Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 65

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 65
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 information, including additional preclinical studies or clinical
data, to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development
program. If we were to obtain approval, regulatory authorities may approve any of Aptorum’s drug candidates for fewer or more limited
indications than we request. Regulatory authorities also may grant approval contingent on the performance of costly post-marketing clinical
trials, or may approve a drug candidate with a label that is not desirable for the successful commercialization of that drug candidate.
In addition, if Aptorum’s drug candidate produces undesirable side effects or involves other safety issues, the FDA may require
the establishment of a Risk Evaluation Mitigation Strategy (“REMS”), or NMPA, EMA, Health Canada or other comparable regulatory
authorities may require the establishment of a similar strategy. Such a strategy may, for instance, restrict distribution of Aptorum’s
drug candidates, require patient or physician education, or impose other burdensome implementation requirements on us.

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Regulatory approval may be substantially delayed or may not be obtained for one or all of Aptorum’s drug candidates if regulatory authorities require additional time or studies to assess the safety or efficacy of Aptorum’s drug candidates.

Aptorum currently does not
have any drug candidates that have gained approval for sale by the FDA, NMPA or EMA, Health Canada or other regulatory authorities in
any other country, and it cannot guarantee that it will ever have marketable drugs. Despite SACT-1 having been granted orphan drug status,
this is not an approval for sale by the FDA. Aptorum’s business is substantially dependent on its ability to complete the development
of, obtain marketing approval for and successfully commercialize drug candidates in a timely manner. Aptorum cannot commercialize drug
candidates without first obtaining marketing approval from the FDA, NMPA, EMA, Health Canada and comparable regulatory authorities. In
the U.S., it hopes to file INDs for the drug candidates from our Lead Projects and, subject to the approval of IND, Phase 1 clinical
trials in humans. The timing and scope of advancing both ALS-4 Phase 2 clinical trials and SACT-1 Phase 1/2 trials are contingent upon
securing appropriate collaborative partnerships and adequate funding resources. The Company is actively seeking strategic collaborators
who can provide both financial support and clinical expertise to advance these therapeutic programs. Even if Aptorum is permitted to commence
such