Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 103

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 103
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financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations, which could result in increased operating expenses and reduced revenues; •workforce uncertainty in countries where labor unrest is more common than in the United States; •production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; •regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, or FCPA, its books and records provisions or its anti -briberyprovisions; •business interruptions resulting from cyber -attacks, geo -politicalactions, including war (such as the Russia -Ukrainewar and Israel’s multi -frontwar) and terrorism, or natural disasters including earthquakes, typhoons, floods and fires. •potential liability resulting from development work conducted by these distributors; and •business interruptions resulting from a local or worldwide pandemic, such as COVID -19, geopolitical actions, including war and terrorism, or natural disasters. Any of these factors could significantly harm its future international expansion and operations and, consequently, its results of operations. Even if any of its product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. The commercial success of Quilience and/or Nolazol will depend upon the acceptance of each product by the medical community, including physicians, patients and third -partypayors. The degree of market acceptance of any approved product will depend on a number of factors, including: •the efficacy and safety of the product; •the potential advantages of the product compared to available therapies; •the convenience and ease of administration compared to alternative treatments; •limitations or warnings, including use restrictions contained in the product’s approved labeling; •distribution and use restrictions imposed by the EMA, FDA, or other regulatory authority or agreed to by us as part of a mandatory or voluntary risk management plan; •availability of alternative treatments, including, in the case of Nolazol, a number of competitive products already approved for the treatment of ADHD or expected to be commercially launched in the near future; •pricing and cost effectiveness in relation to alternative treatments; 27 •if the product is included under physician treatment guidelines as a first-, second-, or third -linetherapy;