“Ilyx’s investment is a seal of approval for our operations”

by time news

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KadimaStem
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Reported that the medical device group


Ilex Medical
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Ilex Medical


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Invest NIS 10 million, which may increase to NIS 21 million. Initially, NIS 10 million will be invested at a share price of NIS 4.26, a premium of approximately 5% on the closing price before the transaction is reported. As part of the raising, Ilex Medical was granted 1.4 million options in 2 series, at exercise prices of NIS 7 and 8.5 per share, and their exercise can increase the scope of the raising to NIS 21 million. Tami Galili, CEO of Ilex Medical, intends to join the board of directors of KadimaStem.

“Ilex is a huge body and they represent huge American companies in the field of medical devices both in the sale of equipment and in partnerships,” explains Ronen Toito, chairman of KadimaStem. The rationale for the deal – Soul for example) and not in the field of drug development and therapy using Stem Cells, and they very much want to enter this field.

“Ilex’s investment beyond the economic potential inherent in it represents growth potential for both companies. Ilex’s CEO Tami Galili will join our board and we will be happy to take advantage of the many relationships she and Ilex have with the large companies abroad. At the same time, we believe that their entry into the field of development will allow them to accumulate a great deal of knowledge in the field. ”

“Ilex has been investing for a long time, you can see that by the maturity date of their options, as they say they will join the board, you can see that we see great potential in the field they want to join and that they believe both companies can get the most out of their investment.” In terms of medical progress ”

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Looking at your reports we see that you are a losing company, it is not surprising of course that there are no approved products yet and you are in the research stages. Why will the money be used with you?
“You have to look at the big picture, this is not about the same company that was here a year ago. Since then, both I and the CEO (Assaf Shiloni) have entered the position in recent months and I think we have made a very big change here. In addition to this investment, we raised more than NIS 50 million in recent months, when in addition to Ilex, two financial funds entered the investment, which also increased their investment thereafter. This is a very large cash flow that will be used by the company for over a year and will help us advance our clinical research in the field of ALS and diabetes.

We know of two main products that you develop, the first is for ALS and the second is for diabetes, what are these products actually?
“Our main product is first and foremost the platform. We have developed a technology that allows us to differentiate embryonic cells and thus develop products in everything related to therapeutics using Stem Cells, this is a very large field that does not focus only on the two drugs we have developed. ALS is a disease. Incurable, diabetes, on the other hand, is a very serious disease that greatly affects the life expectancy of its patients. Daily and it’s something that the vast majority of patients are not really able to stand and they end up dying from it.

“Our diabetes product is basically a tumor of embryonic cells that function just like the original cells in the human body. We insert a capsule inside the abdominal cavity, it is a relatively simple medical procedure because there is no need to install the capsule near the pancreas. The capsule contains identical cells. “And they respond to them automatically and secrete insulin, which on the one hand frees the patient from daily preoccupation with the disease and on the other hand significantly improves his quality of life.”

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What clinical stages are the products in? And what were the results of the experiments of the previous stages?
“Both drugs are in the 1/2 phase, in this phase we are mainly doing animal experiments to make sure the product is safe. We inserted the diabetes capsule into mice, where the experimental results showed that the control group died in a relatively fast period and with very high blood glucose levels, compared to the experimental group that lived for another year during the experiment – this is a long time for a diabetic mouse. In addition during the experiment we observed stable sugar levels in the mice’s blood, so we are convinced that the product is safe.

“We introduced the drug to ALS into rats because their nervous system better represents our nervous system. Also there we saw that the control group died relatively quickly compared to the experimental group that showed improvement in quality of life so even there we expect the product to be safe.”

You talked about the ongoing treatment of diabetes in the aspect of diabetes, how is your product different in this aspect?
“As the saying goes diabetes treatment is a daily treatment, whether with a very significant change in longevity or regular monitoring. Our product replaces this need because it replaces the activity of the pancreas, and it does so automatically. Because it is not the introduction of an organ-like product “We believe that patients will still have to come for re-treatment every period and we do not yet know what the frequency will be but these are years, replacement every year for that matter, it is still very significant for a patient who needs to be treated every day”

Did you report a meeting with the FDA last month, what was the purpose of the meeting and what happened there?
“There were two purposes for meeting with the FDA. The first is that the company has made mistakes in the past. Not only have we made these mistakes, many companies in the field tend to develop their products in ways not recognized by the FDA, they develop a product for several years, invest Resources, based on research.In the end they come to the FDA and he does not recognize the procedure they did, and they are required to start all over again.

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“The purpose of the FDA meeting was after realizing that we did not want to repeat these mistakes again, so even before we moved on with the experimental stages we received guidance from the FDA as to how they want things done, it will help us a lot later and prevent unnecessary friction. “The fact that in the treatment of incurable diseases like ALS the FDA often allows for regulatory benefits to introduce the drug faster to the market and that is of course significant for us.”

What are the plans for the future?
“We are currently planning to launch clinical trials in humans towards the end of next year in the United States. What is important to understand is that both diabetes and ALS are two diseases with a large PR in the market. Even people who are not in the field know them so the market potential here is great. We will get the necessary approvals from the FDA and local regulators next year and go on the market with these drugs. ”

Positive recommendation for Ilex
Ilex made NIS 310 million in the third quarter in the reporting period, an increase of about 4% compared to the previous year. The gross profit margin rose to 45.7% from 30.9% and thus the gross profit rose by 54%. This also had a positive effect on operating profit, which rose by 76% to NIS 106.9 million. Consolidated EBITDA increased by 72% to NIS 118.1 million, compared with NIS 68.6 million in the corresponding period. Following the good reports, the analysis company Rosario Capital gave it a recommendation for a market excess return and a target price of NIS 186 per share or an upside of about 42% on the last closing price, which was NIS 130.7 per share.

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