Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 400

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 400
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Rx ®was demonstrated to promote neuroprotection and to maintain homeostasis through several mechanisms including reuptake of excessive glutamate, neutralizing oxidative stress, immunomodulation and secretion of a variety of potent neurotrophic factors. For example, disruption of the astrocytic TNFR1 — GDNF axis accelerates MN degeneration and disease progression, as the levels of the protective agents for MNs, glial -derivedneurotrophic factor, are reduced. AstroRx ®were tested in vitro, in vivo (animal studies) and on human subjects, as described in the following peer reviewed papers: PMID: 36788520: Safety and efficacy of first -in-man intrathecal injection of human astrocytes (AstroRx ® ) in ALS patients: phase I/IIa clinical trial results. This paper describes the results of Phase 1/2a NCT03482050 clinical trial (further described on page 207). PMID: 29871694: Safety and efficacy of human embryonic stem cell -derived astrocytes following intrathecal transplantation in SOD1 G93A and NSG animal models. This paper describes the development of good manufacturing practice -gradeprotocol for generation of astrocytes from human embryonic stem cells (AstroRx ®), their in vitro function, their efficacy in ALS animal model (hSOD1 G93Atransgenic mice) and their 205 safety and biodistribution in a 9 -monthstudy conducted in immunodeficient NSG mice under good laboratory practice conditions. In vitro, AstroRx ®possess the activities of functional healthy astrocytes, including glutamate uptake, promotion of axon outgrowth and protection of MNs from oxidative stress. A secretome analysis shows that AstroRx ®also secretes several inhibitors of metalloproteases as well as a variety of neuroprotective factors (e.g. TIMP -1, TIMP -2, OPN, MIF and Midkine). Intrathecal injections of the AstroRx ®into transgenic hSOD1 G93Amice and rats significantly delayed disease onset and improved motor performance compared to sham -injectedanimals. A safety study in immunodeficient mice showed that intrathecal transplantation of AstroRx ®demonstrated positive results. Transplanted AstroRx ®attached to the meninges along the neuroaxis and survived for the entire duration of the study without formation of tumors or teratomas. Cell -injectedm