Relay Therapeutics (RLAY) Wells Fargo 21st Annual Healthcare Conference summary

Strategic outlook and regulatory milestones

• Preparing for transition to commercial stage with focus on breast cancer and vascular anomalies.

• Regulatory updates for frontline breast cancer and vascular anomalies expected before year-end, including a phase III trial start for breast cancer early next year.

• Regulatory interactions for accelerated approval in vascular anomalies planned before year-end.

• Additional data releases for vascular anomalies and phase I/II triplet breast cancer expected by mid-next year.

• Moving toward registrational readouts in both breast cancer and vascular anomalies.

Breast cancer program highlights

• Zovegalisib demonstrated 11-month PFS in second-line breast cancer, outperforming capivasertib.

• Early triplet data in third-line setting showed a 44% ORR and strong combinability.

• ReDiscover-2 phase II enrollment is progressing well, with updates on last patient in expected before year-end.

• Safety profile of zovegalisib shows low rates of severe AEs, with no need for prophylactic therapies.

• First-line strategy targets endocrine-sensitive patients, aiming for a straightforward trial design referencing FourLight-3.

Competitive landscape and trial design

• Capivasertib remains the benchmark, with oral administration favored over IV competitors.

• Safety and tolerability are key differentiators, with zovegalisib showing favorable comparisons to existing agents.

• Trial design leverages global infrastructure and distinct teams for frontline and second-line studies.

• CDK4/6 plus endocrine therapy remains the global standard of care for trial control arms.

• HER2-negative, HR-positive metastatic breast cancer is the current focus, with future expansion opportunities considered.