NLS Pharmaceutics Announces Merger with Kadimastem and Secures $25 Million Financing Facility

NLS Pharmaceutics announced a strategic merger with Kadimastem Ltd. and secured a $25 million equity facility. The merger aims to create a Nasdaq-listed entity, NewcelX, with a robust pipeline in neurodegenerative diseases, diabetes, and CNS disorders. Positive clinical developments were reported, including preclinical data for AEX-2 and successful FDA meetings for Type 1 Diabetes treatment. The merger is expected to enhance the company's strategic position and provide comprehensive therapeutic options for patients.

NLS Pharmaceutics Ltd. (NASDAQ: NLSP) and Kadimastem Ltd. (TASE: KDST) have announced a strategic merger that will create a Nasdaq-listed entity, NewcelX. The merger aims to unite the companies' complementary strengths in neurodegenerative diseases, diabetes, and central nervous system (CNS) disorders, thereby enhancing the combined company's strategic position and providing comprehensive therapeutic options for patients.

In a letter to shareholders, NLS Pharmaceutics reported significant progress since the fourth quarter of 2024. The company completed major financing events, raising over $6 million to support the merger and the combined company's clinical trials post-merger. Additionally, the company converted all outstanding liabilities into equity, reflecting a strong balance sheet free of debt.

Positive clinical and preclinical developments were also highlighted. Encouraging preclinical data for AEX-2, a dual orexin receptor agonist platform for CNS disorders, was announced in February 2025. Furthermore, Kadimastem and iTolerance successfully completed a Pre-IND Meeting with the U.S. Food and Drug Administration (FDA) for their Type 1 Diabetes Treatment, representing a significant asset for the merged company, NewcelX. In April 2025, positive results from Study KO-943 revealed that Mazindol ER significantly reduced fentanyl-induced reward behaviors in animal models, providing important proof-points for both safety and therapeutic potential.

The merger process is progressing, with the target completion date set for early Q3 2025, subject to regulatory requirements. The combined entity, NewcelX, will have a robust pipeline spanning neurodegenerative diseases, diabetes, and CNS disorders. The merger is expected to mark a transformational pivot, uniting the proprietary DOXA platform and cell-therapy assets under one roof.

NLS Pharmaceutics anticipates the closing of the merger to occur in the near future, followed by an energized integration phase and accelerated clinical momentum. The companies are committed to ensuring a smooth integration process and preparing for the initiation of Phase IIa multi-site clinical trials for ALS and Phase I studies for Type I diabetes.

The merger is expected to enhance the combined company's balance sheet and provide flexibility to support future pipeline development. With a fortified capital structure and a unified board guiding research and development direction, NewcelX is strategically positioned for meaningful value creation.

For more information, please visit www.nlspharma.com [1] and www.kadimastem.com [2].

References:
[1] https://www.kadimastem.com/post/kadimastem-shares-that-nls-pharmaceutics-ceo-issues-letter-to-shareholders
[2] https://www.kadimastem.com/post/kadimastem-shares-that-nls-pharmaceutics-ceo-issues-letter-to-shareholders