Zenas BioPharma, Inc. (ZBIO)

Key figures

The last twelve months reported, with the latest price and balance sheet.

Market value

$1.8B

Cash

$196.6M

Debt

$297.0M

Debt to equity

1.20

Shares outstanding

63.3M

Financial statements

Revenue, profit and cash flow by fiscal year, each year linked to its annual report.

By quarter

What the company said with its results

From the second quarter of 2026 results, filed 13 August 2026.

• Net loss widened to $111.5 million. Net loss was $111.5 million, against $52.2 million a year earlier. Net loss per share was $1.77 on 63,112,314 weighted-average shares.
• Revenue from ZB005 development milestone. Revenue of $1.0 million came from a development milestone under the Tenacia agreement for ZB005. No revenue was recognized in the prior-year quarter.
• Other expense rose on interest costs. Other income (expense), net was $3.7 million of expense, against $3.0 million of income a year earlier, mainly from higher interest expense on the royalty and debt obligations.
• R&D rose to $62.9 million. R&D expense was $62.9 million, against $43.0 million a year earlier, on clinical trial and regulatory costs and higher personnel costs including stock-based compensation.
• G&A rose on personnel costs. G&A expense was $15.7 million, up $3.6 million, mainly from personnel costs tied to pre-commercialization activities and costs of running a public company.
• Acquired IPR&D charge of $30.0 million. Acquired in-process R&D expense of $30.0 million related to a Xencor milestone for the FDA marketing authorization submission and an InnoCare regulatory milestone.
• Phase 3 INDIGO met primary endpoint. INDIGO met its primary endpoint with a 56% reduction in IgG4-RD flare risk versus placebo over the 52-week randomized period (HR 0.44, p=0.0005).
• Week 52 flare-free rates reported. At Week 52, 73.2% of obexelimab-treated patients remained flare-free, against 45.4% on placebo. Grade 3 or higher TEAEs and infections were lower on obexelimab.
• Prefilled pen bioequivalence confirmed. New study data show the single-dose prefilled pen is bioequivalent to the prefilled syringe. Zenas plans a supplemental application if obexelimab is approved.
• Bristol Myers Squibb filed in Japan. BMS, which holds exclusive rights in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia, submitted an MAA to Japan’s PMDA in August.
• SunStone SLE topline due Q4 2026. Topline overall and biomarker population results from the Phase 2 SLE trial are expected in the fourth quarter of 2026.
• ZB021 Phase 1 moved to MAD dosing. ZB021 Phase 1 dosing in healthy volunteers continues, now including the multiple ascending dose part after the single ascending dose part.
• Orelabrutinib MS trials and abstracts. Phase 3 PriMroSe (PPMS) and Monarch (naSPMS) trials are ongoing. Four orelabrutinib abstracts were accepted for MSToronto 2026.
• ZB014 once-monthly antibody in IND studies. ZB014, a half-life extended anti-CD19 antibody, remains in IND-enabling studies. Management cites potential once-monthly dosing with obexelimab-like activity.

Company events

The newest 8-K filings of 20 held.

Every filing

The newest filings with the SEC of 70 held.

Insider trades

Form 4 trades by officers, directors and 10% owners, last 12 months.

Planned insider sales

Form 144 notices, filed when the sell order goes to the broker.

Large holders

Schedule 13D and 13G filings by holders of more than 5% of the voting shares.

Short interest

Shares sold short and not yet bought back, on each FINRA settlement date.

Funds that hold it

From each fund's latest Form 13F.

166 funds held it at 30 Jun 2026: 84 added and 39 trimmed in the quarter. The largest:

Peers

Companies in the same industry.

• Eli Lilly & Co. (LLY): revenue $79.7B, market value $1.21T
• Johnson & Johnson (JNJ): revenue $99.3B, market value $652.9B
• AbbVie Inc. (ABBV): revenue $64.4B, market value $506.1B
• Merck & Co., Inc. (MRK): revenue $66.6B, market value $348.1B
• Novartis AG (NVS): revenue $54.5B, market value $297.8B
• AstraZeneca PLC (AZN): revenue $58.7B, market value $263.1B
• Abbott Laboratories (ABT): revenue $46.6B, market value $177.7B
• Novo Nordisk A/S (NVO): revenue $46.8B, market value $171.0B
• Pfizer Inc. (PFE): revenue $63.7B, market value $168.0B
• Vertex Pharmaceuticals Inc. (VRTX): revenue $12.6B, market value $134.2B

What the company does

Zenas BioPharma is a clinical stage global biopharmaceutical company that develops immunology-based therapies for autoimmune diseases. Its main product candidate is obexelimab, a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb on B cells. The company also develops orelabrutinib, an oral BTK inhibitor for progressive forms of multiple sclerosis, and holds several earlier programs. It has no product approved for sale in any country and has not generated revenue from product sales. It acquired each of its product candidates by in-licensing them from third parties.

What obexelimab is

Obexelimab is designed to inhibit the activity of B cells without depleting them. The filing says B cells in the blood recover within six weeks of stopping obexelimab, compared with six months or longer after depleting agents such as anti-CD20 antibodies. The company says this could let patients be vaccinated within as few as six weeks of a last dose. Current and planned trials use a fixed 250 mg dose given weekly as a self-administered subcutaneous injection.

Obexelimab has been studied in eight clinical trials in which 383 subjects received it, 158 by intravenous infusion and 225 by subcutaneous injection.

- IgG4-related disease: The Phase 3 INDIGO trial enrolled 194 patients and runs at approximately 100 sites in 20 countries. The company says it plans to submit a Biologics License Application to the FDA in the second quarter of 2026 and a Marketing Authorization Application to the EMA in the second half of 2026. - Relapsing multiple sclerosis: The Phase 2 MoonStone trial enrolled 116 patients. - Systemic lupus erythematosus: The Phase 2 SunStone trial is enrolling patients. The company says it expects approximately 190 patients and to report results in the fourth quarter of 2026.

Orelabrutinib and the other programs

Orelabrutinib is an oral small molecule BTK inhibitor that the filing says is designed to cross the blood-brain barrier. It has been approved in China for chronic lymphocytic leukemia and small lymphocytic lymphoma since December 2020. Zenas is developing it for multiple sclerosis. The Phase 3 PriMroSe trial in primary progressive multiple sclerosis began in September 2025. The company says it expects to enroll approximately 705 patients at over 300 sites. It says it plans to start a second Phase 3 trial, Monarch, in non-active secondary progressive multiple sclerosis, with approximately 990 patients at over 300 sites.

- ZB021: an oral IL-17AA/AF inhibitor. - ZB022: an oral, brain-penetrant TYK2-JH2 inhibitor, in studies that precede an application to begin human trials. - ZB002: an anti-TNFα antibody. - ZB004: a CTLA-4-Ig fusion protein. The company retains global rights to ZB002 and ZB004 and says it may advance them with partners.

Where its rights come from

Zenas licenses obexelimab, ZB002 and ZB004 from Xencor. It pays Xencor tiered royalties on net sales, ranging from the mid-single digits to the mid-teens depending on region. In October 2025 it licensed orelabrutinib for multiple sclerosis worldwide from InnoCare, along with ZB021 and ZB022, with territory limits that vary by product. Zenas also pays InnoCare milestones and royalties on net sales.

- Bristol-Myers Squibb: It holds exclusive rights to obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia. Zenas keeps rights elsewhere. - Zai Lab: Zenas sublicensed ZB001, an IGF-1R antibody it licenses from Viridian Therapeutics, to Zai Lab for greater China. - Tenacia Biotechnology: Zenas transferred its rights and obligations for ZB005 to Tenacia.

As of 1 February 2026 the company owned or exclusively in-licensed 28 patent families covering its product candidates. They include 25 issued United States patents and 198 issued foreign patents. Patents issued from these families are scheduled to expire on various dates from 2027 through 2047, before any extensions.

Manufacturing and selling

WuXi Biologics is its single source for obexelimab drug product, and InnoCare supplies orelabrutinib, ZB021 and ZB022. The company has also selected new contract manufacturers in the United States for obexelimab drug substance and drug product. The company says that if its candidates are approved it intends to build its own commercial organisation in the United States and Europe. It currently has limited sales and marketing capabilities.

Who it competes with

The filing lists large and specialty pharmaceutical and biotechnology companies, academic institutions and government agencies as competitors, and says many have greater financial resources than Zenas. The FDA approved Uplizna, an anti-CD19 antibody marketed by Amgen, for IgG4-related disease in April 2025. For primary progressive multiple sclerosis, Ocrevus from F. Hoffmann-La Roche is the one FDA-approved therapy. For non-active secondary progressive multiple sclerosis there are currently no FDA-approved therapies. Other companies have BTK inhibitors, including remibrutinib and fenebrutinib, in Phase 3 development for multiple sclerosis. The company names safety, efficacy, convenience, price and reimbursement as the main competitive factors.

Who leads it

Leon (Lonnie) O. Moulder, Jr. is the Founder, Chief Executive Officer and Chairman. He co-founded TESARO, where he served as Chief Executive Officer until its acquisition by GlaxoSmithKline.

*From Zenas BioPharma's annual report on Form 10-K for the year ended 31 December 2025. [The filing](https://www.sec.gov/Archives/edgar/data/1953926/000110465926027964/zbio-20251231x10k.htm)*

From the company's 10-K.