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Sep 30, 2022
Checkpoint Therapeutics Q3 2022 Earnings Report
Announced financial results for the third quarter ended September 30, 2022, and recent corporate highlights.
Key Takeaways
Checkpoint Therapeutics reported its Q3 2022 financial results and highlighted the successful completion of pre-BLA meetings and the planned BLA submission for cosibelimab by January 2023.
Successfully completed pre-Biologics License Application (“BLA”) meetings in July.
Biologics license application (“BLA”) for both metastatic and locally advanced cutaneous squamous cell carcinoma indications expected to be submitted by January 2023.
Planned BLA submission will represent a significant milestone both for the company and for patients seeking treatment for cSCC.
Reverse stock split recently approved by shareholders and planned for December.
Checkpoint Therapeutics
Checkpoint Therapeutics
Forward Guidance
The company anticipates submitting a BLA for cosibelimab by January 2023 and believes it will improve long-term liquidity.
Positive Outlook
- Successful completion of pre-BLA meetings.
- Planned BLA submission by January 2023.
- Cosibelimab has the potential to be the first anti-PD-L1 antibody approved for advanced cSCC.
- Reverse stock split expected to improve long-term liquidity.
- Increased visibility with institutional investors expected.
Challenges Ahead
- Ability to successfully deliver the complete dataset from the clinical trial and complete a BLA submission on schedule as planned.
- The risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data previously published.
- The risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed.
- Dependence on third-party suppliers.
- Our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones.