Outlook Therapeutics Inc. (NASDAQ:OTLK) Secures $10 Million Funding To Support BLA For ONS-5010 In Wet AMD

Outlook Therapeutics Inc. (NASDAQ:OTLK) has announced the issuance of an unsecured promissory note of $10.2 million to an accredited investor for cash proceeds of $10 million. The company will use the proceeds for additional working capital and also paying off its existing demand notes.

Additional funding for working capital

Lawrence Kenyon, the CEO, President, and CFO of the company, said that the non-dilutive funding offers the company more flexibility. This, as Outlook Therapeutics, makes progress in the advancement of ONS-5010/LYTENAVA™ towards a Biologics Licence Application for wet age-related macular degeneration (AMD) in 2H 2021. Kenyon said that all the company’s planned clinical studies for wet AMD BLA have completed enrolment, and the focus is on advancing ONS-5010 towards vital data readout in mid next year. Outlook Therapeutics is also seeking to secure commercial partnerships for ONS-5010.

The promissory Note issued bears an interest rate of 7.5% per year and will mature on January 1, 2022. It includes an issue discount of $200,000 plus $20,000 for investor’s costs, fees as well as other transaction costs. The company will repay all or part of the Note at any time by settlement 105% of the outstanding balance elected for pre-payment.

Outlook completes enrolment in ONS-5010 study

Recently the company announced that it had finalized enrolment of its planned open-label NORSE THREE study evaluating ONS-5010. Outlook completed patient enrolment for the trial a month ahead of the 4-month planned enrolment schedule. The study enrolled 195 subjects with various retinal diseases for which an anti-VEGF drug is used as a therapeutic option. The diseases include wet age-related AMD, diabetic macular edema (DME) as well as branch retinal vein occlusion (BRVO); the subjects will receive three intravitreal (IVT) ONS-5010 doses monthly.

Data from the study will be used to support the company’s planned BLA submission for wet AMD to the  FDA in 2H 2021. The company’s Medical Advisor Mark Humayun said that the accelerated way the recruitment was finalized strengthens confidence that an approved ophthalmic bevacizumab formulation represents an unmet ophthalmic need.