Zenas BioPharma Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Completion of Acquisition or Disposition of Assets, Creation of a Direct Financial Obligation, Regulation FD Disclosure, Financial Statements and Exhibits
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Item 1.01 Entry into a Material Definitive Agreement
On September 2, 2025, Zenas BioPharma, Inc. (“Zenas” or the “Company”) entered into a Revenue Participation Right Purchase and Sale Agreement (the “Agreement”) with Royalty Pharma Investments 2019 ICAV (“RPI”), pursuant to which RPI purchased rights to certain revenue streams from (i) worldwide net sales of obexelimab and certain other related products (referred to herein, collectively, as obexelimab) by Zenas and its affiliates, (ii) net sales of obexelimab by licensees of Zenas and its affiliates in certain partnered territories, and (iii) non-sales based payments related to obexelimab owed to Zenas and its affiliates by licensees in exchange for up to $300 million in consideration consisting of, (a) $75 million of which was paid on the closing date (the “Initial Purchase Price”), (b) $75 million of which is payable following the achievement of certain milestones with respect to Zenas’ INDIGO Phase 3 Trial of obexelimab for the treatment of patients with IgG4-Related Disease on or before a specified date, (c) $75 million of which is payable following receipt of marketing approval for obexelimab from the United States Food and Drug Administration (the “FDA”) for the treatment of IgG4-Related Disease on or before a specified date and (d) $75 million of which is payable following receipt of marketing approval for obexelimab from the FDA for the treatment of systemic lupus erythematosus on or before a specified date.
Pursuant to the Agreement, RPI purchased the right to receive, for each calendar quarter, (i) 5.5% of net sales of obexelimab products sold by Zenas and its affiliates worldwide, (ii) 5.5% of net sales of obexelimab products sold by licensees of Zenas and its affiliates in the United States, the United Kingdom and the European Union, (iii) 25% of royalty income payable to Zenas or any of its affiliates on sales of obexelimab products in countries other than the United States, the United Kingdom, and in the European Union by its licensees pursuant to out-licenses less royalty payments payable by Zenas to Xencor Inc. and (iv) 25% of non-royalty income attributable to obexelimab products payable to Zenas or any of its affiliates by its licensees (other than certain milestone payments payable by Bristol-Myers Squibb) pursuant to out-licenses and allocated to countries other than the United States, the United Kingdom and in the European Union.
The Agreement contains customary representations, warranties and indemnities of Zenas and RPI and customary covenants on the part of Zenas, as well as a limit on the amount of incurrence of certain types of indebtedness which limit automatically terminates on certain conditions, including a change of control. The Agreement may only be terminated by mutual written agreement of Zenas and RPI.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which Zenas expects to file, with certain confidential terms redacted, as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending September 30, 2025.
Item 2.01 Completion of Acquisition or Disposition of Assets
The information in Item 1.01 is incorporated by reference into this Item 2.01.
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The information in Item 1.01 is incorporated by reference into this Item 2.03.
Item 7.01 Regulation FD Disclosure
On September 2, 2025, Zenas BioPharma, Inc. issued a press release announcing its entry into the Agreement with RPI. 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 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “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 it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by the Company on September 2, 2025 | |
| 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.
| ZENAS BIOPHARMA, INC. | |||
| By: | /s/ Jennifer Fox | ||
| Name: | Jennifer Fox | ||
| Title: | Chief Business Officer and Chief Financial Officer | ||
Date: September 2, 2025