Black Diamond Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
BDTX$1.74+4.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001701541-25-000030
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001701541-25-000039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 134 previous paragraphs and 134 current paragraphs.
111 unchanged; 21 reworded; 2 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (2)
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Current report
As of September 30, 2025, we had cash, cash equivalents and investments of $135.5 million.
Removed paragraphs (2)
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
As of June 30, 2025, we had cash, cash equivalents and investments of $142.8 million.
Reworded paragraphs (21)
Previous wording
Enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed in July 2025 and initial results from this cohort are anticipated in the fourth quarter of 2025. We plan to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in the first half of 2026, when progression free survival data from the ongoing Phase 2 trial is anticipated. We are also exploring potential partnership opportunities to advance silevertinib into pivotal development.
Current wording
Enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed in July 2025, and we are on track to announce initial results from this cohort in the fourth quarter of 2025. We plan to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in the first half of 2026, when progression free survival data from the ongoing Phase 2 trial is anticipated. We are also continuing to explore potential partnership opportunities to advance silevertinib into pivotal development.
Previous wording
In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented preliminary data from the Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data from the dose escalation portion of the Phase 1 trial presented in 2023. At the June 2024 ASCO meeting, our collaborators at the Ivy Brain Tumor Center also presented initial intratumoral pharmacokinetic data from a Phase 0/1 trial in patients with recurrent high-grade glioma with EGFR alterations and/or fusions at initial diagnosis. Initial results from this trial, sponsored by the Ivy Brain Tumor Center, demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in brain tumor tissue and was generally well tolerated with expected EGFR-mediated side effects. Additional promising results from this trial were presented by the Ivy Brain Tumor Center at the European Association of Neuro-Oncology meeting in October 2024, at the Society of Neuro-Oncology Annual Meeting in November 2024 and at the American Association for Cancer Research annual meeting in April 2025. The data demonstrated that silevertinib penetrated rarely accessible regions of GBM and suppressed EGFR signaling in patient tumors. In March 2025, the Phase 0/1 trial was modified by the Ivy Brain Tumor Center to include newly diagnosed GBM patients with EGFR alterations.
Current wording
In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented preliminary data from the Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity, and a tolerability profile consistent with the initial safety data from the dose escalation portion of the Phase 1 trial presented in 2023. At the June 2024 ASCO meeting, our collaborators at the Ivy Brain Tumor Center also presented initial intratumoral pharmacokinetic data from a Phase 0/1 trial in patients with recurrent high-grade glioma with EGFR alterations and/or fusions at initial diagnosis. Initial results from this trial, sponsored by the Ivy Brain Tumor Center, demonstrated that silevertinib exceeded the pre-specified threshold for drug concentration in brain tumor tissue and was generally well tolerated with expected EGFR-mediated side effects. Additional promising results from this trial were presented by the Ivy Brain Tumor Center at the European Association of Neuro-Oncology (EANO) meeting in October 2024, at the Society of Neuro-Oncology Annual Meeting in November 2024, at the American Association for Cancer Research annual meeting in April 2025, and at the EANO meeting in October 2025. The data demonstrated that silevertinib penetrated rarely accessible regions of GBM and suppressed EGFR signaling in patient tumors. In March 2025, the Phase 0/1 trial was modified by the Ivy Brain Tumor Center to include newly diagnosed GBM patients with EGFR alterations.
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 income was $46.0 million and our net loss was $38.1 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $441.1 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 income was $37.5 million and our net loss was $53.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $449.6 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
As of June 30, 2025, we had cash, cash equivalents and investments of approximately $142.8 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. 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 September 30, 2025, we had cash, cash equivalents and investments of approximately $135.5 million, which we believe will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2027. 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 $9.3 million for the three months ended June 30, 2025, compared to $12.6 million for the three months ended June 30, 2024. The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024:
Current wording
Research and development expenses were $7.4 million for the three months ended September 30, 2025, compared to $12.9 million for the three months ended September 30, 2024. The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:
Previous wording
The decrease of $3.2 million for the three months ended June 30, 2025 was primarily due to workforce efficiencies and decreased spend related to BDTX-4933 of $1.6 million as a result of its outlicensing to Servier in the first quarter of 2025, compared to the three months ended June 30, 2024. In addition, personnel expenses decreased by $1.8 million as we continue to capitalize on workforce efficiencies and focus on our development program.
Current wording
The decrease of $5.5 million for the three months ended September 30, 2025 was primarily due to a decrease of $2.6 million related to operational efficiencies gained as we progressed our clinical trial for silevertinib, combined with decreased spend related to BDTX-4933 of $0.8 million as a result of its outlicensing to Servier in the first quarter of 2025, compared to the three months ended September 30, 2024. In addition, personnel expenses decreased by $1.8 million as we continue to capitalize on workforce efficiencies and focus on our development program.
Previous wording
General and administrative expenses were $4.1 million for the three months ended June 30, 2025 compared to $9.6 million for the three months ended June 30, 2024. The decrease was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in the fourth quarter of 2024.
Current wording
General and administrative expenses were $3.5 million for the three months ended September 30, 2025 compared to $5.2 million for the three months ended September 30, 2024. The decrease was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in the fourth quarter of 2024.
Previous wording
Other income was $4.9 million for the six months ended June 30, 2025, compared to $4.2 million for the six months ended June 30, 2024. The increase was primarily attributable to an increase in interest income in 2025 compared to 2024.
Current wording
Other income was $2.5 million for the three months ended September 30, 2025, compared to $2.6 million for the three months ended September 30, 2024. The decrease was primarily attributable to an increase in interest income offset by a decrease in accretion on investments in 2025 compared to 2024.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous wording
Revenue was $70.0 million for the six months ended June 30, 2025 compared to none for the six months ended June 30, 2024. The increase was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.
Current wording
Revenue was $70.0 million for the nine months ended September 30, 2025 compared to none for the nine months ended September 30, 2024. The increase was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.
Previous wording
Research and development expenses were $19.8 million for the six months ended June 30, 2025, compared to $26.1 million for the six months ended June 30, 2024. The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Current wording
Research and development expenses were $27.3 million for the nine months ended September 30, 2025, compared to $39.0 million for the nine months ended September 30, 2024. The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
Previous wording
The decrease of $6.3 million for the six months ended June 30, 2025 was primarily due to a decrease of $0.3 million related to operational efficiencies gained as we progressed our clinical trial for silevertinib, combined with decreased spend relating to BDTX-4933 of $2.1 million related to the deprioritization of the program and subsequent licensing to Servier, compared to the six months ended June 30, 2024. In addition, personnel expenses decreased by $3.6 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib.
Current wording
The decrease of $11.8 million for the nine months ended September 30, 2025 was primarily due to a decrease of $2.9 million related to operational efficiencies gained as we progressed our clinical trial for silevertinib, combined with decreased spend relating to BDTX-4933 of $2.9 million related to the deprioritization of the program and subsequent licensing to Servier, compared to the nine months ended September 30, 2024. In addition, personnel expenses decreased by $5.4 million as we continue to capitalize on workforce efficiencies and focus on advancing and optimizing development for silevertinib.
Previous wording
General and administrative expenses were $9.1 million for the six months ended June 30, 2025 compared to $16.3 million for the six months ended June 30, 2024. The decrease was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in the fourth quarter of 2024.
Current wording
General and administrative expenses were $12.6 million for the nine months ended September 30, 2025 compared to $21.5 million for the nine months ended September 30, 2024. The decrease was primarily a result of operational and workforce efficiencies from our corporate restructuring announced in the fourth quarter of 2024.
Previous wording
Other income was $2.9 million for the three months ended June 30, 2025, compared to $2.2 million for the three months ended June 30, 2024. The increase was primarily attributable to an increase in interest income in 2025 compared to 2024.
Current wording
Other income was $7.4 million for the nine months ended September 30, 2025, compared to $6.8 million for the nine months ended September 30, 2024. The increase was primarily attributable to an increase in interest income in 2025 compared to 2024.
Previous 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.
Current wording
During the nine months ended September 30, 2025, we had cash provided by operating activities of $36.4 million, primarily resulting from our net income of $37.5 million, along with $6.7 million of non-cash items, partially offset by changes in our operating assets and liabilities of $7.7 million.
Previous wording
During the six months ended June 30, 2024, we used cash in operating activities of $35.9 million, primarily resulting from our net loss of $38.1 million, partially offset by the non-cash charge related to stock compensation expense of $7.0 million.
Current wording
During the nine months ended September 30, 2024, we used cash in operating activities of $47.2 million, primarily resulting from our net loss of $53.7 million, partially offset by the non-cash charge related to stock compensation expense of $9.0 million.
Previous 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.
Current wording
During the nine months ended September 30, 2025, we had cash used in investing activities of $42.0 million primarily from the sales and maturities of investments, netted against our purchase of investments.
Previous wording
During the six months ended June 30, 2024, we had cash used in investing activities of $13.0 million primarily from the sales and maturities of investments, netted against our purchase of investments.
Current wording
During the nine months ended September 30, 2024, we had cash used in investing activities of $10.8 million primarily from the sales and maturities of investments, netted against our purchase of investments.
Previous 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 (ESPP) offset by the shares surrendered to cover taxes from a restricted stock unit vesting.
Current wording
During the nine months ended September 30, 2025, we had cash provided by financing activities of less than $0.1 million, consisting of proceeds from exercises of stock options and the participation in the 2020 Employee Stock Purchase Plan (ESPP) offset by the shares surrendered to cover taxes from a restricted stock unit vesting.
Previous wording
During the six months ended June 30, 2024, we had cash provided by financing activities of $25.5 million consisting of proceeds from the sale of shares of our common stock pursuant to the ATM Program as well as exercises of stock options and participation in the ESPP.
Current wording
During the nine months ended September 30, 2024, we had cash provided by financing activities of $25.3 million consisting of proceeds from the sale of shares of our common stock pursuant to the ATM Program as well as exercises of stock options and participation in the ESPP.
Previous wording
As of June 30, 2025, we had cash, cash equivalents and investments of $142.8 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 fourth quarter of 2027. 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 September 30, 2025, we had cash, cash equivalents and investments of $135.5 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 fourth quarter of 2027. 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.