BDTX

A month has gone by since the last earnings report for Black Diamond (BDTX). Shares have added about 9.4% 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 drivers for Black Diamond Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. Black Diamond reported second-quarter 2026 loss of 17 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents. The company had incurred a loss of 19 cents in the year-ago quarter. Black Diamond did not generate any revenues in the second quarter of 2026, consistent with the prior-year period. Research and development expenses declined 21% year over year to $7.4 million, primarily due to a decrease in spending related to the progression of the phase II NSCLC study of silevertinib, partially offset by increased spending on the phase II GBM study of the candidate. General and administrative expenses increased 14% to $4.7 million, primarily due to higher IP-related costs. Consequently, total operating expenses decreased to $12.1 million from $13.4 million reported in the prior-year quarter. Black Diamond ended the quarter with cash, cash equivalents and investments of $110.5 million compared with $118.3 million as of March 31, 2026. Management believes the current cash balance is sufficient to fund operations into the second half of 2028. Since the earnings release, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted 40% due to these changes. Currently, Black Diamond has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. Charting a somewhat similar path, the stock was allocated a score of B on the value side, putting it in the second quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions looks promising. Interestingly, Black Diamond has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Black Diamond is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Regeneron (REGN), a stock from the same industry, has gained 9.2%. The company reported its results for the quarter ended June 2026 more than a month ago. Regeneron reported revenues of $4.29 billion in the last reported quarter, representing a year-over-year change of +16.7%. EPS of $14.29 for the same period compares with $12.89 a year ago. Regeneron is expected to post earnings of $15.26 per share for the current quarter, representing a year-over-year change of +29%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Regeneron. Also, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Black Diamond Therapeutics, Inc. (BDTX) : Free Stock Analysis Report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Presented positive Phase 2 results for silevertinib in frontline patients with non-classical EGFRm NSCLC at the 2026 ASCO Annual Meeting, including that no patients developed de novo brain metastases and that patients with baseline brain metastases achieved a CNS objective response rate of 86% The results position silevertinib as a potential best-in-class brain-penetrant EGFR inhibitor; an update on the Phase 2 trial and FDA feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC are anticipated in Q4 2026 Cash, cash equivalents, and investments of $110.5 million as of June 30, 2026, expected to be sufficient to fund operations into 2H of 2028 CAMBRIDGE, Mass., Aug. 05, 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, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. “Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO in May,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib’s potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter.” Recent Developments & Upcoming Milestones: On May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting, data were presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR non-classical mutations, including compound and P-Loop and C-Helix Compressing (PACC) mutations. As of an April 11, 2026 data cutoff date, results were as follows: The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026. The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026. The Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients in the safety lead-in portion of the study. The Company remains on track to initiate the randomized portion of the study in the fourth quarter of 2026. Financial Highlights Cash Position: Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.0 million for the second quarter of 2026 compared to net cash used in operations of $9.2 million for the second quarter of 2025. Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the second quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up activities for the Phase 2 trial for silevertinib in GBM. General and Administrative Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2026, compared to $4.1 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs. Net Loss: Net loss for the second quarter of 2026 was $9.9 million, as compared to a net loss of $10.6 million for the same period in 2025. Financial Guidance Black Diamond ended the second quarter of 2026 with approximately $110.5 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 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 EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib. In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical 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, the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, and the anticipated timing of initiation of the randomized portion of the Phase 2 clinical trial in GBM, the Company’s planned interactions with the FDA, including expectations regarding anticipated feedback from the FDA on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC and the timing thereof, the selection of a dose for pivotal development, 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, 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, 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 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 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. Contact For Investors:[email protected] For Media:[email protected]

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 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 InstituteDate 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 InformationBlack 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. ContactFor 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 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) Black Diamond Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) Contact For Investors: [email protected] For Media: [email protected]

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 trial in 2026. The company is also exploring partnerships to support later-stage development. The balance sheet remains a key strength, with cash, cash equivalents, and investments rising to $128.7 million at year-end 2025, up more than 30% year over year. Management expects this liquidity to fund operations into the second half of 2028. Notably, full-year operating cash flow turned positive at $29.6 million, compared to a significant outflow in FY2024, driven by the Servier upfront payment, reduced expenses, and higher interest income. In the past month, investors have witnessed a flat trend in estimates revision. Currently, Black Diamond has a subpar Growth Score of D, a score with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of C on the value side, putting it in the middle 20% for value investors. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Black Diamond has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Black Diamond is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Editas Medicine (EDIT), a stock from the same industry, has gained 37.8%. The company reported its results for the quarter ended December 2025 more than a month ago. Editas reported revenues of $24.74 million in the last reported quarter, representing a year-over-year change of -19.2%. EPS of -$0.06 for the same period compares with -$0.55 a year ago. For the current quarter, Editas is expected to post a loss of $0.30 per share, indicating a change of +30.2% from the year-ago quarter. The Zacks Consensus Estimate has changed -29.2% over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Editas. Also, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Black Diamond Therapeutics, Inc. (BDTX) : Free Stock Analysis Report Editas Medicine, Inc. (EDIT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 quarter of 2026 (NCT05256290). Initiation of a randomized Phase 2 trial in patients with newly diagnosed EGFR-altered GBM in the second quarter of 2026 (NCT07326566). Financial Highlights Cash Position: Black Diamond ended 2025 with approximately $128.7 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $29.6 million for the year ended December 31, 2025 compared to net cash used in operations of $62.3 million for the year ended December 31, 2024. Research and Development Expenses: Research and development (R&D) expenses were $6.3 million for the fourth quarter of 2025, compared to $12.3 million for the same period in 2024. R&D expenses were $33.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 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 $4.0 million for the fourth quarter of 2025, compared to $6.0 million for the same period in 2024, and $16.6 million for the year ended December 31, 2025, compared to $27.5 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due operational and workforce efficiencies from the restructuring announced in October 2024. Net Loss: Net loss for the fourth quarter of 2025 was $15.1 million, as compared to $16.0 million for the same period in 2024. Net income for the year ended December 31, 2025 was $22.4 million compared to a net loss of $69.7 million for the year ended December 31, 2024. Financial Guidance Black Diamond ended 2025 with approximately $128.7 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 trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, expectations regarding the planned initiation of a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFR-altered GBM, 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, evaluation of potential partnership opportunities for silevertinib and the ability to realize the anticipated benefits thereof, 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. Contact For Investors: [email protected] For Media: [email protected]

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 Buying Black Diamond’s thesis is that silevertinib is designed to address these patients by combining: Broad mutational coverage across the non-classical EGFR spectrum High brain penetrance, aimed at treating central nervous system (CNS) metastases Once-daily oral dosing Velleca reviewed the company’s phase 2 development approach in NSCLC, noting that the trial began in 2023 in the recurrent setting (cohorts 1 and 2) and later expanded to enroll frontline patients (cohort 3) in 2024. He said final data from the recurrent cohorts are expected to be presented at a medical meeting in the second quarter of this year. → Archer Aviation Stock Tanks—The Real Story Is What Wall Street Overlooked In frontline cohort 3, Velleca said Black Diamond enrolled 43 patients representing what he described as a real-world spectrum of non-classical EGFR mutations, with 35 distinct mutations and more than a third of patients harboring multiple or compound mutations. He also emphasized that more than one-third of patients had untreated brain metastases. Patients received 200 mg once daily. Based on data the company disclosed in December, Velleca highlighted: Confirmed objective response rate (ORR): 60% Disease control rate (DCR): 93% CNS response rate: 86% He said early durability signals were “encouraging,” citing 29 patients remaining on therapy and the longest on treatment for more than 19 months. The company expects to present preliminary duration of response and PFS data at a medical meeting in the second quarter. In the Q&A, TD Cowen’s Marc Frahm asked how silevertinib’s data compares with other efforts in non-classical EGFR NSCLC, including furmonertinib. Velleca pointed to several distinctions: Black Diamond’s larger cohort (43 patients versus 22 cited for the comparator), the U.S.-heavy enrollment for Black Diamond versus primarily China enrollment for the referenced study, and broader mutation representation in Black Diamond’s cohort. He also underscored the difference in CNS response rates, stating that the comparator’s CNS response rate was 47% versus 86% with silevertinib. Velleca said adverse events observed with silevertinib were typical of EGFR tyrosine kinase inhibitors, with grade 3 events described as EGFR-mediated (including rash, diarrhea, stomatitis, and paronychia). He said less than 10% of patients discontinued due to adverse events. Frahm asked about a higher rate of dose reductions in the frontline cohort compared with prior trials. Velleca attributed this to frontline patients being more sensitive to EGFR-mediated adverse events than patients treated in later lines, and said the events were manageable with standard supportive care and/or dose reductions without compromising efficacy. He added that the company had not seen patients lose response after dose reduction to 150 mg and that some patients achieved their first response after a dose reduction. On dosing strategy, Velleca said Black Diamond previously held a dose optimization meeting with the FDA in the recurrent setting, where the agency had no objections to moving forward with 200 mg, which is why 200 mg was selected for the frontline cohort. He said additional data are expected to inform discussions with regulators at an end-of-phase-2 meeting, including exposure-response analyses, population pharmacokinetics, and median dose intensity. Velleca also outlined Black Diamond’s plan to develop silevertinib in GBM, citing the high unmet need and the role of EGFR alterations in the disease. He said approximately 50% of GBM patients have an oncogenic EGFR alteration, with EGFR variant III present in about 30% of patients. He said previous EGFR approaches in GBM have been limited by insufficient potency across the range of EGFR alterations and inadequate brain penetrance. Velleca stated that Black Diamond has treated more than 60 patients with recurrent GBM with silevertinib and has seen encouraging tolerability, preliminary evidence of clinical activity, and brain penetrance. He also described a phase 1 “window of opportunity” study showing pharmacologically relevant exposures in tumor tissue from non-contrast-enhancing brain regions, which he said had not been documented before with an EGFR TKI. The company plans to initiate a randomized phase 2 trial in newly diagnosed GBM patients next quarter. After surgery and a brief course of chemoradiation, patients will be randomized to standard-of-care maintenance temozolomide (TMZ) or TMZ plus silevertinib. PFS analyses will be performed by an independent data monitoring committee. During Q&A, Velleca said the trial design is finalized, with protocol feedback addressed and central IRB approval obtained, and that details are available on ClinicalTrials.gov. He described a safety run-in that starts at 150 mg plus TMZ and escalates to 200 mg plus TMZ if no dose-limiting toxicities are observed, with three patients per dose level and 30 days of observation at each level. He expects the safety run-in to be completed by the end of the third quarter, followed by the randomized portion, and said the company expects preliminary PFS data from the study in the first half of 2028. Velleca said Black Diamond has had partnering discussions starting in late summer, with most interest focused on the frontline NSCLC population and some interest in GBM. He said “indication splits” have not historically worked well in oncology deals and emphasized that any deal structure would need to reflect the value of the drug across multiple indications. He also suggested that a partner could help address capital needs for pivotal lung cancer studies, particularly given higher EGFR prevalence in Asia. Beyond silevertinib, Velleca briefly highlighted two additional pipeline programs: BDTX-4933, a clinical-stage Ras/Raf inhibitor partnered with Servier, and BDTX-4876, a preclinical FGFR inhibitor. He noted that milestone payments from the Servier agreement and potential partnering revenue for BDTX-4876 were not included in the company’s cash runway assumptions. In response to investor questions about share-price performance versus the opportunity, Velleca said some investors appear to be waiting for a more mature dataset, including PFS, and cited the competitive landscape and broader swings in sentiment around precision small-molecule oncology. Black Diamond Therapeutics, Inc is a precision oncology company focused on the discovery and development of small-molecule therapies that selectively target oncogenic proteins bearing tumor-driving mutations. Leveraging its proprietary Genetic Defined Allosteric (GDA) therapeutic platform, the company aims to identify unique allosteric binding sites in mutant proteins and engineer highly selective inhibitors. Headquartered in Cambridge, Massachusetts, Black Diamond applies structure-based drug design and molecular modeling to advance personalized cancer treatments. The company's development pipeline includes lead candidate BDTX-189, an allosteric inhibitor of mutant HER2, as well as programs directed at clinically relevant EGFR and KRAS mutations. The article "Black Diamond Therapeutics Teases Next-Quarter PFS Data for Silevertinib at TD Cowen Conference" was originally published by MarketBeat.