Black Diamond Therapeutics, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; filed March 12, 2024. Black Diamond is a clinical-stage oncology company with no approved products and no product revenue. Its development focus is two clinical-stage candidates: BDTX-1535 and BDTX-4933.
Financial results and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $59.4 million | $64.4 million |
| General and administrative expense | $27.1 million | $28.4 million |
| Total operating expenses / operating loss | $86.5 million | $92.8 million |
| Net loss | $82.4 million | $91.2 million |
| Net loss per share, basic and diluted | $1.88 | $2.52 |
| Cash used in operating activities | $66.7 million | $85.1 million |
| Cash, cash equivalents and investments at year-end | $131.4 million | $122.8 million |
At December 31, 2023, current assets were $134.0 million and current liabilities were $19.6 million. Total assets were $158.6 million, total liabilities $41.8 million, and stockholders’ equity $116.7 million. Liabilities included $25.3 million of operating lease liabilities; the filing does not report borrowings or other financial debt. The company reported an accumulated deficit of $417.4 million. Gross margin is not applicable because the company had no product sales.
FY2023 cash flow from investing activities was positive $16.3 million, principally from investment sales and maturities; financing activities provided $71.9 million, primarily from the July 2023 stock offering. Cash and cash equivalents, including restricted cash, increased $21.6 million during the year. The company sold 15.0 million shares at $5.00 per share in the offering, receiving approximately $71.6 million net proceeds. It had 51.6 million common shares outstanding at year-end and 51.7 million as of March 5, 2024.
Changes versus FY2022
- Net loss narrowed by $8.7 million, while total operating expenses declined by $6.4 million. The company attributed the expense reduction mainly to lower early discovery and platform spending, discontinued BDTX-189 development, and lower personnel costs following a 2022 workforce realignment.
- BDTX-1535 R&D expense rose $12.7 million as its clinical program advanced; reduced spending on other research programs and BDTX-189 more than offset that increase.
- Operating cash use decreased by $18.4 million. The 2023 financing inflow was substantially higher, primarily reflecting the follow-on equity offering.
- FY2022 included a $2.2 million gain on sale of intellectual property and $2.3 million of equity-method investment losses; neither item was recorded in FY2023.
Programs, outlook and risks
- BDTX-1535: The Phase 1 dose-escalation study reported clinical activity in EGFR-mutated NSCLC, including confirmed partial responses in 5 of 13 evaluable patients with measurable disease in specified mutation groups. The company reported one confirmed partial response and eight cases of stable disease among 19 measurable GBM patients; EGFR status was not confirmed before dosing in that study. A Phase 2 NSCLC study was enrolling, including second-/third-line cohorts and a first-line non-classical EGFR mutation cohort. Management expected second-/third-line results in Q3 2024, first-line results in 2025, and GBM study updates in Q2 2024. The candidate received FDA Fast Track designation for a defined C797S-positive NSCLC population.
- BDTX-4933: The Phase 1 dose-escalation trial, initiated in Q2 2023, was enrolling, with emphasis on non-G12C KRAS-mutated NSCLC. Data were expected in Q4 2024. The broad activity and brain penetration described by management are based on preclinical findings; clinical efficacy remains unestablished.
- Other programs: The company nominated BDTX-4876, an FGFR2/3 development candidate, and a candidate against an undisclosed solid-tumor target; it was exploring partnership opportunities for both. It also described evaluating strategic alternatives for these early-stage assets.
- Management estimated that year-end cash, cash equivalents and investments would fund planned operations into Q2 2025, while warning that assumptions may prove wrong and additional financing will be needed. The audited statements were prepared on a going-concern basis; the auditor’s unmodified opinion included an emphasis that additional financing is required. There is no product-revenue or profitability guidance in the filing.
- Key risks include clinical-trial failure or delay, enrollment challenges for mutation-defined patient groups, safety and regulatory uncertainty, companion-diagnostic development, dependence on CROs and contract manufacturers, competition, intellectual-property protection, and the need to raise capital. Further equity financing could dilute shareholders; the company had not used its $150 million ATM program as of year-end.
- The company reported no material legal proceedings and stated that cybersecurity threats had not materially affected, and were not believed reasonably likely to materially affect, its business as of the report date. Management concluded disclosure controls and internal control over financial reporting were effective; the auditor did not attest to internal controls.
Investor facts to verify
- Whether BDTX-1535 Phase 2 results support efficacy and durability in each NSCLC cohort, with attention to cohort sizes, response criteria, follow-up, and safety.
- Whether GBM follow-up confirms tumor EGFR status and adequate brain-tissue drug exposure, and whether reported activity translates into a defined development plan.
- BDTX-4933 dose-escalation safety, pharmacokinetics, and antitumor activity, including the targeted non-G12C KRAS population.
- Actual cash burn and financing needs against management’s Q2 2025 runway estimate, including potential dilution or partnership terms.
- Execution and economics of potential partnerships for BDTX-4876 and the undisclosed program, and any material changes in clinical, manufacturing, or intellectual-property risks.