Every 8-K that Zenas BioPharma, Inc. (ZBIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ZBIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ZBIO filings page.
Zenas BioPharma, Inc. reported second quarter 2026 results and provided a pipeline and governance update. For the quarter ended June 30, 2026, license and collaboration revenue was $1.0 million. Total operating expenses rose to $108.7 million, including $62.9 million in research and development, $15.7 million in general and administrative costs, and $30.0 million of acquired in-process R&D, resulting in a net loss of $111.5 million versus $52.2 million a year earlier.
As of June 30, 2026, Zenas reported cash, cash equivalents and investments of $673.9 million, total assets of $701.7 million, working capital of $588.0 million, and total liabilities of $454.6 million, including a royalty obligation, a senior secured term loan and convertible senior notes. The FDA accepted the obexelimab BLA for IgG4-related disease with a PDUFA target action date of May 27, 2027Christy J. Oliger as a Class II director effective September 1, 2026, and the CFO will transition to Strategic Advisor to the Board Chair at the end of September.
Zenas BioPharma, Inc. reported first quarter 2026 results showing no revenue versus $10.0 million a year earlier and a higher net loss of $80.99 million, or $1.46 per share, compared with a $33.57 million loss, or $0.80 per share, in 2025. Operating expenses rose sharply, led by research and development spending of $60.44 million. Cash, cash equivalents and investments increased to $718.55 million as of March 31, 2026, from $360.46 million, after completed public offerings and new debt financing, which the company says extends its cash runway into 2029. Total liabilities increased to $411.85 million, including royalty obligations, a senior secured term loan and convertible senior notes.
Zenas highlighted progress in its autoimmune pipeline, including Phase 3 INDIGO results for obexelimab in IgG4‑Related Disease, ongoing Phase 3 multiple sclerosis trials for orelabrutinib, and Phase 1 development of oral IL‑17 inhibitor ZB021. At its 2026 Annual Meeting, stockholders elected two Class II directors, ratified Ernst & Young LLP as auditor, and the board size was reduced by one following Tomas Kiselak’s previously announced departure.
Zenas BioPharma, Inc. completed two financings: a public offering of $200 million in 2.50% Convertible Senior Notes due 2032 and an equity offering of 5,000,000 common shares at $20.00 per share. The notes bear 2.50% annual interest, payable semiannually, and are convertible at an initial rate of 37.7358 shares per $1,000 of principal, with customary anti-dilution and make-whole adjustments. The company may redeem the notes after April 8, 2030 if stock price conditions are met, and holders have repurchase rights upon specified “Fundamental Change” events. Net proceeds were approximately $193.7 million from the notes and $93.7 million from the equity, which the company intends to use to support the planned U.S. commercial launch of obexelimab for IgG4-RD, advance its pipeline (including orelabrutinib and ZB021 trials), and for working capital and general corporate purposes. The company also reiterates previously disclosed risks, including that its auditors have expressed substantial doubt about its ability to continue as a going concern.
Zenas BioPharma reported wider losses for the fourth quarter and full year 2025 while advancing its autoimmune pipeline and securing new financing. For Q4 2025, total revenue was $0 compared with $5,000 (thousand) a year earlier, as prior license and collaboration revenue did not recur. Q4 total operating expenses rose to $237,984 (thousand), driven by $166,672 (thousand) of acquired in-process R&D, leading to a Q4 net loss of $240,442 (thousand) versus $52,604 (thousand) in Q4 2024.
For full year 2025, total revenue was $10,000 (thousand) versus $5,000 (thousand) in 2024, while total operating expenses more than doubled to $393,057 (thousand), including $171,672 (thousand) of acquired in-process R&D. Net loss for 2025 increased to $377,737 (thousand) from $156,988 (thousand) in 2024, with basic and diluted net loss per share of $8.44. Cash, cash equivalents and investments were $360,464 (thousand) as of December 31, 2025, and the company noted an accumulated deficit of $765,128 (thousand).
Operationally, Zenas highlighted positive Phase 3 INDIGO results for obexelimab in IgG4-related disease and plans to submit marketing applications to the FDA in Q2 2026 and the EMA in the second half of 2026. It expects topline data from the global Phase 2 SunStone trial of obexelimab in systemic lupus erythematosus in Q4 2026 and continues Phase 3 development of orelabrutinib in progressive multiple sclerosis, with a non-active secondary progressive MS trial expected to start in Q1 2026. The company is also progressing earlier-stage programs ZB021, ZB022 and ZB014 and has secured up to $250 million in non-dilutive, multi-tranche debt financing from Pharmakon to support commercialization and pipeline investment.
Zenas BioPharma, Inc. has amended and restated its Short-Term Incentive Plan, an annual discretionary cash bonus program effective January 1, 2026. The plan allows eligible full- and part-time employees to earn bonuses based on company performance and individual achievement of agreed goals.
The Board of Directors or its committee administers the plan for executives, while the Chief Executive Officer and executive leadership team oversee it for other employees. Awards are subject to Board or administrator approval, must be paid no later than March 15 following each calendar year, require employment through the payment date, and are subject to the company’s incentive compensation recoupment policies.
Zenas BioPharma, Inc. reported that its board approved a new 2026 Inducement Plan, allowing the company to grant equity-based awards covering up to 1,000,000 shares of its common stock. These awards, which can include non-statutory stock options, stock appreciation rights, restricted stock units, restricted stock and other stock-based awards, are intended as hiring inducements for new employees or those rehired after a bona fide break in service at the company or its subsidiaries.
The company adopted the plan without a stockholder vote in reliance on Nasdaq Listing Rule 5635(c)(4), which permits inducement grants outside stockholder-approved plans under specific conditions. Standard form agreements for stock options and restricted stock units, including global versions, will be used to document awards made under this 2026 Inducement Plan.
Zenas BioPharma (ZBIO) furnished a press release announcing its financial results for the quarter ended September 30, 2025. The press release is included as Exhibit 99.1 to this Form 8-K.
The company states the information in this Form 8-K (including Exhibit 99.1) is furnished, not filed under the Exchange Act. Zenas BioPharma’s common stock trades on the Nasdaq Global Select Market under the symbol ZBIO, and the company is identified as an emerging growth company.
Zenas BioPharma (ZBIO) reported positive Phase 2 results for obexelimab in relapsing multiple sclerosis. The trial met its primary endpoint, showing a 95% relative reduction in the cumulative number of new Gd‑enhancing T1 lesions over weeks 8 and 12 versus placebo (p=0.0009).
The adjusted mean number of new Gd‑enhancing T1 lesions per scan was 0.01 (95% CI: 0.00, 0.06; n=72) with obexelimab compared to 0.23 (95% CI: 0.11, 0.51; n=38) with placebo. Obexelimab also significantly reduced new and/or enlarging T2 lesions. The safety profile was consistent with prior trials, with infections and hypersensitivity reported, most commonly mild injection‑site reactions.
The company plans to report 24‑week MoonStone data in Q1 2026. Additional milestones include topline Phase 3 INDIGO results in IgG4‑RD around year‑end 2025, SunStone Phase 2 topline in SLE in mid‑2026, a global Phase 3 in PPMS underway for orelabrutinib, and a Phase 3 in SPMS expected to start in Q1 2026.
Zenas BioPharma, Inc. (ZBIO) reported a material event announcing licensing and financing documents executed in early October 2025. The company obtained exclusive rights for three clinical-stage programs: orelabrutinib (a BTK inhibitor) in the multiple sclerosis field worldwide and in non-oncology indications outside Greater China and specified Southeast Asia countries; ZB021 (an IL-17AA/AF inhibitor) in all fields worldwide excluding Greater China and Southeast Asia; and ZB022 (a TYK2 inhibitor) in all fields worldwide. The filing lists a Subscription Agreement, Registration Rights Agreement and related securities purchase forms dated October 7, 2025, plus a press release and investor presentation dated October 8, 2025.
The disclosure identifies geographic carve-outs for two programs and confirms executed commercial and investor agreements, but it does not state any monetary terms, milestone schedules, or expected timelines for development or commercialization.
Zenas BioPharma entered a Revenue Participation Right Purchase and Sale Agreement with Royalty Pharma Investments 2019 ICAV, under which Royalty Pharma will pay up to $300 million in exchange for rights to future revenue from the antibody obexelimab. Zenas received an Initial Purchase Price of $75 million at closing, with three additional $75 million tranches tied to milestones for the INDIGO Phase 3 trial in IgG4-Related Disease and U.S. Food and Drug Administration marketing approvals for obexelimab in IgG4-Related Disease and systemic lupus erythematosus.
In return, Royalty Pharma is entitled each quarter to 5.5% of net sales of obexelimab products sold by Zenas and its affiliates worldwide, 5.5% of net sales by licensees in the United States, United Kingdom and European Union, 25% of certain royalty income on sales in other countries, and 25% of specified non-royalty income related to obexelimab. The agreement includes customary representations, covenants and a limit on certain indebtedness that can terminate on conditions such as a change of control.
Zenas BioPharma, Inc. filed a current report to note that it issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release, dated August 12, 2025, is furnished as Exhibit 99.1.
The company’s common stock, par value $0.0001 per share, trades on The Nasdaq Global Select Market under the symbol ZBIO. The information in this report and Exhibit 99.1 is furnished rather than filed under the Exchange Act, which limits how it is treated for certain liability and incorporation-by-reference purposes.