Zenas BioPharma Reports $377.7 Million Net Loss and Operational Progress in 10-K Filing

**Zenas BioPharma Reports Financial Results and Operational Progress in Latest 10-K Filing**

Zenas BioPharma, a clinical-stage biopharmaceutical company, has released its 10-K filing, detailing its financial performance and operational activities. The company, focused on developing immunology-based therapies, reported no revenue from product sales for the fiscal year, as it has no approved products on the market. The company's net loss for the year ended December 31, 2025, was $377.7 million, compared to a net loss of $157.0 million for the previous fiscal year. This increase in net loss is attributed to higher research and development expenses, as well as acquired in-process research and development expenses related to the InnoCare license agreement.

The company's research and development expenses for the year ended December 31, 2025, totaled $168.1 million, up from $139.1 million in the prior year. This increase was primarily driven by the advancement of obexelimab, the company's lead product candidate, and the addition of orelabrutinib to the pipeline. General and administrative expenses also increased to $53.3 million from $29.7 million, reflecting higher personnel costs and professional fees associated with operating as a public company. A significant expense item for the year was the $171.7 million in acquired in-process research and development, stemming from the InnoCare license agreement.

Operationally, Zenas BioPharma highlighted the positive results from the Phase 3 trial of obexelimab in IgG4-related disease, with plans to submit a Biologics License Application (BLA) to the FDA in the second quarter of 2026. The company also reported positive topline data from the Phase 2 trial of obexelimab in relapsing multiple sclerosis (RMS). Zenas is advancing orelabrutinib in a Phase 3 trial for primary progressive multiple sclerosis (PPMS) and plans to initiate a Phase 3 trial for non-active secondary progressive multiple sclerosis (SPMS) in the first quarter of 2026. As of February 28, 2026, the company had 167 full-time employees.

Looking ahead, Zenas BioPharma anticipates continued increases in research and development expenses as it progresses its clinical programs. The company also expects to incur higher general and administrative costs related to operating as a public company. Zenas BioPharma acknowledges that its future success depends on obtaining regulatory approval and successfully commercializing its product candidates. The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern. As of December 31, 2025, Zenas BioPharma had $360.5 million in cash, cash equivalents, and investments. In March 2026, the company entered into a loan agreement with Pharmakon for up to $250 million.