On August 11, 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 second quarter ended June 30, 2025 (Press release, Olema Oncology, AUG 11, 2025, View Source [SID1234655073]).

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"Having achieved regulatory alignment on the selected dose for our pivotal palazestrant program during the second quarter, we are focused on accelerating enrollment in OPERA-01, which is on track for top-line data in the second half of 2026, and initiating the OPERA-02 combination trial in the frontline setting," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Palazestrant’s demonstrated activity and combinability with multiple compounds offers the potential for it to become a best-in-class, backbone endocrine therapy for metastatic breast cancer. Our Phase 1 study of OP-3136, our potent and selective KAT6 inhibitor, is also generating strong investigator interest and patient enrollment, reinforcing our leadership in developing novel therapies for breast cancer and beyond."

Recent Progress

Selected 90 mg of once-daily palazestrant for Part 2 of the ongoing registrational OPERA-01 Phase 3 trial in second- and third-line (2/3L) estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer, and for the OPERA-02 Phase 3 trial in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
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.
Anticipated Upcoming Events

Present mature data from the Phase 1b/2 study of palazestrant in combination with ribociclib in ER+/HER2- metastatic breast cancer at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in a presentation entitled "Palazestrant (OP-1250) plus ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced breast cancer (ABC)"
Initiate the OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer in Q3 2025.
Report initial clinical results for OP-3136 in 2026.
Report top-line data from OPERA-01 in the second half of 2026.
Second Quarter 2025 Financial Results
Cash, cash equivalents, and marketable securities of $361.9 million as of June 30, 2025.

Net loss for the quarter ended June 30, 2025 was $43.8 million, as compared to $30.4 million for the quarter ended June 30, 2024. The increase in net loss for the second quarter was related to a one-time milestone payment of $10 million made to Aurigene in conjunction with our KAT6 clinical development program as well as 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 $43.9 million for the quarter ended June 30, 2025, as compared to $29.1 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily related to a one-time milestone payment of $10 million made to Aurigene as well as increased spending on clinical development-related activities as Olema continues to advance palazestrant through late-stage clinical trials, and the advancement of OP-3136.

Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $24.9 million for the quarter ended June 30, 2024, which excluded $4.2 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 $4.0 million for the quarter ended June 30, 2025, as compared to $4.4 million for the quarter ended June 30, 2024. The decrease in G&A expenses was primarily due to a decrease in non-cash stock-based compensation expense of $0.5 million.

Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $2.9 million for the quarter ended June 30, 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.