Olema Oncology has announced that it has entered into a clinical trial collaboration and supply agreement with Novartis to initiate a pivotal phase 3 opera-02 clinical trial of palazestrant in combination with ribociclib in frontline ER+/HER2* metastatic breast cancer. The trial, expected to commence in mid-2025, will involve approximately 1,000 patients. This agreement includes sufficient ribociclib drug supply for the trial, and all clinical data and inventions from the trial will be jointly owned, while Olema maintains global commercial and marketing rights to palazestrant.
In addition, Olema has secured a $250.0 million equity private placement with participation from new and existing investors, including Adage Capital Partners LP, Bain Capital Life Sciences, BVF Partners L.P., Driehaus Capital Management, Janus Henderson Investors, Paradigm Biocapital Advisors, Wellington Management, Woodline Partners LP, and a large investment manager. This private placement is expected to close on or about December 4, 2024, and will provide Olema with the necessary resources to execute the opera-02 trial, the phase 1/2 study of OP-3136, and the ongoing phase 3 opera-01 monotherapy trial.
Under the terms of the securities purchase agreement, Olema will issue 19,928,875 shares of common stock at a purchase price of $9.08 per share and pre-funded warrants to purchase up to an aggregate of 7,604,163 shares of common stock at a purchase price of $9.0799 per pre-funded warrant. The net proceeds from the private placement, together with Olema's current cash, cash equivalents, and marketable securities, will be used to fund the opera-02 trial, the phase 1/2 study of OP-3136, and the ongoing phase 3 opera-01 monotherapy trial, as well as for working capital and general corporate purposes.
Moreover, Olema is set to present its latest data from the ongoing phase 1b/2 study of palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) next week, and remains on track to share topline data from opera-01 in 2026.
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as a complete estrogen receptor (ER) antagonist and selective ER degrader, currently being investigated in patients with recurrent, locally advanced, or metastatic ER-positive, HER2-negative breast cancer. It has been granted U.S. Food and Drug Administration (FDA) fast track designation for the treatment of ER+/HER2* metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor.
Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, with its lead product candidate, palazestrant (OP-1250), currently in a phase 3 clinical trial called opera-01. Today the company's shares have moved 2.7% to a price of $10.39. If you want to know more, read the company's complete 8-K report here.
