Black Diamond completes enrollment in silevertinib Phase 2 trial for NSCLC and plans FDA meeting in 2026.
Quiver AI Summary
Black Diamond Therapeutics has completed enrollment in a Phase 2 trial of silevertinib (BDTX-1535) for newly diagnosed patients with non-classical EGFR mutations in non-small cell lung cancer (NSCLC), with results on objective response rate and preliminary duration of response expected by Q4 2025. The company is seeking partnerships to further develop silevertinib in NSCLC and glioblastoma, and it plans to engage with the FDA regarding its development path for frontline NSCLC in early 2026 when additional data becomes available. As of June 30, 2025, Black Diamond reported $142.8 million in cash and equivalents, sufficient to fund operations into Q4 2027, with a reduced net loss this quarter compared to last year.
Potential Positives
- Enrollment completion for the Phase 2 trial of silevertinib (BDTX-1535) suggests significant progress in the development of a potential new treatment for non-small cell lung cancer (NSCLC).
- The company expects to release objective response rate (ORR) and preliminary duration of response (DOR) data in Q4 2025, which could provide valuable insights into the treatment's efficacy.
- Black Diamond has a strong cash position of approximately $142.8 million, which is projected to be sufficient to fund operations into Q4 2027, ensuring ongoing support for their clinical programs.
- The exploration of partnership opportunities for silevertinib indicates proactive steps to advance pivotal development and enhance the drug's market potential in both NSCLC and glioblastoma (GBM).
Potential Negatives
- Completing enrollment with only 43 patients in the Phase 2 trial may indicate limited early-stage interest or challenges in recruitment for the study.
- The net loss of $10.6 million in Q2 2025, although an improvement from the previous year, still signals continued financial strain on the company.
- The company’s accumulated deficit has increased to $(441.1) million, indicating significant historical financial losses that could concern investors.
FAQ
What is the current status of the silevertinib trial?
The Phase 2 trial of silevertinib in NSCLC has completed enrollment with 43 patients, results expected in Q4 2025.
When will data from the silevertinib trial be released?
Black Diamond anticipates sharing objective response rate and preliminary duration of response data in Q4 2025.
What financial position does Black Diamond Therapeutics have?
As of June 30, 2025, the company reported $142.8 million in cash and equivalents, sufficient to fund operations into Q4 2027.
What are Black Diamond's plans with the FDA?
The company plans to meet the FDA in 1H 2026 to discuss a developmental path for silevertinib in NSCLC.
Is Black Diamond searching for partnerships for silevertinib?
Yes, Black Diamond is exploring partnership opportunities to advance silevertinib’s development in NSCLC and glioblastoma.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$BDTX Insider Trading Activity
$BDTX insiders have traded $BDTX stock on the open market 7 times in the past 6 months. Of those trades, 0 have been purchases and 7 have been sales.
Here’s a breakdown of recent trading of $BDTX stock by insiders over the last 6 months:
- GROWTH N V BIOTECH has made 0 purchases and 7 sales selling 5,784,292 shares for an estimated $11,997,749.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$BDTX Hedge Fund Activity
We have seen 39 institutional investors add shares of $BDTX stock to their portfolio, and 45 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- BELLEVUE GROUP AG removed 5,784,292 shares (-67.9%) from their portfolio in Q1 2025, for an estimated $8,965,652
- RENAISSANCE TECHNOLOGIES LLC removed 824,100 shares (-91.2%) from their portfolio in Q1 2025, for an estimated $1,277,355
- MILLENNIUM MANAGEMENT LLC added 545,836 shares (+97.8%) to their portfolio in Q1 2025, for an estimated $846,045
- BOXER CAPITAL MANAGEMENT, LLC removed 506,000 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $784,300
- AWM INVESTMENT COMPANY, INC. added 500,000 shares (+inf%) to their portfolio in Q1 2025, for an estimated $775,000
- KENNEDY CAPITAL MANAGEMENT LLC removed 370,270 shares (-85.4%) from their portfolio in Q1 2025, for an estimated $573,918
- AFFINITY ASSET ADVISORS, LLC removed 309,163 shares (-55.3%) from their portfolio in Q1 2025, for an estimated $479,202
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$BDTX Analyst Ratings
Wall Street analysts have issued reports on $BDTX in the last several months. We have seen 3 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Raymond James issued a "Outperform" rating on 07/01/2025
- HC Wainwright & Co. issued a "Buy" rating on 03/18/2025
- Stifel issued a "Buy" rating on 03/07/2025
To track analyst ratings and price targets for $BDTX, check out Quiver Quantitative's $BDTX forecast page.
$BDTX Price Targets
Multiple analysts have issued price targets for $BDTX recently. We have seen 3 analysts offer price targets for $BDTX in the last 6 months, with a median target of $12.0.
Here are some recent targets:
- Sean McCutcheon from Raymond James set a target price of $11.0 on 07/01/2025
- Robert Burns from HC Wainwright & Co. set a target price of $12.0 on 03/18/2025
- Bradley Canino from Stifel set a target price of $15.0 on 03/07/2025
Full Release
- Enrollment completed for the Phase 2 trial of silevertinib (BDTX-1535) in 1L patients with non-classical EGFRm NSCLC (n=43); ORR and preliminary DOR data on track for Q4 2025
- Exploring partnership opportunities to advance pivotal development of silevertinib in NSCLC and GBM
- Plan to meet with FDA regarding 1L NSCLC development path in 1H 2026, when PFS data becomes available
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Cash, cash equivalents, and investments of
$142.8 million
as of
June 30, 2025
;
expected to be sufficient to fund operations into Q4 of 2027
CAMBRIDGE, Mass., Aug. 07, 2025 (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 second quarter ended June 30, 2025, and provided a corporate update.
“With enrollment completed in our silevertinib Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC, we look forward to sharing a clinical update in the fourth quarter of 2025,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Given the evolving competitive and regulatory landscape, we are also exploring partnership opportunities to advance silevertinib into pivotal development and bring this potential best-in-class treatment to patients as quickly as possible.”
Recent Developments & Upcoming Milestones:
Silevertinib (BDTX-1535):
- In July 2025, Black Diamond completed enrollment (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations.
- In the fourth quarter of 2025, Black Diamond expects to disclose objective response rate (ORR) and preliminary duration of response (DOR) data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline NSCLC with non-classical EGFR mutations.
- Black Diamond is exploring partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
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The Company plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in 1H 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.
Financial Highlights
- Cash Position: Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash used in operations was $9.2 million for the second quarter of 2025 compared to net cash used in operations of $14.7 million for the second quarter of 2024.
- Research and Development Expenses: Research and development (R&D) expenses were $9.3 million for the second quarter of 2025, compared to $12.6 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
- General and Administrative Expenses: General and administrative (G&A) expenses were $4.1 million for the second quarter of 2025, compared to $9.6 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
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Net Income/Loss:
Net loss for the second quarter of 2025 was $10.6 million, as compared to a net loss of $19.9 million for the same period in 2024.
Financial Guidance
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Black Diamond ended the second quarter of 2025 with approximately $142.8 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 fourth quarter of 2027.
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 a Phase 2 NSCLC trial of 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 trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, enrollment in the investigator sponsored Phase 0/1 clinical trial of silevertinib of newly diagnosed GBM patients with EGFR alterations, the expected timing for regulatory feedback and the disclosure of a potential registrational pathway for silevertinib in NSCLC, the potential of silevertinib to address the unmet medical need 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, a potential partnership for silevertinib, 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, 2024, 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.
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Black Diamond Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited) (in thousands) |
|||||||
| June 30, 2025 | December 31, 2024 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents, and investments | $ | 142,829 | $ | 98,575 | |||
| Total assets | $ | 166,385 | $ | 122,640 | |||
| Accumulated deficit | $ | (441,126 | ) | $ | (487,107 | ) | |
| Total stockholders’ equity | $ | 132,610 | $ | 83,285 | |||
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Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) |
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Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||
| License revenue | $ | — | $ | — | $ | 70,000 | $ | — | ||||||
| Operating expenses: | ||||||||||||||
| Research and development | $ | 9,319 | $ | 12,556 | $ | 19,825 | $ | 26,101 | ||||||
| General and administrative | 4,101 | 9,574 | 9,065 | 16,275 | ||||||||||
| Total operating expenses | 13,420 | 22,130 | 28,890 | 42,376 | ||||||||||
| Income (loss) from operations | (13,420 | ) | (22,130 | ) | 41,110 | (42,376 | ) | |||||||
| Other income (expense): | ||||||||||||||
| Interest income | 1,118 | 464 | 1,713 | 1,101 | ||||||||||
| Other income (expense) | 1,741 | 1,757 | 3,158 | 3,141 | ||||||||||
| Total other income (expense), net | 2,859 | 2,221 | 4,871 | 4,242 | ||||||||||
| Net income (loss) | $ | (10,561 | ) | $ | (19,909 | ) | $ | 45,981 | $ | (38,134 | ) | |||
| Net income (loss) per share - basic | $ | (0.19 | ) | $ | (0.36 | ) | $ | 0.81 | $ | (0.71 | ) | |||
| Net income (loss) per share - diluted | $ | (0.19 | ) | $ | (0.36 | ) | $ | 0.80 | $ | (0.71 | ) | |||
| Weighted average common shares outstanding - basic | 56,803,450 | 55,155,220 | 56,734,010 | 53,482,034 | ||||||||||
| Weighted average common shares outstanding - diluted | 56,803,450 | 55,155,220 | 57,474,118 | 53,482,034 | ||||||||||
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