Announcement • Jul 17
Bird Foundation Approves Additional Milestone Payment to Kadimastem and Itolerance for Continued Co-Development of Type 1 Diabetes Cell Therapy NLS Pharmaceutics Ltd. announced that the Israel-U.S. Binational Industrial Research and Development Foundation has approved another milestone-based funding payment to Kadimastem Ltd., iTolerance, Inc. 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 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. Kadimastem's IsletRx technology, a scalable, stem cell-derived source of insulin-producing islet-like cells, is combined with iTolerance's proprietary iTOL-100 immunomodulatory platform in iTOL-102. In preclinical studies, the combined therapy demonstrated functional insulin secretion and disease reversal in diabetic animal models. The product has been tested at the Diabetes Research Institute at the University of Miami and is regarded as a potential breakthrough in transplant-based diabetes therapies. The companies are currently preparing for safety toxicology studies and the initiation of clinical trial submissions based on FDA guidance. Announcement • May 19
Kadimastem Ltd, Annual General Meeting, Jun 19, 2025 Kadimastem Ltd, Annual General Meeting, Jun 19, 2025. Location: sullivan & worcester tel-aviv, Israel Announcement • Feb 26
Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment NLS Pharmaceutics Ltd. and Kadimastem Ltd. announced the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration ("FDA") on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem's allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance's immunomodulator (iTOL-100). Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation.iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100.Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial. Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes.iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets.Kadimastem's IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. Announcement • Feb 11
NLS Pharmaceutics Ltd. and Kadimastem Ltd. Unveil Multi-Target Approach to Diabetes, Expanding Beyond GLP-1 Therapies NLS Pharmaceutics Ltd. and Kadimastem Ltd. are on a mission to create a leading biotechnology entity. The upcoming expected merger aims to transform the treatment landscape for complex conditions such as diabetes. By uniting the core competencies of both organizations, NLS and Kadimastem believe that this merger is positioned to potentially create a holistic solution that addresses the multifaceted challenges of diabetes management. Cathepsin Inhibition (CTSS/CTSL): Aiming to protect neuronal integrity and b-cell survival, crucial for long-term metabolic health. Sodium-Glucose Cotransporter-2 (SGLT2) Modulation: Aiming to improve glucose metabolism while reducing neuropathic and vascular damage. Adiponectin Receptor Activation: Aiming to enhance insulin sensitivity and mitochondrial function, addressing core metabolic dysfunctions. Preclinical studies to be presented at the 2025 ASCP Annual Meeting demonstrate that DOXA compounds: Restore orexinergic function, improving metabolic balance and sleep- wake disturbances. Reduce inflammatory markers and neurodegeneration, preventing diabetes-induced neuronal damage. Enhance b-cell survival and glucose metabolism, positioning DOXA as a disease-modifying therapy rather than a glucose-dependent intervention. For example, NLS and KadimASTem are using forward-looking statements when they discuss the expected closing of the transaction and the potential benefits of the transaction to NLS and KadimastEM and their respective shareholders, including value creation for shareholders, the expected strategic position of the combined company following the merger, if completed and the expected benefits of DOXA in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastimastem and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements: risks related to the companies' ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies' products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the companies' patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or or or or or any other companies may adversely impact either or or other companies or other companies or other companies may be able to retain or attract key employees who may be able to retain or attracting key employees whose knowledge is essential To the development of their products; unexpected scientific difficulties may develop with the product being advanced by the companies; Their products may wind up being more costly than anticipated; results in the lab may not translate to equally good Results in real clinical settings; results the results of preclinical studies may Not correlate with the results of humanclinical trials; the companies' patents will not be sufficient; their products will harm recipients; changes in legislation will adversely impact either or or or other companies will affect either or or other companies. Announcement • Dec 19
NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment NLS Pharmaceutics Ltd. and Kadimastem Ltd. (Kadimastem) announced in collaboration with iTolerance, Inc, (iTolerance that a request for a Pre-Investigational New Drug ("Pre-IND") meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration (FDA) for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment. This submission comes after a successful INTERACT ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation ("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes. iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets. Kadimastem's IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. The iTOL102 product was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated by DRI to be a novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrating functional insulin release and disease reversal in an animal model. As previously reported, NLS Pharmaceuticals and Kadimastem entered into an agreement and plan of merger in November 2024. The merger is subject to closing conditions, including the approval of the shareholders of each of the NLS Pharmaceutics and Kadimastem. Announcement • Jul 30
Kadimastem Ltd (TASE:KDST) signed a letter of intent to acquire NLS Pharmaceutics AG (NasdaqCM:NLSP) in a reverse merger transaction. Kadimastem Ltd (TASE:KDST) signed a letter of intent to acquire NLS Pharmaceutics AG (NasdaqCM:NLSP) in a reverse merger transaction on July 29, 2024. In consideration, NLS will issue its shares to the Kadimastem shareholders who, after completing the Transaction, will hold 85% of the issued and outstanding shares of NLS, and the existing shareholders of NLS will hold the remaining 15% of NLS. Tthe combined company is expected to operate under the name Kadimastem and be traded on the Nasdaq Capital Market. Under the proposed terms, existing Kadimastem shareholders will hold 85% of the issued and outstanding shares of the merged company and the existing shareholders of NLS will hold the remaining 15% of the issued and outstanding shares of NLS.
The definitive agreement is expected to be executed in September 2024. The transaction is subject to approval of offer by acquirer shareholders and approval of offer by target shareholders. The expected completion of the transaction is before December 31, 2024. 
