Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 89

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 89
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 the section entitled “Risk Factors” in this proxy statement/prospectus. These risks are summarized below. Summary of Risk Factors Investing in our common shares and Warrants involves substantial risks. Our ability to execute our strategy is also subject to certain risks. The risks described below may cause us not to realize the full benefits of our strengths or may cause us to be unable to successfully execute all or part of our strategy. In particular, our risks include, but are not limited to, the following summary of such risk factors: Risks Related to Our Business •We may be unable to successfully use mazindol, on which we depend substantially, as the drug substance for each of our current clinical mid -stageproduct candidates, Quilience, for the treatment of narcolepsy, and Nolazol, for the treatment of ADHD, and which outcome could prove costly to our business and could prevent us from obtaining regulatory or marketing approval; •We may not be able to initiate our Phase 3 clinical trials in Quilience without additional pre -clinicalstudies, chemistry, manufacturing, controls, work or early -stageclinical trials; •Prior results of mazindol for the treatment of other indications may not be replicated in the clinical trials that we conduct for the treatment of narcolepsy or ADHD; and •If, and when, we seek to commercialize Quilience and/or Nolazol, we may be partially dependent upon prescriptions from physicians for the sale of both such product candidates, and therefore, the loss of a significant number of patient referrals by physicians prescribing Quilience and/or Nolazol may have an adverse effect on our future revenues, if any, which could have an adverse effect on our business, financial condition and results of operations. Risks Related to Our Relationships with Third Parties •We are dependent on a sole manufacturer for mazindol drug substance as well as the drug product. Any delay, price increase or unavailability of mazindol could materially adversely affect our ability to conduct clinical trials and, if this were to occur after we obtained commercialization and marketing approval, could cause us to cease operations. •We may seek to form additional strategic alliances in the near future with respect to our product candidates and to mazindol in particular, and if we do not achieve such alliances, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected. Risks Related to Our Intellectual Property •If we are unable to obtain and maintain effective patent rights for our