Quarterly ResultMay 5, 2026, 04:15 PM
Relay Therapeutics Q1 Net Loss $73.3M; Zovegalisib Gets FDA BTD
AI Summary
Relay Therapeutics reported its first quarter 2026 financial results, with a net loss of $73.3 million, an improvement from the $77.1 million loss in Q1 2025, though revenue decreased to $3.0 million. The company announced significant corporate progress, including the FDA granting Breakthrough Therapy designation to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer. Relay Therapeutics also initiated a Phase 1/2 trial for RLY-8161 and plans to start a Phase 3 trial for a zovegalisib triplet regimen in 1L breast cancer in early 2027, extending its cash runway into 2029.
Key Highlights
- FDA granted Breakthrough Therapy designation to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer.
- Q1 2026 net loss was $73.3 million, an improvement from $77.1 million in Q1 2025.
- Q1 2026 revenue was $3.0 million, down from $7.7 million in Q1 2025.
- Cash, cash equivalents, and investments totaled $642.1 million as of March 31, 2026.
- Company expects current cash to fund operations into 2029.
- Initiated Phase 1/2 trial for RLY-8161, an NRAS-selective inhibitor, in solid tumors.
- Phase 3 1L breast cancer trial for zovegalisib plus atirmociclib triplet expected to initiate in early 2027.
- Zovegalisib doublet data showed 11.1-month median PFS in heavily pre-treated breast cancer patients.