Olema Pharmaceuticals, Inc. (OLMA), a clinical-stage biopharmaceutical company, Monday announced a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer. The company's shares were more than 10 percent up in pre-market.
Olema has also entered into a securities purchase agreement for the private placement of about $250 million of shares and pre-funded warrants with new and existing institutional and accredited investors. The private placement is expected to close by December 4, 2024.
As per the deal, Novartis will supply ribociclib for the Phase 3 OPERA-02 study of Olema's palazestrant in combination with ribociclib in frontline breast cancer. All clinical data and inventions from the study will be jointly owned while Olema maintains global commercial and marketing rights to palazestrant.
"We are now fully enabled to initiate our planned pivotal Phase 3 clinical trial, OPERA-02, for palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer. Our new agreement with Novartis, which includes sufficient ribociclib drug supply for the planned approximately 1,000 patient trial, is a major milestone. When combined with our Private Placement of $250.0 million of common stock and pre-funded warrants with high-quality, long-term investors, Olema now expects to have the necessary resources to execute OPERA-02, the Phase 1/2 study of OP-3136, and the ongoing Phase 3 OPERA-01 monotherapy trial," said Sean P. Bohen, President and Chief Executive Officer of Olema Oncology.
Olema stock had closed at $10.12 on Friday. It has traded in the range of $7.68 - $16.77 in the last 1 year.
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