Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 26

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 26
---
 Inc. However,
to the best of Kadimastem’s knowledge, Corestem did not conduct an experiment and was unable to obtain regulatory approval outside
of Korea. In addition, to the best of Kadimastem’s knowledge, there are currently several medical applications based on stem cells
that are in various development processes mainly by academic principal investigator, and which Kadimastem considers to be direct potential
competitors to the medicine that Kadimastem is developing in the field of activity. These include Q Therapeutics, Neuralstem and NurOwn
by Brainstorm Cell Therapeutics, Inc. NurOwn is the only product of direct competition that reached high stages in a Phase 3 clinical
trial. To the best of Kadimastem’s knowledge, this product was denied a Biological Licensing Approval, or BLA, an FDA marketing
approval of a biological drug, for ALS treatment in 2022. As of April 2023, the FDA has agreed to have an additional advisory meeting
to reconsider the marketing of this product to ALS patients. Since all the MSC product candidates do not replace astrocytes, but rather
have a few astrocytes-like attributes, Kadimastem considers them competition for the short run, but strongly believe it has a competitive
edge on them.

There
are currently on the market several products (not based on the use of cells) or under development for the treatment of ALS, which are
in various stages of development, as well as three products approved by the FDA: (1) Rilutek, which has been marketed since the 1990s;
(2) Edaravone, which was approved in mid-2017 as an intra venous agent and again in late 2022 as an oral drug (Marketed by Mitsubishi
Tanabe Pharmaceuticals as Radicava), which, to the best of Kadimastem’s knowledge, each has limited efficacy; and (3) RELYVRIO
(sodium phenylbutyrate and taurursodiol, AMX0035) which is marketed by Amylyx, which has been approved by the FDA and the Ministry of
Health in Canada, and is in the stages of evaluation by EMA regarding the granting of a marketing authorization for its use. Kadimastem
sees these products as potential indirect competition with the drug that Kadimastem is developing.

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IsletRx - Development of a Drug for the Treatment of