Zenas BioPharma Net Loss Widens as Spending Rises

The Tip Desk · November 6, 2026 · 4 min read

The biopharmaceutical company posted a $108.9 million net loss, or $1.65 a share, as it prepared for a potential obexelimab launch after FDA acceptance of its IgG4-RD BLA.

Zenas BioPharma (ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for autoimmune and inflammatory diseases, reported a net loss of $108.9 million for the quarter ended September 30, 2026, compared with a net loss of $51.5 million a year earlier, or $1.65 a share versus $1.22 a share. Weighted-average shares outstanding were 66.1 million.

The company recognized $10.0 million of license and collaboration revenue from a development milestone with Bristol-Myers Squibb, after no revenue in the year-ago quarter.

Research and development expenses were $58.5 million, up from $34.4 million a year earlier. Zenas said the $24.1 million increase was primarily due to higher clinical trial and regulatory costs for orelabrutinib and obexelimab and higher personnel costs, including stock-based compensation from increased headcount. General and administrative expenses were $27.4 million, compared with $13.2 million a year earlier. The company attributed the $14.3 million rise to personnel costs, stock-option modification related to employee transitions, and pre-commercialization headcount.

Acquired in-process research and development expenses were $27.5 million, including $25.0 million for a development milestone under the InnoCare license agreement and $2.5 million for a regulatory milestone with Xencor. A year earlier, acquired IPR&D was $5.0 million, related to a deposit toward a $35.0 million upfront payment under the InnoCare agreement.

Other income (expense), net was $5.5 million of expense, versus $1.1 million of income a year earlier. Zenas said the $6.5 million swing was primarily related to higher interest expense on its royalty obligation, senior secured term loan and convertible senior notes, partly offset by interest income on larger cash balances.

Cash, cash equivalents and investments were $647.1 million as of September 30, 2026, down from $673.9 million as of June 30, 2026. The company said that cash, assuming a potential $75 million milestone from Royalty Pharma and $75 million drawn from the Pharmakon debt facility associated with FDA marketing approval of obexelimab for IgG4-RD, will fund operating expenses and capital expenditure at least through the second quarter of 2029.

The U.S. Food and Drug Administration accepted the company’s Biologics License Application for obexelimab for IgG4-RD in August and assigned a PDUFA target action date of May 27, 2027. The BLA remained under active review. Zenas submitted a Marketing Authorization Application to the European Medicines Agency for IgG4-RD; the EMA validated the application. The company said it plans to submit second-quarter 2026 bioequivalence data between prefilled syringe and single-dose prefilled pen in a supplemental application if the BLA is approved.

Zenas presented additional Phase 3 INDIGO data at the IgG4ward! 6th International Symposium on IgG4-Related Disease, including open-label extension results, reduced glucocorticoid-associated toxicity, and influenza and SARS-CoV-2 vaccine responses after a treatment-free window. Three abstracts were accepted at ACR Convergence 2026, including a late-breaking poster with INDIGO open-label extension data.

Topline results from the global Phase 2 SunStone trial of obexelimab in systemic lupus erythematosus remain expected in the fourth quarter of 2026. Dosing in the Phase 1 trial of ZB021, an oral IL-17AA/AF inhibitor, moved from the single ascending dose portion into the multiple ascending dose portion; initial clinical data are still expected in the fourth quarter of 2026. Zenas said it plans to initiate a proof-of-concept trial after the SAD and MAD study, with data anticipated in 2027.

Orelabrutinib Phase 3 PriMroSe in primary progressive multiple sclerosis and Phase 3 Monarch in non-active secondary progressive multiple sclerosis remained ongoing. The company presented seven posters at MSToronto2026, including 24-week efficacy and safety data and pharmacokinetic analysis from a Phase 2 trial in relapsing-remitting multiple sclerosis.

In October, Zenas appointed Jerald Korn as Chief Legal and Strategy Officer, where he will oversee legal, compliance, government affairs, business development, alliance management, and international business initiatives. Founder and Chief Executive Officer Lonnie Moulder said the company remained focused on commercial readiness ahead of a potential launch.