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10-K 414 false 0001812364 389 FY 386 350 http://fasb.org/us-gaap/2025#LicenseAndServiceMember http://fasb.org/us-gaap/2025#LicenseAndServiceMember http://fasb.org/us-gaap/2025#LicenseAndServiceMember http://relaytx.com/20251231#PresidentAndChiefExecutiveOfficerMember http://relaytx.com/20251231#PresidentAndChiefExecutiveOfficerMember http://fasb.org/us-gaap/2025#LicenseAndServiceMember http://fasb.org/us-gaap/2025#LicenseAndServiceMember http://fasb.org/us-gaap/2025#LicenseAndServiceMember On June 3, 2025, the Company and ARE MA Region No.
Overview We are a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease.
We are also advancing triplet combination arms with zovegalisib, fulvestrant and cyclin dependent kinase 4/6, or CDK 4/6, inhibitors, or atirmociclib, the investigative selective-CDK4 inhibitor from Pfizer Inc., or Pfizer.
In the second quarter of 2025, we initiated a global Phase 3 registrational study, or the ReDiscover-2 Trial, which is designed to evaluate the safety and efficacy of zovegalisib plus fulvestrant in PI3K -mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor.
The comparator arm in the ReDiscover-2 Trial is capivasertib plus fulvestrant.
Food and Drug Administration, or FDA, granted Breakthrough Therapy designation to zovegalisib in combination with fulvestrant for the treatment of adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
In June 2025, we announced updated interim clinical data for the zovegalisib plus fulvestrant arm of the ReDiscover Trial with a data cut-off date of March 26, 2025, and in December 2025, we announced an efficacy subset analysis of interim clinical data for zovegalisib at the San Antonio Breast Cancer Symposium 2025 with a data cut-off date of October 15, 2025.
These interim clinical data are discussed further below in "Our Product Pipeline and Programs Our Lead Product Candidate Breast Cancer and Solid Tumors - Interim Clinical Data." We believe that while the clinical data from the ReDiscover Trial disclosed to date are preliminary, the data suggest differentiated interim efficacy signals in the specified patient population and support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.
In the first quarter of 2025, we initiated the global Phase 1/2 clinical trial for zovegalisib in patients with PIK3CA-related overgrowth spectrum, or PROS, and vascular anomalies driven by PIK3CA mutations, or the ReInspire Trial.
In addition to the programs mentioned above, we are progressing our NRAS-selective inhibitor, RLY-8161, to address NRAS-mutated solid tumors as well as our non-inhibitory chaperone for Fabry disease.
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Overview We are a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients.
As we believe we are among the first of a new breed of biotech created at the intersection of complementary techniques and technologies, we aim to push the boundaries of what s possible in drug discovery.
Our initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications.
In the fourth quarter of 2023, we initiated a triplet combination arm with RLY-2608, fulvestrant and the cyclin dependent kinase 4/6, or CDK 4/6, inhibitor ribociclib.
In the fourth quarter of 2024, we initiated an additional triplet combination arm with RLY-2608, fulvestrant, and atirmociclib, Pfizer Inc.
s, or Pfizer s, investigative selective-CDK4 inhibitor, pursuant to a clinical trial collaboration with Pfizer.
We also intend to initiate a Phase 3 registrational study, or the ReDiscover-2 Trial, which will evaluate the safety and efficacy of RLY-2608 plus fulvestrant in PI3K -mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor.
The comparator arm in the ReDsicover-2 Trial will be capivasertib plus fulvestrant.
In September 2024, we announced interim clinical data for RLY-2608 with a data cut-off date of August 12, 2024, and in December 2024, we announced additional updated interim clinical data for RLY-2608 at the San Antionio Breast Cancer Symposium 2024 with a data cut-off date of November 4, 2024.
These interim clinical data are discussed further below in "Our Product Pipeline and Programs Our Lead Product Candidate RLY-2608 Interim Clinical Data." We believe that, overall, while the clinical data from the ReDiscover Trial disclosed to date are preliminary, the data suggest differentiated interim efficacy signals in the specified patient population and support selective target engagement across doses and mutation types with an encouraging interim safety and tolerability profile.