Core Insights - Olema Pharmaceuticals has appointed Shawnte M. Mitchell as Chief Legal Officer and Corporate Secretary, bringing extensive experience in the biotechnology industry [1][2] - The company is focused on advancing its late-stage palazestrant programs and OP-3136 KAT6 program through clinical development [2][3] - Olema is committed to transforming the standard of care for breast cancer patients with a pipeline of novel therapies [3] Company Overview - Olema Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of targeted therapies for breast cancer and other conditions [1][3] - The lead product candidate, palazestrant (OP-1250), is currently in a Phase 3 clinical trial called OPERA-01, and the company is also developing a potent KAT6 inhibitor (OP-3136) [3] Leadership Background - Shawnte M. Mitchell has 20 years of experience in the healthcare and life sciences sectors, previously serving as Chief Legal Officer at Genomatica and holding senior legal positions at Zogenix and Aptevo Therapeutics [2] - Ms. Mitchell's expertise includes regulatory, commercial, intellectual property, and business development matters, which will support Olema's strategic priorities [2]

Core Insights - Olema Pharmaceuticals is set to present new data from the Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS 2024) from December 10-13, 2024 [1] Company Overview - Olema Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing targeted therapies for breast cancer and other conditions [1][5] - The company is advancing a pipeline of novel therapies, including palazestrant (OP-1250), which is currently in a Phase 3 clinical trial called OPERA-01 [5] Product Information - Palazestrant (OP-1250) is a novel orally available small molecule that acts as both a complete estrogen receptor antagonist and a selective estrogen receptor degrader [4] - It is being investigated for its efficacy in patients with recurrent, locally advanced, or metastatic ER-positive, HER2-negative breast cancer [4] - The drug has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after one or more lines of endocrine therapy [4] Clinical Study Details - The upcoming presentation will focus on a Phase 1b/2 study of palazestrant in combination with ribociclib for patients with advanced or metastatic ER+/HER2- breast cancer [2] - The poster session is scheduled for December 11, 2024, from 5:30 to 7:00 p.m. CT [2] Investor Engagement - Olema will hold a conference call on December 10, 2024, at 8:00 a.m. ET to discuss the new data with the investment community [3]

Financial Reporting and Disclosure - Olema Pharmaceuticals reported financial results for the quarter ended September 30, 2024 [5] - The press release detailing the financial results was dated November 12, 2024 [4] - The financial results are included in Exhibit 99.1, which is incorporated by reference [5] - The information in Item 2.02, including the press release, is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 [6] Executive Signatory - The report was signed by Shane Kovacs, Chief Operating and Financial Officer, on November 12, 2024 [8]

Presented compelling new preclinical data demonstrating anti-tumor activity for OP-3136, a novel KAT6 inhibitor, with enhanced activity of palazestrant combinations at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) New clinical data for palazestrant (OP-1250) in combination with ribociclib to be presented at the San Antonio Breast Cancer Symposium (SABCS) in DecemberIND submission for OP-3136 expected before year end; clinical study to initiate early 2025Cash, cash equivale ...

SAN FRANCISCO, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced that its management team will participate in the following upcoming investor conferences: Jefferies London Healthcare ConferenceDate: Wednesday, November 20, 2024, at 1:30 p.m. GMT (8:30 a.m. ET)Location: London, UKForma ...

OP-3136, a potent KAT6 inhibitor, demonstrated robust anti-tumor activity as a single agent, as well as synergy and enhanced anti-tumor activity in combination with palazestrant; IND submission expected before year endPalazestrant demonstrated combinability and enhanced tumor suppression with both everolimus and capivasertib SAN FRANCISCO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the disco ...

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SAN FRANCISCO, May 28, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women's cancers, today announced that its management team will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference Date: Wednesday, June 5, 2024, at 2:00 p.m. ET Location: Marriott Marquis in New York, NY Format: Fir ...

SAN FRANCISCO, May 28, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women's cancers, today announced that its management team will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference Date: Wednesday, June 5, 2024, at 2:00 p.m. ET Location: Marriott Marquis in New York, NY Format: Fir ...

Core Insights - Olema Pharmaceuticals announced interim results from a Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with ribociclib for treating ER+/HER2- metastatic breast cancer, with results to be presented at the 2024 ESMO Breast Cancer Annual Congress [1][2] Enrollment and Study Design - As of March 13, 2024, 50 patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer were treated, with 74% being 2nd/3rd line+ and 70% having prior CDK4/6 inhibitors [3] - The study is fully enrolled with a total of 60 patients [3] Pharmacokinetics and Safety - Palazestrant showed high oral bioavailability, a half-life of eight days, and was well tolerated with no new safety signals [4][5] - The combination treatment had an 85% clinical benefit rate (CBR) across all eligible patients, indicating promising preliminary efficacy [4][5] Efficacy Results - The CBR was 83% in ESR1-mutant patients and 86% in ESR1-wild-type patients, with partial responses observed in five patients [5][8] - 66% of patients remained on treatment as of the data cut-off, with the longest duration on treatment being 44 weeks [8] Company Overview - Olema Oncology is focused on transforming the standard of care for women with cancer, advancing a pipeline of novel therapies including palazestrant, which has received FDA Fast Track designation [11][12]