earnings
confidence high
sentiment neutral
materiality 0.85
Outlook Therapeutics reports Q3 net loss $20.7M; reiterates Aug 29 PDUFA for ONS-5010
Outlook Therapeutics, Inc.
2023-Q3 EPS reported
-$0.19
- Net loss attributable to common stockholders of $20.7M ($0.08/share) vs $17.5M in prior-year quarter.
- Cash and cash equivalents of $33.7M expected to fund operations through potential BLA approval in Q3 2023.
- FDA PDUFA goal date of August 29, 2023 for ONS-5010 (ophthalmic bevacizumab) for wet AMD.
- Pre-launch activities ongoing with AmerisourceBergen distribution partnership for U.S. launch.
- MAA decision from EMA CHMP for ONS-5010 in EU expected in first half of 2024.