Relay Therapeutics (RLAY) TD Cowen 46th Annual Health Care Conference summary

Strategic focus and pipeline updates

• Capital allocation prioritized to advance zovegalisib, extending cash runway into 2029 and focusing on three major clinical areas: breast cancer (2nd and 1st line) and PI3Kα-driven vascular anomalies.

• Three key datasets will be disclosed this year to de-risk these opportunities, starting with 2nd-line metastatic breast cancer data at ESMO TAT in Paris.

• Enrollment for the pivotal ReDiscover-2 trial is progressing globally, with no current guidance on full enrollment or top-line data timing.

• Outlicensed lirafugratinib to focus resources on core programs.

Clinical trial design and upcoming data

• 2nd-line breast cancer data will include 57 patients dosed at 400 mg BID fed, matching the phase III regimen, aiming for consistency with prior 600 mg BID fasted cohort results (PFS >10 months, ~40% response rate).

• Frontline breast cancer trial design and go-forward regimen will be shared this year, focusing on tolerability in triplet combinations with CDK4 or CDK4/6 inhibitors.

• ReInspire phase I/II trial in vascular anomalies randomizes patients 12+ years across three zovegalisib doses, with expansion cohorts and ORR as the primary endpoint; younger cohorts (6–11 years) recently opened.

• Initial vascular anomaly data will cover 20 patients at 12 weeks, aiming to show differentiation from existing therapies.

Market opportunity and competitive landscape

• Estimated 170,000 PIK3CA-driven vascular anomaly patients in the US; 100,000 in key subtypes (PROS, lymphatic, venous malformations), with 25,000 likely to seek chronic systemic therapy.

• Current standard of care includes alpelisib (accelerated approval for PROS) and sirolimus, with significant unmet need due to disease heterogeneity and limitations of local therapies.

• Zovegalisib aims for a differentiated efficacy and safety profile, with regulatory endpoints focused on ORR by volumetric MRI and a goal to exceed historical benchmarks (11–27% response rates).

• Differentiation from topical QTORIN rapamycin is based on systemic versus topical treatment and patient population (macrocystic/mixed vs. microcystic/cutaneous).