UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On June 12, 2024, Day One Biopharmaceuticals, Inc. (the “Company”) updated its corporate presentation in connection with recent updates to the Company’s pivotal Phase 3 trial (“FIREFLY-2”) evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pediatric low-grade glioma (“pLGG”).
A copy of the updated presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished in this Item 7.01, including Exhibit 99.1 to 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Current Report on Form 8-K and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
| Item 8.01. | Other Events. |
On June 12, 2024, the Company announced the following changes with respect to its FIREFLY-2 trial:
| • | The primary endpoint of objective response rate will be assessed according to the Response Assessment in Pediatric Neuro-Oncology Low-Grade Glioma (“RAPNO-LGG”) criteria |
| • | Key secondary endpoints of progression free survival and duration of response will be assessed according to RAPNO-LGG criteria |
| • | New patients will be initiated on a starting dose of 380 mg/m2/dose once weekly |
| • | Addition of a once-monthly carboplatin regime as a fourth standard of care option for arm 2 |
Those updates to the tovorafenib program were made based on feedback from the U.S. Food and Drug Administration during review of the New Drug Application forming the basis of the approval of OJEMDATM (tovorafenib) for the treatment of pediatric patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Corporate Presentation. | |
| 104 | Cover Page Interactive Data File (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: June 12, 2024 | By: | /s/ Charles N. York II, M.B.A. | ||||
| Charles N. York II, M.B.A. | ||||||
| Chief Operating Officer and Chief Financial Officer | ||||||