Business
Immunic, Inc. Reports Year End 2022 Financial Results and Provides Corporate Update
– Initial Results From Ongoing Part C of Phase 1 Clinical Trial of IMU-856 in Celiac Disease Expected Mid-2023 – – Interim Results From Phase 2 CALLIPER Trial
About this update from Immunic, Inc.
[{"type":"text","content":"– Initial Results From Ongoing Part C of Phase 1 Clinical Trial of IMU-856 in Celiac Disease Expected Mid-2023 –\n– Interim Results From Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in the Second Half of 2023 –\n– $116.4 Million in Cash, Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 –\n– Webcast to be Held Today, February 23, 2023, at 8:00 am ET –\nNEW YORK, Feb. 23, 2023 /PRNewswire/ -- 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 financial results for the year ended December 31, 2022, and provided a corporate update.\n\"We made significant progress throughout the year in advancing our lead asset, vidofludimus calcium, for the treatment of multiple sclerosis (MS). Our next MS-related data inflection point, expected in the second half of 2023, is an interim analysis of our phase 2 CALLIPER trial in progressive MS, which will provide selected biomarker data to guide study progress,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"As previously announced, the CALLIPER trial is designed to corroborate the neuroprotective potential of vidofludimus calcium, which, if confirmed, would provide an additional key differentiator for the drug in the MS market. Furthermore, we look forward to reporting data from the interim analysis of the phase 3 ENSURE program late next year and to read-out the first of our identical, twin phase 3 ENSURE trials in relapsing MS at the end of 2025. Considering the promising clinical activity observed, thus far, along with vidofludimus calcium's established safety and tolerability profile, we believe that the design of the ENSURE program gives us a straightforward path toward potential regulatory approval in relapsing MS. Vidofludimus calcium has the potential to be a unique treatment option targeted to the biology of MS, differentiated by its combined anti-inflammatory, antiviral and neuroprotective effects.\"\n\"Our second clinical asset, IMU-935, recently received the proposed International Nonproprietary Name (INN), izumerogant, from the World Health Organization. We plan to provide further updates and guidance on potential next step...