Relay Therapeutics, Inc. operates as a clinical-stage precision medicines company. It engages in transforming the drug discovery process with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. The company's lead product candidates include RLY-4008, an oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), which is in a first-in-human clinical trial for patients with advanced or metastatic FGFR2-altered solid tumors; RLY-2608, a lead mutant-PI3Ka inhibitor program that targets phosphoinostide 3 kinase alpha; and RLY-1971, an oral small molecule inhibitor of protein tyrosine phosphatase Src homology region 2 domain-containing phosphatase-2 that is in Phase 1 trial in patients with advanced solid tumors. It has collaboration and license agreements with D. E. Shaw Research, LLC to research certain biological targets through the use of D. E. Shaw Research computational modeling capabilities focused on analysis of protein motion to develop and commercialize compounds and products directed to such targets; and Genentech, Inc. for the development and commercialization of RLY-1971. The company was formerly known as Allostery, Inc. and changed its name to Relay Therapeutics, Inc. in December 2015. Relay Therapeutics, Inc. was incorporated in 2015 and is headquartered in Cambridge, Massachusetts.
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Here are 1-2 brief analogies for Relay Therapeutics (RLAY):
Think of it as a Moderna for cancer drugs, leveraging a unique computational platform to discover new therapies.
It's like a "Google DeepMind for drug discovery," applying advanced computational methods to develop new cancer treatments, specifically for oncology.
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- RLY-2608: An investigational PI3Kα inhibitor designed to treat patients with PI3Kα-mutated solid tumors.
- RLY-4008: An investigational selective FGFR2 inhibitor being developed for patients with FGFR2-altered cholangiocarcinoma and other solid tumors.
- RLY-1971: An investigational SHP2 inhibitor, partnered with Genentech, aimed at treating various advanced solid tumors.
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Relay Therapeutics (RLAY) is a clinical-stage precision medicine company focused on discovering and developing small molecule medicines. As a company in the research and development phase, it does not currently sell commercial products directly to individuals (patients) or to institutions like hospitals or pharmacies. Instead, its business model involves strategic collaborations and partnerships with larger pharmaceutical companies.
Relay Therapeutics primarily sells to other companies through collaboration agreements. Its major customer in this context is:
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Genentech (a member of the Roche Group)
- Parent Company: Roche Holding AG
- Symbol: ROG (SIX Swiss Exchange) / RHHBY (OTC Markets)
This collaboration typically involves upfront payments, research funding, and potential milestone payments and royalties to Relay Therapeutics if drug candidates successfully advance through clinical development and commercialization by its partner.
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Sanjiv K. Patel, President & Chief Executive Officer
Sanjiv Patel brings over 20 years of experience in the life sciences industry. Before joining Relay Therapeutics, he spent more than a decade at Allergan, where he held positions of increasing responsibility, including Chief Strategy Officer. In this role, he was central to some of the industry's largest transactions, leading transformative mergers, acquisitions, divestment, and integration planning activities. Prior to Allergan, Dr. Patel was a management consultant at Boston Consulting Group and began his career as a surgeon in the U.K.'s National Health Service. Relay Therapeutics was launched with Series A financing from Third Rock Ventures, a healthcare venture firm, and an affiliate of D. E. Shaw Research, indicating his leadership in a company backed by venture capital.
Thomas Catinazzo, Chief Financial Officer and Principal Accounting Officer
Thomas Catinazzo serves as the Chief Financial Officer and Principal Accounting Officer of Relay Therapeutics.
Don Bergstrom, President, R&D
As President, R&D, Don Bergstrom oversees Relay Therapeutics' research and development efforts. Before joining Relay Therapeutics, he was Chief Medical Officer at Mersana Therapeutics, where he was responsible for non-clinical and early clinical development. He also held leadership roles in translational medicine and early clinical development at Sanofi and Merck. Throughout his career in the industry, Dr. Bergstrom has been a scientific leader on more than 15 successful Investigational New Drug (IND) applications and contributed to the development of five marketed drugs.
Peter Rahmer, Chief Corporate Development Officer
Peter Rahmer holds the position of Chief Corporate Development Officer at Relay Therapeutics.
Imogen Pryce, Chief Operating Officer, R&D
Imogen Pryce serves as the Chief Operating Officer, R&D at Relay Therapeutics.
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The key risks to Relay Therapeutics (RLAY) largely stem from the inherent challenges of the biotechnology industry, particularly for a clinical-stage company.
- Clinical Trial and Regulatory Risk: The most significant risk for Relay Therapeutics is the successful development and regulatory approval of its product candidates, especially its lead candidate, RLY-2608. The company's future is heavily reliant on positive outcomes from its clinical trials, such as the crucial Phase 3 ReDiscover-2 trial for RLY-2608. Any setbacks, such as a failure to demonstrate superior efficacy, safety concerns, or delays in clinical trials, could severely impact the drug's approval chances and market potential. The mid-2026 readouts for the ReDiscover-2 trial represent a critical inflection point, with potential for significant valuation swings. The regulatory landscape for drug approval is complex and ever-changing, posing additional hurdles to bringing products to market.
- Intense Competition: Relay Therapeutics operates in the highly competitive oncology space, particularly within the PI3Kα inhibitor market. The company faces significant competition from larger pharmaceutical companies with greater resources and other biotechnology firms developing similar treatments. There is a risk that competing drugs from companies like Roche, Scorpion, and OnKure could prove more efficacious or selective, making it challenging for Relay Therapeutics to capture significant market share even if its candidates receive approval.
- Cash Burn and Path to Profitability: As an early-stage biotechnology company focused on research and development, Relay Therapeutics consistently operates at a loss and has a high cash burn rate. While the company has a robust cash position that is projected to fund operations into 2029 (or 2027 by another account), its continued operational losses may necessitate future capital raising. Such fundraising could potentially dilute existing shareholders and impose financial constraints on the company's operations, especially if clinical data does not justify further investment. Analysts do not anticipate profitability for the company in the near term.
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Relay Therapeutics (RLAY) is developing several product candidates targeting various oncology and genetic disease indications. The addressable markets for their main products are primarily focused on the U.S. region, with some broader implications for global potential:
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RLY-2608 (PI3Kα Inhibitor):
- For PI3Kα-mutated, HR+/HER2- metastatic breast cancer, approximately 87,002 new patients annually in the U.S. could be candidates for RLY-2608 therapy. The total addressable market (TAM) for this indication in the United States is estimated to be around $17.4 billion annually, based on a hypothetical treatment cost of $200,000 per patient.
- For PI3Kα-driven vascular malformations, an estimated 170,000 people in the U.S. have one of these subtypes driven by a PI3Kα mutation.
- Across all PI3Kα-mutated solid tumors, RLY-2608 has the potential to address more than 300,000 patients per year in the United States.
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RLY-4008 (Lirafugratinib, FGFR2 Inhibitor):
- For cholangiocarcinoma (CCA), a bile duct cancer, the estimated patient population in the U.S. is approximately 1,000, representing a potential annual revenue opportunity of less than $100 million.
- When considering the potential for expansion into other tumor types with FGFR alterations, such as pancreatic, skin/melanoma, lung, and breast cancer, the addressable market for RLY-4008 is estimated to easily exceed $50 billion. Relay Therapeutics out-licensed RLY-4008 to Elevar Therapeutics in December 2024.
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RLY-8161 (NRAS-selective Inhibitor):
- This product candidate targets NRAS-driven solid tumors. In the U.S., an estimated 28,000 people are diagnosed with mutated NRAS solid tumors each year.
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Fabry Disease Program:
- For Fabry disease, there are an estimated 8,000 patients in the U.S. requiring chronic treatment. The current market for Fabry disease treatments is estimated at $2 billion.
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Relay Therapeutics (RLAY) is a clinical-stage precision medicine company, and its future revenue growth over the next 2-3 years is primarily expected to be driven by the advancement and potential commercialization of its pipeline assets and strategic partnerships.
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Advancement and Potential Approval of RLY-2608 in PI3Kα-Mutated Breast Cancer: RLY-2608, a PI3Kα inhibitor, is the lead program for Relay Therapeutics. The company is currently focused on its development for PIK3CA-mutated breast cancer. Updated data from the ASCO 2025 meeting demonstrated a median progression-free survival (PFS) of 9.2 months (11.4 months at the recommended Phase 2 dose) for RLY-2608 in combination with fulvestrant in advanced, hormone receptor-positive breast cancer patients who had previously progressed on endocrine therapy plus a CDK4/6 inhibitor. A pivotal Phase 3 trial, ReDiscover-2, is anticipated to begin in mid-2025, comparing RLY-2608 plus fulvestrant against capivasertib plus fulvestrant in this patient population. If approved, RLY-2608 has the potential to address a significant patient population, estimated at over 300,000 per year in the United States, making it a substantial potential precision oncology medicine. Additionally, Relay is exploring RLY-2608 in triplet combinations with other therapies like ribociclib and atirmociclib for earlier breast cancer settings.
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Milestone Payments and Royalties from RLY-4008 (Lirafugratinib) Licensing Agreement: In December 2024, Relay Therapeutics entered into a global licensing agreement with Elevar Therapeutics for lirafugratinib (RLY-4008), a selective FGFR2 inhibitor. Under this agreement, Relay is eligible to receive up to $500 million in upfront, regulatory, and commercial milestone payments, including $75 million in upfront and regulatory milestones. Relay will also receive tiered royalties on global sales. This partnership allows Relay to generate revenue from RLY-4008's development and commercialization without bearing the full costs and responsibilities, while focusing on its core pipeline.
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Expansion of RLY-2608 into Vascular Malformations: Beyond breast cancer, Relay Therapeutics is also advancing RLY-2608 for genetic diseases, specifically in vascular malformations driven by PI3Kα mutations. The company initiated clinical development for RLY-2608 in vascular malformations in the first quarter of 2025, with the ReInspire trial currently ongoing. This indication represents another significant market opportunity, as PI3Kα mutations are estimated to drive 55% of certain vascular malformations, affecting approximately 170,000 individuals in the U.S.
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Progression of Early-Stage Pipeline Assets: Relay Therapeutics continues to advance other high-value, next-generation programs within its preclinical pipeline. Clinical starts for new programs, including those for Fabry disease and an NRAS-selective inhibitor, are anticipated in the second half of 2025. The successful progression of these early-stage assets into and through clinical development could lay the groundwork for additional future revenue streams, leveraging Relay's Dynamo platform for innovative drug discovery.
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Share Issuance
- Relay Therapeutics had 173.32 million shares outstanding.
- The number of outstanding shares increased by 28.69% in the last year.
- The company's strong cash and investment balances have been supported by recent equity financing rounds.
Inbound Investments
- As of September 30, 2025, Relay Therapeutics reported $596.4 million in cash, cash equivalents, and investments.
- This cash position is expected to fund the company's operating expenses and capital expenditure requirements into 2029.
- Institutional investors hold approximately 60.80% of Relay Therapeutics' shares.
Capital Expenditures
- Capital expenditures totaled approximately -$409,000 in the last 12 months.
- The company is investing significantly in its research and development pipeline, supported by these capital expenditures.
- Relay Therapeutics anticipates its current cash and investments will cover capital expenditure requirements until 2029.