(TASE: KDST), a clinical stage cell therapy company developing cell therapy treatments for ALS and diabetes, announced today that the Company held a preliminary meeting with the FDA (INTERACT) on October 7, 2021 regarding IsletRx, the company's cell therapy product in development for the treatment of diabetes.

During the meeting, Kadimastem received a response document from the FDA noting that the company's clinical development plan for IsletRx was being positively considered. It also included constructive comments and guidelines applicable for the next step pre-IND submission.

This interaction is of great importance to Kadimastem's clinical product development process and is an important milestone for the company. It was Kadimastem's first meeting with the FDA regarding its diabetes project and the FDA's first review of IsletRx, which demonstrated positive results in preclinical trials.

IsletRx is an expanded population of allogeneic stem cells differentiated into functioning insulin producing pancreatic islet cells. The company then uses a proprietary technology to select the purest performing cells from its population and puts them into a microcapsule that protects the cells from being rejected by the body's immune system. The implanted cells have shown in preclinical studies to be able to detect the sugar levels in the body and to, produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas.

Kadimastem CEO Asaf Shiloni said, "Thanks to Dr. Kfir Molakandov, the Director of Diabetes at Kadimastem, who presented the IsletRx project in an impressive manner, we received a positive response to the company's clinical development outline from the FDA's expert team, who we believe were overall very impressed with our technology. The FDA's expert team provided us with important feedback that we will use to prepare for the next step, our Pre-IND submission for IsletRx. I am convinced that the successful meeting and the relevant feedback will contribute to the continued progress of our product development and if all goes well, ultimately provide a cure for those living with diabetes.'

Kadimastem Chief Scientist Professor Michel Revel said, 'The INTERACT meeting with the FDA is an important step forward and shows that Kadimastem's development plan for its diabetes treatment product, IsletRx, is in the right direction.'

Kadimastem

Sarah Herzl

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