UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01. | Entry into a Material Definitive Agreement. |
On May 29, 2024, Day One Biopharmaceuticals, Inc. (the “Company”) entered into an asset purchase agreement (the “PRV Transfer Agreement”), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”) for $108.0 million, payable in cash, upon the closing of the sale, which occurred simultaneously with the parties entering into the PRV Transfer Agreement. As part of the transaction, $8.1 million of the total consideration received from the sale of the PRV pursuant to the PRV Transfer Agreement will be paid to Viracta Therapeutics, Inc. (“Viracta”) pursuant to the Company’s License Agreement with Viracta, dated December 16, 2019, as amended.
The Company was awarded the PRV under a U.S. Food and Drug Administration (“FDA”) program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when OJEMDA™ (tovorafenib) drug product was approved by the FDA on April 23, 2024 for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
The PRV Transfer Agreement contains customary representations, warranties, covenants and indemnification provisions subject to certain limitations.
The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the text of the PRV Transfer Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2024.
| Item 2.01. | Completion of Acquisition or Disposition of Assets. |
The information contained above in Item 1.01 is hereby incorporated by reference into this Item 2.01.
| Item 7.01 | Regulation FD Disclosure. |
On May 30, 2024, the Company issued a press release pursuant to which it announced that it had entered into the PRV Transfer Agreement. In addition, on May 30, 2024, the Company updated its corporate presentation.
Copies of the press release and updated presentation are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information furnished in this Item 7.01, including Exhibits 99.1 and 99.2 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of 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 Exhibits 99.1 and 99.2 shall not be incorporated by reference into any other filing under the Securities Exchange Act of 1934, as amended, or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release. | |
| 99.2 | 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: May 30, 2024 | By: | /s/ Charles N. York II, M.B.A. | ||
| Charles N. York II, M.B.A. | ||||
| Chief Operating Officer and Chief Financial Officer | ||||