The Israeli biotechnology company KadimaStem published a voluntary update on the company’s business, in which it revealed that the company’s stakeholders, Prof. Michel Rebel (28.8%) and Julian Rogeri (10.3%), announced their intention to exercise rights in the amount of approximately NIS 4.92 million at least.
Regarding the AstroRX product for the treatment of ALS, the company updated that it intends to submit an IND to the FDA for the purpose of conducting a Phase IIa clinical trial by the end of January 2023. For the purpose of the submission, the company hired an American CRO for the purpose of planning and implementing the clinical trial. Also, the company is in talks with experts in the field in the US, in preparation for their potential collaboration in the implementation of the clinical trial, and is examining potential sites for the trial.
Regarding the IsletRX product for the treatment of diabetes, the company informed that following the agreement with the French Defymed, which is engaged in the development of advanced encapsulation solutions to examine an integrated solution for the treatment of diabetes patients, the companies are in advanced contacts for cooperation on the development of a joint product for the field of diabetes.
In addition, in October, the company submitted an application for a BIRD fund grant with a total budget of approximately 1.5 million dollars as part of a potential collaboration with an American company that developed a product with the potential to protect the cells from the immune system to be integrated with the company’s product for diabetes. The company is constantly exploring collaborations with other advanced technology companies, for the purpose of joint development of innovative products in the field of diabetes.
Regarding the intention to register for trading on Nasdaq, the company updated that it is in the process of writing the documents for dual listing on Nasdaq. In order to carry out such dual listing in practice, the company will have to meet the conditions required for listing on Nasdaq, including equity of at least 5 million dollars and the value of public holdings of at least 15 million dollars. As of this date, the company is unable to estimate whether it will be registered in double registration as mentioned, as well as the date of double registration.
Another update: the company is in initial talks with a private company to consider strategic investment in the company and/or strategic cooperation.
Kadimastem is a leading company in the field of cell therapy that is in the clinical development stages of cellular therapies, which develops and manufactures cellular “shelf” products based on the company’s technological platform for the growth and differentiation of embryonic stem cells into active cells of clinical quality. AstroRx, an advanced development program of the company, is a cellular product consisting of astrocyte cells for the treatment of ALS, which showed promising results in a preliminary clinical trial. and IsletRx, a cellular product consisting of active pancreatic cells, produced from stem cells, which have been found to be effective and safe for the treatment of insulin-dependent diabetes, and are in an advanced preclinical process.
KadimaStem was founded by Prof. Michel Rebel, the company’s chief scientist and professor emeritus of molecular genetics at the Weizmann Institute. Prof. Rebel won the Israel Prize for the invention and development of Rebif, the conventional drug for multiple sclerosis sold worldwide.