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COMPANY

Relay Therapeutics, Inc.

HQ: Cambridge, MA source · relaytx.com ↗ · New England

Clinical Phase 3

Keywords: oncology genetic disease cryo-EM PIK3CA Mutation HER2- Negative Breast Cancer Breast Cancer Metastatic Breast Cancer Advanced Breast Cancer Hormone Receptor Positive Tumor PIK3CA-Related Overgrowth Spectrum Lymphatic Malformations Vascular Malformations CLOVES Syndrome Klippel Trenaunay Syndrome Megalencephaly-capillary Malformation Polymicrogyria Syndrome Vascular Anomalies Advanced NRAS-Mutant Melanoma Advanced NRAS-Mutant Solid Tumors NRAS Mutation NRAS G12D NRAS G13R NRAS G13D NRAS G12V NRAS Q61R NRAS Q61K NRAS Q61L NRAS Q61H RLY-2608 RLY-8161 RLY-5836

Location: Cambridge, MA · source · Aug 6, 2026

Profile checked Oct 10, 2026

$275.0MRaised (2 yrs)5Trials (company is sponsor)

Timeline

  1. Raise Follow-on offering: $275M (total, as published), announced May 21, 2026. Source: company release on GlobeNewswire. source ↗
  2. Trial start Phase 1: A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors source ↗
  3. Trial start 3: Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer source ↗
  4. Trial start 2: A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study) source ↗
  5. Trial start Phase 1: First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors source ↗
  6. Trial start Phase 1: First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inh source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $275.0M. Last 2 years.

Clinical trials (lead sponsor) 5

RecordTitlePhaseStatusStartPrimary completion
NCT06982521Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer3RecruitingAug 26, 2025Apr 30, 2028 (estimated)
NCT06789913A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)2RecruitingJun 13, 20252031-07 (estimated)
NCT07584226A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid TumorsPhase 1RecruitingMar 9, 2026Dec 30, 2027 (estimated)
NCT05216432First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast CancerPhase 1RecruitingDec 8, 2021Apr 30, 2027 (estimated)
NCT05759949First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid TumorsPhase 1CompletedMar 29, 2023Mar 18, 2025 (actual)
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