Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 41

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 41
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by our technologies, or technologies available to us. We may encounter delays and incur additional development and production costs and
expenses, over and above those expected, in order to develop technologies and products suitable for licensing. If any of our development
programs are curtailed, this may have a material adverse effect on our business and financial conditions.

Our business is dependent
on our ability to complete the development of product candidates, and license our product candidates to partners who will seek to obtain
regulatory approval for and commercialize our product candidates in a timely manner. Any licensing partner cannot commercialize a product
without first obtaining regulatory approval from the appropriate regulatory authorities in a country. Before obtaining regulatory approvals
for the commercial sale of any product candidate for a target indication, it must be demonstrated with substantial evidence gathered in
preclinical and well-controlled clinical studies that the product candidate is safe and effective for use for that target indication and
that the manufacturing facilities, processes and controls are adequate. The process of developing, obtaining regulatory approval for and
commercializing product candidates is long, complex and costly. Even if a product candidate were to successfully obtain approval from
the EMA, the MHRA, the FDA and/or comparable foreign regulatory authorities, any approval might contain significant limitations related
to use restrictions for certain age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval
study or risk management requirements. If our product candidates are unable to obtain regulatory approval in one or more jurisdictions,
or any approval contains significant limitations, we may not be able to obtain sufficient funding or generate 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