Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 202

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 202
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 frequently in the adrenal glands as well as spine, chest, abdomen or neck, predominantly in children, especially
for those aged 5 years and below. For the high-risk group, which is close to 20% (Annu Rev Med. 2015; 66: 49–63.) of total new patient
population per year, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society (https://www.cancer.org/cancer/neuroblastoma/detection-diagnosis-staging/survival-rates.html).
The current high drug treatment cost for high-risk patients can average USD200,000 per regimen (all 6 cycles) (https://www.cadth.ca/sites/default/files/pcodr/Reviews2019/10154DinutuximabNeuroblastoma_fnEGR_NOREDACT-ABBREV_Post_26Mar2019_final.pdf).
In addition, most pediatric patients often do not tolerate or survive the relevant chemotherapy stage which, subject to further clinical
studies, may be positively addressed by the SACT-1 candidate due to the potential synergistic effects when applied with standard chemotherapy.

<div align='center'>102</div>

In our studies, SACT-1 has
been shown to be effective against numerous neuroblastoma cell lines, of which 2 are MYCN-amplified cells, which represent the high-risk
neuroblastoma patient group. In addition, by using a bliss score as a quantitative measure of the extent of drug interaction, Aptorum
Group has seen a high and robust synergism between SACT-1 and traditional chemotherapy in vitro (Figure 4), indicating a potential efficacy
enhancement/dose reduction of the chemotherapy.

Figure 4

Figure 4: synergism between
SACT-1 and traditional chemotherapy in vitro

In addition, in our study,
the maximum tolerable dose of SACT-1 in a rodent model was determined to be higher than 400mg/kg. Compared with the MTD of standard chemotherapy
such as paclitaxel (20-30mg/kg) (Clin Cancer Res. 5(11):3632-8) and cisplatin (6mg/kg) (BMC Cancer 17: 684 (2017)), the safety profile
of SACT-1 appears to be very impressive. Based on our internal observations of pre-existing information from approved products, (subject
to FDA’s approval