Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 24

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 24
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 developed by competitors. As the industry matures, companies will compete based upon the performance and cost-effectiveness of their products.

Products for Regenerative Medicine

The cell therapy industry
is characterized by rapidly evolving technology and intense competition. Kadimastem’s competitors include major multinational pharmaceutical
companies, specialty biotechnology companies, and chemical and medical products companies operating in the fields of regenerative medicine,
cell therapy, tissue engineering, and tissue regeneration. Many of these companies are well established and possess technical, research
and development, financial, and sales and marketing resources significantly greater than Kadimastem’s. In addition, certain smaller
biotech companies have formed strategic collaborations, partnerships, and other types of joint ventures with larger, well-established
industry competitors that afford the smaller companies’ potential research and development as well as commercialization advantages.
Academic institutions, governmental agencies, and other public and private research organizations are also conducting and financing research
activities, which may produce products directly competitive to those Kadimastem is developing.

Potential Competition for the AstroRx® product

To the best of Kadimastem’s knowledge, there is currently no cell/astrocytes-based therapy that has been differentiated from pluripotent stem cells for the treatment of ALS approved for marketing by the FDA, the European Medicines Agency, or EMA, or any other jurisdiction. ALS is a multifactorial disease, characterized by a progressive loss of motor neurons that eventually leads to paralysis and death. The current ALS-approved drugs modestly change the clinical course of the disease. The contribution of astrocytes to the maintenance of motor neurons by diverse mechanisms makes them a promising therapeutic candidate for the treatment of ALS. Therapeutic approaches targeting at modulating the function of endogenous astrocytes or replacing lost functionality by transplantation of healthy astrocytes, may contribute to the development of therapies which might slow down or even halt the progression of ALS diseases.

MSCs are adult multipotent-precursors
that can be derived from bone-marrow or placenta, with the potential to differentiate into osteocytes, chondrocytes, fibroblasts, and
adipocytes. MSC are not natural residents of the CNS but can be induced to secrete some of the neurotrophic factors secreted by astrocytes.
There is a product based on mesenchymal stem cells that was approved through an expedited process in South Korea by Corestem, Inc. However,
to the best of Kadimastem’s knowledge, Corestem did not conduct an experiment