Olema Oncology (OLMA), a clinical-stage biopharmaceutical company, on Monday announced a new clinical trial collaboration and supply agreement with Novartis (NVS) to advance its treatment for frontline metastatic breast cancer. The collaboration will support the pivotal Phase 3 OPERA-02 clinical trial, which will investigate the combination of Olema's investigational drug Palazestrant with Novartis' approved breast cancer drug Ribociclib in ER+/HER2- metastatic breast cancer. The trial is set to begin in mid-2025.
Additionally, Olema revealed a $250 million equity private placement with both new and existing investors.
The placement includes participation from prominent investors like Adage Capital Partners LP, Bain Capital Life Sciences, BVF Partners L.P., Driehaus Capital Management, and others.
The financing will help fund Olema's ongoing clinical programs, including the OPERA-02 trial, the Phase 1/2 study of OP-3136, and the Phase 3 OPERA-01 trial of palazestrant.
The Phase 3 OPERA-02 trial will be a large, multi-site study, and Novartis will provide ribociclib supply for the trial, which plans to enroll around 1,000 patients.
Olema will retain global commercial and marketing rights for palazestrant, while both companies will jointly own the clinical data and inventions from the trial.
The private placement, expected to close by December 4, 2024, includes the issuance of approximately 19.9 million shares of common stock at $9.08 per share, along with pre-funded warrants for an additional 7.6 million shares.
The financing ensures Olema has the resources to continue its clinical development and hit key milestones, including top-line data from OPERA-01 in 2026.
The company plans to present new data from the ongoing Phase 1b/2 study of palazestrant combined with ribociclib at the San Antonio Breast Cancer Symposium next week.
Olema's palazestrant is a promising oral small molecule under investigation for treating ER+/HER2- metastatic breast cancer. The compound has shown encouraging results in preclinical studies and has received Fast Track designation from the FDA.
With the new partnership and funding, Olema is well-positioned to advance its pipeline and drive progress in breast cancer treatment.
OLMA closed Friday's trading at $10.12. In premarket trading today, the stock is up by 17.49 % at $ 11.89.
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