Clinical Trial and Regulatory Approval Failures: The success of CGEM's product candidates depends on successful completion of clinical trials and obtaining regulatory approvals, which are uncertain, costly, and time-consuming processes.

Significant Capital Requirements and Future Funding Needs: CGEM has incurred significant net losses since inception and will require substantial additional capital to fund its operations and develop its product candidates, which may not be available on acceptable terms or at all.

Intense Competition and Market Acceptance Challenges: The biopharmaceutical industry is highly competitive, and CGEM's product candidates may not compete effectively against existing or future therapies developed by larger, more established companies, or gain sufficient market acceptance.