Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said.
ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
A key highlight for New Jersey-based Outlook during the the three-month period ended March 31, 2022 was the successful submission of a Biologics License Application (BLA) to the US Food and Drug Administration for ONS-5010.
READ: Outlook Therapeutics says its COO to talk wet AMD drug Lytenava at World Retina Conference this week
A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.
Outlook CEO Russell Trenary called the BLA submission “the most important milestone to date” in a statement accompanying the firm’s 1Q results.
“In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States, we are ramping up our pre-commercial launch activities,” Trenary told investors.
“To support these efforts, we have continued to add to the expertise of our commercial team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential of ONS-5010.”
CFO Lawrence Kenyon added that the group believes it has “charted a path” that would allow Outlook to launch Lytenava without the need to raise significant additional capital.
"We have successfully accessed capital via our ATM program and plan to continue using this financing option, subject to market conditions. Also, we have initiated discussions with the holders of our unsecured notes to extend the maturity of these notes until 2024 after we begin generating revenue from Lytenava, if approved,” Kenyon said.
READ: Outlook Therapeutics is bringing a treatment for retinal disease to the market at the right time
Outlook said it has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product, in anticipation of potential FDA marketing approval in early 2023. The company also is actively building out its distribution and commercial team structures, it added.
For the fiscal second quarter ended March 31, 2022, Outlook reported a net loss attributable to common stockholders of $19.7 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, for the same period last year.
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