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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 (Nasdaq: OLMA) announces plans to present two posters on nonclinical data for OP-1250 at the American Association for Cancer Research (AACR) Annual Meeting from April 8-13, 2022. The first presentation focuses on transcriptional changes in ER+ breast cancer cell lines in response to OP-1250, while the second highlights its efficacy in preventing tumor spread in metastatic ERα+ breast cancer models. OP-1250 is currently undergoing clinical trials in patients with advanced ER-positive breast cancer.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) reported significant progress in clinical studies for OP-1250, targeting ER+ / HER2- breast cancer. Phase 1a data showed favorable pharmacokinetics and encouraging anti-tumor activity in heavily pretreated patients. Enrollment for Phase 1b expansion is on track for completion in Q1 2022, with a Phase 2 study set to begin in H1 2022. The company's financial position is strong, with $287.3 million in cash, sufficient to fund operations into 2024, despite a net loss of $71.1 million for 2021, reflecting increased R&D and G&A expenses.
Olema Pharmaceuticals (Nasdaq: OLMA) announced that CEO Sean P. Bohen will present a corporate overview at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 2:50 p.m. ET. The presentation can be accessed via a live webcast on Olema's website and will be archived for 14 days. Olema Oncology focuses on developing targeted therapies for women’s cancers, with their lead product candidate, OP-1250, currently in Phase 1/2 trials for treating ER-positive breast cancer.
Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) announced the grant of stock options for a total of 270,000 shares to two new employees, effective February 1, 2022. Dr. Naseem Zojwalla received an option for 250,000 shares as the new Chief Medical Officer, while another employee got 20,000 shares. These stock options are part of Olema's 2022 Inducement Plan, vesting over four years with the last reported share price at $7.02. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) to incentivize key hires.
Olema Oncology has appointed Dr. Naseem Zojwalla as Chief Medical Officer, succeeding Dr. Pamela Klein, who transitions to a senior advisory role. With over 15 years of oncology experience, Dr. Zojwalla will focus on advancing OP-1250, a promising therapeutic candidate for metastatic breast cancer, into Phase 2 trials. Dr. Bohen expressed confidence in Dr. Zojwalla's leadership during this critical phase, highlighting the significant potential of OP-1250 as a treatment option for women with breast cancer. The company aims to reshape standard care through innovative therapies.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 5:15 p.m. ET. The presentation will be led by President and CEO Sean P. Bohen, M.D., Ph.D. A live webcast can be accessed on Olema's website and will remain available for 14 days. Olema is a clinical-stage biopharmaceutical company focused on developing targeted therapies for women’s cancers, with its lead candidate, OP-1250, currently in a Phase 1/2 clinical trial for ER-positive breast cancer.
Olema Pharmaceuticals (Nasdaq: OLMA) reported promising results from the Phase 1 dose-escalation study of OP-1250, a novel treatment for metastatic breast cancer. Key findings included an overall response rate of 17% and a clinical benefit rate of 46% in patients on a recommended Phase 2 dose. Three partial responses were noted, with target lesions reduced by up to 100%. OP-1250 demonstrated favorable pharmacokinetics and tolerability. The company plans to advance into Phase 2 studies and combination trials in early 2022, bolstering its position in women’s cancer treatment.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) has issued a warning about falsified information circulating on social media regarding its planned poster presentation for the Phase 1 dose-escalation of OP-1250, part of an ongoing Phase 1/2 clinical trial at the San Antonio Breast Cancer Symposium. Olema clarifies that the unauthorized poster image was not released by the company. OP-1250 is being developed as a treatment for women with recurrent, locally advanced or metastatic ER-positive breast cancer.
Olema Pharmaceuticals (NASDAQ: OLMA) announced that it will present interim pharmacokinetic, safety, tolerability, and preliminary efficacy data for OP-1250, its investigational complete estrogen receptor antagonist, at the San Antonio Breast Cancer Symposium (SABCS) from December 7-10, 2021. The data, which will highlight OP-1250's potential in treating advanced or metastatic ER+/HER2- breast cancer, will be presented by experts on December 8 and 10. Additionally, an investor webcast will occur on December 8 at 8:30 a.m. ET, where Olema will review the Phase 1 clinical data for OP-1250.
Olema Pharmaceuticals (OLMA) announced the completion of the dose-escalation stage in its Phase 1/2 clinical trial for OP-1250, targeting metastatic, ER+/HER2- breast cancer. Interim data will be presented at the 2021 San Antonio Breast Cancer Symposium. The company plans to initiate a Phase 2 study and a Phase 1b trial with a CDK4/6 inhibitor in early 2022. Financially, Olema reported a Q3 net loss of $17.7 million, up from $7.8 million in 2020, with R&D expenses reaching $12.5 million, reflecting ongoing trial costs. Cash reserves total $306 million, sufficient until late 2023.
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