Kadimastem and NLS Pharmaceutics Clear Final SEC Hurdle for Merger Creating NewCelX
Key Insights
The SEC has declared effective the registration statement for the merger between Kadimastem (search) and NLS Pharmaceutics, marking the final U.S. federal regulatory hurdle for the transaction.
The combined company, NewCelX Ltd. (search), will trade on Nasdaq under ticker "NCEL" and unite Kadimastem (search)'s cell therapy platforms with NLS's small-molecule expertise.
Kadimastem (search) is preparing to initiate a Phase 2a clinical trial of AstroRx for ALS (search) treatment and continues advancing IsletRx (search) for insulin-dependent diabetes (search).
Kadimastem (search) Ltd. and NLS Pharmaceutics Ltd. have achieved a critical milestone in their proposed merger, with the U.S. Securities and Exchange Commission declaring effective their registration statement on Form F-4. This regulatory clearance represents the final U.S. federal securities hurdle required for closing the transaction that will create NewCelX Ltd. (search), a combined biotechnology company with complementary therapeutic approaches.
Merger Creates Diversified Biotech Platform
Upon completion, the merged entity will remain a publicly traded biotechnology company listed on Nasdaq under the ticker "NCEL." The combination unites Kadimastem (search)'s proprietary cell therapy platforms with NLS's expertise in small-molecule therapies, creating a diversified pipeline targeting central nervous system disorders (search) and metabolic diseases.
Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, emphasized the transformational nature of the deal: "We believe this combination represents a transformational opportunity to build a next-generation biotechnology company with a diversified pipeline and global reach."
Advanced Clinical Programs Drive Value
Kadimastem (search) enters the merger with significant clinical momentum. The company is preparing to initiate a Phase 2a clinical trial of AstroRx® in the United States for the treatment of amyotrophic lateral sclerosis (ALS (search)), with global trial site selection and regulatory preparations currently underway.
The company's diabetes program also shows substantial progress. Kadimastem (search) continues to advance IsletRx (search), its scalable, stem cell-derived islet cell therapy for insulin-dependent diabetes (search). The program, developed in collaboration with iTolerance (search), has received continued support from the BIRD Foundation (search) following a successful Pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration earlier this year.
Strategic Positioning and Market Access
Ronen Twito, Executive Chairman and CEO of Kadimastem (search), highlighted the strategic benefits of the merger: "We believe the merger strengthens our global position, provides access to U.S. capital markets, and reinforces our mission to develop transformative therapies for patients suffering from some of the most challenging diseases."
The transaction is expected to close following an extraordinary general meeting scheduled for September 29, 2025. The merger will provide the combined company with enhanced access to U.S. capital markets while maintaining its focus on developing innovative therapies for patients with high unmet medical needs.
Company Profiles
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) is a Swiss-based biopharmaceutical company focused on developing innovative therapies for central nervous system disorders (search) and related indications. Kadimastem (search) Ltd. (TASE: KDST) is a clinical-stage cell therapy company developing allogeneic, "off-the-shelf" cell products for neurodegenerative diseases (search) and diabetes.