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Mar 31, 2024
Outlook Therapeutics Q2 2024 Earnings Report
Reported financial results for Q2 2024 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or $8.01 per basic and diluted share, for the fiscal second quarter ended March 31, 2024. The company is progressing towards potential marketing authorization of ONS-5010 in the EU and has submitted a marketing application in the UK. The NORSE EIGHT clinical trial is advancing towards a topline data readout expected in the fourth quarter of calendar year 2024.
Outlook Therapeutics continues to drive toward anticipated marketing authorization of ONS-5010 in the EU and has also submitted its marketing application for authorization in the UK.
The company is executing on its NORSE EIGHT clinical trial and advancing toward a topline data readout expected in the fourth quarter of calendar year 2024.
Outlook Therapeutics believes it has access to sufficient capital to take ONS-5010 through potential FDA approval and funding of the commercial launch, assuming full exercise of the warrants issued in recent private placement transactions.
Over 30% of the required subjects have been enrolled in the NORSE EIGHT study, with enrollment completion planned in Q3 CY2024 and BLA resubmission by the end of calendar year 2024.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics anticipates several milestones in the near future, including regulatory decisions for ONS-5010/LYTENAVA™ in the EU and UK, completion of enrollment in the NORSE EIGHT trial, resolution of CMC comments from the FDA, and potential resubmission of the ONS-5010 BLA.
Positive Outlook
- Potential marketing authorization of ONS-5010 in the EU following a positive opinion from the CHMP.
- Submission of a marketing application for ONS-5010 in the UK under the International Recognition Procedure.
- Advancement of the NORSE EIGHT clinical trial with topline data expected in Q4 CY2024.
- SPA agreement with the FDA for the NORSE EIGHT trial protocol and statistical analysis plan.
- Plans to resolve Chemistry, Manufacturing and Controls (CMC) comments in the CRL through Type C and Type D meetings with the FDA.
Challenges Ahead
- Uncertainty regarding the timing and outcome of regulatory decisions by the European Commission, MHRA, and FDA.
- Risks associated with developing pharmaceutical product candidates and conducting clinical trials.
- Potential delays in NORSE EIGHT enrollment completion and BLA resubmission.
- Dependence on the full exercise of warrants issued in recent private placement transactions to secure sufficient funding.
- Uncertainty of market conditions and future impacts related to macroeconomic factors.