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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 its participation in several investor conferences this November. Key events include a presentation at the Credit Suisse 31st Annual Healthcare Conference on November 9 at 9:10 AM PT, a fireside chat at the Jefferies London Healthcare Conference on November 16 at 11:30 AM GMT, and a virtual fireside chat at the Evercore ISI HealthCONx Conference on November 29 at 2:40 PM ET. Live webcasts and materials will be accessible on Olema's website for at least 30 days.
Olema focuses on developing targeted therapies for women’s cancers, highlighted by its lead product candidate, OP-1250.
Olema Pharmaceuticals (Nasdaq: OLMA) announced preliminary Phase 1/2 clinical results for OP-1250, a treatment for metastatic breast cancer, showcased at the 34th EORTC-NCI-AACR Symposium. The study involved 68 patients, revealing OP-1250's favorable tolerability, with drug exposure 20 times higher than fulvestrant at the effective dose. Strong anti-tumor activity was noted, with 41% of patients showing tumor reduction. The company plans to initiate a pivotal Phase 3 study mid-2023, aiming to advance OP-1250 as a leading endocrine therapy for ER+ breast cancer.
Olema Pharmaceuticals (Nasdaq: OLMA) announced the presentation of updated clinical results from the OP-1250-001 study at the 34th EORTC-NCI-AACR Symposium in Barcelona, occurring October 26-28, 2022. The study focuses on OP-1250, an oral compound for advanced ER-positive, HER2-negative breast cancer, with preliminary Phase 1/2 results to be showcased. A dedicated investor webcast is scheduled for October 26, 2022, at 8:00 a.m. ET, led by Dr. Erika Hamilton and Olema's management.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the grant of stock options totaling 58,300 shares to four new employees, effective October 3, 2022. These options were approved by the Board’s Compensation Committee under the 2022 Inducement Plan, with a 10-year term and an exercise price of $2.91 per share. The options vest over four years, with 25% vesting on the first anniversary and the rest in monthly installments. This move aligns with Nasdaq Listing Rule 5635(c)(4) and underscores Olema's commitment to attracting talent in the competitive biotech landscape.
Olema Pharmaceuticals (Nasdaq: OLMA) announced that Shane Kovacs, COO and CFO, will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 2:30 p.m. ET. A live webcast of the chat will be available on Olema's website and archived for 14 days. Olema, focused on therapies for women's cancers, is advancing its lead product candidate, OP-1250, an estrogen receptor antagonist and degrader, in clinical trials for ER-positive breast cancer.
Olema Pharmaceuticals, a clinical-stage biopharmaceutical company focused on targeted therapies for women's cancers, has announced the granting of stock options to three new employees. Effective September 1, 2022, a total of 72,200 shares will be available for purchase at an exercise price of $3.69 per share, equivalent to the last reported sale price on that date. The stock options will vest over four years, with 25% vesting after one year and the remainder in monthly installments, contingent on continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4).
Olema Pharmaceuticals has received Fast Track designation from the FDA for OP-1250, targeting ER+/HER2- metastatic breast cancer.
The company reported a strong cash position of $240.7 million as of June 30, 2022, sufficient to support operations until the second half of 2024.
Despite a net loss of $32.9 million in Q2 2022, up from $16.4 million the previous year, Olema continues to advance its clinical development program, having selected a recommended Phase 2 dose of 120 mg for OP-1250.
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.
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