Company: CNTB
Filing Date: 2025-09-10
Form Type: POS AM
Source: 0001193125-25-200186
Chunk: 12

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-09-10
Form: POS AM
Chunk 12
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 to audit and verification procedures that could result in material changes in the final data. |

| • |     | We may attempt to secure approval from the Food and Drug Administration (the “FDA”), the National                                                                                                                                                   
 Medical Products Administration (the “NMPA”) or comparable foreign regulatory authorities through the use of accelerated approval pathways. If we are unable to obtain such approval, we may be required to conduct additional clinical             
 trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals. Even if we receive accelerated approval from the FDA, the NMPA or comparable foreign regulatory    
 authorities, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA, the NMPA or comparable foreign regulatory authorities may seek to withdraw accelerated approval. |

| • |     | We have only one Product Candidate, rademikibart, currently in clinical development. If we are unable to                          
 successfully develop our Product Candidates or experience significant delays in doing so, our business will be materially harmed. |

| • |     | Our approach to the discovery and development of Product Candidates based on potent T cell modulation activity                                                                                                                           
 is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our Product Candidates or render our approach obsolete. |

| • |     | We 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.                                                                                                     |

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

| •