Company: CNTB
Filing Date: 2025-09-10
Form Type: POS AM
Source: 0001193125-25-200186
Chunk: 66

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-09-10
Form: POS AM
Chunk 66
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 have never submitted a New Drug Application or Biologics License Application, and may be unable to do so 
 for any of our Product Candidates.                                                                          |

| • |     | The regulatory approval processes of the FDA, the NMPA and comparable foreign authorities are lengthy, time                                                       
 consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our Product Candidates, our business will be substantially harmed. |

| • |     | Disruptions at the FDA, the NMPA, comparable foreign regulatory authorities, and other government agencies                                                                                                                                              
 caused by shifting governmental policies and priorities, reductions in the federal workforce, funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent 
 new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.                                                                                                     |

4

| • |     | Our Product Candidates for which we intend to seek approval as biologic products may face competition sooner 
 than anticipated.                                                                                            |

| • |     | 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 organization (“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.                                             |

| • |     | 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