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Dec 31, 2019
Outlook Therapeutics Q1 2020 Earnings Report
Reported business highlights and financial results.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $18.5 million, or $0.62 per basic and diluted share, for the fiscal first quarter ended December 31, 2019. The company is advancing towards a new BLA submission to the FDA for ONS-5010 in 2021, with a potential commercial launch in 2022.
Phase 3 development program for ONS-5010 continues to make progress.
Patient recruitment for the NORSE 2 study is expected to be completed by the end of May 2020.
Topline data for the NORSE 1 study is expected to be announced in August 2020.
Agreements with BioLexis and MTTR were entered into to streamline the Company’s capital structure and regain 100% ownership of any future net profits for ONS-5010.
Forward Guidance
Outlook Therapeutics is focused on advancing ONS-5010 towards a BLA submission to the FDA in 2021 and a potential commercial launch in 2022.
Positive Outlook
- Ongoing patient recruitment for the NORSE 2 study, expected to be completed by the end of May 2020.
- Planned announcement of topline data for the NORSE 1 study in August 2020.
- Agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010.
- Intention to complete development of ONS-5010 for submission to the FDA as a new Biologics License Application (BLA) for the treatment of wet AMD, DME and BRVO.
- Intention to seek the requisite stockholder approvals under agreements with BioLexis and MTTR
Challenges Ahead
- 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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Avg. Return Before/After Earnings
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