On November 4, 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 third quarter 2026 financial results and corporate updates.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This quarter, we are very pleased by the pace of enrollment of our ReDiscover-2 trial for second-line breast cancer and also look forward to sharing updated ReInspire data for vascular anomalies at ASH (Free ASH Whitepaper). In addition, we continue to prepare for our frontline breast cancer trial testing the selective-selective combination of zovegalisib and atirmociclib, and we were highly encouraged by the data we saw from Pfizer’s FourLight-1 trial, which we believe showed the potential advantage of a CDK4-selective approach," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "As we move toward potential launches, we are excited to bring Shannon Campbell onto the Relay team, where she will bring decades of experience in helping companies like ours prepare for commercialization. All of this drives us toward our mission of bringing potentially life-changing therapies to patients across multiple PI3Kα opportunities."
Corporate Highlights
ReDiscover-2 Trial in Second-Line (2L) Breast Cancer Estimated to Complete Enrollment in Mid-2027
•
Continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
•
The ReDiscover-2 trial is estimated to complete enrollment in mid-2027 based on current enrollment trajectory, approximately one year faster than recent benchmarks
Vascular Anomalies Data and Regulatory Update at ASH (Free ASH Whitepaper) Annual Meeting in December
•
Abstract accepted for the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition covering updated clinical data for zovegalisib in vascular anomalies
o
Oral presentation date: Monday, December 14, 2026
o
Presentation time: 4:00-4:15 pm E.T. / 3:00-3:15 pm C.T.
o
Abstract Number: 878
o
Title: Updated results from part 1 of the ReInspire study evaluating zovegalisib, a mutant-selective PI3Kα inhibitor, in adults and adolescents with PIK3CA-driven vascular malformations
o
Presenter: Dr. Bryan Sisk
o
Relay Therapeutics plans to host a corporate conference call on December 14 after the ASH (Free ASH Whitepaper) presentation to review the presented data, provide a regulatory update, and provide an overview of next steps (call details to be provided at a later date)
•
Continued enrollment of expansion cohorts for adults and adolescents ages 12+ and dose escalation for pediatric patients ages 6-11 in the Phase 1/2 ReInspire trial to further evaluate zovegalisib in patients with PIK3CA-driven vascular anomalies
Shannon Campbell Joins Relay Therapeutics as Head of Commercial
•
Ms. Campbell brings more than 30 years of commercial leadership experience across the pharmaceutical and biotechnology industries, with a track record of building commercial capabilities and preparing organizations for the transition to commercial-stage operations
•
Most recently, Ms. Campbell served as Executive Vice President and Chief Commercial Officer at Merus, where she led commercial-readiness and launch planning for zenocutuzumab and petosemtamab in oncology indications through Merus’ acquisition by Genmab
•
Previously, she held senior leadership roles at Novartis Pharmaceuticals, including U.S. franchise leadership across solid tumor oncology and rare diseases, where her responsibilities included breast cancer and vascular anomalies
•
Ms. Campbell also serves on the board of directors for Zentalis, Hansa Biopharma, and Black Diamond Therapeutics
Newly Announced Research Program: Mutant-Selective TIE2 Inhibitor
•
TIE2 is a receptor tyrosine kinase that, when mutated, is among the most common drivers of venous malformations and other vascular anomalies; an estimated 50,000-60,000 people have TIE2-mutated venous malformations in the U.S.
•
There are currently no approved systemic therapies for venous malformations, and non-selective approaches, either in development or used off-label, inhibit the wild-type TIE2 protein or target other downstream parts of the pathway, which can lead to significant off-target toxicity and limit efficacy
•
Off-target inhibition of wild-type TIE2 is implicated in severe ocular toxicities
•
Relay Therapeutics has discovered a novel modulation hypothesis leading to the discovery of the first known mutant-selective TIE2 inhibitor, which has been designed to address the liabilities of non-selective approaches
•
The program is currently in late-stage preclinical development
First FDA Approval of Molecule Discovered by Relay Therapeutics: LYRFIGTU (Lirafugratinib)
•
The FDA granted full approval for LYRFIGTU (lirafugratinib) as a treatment option for patients with cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement. Relay Therapeutics entered into a global licensing agreement with Elevar Therapeutics (Elevar) in December 2024, granting Elevar worldwide rights to develop and commercialize lirafugratinib
•
This is the first approved medicine to emerge from Relay Therapeutics’ Dynamo platform
Anticipated Milestones:
Breast Cancer
•
Complete enrollment of Phase 3 ReDiscover-2 trial in 2L breast cancer estimated in mid-2027
•
Regulatory update to confirm design for planned Phase 3 trial in 1L endocrine-sensitive breast cancer by year-end 2026
•
Initiation of Phase 3 trial in 1L breast cancer in early 2027
•
Data update for Phase 1/2 ReDiscover trial triplet combination in 2027
Vascular Anomalies
•
Data and regulatory update at ASH (Free ASH Whitepaper) 2026
Third Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments: As of September 30, 2026, cash, cash equivalents and investments totaled $848.6 million, as compared to $910.9 million as of June 30, 2026. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.
R&D Expenses: Research and development expenses were $77.1 million for the third quarter of 2026, as compared to $68.3 million for the third quarter of 2025. The increase of $8.8 million was primarily due to increases in costs across ongoing clinical trials, as well as non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, partially offset by the impact from strategic choices made to streamline the research organization prior to 2026.
G&A Expenses: General and administrative expenses were $13.1 million for the third quarter of 2026, as compared to $12.1 million for the third quarter of 2025. The increase of $1.0 million was primarily due to non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, as well as increases in other miscellaneous general and administrative costs.
Net Loss: Net loss was $81.7 million for the third quarter of 2026, or a net loss per share of $0.37, as compared to a net loss of $74.1 million for the third quarter of 2025, or a net loss per share of $0.43.
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. For more information on zovegalisib, please visit here.
(Press release, Relay Therapeutics, NOV 4, 2026, View Source [SID1234674178])