On May 5, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported first quarter 2026 financial results and corporate updates.
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"We have made important progress so far in 2026, highlighted by promising data supporting further development for the zovegalisib plus atirmociclib triplet combination in frontline breast cancer," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "With initial clinical data in vascular anomalies expected at ISSVA and preparations underway for our planned Phase 3 frontline study in endocrine-sensitive patients with metastatic breast cancer, we are entering a data-rich period for zovegalisib. Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain focused on executing across these priorities to bring differentiated therapies to patients."
Corporate Highlights
2L Breast Cancer
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U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to zovegalisib in combination with fulvestrant for PIK3CA-mutant, HR+/HER2- advanced breast cancer
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Designation supported by robust clinical data from the Phase 1/2 ReDiscover trial of 600mg twice daily (BID) fasted and 400mg BID fed regimens of zovegalisib in combination with fulvestrant
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Presented 400mg BID zovegalisib doublet data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026
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11.1-month median progression-free survival (PFS) observed in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer, consistent with previously reported data
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Efficacy in patients with kinase and non-kinase domain mutations was similar, with median PFS of 11.2 and 11.0 months, respectively
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Safety and tolerability data were consistent with previously reported 600mg BID fasted data
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Relay Tx continues to execute on the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
1L Breast Cancer
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Announced clinical data for zovegalisib plus atirmociclib triplet combination, plans for frontline breast cancer study, and clinical supply agreement with Pfizer
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Compelling efficacy and tolerability data presented for zovegalisib triplet in median third-line (3L) patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
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44% objective response rate (ORR) reported in heavily pre-treated CDK4/6-experienced patients (median 3L) at unoptimized doses and ORR was similar across kinase and non-kinase PIK3CA mutations
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Adverse events were consistent with those previously reported by each molecule
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Phase 3 1L trial in patients with endocrine-sensitive breast cancer expected to initiate in early 2027, subject to regulatory feedback
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Pfizer has agreed to supply atirmociclib for the experimental arm and the palbociclib portion of the control arm for use in the planned study, and Relay Tx will retain full global rights for zovegalisib
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Relay Tx continues to execute the Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with zovegalisib + atirmociclib + endocrine therapy
Vascular Anomalies
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Corporate conference call planned for May 19 at 8:00am ET during the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 to announce initial clinical results for zovegalisib in vascular anomalies
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Late breaking abstract for clinical data to be presented May 20 from 4:45pm-4:49pm ET
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Pre-clinical data presentation May 22 at 11:10am ET
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Conference call details to be shared at a later date
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Continued execution of the Phase 1/2 ReInspire trial, evaluating zovegalisib in PIK3CA-driven vascular anomalies
NRAS Selective Inhibitor: RLY-8161
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Initiated Phase 1/2 clinical trial for RLY-8161, a NRAS-selective inhibitor, in patients with NRAS-mutant melanoma and other NRAS-mutant solid tumors
First Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments: As of March 31, 2026, cash, cash equivalents and investments totaled $642.1 million, as compared to $554.5 million as of December 31, 2025. The increase in cash was due to $137.1 million in net proceeds from "at-the-market" offerings under our sales agreement with TD Securities (USA) LLC during the quarter. This figure does not include an additional $22.1 million in net proceeds received from "at-the-market" offerings in April. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.
Revenue: Revenue was $3.0 million for the first quarter of 2026, as compared to $7.7 million for the first quarter of 2025. The revenue recognized in each period was under the company’s Exclusive License Agreement with Elevar Therapeutics, Inc.
R&D Expenses: Research and development expenses were $70.6 million for the first quarter of 2026, as compared to $73.8 million for the first quarter of 2025. The decrease was primarily due to the series of strategic choices made to streamline the research organization prior to 2026, offset by increases in costs related to the ReDiscover-2 trial.
G&A Expenses: General and administrative expenses were $11.0 million for the first quarter of 2026, as compared to $18.7 million for the first quarter of 2025. The decrease was primarily due to decreases in employee compensation costs, including stock compensation expense, and costs to obtain the Exclusive License Agreement with Elevar Therapeutics, Inc., which were expensed during the three months ended March 31, 2025.
Net Loss: Net loss was $73.3 million for the first quarter of 2026, or a net loss per share of $0.41, as compared to a net loss of $77.1 million for the first quarter of 2025, or a net loss per share of $0.46.
About Zovegalisib
Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant-selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.
Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a Phase 1/2 study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies.
(Press release, Relay Therapeutics, MAY 5, 2026, View Source [SID1234665140])