Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 71

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 71
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 the provisions of the approved label and may not promote drugs for any off-label use, such as uses
that are not described in the product’s labeling and that differ from those approved by the regulatory authorities. However, physicians
may prescribe drug products for off-label uses and such off-label uses are common across some medical specialties. Thus, they may, unbeknownst
to us, use our product for an “off label” indication for a specific treatment recipient. The FDA, NMPA, EMA, Health Canada
and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are
found to be out of compliance with the requirements and restrictions imposed on us under those laws and restrictions, we may be subject
to significant liability, including civil and administrative remedies as well as criminal sanctions, and the off-label use of our products
may increase the risk of product liability claims. In addition, management’s attention could be diverted from Aptorum’s business
operations and our reputation could be damaged.

The policies of the FDA, NMPA,
EMA, Health Canada and other regulatory authorities may change and we cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable
to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory
compliance, we may lose any regulatory approval that we may have obtained and we may not achieve or sustain profitability.

Despite FDA’s consent for us to pursue the 505(b)(2) development pathway for SACT-1, we may be unable to successfully complete the 505(b)(2) pathway for the pediatric formulation of SACT-1 to treat neuroblastoma as planned, which would materially impact our likelihood of obtaining FDA approval.

Even though the FDA is allowing
us to pursue the 505(b)(2) regulatory pathway for our product candidates, we will need to conduct additional clinical trials, provide
additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources
required to obtain FDA approval for our product candidates would likely substantially increase. We cannot assure you that we will receive
the requisite or timely approvals for commercialization of such product candidate. Any failure to obtain regulatory approval of our product
candidates would significantly limit our ability to generate revenues, and any failure to obtain such approval for all of the indications