Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 397

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 397
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’s research and development efforts are focused primarily in the following areas and serve as a basis for future development, if any, of a more diverse product pipeline, of which certain product candidate leads, such as NLS -4are in preclinical development stages. As NLS navigates the competitive landscape of its industry, while focusing on development of its product candidates, NLS also intends to continually pursue out -licensingagreements and asset sale transactions that it believes will allow us to drive greater value for its shareholders. Key elements of NLS’s research and development strategy include the following: • Efficiently advance NLS’s lead product candidate, Quilience, and follow -on product candidate, Nolazol, through marketing approval.NLS plans to first advance the development of Quilience, followed by the development of NLS -4(follow on). If successful, NLS plans to initially file for marketing approval in the United States and potentially also in the EU for Quilience and subsequently develop NLS -4(NCE) for post -COVIDchronic fatigue syndrome for global markets. • Find partners for out -licensing and asset sale agreements.While NLS continues with its goal of progressing its product candidates, Quilience and Nolazol, on its own into further clinical development in order to initiate commercialization of such product candidates, NLS may seek to enter into transactions to sell or out -licenseQuilience, Nolazol or certain other product candidates or intellectual property that it develops. This strategy allows NLS to potentially create value for its shareholders ahead of its approval timelines. • Reduce clinical and regulatory risk, limit development costs, and accelerate time to market.NLS’s product candidates, Quilience and Nolazol, incorporate a known molecule in a proprietary CR and ER formulation. The former immediate release formulation of mazindol has a well -establishedsafety record from its long history of clinical use across the United States and several countries in Europe and, as a result thereof, a well -characterizedsafety profile that has allowed NLS to rapidly begin conducting clinical development of Nolazol and to generate supportive Phase 2 data in a study conducted in 85 patients with ADHD in the United States in May 2017 and complete a Phase 2 study in patients with narcolepsy in the United States. NLS believes that 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