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].

Financial Performance - As of September 30, 2025, Immunic, Inc. has an accumulated deficit of approximately $589.3 million, up from $511.4 million as of December 31, 2024[176]. - The company has incurred operating losses since its inception in 2016, with significant expenses expected to continue as product candidates are developed[177]. - The net loss for the three months ended September 30, 2025, was $25.6 million, a 5% increase from a net loss of $24.4 million in the same period in 2024[217]. - For the nine months ended September 30, 2025, the company reported a net loss of $77.9 million, with cash used in operating activities amounting to $66.5 million, compared to a net loss of $75.3 million and cash used of $61.8 million for the same period in 2024[249][250]. - The company has not generated any revenue from product sales and anticipates needing substantial additional funding for ongoing operations and clinical trials[244][245]. - The company is facing substantial doubt about its ability to continue as a going concern without raising additional capital[228]. Clinical Trials and Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) has enrolled 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2, with top-line data expected by the end of 2026[165]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in confirmed disability progression and improvements in disability endpoints[166]. - The ongoing development of IMU-856 is aimed at treating gastrointestinal diseases, with positive Phase 1b trial results indicating improvements in celiac disease symptoms and gut architecture[169]. - The company is focused on executing the ongoing Phase 3 ENSURE clinical trials and preparing for additional clinical testing of IMU-856[175]. - Long-term data from the Phase 2 EMPhASIS trial showed that vidofludimus calcium was well-tolerated for treatment durations of up to 5.5 years, with an annualized discontinuation rate of approximately 6.4% among 182 patients[180]. - The Phase 3 ENSURE trials for vidofludimus calcium completed enrollment with a total of 2,221 patients across two trials, with top-line data expected by the end of 2026[185]. - The Phase 2 CALLIPER trial demonstrated that vidofludimus calcium reduced the relative risk of 24-week CDW events in the overall PMS patient population compared to placebo[187]. Financial Position and Liquidity - Immunic has raised approximately $496.3 million from various offerings since inception, but as of September 30, 2025, it has only $35.1 million in cash and cash equivalents, raising concerns about liquidity[178]. - The company may seek additional funding through debt, equity financing, or product licensing to meet long-term liquidity needs[227]. - The company filed a shelf registration statement allowing for the offering of up to $250 million in various securities, with $342.2 million available as of September 30, 2025, after previous offerings[229]. - The company raised gross proceeds of $5.1 million from the April 2025 Offering, selling 5,666,667 shares at $0.90 per share, with net proceeds of approximately $4.7 million after expenses[234][236]. - The May 2025 Offering generated approximately $65 million in gross proceeds, with potential additional proceeds of up to $130 million if warrants are fully exercised[240]. - The company has incurred approximately $441.2 million in research and development expenses since its inception in March 2016, as of September 30, 2025[208]. Strategic Initiatives - Immunic is exploring options for further development of certain assets, including potential spin-offs and licensing transactions[171]. - The company is evaluating potential strategic collaborations to enhance the commercialization of its product candidates[181]. - Immunic's strategy includes maximizing the potential of its development programs by addressing high unmet medical needs and exploring additional indications for its product candidates[174]. Safety and Efficacy - Vidofludimus calcium has shown a favorable safety and tolerability profile, having been tested in approximately 2,700 human subjects across various trials[167]. - The company reported a favorable safety profile for vidofludimus calcium, with no new safety signals identified during the trials[190]. - IMU-856 showed a dose-dependent increase of GLP-1 levels in celiac disease patients, indicating potential for weight management treatment[191]. - The cumulative exposure in the EMPhASIS OLE period totaled approximately 952 treatment years, reinforcing the drug's long-term safety and tolerability[184]. Regulatory and Compliance - The company received a Notice of Allowance for a patent covering dose strengths of vidofludimus calcium for the treatment of primary progressive multiple sclerosis (PMS), expected to provide protection until 2041[182]. - The company received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period until December 24, 2025[201]. Operational Expenses - Research and development expenses for the three months ended September 30, 2025, decreased by 6% to $20.0 million compared to $21.4 million in the same period in 2024[217]. - General and administrative expenses increased by 37% to $6.0 million for the three months ended September 30, 2025, compared to $4.4 million in the same period in 2024[218]. - Research and development expenses for the nine months ended September 30, 2025, increased by 8% to $58.4 million compared to $62.9 million in the same period in 2024[221]. Currency and Inflation Impact - A hypothetical 10% adverse change in foreign currency exchange rates could result in an increase of approximately $1.4 million in net current liabilities as of September 30, 2025[263]. - A 10% change in foreign currency exchange rates for the nine months ended September 30, 2025, would have impacted the company's net loss by approximately $6.1 million, primarily due to fluctuations in the Euro[263]. - The company experienced a general increase in costs due to global inflation, but it did not have a material impact on the results of operations for the periods presented[264]. - The company has not entered into any foreign currency hedging transactions or derivative financial transactions to mitigate foreign currency exchange risk[261].

Core Insights - Immunic, Inc. presented significant data on vidofludimus calcium's therapeutic potential for multiple sclerosis (MS) at the 41st Congress of ECTRIMS, highlighting its ability to improve disability outcomes in progressive MS and its neuroprotective properties [1][2][5] Clinical Development - Phase 2 CALLIPER trial data showed a statistically significant 24-week confirmed disability improvement in progressive MS, with consistent results across various subgroups, supporting the drug's neuroprotective potential [1][2][5] - Long-term data from the phase 2 EMPhASIS trial indicated high rates of patients remaining free from confirmed disability worsening, demonstrating favorable safety and tolerability over treatment durations of up to 5.5 years [1][2][5] - Top-line data from the twin phase 3 ENSURE trials in relapsing MS is expected by the end of 2026, with the potential to address a significant market need in progressive MS [1][2][5] Financial Performance - Research and Development (R&D) expenses for Q3 2025 were $20.0 million, a decrease from $21.4 million in Q3 2024, primarily due to reduced external development costs [4][6] - General and Administrative (G&A) expenses increased to $6.0 million in Q3 2025 from $4.4 million in Q3 2024, driven by higher personnel costs [9] - The net loss for Q3 2025 was approximately $25.6 million, compared to a net loss of $24.4 million in Q3 2024, reflecting an increase in weighted average common shares outstanding [9][10] Intellectual Property - The company received a Notice of Allowance from the U.S. Patent and Trademark Office for a key patent covering dose strengths of vidofludimus calcium for the treatment of progressive MS, potentially extending market exclusivity into 2041 [2][5] Market Opportunity - With only one approved therapy currently available for primary progressive MS, vidofludimus calcium presents a significant opportunity in an underserved multi-billion-dollar market [2][5]

Core Insights - Immunic Inc is experiencing strong momentum in its late-stage clinical programs, particularly with its lead asset vidofludimus calcium, which is currently in the fully enrolled ENSURE Phase 3 trials for multiple sclerosis, expected to report data by the end of 2026 [1][5][7] - The company is also making progress in its gastrointestinal program, IMU-856, which has shown promising data in celiac disease and GLP-1 upregulation, indicating potential for further development and partnerships [2][6] Conference Insights - The atmosphere at BIO-Europe 2025 was described as exciting and energetic, with significant international attendance, highlighting its importance as a networking platform for investors, business development professionals, and scientists [3][4] - The conference provided Immunic with valuable exposure to European investors and companies, complementing its existing networking efforts in the US [4] Clinical Program Feedback - Immunic received strong interest in its Phase 3 ENSURE studies for multiple sclerosis, which are seen as a unique growth opportunity in a multi-billion market [5][6] - The GI program, IMU-856, also garnered interest due to its proof-of-concept data in celiac disease and the upregulation of GLP-1, presenting an intriguing opportunity for future development [6] Strategic Outlook - The company aims to bring vidofludimus calcium to market and is focused on the upcoming Phase 3 data readouts next year, while also seeking to advance IMU-856 through clinical trials and potential partnerships [7]

Core Insights - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [1] - The lead development 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 [1] - The company is participating in several industry and investor conferences in November, including BIO-Europe and the Jefferies Global Healthcare Conference [3] Company Overview - Immunic, Inc. is listed on Nasdaq under the ticker IMUX and specializes in therapies for chronic inflammatory and autoimmune diseases [1] - Vidofludimus calcium acts as a first-in-class nuclear receptor-related 1 (Nurr1) activator and selectively inhibits dihydroorotate dehydrogenase (DHODH) [1] - Other development programs include IMU-856, targeting Sirtuin 6 (SIRT6) for gastrointestinal diseases, and IMU-381, currently in preclinical testing [1] Clinical Development - Vidofludimus calcium has shown therapeutic activity in phase 2 trials for relapsing-remitting and progressive multiple sclerosis [1] - IMU-856 aims to restore intestinal barrier function and could be applicable in various gastrointestinal diseases [1] - IMU-381 is being developed to address specific needs in gastrointestinal diseases and is currently in preclinical testing [1]

Core Insights - Immunic Inc is focusing on addressing both physical and mental health challenges faced by multiple sclerosis (MS) patients, recognizing the strong link between MS and mental health issues such as depression and anxiety [1][2][3] Research Focus - The company emphasizes the importance of treating MS as more than just a neurological disease, highlighting that approximately 30% of MS patients experience depression and around 20% experience anxiety [2][3] - Immunic's research aims to slow disease progression, particularly focusing on progression independent of relapse activity (PIRA), which accounts for at least 50% of disability accumulation in relapsing-remitting MS [3][4] Treatment Development - Immunic is dedicated to addressing unmet needs in all forms of MS, especially for patients with primary progressive MS (PPMS), where over 50% experience depressive symptoms and treatment options are limited [4] - The company has reported positive data from its Phase 2 clinical trials, including the EMPhASIS trial and CALLIPER trial, which focus on the drug vidofludimus calcium [3][4] Vision for Future Treatment - The vision for future MS treatments includes a holistic approach that integrates mental health support into every stage of care, aiming for effective and tolerable treatments that improve patients' overall quality of life [5][6]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

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]

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