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Olema Oncology Reports Third Quarter 2025 Financial and Operating Results
Globenewswireยท 2025-11-10 12:00
Core Insights - Olema Pharmaceuticals reported significant advancements in its clinical programs, particularly the initiation of the Phase 3 OPERA-02 trial for palazestrant in combination with ribociclib, positioning it as a potential leading therapy for ER+/HER2- metastatic breast cancer [2][5] - The company ended the third quarter of 2025 with $329.0 million in cash and marketable securities, indicating a strong financial position to support ongoing clinical trials [7][8] Recent Progress - Olema announced a clinical trial agreement with Pfizer to evaluate palazestrant in combination with atirmociclib for ER+/HER2- metastatic breast cancer [5][6] - The OPERA-01 trial, assessing palazestrant as a monotherapy, continues to enroll patients, with top-line data expected in the second half of 2026 [2][6] - The Phase 1/2 study of OP-3136 has expanded to include combinations with fulvestrant and palazestrant, reflecting strong investigator interest [2][6] Financial Results - The net loss for Q3 2025 was $42.2 million, an increase from $34.6 million in Q3 2024, primarily due to higher R&D expenses related to late-stage clinical trials [8][9] - GAAP R&D expenses for Q3 2025 were $40.0 million, up from $33.2 million in Q3 2024, driven by increased clinical development activities [9][10] - GAAP general and administrative expenses rose to $5.9 million in Q3 2025 from $4.4 million in Q3 2024, attributed to corporate-related costs [11][12] Anticipated Upcoming Events - The company plans to present a trial-in-progress poster for OPERA-02 at the San Antonio Breast Cancer Symposium in December 2025 [6] - Initial clinical results for OP-3136 are expected to be reported in mid-2026, with top-line data from OPERA-01 anticipated in the second half of 2026 [6]