Kadimastem Announces the Approval of a 4M NIS ($1.29M) Budget from the Israel Innovation Authority

NESS ZIONA, ISRAEL, December 12, 2021 – Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, has received a grant of NIS 1.6 million ($500K), 40% of the approved budget of NIS 4 million ($1.29M) from the Israel Innovation Authority (IIA).This brings the total amount of financing raised by Kadimastem in 2021 to NIS 51.6 million ($16 M).

As Kadimastem intends to submit the IND for the Phase IIa clinical study before the end of 2022, the IIA funding will be used to scale up the production of a frozen, off-the-shelf product of AstroRx® in preparation for the trial. Using large reactors and special tools, hundreds of millions of high-quality astrocyte cells, the brain supporting cells that comprise AstroRx®, will be produced for the clinical trial, as well as for future commercialization purposes for the benefit of the hundreds of thousands of ALS patients worldwide.

Five ALS patients were injected with 100 million cells and five patients were injected with 250 million cells. The results of both doses demonstrated a high safety profile. No serious treatment-related side effects were reported and no side effects limiting the treatment dose were found.

In order to determine initial efficacy, an analysis was performed comparing the rate of disease progression according to the ALSFRS-R index in the pre-treatment follow-up period and the post-treatment follow-up period. It was found that with both doses the rate of disease progression slowed significantly during the three months following injection.

In light of these clinical trial results, in the next study, the company intends to examine if dosing every three months with the cellular off-the-shelf AstroRx® product prolongs the therapeutic effect.