Black Diamond Therapeutics (Nasdaq: BDTX) swings to Q1 loss as silevertinib trials advance
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Black Diamond Therapeutics, Inc. reported first quarter 2026 results, showing a net loss of $9.0 million after earning $56.5 million in the same period of 2025, mainly because prior-year license revenue of $70.0 million did not recur. Cash, cash equivalents and investments were $118.3 million as of March 31, 2026, and the company believes this will fund operations into the second half of 2028. R&D and G&A expenses declined year over year as the company sharpened its focus on silevertinib. Clinically, Black Diamond dosed the first patient in its randomized Phase 2 trial of silevertinib in newly diagnosed EGFRvIII+ GBM and plans multiple silevertinib data presentations at the 2026 ASCO Annual Meeting.
Positive
- None.
Negative
- None.
Insights
Results show a shift back to typical R&D-stage losses after one-time 2025 revenue.
Black Diamond Therapeutics posted a Q1 2026 net loss of $9.0M versus net income of $56.5M a year earlier. The swing is largely explained by the absence of prior license revenue of $70.0M, which made 2025 atypically profitable for a clinical-stage company.
Operating expenses declined, with R&D at $7.0M and G&A at $4.3M, reflecting a tighter focus on silevertinib and operational efficiencies. Cash, cash equivalents and investments of $118.3M are expected to fund operations into the second half of 2028, providing a multiyear runway.
Clinically, progress centers on silevertinib, including first patient dosing in a randomized Phase 2 GBM trial and multiple data presentations at the 2026 ASCO Annual Meeting. Future updates from these trials will be important for understanding the asset’s potential in EGFRm NSCLC and EGFRvIII+ GBM.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Cash, cash equivalents and investments: $118.3M
Net income (loss): ($9.0M)
License revenue: $0 vs $70.0M
+5 more
8 metrics
Cash, cash equivalents and investments
$118.3M
As of March 31, 2026; expected to fund operations into 2H 2028
Net income (loss)
($9.0M)
Q1 2026 net loss vs $56.5M net income in Q1 2025
License revenue
$0 vs $70.0M
Q1 2026 vs Q1 2025 license revenue
R&D expenses
$7.0M
Q1 2026 research and development vs $10.5M in Q1 2025
G&A expenses
$4.3M
Q1 2026 general and administrative vs $5.0M in Q1 2025
Total assets
$132.9M
Total assets as of March 31, 2026
Total stockholders’ equity
$104.3M
Stockholders’ equity as of March 31, 2026
Net loss per share, basic
($0.16)
Basic net loss per share for Q1 2026
Key Terms
EGFRm NSCLC, EGFRvIII+ GBM, duration of response (DOR), progression-free survival (PFS), +2 more
6 terms
EGFRm NSCLC medical
"Phase 2 data will highlight silevertinib’s potential to benefit frontline EGFRm NSCLC patients"
EGFRvIII+ GBM medical
"randomized Phase 2 trial in newly diagnosed EGFRvIII+ GBM also initiated this month"
A tumor type defined by glioblastoma (an aggressive brain cancer) that carries the EGFRvIII mutation, a specific change in the EGFR gene that makes cells grow abnormally. Investors care because this mutation creates a distinct patient subgroup with different treatment needs and measurable diagnostic tests, making it a target for drugs and diagnostics; like finding a unique lock that only some keys (therapies) will fit, treatments aimed at EGFRvIII can drive focused clinical development and potential market value.
duration of response (DOR) medical
"including preliminary duration of response (DOR) and progression-free survival (PFS) data"
Duration of response (DOR) measures how long a meaningful positive reaction to a treatment lasts before the disease worsens or returns. Think of it as a stopwatch that starts when a patient improves and stops when that improvement ends; longer times suggest a treatment’s benefit is more reliable. For investors, DOR helps judge a drug’s commercial staying power, pricing power, and likelihood of regulatory approval or broader adoption.
progression-free survival (PFS) medical
"including preliminary duration of response (DOR) and progression-free survival (PFS) data"
Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.
MasterKey therapies medical
"a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations"
fourth-generation EGFR MasterKey inhibitor medical
"a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM"
Earnings Snapshot
License revenue: $0 · Guidance included
Q1 2026
License revenue
$0
Net income (loss)
($9.0M)
R&D expenses
$7.0M
G&A expenses
$4.3M
Cash, cash equivalents and investments
$118.3M
Guidance
Black Diamond believes its cash, cash equivalents and investments will fund anticipated operating expenses and capital expenditures into the second half of 2028.
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 7, 2026
BLACK DIAMOND
THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(Address of principal executive offices, including zip code)
(617 ) 252-0848
(Registrant’s telephone number, including area code)
Not Applicable
(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 | Trade Symbol(s) | Name of each exchange on which registered | ||||||||||||
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 ☐
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 2.02. Results of Operations and Financial Condition.
On May 7, 2026, Black Diamond Therapeutics, Inc. announced its financial results for the three months ended March 31, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) 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 9.01. Financial Statements and Exhibits.
(d) Exhibits:
| Exhibit No. | Description | |||||||
99.1 | Press Release issued by Black Diamond Therapeutics, Inc., dated May 7, 2026. | |||||||
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 7, 2026 | By: | /s/ Brent Hatzis-Schoch | ||||||
| Brent Hatzis-Schoch | ||||||||
| Chief Operating Officer and General Counsel | ||||||||
Black Diamond Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
•Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC patients, including preliminary DOR and PFS data, to take place at the 2026 ASCO Annual Meeting
•First patient dosed in the Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII+ GBM
•Cash, cash equivalents, and investments of $118.3 million as of March 31, 2026, expected to be sufficient to fund operations into 2H of 2028
CAMBRIDGE, MA, May 7, 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 reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.
“We remain focused on advancing silevertinib into pivotal development and are looking forward to the 2026 ASCO Annual Meeting later this month where an oral presentation of Phase 2 data will highlight silevertinib’s potential to benefit frontline EGFRm NSCLC patients,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Our randomized Phase 2 trial in newly diagnosed EGFRvIII+ GBM also initiated this month with the dosing of our first patient.”
Recent Developments & Upcoming Milestones:
•In April 2026, Black Diamond announced the following presentations at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago:
◦May 30, 2026, 1:15 PM-2:45 PM CDT: Oral presentation on updated clinical data from the Phase 2 trial in patients with non-classical EGFRm NSCLC in the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data (Abstract: 8519).
◦May 31, 2026, 9:00 AM-12:00 PM CDT: Poster presentation on the Phase 2 data of silevertinib in recurrent EGFRm NSCLC patients (Abstract: 8620).
◦June 1, 2026, 1:30 PM-4:30 PM CDT: Trial-in-progress poster on the randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (Abstract: TPS2098).
•In May 2026, the first patient was dosed with silevertinib in combination with temozolomide (TMZ) in the safety lead-in portion of the randomized Phase 2 trial in patients with newly diagnosed EGFRvIII+ GBM (NCT07326566).
Financial Highlights
•Cash Position: Black Diamond ended the first quarter of 2026 with approximately $118.3 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $10.2 million for the first quarter of 2026 compared to net cash provided by operations of $53.4 million for the first quarter of 2025.
•Research and Development Expenses: Research and development (R&D) expenses were $7.0 million for the first quarter of 2026, compared to $10.5 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
•General and Administrative Expenses: General and administrative (G&A) expenses were $4.3 million for the first quarter of 2026, compared to $5.0 million for the same period in 2025. The decrease in G&A expenses was primarily due to the realization of continued operational efficiencies.
•Net Loss: Net loss for the first quarter of 2026 was $9.0 million, as compared to net income of $56.5 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the first quarter of 2026 with approximately $118.3 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
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, a 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 EGFRm NSCLC and in patients with newly diagnosed EGFRvIII+ GBM, the potential of silevertinib to address the unmet medical need for newly diagnosed GBM patients and for 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 Company’s expected cash runway. 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.
Black Diamond Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)
| March 31, 2026 | December 31, 2025 | ||||||||||
| (in thousands) | |||||||||||
| Cash, cash equivalents, and investments | $ | 118,258 | $ | 128,652 | |||||||
| Total assets | $ | 132,922 | $ | 143,010 | |||||||
| Accumulated deficit | $ | (473,776) | $ | (464,740) | |||||||
| Total stockholders’ equity | $ | 104,300 | $ | 112,211 | |||||||
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| License revenue | $ | — | $ | 70,000 | |||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 7,003 | $ | 10,506 | |||||||
| General and administrative | 4,256 | 4,964 | |||||||||
| Total operating expenses | 11,259 | 15,470 | |||||||||
| Income (loss) from operations | (11,259) | 54,530 | |||||||||
| Other income (expense): | |||||||||||
| Interest income | 1,023 | 595 | |||||||||
| Other income (expense) | 1,200 | 1,417 | |||||||||
| Total other income (expense), net | 2,223 | 2,012 | |||||||||
| Net income (loss) | $ | (9,036) | $ | 56,542 | |||||||
| Net income (loss) per share - basic | $ | (0.16) | $ | 1.00 | |||||||
| Net income (loss) per share - diluted | $ | (0.16) | $ | 0.98 | |||||||
| Weighted average common shares outstanding - basic | 57,233,413 | 56,663,798 | |||||||||
| Weighted average common shares outstanding - diluted | 57,233,413 | 57,673,099 | |||||||||
Contact
For Investors:
investors@bdtx.com
For Media:
media@bdtx.com
# # #
FAQ
How did Black Diamond Therapeutics (BDTX) perform financially in Q1 2026?
Black Diamond reported a net loss of $9.0 million for Q1 2026, compared with net income of $56.5 million in Q1 2025. The prior year included $70.0 million of license revenue that did not recur, making 2025 unusually profitable.
What is Black Diamond Therapeutics’ (BDTX) cash runway after Q1 2026?
Black Diamond ended Q1 2026 with $118.3 million in cash, cash equivalents and investments. The company believes this balance will fund anticipated operating and capital needs into the second half of 2028, providing a multiyear financial runway.
How did R&D and G&A expenses change for BDTX in Q1 2026?
Research and development expenses were $7.0 million in Q1 2026 versus $10.5 million a year earlier. General and administrative expenses declined to $4.3 million from $5.0 million, reflecting greater focus on silevertinib and operational efficiencies.
What key clinical milestones did Black Diamond Therapeutics (BDTX) report for silevertinib?
Black Diamond dosed the first patient in a randomized Phase 2 trial of silevertinib in newly diagnosed EGFRvIII+ GBM. The company also highlighted upcoming ASCO presentations featuring Phase 2 data in EGFR-mutant NSCLC and trial-in-progress updates in GBM.
What ASCO 2026 presentations will feature Black Diamond’s silevertinib data?
At ASCO 2026, Black Diamond will present an oral session with updated Phase 2 frontline EGFRm NSCLC data, including preliminary DOR and PFS, plus posters on recurrent EGFRm NSCLC and a trial-in-progress poster for the randomized EGFRvIII+ GBM Phase 2 study.
Why did Black Diamond Therapeutics’ (BDTX) revenue decline in Q1 2026?
License revenue was $0 in Q1 2026 compared with $70.0 million in Q1 2025. The 2025 quarter benefited from significant license revenue that did not repeat, explaining much of the shift from net income to a net loss year over year.