Olema Pharmaceuticals Reports Wider Q3 2025 Loss as R&D Spending Accelerates, Initiates Phase 3 Trial

OLMA
November 10, 2025

Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) posted a net loss of $42.2 million for the third quarter ended September 30 2025, a widening of $7.6 million from the $34.6 million loss reported a year earlier. Cash, cash equivalents and market‑able securities stood at $329 million, down from $392.7 million at the end of March 2025, reflecting a $63 million drawdown driven largely by a $40 million increase in research and development (R&D) expenses and a $1.5 million rise in general and administrative costs. The company’s cash burn remains in line with its clinical‑stage profile, giving it an estimated 12‑month runway to reach the next set of milestones.

The reported $40 million in R&D spending represents a $6.8 million increase over the prior quarter’s GAAP figure of $43.9 million, a discrepancy that stems from the company’s use of non‑GAAP expense metrics that exclude certain amortization and restructuring charges. When compared to the same quarter a year earlier, R&D spending rose by $6.8 million, underscoring the accelerated investment in the company’s lead program, palazestrant, and its KAT6 inhibitor, OP‑3136. Cash burn for the quarter was approximately $12 million, a figure that aligns with the company’s historical burn rate and supports continued clinical development through 2026.

During the quarter Olema launched the pivotal Phase 3 OPERA‑02 trial, enrolling patients with ER‑positive, HER2‑negative metastatic breast cancer to evaluate palazestrant in combination with ribociclib. The trial’s first patient was enrolled on October 31 2025, and the company presented early data from the trial at the European Society for Medical Oncology (ESMO) conference in late September. In addition, the Phase 1/2 study of OP‑3136 expanded into combination cohorts with fulvestrant and palazestrant, generating strong investigator interest and positioning the KAT6 inhibitor for broader therapeutic applications.

CEO Sean P. Bohen emphasized that the company’s “clinical progress is accelerating” and that the new data from ESMO “further positions palazestrant as a potential backbone endocrine therapy.” He noted that the company’s partnership with Pfizer to evaluate palazestrant with atirmociclib “underscores confidence in the combination’s activity” and that enrollment in the OPERA‑01 monotherapy trial remains on track for top‑line results in the second half of 2026. Bohen also highlighted the expansion of OP‑3136 into combination cohorts as a “strategic move to broaden the drug’s clinical utility.”

Looking ahead, Olema’s cash balance of $329 million is expected to sustain operations through the next 12 months, providing a financial cushion for the upcoming OPERA‑01 top‑line data and the continued execution of the OPERA‑02 trial. The company’s focus on late‑stage clinical development, coupled with its strategic collaborations, positions it to potentially bring palazestrant to market as a backbone endocrine therapy, while OP‑3136 could open new indications beyond breast cancer.

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