Company: CNTB
Filing Date: 2025-09-10
Form Type: POS AM
Source: 0001193125-25-200186
Chunk: 13

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-09-10
Form: POS AM
Chunk 13
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 |     | The proposed revision of the EU legislation on pharmaceuticals could lead to uncertainties over the regulatory 
 framework that will be applicable to medicinal products in the EU.                                             |

Risks Related to Our Reliance on Third Parties

| • |     | We rely, and expect to continue to rely, on third parties, including independent clinical investigators and                                                                                                                        
 contract research organizations (“CROs”), to conduct some aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory 
 requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our Product Candidates and our business could be substantially harmed.                                              |

7

| • |     | We contract with third parties for the manufacture of our Product Candidates for preclinical studies and our                                                                                                                                              
 ongoing clinical trials, and expect to continue to do so for additional clinical trials and ultimately, for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our Product Candidates or 
 drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.                                                                                                                        |

| • |     | Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a       
 competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed. |

| • |     | We have entered into and expect to seek to enter into collaborations, licenses and other similar arrangements 
 and may not be successful in doing so, and we may not realize the benefits of such relationships.             |

| • |     | If the custodians or authorized users of our controlling non-tangible                                                                                                                      
 assets, including chops and seals, fail to fulfill their responsibilities, or misappropriate or misuse these assets, our business and operations may be materially and adversely affected. |

Risks Related to Commercialization of Our Product Candidates

| • |     | Even if our Product Candidates receive regulatory approval, they will be subject to ongoing regulatory review 
 and significant post-marketing regulatory requirements and oversight.                                         |

| • |     | The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability. |

| • |     | The commercial success of our Product Candidates will depend upon the degree of market acceptance of such 
 Product Candidates by physicians, patients,