Business
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 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially
About this update from Immunic, Inc.
[{"type":"text","content":"SAN DIEGO, June 21, 2019 /PRNewswire/ -- 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.\nThe 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.\nClinical Development Progressing Well\nAlthough 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 tria...