Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 204

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 204
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 the control
group which received SOC only. The combination reduced the tumor size by up to 54.2% in the first 22 days compared with the control (SOC
only). SACT-1 appears to be effective in accelerating the effect of the SOC in early time points (from Day 1 - 7 vs control). This further
supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.

<div align='center'>104</div>

Figure 5

Figure 5: 22 days data of in vivo studies
in a xenograft mouse model of neuroblastoma

| ** | Unpaired                                                        
 student’s t-test, p<0.01, n=8 (based on initial 22 days period) |

In September 2021, we announced
that we received clearance from the US FDA regarding the IND application to initiate clinical trials of SACT-1. In January 2022, we further
announced that the completion of our Phase I clinical trial for assessing relative bioavailability and food effect of SACT-1, and no serious
adverse events were observed. SACT-1’s Phase 1 clinical trial is an Open-label Randomized, Single Cross Over Bioavailability and
Food Effect Study of SACT-1 in healthy adult volunteers. In additions, the US FDA has granted Orphan Drug Designation to SACT-1 in January
2022. In March 2023, we further announced the completion of the End of Phase 1 (EOP1) meeting with the US FDA on SACT-1. The EOP1 meeting
was focused on gaining alignment with the US FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma
in pediatric patients aged 2-18. The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and our proposed clinical
development plan for Phase 1/2 trials.

Currently, ALS-4 and SACT-1
are Phase 2 clinical trials ready.

Patent License

In January 2022, the US Patent
and Trademark Office has granted the first patent regarding Aptorum’s SACT-1 (through Aptorum’s subsidiary) repurposed drug
for the treatment of various cancers including but not limited to neuroblastoma (US Patent 11,166,952 B2). Another US patent (US Patent
11,571,422) was granted in February 2023