Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 46

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 46
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drug candidates. None of our drug candidates has been approved for marketing in the U.S., Europe, the PRC or any other jurisdictions and
may never receive such approval. Our ability to generate revenue and achieve profitability is dependent on our ability to complete the
development of our drug candidates and any future drug candidates we develop in our portfolio, obtain necessary regulatory approvals,
and have our drugs products under development manufactured and successfully marketed, of which there can be no guarantee. We may not be
able to generate a profit until our drug candidates become profitable.

Even if we receive regulatory
approval and marketing authorization for one or more of our drug candidates or one or more of any future drug candidates for commercial
sale, a potential product may not generate revenue at all unless we are successful in:

| ● | developing a sustainable and scalable manufacturing process for our drug candidates and any approved products, including establishing and maintaining commercially viable supply relationships with third parties; |
| ● | launching and commercializing drug candidates following regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;                                                  |
| ● | obtaining market acceptance of our drug candidates as viable treatment options;                                                                                                                                    |

| ● | addressing any competing technological and market developments;                                                                                                                                                                           |
| ● | negotiating and maintaining favorable terms in any collaboration, licensing or other arrangement into which we may enter to commercialize drug candidates for which we have obtained required approvals and marketing authorizations; and |
| ● | maintaining, protecting and expanding our portfolio of IP rights, including patents, trade secrets and know-how.                                                                                                                          |

In addition, our ability to
achieve and maintain profitability depends on timing and the amount of expenses we will incur. Our expenses could increase materially
if we are required by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities to perform studies in addition to those
that we currently have anticipated. Even if our drug candidates are approved for commercial sale, we anticipate incurring significant
costs associated with the commercial launch of these products.

Our ability to become and
remain profitable depends on our ability to generate revenue. Even if we are able to generate revenues from the sale or sublicense of
any products we may develop or license, we may not become profitable on a sustainable basis or at all. Our failure to become and remain
profitable would decrease the value of our Company and adversely affect the market price of our Class A Ordinary Shares, which could impair
our ability to raise capital, expand our business or continue our operations.

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