk)[17](index=17&type=chunk) [Cash and Liquidity Position](index=4&type=section&id=Cash%20and%20Liquidity%20Position) As of June 30, 2025, Immunic held $55.3 million in cash and cash equivalents but stated existing liquidity is insufficient to fund operations for at least twelve months without additional capital - As of June 30, 2025, cash and cash equivalents totaled **$55.3 million**[11](index=11&type=chunk)[19](index=19&type=chunk) - The company does not have sufficient liquidity to fund its operations for at least twelve months beyond June 30, 2025, without raising additional capital[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Immunic's unaudited condensed consolidated financial statements, including statements of operations and balance sheets [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section provides unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, detailing operating expenses, other income (expense), and net loss Condensed Consolidated Statements of Operations (in thousands of USD, except per share amounts) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $21,369 | $18,323 | $42,902 | $37,059 | | General and administrative | $5,714 | $4,491 | $11,006 | $9,636 | | Total operating expenses | $27,083 | $22,814 | $53,908 | $46,695 | | Loss from operations | $(27,083) | $(22,814) | $(53,908) | $(46,695) | | Interest income | $241 | $998 | $424 | $2,185 | | Change in fair value of the tranche rights | $0 | $0 | $0 | $(4,796) | | Other income (expense), net | $22 | $436 | $1,191 | $(1,658) | | Total other income (expense) | $263 | $1,434 | $1,615 | $(4,269) | | Net loss | $(26,820) | $(21,380) | $(52,293) | $(50,964) | | Net loss per share, basic and diluted | $(0.20) | $(0.21) | $(0.45) | $(0.51) | | Weighted-average common shares outstanding | 132,175,202 | 101,272,580 | 116,844,985 | 99,607,158 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides unaudited condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands of USD) | | June 30, 2025 (Unaudited) | December 31, 2024 | | :---------------------------------- | :-------------------------- | :------------------ | | **Assets** | | | | Cash and cash equivalents | $55,310 | $35,668 | | Total current assets | $59,842 | $39,332 | | Total assets | $61,429 | $40,868 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $27,313 | $22,175 | | Total liabilities | $27,518 | $22,439 | | Total stockholders' equity | $33,911 | $18,429 | | Total liabilities and stockholders' equity | $61,429 | $40,868 | - As of June 30, 2025, cash and cash equivalents increased to **$55.31 million** from **$35.67 million** as of December 31, 2024[19](index=19&type=chunk) - As of June 30, 2025, total stockholders' equity increased to **$33.91 million** from **$18.43 million** as of December 31, 2024[19](index=19&type=chunk) [About Immunic, Inc.](index=4&type=section&id=About%20Immunic%2C%20Inc.) Immunic, Inc. is a biotechnology company focused on developing oral small molecule therapies for chronic inflammatory and autoimmune diseases, with lead program vidofludimus calcium (IMU-838) in Phase 3 for RMS and other pipeline candidates like IMU-856 and IMU-381 - Immunic, Inc. is dedicated to developing oral small molecule therapies for chronic inflammatory and autoimmune diseases[12](index=12&type=chunk) - The lead development program, vidofludimus calcium (IMU-838), a Nurr1 activator and DHODH inhibitor, is currently in Phase 3 clinical trials for relapsing multiple sclerosis and has shown therapeutic activity in Phase 2 trials for relapsing-remitting multiple sclerosis and progressive multiple sclerosis[12](index=12&type=chunk) - Other pipeline programs include IMU-856 (SIRT6 modulator), designed to restore gut barrier function and regenerate intestinal epithelium, potentially applicable to various gastrointestinal diseases and weight management; and IMU-381, a next-generation molecule in preclinical testing specifically targeting gastrointestinal disease needs[12](index=12&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This press release contains forward-looking statements subject to significant risks and uncertainties, where actual results may differ materially from expectations due to factors like inflation, geopolitical conflicts, financing, clinical trial outcomes, and regulatory approvals. Immunic disclaims any obligation to update these statements - This press release contains "forward-looking statements" subject to significant risks and uncertainties[14](index=14&type=chunk) - Actual results and performance may differ materially from those projected in forward-looking statements due to various factors, including inflation, geopolitical conflicts, cash use and reserves, financing capabilities, unpredictability of clinical trial results, changes in target market size, intellectual property protection, drug development and regulatory approval processes, and competitive product and technology changes[14](index=14&type=chunk) - Immunic disclaims any intention or obligation to update these forward-looking statements to reflect events or circumstances occurring after the date of publication[14](index=14&type=chunk) [Contact Information](index=6&type=section&id=Contact%20Information) This section provides contact details for Immunic, Inc.'s investor relations and media inquiries, including internal contacts and US-based representatives - Immunic, Inc. Vice President Investor Relations and Communications: Jessica Breu, Contact: **+49 89 2080 477 09**, jessica.breu@imux.com[15](index=15&type=chunk) - US Investor Relations Contact: Rx Communications Group, Paula Schwartz, Contact: **+1 917 633 7790**, immunic@rxir.com[15](index=15&type=chunk) - US Media Contact: KCSA Strategic Communications, Caitlin Kasunich, Contact: **+1 212 896 1241**, ckasunich@kcsa.com[15](index=15&type=chunk)

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]