IDEAYA Biosciences, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Unaudited. IDEAYA is a clinical-stage precision oncology company; it has no approved products and has generated no commercial product revenue.
Financial performance and liquidity
| Metric | Q1 2024 | Q1 2023 |
|---|---|---|
| Collaboration revenue | $0 | $7.9 million |
| Research and development expense | $42.8 million | $27.9 million |
| General and administrative expense | $8.2 million | $6.3 million |
| Operating loss | $51.0 million | $26.3 million |
| Interest and other income, net | $11.4 million | $2.6 million |
| Net loss | $39.6 million | $23.6 million |
| Net loss per share, basic and diluted | $0.53 | $0.49 |
| Net cash used in operating activities | $43.8 million | $27.8 million |
- Revenue fell to zero because all performance obligations associated with the GSK upfront payment and research services had been completed by December 31, 2023. Future collaboration revenue depends on milestones or other contingent payments.
- R&D expense rose 54% year over year, primarily from higher external clinical and manufacturing costs, personnel costs, and stock-based compensation. G&A expense increased 30%.
- Interest income increased substantially, largely reflecting higher investment balances and rates, but did not offset increased operating losses.
- At March 31, cash and cash equivalents were $108.3 million; short- and long-term marketable securities totaled $833.1 million. Together, cash, cash equivalents, and marketable securities were approximately $941.4 million. Total assets were $961.5 million.
- Total liabilities were $26.2 million, principally accounts payable, accruals, and operating lease liabilities. The filing reports no debt balance.
- Operating cash use was $43.8 million. Investing activities used $354.0 million, mainly reflecting purchases of marketable securities, while financing activities provided $349.1 million, mainly from ATM equity sales. Cash, cash equivalents, and restricted cash ended the quarter at $109.1 million.
Material changes and financing
- Compared with Q1 2023, net loss increased by $15.9 million, despite higher interest income, as operating expenses rose and collaboration revenue declined by $7.9 million.
- During Q1, IDEAYA raised approximately $343.5 million net through its at-the-market programs, selling about 9.26 million shares. Outstanding common shares increased from 65.0 million at year-end 2023 to 74.8 million at March 31, 2024.
- Approximately $219.4 million remained available under the January 2024 ATM facility at quarter-end. From April 1–24, the company sold additional shares for approximately $36.5 million in net proceeds; about $182.1 million remained available as of April 24.
- Accumulated deficit was $387.9 million. Management expects operating losses to continue and increase, but believes available cash, cash equivalents, and marketable securities will fund planned operations for at least 12 months from the May 7, 2024 filing date.
Outlook, programs, and risks
- Darovasertib: Enrollment is ongoing in the Phase 2/3 combination trial with crizotinib for HLA-A2-negative metastatic uveal melanoma. The company targeted clinical program updates in 2024, and a clinical efficacy update for its primary uveal melanoma study, plus FDA regulatory guidance, in the second half of 2024.
- IDE397: Phase 2 monotherapy enrollment is ongoing for MTAP-deletion tumors. Combination studies with Amgen’s AMG 193 and Gilead’s Trodelvy are progressing; first-patient dosing for the Trodelvy study was anticipated in mid-2024.
- IDE161: Phase 1 expansion and dose optimization are ongoing. The company targeted an initial Phase 2 monotherapy expansion in the second half of 2024 and first-patient dosing in the Merck KEYTRUDA combination study in the second half of 2024.
- GSK programs: GSK is leading clinical development of the Pol Theta inhibitor GSK101 and bears its R&D costs. For the Werner Helicase program, IDEAYA and GSK were targeting an IND submission in the second half of 2024; IDEAYA bears 20% of global R&D costs.
- These dates and development plans are forward-looking targets, not assurances. Clinical results, enrollment, regulatory decisions, manufacturing, collaboration arrangements, and the ability to raise additional capital could materially affect outcomes. IDEAYA expects significant ongoing R&D spending and may need additional financing; equity financing could dilute shareholders.
- The company reported no material change to the risk factors in its 2023 Form 10-K, no litigation believed likely to have a material adverse effect, and no material changes to internal control over financial reporting. It is under California tax audit for 2020–2021.
Important facts for investors to verify
- Progress, enrollment, safety, and efficacy data for the darovasertib, IDE397, IDE161, and partnered GSK programs, including whether stated 2024 milestones were achieved.
- Actual operating cash burn and the assumptions behind management’s estimate that current resources cover at least 12 months of planned operations.
- Future ATM share sales, remaining facility capacity, and the resulting dilution.
- Timing and amount of GSK or other collaboration milestone receipts; Q1 2024 had no collaboration revenue.
- Clinical-trial, regulatory, manufacturing, and collaboration risks, as well as potential contingent license and milestone obligations.