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Dec 31, 2020
Outlook Therapeutics Q1 2021 Earnings Report
Outlook Therapeutics reported financial results for Q1 2021 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $14.5 million, or $0.12 per basic and diluted share, and had cash and cash equivalents of $5.6 million at the end of the quarter.
Net loss attributable to common stockholders was $14.5 million, or $0.12 per basic and diluted share.
Adjusted net loss attributable to common stockholders was $13.7 million, or $0.11 per basic and diluted share.
Cash and cash equivalents were $5.6 million at December 31, 2020.
Completed patient enrollment in its pivotal Phase 3 (NORSE TWO) 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 plans to submit a new BLA filing to the FDA in the fourth quarter of calendar 2021.
Positive Outlook
- Pivotal safety and efficacy data from NORSE TWO expected in Q3 2021.
- Data from open-label safety study expected in Q2 2021.
- BLA submission to FDA planned for Q4 2021.
- If approved, ONS-5010 will have 12 years of marketing exclusivity.
- Commercial launch planning has begun.
Challenges Ahead
- Developing pharmaceutical product candidates
- Conducting clinical trials
- Obtaining necessary regulatory approvals
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
- Risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission