IDEAYA Biosciences, Inc. — Q1 2020 Form 10-Q
Reporting period: Three months ended March 31, 2020; balance sheet compared with December 31, 2019. Unless stated otherwise, amounts are in U.S. dollars. IDEAYA is a development-stage oncology precision-medicine company with no approved products and no revenue to date.
Financial performance and liquidity
| Metric | Q1 2020 | Q1 2019 / comparison |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $9.0 million | $8.0 million; up 13% |
| General and administrative expense | $3.5 million | $2.1 million; up 65% |
| Total operating expenses / operating loss | $12.5 million | $10.1 million |
| Net loss | $12.0 million | $9.6 million; loss increased 26% |
| Net loss per share, basic and diluted | $0.59 | $8.69 |
| Net cash used in operating activities | $9.5 million | $9.8 million |
The 2019 per-share loss is not directly comparable because the weighted-average share count changed substantially following the 2019 IPO and reverse stock split. Gross margin is not applicable because the company has no product revenue.
At March 31, cash and cash equivalents were $35.5 million and marketable securities were $55.4 million, totaling $90.9 million; restricted cash was $0.1 million. Current assets were $89.5 million versus current liabilities of $7.3 million. Total liabilities were $12.7 million, including $6.5 million of lease liabilities. The filing reports no borrowings or other conventional financial debt. Accumulated deficit was $104.5 million. Management expects available cash, cash equivalents and marketable securities to fund planned operations for at least 12 months from issuance of the financial statements.
Operating cash use was partly offset by $10.9 million of net investing cash inflow, primarily from maturities of marketable securities; financing provided less than $0.1 million. Cash, cash equivalents and restricted cash increased $1.4 million during the quarter.
Material changes versus the prior comparable period
- Net loss rose $2.5 million, primarily reflecting higher R&D and G&A spending; interest and other income declined $0.1 million.
- R&D expense increased $1.0 million, mainly from CRO/CMO and contractor costs supporting IDE196 clinical work and preclinical programs, partly offset by lower payroll and laboratory supply costs.
- G&A expense increased $1.4 million, primarily from higher personnel and stock-based compensation costs and public-company D&O insurance premiums.
- Compared with year-end 2019, cash and cash equivalents increased $1.4 million, while marketable securities declined by a net $11.0 million; total assets decreased from $113.0 million to $101.8 million.
Business update, outlook and risks
- IDE196: The Phase 1 dose-escalation portion and MUM tablet-formulation sub-study were fully enrolled. As of May 1, 2020, 56 patients were enrolled in the company’s Phase 1/2 trial, including 51 with metastatic uveal melanoma (MUM) and five with other GNAQ/GNA11-mutated solid tumors. The company planned to disclose interim monotherapy data in Q4 2020.
- The FDA indicated that a proposed single-arm Phase 2 trial might support an NDA seeking accelerated approval for IDE196 in MUM; the discussion contemplated 60 evaluable MUM patients. This is a potential pathway, not an assurance of approval. IDEAYA said it would assess monotherapy and combination data before deciding on a potentially registrational trial and would update NDA timing after that decision.
- IDEAYA and Pfizer entered a clinical-trial collaboration and supply agreement for binimetinib. The company targeted initiation of an IDE196/binimetinib combination arm in MUM in mid-2020.
- Pipeline: IDEAYA selected a lead MAT2A inhibitor and anticipated an IND submission in Q4 2020, subject to development-candidate selection and satisfactory toxicology. It targeted selection of a Pol-theta development candidate and WRN in-vivo proof of concept in the second half of 2020. PARG research continued, with in-vivo proof of concept reported in a relevant model.
- COVID-19: Management reported no substantial impact at the time on the ongoing IDE196 monotherapy arm or supply chain, but enrollment in non-MUM Phase 2 expansion could be delayed. As of May 1, two of four active U.S. sites for that arm continued enrollment and two had suspended it. Further effects on trials, research, suppliers, financing and operations were uncertain.
- Management expects losses and expenses to continue and increase as clinical and preclinical development advances. Additional capital will be needed; future financing may be unavailable or involve dilution, restrictive debt terms, or relinquishment of product rights. Failure to obtain funding could force delays, reductions or termination of programs.
- Other notable items: the company expanded its South San Francisco lease by approximately 5,500 square feet, with possession anticipated in Q3 2020, and amended its Cancer Research UK/University of Manchester research and option agreement. Management reported no material litigation, no material changes in contractual commitments, no off-balance-sheet arrangements, and effective disclosure controls as of March 31, 2020.
Important facts for investors to verify
- Whether IDE196 trial enrollment, interim data timing, tolerability and efficacy support the proposed MUM development and regulatory pathway.
- Whether COVID-19-related site restrictions or supply issues materially affect enrollment, trial execution or the targeted combination-trial start.
- Whether the company meets its MAT2A, Pol-theta and WRN development milestones and whether preclinical results translate into clinical progress.
- Whether the stated cash runway remains adequate as expenses rise, and the timing, terms and potential dilution of any required financing.
- Whether pipeline, collaboration, lease and licensing commitments—including potential IDE196 milestones and royalties—change materially from the disclosures in this filing.