Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 301

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 301
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 centralized procedure. These review mechanisms may ultimately lead to approval in all EU countries, but each method grants all participating countries some decision -makingauthority in product approval. The UK has a separate review period but for a transitional period until 31 December 2022, may rely on approvals under the EU mutual recognition and/or centralized procedure. Foreign governments also have stringent post -approvalrequirements including those relating to manufacture, labeling, reporting, record keeping and marketing. Failure to substantially comply with these on -goingrequirements could lead to government action against the product, us and/or Kadimastem’s representatives. Company Information We were established as an Israeli company on October 6, 2008. We began trading on the TASE in June 2013. 161 NLS’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read in conjunction with NLS’s unaudited interim condensed financial statements and related notes as of and for the six months ended June 30, 2024, included as Exhibit 99.1 to the Report on Form 6 -K file with the SEC on October 18, 2024. This discussion and other parts of the interim report contain forward -looking statements based upon current expectations that involve risks and uncertainties. NLS’s actual results and the timing of selected events could differ materially from those anticipated in these forward -looking statements as a result of several factors, including but not limited to those set forth under Item 3.D. “Risk Factors” in NLS’s Annual Report on Form 20 -F for the year ended December 31, 2023, or the Annual Report, on file with the SEC and those set forth in this proxy statement/prospectus. Overview We are a clinical -stagebiopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex CNS disorders, which have unmet medical needs. Our lead compound mazindol, a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary extended -releaseformulation, is being developed for the treatment of narcolepsy (lead indication) and ADHD (follow -onindication). We believe that this dual mechanism of action will also enable mazindol ER to have the potential therapeutic benefit in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. We have no product candidates approved for