Immunic AG
Immunic, Inc. Files Financial Statements and Pro Forma Financial Information in Accordance with Previously Completed Stock-for-Stock Exchange Transaction and Provides Corporate Update
DGAP-News: Immunic, Inc. / Key word(s): Miscellaneous Immunic, Inc. Files Financial Statements and Pro Forma Financial Information in Accordance with Previously Completed Stock-for-Stock Exchange Transaction and Provides Corporate Update SAN DIEGO, June 21, 2019 – Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that it has filed an amended Current Report on Form 8-K containing certain financial statements and pro forma financial information required to be provided in connection with the stock-for-stock exchange transaction between Immunic, Inc. (then known as Vital Therapies, Inc.) and Immunic AG, which was completed on April 12, 2019. Management also provided an update on the progress of its key development programs. The amended Current Report on Form 8-K contains the audited consolidated financial statements of Immunic AG as of and for the years ended December 31, 2018 and December 31, 2017, and the unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2019 and the corresponding period of the preceding fiscal year. The filing also includes pro forma combined financial information of Immunic AG and Vital Therapies, Inc. Clinical Development Progressing Well – Although all ongoing phase 2 trials with IMU-838 remain blinded, the observed safety results from these trials are consistent with the previously defined reference safety information and no new safety signals have been observed to date. – Patient recruitment for the company’s phase 2, international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial of IMU-838, in development for the treatment of relapsing-remitting multiple sclerosis (EMPhASIS), is progressing faster than anticipated and is expected to be completed in the first half of 2020. Top-line data is anticipated to be available during the third quarter of 2020. – Patient recruitment for the phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study of IMU-838 in patients with moderate-to-severe ulcerative colitis (CALDOSE-1) was updated based on current recruitment rates and the anticipated impact of supportive measures. Study enrollment is projected to conclude during the second half of 2020. Top-line data is expected to be available in the first quarter of 2021. – Initiation of the phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial of IMU-838 for the treatment of active Crohn’s disease (CALDOSE-2) is expected to occur during the second half of 2019, as per previous guidance. All preparations are in the advanced stage in anticipation of the interim dosing analysis of CALDOSE-1 in the third quarter of 2019, which will inform the dose selection for CALDOSE-2. – The investigator-sponsored trial of IMU-838 in patients with primary sclerosing cholangitis, which will be conducted at the Mayo Clinic, is expected to start enrollment soon. – Immunic’s earlier stage programs are on track. The company expects to begin its phase 1 double-blind, placebo-controlled, single and multiple ascending dose trials of IMU-935 during September 2019. Immunic also plans to extend these studies in the first half of 2020 to assess safety and mechanism-related biomarkers in patients with psoriasis. – Immunic has started preclinical regulatory safety studies of IMU-856, a drug candidate targeting the intestinal barrier function. Initiation of phase 1 clinical trials is expected in the first half of 2020. About Immunic, Inc. Cautionary Statement Regarding Forward-Looking Statements Contact Information Or
21.06.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |