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Dec 31, 2023
Outlook Therapeutics Q1 2024 Earnings Report
Reported a net loss attributable to common stockholders and provided a corporate update, highlighting progress with the FDA on the NORSE EIGHT trial and CMC comments in the CRL.
Key Takeaways
Outlook Therapeutics reported its financial results for the first quarter of fiscal year 2024. The company highlighted the FDA's agreement on the NORSE EIGHT trial protocol and progress in addressing CMC comments in the CRL. They also entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval.
Received FDA agreement on NORSE EIGHT trial protocol under a SPA.
First subject enrolled in NORSE EIGHT in January 2024.
Identified approaches to resolve CMC comments in the CRL.
Entered into purchase agreements for financing of up to $172 million, pending shareholder approval.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics anticipates several milestones, including the NORSE EIGHT topline results, resubmission of the ONS-5010 BLA by the end of calendar year 2024, and a decision from the EMA on the ONS-5010 MAA expected in the first half of 2024.
Positive Outlook
- Potential approval of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first approved ophthalmic formulation of bevacizumab in the U.S. or EU.
- Expected NORSE EIGHT topline results by the end of calendar year 2024.
- Potential resubmission of the ONS-5010 BLA by the end of calendar year 2024.
- Estimated decision date from the EMA on the ONS-5010 MAA expected in the first half of 2024.
- Potential strategic partnering opportunities in the EU and other regions.
Challenges Ahead
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
- Uncertainty of market conditions and future impacts related to macroeconomic factors.
- Potential delays in regulatory decisions.