Outlook Therapeutics Inc
NASDAQ:OTLK
Outlook Therapeutics Inc
Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. The company is headquartered in Iselin, New Jersey and currently employs 9 full-time employees. The company went IPO on 2016-06-13. The firm focuses on developing and commercializing ONS-5010 (LYTENAVA (bevacizumab-vikg)), an ophthalmic formulation of bevacizumab for use in retinal indications. ONS-5010, is the Company's product candidate, which is developed to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb), that inhibits VEGF and associated angiogenic activity. Its clinical program for ONS-5010 in wet AMD involves three clinical trials, which includes NORSE ONE, NORSE TWO and NORSE THREE. Outlook sells ONS-5010 in the United States, United Kingdom, Europe, Japan and other markets for the treatment of wet AMD, diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).
Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. The company is headquartered in Iselin, New Jersey and currently employs 9 full-time employees. The company went IPO on 2016-06-13. The firm focuses on developing and commercializing ONS-5010 (LYTENAVA (bevacizumab-vikg)), an ophthalmic formulation of bevacizumab for use in retinal indications. ONS-5010, is the Company's product candidate, which is developed to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb), that inhibits VEGF and associated angiogenic activity. Its clinical program for ONS-5010 in wet AMD involves three clinical trials, which includes NORSE ONE, NORSE TWO and NORSE THREE. Outlook sells ONS-5010 in the United States, United Kingdom, Europe, Japan and other markets for the treatment of wet AMD, diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).
EU/UK Approval: Outlook Therapeutics received marketing authorization for its ophthalmic bevacizumab in both the European Union and the United Kingdom.
US Progress: Enrollment in the NORSE EIGHT clinical trial is on track, with 359 of 400 subjects enrolled and completion expected by the end of Q3.
BLA Resubmission Timing: Top line NORSE EIGHT results are expected in Q4 2024, with BLA resubmission to the FDA planned for the first quarter of 2025.
Financial Position: Cash of $32 million as of June 30, 2024, plus potential $107 million from warrant exercises, should support operations through 2025.
R&D and G&A Expenses: R&D expenses decreased quarter-over-quarter after most NORSE EIGHT initiation costs, while G&A rose due to European prelaunch activities.
Inventory Ready: Product inventory built for prior FDA approval now being used for European launch, with shelf life being extended.
Market Access Efforts: Active work ongoing with health technology assessment agencies and payers in Europe, including NICE in the UK.
