Core Viewpoint - Immunic, Inc. has initiated an underwritten public offering of various warrants to purchase shares of common stock, aimed at funding clinical trials and operations for its pipeline of therapies targeting chronic inflammatory and autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes pre-funded warrants, Series A warrants expiring on December 31, 2025, and Series B warrants expiring five years after issuance [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. - Leerink Partners is acting as the sole bookrunner for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund clinical trials, operations, and other general corporate purposes [2]. Group 3: Company Overview - Immunic, Inc. is focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [5]. - The lead program, vidofludimus calcium (IMU-838), is in phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [5]. - Vidofludimus calcium has shown therapeutic activity in earlier phase 2 trials and works as a first-in-class nuclear receptor related 1 (Nurr1) activator [5]. - Other candidates include IMU-856, targeting gastrointestinal diseases, and IMU-381, currently in preclinical testing [5].

Financial Position - Immunic, Inc. reported an accumulated deficit of approximately $536.9 million as of March 31, 2025, up from $511.4 million as of December 31, 2024[152]. - As of March 31, 2025, Immunic had cash and cash equivalents of approximately $14.3 million, which is insufficient to fund operations for at least twelve months without raising additional capital[153]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[162]. - Cash and cash equivalents were approximately $14.3 million as of March 31, 2025, indicating inadequate liquidity to fund operations for at least twelve months without raising additional capital[181]. - As of March 31, 2025, the Company had approximately $14.3 million in cash and cash equivalents[199]. - The Company filed a shelf registration statement in November 2023 allowing for the offering of up to $250 million in various securities, with a total shelf availability of approximately $412.3 million as of March 31, 2025[184]. - The Company incurred no cash from financing activities for the three months ended March 31, 2025, compared to $74.4 million in the same period of the previous year[205][206]. Clinical Trials and Product Development - The Phase 3 ENSURE program for vidofludimus calcium in relapsing multiple sclerosis (RMS) is ongoing, with completion expected in the second quarter of 2026[139]. - Positive interim data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in disability progression and thalamic brain volume[140]. - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[144]. - The company is preparing for a Phase 2 clinical trial of IMU-856 in patients with ongoing active celiac disease[144]. - Immunic is focused on executing ongoing clinical trials and exploring additional indications for its product candidates[150]. - Vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening by 30% in primary progressive multiple sclerosis patients compared to placebo[156]. - IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels in celiac disease patients, with significant increases of 80 mg (p=0.014) and 160 mg (p=0.003) compared to placebo[155]. Financial Performance - The company incurred a net loss of $25.5 million for the three months ended March 31, 2025, a decrease of 14% compared to a net loss of $29.6 million for the same period in 2024[173]. - Research and development expenses increased by $2.8 million (15%) to $21.5 million for the three months ended March 31, 2025, compared to $18.7 million for the same period in 2024[173][174]. - The total operating expenses for the three months ended March 31, 2025, were $26.8 million, an increase of 12% from $23.9 million in the same period in 2024[173]. - Interest income decreased by $1.0 million (85%) to $183,000 for the three months ended March 31, 2025, compared to $1.2 million for the same period in 2024[173][175]. - For the three months ended March 31, 2025, operating activities used $21.8 million in cash, primarily due to a net loss of $25.5 million[201]. Strategic Plans and Collaborations - Immunic plans to evaluate potential strategic collaborations to enhance the commercialization of its product candidates[151]. - The Company expects future expenses to increase as it continues research, development, and clinical trials for its product candidates[196]. - The Company has non-cancelable contractual obligations totaling approximately $2.6 million related to its development programs, expected to be paid in 2025 and 2026[210]. Currency and Inflation Risks - The company has significant exposure to foreign currency exchange rates, primarily the Euro and the Australian dollar, which could adversely affect financial results[214]. - A 10% change in currency exchange rates could materially impact the company's financial position, with a potential effect of approximately $1.3 million on net current liabilities as of March 31, 2025[216]. - For the three months ended March 31, 2025, a 10% change in foreign currency exchange rates would have impacted the company's net loss by approximately $2.0 million, primarily due to the Euro[216]. - The company has not entered into any foreign currency hedging transactions and does not have current plans to do so[214]. - The company has experienced a general increase in costs due to global inflation, but does not believe it has had a material impact on operations[217]. - The company’s German subsidiary is a significant portion of its business, and fluctuations in exchange rates could affect its consolidated financial position[215]. Accounting and Disclosure - The company has adopted ASU No. 2023-09 for income tax disclosures, effective January 1, 2025, which will improve the consistency and disaggregation of information[212]. - The company evaluates its accounting estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[211].

Core Insights - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [2][3] - The company is actively participating in several scientific and industry conferences in May 2025 to present its research and findings [1][2] Conference Participation - Immunic will present two abstracts at the Digestive Disease Week (DDW) from May 3-6, 2025, in San Diego, CA, focusing on its phase 1/1b clinical trial of IMU-856 for celiac disease [2] - A case study on clinical trial supply chain challenges in the Middle East and North Africa (MENA) will be presented at the Clinical Trial Supply Forum 2025 in Brussels, Belgium, from May 13-15, 2025 [2] - The company will also attend the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025 in Phoenix, AZ, from May 28-31, 2025, where preclinical data on vidofludimus calcium (IMU-838) will be showcased [2] Product Development - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with completion expected in 2026 [3] - IMU-856 targets SIRT6 to restore intestinal barrier function and has potential applications in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3] - IMU-381 is a next-generation molecule currently in preclinical testing aimed at addressing gastrointestinal diseases [3]

CALLIPER Trial Results - Vidofludimus Calcium showed a 20% relative risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo [38, 89] - In the primary progressive multiple sclerosis (PPMS) subgroup, Vidofludimus Calcium demonstrated an even more prominent 30% relative risk reduction in 24wCDW compared to placebo [38, 89] - Patients without gadolinium-enhancing (Gd+) lesions at baseline experienced a 29% reduction in disability worsening with Vidofludimus Calcium [41, 42, 90] - Vidofludimus Calcium resulted in a 5% improvement in the annualized rate of whole brain atrophy compared to placebo at 24 months [49] - Vidofludimus Calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo at 24 months [49] - The volume of new/enlarging T2 lesions was 319% lower in the Vidofludimus Calcium group compared to the placebo group at month 24 [50, 52] Safety and Tolerability - The trial confirmed a favorable safety and tolerability profile for Vidofludimus Calcium, consistent with previous clinical trials, with similar frequencies of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in both treatment arms [56, 58, 90] Commercial Opportunity - The market for PPMS treatment is estimated to be over $6 billion, with a significant portion of diagnosed patients currently untreated [72, 74, 85] - Vidofludimus Calcium has a potential peak sales opportunity of $3-7 billion across relapsing MS (RMS), non-active secondary progressive MS (naSPMS), and PPMS indications [76, 80]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Summary of the Conference Call on CALIBER Trial Results Company and Industry Overview - **Company**: Munich - **Industry**: Multiple Sclerosis (MS) Treatment - **Product**: Beta-flutamious calcium (venoflunomous calcium), a novel treatment for various forms of MS, particularly progressive MS Key Points and Arguments 1. **CALIBER Trial Overview**: The CALIBER Phase II clinical study focused on beta-flutamious calcium for patients with progressive MS, specifically targeting non-active disease forms [4][12] 2. **Patient Demographics**: Approximately 120,000 patients diagnosed with primary progressive MS (PPMS) and 175,000 with secondary progressive MS (SPMS) in the U.S. and EU5 [7][32] 3. **Unmet Medical Need**: There is a significant unmet need in treating disability progression in MS, with only one approved drug for PPMS and no treatments for non-active SPMS [9][10] 4. **Mechanism of Action**: Beta-flutamious calcium is a first-in-class drug that activates NUR1 for neuroprotection and inhibits DHODH to reduce inflammation [6][38] 5. **Study Design**: The trial included 467 patients, focusing on those without recent relapse events, and aimed to assess the drug's neuroprotective effects [17][12] 6. **Results on Disability Worsening**: The trial showed a 20% decrease in confirmed disability worsening events at 24 weeks for beta-flutamious calcium compared to placebo, with a 30% reduction in PPMS patients and 15% in non-active SPMS patients [21][22] 7. **Safety Profile**: No new safety signals were identified, and treatment-emergent adverse events were similar between treatment and placebo groups [29][30] 8. **Market Opportunity**: The global market for primary progressive MS therapies is estimated at $6 billion, with significant potential for beta-flutamious calcium to capture market share due to its unique profile [36][39] 9. **Future Steps**: Discussions with healthcare authorities will determine the next steps for further development and potential approval pathways, including a Phase III trial focusing on PPMS [41][42] Additional Important Insights 1. **Comparison with Existing Treatments**: Current treatments like ocrelizumab have limitations, including safety concerns and administration difficulties, highlighting the need for a more convenient and safer option [34][35] 2. **Potential for Breakthrough Designation**: The company is considering applying for breakthrough designation based on the promising results from the CALIBER trial [42][96] 3. **Long-term Vision**: The company aims to establish beta-flutamious calcium as a cornerstone treatment for both relapsing and progressive forms of MS, with projected peak sales ranging from $3 billion to $7 billion [39][38] 4. **Regulatory Considerations**: The company is preparing for discussions with regulators to ensure the design of the Phase III trial meets approval requirements [62][96] This summary encapsulates the critical findings and strategic implications from the conference call regarding the CALIBER trial results and the future of beta-flutamious calcium in the MS treatment landscape.

Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in IMUX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...

Core Viewpoint - Immunic, Inc. has successfully closed a registered direct offering of 5,666,667 shares of common stock at a price of $0.90 per share, raising approximately $5.1 million in gross proceeds to fund clinical trials and operations [1][2]. Group 1: Offering Details - The offering was led by Aberdeen Investments and closed on April 10, 2025 [1]. - The gross proceeds from the offering were approximately $5.1 million before deducting commissions and offering expenses [2]. - Titan Partners Group acted as the sole placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund clinical trials, operations, and other general corporate purposes [2]. Group 3: Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [5]. - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for multiple sclerosis and has shown therapeutic activity in earlier trials [5]. - Other development programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, which is in preclinical testing [5].

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...