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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.
Olema Pharmaceuticals (Nasdaq: OLMA) announced the grant of stock options to three new employees totaling 42,300 shares effective March 1, 2023. These stock options, approved by the Compensation Committee, are part of the 2022 Inducement Plan and vest over four years, with an exercise price of $4.01 per share. Olema is a clinical-stage biopharmaceutical company focused on targeted therapies for women’s cancers, notably their lead candidate OP-1250, which is under evaluation for ER+/HER2- breast cancer and has received FDA Fast Track designation.
Olema Pharmaceuticals, Nasdaq: OLMA, announced that CEO Sean Bohen will present at the Oppenheimer 33rd Annual Healthcare Conference on March 15, 2023, at 2:40 p.m. ET. A live webcast of this event will be accessible on Olema's investor relations website, and it will remain archived for 30 days. Olema focuses on developing targeted therapies for women's cancers, with its lead candidate OP-1250, an oral small molecule, currently in a Phase 2 trial for ER+/HER2- breast cancer. OP-1250 has received FDA Fast Track designation for patients who have not responded to prior endocrine therapy.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on women’s cancers, is set to present at two investor conferences. Sean Bohen, M.D., will engage in a fireside chat at Citi’s 2023 Virtual Oncology Leadership Summit on February 23, 2023, at 12:00 p.m. ET. Additionally, Shane Kovacs will participate in the Breast and Lung Cancer Corporate Panel at Cowen’s 43rd Annual Healthcare Conference on March 7, 2023, at 10:30 a.m. ET in Boston, MA. A live webcast of these events will be available on Olema’s Investor Relations website and archived for 30 days. Olema's lead candidate, OP-1250, is an FDA Fast Track designated drug for ER-positive breast cancer.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced on February 2, 2023, the grant of stock options to four new employees, totaling 97,200 shares of common stock. These options, part of the 2022 Inducement Plan, were approved by the Compensation Committee and are effective from February 1, 2023. The options will vest over four years, with an initial 25% vesting on the first anniversary and the remainder in equal monthly installments. The exercise price is set at $4.87 per share, matching the last reported sale price as of the grant date. Olema, focusing on targeted therapies for women’s cancers, is evaluating its lead candidate, OP-1250, in active clinical trials.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced on January 4, 2023, the granting of stock options to three new employees, totaling 54,400 shares. This decision, approved by the Compensation Committee, was effective January 3, 2023, as part of the 2022 Inducement Plan. The stock options will vest over four years, with 25% vesting after one year and the remainder in monthly installments. The options have a 10-year term with an exercise price of $2.64 per share, matching the last reported sale price on the grant date.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that CEO Sean Bohen will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 2:15 p.m. PT. The presentation will be available via a live webcast on Olema's Investor Relations website and archived for at least 30 days. Olema focuses on targeted therapies for women's cancers, with its lead candidate, OP-1250, currently in Phase 2 trials and granted FDA Fast Track designation. The company is headquartered in San Francisco.
Olema Pharmaceuticals announced favorable results from a Phase 1b study of OP-1250, a complete estrogen receptor antagonist, in combination with palbociclib for treating ER+/HER2- breast cancer. The study, presented at the 2022 San Antonio Breast Cancer Symposium, included 12 patients and demonstrated that the combination is well-tolerated with no dose-limiting toxicities or drug-drug interactions. OP-1250 exhibited a favorable pharmacokinetic profile, and a Phase 2 dose expansion is underway, with additional data expected in 2023.
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