Olema Pharmaceuticals (OLMA) Q4 2025 earnings summary

Executive summary

• Advanced pivotal Phase 3 trials for palazestrant, including OPERA-01 (monotherapy) and OPERA-02 (combination with ribociclib), targeting ER+/HER2- metastatic breast cancer.

• Initiated Phase 1b/2 study of palazestrant with Pfizer's atirmociclib and continued enrollment in OP-3136 studies.

• Transformation into a fully integrated oncology company underway, with commercial launch preparations for late 2027.

Financial highlights

• Ended 2025 with $505.4 million in cash, cash equivalents, and marketable securities, up from $434.1 million at year-end 2024.

• Net loss for Q4 2025 was $46.1 million, and for the full year $162.5 million, compared to $33.6 million and $129.5 million in 2024.

• Gross proceeds of $218.5 million raised from a public offering in November 2025.

• GAAP R&D expenses for 2025 were $157.7 million, up from $124.5 million in 2024; non-GAAP R&D expenses were $145.5 million, up from $108.0 million.

• GAAP G&A expenses for 2025 were $21.0 million, up from $17.7 million in 2024; non-GAAP G&A expenses were $15.6 million, up from $11.7 million.

Outlook and guidance

• Top-line data from OPERA-01 expected in fall 2026; initial clinical results from OP-3136 anticipated in Q2 2026.

• Commercial launch preparations underway for a potential approval in late 2027.