Olema Pharmaceuticals (OLMA) Q2 2026 earnings summary

Executive summary

• Lead candidate palazestrant advanced in pivotal Phase 3 trials for ER+/HER2- breast cancer, with top-line results expected in Q1 2027 and potential FDA approval in 2028.

• Completed enrollment in pivotal Phase 3 OPERA-01 trial for palazestrant monotherapy in ER+/HER2- metastatic breast cancer.

• OP-3136, a KAT6 inhibitor, is in Phase 1 trials with promising early safety and anti-tumor activity; combination studies with Bayer's NUBEQA®/darolutamide to start in late 2026.

• Multiple collaborations with Novartis, Pfizer, and Bayer support clinical development and supply for combination studies.

• Advanced multiple clinical programs, including OPERA-02 and combination studies with palazestrant.

Financial highlights

• Net loss for Q2 2026 was $63.2M, up 44% year-over-year, driven by increased clinical and corporate spending; six-month net loss was $116.3M, up 57%.

• Operating expenses rose 40% in Q2 and 51% for the first half, driven by R&D and G&A increases.

• GAAP R&D expenses rose to $57.8M from $43.9M year-over-year; non-GAAP R&D expenses were $48.9M, up from $40.2M.

• GAAP G&A expenses increased to $9.4M from $4.0M; non-GAAP G&A expenses were $5.4M, up from $3.0M.

• Cash, cash equivalents, and marketable securities totaled $461.1M as of June 30, 2026.

Outlook and guidance

• Cash runway expected through mid-2028 based on current operating plans and available credit.

• Top-line data from OPERA-01 Phase 3 trial expected in Q1 2027.

• Enrollment for Phase 1b/2 study of OP-3136 with darolutamide in mCRPC to begin in Q4 2026.

• Anticipates continued increases in R&D and G&A expenses as clinical programs expand and commercialization preparations begin.

• Substantial additional funding will be required for future development and commercialization.