Palazestrant (OP-1250) - (OPERA-1)

May 12, 2026: Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) reported Q1 2026 results and highlighted upcoming clinical catalysts for its ER+/HER2- breast cancer pipeline. For palazestrant (OP-1250), the company said top-line data from the pivotal Phase 3 OPERA-01 monotherapy trial in second-/third-line ER+/HER2- metastatic breast cancer are expected in fall 2026, while the pivotal Phase 3 OPERA-02 trial of palazestrant + ribociclib in frontline ER+/HER2- advanced/metastatic breast cancer continues enrolling; a trial-in-progress poster for OPERA-02 is planned at the 2026 ASCO Annual Meeting. Olema also noted progress in a Phase 1b/2 study of palazestrant + atirmociclib in ER+/HER2- metastatic breast cancer (with Pfizer).

For OP-3136 (a KAT6 inhibitor), Olema plans to present initial Phase 1 clinical data (safety, PK/PD, and preliminary efficacy) at the 2026 ASCO Annual Meeting; the IND was cleared by FDA in December 2024 and enrollment is ongoing.

Financially, Olema ended Q1 (March 31, 2026) with $505.3M in cash/cash equivalents/marketable securities and reported a net loss of $53.1M.