NLS Pharmaceutics and Kadimastem Affirm Ongoing Support for ITOL-102 Diabetes Program Post-Merger
On October 29, 2025, NLS Pharmaceutics Ltd. and Kadimastem Ltd. confirmed the ongoing support of the ITOL-102 diabetes program following their merger. The collaboration is backed by a grant from the Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation, known for promoting industrial collaborations between Israel and the U.S. Established in 1977, BIRD has provided over $300 million in funding for nearly 1,000 projects, boasting significant returns on investment through commercial sales exceeding $10 billion.
The ITOL-102 program aims to develop an innovative cell therapy for Type 1 Diabetes that utilizes stem-cell-derived pancreatic islet cells, potentially offering a cure without lifelong immunosuppression. This project will continue under the newly formed entity, NewCelX Ltd., which emerges from the merger of NLS and Kadimastem.
The BIRD Foundation's commitment to the ITOL-102 initiative reflects its mission to foster beneficial partnerships that drive technological advancements toward real-world applications. Omer Carmel, the BIRD Foundation's Director of Business Development, expressed optimism for the project, emphasizing the goal of facilitating collaboration between U.S. and Israeli companies to bring scientific breakthroughs into tangible healthcare solutions.
Ronen Twito, the Executive Chairman and CEO of Kadimastem, who will retain his position in NewCelX, expressed gratitude for the BIRD Foundation's unwavering support and highlighted its importance in advancing the ITOL-102 project toward clinical readiness. This strategic milestone underscores NLS's dedication to expanding its horizons into regenerative and metabolic medicine, extending beyond its traditional focus on central nervous system disorders.
“This merger allows us to synergize our efforts and resources, aligning our ambitions and capabilities,” he stated. Twito believes that with both NLS and Kadimastem’s collective expertise and the backing of BIRD, NewCelX is well-positioned to drive this promising therapy through the crucial stages of development and into clinics.
The therapy's foundation lies in state-of-the-art stem cell technology, aiming for a groundbreaking breakthrough in the management and potential cure of Type 1 Diabetes. As they progress, the collaborative nature of NewCelX will become essential in tackling the challenges faced in clinical trials and regulatory approvals, not least in validating the efficacy and safety of the therapies developed.
In the wider context, this merger opens up new avenues for leveraging advanced treatments that stand to benefit patients worldwide. By combining the resources and scientific innovations of both companies, NewCelX is poised to become a formidable player in the biopharmaceutical landscape, providing hope for those suffering from chronic conditions like diabetes.
NLS Pharmaceutics, headquartered in Switzerland and traded on Nasdaq under the symbol NLSP, is renowned for its focus on developing advanced therapies aimed at central nervous system disorders. On the other hand, Kadimastem, listed on the Tel Aviv Stock Exchange, specializes in creating clinical cell therapies for neurodegenerative diseases and diabetes, ensuring a complementary mix of expertise.
As NewCelX pursues its aspirations, it will continue to maintain collaborative relationships with key industry partners, including iTolerance Inc. from Miami, further amplifying the potential impact of its initiatives.
In summary, the continuity of the ITOL-102 program, supported by the BIRD Foundation post-merger, reflects strategic growth and partnership in the biopharmaceutical sector. This merger not only enhances the capabilities of NLS and Kadimastem but also instills confidence in their commitment to innovate and transform the treatment landscape for diabetes and other debilitating diseases. As the healthcare community awaits the results of clinical investigations, the efforts of NewCelX hold promising potential in altering the course of diabetes treatment significantly.