NLS and Kadimastem: Swiss-israeli merger in ALS

NLS Pharmaceutics Ltd. (NASDAQ: NLSP) a Swiss clinical-stage biotech focused on CNS disorders, has completed a US$2 million equity financing at a 10% premium to market, with a potential second tranche of US$1m pending shareholder approval. The proceeds will primarily fund its planned merger with Kadimastem, an Israeli cell therapy company targeting Amyotrophic Lateral Sclerosis (ALS) and type 1 diabetes.

In parallel, NLS has signed a US$25 million committed equity facility, providing financial runway to support the merger and post-merger clinical activity. Specifically, the funding will advance Kadimastem’s Phase IIa multi-site ALS trial (AstroRx®), already FDA-approved for trial, and Phase I diabetes programme (IsletRx), expected to launch post-merger.

NLS just announced promising results in a different indication from study KO-943, demonstrating that Mazindol effectively reduces fentanyl-induced reward in an animal model. This research highlights Mazindol’s potential as a novel, non-opioid solution for treating fentanyl use disorder, a pressing issue contributing to the opioid crisis in the U.S. After the merger this project “will be positioned separately for strategic opportunities post-merger”, as the company told. Mazindol’s unique multi-mechanism profile could play a significant role in addressing addiction therapeutics.

Executives from both firms hailed the financing as a strong endorsement of the merger’s value proposition. “We are pleased to have secured this capital on favorable terms, which reflects investor confidence in our vision and the transformative potential of our planned merger with Kadimastem,” said Alex Zwyer, CEO of NLS. “We believe that with these financial resources in place, we are well-positioned to move forward with completing the transaction and creating a leading company in the field of regenerative medicine and CNS disorders.”

The transaction remains subject to regulatory and shareholder approvals and follows the recent amendment of NLS’s Form F-4 with the SEC. This financing was conducted via private placement and is exempt from US registration under the Securities Act.

The merged company aims to become a leader in regenerative medicine, combining NLS’s CNS expertise with Kadimastem’s proprietary allogeneic stem cell platforms.