Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 125

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 125
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 NLS will be subject to additional risks related to entering into or maintaining international business relationships, including: •different regulatory requirements for drug approvals in foreign countries; •differing United States and foreign drug import and export rules, tariffs and other trade barriers; •reduced protection for intellectual property rights in foreign countries; 27 •NLS’s failure to obtain regulatory approvals for the use of its products in various countries; •different reimbursement systems; •economic weakness, including inflation, or political instability in particular foreign economies and markets; •multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; •complexities associated with managing multiple payor reimbursement regimes, government payors or patient self -paysystems; •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