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Olema Oncology Reports Second Quarter 2023 Financial Results and Provides Corporate Update
Initiation of OPERA-01 pivotal Phase 3 monotherapy clinical trial on track; expecting to enroll first patient in fourth quarterNew clinical data for
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"Initiation of OPERA-01 pivotal Phase 3 monotherapy clinical trial on track; expecting to enroll first patient in fourth quarterNew clinical data for palazestrant (OP-1250) to be presented in the fourth quarter including both monotherapy and CDK4/6 inhibitor combination updatesCash, cash equivalents and marketable securities of $167.4 million as of June 30, 2023, expected to fund operations into the second quarter of 2025 SAN FRANCISCO, Aug. 08, 2023 (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 reported financial results for the second quarter ended June 30, 2023, and provided a corporate update. “Olema is on track to deliver on significant milestones this year, including initiating our first pivotal Phase 3 trial, OPERA-01, which will test palazestrant (OP-1250) as a monotherapy in the second- and third-line metastatic setting, as well as presenting new data from our ongoing monotherapy and combination clinical studies,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We are actively engaged in start-up activities for our OPERA-01 Phase 3 clinical trial, with enrollment expected to begin in the fourth quarter. Among other upcoming milestones, we look forward to presenting our mature Phase 2 monotherapy data as part of an oral presentation at the ESMO Congress in Madrid in October. Our goal with palazestrant remains to significantly improve upon current standard-of-care endocrine therapy as the backbone treatment for metastatic breast cancer.” Recent Corporate Highlights Presented interim Phase 1b/2 clinical study results of palazestrant in combination with a CDK4/6 inhibitor (palbociclib) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress in Berlin, Germany. Results demonstrated no dose-limiting toxicities and no observed drug-drug interaction, with an overall tolerability profile of the combination consistent with the FDA-approved label of palbociclib plus an endocrine agent.Presented trials-in-progress poster from the ongoing Phase 1b/2 dose escalation and dose expansion study of palazestrant in combination with CDK4/6 inhibitor, ribociclib, or PI3Ka inhi...