Company: NCEL
Filing Date: 2025-10-17
Form Type: POS AM
Source: 0001213900-25-099986
Chunk: 7

Company: NewcelX Ltd.
Filing Date: 2025-10-17
Form: POS AM
Chunk 7
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. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward -lookingstatements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. All information included herein relating to shares or price per share reflects the 1 -for-40reverse split effected by us on September 27, 2024. Unless otherwise indicated, “we,” “us,” “our,” the “Company” and “NLS” refer to NLS Pharmaceutics Ltd. and its wholly owned subsidiary, NLS Pharmaceutics Inc., a Delaware corporation. 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 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