IDEAYA Biosciences, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual filing; the provided text does not give separate fourth-quarter financial results. IDEAYA is a clinical-stage precision-oncology company with no approved products and no product-sales revenue. Its revenue is collaboration-based.
Financial results and liquidity
| Metric | FY2023 | FY2022 | Change |
|---|---|---|---|
| Collaboration revenue | $23.4 million | $50.9 million | Down 54% |
| Research and development expense | $129.5 million | $89.5 million | Up 45% |
| General and administrative expense | $28.3 million | $23.9 million | Up 18% |
| Operating loss | $134.4 million | $62.5 million | Loss more than doubled |
| Net loss | $113.0 million | $58.7 million | Loss up 93% |
| Net loss per share, basic and diluted | $(1.96) | $(1.42) | |
| Net cash used in operating activities | $115.2 million | $87.2 million |
R&D expense growth primarily reflected higher external development costs and personnel-related expense. Collaboration revenue fell as revenue recognized under the GSK agreement declined; 2023 revenue included progress on WRN research services and GSK milestones. IDEAYA reported no product revenue. Product gross margins are not applicable at this pre-commercial stage.
At year-end, cash, cash equivalents and marketable securities were $632.6 million, versus $373.1 million in 2022. Total assets were $649.3 million and stockholders’ equity was $621.1 million. Total liabilities were $28.2 million, including lease liabilities; the filing reports no borrowings or debt balance. Management estimated existing liquidity would fund planned operations for at least 12 months from issuance of the financial statements.
FY2023 financing cash flow was $362.7 million, mainly from public offerings, pre-funded warrants, ATM sales and equity-plan exercises. Investing cash flow was $(158.5) million, largely reflecting purchases of marketable securities. No dividends were paid or anticipated in the foreseeable future.
Business, pipeline and material developments
- Darovasertib (PKC): IDEAYA advanced a Phase 2/3 trial with crizotinib in HLA-A2-negative metastatic uveal melanoma (MUM), and Phase 2 studies in primary uveal and cutaneous melanoma. The company reported preliminary 2023 Phase 2 data, including 45% investigator-assessed response rate among 20 evaluable first-line MUM patients and about seven months’ median progression-free survival. These were small, preliminary datasets, not confirmatory results. Management targeted further clinical updates in 2024.
- IDE397 (MAT2A): In Phase 1/2 development for MTAP-deleted tumors, with monotherapy expansion and an Amgen-sponsored combination study. A Gilead collaboration will evaluate IDE397 with Trodelvy in MTAP-deleted bladder cancer; first-patient enrollment was anticipated in mid-2024.
- IDE161 (PARG): In Phase 1/2 development for HRD tumors. FDA Fast Track Designation covers specified BRCA1/2-mutant ovarian and breast cancer populations; this designation does not constitute approval. IDEAYA reported early clinical activity and planned further updates in 2024.
- GSK programs: GSK began a Phase 1 trial of GSK101 (Pol Theta) with niraparib and leads development costs for that program. IDEAYA received a $7 million milestone for IND acceptance. IDEAYA and GSK selected a Werner Helicase development candidate and targeted an IND submission in 2024; IDEAYA reported a $3 million 2023 milestone and shares 20% of WRN R&D costs.
Management expects continued significant operating losses and higher R&D spending as clinical programs advance. It gave no revenue or earnings guidance. The company’s ability to generate product revenue depends on successful clinical development, regulatory approval and commercialization.
Capital, risks and other notable items
- Subsequent equity issuance: After year-end, IDEAYA sold shares through its ATM for net proceeds of $215.9 million through January 17, 2024, then $126.4 million on January 24. A new ATM facility authorized sales of up to $350 million; $220.5 million remained available as of January 24. These transactions increased liquidity but diluted existing holders.
- Execution and clinical risk: All major programs remain investigational. Trial enrollment, safety, efficacy, regulatory requirements and whether early results predict later-stage outcomes are uncertain. Darovasertib’s reported clinical data were preliminary and based on investigator review.
- Partner and supply dependence: IDEAYA relies on third parties for clinical trials, manufacturing and drug supply. GSK may discontinue partnered programs; doing so could reduce potential milestone, royalty or profit-share revenue. IDEAYA funds its own clinical programs and shares certain WRN and Amgen-study costs.
- Funding and dilution: The company has a history of losses and expects losses to continue. It may need additional capital; equity financing can dilute holders. Management cites possible delays, increased costs and financing-market uncertainty.
- Other risks and contingencies: Competition, biomarker/diagnostic development, intellectual-property protection, reimbursement and regulatory changes are material risks. IDEAYA said it was not party to litigation it believed would materially adversely affect it. The filing reports no off-balance-sheet arrangements.
- Controls and audit: Management and PwC concluded internal control over financial reporting was effective as of December 31, 2023; PwC issued an unqualified opinion on the financial statements and controls. The audit identified accrued CRO research costs as a critical audit matter because estimating unbilled services requires judgment.
Important facts for investors to verify
- Review subsequent filings for updated cash, operating runway, ATM usage and share count; the filing reported 74,560,273 shares outstanding as of February 16, 2024, versus 65,039,369 at year-end, before considering other potentially dilutive awards and warrants.
- Track enrollment, protocol execution and regulatory feedback for the darovasertib Phase 2/3 trial, and assess whether later, controlled results support the preliminary Phase 2 findings.
- Check updated IDE397 and IDE161 clinical results, safety, dose selection and enrollment; distinguish confirmed trial outcomes from preliminary company-reported observations.
- Monitor GSK’s progress and continuation of Pol Theta and WRN programs, related milestones, cost-sharing obligations and any changes to collaboration terms.
- Compare future collaboration revenue and cash burn with FY2023: collaboration revenue declined while R&D expense and operating cash use increased substantially.