Zenas BioPharma Files 8-K: Agreements, Financials, Equity Sales

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

Sentiment: neutral

Topics: material-definitive-agreement, financial-results, equity-sale

TL;DR

Zenas BioPharma dropped an 8-K detailing new deals, financial results, and stock sales.

AI Summary

On October 7, 2025, Zenas BioPharma, Inc. entered into a material definitive agreement. The company also reported on its results of operations and financial condition. Additionally, Zenas BioPharma disclosed unregistered sales of equity securities and made a Regulation FD disclosure. The filing also included financial statements and exhibits.

Why It Matters

This 8-K filing provides crucial updates on Zenas BioPharma's recent business activities, including financial performance and equity transactions, which are important for investors to assess the company's current standing.

Risk Assessment

Risk Level: medium — The filing covers material definitive agreements, financial results, and unregistered equity sales, which can introduce varying levels of risk and require careful investor scrutiny.

Key Players & Entities

FAQ

What type of material definitive agreement did Zenas BioPharma enter into?

The filing indicates Zenas BioPharma entered into a material definitive agreement, but the specific details of the agreement are not provided in this summary.

What period do the results of operations and financial condition pertain to?

The filing does not specify the exact period for the results of operations and financial condition, only that it is reported as of October 7, 2025.

Were there any unregistered sales of equity securities by Zenas BioPharma?

Yes, the filing explicitly states that there were unregistered sales of equity securities.

What is the Commission File Number for Zenas BioPharma?

The Commission File Number for Zenas BioPharma, Inc. is 001-42270.

When was Zenas BioPharma, Inc. incorporated?

Zenas BioPharma, Inc. was incorporated in Delaware.

Filing Stats: 3,934 words · 16 min read · ~13 pages · Grade level 17.2 · Accepted 2025-10-08 06:01:10

Key Financial Figures

Filing Documents

01

Item 1.01 Entry into a Material Definitive Agreement License Agreement with InnoCare Pharma Inc. On October 7, 2025, Zenas BioPharma, Inc. (" Zenas " or the " Company ") entered into a License Agreement (the " InnoCare License Agreement ") with InnoCare Pharma Inc. (" InnoCare "). Under the InnoCare License Agreement, InnoCare granted Zenas exclusive rights to develop, manufacture, and commercialize certain small molecule compounds and related products in specified fields and territories, as further described below. License Grants 1. Orelabrutinib (a BTK inhibitor): Zenas obtained exclusive rights in the multiple sclerosis (" MS ") field worldwide, and in all non-oncology indications outside mainland China, Hong Kong, Macau and Taiwan (" Greater China ") and Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam (" Southeast Asia "). 2. ZB021 (an IL-17AA/AF inhibitor): Zenas obtained exclusive rights in all fields of use worldwide, excluding Greater China and Southeast Asia. 3. ZB022 (a TYK2 inhibitor): Zenas obtained exclusive rights in all fields of use worldwide. Zenas also obtained certain non-exclusive rights to perform development and manufacturing activities in Greater China and Southeast Asia to support each program in its respective licensed territories. Consideration Zenas has agreed to pay InnoCare an upfront cash payment of $35 million and also issued to InnoCare 5,000,000 shares (the " InnoCare Upfront Shares ") of its common stock, par value $0.0001 per share (" Common Stock "), representing approximately 10.6% of Zenas's issued and outstanding Common Stock as of October 7, 2025, after giving effect to the issuance to InnoCare, and approximately 9.3% of Zenas's issued and outstanding Common Stock after giving effect to the further issuance of the PIPE Shares (as defined below). Zenas has agreed to make a one-time, cash payment of $25 million and issue 2,000,000 shares of Common St

02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition The disclosure regarding the Company's existing cash, cash equivalents and investments as of September 30, 2025 set forth under Item 8.01 of this Current Report on Form 8-K is incorporated by reference under this Item 2.02.

02 Unregistered Sales of Equity Securities

Item 3.02 Unregistered Sales of Equity Securities The disclosure regarding the securities to be sold and issued pursuant to the InnoCare Subscription Agreement and the Securities Purchase Agreement set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference under this Item 3.02. None of the securities described above under Item 1.01 has been registered under the Securities Act or any state securities laws. The Company is relying on exemptions from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof. Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or other securities of the Company.

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure On October 8, 2025, the Company issued a press release announcing the Agreement and the Private Placement. The Company is also hosting a conference call and webcast at 8 a.m. Eastern Time, on October 8, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the presentation the Company intends to present on the conference call and webcast is furnished as Exhibit 99.2 to this Current Report on Form 8-K, and both are incorporated by reference herein. The exhibits 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 Recent Developments Following entry into the InnoCare License Agreement, the Company's pipeline currently comprises four programs it is developing initially for the treatment of immunology and inflammation diseases: (1) obexelimab, a bifunctional monoclonal antibody designed to bind both CD19 and FcRIIb, which are broadly present across the B cell lineage, in order to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them, (2) orelabrutinib, a highly selective and central nervous system-penetrant, oral small molecule Bruton's Tyrosine Kinase inhibitor, (3) ZB021, an IL-17 AA/AF inhibitor and (4) ZB022, a brain-penetrant TYK2 inhibitor. Additional information about the Company's current pipeline can be found in Exhibit 99.3 to this Current Report on Form 8-K, which is incorporated by reference herein. Company Cash Update The Company estimates that, as of September 30, 2025, it had approximately $302 million in existing cash, cash equivalents and investments. During the three months ended September 30, 2025, a $5 million deposit was paid towards the $35 million upfront cash payment due to InnoCare. This estimated amount of cash, cash equivalents and investments as of September 30, 2025 is preliminary and is subject to completion of the Company's financial closing procedures and has not been reviewed or audited by our independent auditors. Consequently, this amount may differ materially from the amount that will be reflected in the Company's unaudited condensed consolidated balance sheet as of September 30, 2025. As of the date of this Current Report on Form 8-K, after giving effect to the upfront cash consideration paid to InnoCare pursuant to the InnoCare License Agreement and the anticipated proceeds from the PIPE Transaction, the Company expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements into the f

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 the Company's milestones, expectations and intentions, including timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, and if successful, the timing of BLA submission, potential approval and commercial launch, the timing of reporting the 12-week and 24-week topline results from the MoonStone trial, the timing of the completion of enrollment and reporting the topline results from the SunStone trial, and if successful, the timing of initiating the Phase 3 trial in SLE, the timing of initiation of the Phase 3 clinical trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of ZB021 and ZB022, the timing of initial patient data in ZB021; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib's potential as a franchise for progressive MS; the expansion of the Company's pipeline; the expected PIPE Closing; the achievement of paymen

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 10.1 Subscription Agreement, dated October 7, 2025, by and between the Company and InnoCare Pharma Inc. 10.2 Registration Rights Agreement, dated October 7, 2025, by and between the Company and InnoCare Pharma Inc. 10.3 Form of Securities Purchase Agreement, dated October 7, 2025, by and among the Company and the investors party thereto. 10.4 Form of Registration Rights Agreement, dated October 7, 2025, by and among the Company and the investors party thereto. 99.1 Press Release, dated October 8, 2025 99.2 Zenas BioPharma, Inc. Presentation, dated October 8, 2025 99.3 Zenas BioPharma, Inc. Business Updates 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 8, 2025

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