Checkpoint Therapeutics Q4 2023 Earnings Report
Key Takeaways
Checkpoint Therapeutics announced their full-year 2023 financial results, highlighting their ongoing efforts to address the CRL for cosibelimab and targeting a BLA resubmission by mid-year.
Working closely with a third-party contract manufacturing organization to resolve deficiencies noted in the complete response letter (CRL).
Targeting a Biologics License Application (BLA) resubmission for cosibelimab by mid-year.
Executing key long lead time commercial launch preparation activities to shorten the launch timeline.
Confident in the clinical data and safety package supporting cosibelimab.
Checkpoint Therapeutics
Checkpoint Therapeutics
Forward Guidance
Checkpoint Therapeutics is focused on resubmitting the BLA for cosibelimab and preparing for its potential commercial launch, while also managing risks related to regulatory approvals, manufacturing, and funding.
Positive Outlook
- Targeting a Biologics License Application (BLA) resubmission for cosibelimab by mid-year.
- Potential marketing approval before the end of 2024.
- Executing on a select number of key long lead time commercial launch preparation activities.
- Aims to shorten launch timeline in anticipation of a potential approval.
- Highly confident in the clinical data and safety package in support of cosibelimab.
Challenges Ahead
- Risk that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial.
- Risks related to our chemistry, manufacturing and controls and contract manufacturing relationships.
- Risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships.
- Risks related to our need for substantial additional funds.
- Unfavorable market or other economic conditions.