Kadimastem and NLS Pharmaceutics Announce SEC Clearance for Merger Completion

Kadimastem and NLS Pharmaceutics Join Forces for NewCelX Ltd.

In a significant development for the biopharmaceutical industry, Kadimastem Ltd. and NLS Pharmaceutics Ltd. have announced that their merger is on track following the effectiveness of the SEC registration statement. This crucial milestone was reached on September 9, 2025, marking the final regulatory obstacle prior to the merger's completion. The newly formed entity, expected to be named NewCelX Ltd., aims to innovate in the treatment of central nervous system disorders and metabolic diseases.

SEC Effectiveness: A Major Step Forward

The U.S. Securities and Exchange Commission's acceptance of the registration statement related to the merger emphasizes the strong potential of this agreement. This decision allows both companies to unify their expertise—the cutting-edge cell therapy capabilities of Kadimastem with the small molecule therapeutic focus of NLS Pharmaceutics.

Kadimastem's Executive Chairman and CEO, Ronen Twito, expressed excitement over this development, indicating that it marks a pivotal point in the collaborative journey towards creating effective solutions for patients with severe unmet medical needs. Similarly, Alexander C. Zwyer, CEO of NLS Pharmaceutics, underscored the merger as a transformational opportunity that could lead to a diverse pipeline of innovative therapies and a broader global presence.

Clinical and Strategic Advancements

Both companies come into this merger with robust clinical strategies that aim to tackle critical healthcare challenges. For instance, Kadimastem is positioning itself to launch a Phase 2a clinical trial for AstroRx®, aimed at treating Amyotrophic Lateral Sclerosis (ALS). They are currently in the preparatory stages, finalizing regulatory approvals and selecting trial sites across the U.S. This trial represents a significant advancement in Kadimastem's strategic initiatives.

Moreover, Kadimastem is actively advancing its IsletRx program, which focuses on scalable stem cell-derived islet cell therapy to address insulin-dependent diabetes. With continued support from the BIRD Foundation following a successful pre-IND meeting with the FDA, this program stands to further enhance the partnership's clinical offerings.

The Future of NewCelX Ltd.

Upon the merger’s finalization, the combined company will maintain its presence on the Nasdaq under the ticker symbol NCEL. The merger is expected to foster a robust pipeline, where Kadimastem’s advancements in cell therapies can synergistically align with NLS Pharmaceutics’ expertise. This collaboration aims to broaden therapeutic solutions available for patients struggling with CNS disorders and metabolic diseases.

Both company leaders have expressed a commitment to leveraging their collective strengths to innovate and improve treatment accessibility. “We are thrilled to be on the brink of merging our operations to form NewCelX,” said Twito, noting that the unification of their teams will bolster their mission to deliver transformative therapies.

Next Steps and Investor Engagement

Looking forward, the extraordinary general meeting scheduled for September 29 will be key in moving forward with this merger. Investors and shareholders from both organizations are encouraged to engage in the upcoming discussions regarding the future directions of NewCelX and its prospective impact on the biopharmaceutical landscape.

In conclusion, the merger of NLS Pharmaceutics and Kadimastem into NewCelX Ltd. is poised to make significant waves in biotech innovation. With a diverse clinical pipeline and a strong market positioning, the merged entity could become a leader in delivering cutting-edge therapies to those in critical need.

For more information about NLS Pharmaceutics, visit www.nlspharma.com, or for Kadimastem, visit www.kadimastem.com.