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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 has moved OP-1250, a complete estrogen receptor antagonist and selective ER degrader, into Phase 2 clinical development for ER+/HER2- metastatic breast cancer. Phase 1b expansion results noted encouraging anti-tumor activity with 4 partial responses observed among 31 evaluable patients. 50 patients received treatment at two dose levels. The recommended Phase 2 dose is set at 120 mg once daily. Enrollment in Phase 2 includes distinct cohorts, and a pivotal trial is planned for mid-2023.
Olema Pharmaceuticals (Nasdaq: OLMA) announced that its CEO, Sean P. Bohen, will participate in a fireside chat at the Canaccord Genuity 42nd Annual Growth Conference on August 11, 2022, at 1:30 p.m. ET. A live webcast of the event will be available on Olema's website, where it will be archived for 14 days.
Olema is focused on developing targeted therapies for women’s cancers, with its lead candidate, OP-1250, currently in clinical trials for treating ER-positive, HER2-negative breast cancer.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced the grant of stock options to a new employee for 70,000 shares, effective August 1, 2022. This award, approved by the Compensation Committee, is part of the 2022 Inducement Plan. The options vest over four years, starting with 25% on the first anniversary and the rest in monthly installments. The exercise price is $4.95 per share, matching the stock's last reported sale price. Olema focuses on targeted therapies for women’s cancers, with its lead product, OP-1250, currently in clinical trials for ER-positive breast cancer.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced that the FDA granted Fast Track designation to its drug OP-1250, a novel oral complete estrogen receptor antagonist and selective ER degrader, for treating ER-positive, HER2-negative metastatic breast cancer. This designation aims to expedite development and review processes, allowing for closer communication with the FDA. OP-1250 is currently in a Phase 1/2 clinical trial and being evaluated in combination with palbociclib. Fast Track designation represents a significant milestone for Olema in addressing unmet medical needs in women's cancer treatments.
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) announced the grant of stock options to three new employees for a total of 32,000 shares, effective July 1, 2022. Approved by the Compensation Committee, the stock options are part of the 2022 Inducement Plan, vesting over four years with a 10-year term and an exercise price of $4.18 per share. The company aims to attract talent critical for its focus on developing targeted therapies for women's cancers, including its lead candidate, OP-1250, currently in clinical trials for treating ER-positive breast cancer.
Olema Pharmaceuticals reported promising clinical advancements for OP-1250, its compound targeting ER+ / HER2- breast cancer. The Phase 1b study demonstrated favorable tolerability with no grade 3/4 neutropenia and early anti-tumor activity. OP-1250's combinability with palbociclib was confirmed, showing no dose limiting toxicities. Olema plans a pivotal study for OP-1250 in 2023, aiming for continued enrollment in clinical trials through 2024. High enthusiasm from investigators contributed to rapid patient recruitment, reflecting confidence in the candidate's potential.
On June 9, 2022, Olema Pharmaceuticals (Nasdaq: OLMA) announced an exclusive global license agreement with Aurigene Discovery Technologies to develop small molecule inhibitors targeting an undisclosed oncology target. Olema will pay an upfront fee of $8 million, with Aurigene eligible for up to $60 million in clinical milestones and $370 million in commercial milestones. Olema aims to enhance its drug discovery portfolio while maintaining adequate funding for research and development through 2024. This collaboration underscores Olema's focus on cancer treatments for women, particularly with its lead candidate, OP-1250.
On June 2, 2022, Olema Pharmaceuticals granted stock options for 25,400 shares to two new employees under its 2022 Inducement Plan. The options have a grant date of June 1, 2022, with a $2.80 exercise price, matching the last reported sale price. Vested over four years, 25% will vest on the first anniversary, followed by monthly installments. This decision complies with Nasdaq Listing Rule 5635(c)(4). Olema, focused on innovative cancer therapies, is currently evaluating OP-1250 in clinical trials for ER+ breast cancer.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on women’s cancers, announced that CEO Sean P. Bohen will participate in a fireside chat at the Jefferies Healthcare Conference on June 9, 2022, at 8:30 a.m. ET. The event will be accessible through a live webcast on Olema’s website, which will remain available for 14 days post-event.
Olema’s lead candidate, OP-1250, is undergoing clinical trials for treating ER-positive, HER2-negative breast cancer.
Olema Pharmaceuticals (Nasdaq: OLMA) announced its Q1 2022 results, highlighting strong progress in clinical trials for its lead candidate, OP-1250. The Phase 1/2 trial continues to enroll patients, with the recommended Phase 2 dose expected by Q2 2022. The company has $267.9 million in cash, sufficient to fund operations into 2024. Despite a net loss of $23 million for the quarter—up from $15.3 million year-over-year—investments in OP-1250 are pivotal for growth. Olema plans to present updated clinical data later this year.
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