RLAY · Relay Therapeutics, Inc.

Relay Therapeutics announced first quarter 2026 financial results alongside significant clinical advancements for its lead asset zovegalisib, a pan-mutant selective PI3Kα inhibitor. The FDA's Breakthrough Therapy designation for zovegalisib combined with fulvestrant in PIK3CA-mutant, HR+/HER2- advanced breast cancer, based on Phase 1/2 ReDiscover trial data from 600mg BID fasted and 400mg BID fed regimens, underscores the potential to address a large patient population of approximately 140,000 annually in the US. At ESMO TAT 2026, the company presented 400mg BID doublet data showing 11.1-month median PFS in heavily pre-treated, CDK4/6-experienced patients, with consistent efficacy across kinase (11.2 months) and non-kinase (11.0 months) mutations, and a safety profile aligned with prior reports. The Phase 3 ReDiscover-2 trial in 2L breast cancer continues execution. In frontline setting, compelling triplet data with atirmociclib in median 3L patients yielded 44% ORR, similar across mutation types, supporting selection of this regimen for a Phase 3 1L trial in endocrine-sensitive patients starting early 2027, bolstered by Pfizer's supply agreement for atirmociclib and palbociclib while Relay retains full zovegalisib rights. Additional catalysts include initial vascular anomalies data on May 19 at ISSVA and Phase 1/2 initiation of NRAS-selective RLY-8161. Financially, revenue from Elevar Therapeutics license fell to $3.0 million from $7.7 million year-over-year, reflecting agreement dynamics. R&D expenses dipped to $70.6 million from $73.8 million due to prior streamlining, offset by ReDiscover-2 ramp-up, while G&A dropped sharply to $11.0 million from $18.7 million on lower compensation and Elevar-related costs. Net loss improved to $73.3 million or $0.41 per share from $77.1 million or $0.46. Cash swelled to $642.1 million via $137.1 million ATM proceeds, plus $22.1 million in April, projecting runway into 2029 and supporting pipeline execution.