Outlook Therapeutics receives FDA SPA agreement for NORSE EIGHT trial; announces up to $172M private placement
Outlook Therapeutics, Inc.
- FDA agreed under SPA to NORSE EIGHT non-inferiority trial (~400 wet AMD subjects); primary endpoint BCVA change at 8 weeks.
- Private placement of up to $60M in common stock plus warrants for up to $99M additional proceeds upon cash exercise.
- Existing note amended: maturity extended to July 1, 2025; conversion price reduction on $15M principal tied to qualified offering.
- Closing conditioned on stockholder approval of share increase, reverse split, and Nasdaq Rule 5635(d) approval; expected Q1 2024.
- Proceeds to fund NORSE EIGHT, other ONS-5010 development, working capital; BLA resubmission targeted by end of CY2024.