UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On November 17, 2023, Day One Biopharmaceuticals, Inc. (the “Company”) issued a press release announcing that results from the registrational Phase 2 FIREFLY-1 trial evaluating the investigational agent tovorafenib in patients with BRAF-altered, relapsed or progressive pediatric low-grade glioma, with a data cutoff of June 5, 2023, were published in the medical journal Nature Medicine. These results will be shared in two oral plenary presentations at the 2023 Society for Neuro-Oncology Annual Meeting on Friday, November 17, 2023.
Additionally, on November 17, 2023, the Company updated its corporate presentation to reflect the registrational Phase 2 FIREFLY-1 trial results.
A copy of the press release is attached as Exhibit 99.1 to this Current Report on 8-K. A copy of the revised corporate presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K.
The information furnished in this Item 7.01, including Exhibits 99.1 and 99.2, 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 into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release, dated November 17, 2023 | |
| 99.2 | Corporate Presentation | |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| DAY ONE BIOPHARMACEUTICALS, INC. | ||||||
| Date: November 17, 2023 | By: | /s/ Charles N. York II, M.B.A. | ||||
| Charles N. York II, M.B.A. | ||||||
| Chief Operating Officer and Chief Financial Officer | ||||||