Outlook Therapeutics, Inc. (NASDAQ:OTLK) lost a whopping 9.09% in the last trading session to close at $1.20 on a volume of 205.0K shares. Here is hte latest buzz on the company.
Outlook Therapeutics has announced its business highlights and financial results for their Q1. For the quarter that ended in December 2018, the company reported a net loss of $9.9 million with a net loss for the whole FY2018 being $6.9 million.
Lawrence Kenyon the CEO and President indicated that they are approaching FY2019 with momentum as the company continues to execute its new strategy of pursuing a high-value opportunity with their ONS-5010 in the booming anti-VEGF ophthalmic market. Up to date, the Outlook Therapeutics has enrolled 75% of the patients required in the ONS-5010-001 clinical trial. It is the first of the two third phase ONS-5010 clinical trials in the wet AMD program.
The company expects the second wet AMP third phase study to commence enrolment of patients in New Zealand and Australia. There also plans to apply for Investigational New Drug designation to the Food and Drug Administration in the first quarter of 2019 which will allow the company to begin ONS-5010-002 patient enrolment. In previous trials, the product candidate met both the primary and secondary endpoints in the Pharmacokinetic phase 1 clinical study.
The company received an equity financing commitment from BioLexis in 2018 worth $20.0 million. They equally managed to restructured and extend the maturity of the senior notes that were to mature in December last year
In line with the IND expectation, the company had a meeting with the FDA in 2018 after the successful completion of the second phase. The ONS-5010-002 study intends to enroll at least 180 patients across the United States, New Zealand and Canada.
Outlook therapeutics indicates that if their ONS-5010 clinical program turns out to be successful, then it will support their plans of submitting a regulatory approval for commercialization in various markets. Once approved, ONS-5010 will potentially reduce associated risks resulting from off-label use of Avastin and other drugs. Currently, off-label use of Avastin contributes to over 50% of all wet AMD medicines across the United States.