On November 10, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the third quarter ended September 30, 2025.

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"We have made significant progress advancing our programs this quarter, highlighted by the initiation of the Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in the frontline setting and the presentation of compelling data at ESMO (Free ESMO Whitepaper) that further positions palazestrant to become a potential best-in-class backbone endocrine therapy for ER+/HER2- metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our clinical trial agreement with Pfizer to combine palazestrant with atirmociclib further underscores our confidence in palazestrant’s activity in combination with other agents in the metastatic setting."

Bohen continued, "Enrollment in the OPERA-01 trial evaluating palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer continues to progress well and we remain on track for top-line data in the second half of next year. The Phase 1/2 study of our KAT6 inhibitor, OP-3136, recently expanded into combinations with fulvestrant and palazestrant and continues to benefit from strong investigator interest. As we look ahead to 2026, we remain focused on sustaining positive momentum across the business, transforming the breast cancer treatment paradigm, and bringing palazestrant to market."

Recent Progress

Announced a clinical trial collaboration and supply agreement with Pfizer to evaluate the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in a Phase 1b/2 study in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.
Initiated the OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
Presented updated data from the Phase 1b/2 study of palazestrant plus ribociclib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, demonstrating encouraging activity in both ESR1 mutant and wild-type patients.
Continued enrollment in the OPERA-01 Phase 3 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer.
Advanced 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

Initiate the Phase 1b/2 study evaluating palazestrant with atirmociclib in ER+/HER2- metastatic breast cancer in Q4 2025.
Present 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.
Report initial clinical results for OP-3136 in mid-2026.
Report 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. The increase in net loss for the third quarter was primarily related to increased spending on research and development activities as a result of the ongoing late-stage clinical trials for palazestrant and the advancement of OP-3136, partially offset by higher interest income earned from marketable securities.

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. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as Olema continues to advance palazestrant through late-stage clinical trials, and the advancement of OP-3136, partially offset by decreases in stock-based compensation expense of $1.7 million.

Non-GAAP R&D expenses were $37.4 million for the quarter ended September 30, 2025, excluding $2.6 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $28.9 million for the quarter ended September 30, 2024, which excluded $4.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

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. The increase in G&A expenses was primarily due to corporate-related costs, including increases in stock-based compensation expense of $0.3 million.

Non-GAAP G&A expenses were $4.3 million for the quarter ended September 30, 2025, excluding $1.7 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended September 30, 2024, excluding $1.3 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, NOV 10, 2025, View Source [SID1234659722])