Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 95

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 95
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 of UK and EU pharmaceutical regulations. At present, Great Britain has implemented EU legislation on the marketing,
promotion and sale of medicinal products through the Human Medicines Regulations 2012 (as amended) (under the Northern Ireland Protocol,
the EU regulatory framework will continue to apply in Northern Ireland). The regulatory regime in Great Britain therefore currently aligns
in the most part with EU regulations, however it is possible that these regimes will diverge in the future now that Great Britain’s
regulatory system is independent from the EU and the TCA does not provide for mutual recognition of UK and EU pharmaceutical legislation.
For example, the new Clinical Trials Regulation which became effective in the EU on January 31, 2022 and provides for a streamlined clinical
trial application and assessment procedure covering multiple EU Member States has not been implemented into UK law, and a separate application
will need to be submitted for clinical trial authorization in the UK. In addition, as we are headquartered in the UK, it is possible that
Brexit may impact some or all of our current operations. For example, Brexit will impact our ability to freely move employees from our
headquarters in the UK to other locations in the EU. Furthermore, if other EU Member States pursue withdrawal, barrier-free access among
the EEA overall could be diminished or eliminated.

The long-term effects of Brexit
will depend in part on how the terms of the TCA continue to take effect in practice and the terms of any further agreements the UK makes
with the EU. Such a withdrawal from the EU is unprecedented, and it is unclear how the restrictions on the UK’s access to the European
single market for goods, capital, services and labor, or single market, and the wider commercial, legal and regulatory environment, will
impact our future operations (including business activities conducted by third parties and contract manufacturers on our behalf) and clinical
activities in the UK in the long term.

If we commence clinical trials of one of our drug or diagnostics technology candidates, and product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of such drug or diagnostics technology candidates may be affected.

If any of our drug or diagnostics
technology candidates enter clinical trials, we will face an inherent risk of product liability suits and will face an even greater risk
if we obtain approval to commercialize any drugs. For example, we may be sued if our drug candidates cause or are perceived to cause injury
or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.