Zenas BioPharma announces Q3 2026 results and corporate updates

Item 2.02

Results of Operations and Financial Condition.¹

On November 5, 2026, Zenas BioPharma, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 of this Current Report on Form

8-K and the exhibit furnished under Item 2.02 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.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release issued by the Company on November 5, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.²

ZENAS BIOPHARMA, INC.

By:

/s/ Joseph L. Farmer

Name:

Joseph L. Farmer

Title:

President and Chief Operating Officer

Date: November 5, 2026

Zenas

BioPharma Reports Third Quarter 2026 Financial Results and Provides Corporate Update

-

PDUFA target action date of May 27, 2027, following FDA acceptance of Obexelimab BLA submission for the treatment of IgG4-RD in second quarter 2026 -

- Obexelimab MAA submitted to the EMA for the treatment of IgG4-RD -

- New data presented at 6 th International

Symposium on IgG4-Related Disease supports obexelimab's potential role as a reversible, steroid-sparing, B-cell inhibitor for the treatment of IgG4-RD -

- Obexelimab INDIGO open-label extension data to be featured in late-breaking poster at ACR Convergence 2026 -

- Obexelimab global Phase 2 SunStone SLE trial topline results on track for fourth quarter 2026 -

- ZB021 (oral IL-17AA/AF inhibitor) dosing ongoing in Phase 1 trial; initial clinical data expected fourth quarter 2026 -

-

Orelabrutinib 24-week efficacy and safety data and pharmacokinetic analysis from Phase 2 trial in RRMS presented at MSToronto2026 -

- Jerald Korn appointed as Chief

Legal and Strategy Officer -

- Cash, cash equivalents and investments of

$647.1 million as of September 30, 2026 -

WALTHAM, Mass., November 5, 2026 (GLOBE NEWSWIRE)

- Zenas BioPharma, Inc. ("Zenas" or the "Company") (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for patients living with autoimmune and inflammatory diseases, today reported financial results for the quarter ended September 30, 2026, and provided recent corporate updates.

"This quarter we continued to execute across our portfolio as we prepare for the potential commercialization of obexelimab for the treatment of IgG4-RD. Following the FDA's acceptance of our BLA in the second quarter of this year, and the recent submission of our MAA to the EMA, we remain focused on commercial readiness ahead of the potential launch. We continue to generate meaningful data supporting the unique inhibitory mechanism of obexelimab, including open-label extension data, data demonstrating the reduction in glucocorticoid-associated toxicity, and data from the INDIGO vaccine sub-study presented at the IgG4ward! 6th International Symposium on IgG4-RD, and we look forward to the presentation of open-label extension data from INDIGO in a late-breaking poster at ACR Convergence 2026 next week," said Lonnie Moulder, Founder and Chief

Executive Officer of Zenas. "Across our broader pipeline, we remain on track to report topline Phase 2 SunStone data in SLE and initial Phase 1 data for our oral IL-17 inhibitor, ZB021, this quarter. We look forward to closing out a very productive year as we turn our attention to 2027 and continue to build toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company."

Corporate highlights

Obexelimab, inhibitor of B cell function targeting

CD19 and Fc RIIb

The U.S. Food and Drug Administration (FDA) accepted the Company's Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease

(IgG4-RD): The BLA, which was accepted in August, is under active review by the FDA and has been assigned a Prescription Drug User

Fee Act (PDUFA) target action date of May 27, 2027. Clinical data reported in the second quarter of 2026 confirmed bioequivalence between obexelimab delivered via prefilled syringe and single-dose prefilled pen, which has the potential to offer a more convenient delivery option for patients. Zenas plans to submit the bioequivalence data in a supplemental application to the obexelimab IgG4-RD BLA, if approved.

The

European Medicines Agency (EMA) validated the recently submitted Marketing Authorization Application (MAA) for the treatment of IgG4-RD:

EMA validation confirms that all essential regulatory elements required for scientific assessment are included in the application prior to the start of the assessment. The application is based on the results of the global Phase 3 INDIGO trial, as well as clinical data confirming bioequivalence between obexelimab delivered via prefilled syringe and single-dose prefilled pen.

Three abstracts accepted at ACR Convergence 2026, including a late-breaking poster with open-label extension data from the Phase 3 INDIGO trial of obexelimab in IgG4-RD:

Durable

Disease Control with Obexelimab in IgG4-Related Disease: Phase 3 INDIGO Open-Label Extension

Obexelimab

Reduced Glucocorticoid-Associated Toxicity in Patients with IgG4-Related Disease: Results from the Phase 3 Randomized, Placebo-Controlled

INDIGO Trial

Clinically

Meaningful Influenza and SARS-CoV-2 Vaccine Responses Following Treatment-Free Window of Obexelimab in Patients with IgG4-RD

Presented additional positive Phase 3 INDIGO data at the IgG4ward! 6th International Symposium on IgG4-RD: Phase 3 INDIGO results were presented at IgG4ward! highlighting long-term efficacy and safety data from the open-label extension. Additionally, data was presented on reduced glucocorticoid-associated toxicity in patients with IgG4-RD, as well as influenza and SARS-CoV-2 vaccine seroprotection data following a treatment-free window of obexelimab in patients with IgG4-RD.

Phase

2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in the fourth quarter 2026: Zenas anticipates reporting topline results, including results from a biomarker subset from the Phase 2 SunStone trial in the fourth