Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 44

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 44
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 clinical endpoints;                                                                     |

| • | inability to maintain compliance with regulatory requirements, including current good manufacturing practices, or cGMP, and complying 
 effectively with other procedures;                                                                                                    |

| • | inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; |

| • | greater than anticipated clinical trial costs; |

| • | inability to compete with other therapies; |

| • | poor efficacy of our product candidates during clinical trials; |

| • | trial results taking longer than anticipated; |

| • | trials being subjected to fraud or data capture failure or other technical mishaps leading to the invalidation of our trials; |

| • | the results of our trials not supporting application for conditional approval in the EU; |

| • | unfavorable FDA or other regulatory agency inspection and review of a clinical trial site; |

| • | failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual 
 obligations in a timely manner, or at all;                                                                                         |

| • | delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional   
 regulatory oversight around clinical development generally or with respect to our technology in particular; or |

| • | varying interpretations of data by the FDA and similar foreign regulatory agencies. |

In addition, because we have
limited financial and personnel resources and are focusing primarily on developing our lead product candidates, we may forgo or delay
pursuit of other future product candidates that may prove to have greater commercial potential and may fail to capitalize on viable commercial
products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for a future product
candidate, we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements
in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product
candidates.

The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that we advance in clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval.

The research and development
of drugs and biological products is expensive and extremely risky. Only a small percentage of product candidates that enter the development
process ever receive marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of our product candidates,
we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. The outcome of clinical
testing is uncertain.