Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 44

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 44
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 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 to the denial of regulatory approval of our product candidates. It is possible
that none of our product candidates will ever complete successfully the clinical development process and obtain regulatory approval, even
if we expend substantial time and resources seeking such approval.

Negative results in the development
of our lead product candidates may also prevent or delay our ability to continue or conduct clinical programs or receive regulatory approvals
for our other product candidates. For example, although we believe our preclinical studies and animal testing of eRapa, tolimidone and
MTX110 demonstrate indications of acceptable safety and effectiveness profiles, future clinical trials may fail to demonstrate adequate
levels of safety or effectiveness. Moreover, in the case of MTX110, anti-tumor activity may be different in each tumor type that we plan
to evaluate in the clinical trial. Therefore, even though we plan to pursue clinical development for multiple tumor types, the tumor response
may be