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Jun 30, 2020
Outlook Therapeutics Q3 2020 Earnings Report
Reported financial results for the third quarter of fiscal year 2020.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $3.0 million, or $0.03 per basic and diluted share, for the fiscal third quarter ended June 30, 2020. The company had cash and cash equivalents of $24.0 million at June 30, 2020.
Successfully completed two strategic financings during the last quarter.
Continued to achieve important clinical milestones.
On track to report topline safety and efficacy results from NORSE 1 study in wet AMD.
Completed patient enrollment in NORSE 2 clinical trial in July 2020.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics expects to report pivotal safety and efficacy data in the third calendar quarter of 2021 and intends to complete development of ONS-5010 for submission to the FDA.
Positive Outlook
- Topline safety and efficacy results from NORSE 1 study expected soon.
- Pivotal safety and efficacy data from NORSE 2 expected in Q3 2021.
- NORSE 3 open-label safety study will provide additional safety exposure data.
- Received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials.
- Plans to submit for regulatory approvals in Europe, the United Kingdom and Japan.
Challenges Ahead
- Developing pharmaceutical product candidates is subject to risks.
- Conducting clinical trials is subject to risks.
- Obtaining necessary regulatory approvals is subject to risks.
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
- May cause actual results to differ materially from those expressed or implied by forward-looking statements.