Olema completes OPERA-01 enrollment, pushes top-line data to Q1 2027
Olema Oncology also struck a Bayer collaboration testing its KAT6 inhibitor with darolutamide in prostate cancer and ended the quarter with $461.1 million in cash.
Olema Pharmaceuticals reported second quarter 2026 results on August 10, 2026. The company said it completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer1. Top-line data from that trial are now expected in the first quarter of 2027, delayed from prior guidance implied by full enrollment completion, as the company stated it now expects to report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 20271.
On the pipeline's second asset, Olema presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer at the 2026 ASCO Annual Meeting1. The company also announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer's androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer1. That combination study is expected to begin enrolling in the fourth quarter of 2026, per the company's statement that it plans to initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 20261.
Separately, Olema completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer1, and continued advancing enrollment in OPERA-02 and the OP-3136 monotherapy and combination studies, per the release.
Financially, cash, cash equivalents, and marketable securities stood at $461.1 million as of June 30, 20261. Net loss for the quarter was $63.2 million, compared to $43.8 million for the quarter ended June 30, 20251, which the company attributed to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-31361.
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