Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 267

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 267
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. AstroRx ® — Development of a Drug for the Treatment of Neurodegenerative Diseases (With an Emphasis on ALS) 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 novel approaches to address most neurodegenerative diseases, especially for progressive and severe conditions such as ALS. Currently, there are no FDA approved -treatmentsto stop the disease’s progression or prevent onset. There are two FDA -approvedtreatments which attempt to slow ALS progression; Riluzole and Radicava. There are a number of ongoing trials examining potential treatments for ALS. ALS is a multifactorial disease and therapeutic approaches should consider the multiplicity of pathophysiological mechanisms that underlie motor neuron, or MN, degeneration in this disease. Though MNs are the main affected cells in the disease, there is involvement of malfunctioning astrocytes in the pathogenesis and progression of ALS. This notion supports the rationale that transplantation of healthy human astrocytes into the CNS of ALS patients may compensate for the malfunctioning astrocytes and rescue remaining MNs by supply supportive factors, clues and functions. The product AstroRx ®is composed of healthy human astrocytes derived from hESCs which allows ready scale -upof large numbers of donor cells. AstroRx ®cells are manufactured in compliance with GMP guidelines. Once manufactured, the cells are resuspended in PlasmaLyte A (a physiological solution) to formulate the AstroRx ®product. The product is loaded into a syringe and delivered to the physician at point -of-carefor intrathecal injection, or IT injection, into the CSF of ALS patient following minimally invasive lumbar puncture, or LP. Kadimastem’s Solution The cell therapy Kadimastem is developing to treat ALS, AstroRx ®, is based on the transplantation of allogeneic glial cells (mainly cells that support the CNS, or