Zenas BioPharma Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Zenas BioPharma reported significant advancements in its clinical trials, particularly with obexelimab, which showed promising results in treating autoimmune diseases [1][2][3] - The company has secured substantial funding to support its clinical development and commercialization efforts, including a $300 million agreement with Royalty Pharma [1][6] - Zenas is expanding its product pipeline with the acquisition of three new autoimmune product candidates, including orelabrutinib, which is in Phase 3 development for multiple sclerosis [1][3][10] Clinical Trial Updates - The Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) is set to report topline results around year-end 2025, marking it as the largest clinical trial for this condition to date [1][3] - The Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis (RMS) demonstrated a 95% relative reduction in new gadolinium-enhancing lesions compared to placebo, with a p-value of 0.0009 [3][4] - Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026 [3] Financial Highlights - As of September 30, 2025, Zenas had cash, cash equivalents, and investments totaling $301.6 million, which, along with recent financing, is expected to fund operations into the fourth quarter of 2026 [7][18] - The company reported a net loss of $51.5 million for the third quarter of 2025, compared to a net loss of $38.6 million for the same period in 2024 [13][17] - Research and development expenses for the quarter were $34.4 million, while general and administrative expenses increased to $13.2 million from $7.5 million year-over-year [7][17] Pipeline Expansion - Zenas has entered into a license agreement for orelabrutinib, a BTK inhibitor, granting global development and commercialization rights outside Greater China and Southeast Asia [3][10] - The company is also advancing two additional product candidates, ZB021 and ZB022, both of which are expected to enter Phase 1 clinical development in 2026 [4][10] Company Overview - Zenas BioPharma is focused on developing transformative therapies for autoimmune diseases, with a strategy that includes acquiring and developing product candidates that offer superior clinical benefits [11] - The company aims to become a leader in the biopharmaceutical industry, leveraging its experienced leadership and disciplined approach to product development [11]