SAN FRANCISCO, November 10, 2025 — Leads & Copy — Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) reported its third-quarter financial and operating results, highlighting progress in its breast cancer therapy programs.
The clinical-stage biopharmaceutical company, focused on targeted therapies for breast cancer, announced a new clinical trial agreement with Pfizer to evaluate palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer. They also initiated the OPERA-02 Phase 3 trial of palazestrant with ribociclib in frontline ER+/HER2- metastatic breast cancer and presented new data from a Phase 1b/2 study of palazestrant plus ribociclib at ESMO 2025.
According to Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology, these advancements, including the clinical trial agreement with Pfizer, underscore confidence in palazestrant’s activity in combination with other agents. Enrollment in the OPERA-01 trial is progressing well, with top-line data expected in the second half of next year, and the Phase 1/2 study of the KAT6 inhibitor, OP-3136, has expanded into combinations with fulvestrant and palazestrant.
Recent Progress Noted:
- A clinical trial collaboration and supply agreement with Pfizer to evaluate the safety and combinability of palazestrant plus atirmociclib in a Phase 1b/2 study in patients with ER+/HER2- metastatic breast cancer.
- Initiation of the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
- Presentation of updated data from the Phase 1b/2 study of palazestrant plus ribociclib at the European Society for Medical Oncology (ESMO) Congress 2025.
- Continued enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.
- Advancement of the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136, as a monotherapy and in combination with fulvestrant and palazestrant, in participants with advanced solid tumors.
Anticipated Upcoming Events:
- Initiation of the Phase 1b/2 study evaluating palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer in Q4 2025.
- Presentation of a trial-in-progress poster entitled “OPERA-02: a phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer” at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.
- Reporting initial clinical results for OP-3136 in mid-2026.
- Reporting top-line data from OPERA-01 in the second half of 2026.
Third Quarter 2025 Financial Results:
- Cash, cash equivalents, and marketable securities of $329.0 million as of September 30, 2025.
- Net loss for the quarter ended September 30, 2025 was $42.2 million, as compared to $34.6 million for the quarter ended September 30, 2024.
- GAAP research and development (R&D) expenses were $40.0 million for the quarter ended September 30, 2025, as compared to $33.2 million for the quarter ended September 30, 2024.
- GAAP general and administrative (G&A) expenses were $5.9 million for the quarter ended September 30, 2025, as compared to $4.4 million for the quarter ended September 30, 2024.
Olema Oncology is focused on transforming the standard of care for breast cancer and beyond. Their lead product candidate, palazestrant (OP-1250), is in Phase 3 clinical trials, and they are also developing OP-3136, a KAT6 inhibitor in a Phase 1 clinical study.
Courtney O’Konek, Vice President, Corporate Communications, is the media and investor relations contact and can be reached at media@olema.com.
Source: Olema Pharmaceuticals, Inc.
