Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 224

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 224
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 the treatment of other cancers. Based on this discovery, we plan to carry out further in vivostudies
to study the efficacy of SACT-1 over other types of cancers to maximize the potential of SACT-1. Based on the initial 22 day data
of a recent study we conducted in a xenograft mouse model of neuroblastoma, SACT-1 was orally administered daily at 60mg/kg in combination
of SOC chemotherapy brought a statistically significant tumor shrinkage (unpaired student’s t-test, p<0.01) from 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.

<div align='center'>123</div>

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)