Zenas BioPharma, Inc. SEC 10-Q Report
Nov 12, 2025, 07:23 GMT-52 min read
 ZBIO+0.45%
Zenas BioPharma, Inc., a biopharmaceutical company focused on developing innovative therapies for autoimmune diseases, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business developments for the nine months ended September 30, 2025.
Financial Highlights
Total Revenue: $10 million, recognized for the nine months ended September 30, 2025, attributed to a license agreement.
Loss from Operations: $(145.073) million for the nine months ended September 30, 2025, reflecting increased operating expenses.
Net Loss to Common Stockholders: $(137.295) million for the nine months ended September 30, 2025, compared to $(104.384) million for the same period in 2024, indicating a widening loss.
Net Loss Per Share: $(3.27) for the nine months ended September 30, 2025, compared to $(28.83) for the same period in 2024, reflecting an increase in weighted-average shares outstanding.
Weighted-Average Common Stock Outstanding - Basic and Diluted: 41,943,160 shares for the nine months ended September 30, 2025, showing an increase from the prior year due to the IPO and other equity issuances.
Business Highlights
Obexelimab Development: The company is advancing obexelimab as a potential immunology and inflammation (I&I) franchise for several autoimmune diseases. Key trials include the INDIGO Phase 3 trial for IgG4-RD, the SunStone Phase 2 trial for systemic lupus erythematosus (SLE), and the MoonStone Phase 2 trial for relapsing multiple sclerosis (RMS).
MoonStone Trial Results: Topline data from the MoonStone trial showed that obexelimab met the primary endpoint, demonstrating a statistically significant 95% relative reduction in new gadolinium-enhancing T1 hyperintense lesions over weeks 8 and 12 compared to placebo.
Future Clinical Milestones: The company expects to report 24-week data from the MoonStone trial in Q1 2026, topline results from the INDIGO trial around year-end 2025, and topline results from the SunStone trial in mid-2026.
InnoCare License Agreement: In October 2025, the company entered into a license agreement with InnoCare Pharma Inc. for exclusive rights to develop, manufacture, and commercialize orelabrutinib for multiple sclerosis and other non-oncology indications, as well as two early-development product candidates, ZB021 and ZB022.
Orelabrutinib Phase 3 Trial: A Phase 3 trial for orelabrutinib in patients with Primary Progressive Multiple Sclerosis (PPMS) was initiated in September 2025. A second Phase 3 trial for Secondary Progressive Multiple Sclerosis (SPMS) is planned for Q1 2026.
ZB021 and ZB022 Development: The company plans to submit IND applications for ZB021 and ZB022 in 2026, with Phase 1 clinical studies to follow, subject to the results of IND-enabling studies.
Regional Program Developments: The company has sublicensed ZB001 and related programs to a partner in China, with potential milestone payments and royalties structured in the agreement.
IPO and PIPE Financing: The company completed its IPO in September 2024, raising $234.3 million in net proceeds. In October 2025, a PIPE transaction raised approximately $120.0 million, providing additional capital for operations.
Royalty Purchase Agreement: In September 2025, the company entered into a Royalty Purchase Agreement with Royalty Pharma, securing a $75.0 million upfront payment in exchange for a percentage of future net sales and royalty income from obexelimab products.
Operational Outlook: The company anticipates continued operating losses and negative cash flows as it advances its clinical programs and expands its pipeline. Existing cash, cash equivalents, and investments, along with PIPE proceeds, are expected to fund operations into Q4 2026.
SEC Filing: Zenas BioPharma, Inc. [ ZBIO ] - 10-Q - Nov. 12, 2025 |
