Black Diamond Therapeutics(BDTX) - 2024 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) Unaudited financial statements for Q2 and H1 2024 report net losses of $19.9 million and $38.1 million, with $123.0 million in cash and investments as of June 30, 2024 Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $32,811 | $56,221 | | Investments | $90,160 | $75,179 | | Total current assets | $126,754 | $134,034 | | Total assets | $149,986 | $158,567 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $18,439 | $19,646 | | Total liabilities | $38,965 | $41,831 | | Total stockholders' equity | $111,021 | $116,736 | | Total liabilities and stockholders' equity | $149,986 | $158,567 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | 2024 | 2023 | 2024 | 2023 | | Research and development | $12,556 | $13,154 | $26,101 | $27,907 | | General and administrative | $9,574 | $6,878 | $16,275 | $13,686 | | Loss from operations | $(22,130) | $(20,032) | $(42,376) | $(41,593) | | Net loss | $(19,909) | $(19,152) | $(38,134) | $(40,027) | | Net loss per share, basic and diluted | $(0.36) | $(0.52) | $(0.71) | $(1.09) | Condensed Consolidated Statements of Cash Flows (in thousands) | Six Months Ended June 30, | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,925) | $(34,399) | | Net cash (used in) provided by investing activities | $(12,994) | $41,981 | | Net cash provided by financing activities | $25,508 | $51 | Notes to Unaudited Condensed Consolidated Financial Statements These notes detail the company's clinical-stage oncology focus, recent capital raises, sufficient cash runway for 12 months, and stock-based compensation and lease obligations - The company is a clinical-stage oncology company developing MasterKey therapies using its Mutation-Allostery-Pharmacology (MAP) drug discovery engine[21] - As of June 30, 2024, the company had sold 4,490,853 shares through its ATM Program, raising gross proceeds of approximately $25.0 million. In July 2023, a Follow-on Offering raised net proceeds of about $71.9 million[23] - Management expects that its cash, cash equivalents, and investments will be sufficient to fund planned operations for at least the next 12 months from the financial statement issuance date[24] - As of June 30, 2024, total unrecognized compensation cost related to unvested stock-options was $17.3 million, expected to be recognized over a weighted average period of 2.9 years[54] - The company has entered into sublease agreements for its office space in Cambridge, MA (terminating Aug 2028) and its office/lab space in New York, NY (terminating June 2026)[62][63] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and operational progress, highlighting clinical program advancements, reduced net loss, and a $123.0 million cash position funding operations into Q4 2025 Overview Black Diamond, a clinical-stage oncology company, advances BDTX-1535 and BDTX-4933 programs with upcoming data readouts and a cash runway into Q4 2025 - The company is advancing two primary clinical-stage programs: BDTX-1535 (EGFR inhibitor) and BDTX-4933 (RAF inhibitor)[74] - Key upcoming milestones include BDTX-1535 Phase 2 results in Q3 2024 and Q1 2025, and a BDTX-4933 Phase 1 update in Q4 2024[77][80] - As of June 30, 2024, the company had cash, cash equivalents, and investments of approximately $123.0 million, which is expected to fund operations into the fourth quarter of 2025[87] Results of Operations Operating results for H1 2024 show decreased R&D expenses to $26.1 million, increased G&A to $16.3 million, and an improved net loss of $38.1 million Comparison of Results of Operations (in thousands) | Six Months Ended June 30, | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $26,101 | $27,907 | $(1,806) | | General and administrative | $16,275 | $13,686 | $2,589 | | Total operating expenses | $42,376 | $41,593 | $783 | | Net loss | $(38,134) | $(40,027) | $1,893 | Research & Development Expense Breakdown (in thousands) | Six Months Ended June 30, | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | BDTX-1535 expenses | $10,977 | $7,161 | $3,816 | | BDTX-4933 expenses | $3,071 | $3,397 | $(326) | | Other research programs | $1,157 | $4,893 | $(3,736) | | Personnel expenses | $8,674 | $9,779 | $(1,105) | | Total R&D | $26,101 | $27,907 | $(1,806) | Liquidity and Capital Resources Liquidity is driven by equity financings, with $123.0 million in cash and investments as of June 30, 2024, projected to fund operations into Q4 2025 - The company has funded operations through its IPO, a 2023 Follow-on Offering, and an ATM Program, which has generated gross proceeds of approximately $25.0 million as of June 30, 2024[107][109][111] Summary of Cash Flows (in thousands) | Six Months Ended June 30, | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | $(35,925) | $(34,399) | | Cash (used in) provided by investing activities | $(12,994) | $41,981 | | Cash provided by financing activities | $25,508 | $51 | - Existing cash, cash equivalents, and investments of $123.0 million are expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2025[117] Item 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Black Diamond Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[129] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal controls during the quarter - Based on an evaluation as of the end of the reporting period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[130] - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[131] PART II - OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently party to and is not aware of any material legal proceedings[70][133] Item 1A. Risk Factors This section refers readers to the detailed discussion of risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - For a discussion of risk factors, readers are encouraged to carefully consider the information in Part I, "Item 1A. Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2023[134] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered equity sales occurred this quarter, and there is no material change in the planned use of IPO proceeds - There were no recent sales of unregistered equity securities[134] - There has been no material change in the company's planned use of the net proceeds from its IPO as described in the final prospectus[136] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities - None[136] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[137] Item 5. Other Information The Chief Scientific Officer entered a Rule 10b5-1 trading plan on May 30, 2024, for up to 160,000 shares, commencing August 29, 2024 - On May 30, 2024, Elizabeth Buck, the Chief Scientific Officer, entered into a Rule 10b5-1 trading plan scheduled to commence on August 29, 2024. The plan allows for the sale of up to 160,000 shares of common stock[137] Item 6. Exhibits This section lists the exhibits filed with the quarterly report, which include certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act, and Inline XBRL documents - The report includes standard exhibits such as CEO/CFO certifications (pursuant to Rules 13a-14(a) and 15d-14(a), and Section 906 of Sarbanes-Oxley) and XBRL data files[141]