NLS Pharmaceutics and Kadimastem Announce SEC Approval for Proposed Merger

NLS Pharmaceutics and Kadimastem announce the effectiveness of their SEC registration statement, a major milestone in their planned merger to form NewCelX Ltd. The combined company will remain a publicly traded biotech firm listed on Nasdaq. Kadimastem's cell therapy platforms will unite with NLS's small-molecule therapies. The merger will create a diversified pipeline in CNS disorders and metabolic diseases, with Kadimastem preparing to initiate a Phase 2a clinical trial of AstroRx in ALS and advancing its IsletRx program for insulin-dependent diabetes.

NLS Pharmaceutics Ltd. (Nasdaq: NLSP) and Kadimastem Ltd. (TASE: KDST) have announced a significant milestone in their merger process, as the U.S. Securities and Exchange Commission (SEC) has declared effective the registration statement on Form F-4 related to their proposed merger. This marks the final U.S. federal securities regulatory hurdle required for closing the merger Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger^[1].

The merger, set to create NewCelX Ltd., will combine Kadimastem's advanced clinical-stage cell therapy platforms with NLS's expertise in small-molecule therapies. The resulting company will be a publicly traded biotechnology firm listed on Nasdaq under the ticker "NCEL". The merger will create a diversified pipeline in central nervous system (CNS) disorders and metabolic diseases.

Kadimastem is preparing to initiate a Phase 2a clinical trial of AstroRx in the United States for the treatment of ALS, with global trial site selection and regulatory preparations underway. The company is also advancing its IsletRx program, a scalable, stem cell-derived islet cell therapy for insulin-dependent diabetes, which has received continued support from the BIRD Foundation following a successful Pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration earlier this year Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger^[1].

Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, stated, "We are thrilled to announce this pivotal milestone. The SEC clearance of our F-4 filing marks the final step on the U.S. federal regulatory path toward closing our merger with Kadimastem. We believe this combination represents a transformational opportunity to build a next-generation biotechnology company with a diversified pipeline and global reach" Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger^[1].

Ronen Twito, Executive Chairman and CEO of Kadimastem, commented, "We are proud to reach this milestone and to be so close to completing the merger with NLS. Kadimastem is entering an advanced stage in its clinical journey, with a Phase 2a ALS trial for AstroRx® on the horizon and meaningful progress in our IsletRx diabetes program. 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" Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger^[1].

The merger is expected to be completed following an extraordinary general meeting on September 29, 2025. Investors and shareholders are urged to read the proxy statement/prospectus and any other relevant documents filed with the SEC regarding the proposed transaction carefully Kadimastem and NLS Pharmaceutics Announce Effectiveness of SEC Registration Statement in Connection with Proposed Merger^[1].