Outlook Therapeutics(US:OTLK)2026-02-17 13:30Financial Performance - For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported a net loss of $23.1 million, or $0.38 per share, compared to a net income of $17.4 million, or $0.72 per share for the same period last year [3]. - The adjusted net loss for the same quarter was $13.5 million, or $0.22 per share, an improvement from an adjusted net loss of $21.6 million, or $0.89 per share in the first fiscal quarter of 2025 [4]. - Total assets as of December 31, 2025, were $18.2 million, while current liabilities stood at $49.1 million [22]. - The loss from change in fair value of promissory notes for the quarter was $6.7 million, and the loss from change in fair value of warrant liability was $2.8 million [5]. Revenue and Sales - Revenue for the fiscal quarter was negatively impacted by an increase in the returns reserve for estimated product returns, but unit sales of LYTENAVA in Europe more than doubled compared to the previous quarter [7]. Product Development and Regulatory Matters - A Type A meeting request has been submitted to the U.S. FDA to discuss the Complete Response Letter regarding the Biologics License Application for ONS-5010 [9]. - The company believes the FDA's determination regarding the effectiveness of ONS-5010 is inconsistent with the totality of evidence submitted in the BLA [10]. - Outlook Therapeutics is committed to advancing ONS-5010 in the U.S. and is in ongoing discussions with the FDA regarding the path forward [10]. Expansion Plans - The company is expanding LYTENAVA in Europe, with planned launches in Ireland and the Netherlands in 2026, followed by France, Italy, and Spain in 2027 [2]. Cash Position - As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after that date [8].