0001104659-26-027964
SEC filingZenas BioPharma, Inc. (ZBIO) reported total revenue of $10.0 million for FY 2025, up 100% YoY from $5.0 million in 2024, driven by $10.0 million from the Zai License Agreement upfront payment, compared to $5.0 million from the Tenacia Agreement in 2024. The company posted a net loss of $377.7 million, a significant increase from $157.0 million in 2024, primarily due to $171.7 million in acquired in-process research and development expenses from the InnoCare License Agreement, higher R&D at $168.1 million (up from $139.1 million), and G&A at $53.3 million (up from $29.7 million). Operating expenses totaled $393.1 million. Basic and diluted EPS was -$8 per share on 44.7 million weighted-average shares. Cash used in operations was $172.3 million, with net cash decrease of $209.2 million, ending with $110.6 million in cash equivalents and $232.6 million in short-term investments. Total assets stood at $383.6M, stockholders' equity at $242.1M. Despite positive Phase 3 INDIGO topline for obexelimab in IgG4-RD, substantial losses and cash burn raise going concern doubts; management plans further financing amid BLA submission in Q2 2026.
Zenas BioPharma reported FY 2025 revenue of $10.0M, doubling from $5.0M in 2024, solely from license upfronts: $10.0M Zai License vs $5.0M Tenacia. Net loss widened to $377.7M from $157.0M YoY, driven by $171.7M IPR&D from InnoCare (new in 2025), R&D up to $168.1M (from $139.1M), G&A to $53.3M (from $29.7M). Total op ex $393.1M vs $168.9M. Loss from ops -$383.1M. Other income net $5.2M. EPS basic/diluted -$8 on 44.7M shares. Cash flows: ops -$172.3M, investing -$251.9M (investments net -$216.9M, InnoCare $35.0M), financing +$215.3M (royalty $75.0M, equity $149M net). Balance sheet: assets $383.6M (cash equiv $110.6M, ST inv $232.6M), liabilities $141.5M, equity $242.1M. Going concern doubt noted due to losses and cash needs.
Revenue $10.0M from Zai License upfront (sublicense ZB001 in greater China). Prior year $5.0M from Tenacia novation (ZB005 rights transfer). No product sales; all collaboration-derived. BMS Agreement reimburses INDIGO costs as R&D reduction ($5.5M in 2025). Future: milestones/royalties from BMS ($79.5M dev/reg, $70.0M sales), Tenacia ($86.0M), Zai ($96.0M). No geographic breakdown disclosed.
No gross profit (pre-revenue). Op margin N/A (loss -$383.1M on $10.0M rev). Costs rose: R&D +$28.9M (obexelimab +$10.0M, orelabrutinib $7.2M new, personnel +$15.7M), G&A +$23.6M (personnel +$17.1M, fees +$4.2M), IPR&D $171.7M (InnoCare equity/cash). Royalty interest expense $7.3M new. Tax benefit -$79K.
Op cash -$172.3M (net loss adjusted for $171.7M IPR&D, $26.3M SBC). Investing -$251.9M (inv purchases $417.8M, maturities $200.9M, licenses $35.0M). Financing +$215.3M (royalty $75.0M, Series C pref $178.4M net? Wait, PIPE/ATM $149M net, options/ESPP $4.4M). Net cash decline $209.2M; end cash/restricted $56.9M (but total cash/inv $360.5M per MD&A). Assets $383.6M (curr $351.2M), liab $141.5M (royalty $78.6M), equity $242.1M (APIC $1.01B, deficit -$765.1M). Liquidity ~12 months post-filing.
Plans: obexelimab BLA Q2 2026 (IgG4-RD), EMA MAA H2 2026; SLE Ph2 data Q4 2026, potential Ph3 H1 2027; orelabrutinib Ph3 PPMS ongoing (topline 2030), non-active SPMS Q1 2026 start. Cash sufficient ~12 months; need financing (ATM $96.8M avail, Pharmakon up to $250M). Risks: trial delays, funding, competition, going concern.