Olema Oncology — Third Quarter 2026 Earnings Summary

Financial Performance:

• Ended the quarter with $413.8 million in cash, cash equivalents, and marketable securities, down from $505.4 million as of December 31, 2025.
• Reported a net loss of $73.6 million for the quarter ended September 30, 2026, compared to a net loss of $42.2 million for the same period in 2025.
• GAAP research and development (R&D) expenses were $67.6 million for the quarter, an increase from $40.0 million in the prior year period.
• Non-GAAP R&D expenses were $59.9 million for the quarter, excluding $7.7 million in stock-based compensation, compared to $37.4 million in the prior year period.
• GAAP general and administrative (G&A) expenses were $9.9 million for the quarter, up from $5.9 million in the prior year period.
• Non-GAAP G&A expenses were $5.5 million for the quarter, excluding $4.4 million in stock-based compensation, compared to $4.3 million in the prior year period.
• Total operating expenses for the quarter were $77.5 million, compared to $45.9 million in the prior year period.
• Net loss per share (basic and diluted) was $(0.73) for the quarter, compared to $(0.49) in the prior year period.
• For the nine months ended September 30, 2026, total operating expenses were $202.7 million compared to $128.6 million in the prior year period, and net loss was $189.9 million compared to $116.4 million.

Guidance and Future Outlook:

• On track to announce top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.
• Enrollment in the pivotal Phase 3 OPERA-02 trial is accelerating with strong investigator interest.
• Anticipates initiating enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
• Plans to present preclinical data on selective degradation of KAT6A at the 38th EORTC-NCI-AACR Symposium in November 2026.
• Plans to present data from multiple Phase 1b/2 studies at the 2026 San Antonio Breast Cancer Symposium (SABCS) in December 2026.
• Management expresses confidence that palazestrant could emerge as a differentiated endocrine therapy and potentially become the new standard of care in first-line metastatic breast cancer when combined with ribociclib.

Business Segments and Product Lines:

• Palazestrant (OP-1250): A proprietary, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two Phase 3 trials (OPERA-01 and OPERA-02) for ER+/HER2- metastatic breast cancer. It holds FDA Fast Track designation.
• OP-3136: A novel KAT6 inhibitor currently in a Phase 1 clinical study; the IND application was cleared in December 2024.
• Clinical Progress: Continued strong enrollment in the OPERA-02 trial and the Phase 1b/2 study of OP-3136.
• Partnerships: Collaboration with Bayer to evaluate OP-3136 in combination with darolutamide for mCRPC.

Market and Competitive Landscape:

• Operates in the breast cancer treatment market, specifically targeting ER+/HER2- metastatic breast cancer.
• Management notes that patients with frontline disease continue to require better therapeutic options.
• Palazestrant is positioned to transform the metastatic breast cancer treatment paradigm due to its dual mechanism of action and potential for use as a monotherapy or in combination with other agents.

Risks and Challenges:

• Increased net loss is driven by higher spending on patient enrollment in Phase 3 trials, manufacturing and clinical supply activities, and personnel costs.
• Stock-based compensation expense increased significantly, contributing to higher GAAP expenses ($5.1 million increase in R&D and $2.7 million increase in G&A).
• Forward-looking statements regarding clinical trial results, timing, and potential approval are subject to risks and uncertainties, including potential material differences between anticipated and actual results.

Management Commentary and Tone:

• Sean P. Bohen, M.D., Ph.D., President and CEO, expressed confidence in palazestrant's potential and noted that momentum is building for the OPERA-02 trial.
• Management highlighted the "unique positioning" of palazestrant to become the new standard of care in the first-line setting.
• The company welcomed Jason O'Byrne as the new Chief Financial Officer, citing his experience in corporate strategy and capital markets as invaluable for the 2027 catalysts and transformation into a fully integrated oncology company.
• Tone is optimistic regarding the clinical profile of palazestrant and the potential of OP-3136.

Other Key Points:

• Appointed Jason O'Byrne, MBA, as Chief Financial Officer during the quarter.
• Cash balance decreased by approximately $91.7 million from the end of 2025 to the end of Q3 2026.
• The company is preparing for potential approval and commercialization of palazestrant.
• Total liabilities increased to $72.2 million as of September 30, 2026, from $54.9 million as of December 31, 2025.
• Total stockholders' equity decreased to $368.8 million as of September 30, 2026, from $478.6 million as of December 31, 2025.