Earnings summaries and quarterly performance for Black Diamond Therapeutics.
Executive leadership at Black Diamond Therapeutics.
Mark Velleca
Detailed
President and Chief Executive Officer
CEO
BH
Brent Hatzis-Schoch
Detailed
Chief Operating Officer and General Counsel
EB
Elizabeth Buck
Detailed
Chief Scientific Officer
EJ
Erika Jones
Detailed
Senior Vice President, Finance (Principal Financial Officer and Principal Accounting Officer)
MM
Melanie Morrison
Detailed
Chief Development Officer
SY
Sergey Yurasov
Detailed
Chief Medical Officer
Board of directors at Black Diamond Therapeutics.
Research analysts covering Black Diamond Therapeutics.
Recent press releases and 8-K filings for BDTX.
Black Diamond Therapeutics Reports Positive BDTX-1535 Phase 2 Lung Cancer Data and Initiates Glioblastoma Phase 2 Trial
BDTX
Product Launch
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics reported positive Phase 2 data for its lead asset, BDTX-1535, in frontline lung cancer patients with non-classical EGFR mutations, demonstrating a 60% response rate and significant CNS activity.
- The company plans to engage with the FDA in H1 2026 for a pivotal trial path for BDTX-1535 in lung cancer, with progression-free survival (PFS) data expected in Q2 2026.
- BDTX-1535 is advancing into a randomized Phase 2 trial for newly diagnosed glioblastoma (GBM) patients, with initial PFS data anticipated in H1 2028.
- The company maintains a cash runway until the second half of 2028, supported by a $70 million upfront payment from out-licensing its RAF inhibitor.
Dec 4, 2025, 6:00 PM
Black Diamond Therapeutics Presents Positive BDTX-1535 Phase 2 Lung Cancer Data and Announces Glioblastoma Trial
BDTX
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics announced positive Phase 2 data for its lead asset, BDTX-1535, in frontline non-classical mutant lung cancer patients, demonstrating a 60% response rate and an 86% CNS response rate with 7.2 months median follow-up.
- The company is advancing BDTX-1535 into a Phase 2 trial for newly diagnosed glioblastoma, with initial progression-free survival (PFS) data anticipated in the first half of 2028.
- BDTX-1535 is highlighted for its broad spectrum coverage of non-classical EGFR mutations and high brain penetrance, addressing key unmet needs in both lung cancer and glioblastoma.
- Black Diamond expects to release PFS data for BDTX-1535 in lung cancer in Q2 2026 and maintains a cash runway until the second half of 2028, supported by a $70 million upfront payment from a RAF inhibitor out-license.
Dec 4, 2025, 6:00 PM
Black Diamond Therapeutics Announces Preliminary Phase 2 Silevertinib Data and Updated Financial Guidance
BDTX
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics announced preliminary Phase 2 data for silevertinib in frontline non-small cell lung cancer (1L NSCLC) patients, demonstrating a 60% Objective Response Rate (ORR) and an 86% CNS ORR in 43 patients with non-classical EGFR mutations as of November 3, 2025.
- The company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed glioblastoma (GBM) patients in 1H 2026, with initial data anticipated in 2028.
- As of September 30, 2025, Black Diamond Therapeutics reported $135.5 million in cash, cash equivalents, and investments, which is expected to fund operations into the second half of 2028. This financial guidance assumes a potential partner funds pivotal development of silevertinib in NSCLC.
Dec 3, 2025, 1:20 PM
Black Diamond Therapeutics reports encouraging silevertinib Phase II results and new GBM trial plans
BDTX
New Projects/Investments
- Black Diamond Therapeutics reported encouraging initial results from its Phase II trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations, demonstrating an Overall Response Rate (ORR) of 60% in 43 patients.
- Silevertinib exhibited robust CNS activity, achieving responses in all seven patients with target CNS lesions, which is crucial for this patient population prone to brain metastasis.
- The company plans to initiate a randomized Phase II trial of silevertinib in newly diagnosed glioblastoma (GBM) patients (specifically unmethylated/MGMT negative with EGFR variant 3), with data anticipated in 2028.
- PFS data from the lung cancer trial is expected in the second quarter of next year (2026), and the company intends to fund the GBM trial with its existing cash on hand.
Dec 3, 2025, 1:00 PM
Black Diamond Therapeutics Provides Silveritinib Phase 2 Update
BDTX
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics presented encouraging initial results from its Phase 2 trial of Silveritinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations, demonstrating a robust response rate across a broad range of distinct mutations.
- The company expects PFS data in the second quarter of next year (2026) for the NSCLC trial, which will inform the path to a registrational study.
- Silveritinib showed remarkable anti-tumor activity in the brain , leading to plans for a randomized Phase 2 trial in newly diagnosed glioblastoma (GBM) patients, combining Silveritinib with Temozolomide. This GBM trial is expected to initiate in the first half of next year (2026) with data anticipated in 2028.
- Black Diamond Therapeutics is actively engaging potential partners for pivotal development of Silveritinib to maximize its global reach and value.
Dec 3, 2025, 1:00 PM
Black Diamond Therapeutics Provides Phase 2 Silveritinib Update and Announces Glioblastoma Trial
BDTX
Product Launch
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics reported encouraging initial results from its Phase 2 trial of Silveritinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations, showing a 60% overall response rate (ORR) across a broad range of mutations.
- The trial demonstrated robust central nervous system (CNS) activity, with confirmed responses in six of seven patients with target CNS lesions at baseline, and preliminary durability trends are encouraging with 29 of 43 patients remaining on therapy after a median follow-up of 7.2 months.
- The company plans to initiate a randomized Phase 2 trial of Silveritinib in newly diagnosed glioblastoma (GBM) patients in the first half of next year (2026), with data expected in 2028.
- This GBM trial, focusing on EGFR variant 3 and unmethylated patients, will randomize 150 patients to Silveritinib plus TMZ or TMZ alone, with progression-free survival (PFS) as the primary endpoint.
- Black Diamond Therapeutics expects to fund the GBM trial with existing cash on hand and continues to engage potential partners for pivotal development of Silveritinib.
Dec 3, 2025, 1:00 PM
BDTX Discusses Silevertinib Program, Market Opportunity, and Financial Outlook
BDTX
New Projects/Investments
Guidance Update
- BDTX's lead program, silevertinib, is an investigational drug targeting non-classical EGFR mutations in non-small cell lung cancer (NSCLC) and glioblastoma, addressing a market of 8,000-9,000 patients in the G7 for NSCLC with an estimated opportunity of $2 billion plus.
- The company anticipates releasing overall response rate (ORR) data from its frontline non-classical EGFR NSCLC Phase 2 study in Q4 2025, with progression-free survival (PFS) data expected in H1 2026.
- BDTX maintains a cash runway until the end of 2027, which includes funding for the initiation of a pivotal Phase 3 trial in H1 2026. This runway does not include potential development milestones from a $70 million upfront payment from a partnership with Servier.
Nov 12, 2025, 2:00 PM
Black Diamond Provides Update on Silavertinib Development and Market Opportunity
BDTX
Product Launch
Guidance Update
New Projects/Investments
- Black Diamond's lead program, silavertinib, is designed to address multiple mutations in non-small cell lung cancer (NSCLC) and glioblastoma (GBM), specifically targeting nonclassical EGFR mutations in NSCLC where current treatments fall short.
- The company anticipates releasing overall response rate (ORR) data for its 43-patient frontline nonclassical EGFR NSCLC trial later this quarter (Q4 2025), with a 60% ORR considered a significant success.
- Black Diamond estimates the total addressable market for silavertinib to be $2 billion+, combining opportunities in lung cancer and glioblastoma.
- The company has a cash runway until 2027, which includes the planned initiation of a pivotal trial in the first half of next year (2026). This runway does not account for potential development milestones from the $70 million upfront payment received from Servier in March.
Nov 11, 2025, 2:20 PM
Black Diamond Therapeutics Provides Update on BDTX-1535 Clinical Development and Financial Outlook
BDTX
New Projects/Investments
Guidance Update
- Black Diamond Therapeutics' lead program, BDTX-1535, is designed to address non-classical EGFR mutations in non-small cell lung cancer (NSCLC) and glioblastoma (GBM). The NSCLC market for these mutations is estimated at 8,000-9,000 patients in the G7, with an overall market opportunity for BDTX-1535 projected at $2 billion plus.
- The company expects to release an update on its 43-patient front-line NSCLC trial in Q4 2025, which will include overall response rate (ORR) and patient-level mutation data, with a 60% ORR considered a "big win". Final data from recurrent disease patients and PFS data for the front-line trial are anticipated in the first half of 2026.
- Black Diamond Therapeutics has a cash runway until the end of 2027, which incorporates the initiation of a pivotal trial in the first half of 2026. This runway does not include potential meaningful development milestones from the $70 million upfront payment received from a Servier partnership in March.
Nov 11, 2025, 2:20 PM
Black Diamond Therapeutics Reports Q3 2025 Financial Results and Corporate Update
BDTX
Earnings
Guidance Update
New Projects/Investments
- Black Diamond Therapeutics reported $135.5 million in cash, cash equivalents, and investments as of September 30, 2025, which is expected to fund operations into Q4 of 2027.
- For the third quarter ended September 30, 2025, the company reported a net loss of $8.5 million, with Research and Development expenses of $7.4 million and General and Administrative expenses of $3.5 million.
- The company expects to disclose objective response rate (ORR) and preliminary duration of treatment data from its Phase 2 trial of silevertinib in 1L non-classical EGFRm NSCLC patients later this quarter.
- Progression-free survival (PFS) data from the silevertinib Phase 2 trial is anticipated in the first half of 2026, at which time the company also plans to seek FDA feedback on a potential registrational path.
Nov 6, 2025, 12:30 PM
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