Palazestrant (OP-1250) Development - Olema aims to establish Palazestrant as a best-in-class backbone therapy for ER+/HER2- breast cancer, both as a monotherapy and in combination with other anti-tumor agents[8] - The pivotal Phase 3 OPERA-01 clinical trial of Palazestrant as a monotherapy is ongoing, with top-line results expected in 2026[16, 37] - A pivotal Phase 3 OPERA-02 clinical trial of Palazestrant in combination with ribociclib is planned for initiation in 2025[3, 14, 16, 37, 88] - Palazestrant monotherapy Phase 2 data showed a median PFS of 73 months in 2/3L ±CT ESR1-mutant patients and 55 months in 2/3L ±CT ESR1-wild-type patients[45, 46, 47] - Palazestrant, at 120mg in combination with ribociclib, showed a 6-month PFS rate of 74% in all patients and 68% in patients with prior CDK4/6i[75, 80] OP-3136 (KAT6 Inhibitor) Development - Olema is advancing the clinical development of OP-3136, a potential best-in-class KAT6 inhibitor, in breast and other solid tumor cancers[10] - The FDA has cleared the Investigational New Drug (IND) application for OP-3136, and a Phase 1 clinical trial has been initiated[16, 100] - Preclinical data demonstrates that OP-3136 shows synergistic activity in combination with palazestrant[112] Market and Financial Position - The estimated global market for ER+/HER2- metastatic breast cancer is greater than $20 billion[35] - The U S market potential for Palazestrant in the 2/3L setting is estimated at $3-5 billion[63] - Olema has a strong capital position with $3927 million[13]

Core Insights - Olema Pharmaceuticals reported financial and operational results for Q1 2025, highlighting progress in its clinical pipeline and financial position [1][2]. Recent Progress - The pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib for frontline metastatic breast cancer is on track for initiation in 2025, supported by updated efficacy data from the ongoing Phase 1b/2 study [6]. - The OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance, with top-line data expected in 2026 [6]. - New preclinical data for OP-3136, a KAT6 inhibitor, was presented at AACR, showing anti-tumor activity in various solid tumor models, with ongoing Phase 1 trial recruitment [6][7]. Financial Results - As of March 31, 2025, Olema had $392.7 million in cash, cash equivalents, and marketable securities [5]. - The net loss for Q1 2025 was $30.4 million, a slight decrease from $31.0 million in Q1 2024, attributed to higher interest income offset by increased clinical development spending [8]. - GAAP R&D expenses were $30.6 million for Q1 2025, up from $29.9 million in Q1 2024, primarily due to increased clinical operations and development activities [9]. - Non-GAAP R&D expenses were $27.3 million for Q1 2025, compared to $26.5 million in Q1 2024 [10]. Anticipated Upcoming Events - The company plans to present a trial-in-progress poster for OPERA-01 at the ASCO Annual Meeting in June and report top-line data in 2026 [7]. - The initiation of the OPERA-02 trial is expected in 2025 [7].