#Switzerland #NLS Pharmaceutics #Zurich #Kadimastem #NewCelX

NLS Pharmaceutics and Kadimastem to Merge: Major Nasdaq Approval Achieved

On October 21, 2025, NLS Pharmaceutics Ltd. (Nasdaq: NLSP) received an important approval letter from Nasdaq, signaling a new chapter for the Swiss-based biopharmaceutical company. This approval allows NLS to list its common shares on the Nasdaq Capital Market post-merger with Kadimastem Ltd., a company engaged in advanced cell therapies, particularly those addressing neurodegenerative diseases and diabetes. This merger marks a significant moment for both companies and is expected to be finalized by October 30, 2025, with trading under the new name, NewcelX Ltd., commencing the following day.

As per the merger conditions, Kadimastem shareholders will hold a substantial 84.4% of the combined company's issued share capital, while NLS shareholders will retain around 15.6%. This distribution reflects the relative value contributions of both entities based on pre-determined terms and guidelines. The final exchange ratio suggests that each Kadimastem share will convert into approximately 6.92 NLS shares before a reverse stock split, cementing the combined firms’ future potential. No fractional shares will be issued, simplifying the ownership transition process.

The merger will facilitate the consolidation of programs aimed at treating serious conditions affecting the central nervous system, notably through two major clinical trials: AstroRx® and IsletRx. AstroRx® focuses on developing therapies for Amyotrophic Lateral Sclerosis (ALS), currently undergoing a Phase 2a clinical trial in the U.S. Adequate preparations, including a clinical manufacturing agreement with Pluri Inc., have been made to ensure efficient execution of the trial protocols.

IsletRx, on the other hand, represents Kadimastem's innovative response to insulin-dependent diabetes, leveraging stem cell-derived islet cell therapy. Following successful discussions with the U.S. Food and Drug Administration, this program will proceed towards a Phase 1 clinical trial, once further preclinical safety evaluations are completed. Both firms are poised for a period of intensive development aimed at bringing these critical therapies to market.

NLS Pharmaceutics has established its reputation as a leading player in the biopharmaceutical sector, dedicated to offering innovative solutions for CNS disorders. This merger with Kadimastem is set to expand their influence and reach, especially given the latter's expertise in developing advanced cell therapies.

As the merger date approaches, management teams from both companies express a shared optimism regarding the combined entity’s future and its poised advancements in medical therapies. They have indicated that despite the challenges inherent in the integration process and regulatory landscapes, the potential benefits far outweigh the risks. This optimism is also reflected in their commitment to keeping all stakeholders updated on developments as they unfold.

Ultimately, the formation of NewcelX Ltd. heralds a promising trajectory not only for the companies involved but potentially for patients worldwide who are affected by debilitating conditions such as ALS and diabetes. As the clinical development progresses, both investors and medical communities are keenly watching to see how these developments will unfold in the forthcoming months.