Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 55

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 55
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 authorities may approve any of our 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 our 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 our drug candidates, require patient
or physician education, or impose other burdensome implementation requirements on us.

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

We currently do 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 we cannot guarantee that we will ever have marketable drugs. Despite SACT-1 having been granted orphan drug status, this
is not an approval for sale by the FDA. Our business is substantially dependent on our ability to complete the development of, obtain
marketing approval for and successfully commercialize drug candidates in a timely manner. We cannot commercialize drug candidates without
first obtaining marketing approval from the FDA, NMPA, EMA, Health Canada and comparable regulatory authorities. In the U.S., we hope
to file INDs for the drug candidates from our Lead Projects and, subject to the approval of IND, Phase 1 clinical trials in humans. Even
if we are permitted to commence such clinical trials, they may not be successful and regulators may not agree with our conclusions regarding
the data generated by our clinical trials.

We may be unable to complete
development of our drug candidates or initiate or complete development of any future drug candidates we may develop on our projected schedule.
While we believe that our existing cash will likely enable us to complete the preclinical development of at least one of our current Lead
Projects, the full clinical development, manufacturing and launch of that drug candidate, will take significant additional time and likely
require funding beyond the existing cash. In addition, if regulatory authorities require additional time or studies to assess the safety
or efficacy of our drug candidates, we may not have or