Results
Black Diamond Therapeutics Inc.
11/06/2025 | Press release | Distributed by Public on 11/06/2025 06:12
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report and our audited consolidated financial statements and related notes thereto for the year ended December 31, 2024, as well as Management's Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 6, 2025. This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in our Annual Report on Form 10-K and in other SEC filings.
Overview
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, 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). In March 2025 we announced a global licensing agreement with Servier for our second clinical-stage asset, BDTX-4933, a potential best-in-class targeted therapy for RAF/RAS-mutant solid tumors, and received an upfront payment of $70.0 million.
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. We are currently evaluating silevertinib in a Phase 2 clinical trial in patients with EGFRm NSCLC in both the recurrent setting (cohorts 1 and 2) and the frontline setting (cohort 3).
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.
In September 2024, we announced initial data demonstrating encouraging clinical responses and durability of silevertinib from our Phase 2 clinical trial in 27 patients with EGFRm NSCLC in the second- and third-line settings (cohorts 1 and 2). The 200 mg daily dose of silevertinib was selected for pivotal development, showing robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed. Based on an August 2024 data cutoff, a preliminary overall response rate (ORR) of 42% was seen in 19 patients with known osimertinib resistance EGFR mutations (9 patients from cohort 1 with PACC "P-loop αC-helix compressing" mutations and 10 patients from cohort 2 with C797S mutations). Acquisition of C797S was frequently observed in patients who progressed following treatment with osimertinib. PACC mutations represent a structure-function group of non-classical oncogenic driver mutations which may accumulate or be acquired following treatment with osimertinib. Encouraging durability was noted with a duration of response (DOR) of approximately eight months or more in the first three patients who achieved a partial response (PR), while 14 of the 19 patients remained on treatment. We expect to present final results (n=83) from this trial in the first half of 2026 and are exploring potential combination opportunities for silevertinib in the recurrent setting.
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.
In March 2025, we entered into a global licensing agreement (the Servier Agreement) with Servier Pharmaceuticals LLC (Servier) for our second clinical-stage asset, BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors. Under the terms of the Servier Agreement, we granted to Servier a global license to develop and commercialize BDTX-4933. Pursuant to the terms of the Servier 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 condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
Since our inception in 2014, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, business planning, raising capital, discovering product candidates and securing related intellectual property rights while conducting research and development activities for our programs. We do not have any products approved for sale and have not generated any revenue from product sales. We may never be able to develop or commercialize a marketable product. We have not yet successfully completed any pivotal clinical trials, obtained any regulatory marketing approvals, manufactured a commercial-scale drug, or conducted sales and marketing activities.
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:
•advance clinical development of silevertinib;
•obtain, maintain, expand, enforce and protect our intellectual property portfolio;
•maintain existing collaborations or strategic relationships and identify and enter into future license agreements and collaborations with third parties;
•attract and retain key clinical, scientific, management and commercial personnel;
•seek marketing approvals for our product candidates that successfully complete clinical trials, if any; and
•acquire or in-license additional product candidates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings or other capital sources, which may include collaborations and licensing arrangements with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, and reduce headcount and general and administrative costs.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
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.
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.
Components of our results of operations
Revenue
Since our inception, we have not generated any product revenue and do not expect to generate any revenue from the sale of products for the foreseeable future. To date, we have generated revenue solely from licensing of intellectual property. If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such collaboration or license agreements. However, there can be no assurance as to when we will generate such revenue, if at all.
Operating expenses
Research and development expenses
Research and development expenses consist primarily of costs incurred for our research activities, including the development of our product candidates. We expense research and development costs as incurred, which include:
•expenses incurred to conduct the necessary preclinical studies and clinical trials required to obtain regulatory approval;
•expenses incurred under agreements with contract research organizations (CROs) that are primarily engaged in the oversight and conduct of our drug discovery efforts, preclinical studies, and clinical trials as well as under agreements with contract manufacturing organizations (CMOs) that are primarily engaged to provide preclinical and clinical drug substance and product for our research and development programs;
•other costs related to the conduct of preclinical studies, and clinical trials, including acquiring and manufacturing materials, manufacturing validation batches, fees to investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development support services;
•payments made in cash or equity securities under third-party licensing, acquisition and option agreements;
•employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development functions;
•costs related to compliance with regulatory requirements; and
•allocated facilities-related costs, depreciation and other expenses, which include rent and utilities.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Any nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Our direct external research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct research and development expenses also include fees incurred under license, acquisition and option agreements. We do not allocate employee costs, costs associated with our development efforts, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research as well as for managing our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple programs and, therefore, we do not track their costs by program.
Development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years as we continue our clinical development of silevertinib. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.
At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of the following:
•the scope, progress, outcome and costs of our clinical trials and other development activities;
•successful patient enrollment in and the initiation and completion of clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;
•the extent of any required post-marketing approval commitments to applicable regulatory authorities;
•establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully;
•development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulation;
•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and
•maintaining a continued acceptable tolerability profile of our product candidates following approval, if any, of our product candidates.
Any changes in the outcome of any of these variables with respect to the development of our product candidates could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.
General and administrative expenses
General and administrative expenses consist primarily of salaries and benefits, travel and stock-based compensation expense for personnel in executive, business development, finance, human resources, legal, information technology, pre-commercial and support personnel functions. General and administrative expenses also include direct and allocated facility-related costs as well as insurance costs and professional fees for legal, patent, consulting, investor and public relations, accounting and audit services.
We anticipate that our general and administrative expenses will increase in the future as we support continued development of our product candidates and prepare for potential commercialization activities. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in payroll and other employee-related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of that product candidate.
Other income (expense)
Other income (expense) consists primarily of interest income earned on our cash equivalents and investment balances, sublease income, and realized and unrealized foreign currency transaction gains and losses.
Results of operations
Comparison of the three months ended September 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:
|
Three Months Ended September 30, |
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| 2025 | 2024 | Change | |||||||||||||||
| (in thousands) | |||||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 7,437 | $ | 12,914 | $ | (5,477) | |||||||||||
| General and administrative | 3,541 | 5,216 | (1,675) | ||||||||||||||
| Total operating expenses | 10,978 | 18,130 | (7,152) | ||||||||||||||
| Loss from operations | (10,978) | (18,130) | 7,152 | ||||||||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 1,164 | 516 | 648 | ||||||||||||||
| Other (expense) income | 1,316 | 2,057 | (741) | ||||||||||||||
| Total other income (expense), net | 2,480 | 2,573 | (93) | ||||||||||||||
| Net loss | $ | (8,498) | $ | (15,557) | $ | 7,059 | |||||||||||
Research and development
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:
|
Three Months Ended September 30, |
|||||||||||||||||
| 2025 | 2024 | Change | |||||||||||||||
| (in thousands) | |||||||||||||||||
| Silevertinib research and development expenses | $ | 3,760 | $ | 6,372 | $ | (2,612) | |||||||||||
| BDTX-4933 research and development expenses | - | 848 | (848) | ||||||||||||||
| Other research programs and platform development expenses | 434 | 525 | (91) | ||||||||||||||
| Personnel expenses | 2,205 | 4,001 | (1,796) | ||||||||||||||
| Allocated facility expenses | 875 | 972 | (97) | ||||||||||||||
| Other expenses | 163 | 196 | (33) | ||||||||||||||
| $ | 7,437 | $ | 12,914 | $ | (5,477) | ||||||||||||
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.
General and administrative
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.
Other income (expense)
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.
Comparison of the nine months ended September 30, 2025 and 2024
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
|
Nine Months Ended September 30, |
|||||||||||||||||
| 2025 | 2024 | Change | |||||||||||||||
| (in thousands) | |||||||||||||||||
| License revenue | $ | 70,000 | $ | - | $ | 70,000 | |||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 27,262 | 39,015 | (11,753) | ||||||||||||||
| General and administrative | 12,606 | 21,491 | (8,885) | ||||||||||||||
| Total operating expenses | 39,868 | 60,506 | (20,638) | ||||||||||||||
| Income (loss) from operations | 30,132 | (60,506) | 90,638 | ||||||||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 2,877 | 1,617 | 1,260 | ||||||||||||||
| Other (expense) income | 4,474 | 5,198 | (724) | ||||||||||||||
| Total other income (expense), net | 7,351 | 6,815 | 536 | ||||||||||||||
| Net income (loss) | $ | 37,483 | $ | (53,691) | $ | 91,174 | |||||||||||
Revenue
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.
Research and development
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:
|
Nine Months Ended September 30, |
|||||||||||||||||
| 2025 | 2024 | Change | |||||||||||||||
| (in thousands) | |||||||||||||||||
| Silevertinib research and development expenses | $ | 14,482 | $ | 17,349 | $ | (2,867) | |||||||||||
| BDTX-4933 research and development expenses | 1,018 | 3,919 | (2,901) | ||||||||||||||
| Other research programs and platform development expenses | 1,367 | 1,682 | (315) | ||||||||||||||
| Personnel expenses | 7,269 | 12,675 | (5,406) | ||||||||||||||
| Allocated facility expenses | 2,642 | 2,627 | 15 | ||||||||||||||
| Other expenses | 484 | 763 | (279) | ||||||||||||||
| $ | 27,262 | $ | 39,015 | $ | (11,753) | ||||||||||||
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.
General and administrative
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.
Other income (expense)
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.
Liquidity and capital resources
Sources of liquidity
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.
On February 3, 2020, we completed an initial public offering (IPO) of 12,174,263 shares of our common stock, including the exercise in full by the underwriters of their option to purchase up to 1,587,947 additional shares of our common stock, for aggregate gross proceeds of $231.3 million. We received $212.1 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us. Through September 30, 2025, we had received net cash proceeds of $200.6 million from previous sales of our preferred stock.
On November 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf Registration Statement) with the SEC, which covers the offering, issuance and sale of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof up to a maximum price of $500.0 million. We simultaneously entered into an Open Market Sale AgreementSM (the Sales Agreement) with Jefferies LLC (Jefferies), as sales agent, to provide for the issuance and sale by us of up to $150.0 million of our common stock (the Shares) from time to time through Jefferies as our sales agent (the ATM Program). The Shelf Registration Statement became effective on November 22, 2022. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Jefferies may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act. We may sell the Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the Sales Agreement, but we have no obligation to sell any Shares under the Sales Agreement. We or Jefferies may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. As of September 30, 2025, we sold 4,490,853 shares of our common stock pursuant to the ATM Program, resulting in gross proceeds to us of approximately $25.0 million ($24.5 million net of offering costs).
On July 5, 2023, we completed an underwritten public offering (the Follow-on Offering) of 15,000,000 shares of our common stock at a price to the public of $5.00 per share. The aggregate net proceeds from the Follow-on Offering totaled approximately $71.6 million after deducting underwriting discounts and commissions, as well as other offering expenses. The underwriters did not exercise any portion of their 30-day overallotment option to purchase up to an additional 2,250,000 shares of our common stock at the public offering price, which expired on July 29, 2023, and therefore no additional proceeds from the Follow-on Offering were received.
On March 18, 2025, we entered into the Servier Agreement with Servier for BDTX-4933, a small molecule designed to address unmet medical needs in RAF/RAS-mutant solid tumors, pursuant to which we granted to Servier a global license to develop and commercialize BDTX-4933. Under the terms of the Servier 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 condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
As of September 30, 2025, we had cash, cash equivalents and investments of $135.5 million.
Cash flows
The following table summarizes our sources and uses of cash for each of the periods presented (in thousands):
|
Nine Months Ended September 30, |
|||||||||||
| 2025 | 2024 | ||||||||||
| Cash provided by (used in) operating activities | $ | 36,401 | $ | (47,248) | |||||||
|
Cash provided by (used in) investing activities
|
(42,016) | (10,801) | |||||||||
|
Cash provided by (used in) financing activities
|
50 | 25,256 | |||||||||
|
Net increase (decrease) in cash and cash equivalents
|
$ | (5,565) | $ | (32,793) | |||||||
Operating activities
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.
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.
Changes in accounts payable and accrued expenses in all periods were generally due to the advancement of our product candidate and the timing of vendor invoicing and payments.
Investing activities
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.
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.
Financing activities
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.
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.
Funding requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials of silevertinib. In addition, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses. The timing and amount of our operating expenditures will depend largely on our ability to:
•advance silevertinib through clinical trials, either independently or with a partner;
•manufacture, or have manufactured on our behalf, our drug material and develop processes for late stage and commercial manufacturing;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own; and
•obtain, maintain, expand, enforce and protect our intellectual property portfolio.
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.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to further reduce or terminate our operations. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the scope, progress, results and costs of developing our product candidates, and conducting clinical trials;
•the costs, timing and outcome of regulatory review of our product candidates;
•the costs, timing and ability to manufacture our product candidates to supply our clinical development efforts and our clinical trials;
•Servier's ability to develop and commercialize BDTX-4933 and the receipt of potential milestone and royalty payments from commercial product sales, along with tiered royalties based on global net sales, if any, under the Servier Agreement;
•the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
•subject to receipt of regulatory approval, the costs of commercialization activities for our product candidates, to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
•the ability to receive additional non-dilutive funding;
•the revenue, if any, received from commercial sale of our product candidates, should any of our product candidates receive marketing approval;
•the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining, expanding and enforcing our intellectual property rights and defending intellectual property-related claims;
•our ability to establish and maintain additional collaborations and license agreements on favorable terms, if at all, and the ability and willingness of our third-party strategic collaborators to undertake research and development activities relating to our product candidates, and the success of those collaborations and license agreements;
•the extent to which we acquire or in-license other product candidates and technologies;
•the ongoing costs of operating as a public company; and
•general macroeconomic, geopolitical, industry and market conditions, including increases in inflationary rates, tariffs, interest rates and supply chain constraints.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, as we can generate substantial product revenue from product sales, we expect to finance our operations through a combination of public or private equity offerings, debt financings, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties or through other sources of financing. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. However, the trading prices for our common stock and for other biopharmaceutical companies have been highly volatile. As a result, we may face difficulties raising capital through sales of our common stock, and such sales may be on unfavorable terms. Similarly, adverse macroeconomic conditions and market volatility resulting from global economic developments, political unrest, high inflation, global health crises, or other factors could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms or at all. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, the ownership interest of our stockholders may be materially diluted, and the terms of such securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. In addition, debt financing may involve significant cash payment obligations and specific financial ratios that may restrict our ability to operate our business would result in fixed payment obligations.
If we raise additional funds through collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, obtain capital through arrangements with collaborators on terms unfavorable to us or pursue merger or acquisition strategies, all of which could adversely affect the holdings or the rights of our stockholders.
Contractual obligations and commitments
The following summarizes our contractual obligations as of September 30, 2025:
| Payments Due by Period | |||||||||||||||||||||||||||||
| Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | |||||||||||||||||||||||||
|
(in thousands)
|
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|
Property leases - commenced
|
$ | 4,568 | $ | 9,280 | $ | 4,399 | $ | 4,464 | $ | 22,711 | |||||||||||||||||||
|
Total
|
$ | 4,568 | $ | 9,280 | $ | 4,399 | $ | 4,464 | $ | 22,711 | |||||||||||||||||||
Property leases - commenced
The amounts reported for property leases represent future minimum lease payments under non-cancelable operating leases in effect as of September 30, 2025. The minimum lease payments do not include common area maintenance charges or real estate taxes.
Other contractual obligations
The contractual obligations table does not include any potential future milestone payments or royalty payments we may be required to make or receive under our existing license agreements due to the uncertainty of the occurrence of the events requiring payment under those agreements.
Critical accounting policies and significant judgments and use of estimates
Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (GAAP). The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
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, 2024, which was filed with the SEC on March 6, 2025, except as described below:
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. See Note 2,Summary of Significant Accounting Policies, to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report for additional information.
Recently issued accounting pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
Emerging growth company and smaller reporting company status
The Jumpstart Our Business Startups Act of 2012 (the JOBS Act) permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to not "opt out" of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to "opt out" of such extended transition period or (ii) no longer qualify as an emerging growth company.
We are also a "smaller reporting company" meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Effective as of December 31, 2025, the fifth anniversary of the closing of our IPO, we will no longer qualify as an "emerging growth company." As a result, commencing with our Annual Report on Form 10-K for the fiscal year ending December 31, 2025, we will no longer be eligible to take advantage of certain exemptions from various reporting requirements that are applicable to emerging growth companies.
Black Diamond Therapeutics Inc. published this content on November 06, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 06, 2025 at 12:12 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]