Business context and reporting period
Black Diamond Therapeutics, Inc. is an early-stage precision oncology company developing small-molecule therapies for genetically defined cancers using its Mutation-Allostery-Pharmacology (MAP) drug-discovery platform. This Form 10-K covers the fiscal year ended December 31, 2021; it was filed March 17, 2022. The company reported one operating segment and had no products approved for sale.
Pipeline status at filing: BDTX-189 was in a Phase 1 safety-expansion cohort; BDTX-1535’s IND was cleared in January 2022 and its Phase 1 trial began in Q1 2022; BDTX-4933 was in IND-enabling work in Q1 2022. These pipeline milestones are subsequent to the 2021 fiscal year.
Financial performance and liquidity
Amounts below are in millions of dollars, except per-share data. The company generated no revenue and reported no gross margin.
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $96.8 | $48.2 |
| General and administrative expense | $30.0 | $21.4 |
| Total operating expenses / operating loss | $126.9 | $69.6 |
| Net loss | $125.6 | $67.3 |
| Basic and diluted loss per share | $3.47 | $2.05 |
| Net cash used in operating activities | $100.1 | $52.1 |
At December 31, 2021, cash and cash equivalents were $65.8 million and short-term investments were $144.0 million, totaling $209.8 million. Current assets were $215.7 million, current liabilities $23.6 million, and total stockholders’ equity $195.9 million. Total liabilities were $51.8 million, including operating lease liabilities; the filing reports no financial borrowings. The accumulated deficit was $243.8 million.
Investing activities provided $130.6 million in 2021, primarily from investment sales and maturities; financing activities provided $0.7 million, primarily from option exercises. Cash, cash equivalents and restricted cash increased $31.2 million. Stock-based compensation was $14.0 million, a noncash expense. No income tax benefit was recorded; deferred tax assets were fully offset by a valuation allowance.
Material changes versus 2020
- Net loss increased $58.3 million, or about 87%; operating expenses rose $57.3 million.
- R&D expense approximately doubled, rising $48.6 million, reflecting expanded platform and other research programs, greater spending on BDTX-189 and BDTX-1535, and higher personnel and facility costs.
- G&A expense rose $8.7 million, mainly due to headcount growth and public-company-related professional fees.
- Operating cash use increased $48.0 million. Cash and investments declined from approximately $315.1 million at year-end 2020 to $209.8 million at year-end 2021.
- New and expanded office and laboratory leases increased reported right-of-use assets and lease obligations.
Outlook, commentary, risks and unusual items
Management expected existing capital resources to fund operations and capital requirements into 2024, including the BDTX-1535 Phase 1 trial, the BDTX-189 safety-expansion cohort, BRAF IND-enabling work, and continued MAP platform investment. This estimate depends on assumptions that may prove incorrect. The company expects operating losses and expenses to continue increasing and anticipates needing substantial additional funding; no profitability or product revenue timeline is provided.
- BDTX-189: The dose-escalation study established an 800 mg once-daily recommended Phase 2 dose. The company reported two confirmed partial responses in heavily pretreated patients who remained on treatment for more than 10 months. It gated initiation of the planned Phase 2 portion while evaluating additional safety-expansion data, citing changes in the NSCLC treatment landscape. An FDA partial clinical hold related to routine toxicology-study submissions was lifted in January 2022; the filing says it was not prompted by trial safety findings.
- BDTX-1535: Management planned to provide a clinical-data update in the second half of 2023. Clinical benefit and safety remain unproven in humans at this early stage.
- BDTX-4933 and FGFR: The company anticipated IND-enabling progress for BDTX-4933 and selection of an FGFR development candidate in 2022; these were plans, not achieved outcomes at year-end.
- Key risks: Clinical failure or delay, difficulty enrolling patients with rare genetic alterations, regulatory uncertainty including acceptance of tumor-agnostic development, companion-diagnostic development, competition, dependence on contract research and manufacturing organizations, and the need for additional capital. COVID-19 could disrupt trials, research, vendors or supply.
- Contingencies and governance: License milestone payments are contingent and not reasonably estimable. No material legal proceedings were reported. The financial-statement audit opinion was unqualified; management reported effective disclosure controls and internal control over financial reporting, while the auditor was not engaged to opine on internal-control effectiveness.
Important facts for investors to verify
- Whether the stated runway into 2024 remains adequate as clinical, research and operating spending evolves, and what financing may be required.
- Updated BDTX-189 safety-expansion results and the company’s rationale and plans for any Phase 2 study.
- Human safety, pharmacokinetic and antitumor data for BDTX-1535, and progress against the disclosed clinical-update timetable.
- Whether BDTX-4933 and FGFR milestones were achieved, and the resulting development costs and timelines.
- Patient-enrollment pace, companion-diagnostic readiness, regulatory feedback and competitive changes across the targeted cancer populations.
- Lease obligations, contingent license milestones, and potential dilution or other terms if additional capital is raised.