Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 50

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 50
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Changes in the regulatory environment could have a material adverse effect on NLS’ business.

Changes in the regulatory
environment could have a material adverse effect on NLS’ business. NLS’ 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’ 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 anticipate that Kadimastem 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 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 completing these
activities could adversely impact us. Management plans to seek additional equity financing through private and public offerings or strategic
partnerships and, in the longer term, by generating revenues from product sales. Kadimastem has incurred losses in each year since its
inception. Kadimastem’s net loss attributable to holders of Kadimastem’s Ordinary Shares for the six months ended June 30,
2024 and 2023 were $4.6 million and $6.9 million, respectively. Substantially all of Kadimastem’s operating losses resulted from
costs incurred in