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Olema Appoints Jason O'Byrne as CFO
Olema (OLMA) announced the appointment of Jason O'Byrne as CFO. O'Byrne brings more than two decades of finance and global operations leadership across high-growth biotechnology and pharmaceutical organizations. He joins Olema from Vir Biotechnology (VIR), where he served as executive VP and CFO.
Olema Oncology Completes OPERA-01 Trial Enrollment, Expects Data in Q1 2027
"Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027," said Sean P. Bohen, President and Chief Executive Officer of Olema Oncology. "Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO, demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors."
Olema Pharmaceuticals Announces Clinical Trial Collaboration with Bayer
Olema Pharmaceuticals announced a clinical trial collaboration and supply agreement with Bayer AG (BAYRY) to evaluate OP-3136, Olema's investigational lysine acetyltransferase 6 inhibitor, in combination with Nubeqa, Bayer's androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer, mCRPC. The Phase 1b/2 study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of OP-3136 in combination with darolutamide in approximately 36 patients with mCRPC. Under the terms of the agreement, Bayer will supply darolutamide for use in the Phase 1b/2 study and Olema will lead the conduct of the study. All clinical data and inventions related to the combined use of OP-3136 and darolutamide will be jointly owned. Olema will maintain full global commercial and marketing rights to OP-3136.
Olema Oncology Anticipates OPERA-01 Trial Data Release
"We continued to meaningfully advance our pipeline of novel therapies focused on transforming the metastatic breast cancer treatment paradigm during the first quarter, with top-line data from our Phase 3 OPERA-01 trial of palazestrant as a monotherapy expected this fall and initial Phase 1 clinical data for OP-3136 being presented at ASCO later this month," said Sean P. Bohen, President and Chief Executive Officer of Olema Oncology. "We continued patient enrollment in OPERA-02, our Phase 3 trial of palazestrant in combination with ribociclib in the frontline metastatic setting, while advancing our ongoing Phase 1/2 combination studies evaluating palazestrant as a potential combination endocrine therapy of choice for metastatic breast cancer. With important clinical data catalysts on the horizon this year, we believe that we are well-positioned to continue our transformation into a fully integrated oncology company with our first anticipated commercial launch next year."
Olema Oncology Raises $218.5 Million in Public Offering
"2025 was a year of strong execution across the business as we advanced palazestrant as a differentiated endocrine therapy across multiple regimens, highlighted by continued enrollment and strong investigator interest in our OPERA-01 and OPERA-02 trials," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our earlier-phase combination studies with palazestrant continue to advance and we are pleased to have initiated a Phase 1b/2 study with atirmociclib in collaboration with Pfizer, further demonstrating palazestrant's potential as the combination endocrine therapy of choice in the metastatic setting. In November, we strengthened our balance sheet through a public offering that generated gross proceeds of approximately $218.5 million, enabling us to fund operations through numerous expected value-creating events with palazestrant. With initial clinical results from OP-3136 anticipated in Q2 2026, top-line data from OPERA-01 expected in the fall of this year, and commercial launch preparations underway for a potential approval in late 2027, we are entering an exciting chapter in Olema's history. We remain focused on transforming the metastatic breast cancer treatment paradigm and delivering meaningful new treatment options to patients living with breast cancer and beyond."
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