Regulatory Approvals in the EU and UK
Outlook Therapeutics received marketing authorization for an ophthalmic formulation of bevacizumab for the treatment of retina diseases in the European Union and the United Kingdom.
NORSE EIGHT Clinical Trial Progress
NORSE EIGHT clinical trial in the U.S. is progressing well with 359 of the planned 400 subjects enrolled, with expected enrollment completion before the end of the third quarter.
Positive FDA Interactions
Completed Type C and D meetings with the FDA addressing open CMC items, indicating positive discussions and progress towards resubmitting the BLA in Q1 2025.
Strong Financial Position
Cash position of $32 million and expected $107 million from the exercise of warrants should support operations through calendar 2025.
Reduction in Convertible Notes
Outstanding convertible notes reduced to approximately $30.3 million, indicating improved financial health.