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Sep 30, 2023
Outlook Therapeutics Q4 2023 Earnings Report
Announced financial results for fiscal year 2023 and reiterated ONS-5010 clinical and regulatory path forward.
Key Takeaways
Outlook Therapeutics reported its financial results for the fiscal year ended September 30, 2023, with a net loss attributable to common stockholders of $59.0 million and cash and cash equivalents of $23.4 million.
Outlook Therapeutics is working with the FDA to design and undertake an additional clinical study for ONS-5010.
The FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study.
The FDA has already provided written feedback on the protocol, which Outlook Therapeutics has incorporated.
The formal review process of the MAA by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024.
Forward Guidance
Outlook Therapeutics is focused on the regulatory approval and potential commercial launch of ONS-5010, while also exploring strategic partnerships and expanded relationships to support its launch in international markets.
Positive Outlook
- Potential FDA approval of ONS-5010 as the first ophthalmic formulation of bevacizumab.
- Ongoing discussions with the FDA regarding the design of a clinical study for ONS-5010.
- Estimated decision date expected in the first half of 2024 regarding the formal review process of the MAA by the European Medicines Agency (EMA).
- Exploring potential expanded relationships with Cencora to support the launch of ONS-5010 in international markets.
- Strategic partnership with Syntone Biopharma JV in China.
Challenges Ahead
- Uncertainty regarding the timing and outcome of discussions with the FDA.
- Risks associated with conducting clinical trials and obtaining regulatory approvals.
- Uncertainty of future impacts related to macroeconomic factors.
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