(RTTNews) - Zenas BioPharma, Inc. (ZBIO), a clinical-stage biopharmaceutical company, announced financial results for the second quarter, highlighting a wider loss than a year ago, driven by higher operating expenses and other net expenses.
The biotech company has provided several pipeline and corporate updates for the second quarter.
Company Profile
Zenas is focused on developing therapies for autoimmune and immune-mediated diseases. Its lead candidate, obexelimab, is being developed for IgG4-related disease, systemic lupus erythematosus and relapsing multiple sclerosis. The pipeline also includes orelabrutinib, an oral CNS-penetrant BTK inhibitor being evaluated in progressive multiple sclerosis, as well as earlier-stage programs targeting IL-17, TYK2 and B-cell pathways.
Clinical Update
Obexelimab, a CD19 and FcyRIIb inhibitor of B cell function
• The U.S FDA has accepted the Biologics License Application (BLA) for obexelimab in the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) and has set a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027. The company also expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.
• In August, Bristol Myers Squibb submitted a MAA for obexelimab in the treatment of IgG4-RD to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
• Zenas anticipates topline readout from the Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) in the fourth quarter of 2026.
• New clinical study confirmed bioequivalence between obexelimab delivered via prefilled syringe and single-dose prefilled pen. The company expects to submit a supplemental BLA for obexelimab's IgG4-RD. If approved, the company plans to include the bioequivalence data in a European MAA submission in the second half of 2026.
• Additionally, obexelimab met the primary endpoint in the Phase 3 INDIGO registrational trial for the treatment of IgG4-RD.
ZB021, an IL-17AA/AF inhibitor
Dosing is ongoing in the single-ascending-dose (SAD) and multiple-ascending-dose (MAD) Phase 1 trial of ZB021 in healthy volunteers. The trial is being conducted in partnership with InnoCare Pharma in China, with data expected by year-end 2026.
Following completion and evaluation of the trial, Zenas plans to initiate a proof-of-concept (POC) trial in North America in psoriasis patients, with results anticipated in 2027. Orelabrutinib, a CNS-penetrant Bruton's Tyrosine Kinase (BTK) inhibitor
Two Phase 3 trials are ongoing: the PriMrose trial for Progressive Multiple Sclerosis (PPMS) and Monarch trial for non-active Secondary Progressive Multiple Sclerosis (naSPMS).
Early development programs
Zenas plans to initiate two Phase 1 trial in 2027 - ZB022, an oral, brain-penetrant, TYK2-JH2 inhibitor and ZB014, a half-life extended, anti-CD19 and Fc?RIIb monoclonal antibody (mAb), subject to the Investigational New Drug (IND) enabling study results.
Second Quarter Financial Highlights
For the second quarter ended June 30, 2026, loss was $111.46 million, or $1.77 per share, wider than loss of $52.22 million, or $1.25 per share in the previous year.
Total operating expenses significantly jumped to $108.66 million for the quarter, from $55.16 million a year earlier, primarily due to higher Research and Development or R&D expenditures and one-time expenses associated with acquired in-process research and development.
R&D expenses were $62.91 million for the second quarter of 2026, compared to $43.03 million for the same period in 2025. The increase was primarily due to higher clinical trial and regulatory costs and increased personnel-related expenses, including stock-based compensation, associated with increased headcount.
Costs related to acquiring in-process research and development were $30.00 million for Q2 2026, which was absent in the second quarter of 2025. The expense was related to the achievement of a milestone under the Xencor Agreement with completion of the FDA marketing authorization submission, as well as a near-term regulatory milestone under the InnoCare agreement.
Net other expenditures were $3.68 million from a gain of $2.96 million in the prior year, due to royalty obligation, the senior secured term loan and convertible senior notes.
Corporate Update
Jennifer Fox, currently Chief Financial Officer (CFO) and Chief Business Officer, will transition to Strategic Advisor to the Board Chair, effective September 30, 2026.
Joe Farmer, President and Chief Operating Officer, will serve as Principal Financial Officer and Principal Accounting Officer until a new CFO is appointed.
Cash Position
As of June 30, 2026, cash, cash equivalents and investments amounted to $673.89 million.
Financial Guidance
The company expects its current cash runway along with the net proceeds of $48.7 million received in the third quarter of 2026 from sales under its at-the-market (ATM) facility and assuming a potential $75 million milestone from Royalty Pharma and $75 million drawn from the debt facility with Pharmakon associated with achieving FDA marketing approval of obexelimab for IgG4-RD is expected to fund its expenses through the second quarter of 2029.
Stock Quote
Zenas shares have traded between $13.50 and $44.60 over the last year.
ZBIO closed Thursday at $29.20, down 6.68%.
The stock is trading up 1.74% at $29.71.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
