Immunic Highlights 2024 Accomplishments and Upcoming Milestones
|
Issuer: Immunic AG
/ Key word(s): Miscellaneous
Immunic Highlights 2024 Accomplishments and Upcoming Milestones – Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April – – Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 – – Strengthened Management Team and Board of Directors with Key Hires – – Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche – NEW YORK, January 7, 2025 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2024 accomplishments and upcoming milestones. “The past year was marked by substantial progress for our orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as we continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the PMS patient population, hinting to potential neuroprotective effects of the drug.” “We also achieved a significant milestone for our phase 3 ENSURE program, having received a positive interim result from an unblinded Independent Data Monitoring Committee (IDMC), which concluded that the trials are not futile and recommended they should continue as planned, without any sample size increase. These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track. The result makes us immensely confident and excited as we await the completion of the twin phase 3 trials: ENSURE-1 remains on track for completion in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026.” Jason Tardio, President and Chief Operating Officer of Immunic, added, “Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium. There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening. Vidofludimus calcium is the only medicine in development that targets activation of Nurr1 for neuroprotection and combines that with selective inhibition of DHODH for anti-inflammatory and antiviral effects. We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease.” Dr. Vitt concluded, “In 2024, we were also honored to have had our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Data from this study showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease, including protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease.” 2024 Corporate Highlights
Vidofludimus Calcium 2024 Highlights and Upcoming Milestones
IMU-856 2024 Highlights and Upcoming Milestones
Immunic's management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 43rd Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2025, in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 immunic@rxir.com US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 ckasunich@kcsa.com
Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
