ONCY's bought deal to support 2 Phase 3 studies... upon the commencement of the Phase 3 study in metastatic breast cancer with pelareorep + paclitaxel a pre-negotiated payment of US$ 85 million will flow to ONCY as part of the deal with Adlai Nortye that gave AN exclusive rights to pelareorep in China and certain Chinese territories .
The announced US$15 million raise will give ONCY the firepower to initiate 2 Phase 3 studies in pancreatic and metastatic breast cancer.
Adlai Nortye has already received approval from the Chinese regulators to run a Phase 3 involving pelareorep and paclitaxel in mBC.
A Phase 3 in mBC will give ONCY the second trial in ER+/Her2- mBC that the FDA has sought to validate ONCY's first study that showed pelareorep + paclitaxel doubled patient survival nd which would accelerate the FDA's approval of pelareorep as a single agent in the treatment of this cancer that has an unmet medical treatment need.
The second Phase 3 study involves PanCan who intends to rapidly achieve approval for pelareorep in combination with atezolizumab + gemcitabine + chemotherapy for the treatment of early stage pancreatic cancer