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Immunic, Inc. Reports Third Quarter 2021 Financial Results and Highlights Recent Activity

- Fully Enrolled Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis - - Initiated Phase 2 CALLIPER Trial in Progressive Multiple

articleImmunic, Inc.November 4, 20214/company/immunic-inc/news/immunic-inc-reports-third-quarter-2021-financial-results-and-highlights-recent-activity
Immunic, Inc. Reports Third Quarter 2021 Financial Results and Highlights Recent Activity

About this update from Immunic, Inc.

[{"type":"text","content":"- Fully Enrolled Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis -\n - Initiated Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis, Intended to Run Concurrently With and to Complement the Company's Phase 3 ENSURE Program in Relapsing Multiple Sclerosis -\n - $110.4 Million in Cash and Cash Equivalents as of September 30, 2021 Expected to Fund Immunic Into 2023 -\n - Webcast to be Held Today, November 4, 2021, at 8:00 am ET -\n\n\nNEW YORK, Nov. 4, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced financial results for the third quarter ended September 30, 2021 and highlighted recent activity.\n\"During the quarter, we continued to make extraordinary progress advancing multiple programs through the clinic, including our selective oral DHODH inhibitor, IMU-838, as well as IMU-935, a highly potent and selective oral IL-17 inhibitor, setting the stage for an exciting year ahead with several upcoming value creating data readouts,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"Major milestones achieved in lead program, IMU-838, included enrollment of the final patient in our phase 2 CALDOSE-1 trial of IMU-838 in patients with moderate-to-severe ulcerative colitis (UC), for which we expect top-line data to be available in the first half of 2022, and enrollment of the first patients in our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS).\"\n\"We also made significant headway in the development of our second key asset, IMU-935, and expect unblinded safety, pharmacodynamic and pharmacokinetic data from the healthy volunteer portions of our ongoing phase 1 trial to be available in the fourth quarter of this year. We also initiated the patient part of the phase 1 trial in moderate-to-severe psoriasis and anticipate initial data from this patient population during the second quarter of 2022. Additionally, at our virtual R&D Day in July, we presented compelling new preclinical data highlighting the therapeutic potential of IMU-935 to affect metastatic castration resistant prostate cancer (mCRPC). We expect to initiate an open-label phase 1 dose escalation trial in mCRPC during...

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