Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 54

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 54
---
 for approval of
product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining similar foreign regulatory approvals
and compliance with similar foreign regulatory requirements could result in significant delays, difficulties and costs for us and could
delay or prevent the introduction of our products in certain countries. We do not currently have any product candidates approved for sale
in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international
markets. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals,
our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

We seek to establish agreements with potential licensing partners and collaborators and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our current development and
commercialization strategy is to deploy our proprietary drug delivery technologies to formulate a compelling portfolio of novel first-in-class
sustained release formulations of products with significant commercial potential for licensing to pharmaceutical company partners at proof-of-concept
stage, which would potentially result in revenue generation from product royalty and/or milestone deals. We seek to work with licensing
or collaboration partners for the development and commercialization of one or more of our product candidates. For example, in January
2019, we entered into that certain Licensing, Collaboration and Distribution Agreement, or the CMS License Agreement, with China Medical
System Holdings Limited, or CMS, as guarantor, and two of its wholly owned subsidiaries, CMS Bridging Limited, or CMS Bridging, and CMS
Medical Hong Kong Limited, or CMS Medical HK, each a CMS Party, pursuant to which, among other things, we agreed to license certain of
our products to the CMS Parties in exchange for, among other things, royalty revenue. Future collaborators may include large and mid-size
pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies.

| 29 |

We face significant competition
in seeking appropriate licensing or collaboration partners. Whether we reach a definitive agreement will depend, among other things, upon
our assessment of the partner’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed
partner’s evaluation of a number of factors. Those factors may include the potential differentiation of our product candidate from
competing product candidates, design or results of clinical trials, the likelihood of approval by the FDA or comparable foreign regulatory
authorities and the regulatory pathway for any such approval, the potential