On May 13, 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 first quarter ended March 31, 2025 (Press release, Olema Oncology, MAY 13, 2025, View Source [SID1234652984]).

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"During the first quarter, we continued to make important operational progress advancing our pipeline and we enter the second quarter well-positioned across the business," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our focus remains on our pivotal palazestrant program, laying the foundation to successfully initiate OPERA-02 in frontline metastatic breast cancer, while advancing OPERA-01 towards an anticipated top-line readout next year. We were also pleased to present promising new preclinical data at AACR (Free AACR Whitepaper) supporting the use of OP-3136, our potent KAT6 inhibitor, in a number of solid tumor applications beyond breast cancer. Investigator interest in our OP-3136 program remains strong and we are continuing to enroll patients in the Phase 1 study. With a clear strategy and strong balance sheet to support execution against our key priorities, we are working diligently to advance the promise of Olema’s science and striving to change the treatment paradigm for endocrine-driven cancers."

Recent Progress

Disclosed updated median progression-free survival (mPFS) from the ongoing Phase 1b/2 study of palazestrant in combination with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer at the TD Cowen 45th Annual Health Care Conference in March, including a mPFS of 13.8 months among all patients treated with 120 mg of palazestrant and 600 mg of ribociclib daily (n=56) and 13.1 months in patients previously treated with a CDK4/6i plus an endocrine therapy (n=40) as of a February 18, 2025 cutoff date.
Advanced the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer.
Continued enrollment in the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136 in participants with advanced solid tumors.
Presented new preclinical data for OP-3136 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, demonstrating anti-tumor activity in pre-clinical in vitro and in vivo ovarian, non-small cell lung, and prostate cancer models, regardless of KAT6A expression status, as well as synergy with standard of care drugs.
Anticipated Upcoming Events

Present trial-in-progress poster, "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," at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June; report top-line data from OPERA-01 in 2026.
Initiate the pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer in 2025.
Present mature data from the Phase 1b/2 trial of palazestrant in combination with ribociclib at an upcoming medical meeting.
First Quarter 2025 Financial Results
Cash, cash equivalents, and marketable securities as of March 31, 2025, were $392.7 million.

Net loss for the quarter ended March 31, 2025 was $30.4 million, as compared to $31.0 million for the quarter ended March 31, 2024. The decrease in net loss for the first quarter was related to higher interest income earned from marketable securities, primarily offset by increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $30.6 million for the quarter ended March 31, 2025, as compared to $29.9 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as the Company continues to advance palazestrant through late-stage clinical trials, and clinical operations and development-related activities associated with the advancement of OP-3136, and personnel-related costs, partially offset by a one-time $5 million milestone payment incurred to Aurigene and a decrease in non-cash stock-based compensation expense of $0.1 million.

Non-GAAP R&D expenses were $27.3 million for the quarter ended March 31, 2025, excluding $3.3 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $26.5 million for the quarter ended March 31, 2024, which included a $5.0 million milestone payment in connection with the Aurigene Agreement and excluded $3.4 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 G&A expenses were $4.2 million for the quarter ended March 31, 2025, as compared to $4.5 million for the quarter ended March 31, 2024. The decrease in G&A expenses was primarily due to a decrease in non-cash stock-based compensation expense of $0.4 million, offset by increased spending on corporate-related costs.

Non-GAAP G&A expenses were $3.2 million for the quarter ended March 31, 2025, excluding $1.1 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended March 31, 2024, excluding $1.5 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.