Outlook to Get Special Protocol Assessment for Study, Private Placement of Up to $172M

 

• Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010
• NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024
• Private placements to top tier institutional investors and insiders include up to $65 million in common stock and up to an additional $107 million upon cash exercise of warrants, subject to closing conditions
• Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch

https://www.globenewswire.com/news-release/2024/01/23/2814047/0/en/Outlook-Therapeutics-Receives-FDA-Agreement-Under-Special-Protocol-Assessment-SPA-for-90-Day-Non-Inferiority-Study-NORSE-EIGHT-and-Announces-Private-Placement-of-Up-to-172-Million-.html