Business
Olema Oncology Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Presented preliminary results from OP-1250 Phase 1/2 dose expansion study demonstrating favorable tolerability, high drug exposure, and strong anti-tumor
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"Presented preliminary results from OP-1250 Phase 1/2 dose expansion study demonstrating favorable tolerability, high drug exposure, and strong anti-tumor activity at the 34th EORTC-NCI-AACR SymposiumInitial clinical data for OP-1250 in combination with CDK 4/6 inhibitor, palbociclib, to be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS)First pivotal monotherapy Phase 3 study initiation planned for mid-2023Strong cash, cash equivalents and marketable securities position of $222.6 million as of September 30, 2022, sufficient to support execution of clinical, research and operational goals into the second half of 2024 SAN FRANCISCO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today reported third quarter financial results for the period ended September 30, 2022, and provided a business update. “On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer.” Recent Corporate Highlights Presented preliminary clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) in Barcelona, Spain.Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times ...