Zenas BioPharma Announces Key 2024 Accomplishments and 2025 Business Objectives to Support the Global Development and Commercialization of Therapies for Autoimmune Diseases

Core Insights - Zenas BioPharma is advancing its clinical trials for obexelimab, a CD-19 x FcγRIIb inhibitor, with significant milestones expected in 2025 [1][2][5] Group 1: Clinical Trials and Milestones - Topline results from the Phase 2 trial (MoonStone) in Relapsing Multiple Sclerosis (RMS) are anticipated in Q3 2025 [1][6] - The pivotal Phase 3 trial (INDIGO) in Immunoglobulin G4-Related Disease (IgG4-RD) is expected to report results by the end of 2025 [1][7] - Enrollment for the Phase 2 trial (SunStone) in Systemic Lupus Erythematosus (SLE) is projected to be completed in 2025 [1][12] Group 2: Financial Position - As of December 31, 2024, the company reported approximately $350 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into Q4 2026 [2][3] Group 3: Recent Achievements - In 2024, Zenas completed enrollment for the Phase 3 INDIGO trial, initiated the Phase 2 MoonStone and SunStone trials, and provided initial data from the Phase 2 SApHiAre trial [3][4] - The company raised approximately$458.7 million through an upsized Series C and initial public offering to support its activities [3][4] Group 4: Mechanism of Action - Obexelimab is designed to inhibit B cell activity without depleting them, which may provide therapeutic benefits for various autoimmune diseases [5][11][16] - The drug has shown clinical proof of concept in previous trials, demonstrating safety and activity in patients [5][11] Group 5: Market Need and Competition - There are currently no approved therapies for IgG4-RD, indicating a high unmet medical need in this area [8][10] - The pathogenesis of IgG4-RD suggests that B cell-targeted therapies like obexelimab may offer significant benefits compared to existing treatments [10][11]