UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
Zenas BioPharma, Inc. (the “Company”) is furnishing as Exhibit 99.1 to this Current Report on Form 8-K an investor presentation (the “Investor Presentation”) which may be used, in whole or in part, and subject to modification, on December 2, 2024 and at subsequent meetings with investors or analysts. The Investor Presentation provides updated information on the Company’s clinical trials, including the Company’s fully-enrolled Phase 3 INDIGO trial of obexelimab in patients with IgG4-Related Disease and the expected timeline to report topline results, the currently-enrolling Phase 2 MoonStone trial of obexelimab in patients with Relapsing Multiple Sclerosis and the expected timeline to report the 12-week primary endpoint results, the currently-enrolling Phase 2 SunStone trial of obexelimab in patients with Systemic Lupus Erythematosus and the expected timeline to complete enrollment and report topline results and preliminary, interim data from the dose confirmation run-in period of the Phase 2 SApHiAre trial of obexelimab in patients with warm Autoimmune Hemolytic Anemia, as well as the status of the program.
The information in this Item 7.01 (including Exhibit 99.1 attached hereto) is being furnished and 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, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements. The Investor Presentation contains forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. Please refer to the cautionary notes in the Investor Presentation regarding these forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Investor Presentation, dated December 2, 2024 | |
| 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: December 2, 2024