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NLS Pharmaceutics Ltd. (NASDAQ:NLSP) ("NLS"), a Swiss clinical-stage biopharmaceutical company focused on central nervous system disorders, today announced that the Israel-U.S. Binational Industrial Research and Development Foundation (the "Bird Foundation") has approved another milestone-based funding payment to Kadimastem Ltd. (TASE: KDST) ("Kadimastem"), a clinical-stage cell therapy company developing "off-the-shelf," allogeneic regenerative treatments for neurodegenerative diseases and diabetes, with a U.S.-based company, iTolerance, Inc. ("iTolerance"). The milestone payment is based on the significant progress demonstrated by the companies in the co-development of iTOL-102, a novel cell therapy targeting a potential cure for Type 1 diabetes without the need for life-long immunosuppression.
This news follows the February 2025 announcement by NLS and Kadimastem regarding the successful completion of a Type B Pre-IND meeting with the U.S. Food and Drug Administration (the "FDA"). The FDA provided constructive guidance on the clinical development pathway, enabling the companies to advance toward initiating First-in-Human clinical trials of iTOL-102. The BIRD Foundation's approval of a fifth disbursement of funds is based on the program's recent scientific and regulatory progress.
The milestone payment approved by the BIRD Foundation amounts to approximately NIS 564,400 ($166,000 USD), bringing the total support from the BIRD Foundation to nearly NIS 3 million ($882,352 USD) to date. NLS and Kadimastem believe that the continued financial backing reflects the BIRD Foundation's ongoing confidence in the collaboration between Kadimastem and iTolerance and the clinical promise of iTOL-102.
Posted In: NLSP