Annuncio • 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. Annuncio • May 19
Kadimastem Ltd, Annual General Meeting, Jun 19, 2025 Kadimastem Ltd, Annual General Meeting, Jun 19, 2025. Location: sullivan & worcester tel-aviv, Israel Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • Feb 20
Kadimastem Ltd, Annual General Meeting, Mar 21, 2024 Kadimastem Ltd, Annual General Meeting, Mar 21, 2024, at 12:00 Israel Standard Time. Annuncio • Feb 19
Kadimastem to Delist from TASE Kadimastem Ltd. has announced plans to merge with a Canadian company traded on Nasdaq and to delist from the TASE. Board Change • Jan 08
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Director Doron Birger was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Sep 29
Kadimastem Receives Approval of Patent Registration for Its Cell Selection and Enrichment Technology Used to Develop Its IsletRx Treatment for Diabetes in a Third Territory Kadimastem Ltd. has been granted its third patent approval for the company's innovative cell selection and enrichment technology and its use in the production of IsletRx, the company's treatment and potential cure for diabetes. The third patent was awarded by the Israel Patent Office. The patent for the Company's technology was also recently approved and successfully registered in Japan and Australia. This trend is likely to inspire other patent approvals in other important territories such as in the US. The ability to select and enrich only the highest functioning and puresbt islet cells from the expanded and differentiated population of pluripotent stem cells enables the maximum therapeutic effect. The Israel patent is particularly important as it reconfirms the company's production is high quality and more advanced than others. As a result, Kadimastem now has a competitive advantage with regard to future unique collaborations with international companies like Implant Therapeutics Inc. On June 8, 2022, Kadimastem announced that it signed an agreement with Implant Therapeutics Inc. for use of "Immune Evasive Cell" iACT cells, which are implant cells that the immune system does not recognize as foreign to the body and as such can prevent transplant rejection. A joint feasibility study is underway. If successful, the iACTTM cells could be a good cell source for Kadimastem to create its glucose sensing, insulin producing pancreatic cells, the basis for IsletRx, without the need of immune protection or immunosuppression. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent External Director Ziv Ironi was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Mar 06
Kadimastem Ltd Receives Grant for a Total Budget of ILS 10 Million from the Israeli Innovation Authority Kadimastem Ltd. has received a grant from the Israel Innovation Authority (IIA) for a total budget of ILS 10 million and a net grant of ILS 4 million. The funds will be used to advance the filing of an IND with the FDA by the end of 2022, to secure the approval of the FDA of the anticipated Phase IIa, US, multicenter, clinical trial protocol of AstroRx(R) for the treatment of ALS and expand the use of AstroRx(R) cell product for other neurological conditions such as multiple sclerosis and glaucoma. Annuncio • Dec 01
Kadimastem Ltd announced that it has received ILS 10.000001 million in funding from Ilex Medical Ltd Kadimastem Ltd announced that it has issued 2,347,418 common shares at an issue price of ILS 4.26 per share for gross proceeds of ILS 10,000,001 on November 29, 2021. The transaction included participation from new investor, Ilex Medical Ltd. The company has issued a total of 1,407,130 options in 2 series, at an exercise prices of ILS 7 per share and ILS 8.5 per share. As part of the transaction, Tamar Galili of Ilex Medical Ltd has joined the company's board of directors. Annuncio • Mar 11
Kadimastem Granted Patent in Israel for the Directed Differentiation of Astrorx for Use in Drug Screening and the Treatment of ALS Kadimastem Ltd. announced that it has been granted a patent by The Israel Patent Office for its differentiated human astrocytes from human pluripotent stem cells for use in the treatment and drug screening of Amyotrophic Lateral Sclerosis. Specifically, the patent allows for the innovative method of non-genetically modifying a cell population of human progenitor astrocytes or astrocytes, for use in the treatment or prevention of the progression of ALS in a human subject in need and screening an agent for preventing or treating Amyotrophic Lateral Sclerosis by using this cell population. Kadimastem's product, AstroRx®, is comprised of a differentiated cell population of human astrocytes derived from human pluripotent stem cells and is in clinical development as a therapeutic treatment for ALS. Kadimastem recently announced encouraging results of the Cohort B of its Phase 1/2a Clinical Trial of AstroRx® for ALS. The technology was first initiated at the Weizmann Institute of Science while Professor Michel Revel, the co-founder of Kadimastem, was a principal investigator there. It continues to be developed by the experienced and dedicated team in the laboratories of Kadimastem, where Professor Revel serves as the Chief Scientific Officer. Annuncio • Feb 02
Kadimastem Ltd. Appoints Asaf Shiloni as CEO Kadimastem Ltd. announced the appointment of Asaf Shiloni as CEO. Kadimastem's new CEO, Mr. Asaf Shiloni, brings more than 20 years of biotech executive experience and a deep knowledge of the cell therapy industry. Mr. Shiloni joins Kadimastem after an impressive 13 years at PeproTech Inc. Based in California, he served as the company's Vice President of Sales and Business Development. Is New 90 Day High Low • Jan 14
New 90-day low: ₪1.94 The company is down 28% from its price of ₪2.68 on 15 October 2020. The Israeli market is up 25% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 9.0% over the same period. Is New 90 Day High Low • Dec 30
New 90-day low: ₪2.15 The company is down 7.0% from its price of ₪2.32 on 01 October 2020. The Israeli market is up 25% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. Is New 90 Day High Low • Nov 12
New 90-day high: ₪2.98 The company is up 23% from its price of ₪2.43 on 13 August 2020. The Israeli market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 1.0% over the same period. Is New 90 Day High Low • Oct 27
New 90-day high: ₪2.97 The company is up 45% from its price of ₪2.05 on 29 July 2020. The Israeli market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 10.0% over the same period. Annuncio • Oct 06
Kadimastem Ltd announced that it expects to receive ILS 0.72 million in funding Kadimastem Ltd (TASE:KDST) announced that it has entered into investment agreements for a private placement of 334,884 ordinary shares at a price of ILS 2.15 per share for gross proceeds of ILS 720,000.6 on August 10, 2017. The transaction will include participation from Ruth Arnon and Michel Revel for 167,442 ordinary shares each. The company will also issue 167,442 non tradeable warrants to each investor, at an exercise price of ILS 3 per warrant for a period of 18 months. The company announced that it has entered into separate agreements as part of the transaction. The transaction was approved by the board of directors of the company.