Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 202

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 202
---
 on page 129).

Kadimastem implements a technological platform
that uses pluripotent stem cells, or PSCs, either embryonic stem cells and/or induced pluripotent stem cells for the development and production
of various active cells as off-the-shelf products for the treatment of a wide range of diseases. Its technological platform includes processes
for the development, production and biobanks of cells at various stages of differentiation. As of the date of this annual report, Kadimastem
focuses on the development of cell therapy products in the field of regenerative medicine for the treatment of various diseases with an
emphasis on (a) treatment and/or cure of neurodegenerative diseases of the CNS, with the purpose of finding a treatment for ALS,
and (b) development of a cure for Type 1 diabetes and possibly in the future, for Type 2 diabetic patients which are insulin dependent.

Regenerative medicine is an innovative medical
research field that focuses on regeneration of tissue/organs harmed due to disease, injury or due to birth defects in patients, using
one of the following two ways: (1) creating new cells, organ parts or tissues under laboratory conditions, or using donor cells,
organs or parts of organs transplanted into the patient’s body in order to replace the cells or tissues damaged by disease; (2) finding
and developing drugs that will help induce a process of spontaneous regeneration of the damaged tissue/organ by encouraging the adult
stem cells that are regularly present in the tissue, divide, differentiate and take their place in the affected area.

Below is a discussion on Kadimastem’s two
primarily drug products, AstroRx®, for the treatment for ALS, and IsletRx, for the treatment of diabetes.

AstroRx ®

Development of Cell Therapy in the Field of
Regenerative Medicine for Patients with Neurodegenerative Diseases

Neurodegenerative diseases are degenerative diseases
of the CNS. These diseases are characterized by massive mortality of neurons. The prevention of neurodegeneration represents one
of today’s most significant unmet medical needs. The development of therapies that preserve neuron health present unique challenges,
including an imperfect understanding of underlying biology and a lack of translation of activity observed in preclinical studies to results
in clinical trials. Kadimastem believes that currently approved therapies for many neurodegenerative diseases are generally only symptom
modifying and have demonstrated limited efficacy. Accordingly, Kadimastem believes there remains an urgent need for