Akerna Corp Aktie

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will follow the formal presentation. As a reminder, this webinar is being recorded. Yaky, please.

Thank you very much, Michal, and good morning, everyone. Thank you for joining us today. On this session, Alejandro Weinstein, our Chairman and Board member is also in presence and myself. The goal of today's webinar and update is to give a brief about the recent updates with Pluri in the last couple of weeks and to make sure that we are able to convey and to present the way that we see Pluri and what's going to be happening in the company in the coming year.

So as a general introduction, the one that knows the company and the one that know, Pluri is a company that is active in the last 2 decades in regenerative medicine and cell-therapy with a vast experience and knowledge in clinical development. We have treated hundreds of patients in dozens of dozens of clinical sites across the globe, a very technological company with a lot of knowledge and patents for cell technologies and quite experienced. So we were able to get our products, including 2 Phase III studies in the U.S. and in Europe. The ticker symbol is PLUR, traded on NASDAQ.

The agenda for today and the reason that we wanted also to have this call is to update you about recent developments that are across two very important activities. One, we do want to present Pluri strategy and commercialization strategy. We announced earlier this week the transaction that we did with ZEO ScientifiX, a U.S.-based company that we entered into an equity for license transaction. Eventually, Pluri will hold 50% of ZEO and bring our product to the U.S. market through ZEO ScientifiX, and we're going to talk about it.

We're going to like to present also Pluri's entire commercialization strategy and what you can expect from us in the coming year, focus on two additional aspects, other being the ZEO ScientifiX go-to-market in the U.S. -- one; the regenerative aesthetics and why we think it's a short-term very interesting opportunity; we're also going to present our CDMO activity. All the three different activities are revenue generators in the coming 12 months and are important to accomplishment of our strategy.

Alejandro will speak more. We announced last week about the EIB transaction. Mr. Weinstein acquired the loan from the EIB to allow the company a greater and better financial flexibility to execute on our programs. And we will discuss our focus for the coming years in human health and longevity and what are the main catalysts to move forward on these initiatives.

So Pluri is now looking at new chapters, we have a new chapter. We are doing cell-therapy and regenerative medicine for a while. But this is the first time that the company has a very clear pathway to market with products. The U.S. commercialization through the agreement signed with ZEO ScientifiX allow us to bring our biologics technology and knowledge to certain states in the U.S. and start to market and commercialize over there.

On the Cellav, the aesthetic regenerative aesthetics, we got products approved and already launched both in the U.S., European and Israeli markets and are creating revenues on the short-term. The same thing for the CDMO, using our 47,000 square foot facility that meets the highest standard of manufacturing, and we did open it for additional clients to use, which create revenues and allow us to create with the goal to make Pluri a revenue-generating company and a profitable company.

I'd like to take the coming minutes to speak about ZEO. ZEO, the way I see it, and probably this is the best fit for M&A activity, we have a perfect synergy with this company. Pluri brings 20 years of knowledge, probably one of the most advanced technologies in the world for cell expansion that has proven itself again and again and again, including collaboration with some of the largest companies in the world that utilize our technology.

So it's the technology, it's the clinical experience, including 2 Phase III studies, U.S. and Europe, very technological company with more than 200 patents and really the know-how of how to pursue clinical development and clinical products. So we are coming with the publication, with the knowledge, with the patents.

And ZEO, a company that is active in Florida, Fort Lauderdale-based, doubled in the last few years. Quite an impressive product platform with a very active network of physicians that they are working with them closely. ZEO is a company with manufacturing and development capabilities that has developed clinical -- has developed regenerative products over the years that are already in the market. But now with the products that they have and then what Pluri is going to have, they are utilizing their education capabilities.

ZEO is controlling a monthly master class activity with physicians across the U.S. I just came from a 3-day, quite amazing master class that they have conducted. And they are able to educate the physicians and the clinics and what is currently important to regenerative medicine, the difference between the product, the different regulation legislation, and that's a very powerful tool to keep a close contact with the different clinics.

ZEO is already distributing its products with over 200 clinics. So the ability of go-to-market is immediate and relying on years that they have developed their platform.

So how it's going to work? Today, we know that people are using longevity and regenerative medicine agents for a while. Probably all of us know the PRP, but we should understand that regenerative medicine as well as the longevity market is moving one step ahead, one step further with the need to provide products, stem cells product, secretome, and extracellular-vesicles that are well-controlled, scientific-based and also very targeted. So it's not enough to come with a PRP product or something that you can use for your patients.

We hear more and more of the physicians looking for a more precise, accurate, and the right product, which is backed by data. And probably one of the best way to frame that is kind of funny, but I like the quote and I use it, that's coming from Luka Doncic's physician. As you know, Luka Doncic, the NBA player that missed this playoff because he was treated with PRP. And his physician said, PRP, it's like a Toyota Corolla, stem cells are like Ferrari.

So in Pluri, we have the knowledge, the expertise, the data to provide the best-in-class products, both stem cells, EVs and secretome. This is what we know to do best. This is what our technology is able to do. And now through this collaboration with ZEO, we are able to introduce it to the market.

This collaboration is about enlarging or increasing the portfolio of opportunities. Today, ZEO is marketing their products in the U.S. market. Some of them are autologous, some of them are allogeneic. Mainly, we are talking about EVs product. They are using in Wharton's Jelly products that are used for a variety of indications from orthopedics, wounds and more. That is all through physicians and clinics.

Now that Pluri -- with this collaboration, we will give them access and exclusive license to use our technology for these opportunities in the U.S. and give them access to additional products that they will be able to manufacture, including stem cells, including vesicles and also the entire pipeline that we have through our subsidiary, Cellav, that is focusing on providing regenerative aesthetics, including different products that already got the clearance in the U.S., in Europe, and in Israel.

So the concept is to use the same exact marketing through the same marketing channel, which is the clinics that ZEO is keep -- pushing and expanding, but now to be able to provide a much more evidence-based and also a much broader portfolio of products that will allow us to increase the opportunity in our market share in the U.S. market.

And in this presentation, when I'm -- when I'm saying that Pluri is going into commercialization, I'm always going to refer to 3 different elements: the regenerative aesthetics, the regenerative longevity, which is more the stem cells and secretome, and our CDMO. And of course, the combination of the two companies allows us to be able to do it in a very effective way.

ZEO will be their leading and going to have the rights for the regenerative aesthetics and regenerative longevity in the U.S. market. And that's one of the elements that eventually allow Pluri to have a 50% holding in ZEO with the goal to consolidate their financials into Pluri consolidated financial statements.

Let's start with the regenerative aesthetics and where we see the big opportunity. When I'm talking about regenerative aesthetics, we are talking about clinics. We are talking about physicians. This is the only model that we are using, B2B through the physicians themselves that are also providing and subscribing our products.

We develop a full scale of product, both for skin care and for the hair care. It's all paid money. It's all private paid money, and it's distributed by the channel of physicians across the globe, across the U.S. This is one of the most growing industries in the U.S. We are looking at the total numbers and even specifically through the clinics, we are seeing a significant increase year-over-year, and I expect that this will continue at least for the next coming few years, continued interest in regenerative medicine -- in regenerative aesthetics through these clinics.

So what Pluri is able to offer in that end, our subsidiary, Cellav, it's 100% our fully-owned subsidiary. Cellav, has developed in the last 2 years a very strong and robust portfolio of regenerative medicine aesthetics.

We are doing it in two different product types. One is product that we are using in the clinic. So it's only in-clinic use, where we are using extracellular vesicles that are -- that the physicians are able to treat their customers in the clinic itself. Usually, we are looking at 3 months treatment or 3 months activity that they are doing with a monthly treatment with the extracellular vesicles. And on top of that, we have been developed a home kit that between the treatments, we are able to provide our clients with a home use kit that contains also the extracellular vesicles that enhance and promote -- is complementary to the treatment that they got in the clinic.

So all of these products are only marketed by the physicians, which allow them to keep close contact with the client, but also to make sure that they will get the best outcome while using both in-clinic and the home care treatment for the most desirable outcome -- for the optimal outcome of this treatment.

In the U.S., we are marketing our placenta-derived EVs. In Europe and in Israel, we also use our plant-derived EVs because the placenta is not approved to use in Europe and only in the U.S. market. This product has already been registered in all the markets, and we are starting the launch of the product in the U.S., Israel, and after that as well as in Europe.

When you look at this industry, we are already starting the marketing. We do expect to have a couple of millions of revenue already this year. But where we are looking at the opportunity, we are seeing quite a significant opportunity. And I do want to present here a case that we are seeing with a company which is very relevant and doing something similar to Cellav.

I'm talking about ExoCoBio and BENEV. This is information that is available online. And we were able to show BENEV and ExoCoBio are mainly proposing in-clinic treatments and now also some of the home kits, but we are able to see, first of all, the growth. This company is growing quite significantly year-over-year, with expectation of growth also in 2026. And most importantly, we are also seeing the magnitude of business that can be derived from this product.

Cellav are using Pluri's technology and knowledge that has been generated for 20 years, best-in-class manufacturing and batch-to-batch consistency, mechanism of action as well as clinical studies that have been conducted with our aesthetic products to prove the safety and the efficacy. And I believe that Pluri through Cellav and ZEO will become now a very dominant player in the industry for the hair care systems and of course, for the skin care systems, which are very relevant for the U.S. market, but also the European market.

So that's the first part of commercialization. We are talking about regenerative aesthetics.

With that, I would like to move to the second part. As you see, we're talking about the regenerative longevity. As a reminder, and I told you, ZEO are already marketing some of their products into this industry. On top of that and mainly using the additional state laws that passed in the U.S., like the Florida state bill that allow the use of stem cells for a variety of indications, including orthopedics, wound care. Actually, these are the indications that are approved: orthopedics, wound care and pain management.

The deal that is structured with ZEO, we're going to do the tech transfer and giving them access to our 3D platform, where they will be able to manufacture and market the products in the states which is relevant. We are increasing the portfolio of opportunities. We're going to provide access to the stem-cell technologies as well as to the Cellav product that will be distributed and marketed through the ZEO channels.

And just to give you a brief of how ZEO looks financially. And as I mentioned, our target is to be able to consolidate them into our financials. ZEO, already a revenue-generating company. And with the change of the Florida law that passed last year, we are seeing the boost of revenues that we expect to see with the ZEO estimation that we're looking about $8 million in expected revenues for 2026.

The advantage that we see a very nice and strong growth this year with almost 90% growth year-over-year. And with -- if our plans are going to be as we hope, and we will be able to provide new products as we see them, I do expect a continuous increase in growth in the financials in '27 and in '28.

We're going to have the access to some of the best products in the world. And with already active network of physicians and clinics and education, ZEO will be able to be one of the most dominant players in the U.S. for these products and opportunities. And that's basically the opportunity that we see right now.

I do want to give a brief of what currently is happening in the U.S. with the local state laws. We see that the orange states are states that already passed the bill. We are looking at about 45 million people in the U.S. that are living in states that already passed the bill, which allow the use of such products.

We do know that there are few other states that are in process, which could increase the pie. But maybe we should look and learn from past similar bills on the state level, including bills like the Right to Try. And we know that there was a very rapid expansion from about 10% -- the same percentage as we are today -- to over 80% within 4 to 5 years.

So we believe in our expectation and what we hear from the market that in the coming few years, they're going to be north to 50% of the U.S. population that will be able to use such products under similar bills. Quite interesting opportunity for all of us. And of course, we want to make it -- with full compliance with the regulations and state bills to be able to get the best outcome for the patients, for the physicians, and for the companies.

So that's a summary of the regenerative aesthetics. A few words about the CDMO. Pluri holds a 47,000 square foot facility that is able to -- that has been already through a Phase III FDA study. So we are one of the companies with the best-in-class facilities for regenerative medicine and cell expansion.

We know that there is a lot of need in the market right now. Just as an illustration, seeing the expectation of the global cell-therapy CDMO activity in the coming few years, it's a growing demand. The fact that the Chinese market are currently not applicable for U.S. companies create an opportunity for companies like us.

We have the facility, we have the opportunity, we have the expertise, we have the SOPs in place, and that's something that makes Pluri a very interesting player in the CDMO business.

As of today, we just started to build our business. We launched in '25, started to bring several clients in. We already have now 4 active clients that we expect them to create -- to generate several billions of dollars in the coming years with growth that we expect to have year-over-year, utilizing the current facility, and that's something that we'll be able to create also a revenue engine for Pluri that allow us to bring more and more revenue stream to our organization. And I did discuss the three different elements of revenue streams, the aesthetics, the regenerative, and the CDMO.

With that, I would like to hand the presentation discussion to Mr. Weinstein.

As a background, I would like to introduce Alejandro, who is our Co-Chairman and the largest investor with a background of multiple M&As over the years, almost $5 billion in exit, including selling the family business of CFR to Abbott for EUR 2.9 billion. We are very pleased that Mr. Weinstein took a significant position in Pluri.

Alejandro, if you can please have a short introduction about yourself and also talk about in more details about the recent EIB transaction.

Thank you very much, Yaky, and good morning, good afternoon to all of you.

Yes, I only can say about myself that I've been, all my life, working in the health care industry in different forms and formats through funds, through direct investments, through JVs with multinationals. And I saw a big opportunity in Pluri Biotech.

I came in into Pluri as -- I like to define it as a friendly activist. Friendly because I am doing this in coordination with management, and activist because I want to produce change in the company.

Why change? Well, as you saw in Yaky's presentation, the company has an amazing technological platform developed through decades and multimillion dollar investments. The company has, if I recall, 200-plus patents. But as all of us know, having the products, having the technology, having the patents is not enough. This is 50% of the challenge. The other 50% is to have the ability to commercialize and to monetize these intangible assets. And this is the change I would like to lead for Pluri. This is time to execute. This is time to create sales. This is time to create distribution and leverage on all the technology that we have developed and make reality the promise that the company has made to the market for so long.

So this is the reason I define myself as a friendly activist. For doing that, we have to solve the financial struggles of the company, and that's why I bought the EIB loan. That was something that everybody -- public information, knew that was something that was creating financial issues for the company. And now with the management, we are going to find a way to solve this loan issue. So it's not a problem anymore to it. And this transaction is being finalized and paid as we speak now.

Also, we're going to focus. The company did, in my personal opinion, too many things, was in too many industries that require too many capital to execute. And now we're going to focus on health care, as Yaky correctly said, longevity, prevention, CDMO. And we partnered and created the first platform to concretely go to market and recognize sales in the U.S., which is, I think, a pivotal moment for the company.

Also, all the other assets that the company has, we are discussing with management like Kokomodo, biofarming, Coffeesai, we are discussing with management how to monetize those investments, but they are not at the core of the strategy as of today. And this is something that will happen, I hope, sooner rather than later.

So these are the changes I would like to push to be implemented for the company, for the benefit of all the investors. That's it. Short and brief, I hope.

Thank you very much, Alejandro. And I think with what Alejandro said, it summarizes what we presented here, an extreme focus on commercialization, first and foremost, for the agreement with our partners in ZEO: Sanofi and the CDMO. Once we got now the stabilization on the EIB agreement with the acquisition that Alejandro did, allow us the flexibility to execute. And that for me, it was a very important moment, of course, to make sure that we have the support of our largest shareholder and Chairman.

And Pluri will be very focused. We're going to focus on human health, on longevity. I believe we have a very compelling short-term opportunity to make Pluri a significant player. We see the need and the advantage of regenerative medicine now. There is an increasing and increasing demand, and Pluri has the ability to deliver and to provide real products to the market, creating revenues and profitability.

So this is the summary of things that we have discussed. And now I will open it for questions.

So first question, what would you consider a successful 2027 for Pluri?

Successful 2027 for Pluri is very clear. It's about completion of the tech transfer to ZEO starting to manufacture in the U.S., in Fort Lauderdale, our products. And I do want to see a significant increase in revenues, both on our aesthetics, on our biologics through the Florida Law, as well as on our CDMO. Success is Pluri making revenues and moving to the level that we can present the time of breakeven point and profitability. And the next year, 2027, is a critical year that we will be able to implement and to show our strategy in numbers.

The second question for investors, what differentiates Pluri today from what they've known 5 years ago?

Pluri as of today, it's -- and what we presented, I think that's the one message I do want to make sure that I was able to convey during this webinar. Pluri as of today is a company that is focused on commercialization. In the past, we've been heavily involved in R&D and clinical trials, which, of course, can bring us to binary situation of either success or failure.

Today, we are looking in a very operational program of how to increase revenues, how to increase our market penetration, and that's a very different mindset. That's the main reason that we are seeing today around table partners like ZEO ScientifiX, and we're seeing companies like Cellav, that are able to bring the products. So the company totally changed its focus and mindset towards commercialization, utilizing the big opportunity that we see in regenerative medicine.

I'm sure that all of you are also following the quite substantial investments that we're seeing in the longevity business, starting from the leading AI entrepreneurs that are heavily involved in the longevity business through sovereign fund and more and more and more. So the opportunity of you providing products to these markets are here now, and we are in an extreme focus to utilize this opportunity on commercialization.

Do we have time for more questions?

With that, I would like to close the call. I would like to thank all of you for participating. And this presentation will be available online. And of course, please contact us if you need any further information or material. Thank you very much.