IDEAYA Biosciences, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021; filed March 17, 2022. IDEAYA is an early-stage oncology biotechnology company developing precision-medicine therapies. It has no approved products and generated no product-sales revenue. Its reported revenue is from the GSK collaboration.
Financial performance and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Collaboration revenue | $27.9 million | $19.5 million |
| Research and development expense | $58.2 million | $39.7 million |
| General and administrative expense | $20.1 million | $15.2 million |
| Operating loss | $50.3 million | $35.3 million |
| Net loss | $49.8 million | $34.5 million |
| Net loss per share, basic and diluted | $1.41 | $1.40 |
| Net cash used in operating activities | $55.8 million | Net cash provided: $55.5 million |
| Cash, cash equivalents and marketable securities | $368.1 million | $283.6 million |
- Revenue increased 43%; R&D expense rose 47% and G&A expense rose 32%. The company attributed expense growth mainly to increased staffing and higher CRO, CMO, consulting, laboratory and facility costs.
- FY2021 cash flows included $145.5 million from financing, principally $86.0 million net proceeds from a public offering and $57.3 million from at-the-market share sales. Shares outstanding increased from 29.5 million at year-end 2020 to 38.5 million at year-end 2021.
- Current assets were $251.0 million and current liabilities were $45.2 million. The balance sheet reports no borrowings; liabilities were primarily collaboration contract liabilities, accrued liabilities, accounts payable and lease obligations. Total lease liabilities were $5.2 million.
- Accumulated deficit was $176.7 million. Management said available cash, cash equivalents and marketable securities should fund planned operations for at least 12 months from issuance of the financial statements.
Business, pipeline and material developments
- IDE397: Phase 1 MAT2A inhibitor for MTAP-deleted solid tumors, developed with GSK. As of March 1, 2022, 16 patients had enrolled; the company reported no dose-limiting toxicities, no drug-related serious adverse events and one drug-related Grade 3 asthenia event that resolved after dose reduction. Early pharmacodynamic findings and tumor-size reductions were preliminary; the filing does not establish clinical efficacy.
- Darovasertib (IDE196): Phase 1/2 PKC inhibitor for cancers with GNAQ/11 mutations, including metastatic uveal melanoma (MUM). In preliminary combination data with crizotinib, using a November 25, 2021 cutoff, disease control was reported in 16 of 16 evaluable patients and confirmed response in 4 of 13 patients with at least two post-baseline scans (31%). Six of those 13 had tumor reduction greater than 30%. These are interim results from a small, evolving dataset.
- Preclinical pipeline: PARG candidate IDE161 was targeted for an IND submission in Q4 2022, subject to satisfactory preclinical and IND-enabling results. Pol Theta and Werner Helicase programs are partnered with GSK; IDEAYA targeted Pol Theta IND-enabling work in 1H 2022 and WRN candidate nomination in 2023.
- GSK economics: GSK paid a $100 million upfront fee in 2020. IDEAYA could receive a $50 million payment if GSK exercises its IDE397 option, subject to applicable clearance, plus potential development, regulatory and commercial milestones and profit-share/royalty rights. These amounts are contingent, not assured. In January 2022, GSK waived the planned MAT2A combination-trial rights and related IDEAYA supply obligation.
- Post-year-end Pfizer agreements: In March 2022, IDEAYA entered into additional agreements for potential darovasertib/crizotinib trials in MUM and, subject to preclinical validation and FDA guidance, other cMET-driven tumors. IDEAYA would sponsor and fund the trials; Pfizer would supply crizotinib at no cost.
Outlook, risks and unusual items
- Management expects substantial ongoing losses and higher R&D spending as clinical and preclinical programs advance. The company has no product revenue and does not provide revenue or earnings guidance.
- Near-term objectives described in the filing included IDE397 expansion cohorts and delivery of a GSK option data package around mid-2022, further darovasertib/crizotinib interim data and FDA trial-design discussions around mid-2022, and the IDE161 IND target in Q4 2022. These are plans and targets, not assurances.
- Key risks include clinical and regulatory failure or delay, limited patient availability and enrollment challenges, uncertain translation of early or preclinical results, dependence on GSK and other partners, third-party manufacturing and diagnostic supply, intellectual-property disputes, competition, and the need for future capital. COVID-19 could disrupt trials or supply; management said it had not materially affected 2021 operations. The filing also identifies possible effects from Russia-Ukraine-related market and supply-chain disruption.
- Clinical results cited are preliminary and may change with longer follow-up, additional patients and final data review. The company reported no material pending litigation and no off-balance-sheet arrangements.
Investor verification priorities
- Confirm current cash runway, operating cash burn and financing needs against subsequent quarterly filings; the stated runway estimate is based on the filing-date business plan.
- Track IDE397 dose escalation, safety, biomarker findings, expansion progress and whether GSK exercises its option; do not treat potential payments or milestones as committed cash.
- Review updated darovasertib/crizotinib response, duration of response, progression-free survival, safety and FDA feedback before drawing conclusions from the interim results.
- Verify progress and timing for IDE161 IND-enabling work and the Pol Theta and WRN programs, including GSK’s continued participation and cost-sharing.
- Assess dilution from equity offerings and ATM sales, and monitor clinical-trial enrollment, manufacturing, companion-diagnostic and collaboration risks.