On March 16, 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 fourth quarter and full year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant’s potential as the combination endocrine therapy of choice in the metastatic setting."

Bohen continued, "In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. 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."

Recent Progress

Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.
Presented a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- advanced or metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2025.
Continued enrollment in 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.
Completed an underwritten public offering of an aggregate of 11,500,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of approximately $218.5 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Anticipated Upcoming Events

Report initial clinical results for OP-3136 in Q2 2026 at a major medical conference.
Report top-line data from the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in second- and third-line (2/3L) ER+/HER2- metastatic breast cancer in the fall of 2026.
Fourth Quarter and Full Year 2025 Financial Results
Cash, cash equivalents, and marketable securities as of December 31, 2025, were $505.4 million.

Net loss for the quarter and year ended December 31, 2025 was $46.1 million and $162.5 million, respectively, as compared to $33.6 million and $129.5 million for the quarter and year ended December 31, 2024, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical development and research activities as a result of 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 $43.2 million and $157.7 million for the quarter and year ended December 31, 2025, respectively, as compared to $32.3 million and $124.5 million for the quarter and year ended December 31, 2024. The increase in R&D expenses was primarily related to increased spending on clinical operations and development-related activities as Olema continues to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and personnel-related costs, partially offset by a decrease in non-cash stock-based compensation expense.

Non-GAAP R&D expenses were $40.6 million and $145.5 million for the quarter and year ended December 31, 2025, respectively, excluding $2.6 million and $12.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $27.7 million and $108.0 million for the quarter and year ended December 31, 2024, respectively, excluding $4.6 million and $16.5 million non-cash stock-based compensation expense, respectively. 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 $6.9 million and $21.0 million for the quarter and year ended December 31, 2025, respectively, as compared to $4.5 million and $17.7 million for the quarter and year ended December 31, 2024. The increase in G&A expenses was primarily due to increased spending on corporate-related costs.

Non-GAAP G&A expenses were $5.2 million and $15.6 million for the quarter and year ended December 31, 2025, respectively, excluding $1.7 million and $5.4 million non-cash stock-based compensation expense, respectively. Non-GAAP G&A expenses were $2.8 million and $11.7 million for the quarter and year ended December 31, 2024, excluding $1.7 million and $6.0 million non-cash stock-based compensation expense, respectively. 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, MAR 16, 2026, View Source [SID1234663572])