Outlook Therapeutics (NASDAQ:OTLK) Inc said it ended the fiscal third quarter with $26 million in cash and cash equivalents that are expected to fund its work into the first calendar quarter of 2023, including advancing the company's ophthalmic formulation of bevacizumab towards US Food and Drug Administration (FDA) approval.
In reporting its financial results for the three months ended June 30, 2022, the company highlighted a number of recent corporate milestones, including confirming its plans to re-submit a Biologics License Application (BLA) for ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD) to the US FDA by September 2022.
Outlook Therapeutics CEO Russell Trenary said the company had received invaluable line-of-sight related to the additional requirements for a successful ONS-5010 BLA re-submission following feedback from the FDA.
READ: Outlook Therapeutics confirms BLA re-submission date for its ONS-5010 wet AMD treatment
“Additionally, we continue to position ourselves operationally and financially for the potential FDA approval and subsequent launch of ONS-5010,” he said. “Our confidence in its potential remains unwavering," Trenary added.
He noted that if approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, avoiding the public health risk to patients of off-label treatment of bevacizumab.
“We believe there is value in achieving the strict safety and efficacy requirements associated with an FDA approval, and we expect to meet these standards,” Trenary said.
The company also highlighted the full cash pre-payment of its $12.3 million unsecured convertible promissory note dated November 4, 2020, as amended on November 16, 2021.
For fiscal 3Q, the company reported a net loss of $17.5 million or $0.08 per share, compared to a net loss of $12.2 million or $0.07 per share for the same period last year.
Outlook Therapeutics is working to develop and launch ONS-5010, a treatment for wet AMD and other retinal diseases.
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