Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 297

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 297
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 other rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. We have no product candidates 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. For the six months ended June 30, 2024, we have an accumulated deficit of $72.4 million. In February 2019, we entered into a license agreement, or the EF License Agreement, with Eurofarma Laboratorios S.A., or Eurofarma, to develop and commercialize our product candidate, Nolazol, in Latin American countries with Eurofarma. The EF License Agreement covers the grant of non -transferablelicenses, without the right to sublicense, to Eurofarma to develop and commercialize Nolazol in Latin America. Under the EF License Agreement, we received a non -refundable, upfront payment of $2,500,000 and are further eligible to receive nonrefundable milestone payments of up to $16,000,000, based on the achievement of milestones related to regulatory filings, regulatory approvals and the commercialization of Nolazol. As of June 30, 2024, and December 31, 2023, we have long -termdeferred revenues of $2,500,000, which will be recognized when the development services of Nolazol are completed, and the product candidate receives applicable regulatory approval in Latin America that allows Eurofarma to commence commercialization of Nolazol in accordance with the EF License Agreement. The EF License Agreement was terminated on August 28, 2024, effective as of September 30, 2024. It was mutually agreed that neither party has any claims against the other in relation to the Agreement or its termination. Consequently, the deferred revenues amounting to $2,500,000 will be realized as of the termination date. On March19, 2024, NLS entered into an exclusive license agreement, or the Aexon License Agreement, with Aexon. Pursuant to the Aexon License Agreement, Aexon granted NLS an exclusive, royalty -bearinglicense, or the License, with the right to