Outlook Therapeutics Inc (NASDAQ:OTLK) has announced financial results for its fiscal year ended September 30 and laid out plans for 2023 in an end-of-year letter.
“Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023,” CEO Russell Trenary III said. “We are driving our commercialization planning towards expected launch with the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023, and review of our MAA in the EU underway with a decision date expected in early 2024.”
ONS-5010/LYTENAVA (bevacizumab-vikg) is the first US Food & Drug Administration approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO.
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“We believe that ONS-5010 has the potential to be a game-changer for patients and physicians in the retina community, and we now have the necessary capital to support these efforts,” Trenary said. “We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space.”
As of September 30, the company had cash and equivalents of $17.4 million on hand. For the fiscal year, the company reported a net loss of $66.1 million, or $0.31 per share, compared to $53.2 million, or $0.35 per share, for fiscal 2021.
Looking ahead, the company expects to make continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023.
Additionally, Outlook has begun commercial launch planning, including partnerships with FUJIFILM Diosynth Biotechnologies for drug substance and with drug product manufacturer Aji Bio-pharma Services for the finished drug product, the company said.
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first US Food & Drug Administration (FDA) approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO.
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