Black Diamond Therapeutics(BDTX) - 2022 Q3 - Quarterly Report

Financial Performance - The company reported net losses of $70.1 million and $99.7 million for the nine months ended September 30, 2022, and 2021, respectively, with an accumulated deficit of $313.9 million as of September 30, 2022[84]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[92]. - Net loss for the three months ended September 30, 2022, was $21.7 million, an improvement of $13.4 million compared to a net loss of $35.1 million in the same period of 2021[103]. - For the nine months ended September 30, 2022, total operating expenses were $71.0 million, a decrease of $29.8 million from $100.8 million in the same period in 2021[107]. - Cash used in operating activities for the nine months ended September 30, 2022, was $63.1 million, compared to $76.1 million for the same period in 2021[117]. - Other income for the three months ended September 30, 2022, was $0.5 million, an increase from $0.3 million in the same period in 2021[106]. Cash and Funding - As of September 30, 2022, the company had cash, cash equivalents, and investments of approximately $144.2 million, expected to fund operations into the third quarter of 2024[86]. - The company anticipates requiring additional capital for regulatory approvals and potential acquisitions of product candidates[124]. - The company requires substantial additional funding to support ongoing operations and growth strategy, with reliance on public or private equity offerings, debt financings, and collaborations[127]. - The company may face difficulties raising capital due to high volatility in trading prices and adverse macroeconomic conditions, which could affect financing on favorable terms[127]. - Future funding requirements could increase significantly based on various factors, including research and development costs, regulatory review outcomes, and commercialization activities[125]. - The company may need to relinquish valuable rights or grant licenses on unfavorable terms if additional funds are raised through collaborations or partnerships[129]. Research and Development - Research and development expenses are anticipated to increase substantially as the company advances clinical studies for BDTX-1535 and continues preclinical studies for BDTX-4933[96]. - The company is currently conducting a Phase I clinical trial for BDTX-1535, which targets oncogenic mutations in the EGFR[82]. - BDTX-4933 is in IND-enabling studies and is designed to inhibit Class I, II, and III mutations while avoiding paradoxical activation[82]. - The company has discontinued the development of BDTX-189 to focus on progressing BDTX-1535 and BDTX-4933[82]. - Research and development expenses for the three months ended September 30, 2022, were $15.8 million, down $11.8 million from $27.6 million in the prior year, primarily due to reduced trial activities for BDTX-189[104]. - Research and development expenses for the nine months ended September 30, 2022, totaled $49.8 million, down $27.3 million from $77.2 million in the prior year[108]. Operational Challenges - The ongoing COVID-19 pandemic has led to various operational impacts, including potential delays in clinical trials and research programs[89]. - General and administrative expenses are expected to increase as the company prepares for potential commercialization activities[100]. - The company anticipates that adverse conditions could delay or limit research and product development efforts if additional funds are not secured[129]. - The company’s ability to maintain profitability is uncertain, and failure to do so may force operational reductions or terminations[125]. Accounting and Reporting - The company has not experienced material changes to critical accounting policies during the nine months ended September 30, 2022[134]. - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[137]. - There were no changes in internal control over financial reporting that materially affected the company's financial reporting during the period covered by the report[140]. Operating Expenses - Total operating expenses for the three months ended September 30, 2022, were $22.1 million, a decrease of $13.2 million compared to $35.4 million for the same period in 2021[103]. - The company has incurred significant operating losses since its inception in 2014, primarily funding operations through the sale of preferred and common stock[84]. - As of September 30, 2022, total contractual obligations amount to $35.703 million, with property leases categorized as follows: less than 1 year - $4.215 million, 1 to 3 years - $8.777 million, 3 to 5 years - $9.260 million, and more than 5 years - $13.451 million[130].