Core Insights - Olema Pharmaceuticals reported financial and operational results for Q2 2025, highlighting a focus on advancing its clinical programs for breast cancer therapies [1][5][6]. Recent Progress - The company achieved regulatory alignment on the selected dose for the pivotal palazestrant program and is accelerating enrollment in the OPERA-01 trial, with top-line data expected in the second half of 2026 [2][8]. - Olema is also advancing OP-3136, a KAT6 inhibitor, which is generating strong interest and enrollment in its Phase 1 study [2][9]. Financial Results - As of June 30, 2025, Olema had cash, cash equivalents, and marketable securities totaling $361.9 million [5][19]. - The net loss for Q2 2025 was $43.8 million, an increase from $30.4 million in Q2 2024, primarily due to a one-time milestone payment of $10 million and increased R&D spending [6][20]. - GAAP R&D expenses were $43.9 million for Q2 2025, up from $29.1 million in Q2 2024, reflecting ongoing late-stage clinical trials [7][20]. Anticipated Upcoming Events - Enrollment in the OPERA-01 trial is ongoing, with top-line data expected in the second half of 2026, while the OPERA-02 trial is set to initiate in Q3 2025 [8][9]. - Mature data from the Phase 1b/2 study of palazestrant in combination with ribociclib will be presented at ESMO 2025 [9]. Company Overview - Olema Oncology is focused on developing targeted therapies for breast cancer, with its lead candidate, palazestrant, currently in a pivotal Phase 3 trial [13][14]. - The company is also developing OP-3136, which has shown significant anti-proliferative activity in preclinical studies [15].
Olema Oncology Reports Second Quarter 2025 Financial and Operating Results