Company: CNTB
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001835268-25-000014
Chunk: 105

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 105
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 targeting molecules that we believe have potent T cell modulation activity may be unsuccessful in identifying additional Product Candidates, and any Product Candidates based on our technology may be shown to have harmful side effects or may have other characteristics that may necessitate additional clinical testing or make the Product Candidates unmarketable or unlikely to receive marketing approval. Further, adverse developments with respect to our rademikibart program may have a significant adverse impact on the actual or perceived likelihood of success and value of our future Product Candidates based on our drug-screening approach.

In addition, the biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies. Our future success will depend in part on our ability to maintain a competitive position with our T cell modulating activity approach. If we fail to stay at the forefront of technological change in utilizing this technology and approach to create and develop Product Candidates, we may be unable to compete effectively. Our competitors may render our approach obsolete, or limit the commercial value of our Product Candidates, by advancing existing technological approaches or developing new or different approaches (including, for example, using different targeting approaches from ours), potentially eliminating the advantages that we believe we derive from our targeting of molecules with potent T cell modulation activity. By contrast, adverse developments with respect to other companies that attempt to use a similar T cell modulation approach to ours may adversely impact the actual or perceived value of and potential of our Product Candidates.

If any of these events occur, we may be forced to abandon our development efforts for one or more programs, which would have a material adverse effect on our business and could potentially cause us to cease operations.

We have never submitted an NDA or BLA, and may be unable to do so for any of our Product Candidates.

We will need to successfully obtain FDA, NMPA or comparable foreign regulatory approval to market rademikibart or any future Product Candidates. The submission of a successful NDA or BLA is a complicated and expensive time-consuming process. Although our management team has experience doing so, we have limited experience as a company in preparing, submitting and prosecuting regulatory filings and have not previously submitted an NDA or a BLA or other comparable foreign regulatory submission for any Product Candidate. In addition, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that will support regulatory submissions and lead to approval of any of our Product Candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of Product Candidates that we develop. Failure to commence or complete,