Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 81

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 81
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 in the biotech industry will be highly dependent upon the future prices and demand for products that NLS and Kadimastem
currently use. Factors which may affect prices and demand for products that NLS and Kadimastem currently use include, but are not limited
to, the worldwide supply of these products; the price of these products that are produced in the United States, Israel, Switzerland,
or imported from foreign countries; consumer demand for such products; the price and availability of alternative products; federal and
state regulation; and general, national and worldwide economic political conditions.

Changes in the regulatory environment could
have a material adverse effect on NLS’s business.

Changes in the regulatory
environment could have a material adverse effect on NLS’s business. NLS’s exploration, development, production and marketing
operations are subject to extensive environmental regulation at the federal, state and local levels including those governing pharmaceutical
research and testing. Under these laws and regulations, NLS could be held liable for personal injuries, medical malpractice and other
damages. Failure to comply with these laws and regulations may also result in the suspension or termination of NLS’s operations
and subject us to administrative, civil, and criminal penalties. Governmental laws and regulations also increase the costs to plan, permit,
design and install our operations and facilities.

Risks Related to Kadimastem’s Financial
Position and Capital Requirements

Kadimastem has incurred significant operating
losses since Kadimastem’s inception and anticipates that the combined company will incur continued losses for the foreseeable future.

Kadimastem is an
emerging biopharmaceutical company with a limited operating history. Kadimastem has funded its operations to date primarily through
raising capital on the Tel Aviv Stock Exchange (“ TASE”), proceeds from the private placement of common shares, credit
facilities, loans and convertible notes. Kadimastem expects to continue to incur substantial losses over the next several years
during Kadimastem’s clinical development phase. To fully execute Kadimastem’s business plan, it will need to complete
Phase 3 clinical studies and certain development activities, as well as manufacture the required clinical and commercial
production batches in the pilot manufacturing plant. Further, Kadimastem’s product candidates will require regulatory approval
prior to commercialization, and it will need to establish sales, marketing and logistic infrastructures. These activities may span
many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in