ZBIO registers securities, licenses orelabrutinib and plans late‑stage readouts
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.
Positive
- Completed INDIGO target enrollment for Phase 3 obexelimab with topline expected around 2025 year-end
- ATM capacity of $200,000,000 via Jefferies provides immediate capital-raising flexibility
- Licensing agreement dated October 7, 2025 grants exclusive rights to orelabrutinib and two early programs (ZB021, ZB022)
- MoonStone enrollment completed and 12-week primary endpoint results expected early in Q4 2025
Negative
- Outcomes are binary and material: success/failure of INDIGO, MoonStone, SunStone will strongly affect valuation
- Proceeds use is broad and management retains discretion, creating potential dilution without specified allocation
- Significant clinical and regulatory risk noted repeatedly; investing involves a high degree of risk
- No guaranteed liquidity for securities despite Nasdaq listing; ATM sales may dilute existing holders
Insights
TL;DR: Multiple near-term readouts concentrate regulatory and commercial risk in late 2025–2026.
Obexelimab has a registration-directed Phase 3 program (INDIGO) with topline expected around year-end 2025 and potential BLA filing in H1 2026 if results are positive. Two Phase 2 trials (SunStone for SLE, MoonStone for RMS) have upcoming readouts: MoonStone 12-week primary endpoint results early in Q4 2025, SunStone topline in mid-2026. These milestones will materially affect regulatory pathways and next-step trial decisions.
The license of orelabrutinib (ZB020) and initiation of a Phase 3 PPMS trial in September 2025 broaden the pipeline into oral BTK inhibition with CNS penetration, but success depends on late-phase outcomes and comparative safety/efficacy versus existing MS therapies. Watch upcoming top-line dates and any disclosed primary endpoint results over the next 6–18 months.
TL;DR: An $200,000,000 ATM and shelf provide financing optionality but leave allocation flexible.
The Form S-3 establishes an at-the-market facility for up to $200,000,000 of common stock via Jefferies and registers various securities for future issuance. This gives management broad capital-raising flexibility to fund R&D, potential launches, business development, or licensing obligations. The prospectus explicitly states proceeds will be used for general corporate purposes and that management retains wide discretion over allocations.
Key near-term financial watch items include any actual ATM sales (timing and dilution), use of proceeds disclosed in prospectus supplements, and whether trial results prompt accelerated financing, partnerships, or a BLA-driven commercial funding need in 2026. The last quoted share price on October 7, 2025 was $20.85, which provides one observable market reference for ATM executions.
SECURITIES AND EXCHANGE COMMISSION
THE SECURITIES ACT OF 1933
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Delaware
(State or other jurisdiction
of incorporation or organization) |
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93-2749244
(I.R.S Employer
Identification No.) |
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Waltham, Massachusetts 02451
(857) 271-2954
Chief Executive Officer
Zenas BioPharma, Inc.
852 Winter Street, Suite 250
Waltham, Massachusetts 02451
(857) 271-2954
Thomas Danielski
Nicholas Roper
Ropes & Gray LLP
Prudential Tower
800 Boylston St.
Boston, Massachusetts 02199
(617) 951-7000
(Approximate date of commencement of proposed sale to the public)
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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Preferred Stock
Warrants
Debt Securities
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ABOUT THIS PROSPECTUS
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ABOUT THE COMPANY
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RISK FACTORS
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FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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DESCRIPTION OF COMMON STOCK
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DESCRIPTION OF PREFERRED STOCK
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF DEBT SECURITIES
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
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LEGAL MATTERS
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EXPERTS
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Zenas BioPharma, Inc.
852 Winter Street, Suite 250
Waltham, Massachusetts 02451
(857) 271-2954
email address: IR@zenasbio.com
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About this Prospectus
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| | | | S-1 | | |
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Cautionary Statement About Forward-Looking Statements
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Prospectus Summary
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The Offering
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Risk Factors
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Use of Proceeds
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Dilution
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Dividend Policy
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Plan of Distribution
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Legal Matters
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Experts
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Where You Can Find More Information
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Incorporation of Certain Documents by Reference
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Assumed public offering price per share
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| | | | | | | | | $ | 20.85 | | |
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Historical net tangible book value per share at June 30, 2025
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Increase in net tangible book value per share attributable to this offering
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As adjusted net tangible book value per share after this offering
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Dilution per share to new investors in this offering
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Zenas BioPharma, Inc.
852 Winter Street, Suite 250
Waltham, Massachusetts 02451
(857) 271-2954
email address: IR@zenasbio.com
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Securities and Exchange Commission registration fee
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FINRA filing fee
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Printing and engraving expenses
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Legal fees and expenses
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Accounting fees and expenses
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Transfer agent and registrar fees
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Trustee’s fees and expenses
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Miscellaneous
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Total
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Exhibit
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Description
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| | 1.1* | | | Form of Underwriting Agreement | |
| | 1.2 | | | Open Market Sale AgreementSM, dated October 8, 2025, by and between the Registrant and Jefferies LLC (filed herewith) | |
| | 3.1 | | | Second Restated Certificate of Incorporation of Zenas BioPharma, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K as filed with the SEC on September 16, 2024, File No. 001-42270) | |
| | 3.2 | | | Amended and Restated Bylaws of Zenas BioPharma, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K as filed with the SEC on September 16, 2024, File No. 001-42270) | |
| | 4.1 | | | Specimen stock certificate evidencing shares of common stock (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1 as filed with the SEC on September 6, 2024, File No. 333-281713) | |
| | 4.2 | | | Fourth Amended and Restated Shareholders Agreement, among the Registrant and certain of its stockholders, dated May 3, 2024 (incorporated by reference to Exhibit 4.2 to the Registration Statement on Form S-1 as filed with the SEC on September 6, 2024, File No. 333-281713) | |
| | 4.3 | | | Registration Rights Agreement, dated October 7, 2025, by and between the Registrant and InnoCare Pharma Inc. (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K as filed with the SEC on October 8, 2025, File No. 001-42270) | |
| | 4.4 | | | Form of Registration Rights Agreement, dated October 7, 2025, by and between the Registrant and the investors party thereto (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K as filed with the SEC on October 8, 2025, File No. 001-42270) | |
| | 4.5 | | | Description of Securities (incorporated by reference to Exhibit 4.3 to the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 11, 2025, File No. 001-42270) | |
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Exhibit
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Description
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| | 4.6* | | | Form of Common Stock Warrant Agreement and Warrant Certificate | |
| | 4.7* | | | Form of Preferred Stock Warrant Agreement and Warrant Certificate | |
| | 4.8* | | | Form of Debt Securities Warrant Agreement and Warrant Certificate | |
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Form of Indenture (filed herewith)
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Opinion of Ropes & Gray LLP relating to the base prospectus (filed herewith)
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Opinion of Ropes & Gray LLP relating to the at-the-market offering prospectus (filed herewith)
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Consent of Ropes & Gray LLP (included in Exhibit 5.1)
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Consent of Ropes & Gray LLP (included in Exhibit 5.2)
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Consent of Ernst & Young LLP (filed herewith)
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Power of Attorney (incorporated by reference to the signature page hereto)
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Statement of Eligibility of Trustee Under Debt Indenture (filed herewith)
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Filing Fee Table (filed herewith)
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Chief Executive Officer and Director
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SIGNATURES
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TITLE
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DATE
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/s/ Leon O. Moulder, Jr.
Leon O. Moulder, Jr.
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Chief Executive Officer and Director
(Principal executive officer) |
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October 8, 2025
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/s/ Jennifer Fox
Jennifer Fox
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| | Chief Financial Officer, Chief Business Officer and Treasurer (Principal financial and accounting officer) | | |
October 8, 2025
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/s/ Patricia Allen
Patricia Allen
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| | Director | | |
October 8, 2025
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/s/ James Boylan
James Boylan
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October 8, 2025
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/s/ Patrick Enright
Patrick Enright
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October 8, 2025
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/s/ Tomas Kiselak
Tomas Kiselak
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October 8, 2025
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/s/ Hongbo Lu, Ph.D.
Hongbo Lu, Ph.D.
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October 8, 2025
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/s/ Jake Nunn
Jake Nunn
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October 8, 2025
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/s/ John Orloff, M.D.
John Orloff, M.D.
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| | Director | | |
October 8, 2025
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