Outlook Therapeutics(US:OTLK) Globenewswire·2026-02-17 13:05Core Insights - Outlook Therapeutics reported a significant net loss of $23.1 million for the first fiscal quarter of 2026, a stark contrast to a net income of $17.4 million in the same period last year, indicating a challenging financial environment for the company [3][20]. - The company is experiencing increasing adoption of its product LYTENAVA™ (bevacizumab gamma) in Europe, with plans for further market expansion in 2026 and 2027 [2][9]. - Outlook Therapeutics is actively engaging with the FDA regarding its investigational product ONS-5010, following a Complete Response Letter that requested additional confirmatory evidence [8][10]. Financial Performance - For the fiscal first quarter ended December 31, 2025, the adjusted net loss attributable to common stockholders was $13.5 million, an improvement from an adjusted net loss of $21.6 million in the same quarter of the previous year [4][24]. - Revenue was negatively impacted by an increase in returns reserve due to short-dated products shipped to support the launch of LYTENAVA in Europe, although unit sales more than doubled compared to the previous quarter [6][20]. - As of December 31, 2025, the company had cash and cash equivalents of $8.7 million, which does not include additional proceeds from its at-the-market offering program [7][23]. Product Development and Regulatory Updates - The company is planning to launch LYTENAVA in additional EU markets, including Ireland and the Netherlands in 2026, followed by France, Italy, and Spain in 2027 [2][9]. - A Type A meeting has been requested with the FDA to discuss the Complete Response Letter regarding ONS-5010, with the company expressing confidence in the evidence submitted for its Biologics License Application [8][10]. - ONS-5010/LYTENAVA™ is positioned as a potential first approved ophthalmic formulation of bevacizumab for retinal indications in the U.S. if regulatory approval is granted [15].