Outlook Therapeutics Inc (NASDAQ:OTLK) announced that it has ended its first quarter of fiscal 2023 with cash and equivalents of $52.3 million as of December 31, 2022, which the company says is expected to provide sufficient capital to support operations past the anticipated US Food & Drug Administration (FDA) approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023.
The biopharmaceutical firm also noted that pre-launch commercial activities are underway as the company advances toward the FDA Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023, for ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration (wet AMD).
“With the accepted FDA filing of our BLA (Biologics License Application) 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, we are well on our way toward our goal of becoming a commercial-stage company,” Outlook Therapeutics CEO Russell Trenary said in a statement.
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“Looking ahead, we remain focused on execution and positioning ourselves for a commercial launch of ONS-5010 to enhance the standard of care in the retinal anti-VEGF (vascular endothelial growth factor) space,” Trenary added.
Outlook Therapeutics said its commercial launch planning has included best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for the finished drug product.
The company added that to bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians, and payors – it has also been in collaborative discussions with payors and the retina community.
As well, Outlook stated it is developing registration documents on a parallel path for approvals in Europe and submitted them in December 2022, noting that the formal review process of the Marketing Authorization Application (MAA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in early 2024.
The company recorded a 1Q net loss attributable to common stockholders of $18.7 million, or $0.08 per basic and diluted share, compared to a net loss attributable to common stockholders of $14.5 million, or $0.08 per basic and diluted share, during the same period last year.
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO.
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