Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update

Core Insights - Outlook Therapeutics is on track to transition into a commercial-stage company with the planned launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK for wet AMD treatment in Q2 2025 [2][3] - The company anticipates potential FDA approval for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in the US by August 27, 2025, which would provide a much-needed approved ophthalmic formulation of bevacizumab [2][6] Financial Performance - For the fiscal second quarter ended March 31, 2025, the company reported a net loss of $46.4 million, or$1.50 per share, a significant reduction from a net loss of $114.3 million, or$8.01 per share, in the same period last year [10][26] - The adjusted net loss for the same period was $12.5 million, or$0.40 per share, compared to an adjusted net loss of $22.1 million, or$1.55 per share, for the fiscal second quarter of 2024 [10][11] Product Development and Regulatory Updates - LYTENAVA™ (bevacizumab gamma) is the first authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and UK, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [4][16] - The FDA has acknowledged the resubmission of the Biologics License Application (BLA) for ONS-5010, which is undergoing a Class 2 review with a six-month review period [6][9] Market Strategy and Collaborations - Outlook Therapeutics has entered a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [5][16] - The company is also exploring authorization in additional European countries and Japan, indicating a broader market strategy [5]