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

Core Viewpoint - Outlook Therapeutics reported a net loss of $20.2 million for the third quarter of fiscal year 2025, with initial revenue from the sales of LYTENAVA™ in Germany and the UK, marking the company's transition into a commercial entity [2][6][16]. Financial Performance - For the fiscal third quarter ended June 30, 2025, the company reported a net loss attributable to common stockholders of $20.2 million, or $0.55 per share, with revenue of $1.5 million from initial sales of LYTENAVA™ [2][3]. - The adjusted net loss for the same period was $15.8 million, or $0.44 per share, compared to an adjusted net loss of $19.2 million, or $0.83 per share, for the third quarter of 2024 [3][4]. - As of June 30, 2025, the company had cash and cash equivalents of $8.9 million [5]. Product and Market Update - LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD), being the first authorized ophthalmic formulation of bevacizumab in the EU and UK [7][13]. - The FDA has set a PDUFA goal date of August 27, 2025, for ONS-5010, which is expected to receive 12 years of regulatory exclusivity if approved [6][11]. - The company has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals [9][10]. Clinical and Regulatory Developments - The resubmission of the Biologics License Application (BLA) for ONS-5010 was based on the efficacy and safety demonstrated in the NORSE EIGHT trial, with the FDA acknowledging the resubmission [11][12]. - The NORSE EIGHT trial evaluated ONS-5010 against ranibizumab, with a primary efficacy endpoint at 8 weeks [12]. Industry Context - Off-label repackaged bevacizumab is widely used in Europe and the U.S. for retinal diseases, with approximately 2.8 million and 2.7 million injections annually, respectively [8]. - ONS-5010/LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [8].