Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 45

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 45
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 low in patients with some cancers compared to others. As a result, we may be required to discontinue development of MTX110 for
patients with those tumor types and/or mutations due to insufficient clinical benefit, while continuing development for a more limited
population of patients. Consequently, in order to obtain regulatory approval, we may have to reach agreement with the FDA on defining
the optimal patient population, study design, and size, any of which may require significant additional resources and delay our clinical
trials and ultimately the approval, if any, of any of our product candidates.

We may experience setbacks
that could delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

| • | negative or inconclusive results from our preclinical studies or clinical trials or positive results from                                 
 the clinical trials of others for product candidates similar to ours leading to their approval, and evolving to a decision or requirement 
 to conduct additional preclinical testing or clinical trials or abandon a program;                                                        |

| • | product-related side effects experienced by patients or subjects in our clinical trials or by individuals using drugs or therapeutics 
 that we, the FDA, other regulators or others view as relevant to the development of to our product candidates;                        |

| • | delays in submitting INDs or comparable foreign applications or delays or failure in obtaining the necessary               
 approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced; |

| 23 |

| • | conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical 
 trials, including our 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