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Mar 31, 2023
Outlook Therapeutics Q2 2023 Earnings Report
Outlook Therapeutics reported financial results for the second quarter of fiscal year 2023 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $6.7 million, or $0.03 per basic and diluted share, for the fiscal second quarter ended March 31, 2023. The company's cash and cash equivalents were $43.7 million as of March 31, 2023.
Continued to make significant progress in pre-launch activities with a PDUFA goal date set for August 29, 2023.
ONS-5010 Biologics License Application (BLA) was submitted and accepted for filing by the FDA as a 351(a) stand-alone BLA.
Commercial planning is underway to support potential approval of the first ophthalmic formulation of bevacizumab for use in retinal indications.
Submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022.
Forward Guidance
Outlook Therapeutics expects that its cash and cash equivalents will be sufficient to fund its operations through the anticipated approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through the fourth calendar quarter of 2023.
Historical Earnings Impact
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