Company Announcements

Immunic to Host Multiple Sclerosis R&D Day and Participate in Scientific and Investor Conferences in September

NEW YORK, August 28, 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 that the company will host a Multiple Sclerosis (MS) Research and Development (R&D) Day and participate in the following scientific and investor conferences in September:

• September 10: Immunic’s MS R&D Day. Management of Immunic, including Daniel Vitt, Ph.D., Chief Executive Officer; Jason Tardio, M.B.A., Chief Operating Officer and President; Andreas Muehler, M.D., M.B.A., Chief Medical Officer; and Hella Kohlhof, Ph.D., Chief Scientific Officer, will be joined by two of the MS industry’s renowned experts to discuss the MS landscape as well as Immunic’s orally available lead-asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) and its potential to become the treatment of choice for both relapsing and progressive MS patients.
  • Date: Tuesday, September 10, 2024
  • Time: 10:30 am to 12:30 pm ET, followed by a networking lunch
  • Location: One Five One, 151 West 42nd Street, New York, NY 10036
  • Featured Experts:
    • Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University Hospital San Luigi Gonzaga of Orbassano, Turin, Italy
    • Amit Bar-Or, M.D., FRCPC, Melissa and Paul Anderson Distinguished Chair, Director, Center for Neuroinflammation and Experimental Therapeutics, Chief, Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine, University of Pennsylvania
  • To register, please RSVP by sending an email to: ir@imux.com.

• September 18-20: 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Members of Immunic’s management, medical, clinical and preclinical teams will attend this conference in Copenhagen, Denmark. Data on vidofludimus calcium will be presented in an oral presentation and three ePosters. Additionally, the team will be available throughout the event at booth #60. All poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.
• Oral Poster Presentation:
  • Title: Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis
  • Presenting Author: Robert J. Fox, Staff Neurologist, Mellon Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio
  • Poster Number: P753
  • Session Title: Poster Session 2
  • Session Date: Thursday, September 19, 2024
  • Session Time: 4:45 pm – 6:45 pm CEST
• ePosters:
  • Title: Exploring the Potential of Vidofludimus Calcium to Reduce Fatigue in Multiple Sclerosis by Preventing Epstein-Barr Virus Reactivation
  • ePoster Number: P1119
  • Title: Vidofludimus Calcium Activity on NURR1 in Preclinical Models: A Potential Neuroprotective Function in Multiple Sclerosis
  • ePoster Number: P1410
  • Title: Vidofludimus Calcium Shows T Helper Cell Modulatory Effects in Murine Experimental Autoimmune Encephalomyelitis: One of the Potential Mode of Action Pathways for MS Treatment
  • ePoster Number: P1390

• September 2-4: DMDG 50^th Open Meeting 2024. Juliano R. Fonseca, Ph.D., Head of Preclinical Development at Immunic, will present data from Immunic’s phase 1, open-label mass balance and pharmacokinetics study of vidofludimus calcium in a poster presentation at this meeting in York, United Kingdom.
  • Title: Mass Balance and ADME Properties of [¹⁴C]-IMU-838 Following Oral Administration to Healthy Male Subjects
  • The presentation and specific details regarding poster number and session will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations, once they are available.

• September 5-7: 20^th International Celiac Disease Symposium ICDS. Martina Wirth, Senior Manager Translational Pharmacology at Immunic, will present data from Immunic’s phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator targeting SIRT6 (Sirtuin 6), in patients with celiac disease, in a late-breaking poster presentation at this symposium in Sheffield, United Kingdom.
  • Title: First-In-Human Trial of IMU-856, an Orally Available Epigenetic Modulator of Barrier Function and Regeneration for the Treatment of Celiac Disease
  • The presentation and specific details regarding poster number and session will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations, once they are available.
• September 17-19: 2024 Cantor Fitzgerald Global Healthcare Conference. Dr. Vitt will participate in a fireside chat at this conference in New York on Wednesday, September 18, 2024, at 3:05 pm ET. A webcast of the presentation will be available on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of 90 days after the conference.

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 management’s and employee’s participation in investor and scientific conferences. 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.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

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@ksca.com