Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 43

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 43
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 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 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