Issuer: Immunic, Inc.
/ Key word(s): Annual Results
Immunic, Inc. Reports Year End 2023 Financial Results and Provides Corporate Update - Significantly Strengthened Balance Sheet in January 2024 with Execution of Three-Tranche Private Placement of up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025 Based on Initial $80 Million Tranche - - Evidence for Neuroprotective Activity of Vidofludimus Calcium from Phase 2 CALLIPER Interim Analysis, Consistent Across the Entire Progressive Multiple Sclerosis Population and All Subtypes; Top-Line CALLIPER Data Expected in April 2025 - - Phase 3 ENSURE Program in Relapsing Multiple Sclerosis Ongoing - - Expanded Vidofludimus Calcium Patent Portfolio with Additional New Patents Granted; Exclusivity Protection Expected Into 2041 in the United States, Unless Extended Further - - Webcast to be Held Today, February 22, 2024, at 8:00 am ET - NEW YORK, February 22, 2024 - Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update. "Immunic made remarkable progress throughout 2023, and these achievements were punctuated by the successful three-tranche private placement of up to $240 million, which we announced last month. Our ability to execute this transaction, with a group of top-tier, existing and new investors, we believe affirms the enormous value inherent in our two advanced clinical programs" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "During the fourth quarter, we reported an interim biomarker analysis from our phase 2 CALLIPER trial of our lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium. The highly encouraging results demonstrated clear separation from placebo in serum neurofilament light chain (NfL) levels in patients with progressive multiple sclerosis (PMS). Notably, this effect was observed across all subpopulations, including advanced secondary progressive multiple sclerosis (SPMS), which we believe is a segment of very high unmet need in multiple sclerosis (MS). Further, if the top-line CALLIPER data, expected in April 2025, continues to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment option for advanced SPMS. This eagerly anticipated data is fully funded by the first $80 million tranche of our recent financing, which extended our cash runway into the third quarter of 2025. An interim futility analysis for our phase 3 ENSURE program is expected late this year, and the read-out of the first of the ENSURE trials is anticipated in the second quarter of 2026. If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology of MS, based on its combined neuroprotective, anti-inflammatory, and antiviral effects. It is important to note that we continue to build on the multiple layers of patent protection around vidofludimus and its salt and free acid forms. In November, we were granted two fundamental new patents in the United States covering the specific dose strength used in clinical trials for the treatment of relapsing multiple sclerosis (RMS), as well as the dosing regimens associated with the treatment of MS. As a result, our extensive patent portfolio now provides protection into 2041 in the United States, unless extended further." Dr. Vitt continued, "During the fourth quarter, we presented the previously reported positive results from our phase 1b clinical trial of our second key clinical program, IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease, at two prestigious medical conferences. The results demonstrated meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. We believe this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a multitude of gastrointestinal disorders through the regeneration of bowel architecture, rather than the traditional immunomodulatory approaches used in many gastrointestinal indications, today. We are currently preparing for phase 2 testing in ongoing active celiac disease (OACD) and are considering additional clinical applications in other gastrointestinal disorders." Fourth Quarter 2023 and Subsequent Highlights
Anticipated Clinical Milestones
Financial and Operating Results
Webcast Information Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_NCQiFCMpTJ2WEqAc2FnB3A or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. 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; 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, 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 the contents of this press release. Contact Information Immunic, Inc. US IR Contact US Media Contact Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
