Immunic, Inc. (NASDAQ:IMUX) is one of the 11 Best High Volume Penny Stocks to Buy Now. On March 10, 2026, Immunic, Inc. (NASDAQ:IMUX) announced that the European Patent Office granted a key patent covering label-relevant dosing regimens for its lead asset, vidofludimus calcium. The patent is expected to protect Europe through 2038 and may be eligible for a Supplementary Protection Certificate, which could extend exclusivity to as late as 2043. Immunic, Inc. (NASDAQ:IMUX) noted that the claims broadly cov ...

Summary of Immunic Conference Call Company Overview - **Company**: Immunic - **Key Product**: Vidofludimus calcium, a drug in development for treating multiple sclerosis (MS) Industry Context - **Market**: Multiple Sclerosis (MS) treatment landscape, which includes various therapies with differing safety and efficacy profiles Key Points 2026 Outlook - 2026 is expected to be transformative for Immunic with the phase 3 readout of ENSURE-1 and ENSURE-2 studies planned for the end of the year [1] - NDA submission for vidofludimus calcium is planned for the following year [1] Drug Mechanism and Safety Profile - Vidofludimus calcium is designed as a safer and more selective DHODH inhibitor compared to Aubagio, avoiding off-target activities that lead to side effects [3][4] - The drug activates the nuclear receptor Nurr1, providing neuroprotective effects and solid anti-inflammatory activity [3][7] - Safety data indicates that vidofludimus calcium has a favorable liver toxicity profile compared to teriflunomide, with liver enzyme elevations comparable to placebo [10] - The elimination half-life of vidofludimus calcium is approximately 30 hours, allowing for quicker clearance compared to teriflunomide, which has a half-life of 10-19 days [11] Clinical Data and Efficacy - In the EMPhASIS study, vidofludimus calcium showed a 57% lower rate of confirmed disability progression compared to the control group [13] - The CALLIPER study indicated a 31% reduction in confirmed disability worsening in primary progressive MS (PPMS) patients [16] - The primary endpoint for upcoming studies will be time to first relapse, with secondary endpoints including confirmed disability progression and improvement [20] Market Positioning - Vidofludimus calcium aims to capture the oral medication segment, which constitutes 35%-40% of all prescriptions in the U.S. for MS [26] - The drug is positioned to address unmet needs in patients transitioning from CD20 therapies, which have serious infection risks [30] - The company believes that vidofludimus calcium will offer a best-in-class benefit-risk profile, particularly for patients preferring oral administration [27] Future Plans - A confirmatory study for PPMS is expected to start in the second half of the year, with an estimated duration of 3.5-4 years for enrollment and data readout [38] - The company anticipates significant market potential, estimating a multi-billion dollar upside for the PPMS indication [41] Conclusion - Immunic is optimistic about the upcoming data and believes that vidofludimus calcium could provide a new treatment option for individuals living with MS, addressing both relapsing and progressive forms of the disease [40][41]

Summary of Immunic's Conference Call Company Overview - **Company**: Immunic - **Product**: Vidofludimus calcium - **Focus**: Treatment for multiple sclerosis (MS) Key Points Unique Mechanism of Action - Vidofludimus calcium activates Nurr1, a nuclear receptor involved in neuroprotection, which differentiates it from other MS treatments [4][7] - It also acts as a DHODH inhibitor, providing an established anti-inflammatory mechanism [4][7] Clinical Data and Efficacy - The EMPHASIS study showed: - 76% reduction in cumulative active lesions - 78% reduction in gadolinium-enhancing lesions [20] - A numerical reduction of disability progression (CDW) by over 50% in the phase 2 study [14] - Safety and tolerability were comparable to placebo, indicating a favorable profile [21] Comparison with Other Treatments - Current oral therapies show efficacy rates of 30%-50% for glatiramer acetate and Aubagio, while anti-CD20 therapies show 80%-90% [22][24] - Vidofludimus calcium aims to provide a better benefit-risk profile, especially for patients who cannot tolerate existing therapies [43] Market Opportunity - The oral therapy market represents 35%-40% of total prescriptions for MS [77] - An estimated 5%-10% of patients on anti-CD20 therapies may need to switch due to serious infections, representing a potential $1 billion market in the U.S. alone [80][81] - The average cost of branded oral therapies is projected to be around $120,000 WAC at launch [85] Phase 3 Studies - The ENSURE studies for relapsing MS are fully enrolled, with primary endpoints focused on time to first relapse and secondary endpoints including MRI biomarkers and disability progression [57][58] - Expected readout for the studies is at the end of the year [62] Progressive MS Treatment - Immunic is also targeting primary progressive MS (PPMS) with a phase 2 study showing a 31% reduction in disability progression [112][113] - The potential market for PPMS is significant, with Roche's Ocrevus generating over $3 billion in sales from this segment [151] Safety Profile - Vidofludimus calcium has shown a clean safety profile with low rates of adverse events compared to existing therapies [46][48] - No significant liver enzyme changes were observed, differentiating it from other DHODH inhibitors [54] Future Outlook - Immunic plans to initiate pivotal studies for PPMS, with expectations of replicating positive data from previous studies [155] - The company believes it has a differentiated asset that could capture significant market share in both relapsing and progressive MS [161] Conclusion - Immunic is positioned to address unmet needs in the MS market with vidofludimus calcium, focusing on both relapsing and progressive forms of the disease, while emphasizing safety and tolerability as key differentiators [161]

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 into 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]

Core Insights - Immunic, Inc. has received a key European patent for vidofludimus calcium, which protects relevant dosing regimens across all indications, including multiple sclerosis [1] - The patent is expected to provide protection in Europe until 2038, with potential extensions through a Supplementary Protection Certificate (SPC) possibly extending exclusivity to 2043 [1] - The company has a multi-layered intellectual property strategy that includes various patents covering composition-of-matter, treatment methods, and dosing regimens, ensuring robust protection for vidofludimus calcium [1] Company Overview - Immunic, Inc. is a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases [1] - The lead asset, 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 [1] - Vidofludimus calcium has shown therapeutic activity in previous clinical trials, demonstrating significant reductions in brain lesions and disability progression in multiple sclerosis patients [1] Intellectual Property Strategy - The newly granted European patent (EP3713554) covers all forms of vidofludimus, including salts and solvates, and is designed to be difficult to design around [1] - Existing patents in the United States provide protection for vidofludimus calcium until at least 2041, with additional pending applications that could extend protection into 2044 and 2045 [1] - The company is actively working to expand its patent portfolio to maximize long-term exclusivity following potential regulatory approval [1]

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 has a presence in key finance and investing hubs with offices in London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company utilizes technology to enhance workflows and has a forward-looking approach to technology adoption [4] - Proactive employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Immunic, Inc. is participating in multiple investor conferences in March 2026, including the Leerink Partners Global Healthcare Conference and the Stifel 2026 Virtual CNS Forum, where key executives will engage in discussions and one-on-one meetings with investors [1] Company Overview - Immunic, Inc. is a late-stage biotechnology company focused on developing novel oral therapies for neurologic and gastrointestinal diseases [1] - The company's lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for treating relapsing multiple sclerosis, with top-line data expected by the end of 2026 [1] - Vidofludimus calcium has demonstrated therapeutic activity in phase 2 trials for various forms of multiple sclerosis and other diseases [1] - The company is also developing IMU-856, which targets Sirtuin 6 (SIRT6) to restore intestinal barrier function, potentially applicable in several gastrointestinal diseases [1] - Additionally, IMU-381 consists of next-generation molecules in preclinical testing for neurologic, gastrointestinal, and other autoimmune diseases [1]

Core Viewpoint - Immunic Inc has secured up to $400 million in private placement financing to support late-stage trials and prepare for the potential commercial launch of vidofludimus calcium for multiple sclerosis [1][2]. Financing Details - The financing is described as a transformative transaction, with $200 million already received and the remainder available in a second tranche [2][4]. - This capital provides the necessary flexibility for the company to transition into a commercial-stage organization as it approaches a pivotal data milestone [2][4]. Clinical Trials and Milestones - The primary near-term catalyst is the Phase 3 ENSURE program in relapsing multiple sclerosis (RMS), which includes two twin studies [3][6]. - An interim analysis in 2024 led to a recommendation from the Independent Data Monitoring Committee to continue the trials as planned [3][6]. - Topline data from the four-year, 2,200-patient program is expected by the end of the year [3][6]. Future Plans - The financing will cover the completion of the Phase 3 studies in relapsing MS and the preparation for a New Drug Application (NDA) submission in mid-next year [5]. - The company also plans to initiate a Phase 3 study in primary progressive MS, addressing a significant unmet medical need [5].

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 content delivered includes insights across various 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 being a forward-looking technology adopter, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

Financial Position - Immunic has an accumulated deficit of approximately $608.6 million as of December 31, 2025, and $511.4 million as of December 31, 2024, primarily due to research and development expenses[30]. - As of December 31, 2025, the company had cash and cash equivalents of approximately $15.5 million[32]. - The company incurred net losses of $97.2 million and $100.5 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $608.6 million as of December 31, 2025[191]. - The company has no product sales revenue and may never generate product revenue[188]. - The company expects to continue incurring significant expenses and increasing operating losses, with potential fluctuations in net losses from quarter to quarter and year to year[195]. - The company may need to seek additional funding sooner than planned, which could lead to dilution of existing stockholders' interests[201]. - The company has incurred significant operating losses, using net cash of $85.8 million and $84.8 million in operating activities for the years ended December 31, 2025, and December 31, 2024, respectively, primarily related to the development of current product candidates[200]. 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[19]. - The Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) showed substantial reductions in 24-week confirmed disability progression and improvement in disability[21]. - The ongoing development programs include the execution of the IMU-856 program and further preclinical research for additional indications[34]. - The company completed enrollment for both Phase 3 ENSURE trials, with a total of 2,221 patients randomized to receive either 30 mg daily doses of vidofludimus calcium or placebo[59]. - The CALLIPER trial completed enrollment in August 2023, with 467 patients enrolled across more than 70 sites, randomized to either 45 mg daily doses of vidofludimus calcium or placebo[118]. - The Phase 2 EMPhASIS trial demonstrated a statistically significant reduction in cumulative unique active MRI lesions by 62% (p=0.0002) for the 45 mg dose and 70% (p<0.0001) for the 30 mg dose of vidofludimus calcium compared to placebo[104]. - The company has conducted regulatory interactions with health authorities, including the FDA, to discuss potential next steps for vidofludimus calcium in PMS populations[123]. - The company is preparing for further clinical testing of IMU-856, contingent on financing, licensing, or partnering[153]. Product Development and Pipeline - Vidofludimus calcium is being developed as a treatment for multiple sclerosis (MS) and has shown potential neuroprotective and anti-inflammatory effects[78]. - IMU-856 demonstrated positive effects in a Phase 1b clinical trial for celiac disease, including protection of gut architecture and improvement of symptoms[24]. - The company is focused on developing new molecules that address biologically relevant immunological targets to elevate the standard of care for patients[29]. - The rights to IMU-856 were secured through an option and license agreement with Daiichi Sankyo, which includes future milestone payments and royalties[76]. - The company aims to develop vidofludimus calcium as a disease-modifying therapy for MS, addressing unmet medical needs particularly in progressive forms of the disease[93]. - IMU-856 is being developed as a treatment for gastrointestinal diseases, targeting the restoration of intestinal barrier function[136]. Regulatory and Compliance - The company has agreed to a reverse stock split of its Common Stock at a ratio of not less than 10:1, with a preliminary proxy statement filed on February 20, 2026[42]. - The common stock was transferred to the Nasdaq Capital Market on January 7, 2026, after not complying with Nasdaq Listing Rule 5450(a)(1)[73]. - The Company has until June 22, 2026, to regain compliance with the Bid Price Rule, requiring a minimum bid price of at least $1.00 for 10 consecutive business days[74]. - The FDA's goal for acting on the submission of a New Drug Application (NDA) for a new molecular entity is ten months from the date of filing, extending to twelve months with preliminary reviews[174]. - Regulatory requirements for drug approval vary widely across countries, potentially delaying or preventing the introduction of product candidates into relevant markets[209]. Market and Strategic Position - The company plans to evaluate potential strategic collaborations to enhance the commercialization of its product candidates[34]. - The company is in search of a new CEO with commercial expertise in the MS space to lead the next stage of growth[50]. - The company has identified a high medical need for new therapies in non-active secondary progressive MS (SPMS) patients, where current treatments are ineffective[96]. - The complexity of manufacturing development and validation may affect product quality and compliance[212]. Risks and Challenges - The company faces numerous risks and uncertainties in clinical product development, including the potential failure to demonstrate safety and efficacy for its product candidates[207]. - Clinical drug development is lengthy and expensive, with uncertain outcomes[213]. - Unsuccessful clinical trials could materially adversely affect the company's business and financial condition[213]. - Delays in clinical development or manufacturing readiness may postpone or prevent regulatory approval[212]. - Favorable clinical results do not guarantee successful approval due to potential manufacturing challenges[212].