Relay Therapeutics, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual report, not a standalone fourth-quarter report; the supplied filing text does not provide separate Q4 financial results. Relay is a clinical-stage precision-medicine company with no approved products and no product-sales revenue.
Financial results and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| License and other revenue | $25.5 million | $1.4 million |
| Research and development expense | $330.0 million | $246.4 million |
| General and administrative expense | $75.0 million | $66.0 million |
| Operating loss | $373.0 million | $299.3 million |
| Other income, primarily interest | $31.0 million | $8.8 million |
| Net loss | $342.0 million | $290.5 million |
| Basic and diluted net loss per share | $2.79 | $2.59 |
| Net cash used in operating activities | $300.3 million | $229.5 million |
Revenue was primarily from the Genentech collaboration, not product sales. FY2023 revenue included a $25.0 million increase in transaction price after Relay elected not to exercise its U.S. profit/cost-share option; previously constrained consideration was recognized because the agreement’s performance obligations were complete. No product gross margin is reported, and conventional product margins are not meaningful for the current business stage.
At year-end, cash and cash equivalents were $143.7 million and investments were $606.4 million, totaling $750.1 million in cash, cash equivalents and investments. Current assets were $770.1 million and current liabilities were $30.3 million. Relay reported no debt outstanding. Total liabilities were $92.0 million, including $53.5 million of operating lease liabilities and $13.2 million of contingent consideration. Accumulated deficit was $1.4 billion.
Changes versus FY2022
- Net loss increased by $51.5 million, while operating loss widened by $73.7 million.
- R&D expense rose $83.7 million, principally from $50.0 million of additional external clinical-trial costs and $32.4 million of higher employee-related costs, including stock compensation.
- Revenue increased $24.2 million, primarily from the Genentech transaction-price adjustment described above.
- Other income increased $22.3 million, mainly because of higher interest rates; it partly offset the larger operating loss.
- Operating cash use increased $70.8 million. Year-end cash, cash equivalents and investments declined from $998.9 million in 2022 to $750.1 million in 2023.
- Relay raised $30.3 million net through at-the-market stock sales during 2023. After year-end, it announced a $30.0 million gross private placement in January 2024; shares outstanding were 131,179,034 as of February 16, 2024.
Pipeline, outlook and risks
- RLY-2608: The company expanded its ReDiscover trial, opening additional fulvestrant dose-expansion cohorts and a triplet arm with fulvestrant and ribociclib in Q4 2023. Previously reported interim results were preliminary; the company cited target engagement and an encouraging interim safety/tolerability profile. August 2023 combination data included a 86% interim clinical benefit rate among seven evaluable patients and one confirmed partial response among five efficacy-evaluable patients with measurable disease.
- Lirafugratinib (RLY-4008): The ReFocus trial’s pivotal FGFR2-fusion cholangiocarcinoma cohort was fully enrolled, and enrollment was closed across the trial to allow data to mature. Reported efficacy signals and safety observations were interim and preliminary. The company reported that most treatment-emergent adverse events were expected, low-grade and manageable.
- Migoprotafib (GDC-1971): Genentech leads further development and commercialization under the collaboration, with several Phase 1b combination studies initiated. Relay may receive up to $675 million in additional specified milestones and tiered royalties, subject to agreement terms; these are contingent, not assured proceeds.
- Relay has more than seven active discovery-stage programs and has deprioritized backup PI3Kα candidate RLY-5836 to focus resources on RLY-2608.
- Management estimated year-end resources would fund operating expenses and capital requirements into the second half of 2026. This is an estimate based on assumptions; Relay expects continued losses and says additional funding will be needed to advance its pipeline and potentially commercialize products.
- Key risks include clinical-trial failure or delay, patient enrollment and safety, regulatory and companion-diagnostic requirements, reliance on third-party manufacturers and trial operators, competition, intellectual-property protection, and the need for additional capital. Relay disclosed no material litigation pending in management’s view. Its FY2023 financial statements received an unqualified audit opinion, and management and the auditor concluded internal control over financial reporting was effective.
Important facts for investors to verify
- Review subsequent RLY-2608 and lirafugratinib trial updates, especially mature efficacy, durability, safety, enrollment and regulatory-pathway data; company-described interim results may change as data mature.
- Track cash burn against the stated second-half-2026 runway estimate, including clinical-trial spending, collaboration receipts and any future financing or dilution.
- Check the Genentech agreement’s remaining milestone and royalty conditions, and the potential costs and share issuance associated with ZebiAI contingent milestones.
- Confirm the extent of patent protection and rights under the D. E. Shaw Research agreement, as well as manufacturing and companion-diagnostic readiness for potential later-stage development.