Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 42

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 42
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| • | clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance 
 with regulatory requirements, or dropping out of a trial;                                                  |

| 22 |

| • | inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged 
 in other clinical trial programs, including some that may be for the same indication;                       |

| • | failure of third party clinical trial managers or clinical sites to satisfy contractual duties or meet 
 expected deadlines;                                                                                    |

| • | delay or failure in adding new clinical trial sites; |

| • | ambiguous or negative interim results, or results that are inconsistent with earlier results; |

| • | the need for clinical trial protocol modifications based on comments from the EMA, the MHRA, the FDA,                                         
 a responsible IRB, a data safety monitoring boards, or other regulatory authority, or on results from earlier stage or concurrent preclinical 
 and clinical studies;                                                                                                                         |

| • | decisions by the EMA, the MHRA, the FDA, a responsible IRB, other regulatory authorities, or us, or recommendation                 
 by a data safety monitoring board, to suspend or terminate a clinical trial at any time for safety issues or for any other reason; |

| • | unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects; |

| • | failure to demonstrate a benefit from using our product candidate over existing marketed products or established 
 standard of care treatment;                                                                                      |

| • | manufacturing issues, including problems with manufacturing or obtaining from third parties sufficient                        
 quantities of raw materials, active pharmaceutical ingredients, or API, or product candidates for use in clinical trials; and |

| • | changes in governmental regulations or administrative actions or lack of adequate funding to continue 
 the clinical trial.                                                                                   |

Many of these factors are
beyond our control. If we experience delays in the completion of, or termination of, any ongoing or future clinical trial of our product
candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of
these product candidates will be delayed. In addition, any delays in completing clinical trials may slow down our product candidate development
and approval process and jeopardize the ability to commence product sales and generate revenues. Any of these occurrences may harm our
business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead