BDTX

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, Mass., 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 Durability CNS Activity ORR and DCR Safety ASCO Abstract: 8519Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients...

Webcast will be held Thursday, May 21, 2026, at 5:30 p.m. ET CAMBRIDGE, Mass., May 19, 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, will host a webcast for investors to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR mutated non-small cell lung cancer on Thursday, May 21, 2026, at 5:30 p.m. ET. Webcast information The webcast can be accessed under “Events and Presentations” on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event for a limited time. 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. Contacts For Investors:[email protected] For Media:[email protected]

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, Mass., May 07, 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 wit...

CAMBRIDGE, Mass. (AP) — CAMBRIDGE, Mass. (AP) — Black Diamond Therapeutics, Inc. (BDTX) on Thursday reported a first-quarter loss of $9 million, after reporting a profit in the same period a year earlier. The Cambridge, Massachusetts-based company said it had a loss of 16 cents per share. The results exceeded Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. The company's shares closed at $2.85. A year ago, they were trading at $1.47. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on BDTX at https://www.zacks.com/ap/BDTX

A month has gone by since the last earnings report for Black Diamond (BDTX). Shares have added about 19.3% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Black Diamond due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Black Diamond Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Black Diamond Posts Narrower Q4 Loss Black Diamond did not generate any revenue in the fourth quarter of 2025, consistent with the prior-year period. The company posted an adjusted net loss per share of 14 cents per share, slightly narrower than a loss of 28 cents in the year-ago quarter, reflecting modest improvement in overall profitability. Operating performance during the quarter benefited significantly from lower expenses following restructuring efforts and a sharper focus on core assets. Research and development (R&D) expenses fell nearly 49% to $6.3 million, while general and administrative (G&A) expenses declined about 34% to $4.0 million. These reductions more than offset a $7.3 million non-cash impairment charge related to right-of-use assets and property and equipment. As a result, total operating expenses decreased to $17.6 million from $18.3 million in the prior-year quarter. Other income provided a modest tailwind, with interest income increasing to $1.2 million from $0.6 million, contributing to total other income of $2.5 million versus $2.3 million a year earlier. The company also delivered a slight earnings surprise, driven by improved cost control and a narrower loss base. Although no revenue was recorded in the quarter, full-year FY2025 results included $70 million in license revenue from a strategic agreement with Servier. This upfront payment supported a shift to full-year profitability and strengthened cash flows. Black Diamond continues to streamline its operations and prioritize its lead asset, silevertinib, including out-licensing non-core programs. Management highlighted encouraging early clinical data in EGFR-mutant NSCLC and GBM, with strong response rates observed in phase II studies. Upcoming catalysts include additional NSCLC data readouts and the initiation of a randomized phase II GBM tria...

CAMBRIDGE, Mass. (AP) — CAMBRIDGE, Mass. (AP) — Black Diamond Therapeutics, Inc. (BDTX) on Monday reported a loss of $15.1 million in its fourth quarter. The Cambridge, Massachusetts-based company said it had a loss of 27 cents per share. Losses, adjusted for asset impairment costs, were 14 cents per share. The results surpassed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 18 cents per share. For the year, the company reported net income of $22.4 million, or 39 cents per share, swinging to a profit in the period. In the final minutes of trading on Monday, the company's shares hit $2.18. A year ago, they were trading at $1.72. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on BDTX at https://www.zacks.com/ap/BDTX

Clinical update on track for Q2 2026 for Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, including preliminary DOR and PFS data in frontline setting Company is preparing to initiate a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFR altered GBM in Q2 2026 Cash, cash equivalents, and investments of $128.7 million as of December 31, 2025, expected to be sufficient to fund operations into 2H of 2028 CAMBRIDGE, Mass., March 16, 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 fourth quarter and full year ended December 31, 2025, and provided a corporate update. “We continue to focus on advancing silevertinib for the treatment of patients with EGFRm NSCLC and EGFR altered GBM,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “We look forward to presenting updated results from the Phase 2 NSCLC trial in both the frontline and recurrent settings, including preliminary DOR and PFS data for frontline patients, at a medical meeting in the second quarter of 2026. We also expect to initiate our randomized Phase 2 trial in newly diagnosed GBM in the second quarter this year.” Recent Developments & Upcoming Milestones: In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients harboring a broad spectrum of non-classical epidermal growth factor receptor (EGFR) mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate (DCR) as of a November 3, 2025 data cutoff. No new safety signals were observed. Black Diamond continues to explore potential partnership opportunities to advance silevertinib into pivotal development. Black Diamond anticipates the following upcoming key milestones for silevertinib: Presentation of updated clinical data from our Phase 2 trial in patients with non-classical EGFR NSCLC in both the recurrent setting and the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data for frontline EGFRm patients, at a medical meeting in the second qua...

Silevertinib, a fourth‑generation EGFR inhibitor targeting non‑classical EGFR mutations and GBM, has a near‑term catalyst: the company plans to present frontline NSCLC PFS data next quarter, and Black Diamond says it has a lean operating model providing >2 years of runway. In the frontline phase 2 cohort (43 patients, 35 distinct non‑classical mutations), Black Diamond reported a 60% ORR, 93% DCR and an 86% CNS response rate, with encouraging early durability and preliminary DoR/PFS data expected at a medical meeting in Q2. Black Diamond will initiate a randomized phase 2 trial in newly diagnosed GBM next quarter (TMZ vs TMZ + silevertinib) with a safety run‑in and expects preliminary PFS readout in the first half of 2028, after treating >60 recurrent GBM patients showing brain penetrance and early activity. Interested in Black Diamond Therapeutics, Inc.? Here are five stocks we like better. Black Diamond Therapeutics (NASDAQ:BDTX) used a presentation at the 46th annual TD Cowen Healthcare Conference to highlight progress for its lead program, silevertinib, a fourth-generation epidermal growth factor receptor (EGFR) inhibitor being developed for patients with non-small cell lung cancer (NSCLC) harboring non-classical EGFR mutations and for glioblastoma (GBM). Chief executive officer Mark Velleca said the company expects a key near-term catalyst next quarter, when it plans to present progression-free survival (PFS) data for silevertinib in frontline NSCLC patients. He also said Black Diamond has a “lean operating model” that provides more than two years of runway and funds the company through the phase 2 readout of its planned GBM study. → Uber and Joby Aviation Team Up: Game Changer or Hype? Velleca contrasted the treatment landscape for “classical” EGFR mutations—where multiple generations of inhibitors are approved and most patients now receive osimertinib (Tagrisso)—with the large and heterogeneous set of more than 50 “non-classical” EGFR mutations, which he said lack good treatment options. He estimated that about one-quarter of EGFR-mutant NSCLC patients present with a non-classical mutation. According to Velleca, frontline patients with non-classical mutations are often treated with chemotherapy, afatinib, or osimertinib, with reported PFS in the range of six to 10 months in recent studies. → BigBear.ai Stock Is Down Big, But Smart Money Is Quietly Buy...

Webcast to be held Wednesday, December 3, at 8:00am ET CAMBRIDGE, Mass., Dec. 02, 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, will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET. Webcast information The webcast can be accessed under “Events and Presentations” on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event. 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 non-small cell lung cancer (NSCLC) trial of silevertinib, a brain-penetrant fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant NSCLC and glioblastoma. 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. Contact For Investors: [email protected] For Media: [email protected]

CAMBRIDGE, Mass. (AP) — CAMBRIDGE, Mass. (AP) — Black Diamond Therapeutics, Inc. (BDTX) on Thursday reported a loss of $8.5 million in its third quarter. On a per-share basis, the Cambridge, Massachusetts-based company said it had a loss of 15 cents. The results topped Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 22 cents per share. The company's shares closed at $3.87. A year ago, they were trading at $3.25. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on BDTX at https://www.zacks.com/ap/BDTX

ORR and preliminary duration of treatment data for the Phase 2 trial of silevertinib in 1L patients with non-classical EGFRm NSCLC on track for this quarter Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., Nov. 06, 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 third quarter ended September 30, 2025, and provided a corporate update. “We are looking forward to sharing a clinical update later this quarter from our silevertinib Phase 2 trial in newly diagnosed patients with EGFRm NSCLC,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “The update will include ORR and preliminary duration of treatment data, while PFS data is expected in the first half of 2026.” Recent Developments & Upcoming Milestones: Silevertinib Later this quarter, Black Diamond plans to disclose objective response rate (ORR) and preliminary duration of treatment data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) with non-classical epidermal growth factor receptor (EGFR) mutations. Black Diamond continues to explore partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development. The Company intends to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFR mutant NSCLC in the first half of 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available. Financial Highlights Cash Position: Black Diamond ended the third quarter of 2025 with approximately $135.5 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash used in operations was $7.9 million for the third quarter of 2025 compared to net cash used in operations of $11.3 million for the third quarter of 2024. Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the third quarter of 2025, compared to $12.9 million for the same period in 2024. The decrease in R&D expenses was primarily d...

Investors will focus on updates on lead pipeline candidate silevertinib when Black Diamond Therapeutics BDTX reports third-quarter results shortly. The Zacks Consensus Estimate for loss per share is pegged at 22 cents. Earnings estimate for 2025 has decreased a penny to 35 cents per share while loss per share for 2026 has widened to 89 cents from 82 cents. Image Source: Zacks Investment Research BDTX has an excellent track record. Its earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 1,214%. In the last reported quarter, the company’s earnings beat estimates by 24%. Image Source: Zacks Investment Research Per our proven model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. Earnings ESP for BDTX is -2.68%. The company currently carries a Zacks Rank #3. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Since BDTX is a clinical stage company it does not have any approved product in its portfolio and hence does not generate product sales. Nonetheless, the company earns license revenues from its collaboration agreement. In such a scenario, investors will primarily focus on pipeline updates. BDTX is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. Silevertinib is a brain-penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). The candidate was shown to be well tolerated and achieved durable clinical responses in a phase I study in patients with recurrent EGFRm NSCLC whose tumors expressed a range of mutation subtypes, including the acquired C797S resistance mutation and a broad spectrum of non-classical mutations. BDTX is currently evaluating silevertinib in a phase II study in patients with EGFRm NSCLC in both the recurrent setting (cohorts 1 and 2) and the frontline setting (cohort 3). In July 2025, enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed. BDTX plans to disclose objective response rates and preliminary duration of response data from all patients with frontline NSCLC and non-classical EGFR mutations in the fourth quarter of 2025. The developmental...