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Olema Pharmaceuticals, Inc. (Nasdaq: OLMA), also known as Olema Oncology, is a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of targeted therapies for women's cancers. Headquartered in San Francisco with operations in Cambridge, Massachusetts, Olema is advancing a pipeline of novel therapies aimed at improving treatment options for women living with cancer. The core focus of the company centers on endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance.
Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). Palazestrant is currently in Phase 3 clinical trials under the OPERA-01 study for patients with recurrent, locally advanced, or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This innovative therapy has demonstrated significant potential by completely blocking ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer, showing anti-tumor efficacy, favorable pharmacokinetics, CNS penetration, and combinability with CDK4/6 inhibitors.
In addition to palazestrant, Olema is developing a potent KAT6 inhibitor (OP-3136), which addresses an epigenetic target implicated in breast cancer and other cancers. This compound has shown promise in preclinical studies and is expected to move into clinical trials by the end of 2024.
Olema's financial health remains robust, with cash, cash equivalents, and marketable securities totaling $249.0 million as of March 31, 2024. The company reported a net loss of $31.0 million for the first quarter of 2024, primarily driven by increased spending on research and clinical development activities. However, Olema continues to make significant strides in advancing its clinical programs, supported by experienced scientists, healthcare investors, and partnerships with innovative pharmaceutical companies.
Recent corporate highlights include the initiation of a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250, and the selection of a development candidate for the KAT6 program. Olema's commitment to transforming the standard of care for women's cancers is evident in its ongoing clinical studies and presentations at major oncology conferences such as the ESMO Breast Cancer Annual Congress.
For more information about Olema Pharmaceuticals, visit their website at www.olema.com.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on targeted therapies for women’s cancers, announced the participation of its President and CEO, Sean Bohen, in a panel discussion on “ER+/HER2- Breast Cancer” at the Canaccord Genuity 2023 Horizons in Oncology Virtual Conference. This event is scheduled for April 20, 2023, at 2:00 p.m. ET.
Olema's lead product candidate, OP-1250, is an innovative treatment designed as both a complete estrogen receptor antagonist and a selective estrogen receptor degrader. Currently in a Phase 2 clinical trial, OP-1250 is being assessed as a single agent and in combination with existing therapies for patients with recurrent advanced ER-positive, HER2-negative breast cancer. The FDA has granted it Fast Track designation for treating metastatic cases that have failed prior endocrine therapies.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced the grant of stock options to two new employees, totaling 11,800 shares, effective April 3, 2023. The options, part of the 2022 Inducement Plan, vest over four years, with 25% on the first anniversary and the remainder monthly for three years. The exercise price is set at $3.49, reflecting the last reported stock price. This move underscores Olema's commitment to attracting talent as it develops targeted therapies for women’s cancers, particularly the lead candidate, OP-1250, which is in Phase 2 trials for ER-positive breast cancer.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) reported significant progress in its lead program, OP-1250, with over 170 patients treated. The company is set to initiate its first pivotal Phase 3 trial of OP-1250 for metastatic breast cancer in the latter half of 2023. Financially, Olema held $204.4 million in cash as of December 31, 2022, sufficient to fund operations through 2025. However, the company reported a net loss of $26.2 million for Q4 and $104.8 million for the full year, driven by increased R&D spending. Organizational restructuring will reduce the workforce by 25% to focus on OP-1250’s late-stage development.
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