Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 120

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 120
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 Day 15 to Day 22, compared to 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 vitroobservation that SACT-1 promotes tumor DNA damage and tumor cell death.

Figure 5

Figure 5: 22 days data of in vivostudies
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.

We may submit an IND application
to the US FDA seeking to initiate our planned Phase 1b/2a trial for SACT-1 in 2025.

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). Another US patent (US Patent 11,