Olema Oncology Reports Fourth Quarter and Full Year 2025 Financial and Operating Results

Company on track to report top-line data from pivotal Phase 3 OPERA-01 trial of palazestrant in 2/3L ER+/HER2- metastatic breast cancer in fall of 2026

Mar. 16, 2026 at 11:23am by Ben Kaplan

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Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today reported financial and operating results for the fourth quarter and full year ended December 31, 2025. The company advanced palazestrant, its lead product candidate, across multiple clinical trials and strengthened its balance sheet with a $218.5 million public offering, positioning it for potential commercial launch in late 2027.

Why it matters

Olema's progress with palazestrant, a novel endocrine therapy, could transform the treatment paradigm for metastatic breast cancer patients. The company's diversified pipeline and strong financial position also suggest it is well-positioned to deliver meaningful new treatment options to the breast cancer community.

The details

Key highlights from the quarter and full year include initiating a Phase 1b/2 study evaluating palazestrant in combination with Pfizer's atirmociclib, continued enrollment in the pivotal Phase 3 OPERA-02 trial of palazestrant plus ribociclib, and ongoing enrollment in the Phase 1 study of OP-3136. The company also completed a $218.5 million public offering to fund operations through numerous expected value-creating events.

  • Olema initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in Q4 2025.
  • Olema presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial at the San Antonio Breast Cancer Symposium in December 2025.
  • Olema expects to report initial clinical results for OP-3136 in Q2 2026.
  • Olema expects to report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant in the fall of 2026.
  • Olema completed the $218.5 million public offering in November 2025.

The players

Olema Pharmaceuticals, Inc.

A clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond.

Sean P. Bohen, M.D., Ph.D.

President and Chief Executive Officer of Olema Oncology.

Pfizer

A pharmaceutical company that is collaborating with Olema on a Phase 1b/2 study evaluating palazestrant in combination with Pfizer's novel CDK4 inhibitor, atirmociclib.

OP-3136

Olema's novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target dysregulated in breast and other cancers.

Palazestrant (OP-1250)

Olema's lead product candidate, a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD).

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What they’re saying

“2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials.”

— Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology (Globe Newswire)

“With initial clinical results from OP-3136 anticipated in Q2 2026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema's history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond.”

— Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology (Globe Newswire)

What’s next

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The takeaway

Olema's progress with its lead candidate palazestrant, combined with a strengthened balance sheet and diversified pipeline, positions the company to potentially transform the metastatic breast cancer treatment paradigm and deliver meaningful new options for patients.