Form 8-K

8-K — Black Diamond Therapeutics, Inc.

Accession: 0001104659-26-065254

Filed: 2026-05-21

Period: 2026-05-21

CIK: 0001701541

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.

20549

FORM 8-K

CURRENT REPORT

Pursuant

to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

May 21, 2026

BLACK DIAMOND THERAPEUTICS, INC.

(Exact name

of registrant as specified in its charter)

Delaware

001-39200

81-4254660

(State or other jurisdiction

(Commission

(I.R.S. Employer

of incorporation)

File Number)

Identification No.)

245 First Street, 18th Floor

Cambridge, MA 02142

(Address of principal

executive offices, including zip code)

(617) 252-0848

(Registrant’s telephone number, including

area code)

One Main Street, 14th Floor

Cambridge,

02142

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common Stock, $0.0001 par value per share

BDTX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange

Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant

to Section 13(a) of the Exchange Act. ¨

Item 7.01. Regulation FD Disclosure.

On May 21, 2026, Black Diamond Therapeutics, Inc.

(the “Company”) issued a press release titled “Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib

in Frontline NSCLC Patients with EGFR Non-Classical Mutations.” A copy of the press release is furnished as Exhibit 99.1 to

this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.1

attached hereto, is intended to be 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 a filing.

Item 8.01. Other Events.

On May 21, 2026, the Company announced results

from its Phase 2 trial of silevertinib in frontline (“1L”) non-small cell lung cancer (“NSCLC”) patients with

epidermal growth factor receptor (“EGFR”) non-classical mutations (“NCMs”).

Silevertinib 1L NSCLC Phase 2 Results Summary

Forty-three frontline NSCLC patients harboring

a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (“PACC”) mutations, were enrolled, including

19 patients with brain metastases, seven of whom had measurable central nervous system (“CNS”) target lesions. All patients

were enrolled at a 200 mg oral daily dose (“QD”) of silevertinib. Efficacy and safety were assessed with an April 11,

2026 data cutoff date; median follow-up time as of this date was 11.2 months, and the study remains ongoing.

Key data highlights include:

· Durability

o Preliminary median progression-free survival is 15.2 months (95% CI: 10.8, NE)

o Median duration of response (“DOR”) had not been reached (95% CI: 7.0, NE)

o 23 of 43 patients (53%) remain on therapy, with longest at 23.5 months

· CNS Activity

o No patients developed de novo brain metastases

o Previously disclosed CNS Objective Response Rate (“ORR”) (ORR by RANO-BM) remained at 86%

· ORR and DCR

o Previously disclosed ORR (ORR by RECIST 1.1) and Disease Control Rate (“DCR”) remained at 60% and 91%, respectively

o Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC

· Safety

o No new safety signals were observed

o The rate of treatment-related adverse events > Grade 3 was reduced to 28% following dose reduction

o Patients maintained or deepened clinical responses after dose reduction

o Safety and efficacy data support 150 mg QD for pivotal development

Forward-Looking Statements

Statements contained in this Current Report on

Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private

Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially

from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding:

the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trials and the timing of clinical updates

for silevertinib in patients with NSCLC and in patients with GBM, the potential of silevertinib to address the unmet medical need for

newly diagnosed GBM patients and newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across

multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, and the competitive landscape and

market for silevertinib or any of the Company’s other current or future product candidates, including statements relating to the

estimated percentage of newly diagnosed NSCLC patients with non-classical EGFR mutations and the potential addressable patient population.

Any forward-looking statements in this Current Report on Form 8-K are based on management’s current expectations of future

events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from

those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking

statements include those risks and uncertainties set forth in the Company’s Annual Report on Form 10-K for the year ended December 31,

2025, filed with the United States Securities and Exchange Commission (the “SEC”) and in its subsequent filings filed with

the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company

undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they

were made.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

Exhibit No.

Description

99.1

Press Release issued by Black Diamond Therapeutics, Inc. dated May 21, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

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.

Black Diamond Therapeutics, Inc.

Date: May 21, 2026

By:

/s/ Brent Hatzis-Schoch

Brent Hatzis-Schoch

Chief Operating Officer and General Counsel

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2615293d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Black Diamond Therapeutics Announces

Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical Mutations

· Preliminary

mPFS of 15.2 months; mDOR not reached

· Robust

CNS activity, with 86% CNS ORR; no patients developed de novo brain metastases

· ORR

60% in patients with a broad spectrum of EGFR-NCMs, including PACC

· Dose

dependent and manageable AE profile, no new safety signals observed

· Webcast

on Thursday, May 21, 2026 at 5:30 pm EDT

CAMBRIDGE, MA, May 21,

2026 (GLOBE NEWSWIRE) – Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing

MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced positive results from its Phase

2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical

mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber

Cancer Institute, at the 2026 American Society of Clinical Oncology® (ASCO®) Annual Meeting on Saturday, May 30, 2026, 1:15

PM-2:45 PM CDT.

“Silevertinib continues to demonstrate

potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that

far exceeds historical data for currently available therapies” said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black

Diamond Therapeutics. “Importantly, silevertinib prevented the development of de novo brain metastases in this patient population,

where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal

development plan.”

“Patients with EGFR non-classical

mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline

TKIs,” added Dr. Rotow. “The activity we are seeing with silevertinib across the full NCM spectrum, combined with its

CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO next week.”

Silevertinib 1L NSCLC Phase 2 Results

Summary

Results as of an April 11, 2026

data cutoff date include:

· 43

patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib

o Patients

presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing

(PACC) mutations

o 19

patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target

lesions

o 11.2

months median follow-up

· Durability

o Preliminary

median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)

o Median

duration of response (DOR) had not been reached (95%CI: 7.0, NE)

o 23

of 43 patients (53%) remain on therapy, with longest at 23.5 months

· CNS

Activity

o No

patients developed de novo brain metastases

o Previously

disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%

· ORR

and DCR

o Previously

disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained

at 60% and 91%, respectively

o Variant

allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs,

including PACC

· Safety

o No

new safety signals were observed

o The

rate of TRAEs > Grade 3 was reduced to 28% following dose reduction

o Patients

maintained or deepened clinical responses after dose reduction

o Safety

and efficacy data support 150 mg QD for pivotal development

ASCO Abstract: 8519

Title: Safety and efficacy results

of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical

EGFR mutations

Presenter: Julia Rotow, M.D.,

Clinical Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute

Date and Time: May 30, 2026,

1:15 PM-2:45 PM CDT (slides will be available at the time of the presentation on the Black Diamond website)

Company Webcast Information

Black Diamond will hold a webcast for

investors on Thursday, May 21, 2026 at 5:30 p.m. EDT. The webcast can be accessed under “Events and Presentations”

on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com.

About Silevertinib

Silevertinib is an investigational oral,

covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical

EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding

the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR-mutant NSCLC or EGFR-altered GBM

have been treated with silevertinib.

In addition to the ongoing Phase 2 trial

of silevertinib in patients with EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with

newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage

oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s

MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated

toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, an investigational

brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.

From time to time, we may use our website

or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and

other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com.

Investors are encouraged to review the Investors section of our website because we may post material information on that site that is

not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is

not incorporated into, and does not form a part of, this press release.

Forward-Looking Statements

Statements contained in this press release

regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities

Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from

those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding:

the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trials and the timing of clinical updates

for silevertinib in patients with NSCLC and in patients with GBM, the potential of silevertinib to address the unmet medical need for

newly diagnosed GBM patients and newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across

multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, and the competitive landscape and

market for silevertinib or any of the Company’s other current or future product candidates, including statements relating to the

estimated percentage of newly diagnosed NSCLC patients with non-classical EGFR mutations and the potential addressable patient population.

Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject

to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or

implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those

risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the United

States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission.

All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes

no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact

For Investors:

investors@bdtx.com

For Media:

media@bdtx.com

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