Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 441

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 441
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, depending on the type of drug for which approval is sought, there are currently two potential tracks for marketing approval in the European countries: mutual recognition and the 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 December 31, 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, Kadimastem and/or Kadimastem’s representatives. Company Information Kadimastem was established as an Israeli company on October 6, 2008. Kadimastem began trading on the TASE in June 2013. 232 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 financial statements and related notes included elsewhere in this proxy statement/prospectus. This discussion and analysis contains 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 in the section entitled “Risk Factors” in this proxy statement/prospectus. This discussion does not give effect to the possible impacts of the Merger. Overview We are an emerging biopharmaceutical company engaged in the discovery and development of life -improvingdrug therapies to treat rare and complex CNS disorders who have unmet medical needs. Our lead compound mazindol, a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary ER formulation, 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 provide potential therapeutic benefits in other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. Recently, we launched a preclinical program evaluating Mazindol ER as a treatment for fentanyl dependence, aiming to offer a non -opioidalternative in combating the opioid crisis. Our DOXA platform