Core Viewpoint - Outlook Therapeutics has received acceptance from the Scottish Medicines Consortium (SMC) for LYTENAVA™ (bevacizumab gamma) to be used in NHS Scotland for treating wet age-related macular degeneration (wet AMD), marking a significant milestone for the company and enhancing treatment options for patients in Scotland [1][2]. Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to improve the standard of care for retinal diseases [7]. - LYTENAVA™ is the first licensed ophthalmic formulation of bevacizumab for treating wet AMD in the UK, with an initial 10 years of market exclusivity from the date of marketing authorization [1][4]. Clinical Development - The SMC recommendation was based on results from the company's clinical program for ONS-5010/LYTENAVA™, which includes three completed registration clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE [2]. - The product is currently commercially available in the UK for wet AMD treatment [2]. Strategic Collaborations - Outlook Therapeutics has formed a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [3]. Regulatory Status - LYTENAVA™ has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for treating wet AMD [4]. - In the United States, ONS-5010/LYTENAVA™ is still investigational, with a Biologics License Application (BLA) resubmitted to the FDA [8].

Core Viewpoint - Outlook Therapeutics has launched LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in Germany and the UK, marking a significant milestone as it is the first and only authorized ophthalmic formulation of bevacizumab for this condition in the European Union and UK [1][5][9] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ to enhance the standard of care for retinal diseases [8] - The company has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for LYTENAVA™ [5][8] Product Launch and Market Strategy - The commercial launch of LYTENAVA™ in Germany and the UK is supported by a strategic collaboration with Cencora to facilitate market access and distribution [4] - The company aims to ensure success in these markets and is preparing for additional launches across Europe later in 2025 and throughout 2026 [2] Market Context - Off-label repackaged bevacizumab is widely used in Europe and the US, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [3] - LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, and a Biologics License Application (BLA) has been resubmitted to the FDA [6][8] - In certain EU member states, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold [6]

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]