Relay Therapeutics (RLAY) investor relations material

Strategic updates and clinical development plans

• Multiple data disclosures for zovega, a mutant-selective PI3K inhibitor, in breast cancer and vascular anomalies, with ongoing and planned phase III trials in both indications over the next 12–24 months.

• Plans to file for approval and initiate commercialization efforts as phase III trials reach full enrollment, aiming to differentiate on efficacy and safety versus competitors.

• Frontline breast cancer trial to combine zovega with Pfizer’s selective CDK4 inhibitor, targeting robust enrollment and trial initiation within 18–24 months.

• Vascular anomalies program showed a 60% volumetric response rate, with accelerated approval and commercialization targeted in the next 18–24 months.

• Recent capital raise supports execution of all major programs through 2029, including top-line data readouts.

Clinical data highlights and competitive positioning

• Zovega demonstrated 11 months median PFS in second-line HR+/HER2- breast cancer, outperforming capivasertib and matching Celcuity’s IV regimen, with oral dosing seen as a key advantage.

• Triplet regimen achieved a 44% ORR in heavily pre-treated patients, with expectations for improved efficacy and tolerability in frontline settings.

• Selective combination with CDK4 aims to provide a more tolerable long-term therapy compared to CDK4/6 regimens, differentiating from Eli Lilly’s approach.

• Vascular anomalies data showed 100% response at 300 mg BID, with dose optimization ongoing to balance efficacy and tolerability.

• Mechanistic selectivity of zovega enables benefit in patients who failed alpelisib and supports chronic use, especially in pediatric populations.

Regulatory and commercial outlook

• Accelerated approval for vascular anomalies to be discussed with FDA, leveraging precedent from alpelisib and aiming for a patient pool between 37 and 104 for approval.

• U.S. prevalence of target rare diseases estimated at 170,000, with 25,000 likely to seek chronic therapy, representing a multi-billion dollar opportunity.

• Commercial model for rare diseases leverages 30–40 centers of excellence in the U.S. and Europe, facilitating efficient patient access.

• Exclusive agreement with Pfizer for phase III trials in PI3K regimens, with plans to initiate a frontline phase III study in early 2027.

• Dynamo platform and computational approaches incrementally improve drug discovery, but human expertise remains essential.