Immunic(IMUX) Proactiveinvestors NA·2025-01-11 14:22Core Insights - Immunic Inc is advancing its novel therapy vidofludimus calcium, with significant milestones achieved in 2024, including a positive interim analysis of the ENSURE trials for relapsing multiple sclerosis and anticipation of results from the CALLIPER progressive MS study in April 2025 [1][5][7] Company Overview - Immunic is focused on a differentiated pipeline, strong leadership, and patient-centric priorities, with vidofludimus calcium having the potential to transform the multiple sclerosis treatment landscape [4] - The company has also been working on its second clinical program, IMU-856, targeting Sirtuin 6 for gastrointestinal conditions [2][4] Recent Developments - In 2024, Immunic achieved a positive interim analysis in its Phase 3 ENSURE program for relapsing forms of multiple sclerosis, with the independent data monitoring committee recommending the continuation of trials [5][6] - The company has expanded its scientific and medical presence through publications and presentations, enhancing visibility in the multiple sclerosis space [6] Financial Position - Immunic secured a three-tranche private placement totaling $240 million, which strengthens its financial base for ongoing and future projects [6] Future Outlook - 2025 is expected to be pivotal for Immunic, with the CALLIPER study's top-line results anticipated in April, focusing on vidofludimus calcium in progressive multiple sclerosis [7] - The company will continue advancing the ENSURE 1 and ENSURE 2 Phase 3 trials for relapsing multiple sclerosis, with enrollment progressing well [7] Product Differentiation - Vidofludimus calcium features a dual mechanism that addresses both neuroinflammation and neurodegeneration, making it suitable for both relapsing and progressive MS [8] - It is a selective DHODH inhibitor with proven anti-inflammatory effects and neuroprotective properties, showing strong results in interim analyses, including reductions in neural filament light levels, a biomarker for neurodegeneration [9] - Unlike other oral therapies, vidofludimus calcium has no black box warnings, indicating a favorable safety profile, and could potentially be the first oral therapy approved for both relapsing and progressive MS [9]