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]

Olema Pharmaceuticals (OLMA) 2025 Conference June 04, 2025 11:40 AM ET Speaker0 Good afternoon. How are you? Thank you for joining us on the next panel discussion here. I am very fortunate to have the CEO of Olima Pharmaceuticals here, Sean Bowen. Sean is continuing to work on developing and executing on his breast cancer drug, palazestrin. Obviously we just came away from ASCO and continue to learn more about the developments in breast cancer. And so I would love, Sean, maybe just to give a snapshot view. ...

28 May 2025 | 5:02AM BST Europe Healthcare: Pharmaceuticals Setting the scene for SERDs ahead of ASCO updates We expect developments in the SERD (Selective Estrogen Receptor Degrader) class of breast cancer therapies to be a key focus for investors as we enter a catalyst rich 12-24 month period for the class that has relevance to multiple companies. With a 500K+ eligible patient population globally, we believe the class could be worth $15bn+ by 2035. Specifically in our European BioPharma coverage, AZN and ...

Poster Presentation Details Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy Abstract Number: TPS1131 Poster Number: 104b Poster Session: Breast Cancer – Metastatic Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET "Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting i ...

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].