Item 7.01 Regulation FD Disclosure.
On January 10, 2022, Black Diamond Therapeutics, Inc., (the “Company”) issued a
press release titled, “Black Diamond Therapeutics Announces Strategic Priorities
and Expected Milestones for 2022” and updated its corporate presentation for use
in meetings with investors, analysts and others. A copy of the press release and
a copy of the corporate presentation are furnished as Exhibits 99.1 and 99.2,
respectively, to this Current Report on the Form 8-K.
The information furnished under 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
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 8.01. Other Events. BDTX-1535
On January 10, 2022, the Company announced the submission of its Investigational
New Drug application to the US Food and Drug Administration (“FDA”) for
BDTX-1535 and expects to initiate the Phase 1 study of BDTX-1535 in the first
quarter of 2022, subject to allowance of the IND by the FDA. The Company expects
to provide a clinical data update on BDTX-1535 in the second half of 2023.
The Company also announced that, due to the rapid evolution of the treatment
landscape in non-small cell lung cancer harboring either EGFR or HER2 Exon 20
insertion mutations, the Company has decided to enroll additional patients into
the MasterKey-01 Phase 1 safety expansion cohort to obtain more clinical data
and inform future development of BDTX-189. The Company expects to provide
further guidance on the BDTX-189 program in 2022.
The Company announced that it ended 2021 with approximately $210 million in
cash, cash equivalents and investments, which the Company believes is sufficient
to fund its anticipated operating expenses and capital expenditure requirements
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits: Exhibit No. Description Press Release issued by Black Diamond Therapeutics, Inc., dated January 99.1 10, 2022. Corporate Presentation of Black Diamond Therapeutics, Inc., dated 99.2 January 10, 2022. Cover Page Interactive Data File (embedded within the Inline XBRL document 104 contained in Exhibit 104).
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