earnings
confidence high
sentiment positive
materiality 0.75
Outlook Therapeutics reports Q2 FY2024 net loss of $114.3M; positive CHMP opinion for ONS-5010 in EU
Outlook Therapeutics, Inc.
2024-Q2 EPS reported
-$9.20
- Net loss of $114.3M ($8.01/sh); adjusted net loss of $22.1M ($1.55/sh) vs $6.7M loss year ago.
- CHMP issued positive opinion for ONS-5010/LYTENAVA in EU; EC decision expected within ~67 days.
- NORSE EIGHT trial >30% enrolled; topline readout planned in Q4 CY2024; BLA resubmission by end of CY2024.
- UK MAA submitted under International Recognition Procedure.
- Company believes sufficient capital to fund potential FDA approval and commercial launch assuming warrant exercise.