Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 398

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 398
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 use |
| Lauflumide and derivatives thereof for treating chronic fatigue syndrome and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)                                                                                               
 EP 21305944.7                                                                                                                                                                                                                          |     | Europe        |     | Not Applicable  |     |             |     | Compound for use |

In addition to NLS’s patents and patent applications, NLS also relies on unpatented trade secrets, know -how, and continuing technological innovation to develop and maintain NLS’s competitive position. NLS seeks to protect its ownership of know -howand trade secrets through an active program of legal mechanism including invention assignments, confidentiality agreements, material transfer agreements, research collaborations and licenses to protect NLS’s product candidates. For a more comprehensive discussion of the risks related to NLS’s intellectual property, please see “ Risk Factors — NLS Risks Related to its Intellectual Property.” Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies and intense competition. While NLS believes that its knowledge, experience and scientific resources provide it with competitive advantages, NLS faces potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions, which may in the future develop products to treat those diseases that NLS currently or, in the future, seeks to treat. Any product candidates that NLS successfully develops and commercializes may compete with existing therapies and new therapies that may become available in the future. Many of NLS’s competitors have far greater marketing and research capabilities than NLS. All of these companies and institutions may have product candidates in development that are or may become superior to Quilience and Nolazol. NLS’s commercial opportunity would be reduced significantly if NLS’s competitors develop and commercialize products that are safer, more effective, more convenient, have fewer side effects or are less expensive than either or both of Quilience or Nolazol. Public announcements regarding the development of competing drugs could adversely affect the commercial potential of either or both of Quilience and Nolazol. Narcolepsy NLS faces competition from established pharmaceutical and biotechnology companies that currently market products for the treatment of symptoms in narcolepsy. There is no cure and many patients report that their medicines do not improve their complete range of symptoms. For the treatment of both EDS and cataplexy, NLS believes that currently NLS’s only competitors are Jazz Pharmaceuticals (Xyrem/Xywav ®