Olema Pharmaceuticals, Inc.

Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing next-generation targeted therapies for breast cancer and related oncology indications. The company's website is www.olemapharma.com.

Olema's lead product candidate, palazestrant, is an orally-available small molecule designed to function as both a complete estrogen receptor antagonist and selective estrogen receptor degrader. The company is advancing palazestrant through late-stage clinical development for the treatment of estrogen receptor-positive, HER2-negative metastatic breast cancer in multiple settings. OPERA-01, a pivotal Phase 3 monotherapy trial in second and third-line patients, is expected to generate top-line results in fall 2026. OPERA-02, a Phase 3 trial evaluating palazestrant in combination with ribociclib for first-line metastatic breast cancer, initiated in 2025 and is expected to yield data in 2028. Palazestrant has been granted Fast Track designation by the FDA and has demonstrated favorable pharmacokinetics, tolerability, and combinability with cyclin-dependent kinase inhibitors across clinical studies involving more than 400 patients.

The company's second product candidate, OP-3136, is a novel oral small molecule targeting KAT6, an epigenetic regulator dysregulated in breast and other solid tumors. OP-3136 entered Phase 1 clinical development in late 2024 following FDA clearance of its investigational new drug application, with first clinical data anticipated in the second quarter of 2026.

Olema has established clinical collaboration and supply agreements with major pharmaceutical partners including Novartis and Pfizer to support its development programs. The company owns worldwide development and commercialization rights to both palazestrant and OP-3136. Since inception, Olema has devoted substantially all resources to research and development activities, non-clinical studies, clinical trials, and intellectual property development. The company has no approved products generating commercial revenue and relies on third parties for manufacturing of its product candidates.