Black Diamond Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 16, 2026.
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FY2025 · Filed Mar 16, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| Page | |
|---|---|
| PART I | 7 |
| Item 1. Business | 8 |
| Item 1A. Risk Factors | 44 |
| Item 1B. Unresolved Staff Comments | 115 |
| Item 1C. Cybersecurity | 115 |
| Item 2. Properties | 116 |
| Item 3. Legal Proceedings | 117 |
| Item 4. Mine Safety Disclosures | 117 |
| PART II | 118 |
| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 118 |
| Item 6. Reserved | 118 |
| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 118 |
| Item 7A. Quantitative and Qualitative Disclosures about Market Risk | 130 |
| Item 8. Financial Statements and Supplementary Data | 131 |
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 161 |
| Item 9A. Controls and Procedures | 161 |
| Item 9B. Other Information | 162 |
| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 162 |
| PART III | 163 |
| Item 10. Directors, Executive Officers and Corporate Governance | 163 |
| Item 11. Executive Compensation | 163 |
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 163 |
| Item 13. Certain Relationships and Related Transactions and Director Independence | 163 |
| Item 14. Principal Accountant Fees and Services | 163 |
| PART IV | 164 |
| Item 15. Exhibits and Financial Statement Schedules | 164 |
We have applied for various trademarks that we use in connection with the operation of our business. This Annual Report on Form 10-K (Annual Report) may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names or products in this Annual Report is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this Annual Report may appear without the ®, TM or SM symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner of these trademarks, service marks and trade names will not assert, to the fullest extent under applicable law, its rights.
From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this Annual Report.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “could”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Annual Report include, but are not limited to, statements about:
the progress, timing and success of our clinical trials of silevertinib (formerly BDTX-1535) and any of our future product candidates, including the availability, timing and announcement of data and results of such trials;
our ability to obtain and maintain regulatory approval for silevertinib or any of our future product candidates that we may identify or develop;
the scope, timing, progress and results of our clinical trials and investigational new drug (IND) applications, development efforts and other regulatory submissions;
the effects of competition with respect to silevertinib or any of our other current or future product candidates, as well as innovations by current and future competitors in our industry;
our evaluation of potential partnership opportunities to advance the pivotal development of silevertinib in a timely manner and to successfully execute and realize the intended and potential benefits of any such potential partnership;
our partnership with Servier Pharmaceuticals LLC (Servier) and the intended and potential benefits thereof, including the receipt of potential development and commercial milestone payments, along with tiered royalties based on global net sales, if any;
Servier’s ability to develop and commercialize BDTX-4933, including the ongoing Phase 1 clinical trial of BDTX-4933, and the potential of BDTX-4933 to address the unmet medical need for patients with RAF/RAS-mutant solid tumors, including non-small cell lung cancer (NSCLC);
our evaluation of strategic alternatives for BDTX-4876, including our ability to execute and realize the anticipated benefits of any strategic alternatives we may pursue;
our ability to develop our current and future product candidates for the treatment of various cancers;
the rate and degree of market acceptance and clinical utility for any current or future product candidates we may develop;
the implementation of our strategic plans for our business and our product candidates;
our intellectual property position, including the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering our product candidates and Mutation-Allostery-Pharmacology (MAP) drug discovery engine;
our ability to obtain additional funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved;
the period over which we expect our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses and capital expenditure requirements;
the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our future financial performance and our ability to effectively manage our anticipated growth;
our estimates regarding the market opportunities for our product candidates, including our competitive position and the success of competing therapies that are or may become available;
our need for and ability to attract and retain key scientific, management and other personnel and to identify, hire and retain additional qualified professionals;
the potential for our business development efforts to maximize the value of our product candidates;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
our ability to establish or maintain collaborations or strategic relationships, the ability and willingness of our third-party strategic collaborators to undertake research and development activities relating to our current or future product candidates, and the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements, if any;
our ability to maintain an effective system of internal controls;
the impact of macroeconomic and geopolitical developments on our business, including rising inflation and capital market disruptions, changes in or disruptions of U.S. governmental agencies, whether from a U.S. federal government shutdown or reduced resources, new or increased international tariffs and retaliatory tariffs, new laws and regulations or amendments to existing laws and regulations in the U.S. and foreign countries, trade protection measures, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our common stock and our ability to access capital markets; and
other material risks and uncertainties, including those discussed in Part I, Item 1A, “Risk Factors” in this Annual Report.
Any forward-looking statements in this Annual Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part I, Item 1A, “Risk Factors” and elsewhere in this Annual Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
All of our forward-looking statements are as of the date of this Annual Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Annual Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the SEC could materially and adversely affect our business, prospects, financial condition and results of operations. Some of these risks and uncertainties may in the future be amplified by global health crises, macroeconomic conditions and geopolitical developments, and there may be additional risks that we consider immaterial or which are unknown. It is not possible to predict or identify all such risks. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Annual Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Annual Report that modify or impact any of the forward-looking statements contained in this Annual Report will be deemed to modify or supersede such statements in this Annual Report.
This Annual Report contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed as exhibits to this Annual Report.
We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Annual Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.