Zenas BioPharma Files 8-K Report

Ticker: ZBIO · Form: 8-K · Filed: Oct 27, 2025 · CIK: 1953926

Sentiment: neutral

Topics: sec-filing, 8-k, disclosure

TL;DR

Zenas BioPharma filed an 8-K on 10/27/25, likely containing important company updates.

AI Summary

On October 27, 2025, Zenas BioPharma, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events beyond the filing itself were detailed in the provided text.

Why It Matters

This filing indicates Zenas BioPharma is providing updated information to the SEC, which could include material disclosures about its operations or financial status.

Risk Assessment

Risk Level: low — The filing is a standard procedural disclosure without immediate negative or positive financial implications mentioned in the provided text.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing by Zenas BioPharma, Inc.?

The filing is a Current Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, and includes information on Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

On what date was the earliest event reported in this 8-K filing?

The date of the earliest event reported is October 27, 2025.

In which state is Zenas BioPharma, Inc. incorporated?

Zenas BioPharma, Inc. is incorporated in Delaware.

What is the SEC file number for Zenas BioPharma, Inc.?

The SEC file number for Zenas BioPharma, Inc. is 001-42270.

What is the business address and phone number listed for Zenas BioPharma, Inc.?

The business address is 852 Winter Street, Suite 250, Waltham, MA 02451, and the telephone number is (857) 271-2954.

Filing Stats: 2,013 words · 8 min read · ~7 pages · Grade level 17.7 · Accepted 2025-10-27 07:19:24

Key Financial Figures

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure On October 27, 2025, Zenas BioPharma, Inc. (the "Company") issued a press release announcing positive results from its Phase 2, double-blind, randomized, placebo controlled trial (the "MoonStone" trial) of obexelimab in relapsing multiple sclerosis ("RMS"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.

01 Other Events

Item 8.01 Other Events On October 27, 2025, the Company announced positive results from the MoonStone trial of obexelimab in RMS. Obexelimab met the primary endpoint, demonstrating a statistically significant 95% relative reduction in the cumulative number of new gadolinium ("Gd")-enhancing ("GdE") T1 hyperintense lesions, which are markers of active inflammation, over week 8 and week 12 compared with placebo (p=0.0009). The adjusted mean number of new GdE T1 hyperintense lesions per scan in the obexelimab group (n=72) was 0.01 (95% CI: 0.00, 0.06) compared to 0.23 (95% CI: 0.11, 0.51) with placebo (n=38). Additionally, over weeks 8 and 12 of treatment, obexelimab significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions compared to placebo, which represent the amount of disease burden or chronic lesion load. The safety profile of obexelimab was consistent with that observed in prior completed trials, including cases of infections and hypersensitivity, most commonly mild injection site reactions. The Company expects to report 24-week data from the MoonStone trial in the first quarter of 2026, which will include additional secondary and exploratory endpoints that may inform obexelimab's potential impact on disability progression and inform next steps for future development of obexelimab in relapsing multiple sclerosis. The Company also expects to report topline results from the obexelimab Phase 3 INDIGO trial in IgG4-RD around year-end 2025 and topline results from the Phase 2 SunStone trial in Systemic Lupus Erythematosus in mid-2026. In addition, orelabrutinib, a highly-selective central nervous system--penetrant, oral, small molecule Bruton's Tyrosine Kinase ("BTK") inhibitor, which the Company recently in-licensed from InnoCare Pharma Limited, is now being studied in a global Phase 3 clinical trial in patients with Primary Progressive Multiple Sclerosis ("PPMS"). The Company also expects to initiate a global Phase 3

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K contains "forward-looking statements" which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this Current Report on Form 8-K are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning Zenas's milestones, expectations and intentions, including the potential for obexelimab to become a meaningful therapy across multiple autoimmune diseases and to address the pathogenic role of B cells in autoimmune diseases, the timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, the timing of reporting 24-week topline results from the MoonStone trial, the timing of reporting the topline results from the SunStone trial and the timing of initiation of the Phase 3 clinical trial of orelabrutinib in patients with SPMS; and the potential benefits, development and commercialization of orelabrutinib and obexelimab. The forward-looking statements in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company's actual results to differ materially from those anticipated in the forward-looking

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated October 27, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ZENAS BIOPHARMA, INC. By: /s/ Jennifer Fox Name: Jennifer Fox Title: Chief Business Officer and Chief Financial Officer Date: October 27, 2025

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