Black Diamond Therapeutics, Inc.

Previous wording

We are a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The foundation of our company is built upon a deep understanding of cancer genetics, onco-protein structure and function, and medicinal chemistry. Our 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 (CNS) disease. Our compounds target families of oncogenic mutations in clinically validated pathways. Our lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain-penetrant, covalent, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). We are advancing a Phase 2 trial in NSCLC patients and initiated a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFRvIII+ glioblastoma (GBM), with the first patient dosed in May 2026.

Current wording

We are 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. The foundation of our company is built upon a deep understanding of cancer genetics, onco-protein structure and function, and medicinal chemistry. Our 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 (CNS) disease. Our compounds target families of oncogenic mutations in clinically validated pathways. Our lead clinical-stage program, silevertinib (formerly BDTX-1535), is a brain-penetrant, covalent, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM). We are advancing a Phase 2 trial in EGFRm NSCLC patients and initiated a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFRvIII+ glioblastoma (GBM), with the first patient dosed in May 2026.

Previous wording

We believe that our clinical-stage lead product candidate, silevertinib, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon silevertinib’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs), as well as uniquely target the C797S resistance mutation which can be acquired after treatment with osimertinib. Silevertinib was shown to be well tolerated and achieve durable clinical responses in our Phase 1 trial 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. Initial data from a Phase 2 trial of 83 patients with EGFRm NSCLC in the second- and third-line settings demonstrated encouraging clinical responses, robust EGFRm target coverage, a favorable tolerability profile with no new safety signals observed.

Current wording

We believe that our clinical-stage lead product candidate, silevertinib, has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon silevertinib’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs), as well as uniquely target the C797S resistance mutation which can be acquired after treatment with osimertinib. Silevertinib was shown to be well tolerated and achieve durable clinical responses in our Phase 1 trial 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. At the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2026, final clinical data from a Phase 2 trial of 83 patients with EGFRm NSCLC in the second- and third-line settings demonstrated encouraging clinical responses, robust EGFRm target coverage, and a favorable tolerability profile with no new safety signals observed.

Previous wording

In July of 2025, we completed enrollment of 43 patients in a Phase 2 trial of silevertinib in frontline NSCLC patients harboring non-classical EGFR mutations. In December of 2025, we announced initial data from these 43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical EGFR mutations, including 16 patients with brain metastases (7 of whom had measurable CNS target lesions). All patients were enrolled at a 200mg oral daily dose of silevertinib. Efficacy and safety were assessed with a November 3, 2025 data cutoff and median follow-up time as of this date was 7.2 months. The initial data from this trial was encouraging with 25 confirmed partial responses and 1 confirmed complete response equating to a 60% Objective Response Rate (ORR by RECIST 1.1). CNS ORR (by RANO-BM) was 86% and the disease control rate (DCR) was 91%. No new safety signals were observed. Adverse events (AEs) experienced by a majority of patients included rash, stomatitis, diarrhea and paronychia and were managed with standard supportive care and dose interruptions or reductions without compromising response depth or durability. As of the November 3, 2025 data cutoff, 29 patients remained on therapy (5 of 29 after progression) with one patient having been on therapy for more than 19 months. We will present updated results from the Phase 2 NSCLC trial, including preliminary duration of response (DOR) and progression-free survival (PFS) data in the frontline setting (43 patients) as well as final clinical results in the recurrent setting (83 patients), at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29 – June 2, 2026.

Current wording

On May 30, 2026, data from our Phase 2 trial of silevertinib in frontline EGFRm NSCLC patients were presented at the ASCO Annual Meeting. As of an April 11, 2026 data cutoff date, 43 frontline patients presenting with a broad spectrum of EGFR non-classical mutations (NCMs), including compound and P-Loop and C-Helix Compressing (PACC) mutations, were enrolled at a dose of 200 mg once daily (QD). 19 patients presented with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions. At a median follow-up of 11.2 months, preliminary median progression-free survival (mPFS) was 15.2 months (95% CI: 10.8, NE) and median duration of response (DOR) had not been reached (95% CI: 7.0, NE). As of the data cutoff date, 23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months. No patients developed de novo brain metastases. The previously disclosed CNS objective response rate (ORR by RANO-BM) of 86%, objective response rate (ORR by RECIST 1.1) of 60%, and disease control rate (DCR) of 91% each remained unchanged. Reductions in variant allele frequency (VAF) were observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC mutations. No new safety signals were observed. Adverse events (AEs) experienced by a majority of patients included rash, stomatitis, diarrhea, and paronychia and were managed with standard supportive care and dose interruptions or reductions without compromising response depth or durability. Following dose reductions, the rate of Grade 3 or higher treatment-related AEs was reduced to 28%. Collectively, safety, pharmacokinetics, pharmacodynamics and efficacy data support the selection of a 150 mg QD dose for pivotal development.

Previous wording

Silevertinib has demonstrated encouraging CNS activity in multiple trials across NSCLC and GBM. In our Phase 2 in frontline patients with EGFRm NSCLC 86% of patients achieved a confirmed CNS response. The results from our Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM (presented at ASCO in 2024) showed encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data seen in patients with recurrent NSCLC. A Phase 0/1 “window of opportunity” study sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated. It also showed that silevertinib penetrates non-contrast enhancing regions of glioblastoma and suppresses EGFR signaling in patient tumors. Based on these data and together with the robust CNS ORR demonstrated by silevertinib to date in our Phase 2 trial in frontline EGFRm NSCLC patents, we believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM. Following feedback on the study design received from the FDA in January 2026, we initiated a randomized Phase 2 trial in this patient population and dosed the first patient in May 2026. After a combination safety lead-in of silevertinib plus temozolomide (TMZ), the trial is expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (as the control arm) or silevertinib plus TMZ (as the experimental arm). The eligible patient population will be on EGFRvIII-positive patients (approximately 30% of GBM patients) who are O-6-methylguanine-DNA methyltransferase (MGMT) -negative (unmethylated). Randomization and treatment will begin after patients have had surgical resection and radiation and are eligible for maintenance TMZ. The primary endpoint of the trial will be PFS (RANO by blinded independent committee review, or BICR), with a planned futility analysis, and an interim PFS analysis anticipated in the first half 2028. The secondary endpoint of the trial will be overall survival (OS). The trial will be governed by an independent data monitoring committee (IDMC).

Current wording

Silevertinib has demonstrated encouraging CNS activity in multiple trials across NSCLC and GBM. In our Phase 2 in frontline patients with EGFRm NSCLC 86% of patients achieved a confirmed CNS response. The results from our Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM (presented at ASCO in 2024) showed encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data seen in patients with recurrent NSCLC. A Phase 0/1 “window of opportunity” study sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions at initial diagnosis demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in the brain tumor tissue and was generally well tolerated. It also showed that silevertinib penetrates non-contrast enhancing regions of glioblastoma and suppresses EGFR signaling in patient tumors. Based on these data and together with the robust CNS ORR demonstrated by silevertinib to date in our Phase 2 trial in frontline EGFRm NSCLC patients, we believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM. Following feedback on the study design received from the FDA in January 2026, we initiated a randomized Phase 2 trial in this patient population and dosed the first patient in May 2026. After a combination safety lead-in of silevertinib plus temozolomide (TMZ), the trial is expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (as the control arm) or silevertinib plus TMZ (as the experimental arm). The eligible patient population will be EGFRvIII-positive patients (approximately 30% of GBM patients) who are O-6-methylguanine-DNA methyltransferase (MGMT) -negative (unmethylated). Randomization and treatment will begin after patients have had surgical resection and radiation and are eligible for maintenance TMZ. The primary endpoint of the trial will be PFS (RANO by blinded independent committee review, or BICR), with a planned futility analysis, and an interim PFS analysis anticipated in the first half of 2028. The secondary endpoint of the trial will be overall survival (OS). The trial will be governed by an independent data monitoring committee (IDMC).

Previous wording

Our second clinical-stage asset, BDTX-4933 (also known as S241656), was outlicensed to Servier Pharmaceuticals LLC (Servier) in the first quarter of 2025. Pursuant to the license agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the license agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the consolidated financial statements included elsewhere in this Annual Report for additional information.

Current wording

Our second clinical-stage asset, BDTX-4933 (also known as S241656), was outlicensed to Servier Pharmaceuticals LLC (Servier) in the first quarter of 2025. Pursuant to the license agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the license agreement, Servier will lead the development activities and the global commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. In consideration for the license granted to Servier, we received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales. See Note 14, License Revenue, to the consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Previous wording

To date, we have funded our operations primarily with proceeds from sales of our common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. Since inception, we have incurred significant operating losses. Our net loss was $9.0 million and our net income was $56.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $473.8 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Current wording

To date, we have funded our operations primarily with proceeds from sales of our common stock and preferred stock, and through the $70.0 million upfront payment received under the Servier Agreement in March 2025. Since inception, we have incurred significant operating losses. Our net loss was $18.9 million and our net income was $46.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $483.7 million. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our current or future product candidates. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Previous wording

Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, new or increased international tariffs and retaliatory tariffs, high inflation, disruptions in capital markets, changes in international trade relationships, changes in U.S. governmental agencies, new laws and regulations or amendments to existing laws and regulations in the U.S. and foreign countries, and military conflicts. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.

Current wording

Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, new or increased international tariffs and retaliatory tariffs, inflationary pressures, disruptions in capital markets, changes in international trade relationships, changes in U.S. governmental agencies, new laws and regulations or amendments to existing laws and regulations in the U.S. and foreign countries, and military conflicts. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and investments of approximately $118.3 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Current wording

As of June 30, 2026, we had cash, cash equivalents and investments of approximately $110.5 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.” To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.

Previous wording

Research and development expenses were $7.0 million for the three months ended March 31, 2026, compared to $10.5 million for the three months ended March 31, 2025. The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

Current wording

Research and development expenses were $7.4 million for the three months ended June 30, 2026, compared to $9.3 million for the three months ended June 30, 2025. The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:

Previous wording

Other income was $2.2 million for the three months ended March 31, 2026, compared to $2.0 million for the three months ended March 31, 2025. The increase was primarily attributable to an increase in interest income in 2026 compared to 2025.

Current wording

Other income was $2.2 million for the three months ended June 30, 2026, compared to $2.9 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in interest income and a decrease in accretion on investments in 2026 compared to 2025.

Previous wording

No revenue was recorded for the three months ended March 31, 2026 compared to $70.0 million for the three months ended March 31, 2025. The decrease was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.

Current wording

No revenue was recorded for the six months ended June 30, 2026 compared to $70.0 million for the six months ended June 30, 2025. The decrease was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.

Previous wording

The decrease of $3.5 million for the three months ended March 31, 2026 was primarily due to a decrease of $2.4 million related tothe progression of our Phase 2 clinical trial for silevertinib in NSCLC and a decrease of $1.0 million related the deprioritization of the BDTX-4933 program and subsequent licensing to Servier, partially offset by an increase of $1.4 million for silevertinib GBM due to the initiation of a Phase 2 GBM trial, compared to the three months ended March 31, 2025. In addition, personnel expenses decreased by $0.4 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib, and facilities expenses decreased by $0.4 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Current wording

The decrease of $5.4 million for the six months ended June 30, 2026 was primarily due to a decrease of $5.7 million related to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and a decrease of $1.0 million related to the deprioritization of the BDTX-4933 program and subsequent licensing to Servier, partially offset by an increase of $4.0 million for silevertinib GBM due to the initiation of a Phase 2 GBM trial, compared to the six months ended June 30, 2025. In addition, personnel expenses decreased by $0.7 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib, and facilities expenses decreased by $0.9 million due to the sublease of the remaining floor of our Cambridge, Massachusetts office space in December 2025.

Previous wording

General and administrative expenses were $4.3 million for the three months ended March 31, 2026 compared to $5.0 million for the three months ended March 31, 2025. The decrease was primarily a result of continued operational efficiencies.

Current wording

General and administrative expenses were $8.9 million for the six months ended June 30, 2026 compared to $9.1 million for the six months ended June 30, 2025. The decrease was primarily a result of continued operational efficiencies.

Previous wording

Since our inception, we have not generated any product revenue and do not expect to generate any revenue from the sale of products in the foreseeable future. We have funded our operations to date primarily with proceeds from the sale of our common and preferred stock, as well as proceeds from licensing of intellectual property. We have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for several years, if at all.

Current wording

Since our inception, we have not generated any product revenue and do not expect to generate any revenue from the sale of products in the foreseeable future. We have funded our operations to date primarily with proceeds from the sales of our common and preferred stock, as well as proceeds from licensing of intellectual property. We have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for several years, if at all.

Previous wording

During the three months ended March 31, 2026, we had cash used in operating activities of $10.2 million, primarily resulting from our net loss of $9.0 million, along with changes in our operating assets and liabilities of $3.1 million, partially offset by $1.9 million of non-cash items.

Current wording

During the six months ended June 30, 2026, we had cash used in operating activities of $18.2 million, primarily resulting from our net loss of $18.9 million, along with changes in our operating assets and liabilities of $3.0 million, partially offset by $3.8 million of non-cash items.

Previous wording

During the three months ended March 31, 2025, we used cash provided by operating activities of $53.4 million, primarily resulting from our net income of $56.5 million, partially offset by the non-cash charge related to stock compensation expense of $1.7 million.

Current wording

During the six months ended June 30, 2025, we had cash provided by operating activities of $44.3 million, primarily resulting from our net income of $46.0 million, along with $4.3 million of non-cash items, partially offset by changes in our operating assets and liabilities of $6.1 million.

Previous wording

During the three months ended March 31, 2025, we had cash provided by investing activities of $8.5 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Current wording

During the six months ended June 30, 2026, we had cash provided by investing activities of $16.4 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Previous wording

During the three months ended March 31, 2026, we had cash provided by investing activities of $19.5 million primarily from the sales and maturities of investments.

Current wording

During the six months ended June 30, 2025, we had cash used in investing activities of $50.6 million primarily from the sales and maturities of investments, netted against our purchase of investments.

Previous wording

During the three months ended March 31, 2026, we had cash used in financing activities of $0.2 million, resulting from the shares surrendered to cover taxes from a restricted stock unit vesting.

Current wording

During the six months ended June 30, 2026, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from the exercises of common stock options offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Previous wording

During the three months ended March 31, 2025, we had cash provided by financing activities of less than $0.1 million consisting of proceeds from the participation in the employee stock purchase plan.

Current wording

During the six months ended June 30, 2025, we had cash used in financing activities of less than $0.1 million, consisting of proceeds from the participation in the 2020 Employee Stock Purchase Plan offset by the shares surrendered to cover taxes from a restricted stock unit vesting.

Previous wording

As of March 31, 2026, we had cash, cash equivalents and investments of $118.3 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Current wording

As of June 30, 2026, we had cash, cash equivalents and investments of $110.5 million. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We anticipate that we will require additional capital as we seek regulatory approval of our product candidates and if we choose to pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Previous wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 16, 2026. During the three months ended March 31, 2026, there were no material changes to our critical accounting policies from those previously disclosed.

Current wording

Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 16, 2026. During the six months ended June 30, 2026, there were no material changes to our critical accounting policies from those previously disclosed.