– Management Provides Update on Timing of Data for IMU-838 in Primary Sclerosing Cholangitis –
NEW YORK, January 5, 2021 – Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced management’s participation in the following investor conferences in January:
- January 11-14: H.C. Wainwright BioConnect 2021 Conference. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will present a company overview at the conference. Beginning January 11, at 6:00 am ET, the presentation will be available on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations for a period of 90 days after the conference.
- January 11-14: 39th Annual J.P Morgan Healthcare Conference. Glenn Whaley, Vice President Finance, Principal Financial and Accounting Officer of Immunic, will attend the conference.
Management will be hosting virtual one-on-one investor meetings during the conferences. To schedule a meeting, please contact: Jessica Breu at email@example.com.
Management also provided an update on the phase 2, investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis (PSC), being conducted at the Mayo Clinic. The single-arm, open label, exploratory study, for which Immunic is providing the study medication, planned to enroll 30 patients with PSC, aged 18 to 75 years, who receive 30 mg of IMU-838 once daily for a period of six months. Together with the investigators, Immunic determined to readout data from the 18 patients who were enrolled prior to the COVID-19 pandemic, as patients with PSC are considered high risk for COVID-19 infections and are advised to avoid the unnecessary social contacts required in a clinical trial. Immunic currently expects the data to be available during the first quarter of 2021, instead of in the fourth quarter of 2020, as previously announced. This delay is due to the COVID-19 pandemic and its impact on those clinical sites conducting the trial.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic announced positive results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn’s disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. 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, 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 participation in investor 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 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, 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 resources to meet business objectives and operational requirements, the fact that the results of earlier studies and 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, 2019, filed with the SEC on March 16, 2020, the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 6, 2020, 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.
Head of Investor Relations and Communications
+49 89 2080 477 09
US IR Contact
Rx Communications Group
+1 917 322 2571
US Media Contact
+1 781 639 1910