Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 40

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 40
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 sufficient revenue to continue
the development of any other product candidate. Furthermore, even if a product candidate obtains approval from the regulatory authorities,
it is likely that, in order to obtain royalty and/or milestone revenue from any of our licensing partners, our licensing partners may
need to expand their commercial operations, establish commercially viable pricing and obtain approval for adequate reimbursement from
third parties and government departments and healthcare payors for such products. If our product candidates are unable to successfully
be commercialized, we may not be able to earn sufficient revenues to continue our business.

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Our development efforts are in the early stages. All of our product candidates are in clinical development or preclinical development phases. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

Clinical testing is expensive
and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial
process. The results of any preclinical studies and early clinical trials of our product candidates may not be predictive of the results
of later-stage clinical trials, even after seeing promising results in earlier clinical trials. Product candidates in later stages of
clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial
clinical trials. A number of companies in the biopharmaceutical industry, including many with greater resources and experience than us,
have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising
results in earlier trials.

We have determined not to
conduct additional clinical trials in humans, other than pilot trials to establish proof of concept in indications other than those for
which the drug is approved. We expect our licensing partners will be responsible for future clinical trials. We and any of our current
or potential licensing partners may experience delays in ongoing or future clinical trials and we do not know whether planned clinical
trials will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all.

There is no assurance that
current or future clinical trials of our product candidates, will be successful or will generate positive clinical data and we may not
receive marketing approval from the FDA, European Commission, or other regulatory authorities for any of our product candidates. We have
limited experience submitting NDAs, biologics license applications, or BLAs, and investigational new drug applications, or INDs