Company: NCEL
Filing Date: 2025-11-06
Form Type: POS AM
Source: 0001213900-25-106799
Chunk: 7

Company: NewcelX Ltd.
Filing Date: 2025-11-06
Form: POS AM
Chunk 7
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 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 has made significant strides. The development of AEX -41and AEX -2compounds showcases our dedication to addressing unmet needs in sleep -wakedisorders. Preliminary studies have yielded promising results, reinforcing our confidence in these compounds’ potential to transform patient care. NLS has no products approved for commercialization and have never generated any revenue from product sales. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. It may be several years, if ever, before we complete pivotal clinical studies and have a product candidate approved for commercialization and we begin to generate revenues and royalties from product sales. We have also incurred significant operating losses. As of June 30, 2025, we have an accumulated deficit of $74.8 million. As of June 30, 2025, our cash and cash equivalents were $3.1 million. We believe that our existing cash and cash equivalents will not be sufficient to fund our projected operating requirements for a period of one year from the issuance of the financial statements included elsewhere in this Report on Form 6 -K. Our financial statements have been presented on the basis that we are a going concern, which contemplates the realization of revenues and the satisfaction of liabilities in the normal course of business. We have incurred losses from the inception of our operations. These factors raise substantial doubt about our ability to continue as a going concern. Merger Agreement In July 2024, we entered into a binding term sheet with Kadimastem, a clinical -stagecell therapy company developing and manufacturing “off -the-shelf” allogeneic cell products for the treatment of neurodegenerative diseases and potential cure of diabetes, whereby Kadimastem will become our wholly owned subsidiary, and Kadimastem’s shareholders will acquire an 85% interest in NLS, or the Transaction. Upon completion of the Transaction, which is subject to, among other things, approval by NLS and Kadimastem shareholders, the combined company is expected to operate under 3 the name Kadimastem and be traded on the Nasdaq Capital Market. Under the proposed terms, existing Kadim