Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 365

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 365
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 this strategy also allows it to potentially seek FDA approval using the 505(b)(2) regulatory pathway for both product candidates. • Develop products with differentiated pharmacological profiles. NLS is developing product candidates with dual mechanisms of action. For example, Quilience and Nolazol utilize a dual mechanism of action, resulting in a unique pharmacological profile targeting multiple neuronal pathways that are widely thought to be disrupted and lead to the disorders targeted by NLS’s product candidates. NLS believes that products with clearly differentiated features, as compared to currently available drug therapies, will be attractive to patients and physicians and will provide it with a competitive commercial advantage. • Maximize the therapeutic potential of NLS’s existing targets and product candidates.Given the central physiological roles played by the distinct targets of NLS’s lead and follow -onproduct candidates, NLS believes that there is significant potential for NLS to address multiple indications and NLS’s goal is to expand the therapeutic and commercial potential of NLS’s existing product candidates to additional indications. For example, NLS plans to explore the development of Quilience for the treatment of IH, another rare CNS disorder for which Quilience received orphan drug designation in the U.S. and in Europe. • Deploy NLS’s value -driven approach to broaden NLS’s sleep -related product portfolio.NLS’s team has extensive experience in CNS research and a strong record of publication in peer -reviewedjournals and NLS plans to develop additional product candidates to treat indications with a high unmet medical need, and may seek to in -licensefrom or collaborate with third parties to develop product candidates that NLS believes are highly differentiated, promising therapeutic candidates that address major unmet clinical needs. 195 NLS’s scientifically rigorous approach to evaluating new opportunities includes a robust asset evaluation of key factors, including the unmet medical need, biological rationale, safety profile, as determined by applicable regulatory agencies, feasibility of clinical development, potential for accelerated development path, regulatory approval, intellectual property position, competitive landscape and commercial potential. Manufacturing and Suppliers NLS does not own or operate manufacturing or distribution facilities for the production of its product candidates and NLS currently relies, and expects to continue to rely, on third parties for the manufacturing, packaging, labelling and distribution of its product candidates for pre -clinicaland clinical testing, as well as for future commercial manufacturing, if its product candidates receive marketing approval. NLS requires all of its contract manufacturing organizations to conduct manufacturing activities in compliance with cGMP requirements and although NLS