On May 12, 2026 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, 2026.

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"We continued to meaningfully advance our pipeline of novel therapies focused on transforming the metastatic breast cancer treatment paradigm during the first quarter, with top-line data from our Phase 3 OPERA-01 trial of palazestrant as a monotherapy expected this fall and initial Phase 1 clinical data for OP-3136 being presented at ASCO (Free ASCO Whitepaper) later this month," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We continued patient enrollment in OPERA-02, our Phase 3 trial of palazestrant in combination with ribociclib in the frontline metastatic setting, while advancing our ongoing Phase 1/2 combination studies evaluating palazestrant as a potential combination endocrine therapy of choice for metastatic breast cancer. With important clinical data catalysts on the horizon this year, we believe that we are well-positioned to continue our transformation into a fully integrated oncology company with our first anticipated commercial launch next year."

Recent Progress

Presented two preclinical posters at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April:
The first demonstrated that palazestrant fully recruits the corepressor protein, NCoR1, in vitro, supporting complete estrogen receptor antagonism.
The second reinforced that palazestrant in combination with OP-3136 drives synergistic anti-tumor activity in in vivo estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer models.
Continued enrollment in the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer.
Advanced enrollment in the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer in collaboration with Pfizer.

Anticipated Upcoming Events

Present initial clinical data from the Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OP-3136 in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Present trial-in-progress poster for the ongoing pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer at ASCO (Free ASCO Whitepaper).
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line ER+/HER2- metastatic breast cancer in the fall of 2026.

First Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of March 31, 2026, were $505.3 million.

Net loss for the quarter ended March 31, 2026 was $53.1 million, as compared to $30.4 million for the quarter ended March 31, 2025. The increase in net loss for the first quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $49.2 million for the quarter ended March 31, 2026, as compared to $30.6 million for the quarter ended March 31, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs, including an increase in non-cash stock-based compensation expense of $3.3 million, mainly due to higher grant prices in 2026 and higher headcount.

Non-GAAP R&D expenses were $42.7 million for the quarter ended March 31, 2026, excluding $6.6 million non-cash stock-based compensation expense. 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. 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 $8.8 million for the quarter ended March 31, 2026, as compared to $4.2 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs, and personnel-related costs, including an increase in non-cash stock-based compensation expense of $2.5 million, mainly due to higher grant prices in 2026.

Non-GAAP G&A expenses were $5.2 million for the quarter ended March 31, 2026, excluding $3.6 million non-cash stock-based compensation expense. 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. 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, MAY 12, 2026, View Source [SID1234665553])