Relay Therapeutics (RLAY) Status Update summary

Platform productivity and strategic focus

• Announced three new preclinical programs, expanding the portfolio to 11 development candidates, with a focus on solid tumors, breast cancer, and genetic diseases.

• Dynamo platform integrates advanced computational and experimental tools, including AI and robotics, enabling rapid discovery and optimization of selective inhibitors and chaperones.

• Platform has produced eight drug candidates and four INDs since 2016, with expectations to reach 11 candidates, seven INDs, and seven clinical programs by end of 2025.

• Focus remains on genetically defined, clinically validated targets in large, commercially attractive markets.

• Ongoing expansion into new modalities and genetic disease indications, with over five additional unnamed research programs in the pipeline.

PI3Kα franchise and breast cancer updates

• RLY-2608, a mutant-selective PI3Kα inhibitor, is advancing toward a pivotal trial in 2025, with robust efficacy and safety data expected by year-end 2024.

• Entered a clinical trial collaboration with Pfizer to combine RLY-2608 with atirmociclib, a selective CDK4 inhibitor, targeting earlier lines of breast cancer therapy.

• Ongoing trials include monotherapy, doublet (with fulvestrant), and triplet (with ribociclib and atirmociclib) regimens, with over 100 patients exposed to RLY-2608.

• Data will focus on progression-free survival and safety, aiming to demonstrate superiority over current standards like alpelisib and capivasertib.

• ReDiscover trial for RLY-2608 continues broad enrollment across multiple countries and tumor types.

Expansion into vascular malformations

• Vascular malformations program targets PI3Kα mutations, affecting an estimated 170,000 US patients; clinical development of RLY-2608 planned for Q1 2025.

• The goal is to provide a more effective and tolerable chronic therapy compared to current options, with clinical proof of concept targeted for early 2025.

• Current therapies, such as alpelisib and sirolimus, have limitations in selectivity and tolerability.