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Sep 30, 2020
Outlook Therapeutics Q4 2020 Earnings Report
Announced corporate highlights and financial results for the fiscal year ended September 30, 2020.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $48.9 million, or $0.67 per basic and diluted share, compared to a net loss attributable to common stockholders of $36.0 million for the prior fiscal year.
Completed patient enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in July 2020.
Completed enrollment of 195 subjects with a range of retinal diseases for its open-label safety study (NORSE THREE) in November 2020.
Received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials.
Commercial launch planning for ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement, remains ongoing.
Forward Guidance
Outlook Therapeutics is focused on completing the Phase 3 study and data readout in Q3 2021, followed by BLA submission. They are also engaged with regulatory authorities in Europe and planning registration clinical trials for DME and BRVO later in 2021.
Positive Outlook
- Successful completion and data readout for the pivotal Phase 3 study in the third calendar quarter of 2021.
- Planned BLA submission.
- Engaged with regulatory authorities in Europe for anticipated submissions in those markets.
- Planning to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.
Challenges Ahead
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
Historical Earnings Impact
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