Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 57

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 57
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 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 Aptorum Class A ordinary shares, which could impair
our ability to raise capital, expand Aptorum’s business or continue our operations.

Preclinical development is a long, expensive and uncertain process, and we may terminate one or more of our current preclinical development programs.

Traditionally, drug discovery
and development is a time-consuming, costly and high-risk business. On average, the cost of launching a new drug is estimated to approach
US$2.6 billion and can take around 12 years to make it to the market (4 key benefits of drug repositioning. (n.d.). Retrieved
from http://www.totalbiopharma.com/2012/07/04/4-key-benefits-drug-repositioning/). Despite the huge expenditures, only approximately
1 in 1,000 potential drugs is graduated to human clinical trials after pre-clinical testing in the United States, (Norman, G. A.
Drugs, Devices, and the FDA: Part 1. JACC: Basic to Translational Science, 1(3), 170-179, 2016) and nearly 86.2% of
drug candidates entering phase 1 trials fails to achieve drug approval. (Wong C. H., Siah K. W. & Lo A. W. (2019,
April), “Estimation of clinical trial success rates and related parameters,” retrieved from https://academic.oup.com/biostatistics/article/20/2/273/4817524).
Even after a drug is commercialized, there are just too many factors affecting the sales of pharmaceutical products, including unmet need/burden
of disease (68.2%), clinical efficacy (47.3%), comparator choice (36.4