Nanexa AB (publ)

Welcome to this live report with Nanexa, the drug delivery company. You who are watching can ask questions in the live chat, something we see that some of you have already been able to do. There will be many questions today. I greet the CEO, David Westberg. Welcome.

Thank you very much.

You've had a lot to say in the last few days, I think.

Yes, that's true. The days have been intense. Until last night, when we released the announcement about Applied Materials. We'll get back to that, I'm sure, in the questions. We can rest there. It has been intensive with our studies as well.

Yes, it has been a very intensive quarter. How would you say, what has characterized this quarter?

To start with, on the financial side, we had the emissions that we did in January, which was in the planning. So there was a lot to do with that, and I'm very happy that we put it in. It feels fantastic, because now we have funding one year ahead, so the whole Q1 next year. That's definitely the case. We also got some additional funding from Applied, which makes it look a bit better.

The size is 7.5 million.

Yes, 7.5 million. The dollar exchange rate has dropped, so that's a bit of a shame. But apart from that, we started the fourth cohort in the NEXT22 study. And you have seen that I have reported a little bit about it here now. We have generally gotten very good results from it. In terms of safety, it is still fantastic. It is quite remarkable that we do not get these normal side-reactions, and so on, even though we have such a high dose. So that's good. Very limited injection side-reactions, and that's also good. So it's a study that, and I'm very happy that we were able to add that cohort, the dose cohort, to the study that we did last year. So that's good, it has been intensive there. We are working with Novo Nordisk, as you know. It is also intensive there. I make the assessment that it looks very good. So I look carefully forward to what will happen here in the future. We have accelerated our business development in a powerful way. We started with JP Morgan in January, where we met a number of companies that mainly presented Nexi 2, but also Pharmacel technology. A number of new discussions with companies, not only around x22, but also other uses, continued the journey in Bobaio in March here in Milan. I have met more companies for Nexo 2, especially Nexo 2. Since then, I have also hired a new person, Bridget Lacey from England, who strengthens our BD side. We see that we have so much data now regarding Nexo 2. We have data regarding our pharmaceutical technology. So this is the year that we see where we really should lay the groundwork for business development. So it's been a good start, I think.

I understand that. Exciting situation.

Yes, it really is.

We have received a lot of viewer questions and it is quite understandable considering everything that is happening. But I think we will start by letting in analyst Johan Widmark from Emergers. Welcome with your questions, Johan. You can also come back later if you would like to.

Thank you very much. Hello David. I would like to start by asking about Applied Materials, if that's okay? I wonder who initiated this? I can't hear you. It was a bit low, but we can still hear you. Okay, great. I wonder who initiated this? And if you could tell us a little bit about what is the mechanism behind Applied paying? What exactly do they pay for when you terminate this agreement? And what is this amount? Was it predefined in the agreement or was it a matter of negotiation?

All of those questions are great, but I'll see if I can get a hold of this. I can say that it was... Who started the discussion of ending it? It has been quite natural for us. We have gradually entered this situation from both sides, I would say. And from our side, we have experienced a lack of supply from Applied Materials, gradually. If we want to continue, they have to start delivering in a completely different way. From their point of view, I would say that this is a huge American company that is mainly focused on manufacturing of manufacturing equipment for half-leaders. And you know how the semiconductor industry has increased in recent years, markedly due to the geopolitical situation in the world. Therefore, they have, I can understand them, they have probably had to shoot over a whole lot of resources to their core business. So it's probably from their side, now I'm not going to defend them, but this is how I see it, and this is how I have seen it, I should say. But it has probably been a one-sided will to end in one way or another. Then it has gone back and forth and we have reached this task where we cut all the bands in a total way. That we do that means that, among other things, The share that was regulated in our partnership agreement, that we would pay them in advance, so to speak, for the license income we get forward, they now come to Nanexa. Nanexa shares 100%, which is very, very good for both us and for your shareholders who are listening. And to cut the tape for their part, they can now fully focus on their core business, and I think that's good for them too. The amount is not something that has been predetermined, but it is a negotiation solution, and you can probably see it as a as a measure to cover up for the lack of supply from Applied Materials. It is a measure that could have been higher or lower. Now we are at this figure. I think the important thing for an annex is that we have cut and that we move forward so that we can also discuss large-scale equipment with other suppliers. Because this was an exclusive agreement we had with Applied Materials that was signed in 2020. And then we saw it as a very good alternative. given that it was a very large company and so on, to write an exclusive agreement. So there we actually had no right to go to someone else to buy equipment. Now we have, it's completely solved. So this is probably a lead from my side or from the company's side to, what do you say, to prepare for future license discussions with other pharmaceutical companies, quite simply.

Okay, great, thanks. Just to clarify, was this exclusive to both sides? Was there any kind of competition clause that prevented them from selling, or was it exclusively from Nanexa?

It was actually exclusively from Nanexa, or the exclusive suppliers of equipment. Then we had an exclusivity for the development of products within the parental side. So there were two different types of exclusivity, you could say. But when it came to the equipment, it was a one-sided exclusivity. Okay.

Was there anything said in this agreement about the 7 million shares that Applied owns?

Is there a lock-up? No, it's a completely separate issue. We haven't received any signals that they will change the ownership in any way. Without me knowing 100% they will probably remain.

Great, thank you. Two more questions. Are you still expecting to start the phase 1b study last year?

Yes, that is our plan. It will be towards the end of the year. It is a tight schedule, but we tend to be good at keeping a tight schedule, so those plans are still there.

Okay, thank you. And then finally, this new recruitment that I announced with Bridget Lacey, can you just tell us a little, as I understand it, she will own issues that have been owned by Otto Skåling, who he has worked with. I understand that you are a very flat organization, you are not so many, but can you describe the dynamics here?

Yes, absolutely. As I said initially, we see the need to increase to increase presence, to increase activity within the business development side. Can we sign contracts with Nexo 2? Can we sign contracts for other uses of Pharmacel with other companies? And then we see that there are so many contacts we have It requires more. Otto works three days a week and Bridget will now come in and work two days a week. Maybe a little more than that, but about two days a week. She will focus fully on Nexu 2 and Otto will mostly keep these other activities where you use Pharmacel for licensed partner products. So we have seen the division.

Okay, thank you very much. That was all I had.

Thank you very much, Johan, for the mergers. And I'll raise some questions. When it comes to this ending of the collaboration with Applied Materials, does that include the investment from Applied Ventures?

Yes, that's what I... The answer is no, we haven't. We haven't mixed it up in this decision. Actually, Applied Materials and Applied Materials Venture are two completely separate organizations, even if they are partly the same people at the top of the leadership. But we have not received any signals from Applied Ventures that they are making any changes in their ownership.

Another viewer question. You mention that the need for large-scale equipment has so far been limited. What is it that is changing now?

Exactly. It has been limited because we are in phase one with our programs. And that applies to Nexo 2. We are in phase one. If you see a collaboration that goes into a real product development with phase 1, 2 and so on, our equipment that we have today will be enough for 2025 and 2026. After that, we calculate that we will need a larger scale. If we sign a contract with a company relatively soon, we see that in 2027 we should have a scale of three kilos. We have room for that in the facility we have built in Uppsala. That was the idea from the beginning, that Applied's equipment would be installed there, both one for a 200 gram scale and one for a three kilo scale. So everything is prepared for that scaling. It's just the boxes themselves that go there, if you can put it that way.

Thank you. I'm trying to pick up a little here between the questions. What indications do you have that the pharmaceutical market is approaching a commercial breakthrough?

I think it is, from day to day. Look at the NEXT22 project that we have done, where we have really good phase 1 data. We show that we make a one-month deposit. We show that there are limited side effects. For a GLP-1, and then you think GLP-1 and what market it turns into, type 2 diabetes and obesitas. You know, it's a multi-billion US dollar market. I think that is a... one proof that we are very close to a commercial breakthrough. We have Novo Nordisk, I can't go into all the details there, but I think it looks very good. That's all I can say. I look forward to further discussions with them during the year. If you look at other interactions we have, we have exciting projects, so to speak, discussions, those that Otto then drives. So yes, we are getting closer and closer. Then how far is a Yes. When? It's a wonderful and relevant question, really. But it's very hard to say when, actually.

That brings me to a question that might be hard for you to answer. What, in your opinion, is it that the market doesn't really understand when it comes to NAEXA in relation to the bullish development of the stock exchange?

Yes, I think it's like this. Now I'm doing my own interpretation. Some of you may agree, others may not. But I think there has been, too early in Nexa's history, an expectation of contracts. When you look in the back mirror, there may not have been a possibility to write a contract. I think it's in our hands now. There has been a lot of focus on that. And in terms of business, there is focus on that. But if you look at when we started in 2015, 2018 and so on. In 2018 we wrote our first feasibility agreement. And then a number of things have been built up. If you look at the situation then. And now the companies are a completely different company, a completely different maturity. And what you may not understand, or what may be like a small filter, is just when the agreement comes. But if you look at the maturity, operational and scientific, the maturity of the technology itself, how far we have come and what we have shown against Novo Nordisk and what we show in Next 22. I don't know, I may have to try to explain it a little better, but if you look at Next 22 and what market it turns to, a multi-billion US dollar market. There is a great need from the biggest companies in that market to get one-month products. And we have shown that we have it. I don't think I should comment on the stock exchange rate, but that alone should make the rate go up a bit. Yes.

If I say so, would a continued collaboration with Novo Nordisk mean royalties, licenses or production in e-energy? How do you think strategically about this?

That's a great question. If Novo chooses to continue with us, then we see that they sign a license agreement with us. This will mean a signing fee, it will mean milestone payments during the development, which we assess will be significant. After that, a royalty income follows on the sale of goods. On the production side, Novo Nordisk has a history that they would like to have the production closely tied to their company. So it is possible that we set up a production with them. Vi har också öppnat för möjligheten att produktionen kan placeras nära oss och faktiskt föreslagit att låta oss se på möjligheten att bygga den i Uppsala. Det är i så fall sådant som inte vi kommer bekosta, ska jag säga. Utan det kommer ske i samarbete med till exempel Novo, om det skulle vara så att det är de som är först eller det bolag som är först, så att säga. Den möjligheten finns också. Vi har ju en... We have a lot of strong competence in the ALD process. We have strong QA competence within the company and so on. And a person with long experience in production in the company as well. To that belongs that the entire Uppsala and Stockholm region, if you count Södertälje as well, there is an enormous competence in pharmaceutical production. So you could think very well If the license holder we write a license with would like to, then there is that possibility as well. I myself think it's a pretty attractive opportunity, but it needs to be capitalized by the right person or the right company in that case.

How do you see, based on the situation, that it could possibly be preferable to place the production in the US?

That would be possible in the long run, and I think that's a question for the company that takes the license. It's not a question for us, but there are all sorts of opportunities to do that. If you look at Novo, for example, they buy up Catalent and they are a number of factories across the United States. If you look at other companies, global pharmaceutical companies, they have production in the United States. If you put up such a production, it probably has more to do with their specific sourcing strategy, quite simply. And there we are fully flexible, I would say.

Another question. If Novo Nordic's negotiation option is used, will you send a PM about it?

I have received that question before and I really understand that question. However, it is probably so that we will not communicate it if we go into a negotiation for confidentiality reasons. It is very rare that you go out and publish something during a negotiation. It will be shown when we have written a contract and if we have written a contract.

What would be required to show proof of concept for a month's supply of a MABS? Or do you think that data for, for example, NX22 can strengthen the thesis that Pharmacel is well suited for just MABS?

Yes, MABS is monoclonal antibodies and we have worked with monoclonal antibodies before. We know that we can apply them. The similarity between a monoclonal antibody and a peptide is that both, when you make particles of them, you do it via so-called spray drying and then you get particles that don't really matter that much, what is in that particle. But since we see that we can make a one-month deposit of NEXU2, which is a spray-dried particle of a peptide, it tells me that we can most likely, with very high probability, do the same for a monoclonal antibody. That said, it is as if for each new substance that we are going to work with, we need to test it and show it in animal testing. But the probability is high.

What is it that separates Pharmacel from What do you see as competitive technologies? What do you see that you can offer Big Pharma that others can't?

It's just the opportunity to control the issuance over the entire range from time zero until the depot goes out. We have the opportunity to control the initial release. It is very important to have a good relationship between the highest concentration in the blood and the concentration that is towards the end of a depot preparation. We have seen, among other things, in the Liraglutide project, our NEXT22 project, that we can match it very, very well. There are many other depot preparations that have difficulties with substances that are easily soluble. And then we actually have a completely unique construction of our depot, what is it called, drug delivery system, since we fully encapsulate, like an egg shell, encapsulate the active substance. But unfortunately, there is no other drug delivery system that does that. And that creates very large opportunities.

Can you describe how you have developed the analysis methods and what this can mean for Nanexa and partners?

I think that was a very initiated and good question because it is actually important and a question that very often comes up. But when it comes to the development of a new sustained release product, it is important to be able to distinguish good batches from bad batches as soon as possible. and not have to go all the way to an animal test to be able to do that. It takes a very long time and is very expensive. And then we at the lab, our analysts, have developed so-called dissolution methods that are adapted to our pharmaceutical system, which means that now when we look at a release on the lab that takes 24 hours, that is one day, then we can translate that data into animal data, and animal data can be translated into human data, which means that we have a whole chain from the lab to human data or clinical data. And that means that the development of such a product can go much faster. We can create a lot of security. It is also a basis for a so-called QC analysis, that is, quality control analysis in a regular production, where you can then set limits for how much should be released during these 24 hours and how the profile should look and all that. So that's actually a very important job. I'm happy that the question is being asked, but it's not often you get to explain it.

How long does it take to develop this type of analysis method?

That was also a good question, but it has gradually been developed and we made a breakthrough. early last year, where we really saw that now, if we do it this way, we actually get really good curves that match what we see in animal testing. So it is a gradual development that has taken place over several years. So that's good.

We have a question here. Do you have the opportunity to design PharmaCell so that it becomes a progressive release of substances, so that it starts with one milligram and then increases afterwards?

We haven't done that yet. But I can say that in one of the discussions we have with one of the really big companies, there is the current question. And then it's not about a progressive, but about a delayed release, so to speak. That's very interesting. I mean a release that's nothing, nothing, nothing, and then at a certain point there's a rather concentrated release time. But to use... I think this question is based on whether you can titrate the GLP-1s in one injection. I don't think there will be a need for that. Either you will titrate with one-week or one-day injections and then go on with a one-month pharmacy. But now we have also seen such good results when it comes to these side effects, gastrointestinal side effects, that we are a bit like that. Maybe you can go on directly with our monthly depot. So that will be shown in the future.

You have communicated several positive 30 mg results. What is required as the next step before a possible partner can make a decision?

I see that the 30 mg data we have has strengthened our already strong position. So actually, we don't need any more results. We are trying to make sure that a partner comes in before we start this Phase 1b study. So that we write some kind of co-development agreement. That is our focus right now. Then maybe there will be a slightly smaller upfront payment compared to if we would have run the Phase 1b study ourselves. But we don't close the port to run it ourselves either. But our thought right now is that we should do it together with someone, that we write a collaboration agreement or code development agreement.

Has the exclusivity agreement with Nov and Nordisk fallen into the trap of already writing an agreement with another company?

How should I answer that? Actually not. It is clear that... There are other companies that we discuss with that are also really big within type 2 diabetes and obesity, who see that this exclusivity is in the way for them, so to speak. That's how it is, but it's within that narrow field, so to speak.

But generally, no. And to summarize or highlight the most important thing in the quarter, we have the question, David, what is the most important signal to the market in today's report?

I think the most important thing is that the evaluation with Novo Nordisk, that we feel that it is going really well. I think that is a very important signal. The other is that Nexo 2 is doing really, really well. And that there are all the conditions for us to be able to tie a company to it.

Nice. Another technical question.

Yes, sure.

Let's see what this will be in Swedish. Uptip Traded. If that's not the case, what else can reduce side effects by using your pharmaceutical technology?

As we can see, what is it that makes us get less side-effects with the Pharmacel than with the day-to-day injections? If you think about day-to-day injections, the plasma curve, the concentration, or the leaky blood, it goes up like this and then it goes down, and then it goes up like this and then it goes down. While we go in this way, it was a little higher and then it went down. But we don't know, but we speculate that it is the even concentration, i.e. the plasma level, that makes us get a better, or less side effect, I should say. We don't know today, but it can also be with the speed that the concentration goes up. For a Victoza, it is a spike straight up like this, very fast. For us it is a little slower. And in the formulation we will use in the phase 1b study, it will be even slower. So there are all kinds of possibilities, as I see it. But now I'm in a positive mood too. But there are all kinds of possibilities. And I really believe that it is this, or it's not me who believes it, but our experts who believe it, that it is this even plasma curve that does it.

I understand. An interesting question. Is subcutaneous injection generally something that patients do themselves, for example with a diabetes pen?

Absolutely. That is how we see a product in front of us. Patients will have a pen, an auto-injector at home. They will fill it up with a small ampoule or capsule once a month. Use that pen, give an injection here in the belly in the subcutaneous tissue. Then put the pen away in the keyboard box until the next time, a month in advance. And then you take out an ampoule and do the same thing. And that is a very big difference compared to Victoza today, where you do it once a day. Also compared to Novo's newer products, Osempio and Veggovee, where you do it once a week. So it's a big advantage compared to them as well. So that's how we see it. And we also see the possibility, as mentioned earlier, that we can... These don't need refrigeration. That's at least what we think, and we think we have good data to support that. And that makes the treatment or storage and everything like that much easier for the patient. And above all, it reduces costs for cooling logistics for the company, so to speak.

When you are now preparing for a commercial phase, what other measures are you doing? How do you see, for example, the business model? Is it per patient and year, patient and month. How do you develop this model?

Our business model is based on licensing. Some company buys a license from us to use the technology. They pay milestone payments, upfront and milestones, until the product is approved and on the market. Then it goes over to a royalty-based payment per sold krona, you could say. It depends on how many percent of the sales volume that will affect us. It depends on how far we have taken the project and so on. But that's how we see the business model and it's still there.

A question related to Phase 1b. If you don't get any contracts in place and you have to run Phase 1b on your own, will you need additional money in that case?

As the situation is now, we count on it. We have good leads. We see that we should be able to cover the costs with our own funds. If we end up in a different situation, we'll have to come back to that. We really see that 25 is a year where things should happen. We can also work with the level of ambition in that study. You can make a two-step rocket. If we have a problem with money, we can work with it. There are many small screws to screw on so that we can do it.

Your previous studies, if I remember correctly, NEX, were it 18 and 20?

Yes, good.

Are they completely screened or is there any activity in them?

There is no activity in them now. We have been asked about one of the projects from a company But we will not invest resources or money in any of those projects unless we are in a country with other agreements. We have an evaluation in progress if it is specific to those projects or others we will invest in in the future.

Another question here. Are applications of pharmaceutical sources today involving shorter or more acute treatment periods?

No, we don't.

Those were all my questions for you today. Do you have anything to add before we close the store?

Great questions, and thanks to all of you who have asked the questions. I think it's really fun to get questions like this. It's one of the few ways where there's a direct connection to you who are already thinking about or already own Nexa. Vi är rätt glada på jobbet och vi ser fram emot det här året och vad som kommer hända det här året. Det är väl en bra slutord, eller hur?

Det är det. Tusen tack, David Westberg, vd på Nannexant.

Tack så jättemycket.

Och tusen tack till alla er som har tittat. Vi kommer också göra en översättning på den här till engelska för de som föredrar det. Det kommer inom något dygn. Välkomna tillbaka om ungefär tre månader.