CIPhotos Black Diamond Therapeutics, Inc. (NASDAQ:BDTX) is a precision oncology company targeting genetically defined cancers. It calls its approach the Masterkey approach, which aims to provide one solution for many types of cancer mutations and address the disease in a much broader range of patients than current precision therapies can access. Its oral therapies are designed to target families of oncogenic mutations including drug-resistant mutations, and are also designed to cross the blood-brain bar ...

SECURITIES AND EXCHANGE COMMISSION | --- | --- | --- | |---------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------| | Securities registered pursuant to Section 12(b) \nTitle of each class | of the Act: \nTrading Symbol(s) | Name of each exchange on which registered | | Common stock, par value $0.0001 | BDTX | The Nasdaq Global Select Market | Non-accelerated filer ☒ Smaller reporting ...

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the company's unaudited condensed consolidated financial statements for the six months ended June 30, 2023, including balance sheets, statements of operations, and cash flows, with accompanying notes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,888 | $34,315 | | Investments | $47,639 | $88,492 | | Total current assets | $92,992 | $127,706 | | Total assets | $119,879 | $156,255 | | **Liabilities & Equity** | | | | Total liabilities | $37,680 | $40,560 | | Total stockholders' equity | $82,199 | $115,695 | Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30, in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $27,907 | $33,981 | | General and administrative | $13,686 | $14,871 | | Total operating expenses | $41,593 | $48,852 | | Loss from operations | $(41,593) | $(48,852) | | Net loss | $(40,027) | $(48,437) | | Net loss per share | $(1.09) | $(1.33) | Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30, in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,399) | $(46,667) | | Net cash provided by investing activities | $41,981 | $36,537 | | Net cash provided by financing activities | $51 | $153 | | Net increase (decrease) in cash | $7,633 | $(9,977) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section reviews the company's clinical-stage oncology programs and financial results for the six months ended June 30, 2023, highlighting reduced operating losses and liquidity [Overview](index=25&type=section&id=Overview) The company is a clinical-stage precision oncology firm developing 'MasterKey' therapies, with lead candidates BDTX-1535 and BDTX-4933 advancing in clinical trials - Lead product candidate **BDTX-1535** demonstrated a favorable tolerability profile and clinical proof of activity in a Phase 1 study for non-small cell lung cancer (NSCLC) patients[243](index=243&type=chunk) - Second product candidate, **BDTX-4933**, initiated a Phase 1 clinical trial in Q2 2023 for patients with all-class BRAF or RAS mutations[233](index=233&type=chunk) - The company has incurred significant operating losses since inception, with a **net loss of $40.0 million** for the six months ended June 30, 2023, and an **accumulated deficit of $375.0 million**[236](index=236&type=chunk) [Results of operations](index=29&type=section&id=Results%20of%20operations) Total operating expenses decreased for the three and six-month periods ending June 30, 2023, primarily due to reduced R&D and personnel costs, partially offset by increased clinical trial spending Comparison of Results of Operations (in thousands) | Period | Metric | Q2 2023 | Q2 2022 | Change | H1 2023 | H1 2022 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Three Months** | R&D Expenses | $13,154 | $16,195 | $(3,041) | - | - | - | | | G&A Expenses | $6,878 | $6,978 | $(100) | - | - | - | | | **Net Loss** | **$(19,152)** | **$(22,930)** | **$3,778** | - | - | - | | **Six Months** | R&D Expenses | - | - | - | $27,907 | $33,981 | $(6,074) | | | G&A Expenses | - | - | - | $13,686 | $14,871 | $(1,185) | | | **Net Loss** | - | - | - | **$(40,027)** | **$(48,437)** | **$8,410** | - The **$6.1 million decrease in R&D expenses** for the first six months of 2023 was primarily due to a **$5.0 million reduction in BDTX-189 expenses** and a **$3.1 million decrease in personnel costs**, partially offset by a **$7.9 million net increase in spending** for the BDTX-1535 and BDTX-4933 clinical trials[25](index=25&type=chunk) - General and administrative expenses for the six months ended June 30, 2023, **decreased by $1.2 million to $13.7 million**, mainly due to lower personnel-related costs, legal, and other professional fees[38](index=38&type=chunk) [Liquidity and capital resources](index=33&type=section&id=Liquidity%20and%20capital%20resources) The company's operations are funded primarily through equity sales, with current capital expected to support operations into the first half of 2025 following a recent equity offering - As of June 30, 2023, the company had **cash, cash equivalents, and investments of $89.5 million**[4](index=4&type=chunk)[34](index=34&type=chunk) - In July 2023, the company completed a Follow-on Offering, raising approximately **$71.6 million in net proceeds**[43](index=43&type=chunk)[175](index=175&type=chunk)[239](index=239&type=chunk) - Management believes that existing cash, combined with the proceeds from the July 2023 Follow-on Offering, will be sufficient to fund operating expenses and capital expenditure requirements into the **first half of 2025**[4](index=4&type=chunk)[250](index=250&type=chunk) Contractual Obligations as of June 30, 2023 (in thousands) | Obligation Type | Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Property leases | $4,301 | $8,955 | $9,449 | $9,845 | $32,550 | [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company defined by Rule 12b-2 of the Exchange Act, the company is not required to provide the information under this item[81](index=81&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the Chief Executive Officer and Chief Financial Officer, concluded that the company's disclosure controls and procedures were **effective as of June 30, 2023**[63](index=63&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, its internal controls[64](index=64&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and does not anticipate any significant adverse effects from ordinary course legal matters - The company is not currently a party to any material legal proceedings[84](index=84&type=chunk)[228](index=228&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor addresses potential adverse effects from banking and financial market instability, though the company has not experienced any adverse impact to date - A new risk factor was added to address potential adverse effects from instability in the banking system and financial markets, referencing the failure of Silicon Valley Bank (SVB)[65](index=65&type=chunk)[85](index=85&type=chunk) - As of the report date, the company does not hold material cash deposits at SVB and has not experienced any adverse impact to its liquidity or business operations[66](index=66&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period, and no material change in the planned use of IPO proceeds - There were no unregistered sales of equity securities during the period[67](index=67&type=chunk)[90](index=90&type=chunk) - The company confirmed there has been no material change in its planned use of the net proceeds from its February 2020 IPO[89](index=89&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None reported[70](index=70&type=chunk)[91](index=91&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business operations - Not applicable[70](index=70&type=chunk)[92](index=92&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No information was reported for this item - None reported[70](index=70&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The report includes a list of filed exhibits, such as CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and Inline XBRL data files[72](index=72&type=chunk) [SIGNATURES](index=42&type=section&id=SIGNATURES) The quarterly report was formally signed by the company's principal executive and financial officers on August 11, 2023 - The report was duly signed on behalf of Black Diamond Therapeutics, Inc. on **August 11, 2023**[98](index=98&type=chunk)[95](index=95&type=chunk) - Signatories include **David M. Epstein** (Principal Executive Officer) and **Fang Ni** (Principal Financial Officer)[74](index=74&type=chunk)

• the timing, receipt and terms of any marketing approvals from applicable regulatory authorities including the U.S. Food and Drug Administration (FDA) and non-U.S. regulators; • the extent of any required post-marketing approval commitments to applicable regulatory authorities; • development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; General and administrative Other income was $0.7 million for the three mon ...

• 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; Table of Contents PART I Approved targeted therapies, such as kinase inhibitors, have transformed the treatment of cancers and demonstrated a significant benefi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-Q _______________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-Q _______________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBE ...

Pipeline and Programs - Black Diamond Therapeutics is developing MasterKey therapies targeting oncogene mutation families to provide precision oncology medicines for genetically defined tumors[7] - BDTX-1535, a brain-penetrant, mutant-selective, irreversible EGFR inhibitor, is in Phase 1 clinical trials for GBM and NSCLC patients with EGFR intrinsic & acquired resistance mutations[7] - BDTX-4933, a brain-penetrant inhibitor of Class I, II, and III oncogenic BRAF mutations, is in IND-enabling studies with an expected IND filing in the first half of 2023[7, 11] - The company anticipates nominating a development candidate for its FGFR2/3 program in 2022 and for an undisclosed target program in 2023[11] Technology and Approach - Black Diamond's MAP drug discovery engine is designed to predict and validate novel oncogenic mutant families, pioneer mutant family conformation-based MasterKey drug design, and provide opportunities beyond oncology and small molecules[7] - The MasterKey approach targets mutation families to expand the opportunity for precision oncology, addressing populations lacking suitable precision therapies; less than 15% of patients with metastatic cancer are eligible for approved precision oncology medicines[10] - BDTX-1535 is designed for potent & selective inhibition across mutant families, with average IC50 of 3.8 nM against intrinsic resistance mutations and 3.5 nM against classical & acquired resistance mutations in NSCLC[25, 26] Financials and Milestones - As of December 31, 2021, Black Diamond Therapeutics had $209 million in cash, cash equivalents, and investments, providing a cash runway into the third quarter of 2024[59]

Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 BDTX The Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ...

Table of Contents ___________________________________________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________________________________ FORM 10-K ___________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE N ...