Outlook Therapeutics Reports Financial Results for Fiscal Year 2025

Core Insights - Outlook Therapeutics reported a net loss of $62.4 million for fiscal year 2025, an improvement from a net loss of $75.4 million in the previous year, with revenue of $1.4 million compared to no revenue in fiscal 2024 [2][17] - The company has initiated sales of LYTENAVA™ in Germany and the UK, with a positive trend in the number of accounts ordering the product and the breadth of prescribing clinicians [3][12] - The company is preparing for potential FDA approval of ONS-5010, with a goal date set for December 31, 2025 [7][8] Financial Performance - For the fiscal year ended September 30, 2025, Outlook Therapeutics reported a gross profit of $57,000, with total revenues of $1.4 million [2][17] - Operating expenses decreased by $4.6 million compared to fiscal 2024, primarily due to reduced R&D expenses following the completion of the NORSE Eight clinical trial [4][17] - As of September 30, 2025, the company had cash and cash equivalents of $8.1 million, not including $14.9 million from recent sales under its at-the-market offering program [5][19] Market and Product Development - LYTENAVA™ has been accepted into the tender framework in the UK, which is expected to enhance unit sales [3] - The company is actively pursuing commercial launch activities in the U.S. and expanding into additional European markets, including Austria and the Netherlands [6][12] - ONS-5010/LYTENAVA™ is an investigational product in the U.S. and requires pricing and reimbursement approval in certain EU member states before it can be sold [9][13]