Zenas BioPharma Inc. SEC Filings

Zenas BioPharma, Inc. filed a shelf registration on October 8, 2025 to offer an indeterminate mix of common stock, preferred stock, warrants and debt securities and an at-the-market equity program allowing up to $200,000,000 of common stock sales through Jefferies.

The company is clinical-stage and focused on immunology & inflammation. Lead asset obexelimab is in a Phase 3 registration-directed INDIGO trial for IgG4-RD with topline expected around year-end 2025 and potential BLA filing in H1 2026 if positive. Phase 2 programs in SLE (SunStone) and RMS (MoonStone) are ongoing, with key readouts across late 2025–2026. On October 7, 2025, the company licensed orelabrutinib and two early candidates (ZB021, ZB022) and expects Phase 3 PPMS initiation in September 2025 with additional planned Phase 3/SPMS activity in Q1 2026. The prospectus highlights material risks, reliance on trial outcomes, and broad management discretion over proceeds.

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.

FMR LLC and Abigail P. Johnson each report beneficial ownership of 4,644,279 shares of Zenas BioPharma Inc. common stock, representing 11.0% of the class. The filing states FMR LLC holds 4,643,356 shares with sole voting power and 4,644,279 shares with sole dispositive power, while Abigail P. Johnson is reported with sole dispositive power over 4,644,279 shares. The filing affirms these shares are held in the ordinary course of business and not acquired to change or influence control of the issuer. The document references an Exhibit 99 agreement and incorporated powers of attorney for signature authority.

Zenas BioPharma is registering 762,000 shares of its common stock to cover inducement stock option grants made to three employees under the employment inducement exemption of Nasdaq Rule 5635(c)(4). The filing omits Part I prospectus text under Rule 428(a) and confirms that the omitted documents will be delivered to the option recipients and that certain company reports are incorporated by reference, including the company’s annual report for the fiscal year ended December 31, 2024 and subsequent quarterly reports.

The filing discloses corporate governance protections: elimination of director liability to the extent permitted by DGCL Section 102(b)(7), indemnification powers under DGCL Section 145, indemnification agreements with directors and officers providing broader rights than statute, and directors’ and officers’ liability insurance. Exhibits include the Form of Inducement Option Award Agreement, the 2024 Equity Incentive Plan, counsel opinion and auditor consents.

Zenas BioPharma (ZBIO) reported a net loss of $52.2 million for the quarter and $85.8 million for the six months ended June 30, 2025, driven by higher research and development and general and administrative spending. Research and development expense was $43.0 million for the quarter versus $33.8 million a year earlier; total operating expenses for the quarter were $55.2 million. Revenue recognized was $10.0 million for the six months (sublicense with Zai), and no revenue was recognized in the quarter.

The company held $274.9 million of cash, cash equivalents and investments as of June 30, 2025 and management expects these resources to fund operations into the fourth quarter of 2026. Total assets were $293.1 million, total liabilities $53.5 million, and stockholders' equity $239.6 million. Accumulated deficit reached $473.2 million. Material agreements disclosed include a $50.0 million upfront payment from BMS and a $10.0 million upfront payment from Zai recognized in the period.