Nanexa AB (publ)

Welcome. Nanexa, the drug delivery company, has released a report for the second quarter of 2025. In the studio we of course have David Wessberg, who is the CEO of Nanexa. Welcome David.

Thank you very much.

What would you say has been the focus during the quarter?

Of course, a focus on the GLP-1s, Nexio 2 of course, and a lot of focus on commercialization, agreements, discussions with different companies. So it has been a very intense quarter, I can say. And we have already provided some results on Nexio 2, so we can come back to that later. But in short, that's it.

Thank you very much. Let's look at some figures before we move on and look a little more in detail at what you mentioned. The turnover in the quarter is halved to about 2.7 million Swedish kronor against 5.6 last year. Is this in line with your expectations?

Yes, there will always be this type of fluctuation, but it is completely in line.

Losses decrease somewhat, liquid funds at the start of the period land on 40 million SEK and that is also in line with the opposite period last year.

Yes, the economy is completely in line with how we have planned. There is not much to comment on that, but it is in line. We got this grant from Applied Materials, for example. There are a few of them who have made cover option solutions here during June and July as well, which gave us 3.5 million in total. But I think it's good.

The biggest focus is on NEXT22, the monthly dose of liraglutide, a GLP-1 substance for patients with type 2 diabetes and obesity. How would you describe the development during the quarter?

What we did during the quarter, if you remember, we delivered data on three doses where the highest was 10 mg. We continued into the 30 mg dose, which was an addition to the study we did and we have had very good results from that study. You can clearly see a release profile of one month and an increase in the plasma profile corresponding to that increase in the dose. So it's really good and we have also been able to present it at the ADA conference, American Diabetes Association in Chicago this summer. I think we were the only one who had clinical data on a GLP-1 long-acting at that conference, and it's a huge conference. Very interesting, very interesting. What we have continued with, as we also said, is that we have reformulated the formulation to adjust the release profile. For those of you who are really involved, if you look at the release profile, if you see a picture, you see that we have a little too high Cmax. We have now pushed that down, and we have shown that now. We have animal data from rod studies that show that we have pushed it down. So we have a formulation to include in the next clinical study, so to speak. So it has moved on properly, we can say.

If we go on and look at when you have continued to work with Pharmachelle, especially in the three main areas here, could you Tell us a little bit about how it has developed.

Yes, exactly. These are three areas that we have worked on for quite a long time. One is related to stability and how you need to store and store and how you transport biologics. It is often about cold chain logistics. It is a storage and transport method that adds a lot of cost to this type of product. But we have shown that when we put on Pharmacel as a protective layer, we can store these in room temperature. It will be very valuable for those who then commercialize such a product, which will greatly reduce production costs. The other is ready-to-use suspension. We have normally, and until now, largely worked with water-based formulations. And then we need to have, in the finished product, the powder and the liquid separated in a dual-chamber syringe. That's what's on the market, so there's nothing strange about it. But there has been a demand from the companies we have discussed that you can not do a ready-to-use. You make a suspension and we fill that suspension with a syringe. And then it's a ready-to-use product. The patient just needs to shake it a little bit and then inject it. But especially for those who are going to produce, this is a big advantage because you can use the same filling lines that you use for today's products. If we take Osempic or Veggovi or Munjaro or whatever we take now, they are filled in a spray in one process, so to speak. So this is another thing that lowers production costs. And then the last and perhaps very important thing is terminal sterilization. And what does that mean? It means that you start working aseptic. Aseptic production is very expensive. Aseptic is the same thing as sterile production, you can say. And then you understand that everything must be sterile when you produce. What we do now is that what we can allow is that you work in a still clean environment, but not the enormous strict requirements that aseptic production requires. And then terminal, when everything is finished, you sterilize with a gamma irradiation radiation. And it has turned out that we By adding pharma cells, we protect the peptides inside the particle, so they do not break down, which is another case. These are three areas that are very important for these large companies. We take the product to the market, we put it into production and we see that production costs can go down. And when it comes to room temperature storage, it is also a great advantage for the patients. You don't have to have it in the fridge, you can have it in room temperature. So these are three super important areas. I am very happy that we have, but it is something we have worked with successively for many years actually.

And what, according to you, is it that makes Pharmacel so valuable to be able to make a monthly deposit compared to daily and so on?

Above all, if you look at the market and the clinical need, it is about adherence. Adherence to treatment. Approximately 50% of all patients who go into a GLP-1 treatment, they end within a year. And it's difficult. There are side effects, of course. But you have to remember to take a shot once a day or once a week. Studies have shown that if you have a product that requires fewer injections, you increase adherence to treatment. If you think about how much money Novo, Lilly and others invest in their effect studies, where you see that it is 20%, 21% or 22% weight loss. If the patient does not take the medicine, there will be no weight loss, right? And if you have a product that instead make it possible for more patients to stay for treatment, not just one year, but two years and three years. That's where you get the real, real profit. And this is what the market understands. Therefore, there is a surge after one month and actually also after three months. So there we have results that indicate that we are on the way there too, to be able to deliver a three-month. So I am extremely optimistic in the future, actually.

Exciting. This leads us to Bridget Lacey, who is your new Chief Business Officer. She started de facto in May. What happened here? You mentioned Ada. You have been active in several places.

Yes, we have been active. I am very happy that Bridget has joined the organization. It is a sign that we are strengthening the business development side. Otto Skåling, who also works with us, is still there. But we want to strengthen this side enormously because now we have the opportunity to really go out and discuss with many companies. And Bridget has been with us both at Bayo in Boston and then Ada in Chicago. And she and I have worked quite intensively during the summer as well, because we got a lot of leads at these conferences that we have continued. So we've had a number of discussions and really fun ones as well. Now I'm not going to rush it all too much, but it is obviously the case that our results in NEXT 22 have It has not only given an interest to Nexo 2, but it has given an interest to a whole lot of other things as well. There are many GLP-1s, GIPs, Amulins.

That's exciting. Before we move on, we will let in an analyst from Emergers, Johan Widmark, to ask some questions and cheer you up a bit. So I say hello, Johan, are you with us?

Hello, hello everyone. Hi David. Hi Johan. Can I hear you?

Yes, so please go ahead with your questions Johan.

Thank you. First I just want to check with NEX 22 here and preparations for the next phase. Is the goal still starting during the year and what is it that remains here?

That is a very good question. As I mentioned, the optimization of the formulation is finished. I have also mentioned that we have discussions with companies and we are trying to link this to a plan for the future. And I want to say that it is not entirely certain that we will proceed exactly according to the plan that I said earlier, that we will as soon as possible, as soon as possible, excuse me, go into phase 1b, but we will probably modify it based on discussions we have with companies, so that it follows. And I think you understand that it is very important for us to do it that way. But we have made preparations for it, so it is stuck. Should I interpret it as that it is not certain that we are starting? Yes, you should interpret it as that it is not certain that we are starting. Yes, and that is due to the fact that we have other signals from possible partners.

What kind of signals would that be?

It's like looking at how you want to do the next step and so on. Is it just this study or is it something else? Is it another type of study or what can it be? No, I can't go into details more than that. It depends. I don't think you should interpret it as insecurity. You should interpret it as a strength.

Okay. And then I would like to hear about the extension of the evaluation agreement. If you can give some details here. Did it take longer to do what you had planned according to the plan or did you want to do other things? How does this process compare to other processes you have been in for Pharmacel?

It is not that it has taken longer, but we have drawn conclusions from what we have done together with this company. And then the company said that now we want to use this for this commercially very important product that we have. And that product, which is a product that today sells for, I actually believe that it is 3 billion US dollars that it is sold for, there we want to do a long-acting, because we see that there is a clear clinical need for a long-acting for that product. And then this agreement is a first step in that development and a step that I feel is a very low-risk step that will be implemented as soon as possible. Let's say that you are going to count on a continuation of this, I would say, during the first, absolutely first half of next year, then we hope for a continuation, which then means a significant agreement. Given that everything is on the way then, but for me it is a low-risk project actually.

Okay. And then a last question that might relate to my first question a little. There is a lot of focus on Orala GLP now with Orfor and Prån from Eli Lilly, among other things. It seems to be what also determines the sentiment around these big dream license partners. How do you feel that this has affected the interest in your direct counterparts who are deeper in the organization and more focused on their individual projects? Is that something that goes along with your answer to the first question?

No, it does not go along with the answer to the first question. There are two directions for this incretin, the GLP-1 market, gippar and ammolins within type 2 diabetes and obesitas. One is, as you can see, we talk a lot about oral tablets and oral intake and so on. You should remember that the peptides that are given orally have a bioavailability of 4-5%. Extremely low bioavailability. The small molecules that you work with, and a lot is done with different small molecules. It is possible that they can be good, but you have seen, among other things, in Lilly's study, that you have not got the results you want. You see many question marks appear around more serious side effects of these oral tablets. And you can speculate on what that is all about. You can guess, or you can guess that it might have to do with a high local concentration in the intestines where there are receptors and so on. I don't know. It's a kind of kill guess. But there are several that suggest that it might be so. At the Ada conference in Chicago, there was a whole morning that was about oral and small molecules. And there are a lot of question marks about that. The question is, will they really be able to have the same effect as these peptides that are very well tested and so on? We don't know in the current situation. The other direction, now I'm talking a lot about the oral, the other direction is quite clear that you will go over especially on the maintenance side of the long treatment of obesity and type 2 diabetes, which in turn is a market or indications that shrink together. You see that The obese people, or a very large proportion of those who have type 2 diabetes are also obese, so to speak. But there you go against long-term, or what is it called, less frequent dosing, that is, one-month formulation. You even wish for three months in some cases, or in some cases, some companies aim at that. But we are in the right position there. I think it's a long answer to a good question.

I just have one last follow-up question based on the first question here with the prospects for NEXT 2022. It is very quickly moving what is interesting and hot in this area, which is a giant area. Is it so that you feel that time has started to run out of liraglutide? Is that what you can raise question marks about and that you would like to There have been a lot of thoughts about the side effects of the GLP1s.

There is nothing to do with the GLP1s as such.

I was just thinking about liraglutide.

Yes, I know, liraglutide. No, but what should I say there? I think I fit a little bit on that question, but liraglutide is still very interesting, so to speak. There are other GLPETs that are also very interesting. It is there in discussions with companies that we resonate back and forth. I have to come back when I know more about what the plans will be like in the future. I think I have to end there. Thank you very much. Thank you for the questions, Johan.

Thank you very much, Johan Widmark at Emergers. Let's move on to some viewer questions. We have received a collection of questions from an investor collective. Is it correct that the pre-paid revenues for the valuation agreement with Novo Nordisk are now periodized, but that the exclusivity still applies? And in that case, how should we interpret that?

A lot of interpretation issues here, I notice. And so it is when you are in an intensive period, I would say. It is true, the first thing you say, or the question that the periodization, purely bookkeeping-wise, is over. I was about to say, it is fully periodized. As for the exclusivity, that's where I get what fits, because it is confidentiality situations that make me unable to say anything about it.

Okay. How do you see the strategic role of NEXT22 in relation to potential agreements with Novo Nordisk today? You said recently that NEXT22 could become part of an agreement or be resolved in another way. How do you see that today?

I think I can say that we will probably see Liraglutid and NEXT22 as a separate part where Novo... No, you should probably see it as a separate part. That's my best guess. Nothing is spiked, of course, but that's what I can say.

What is the meaning of the extension of the recently announced valuation agreement? And how is the exchange rate? And why did the customers choose to extend instead of signing the license agreement?

No, as I mentioned earlier, they have gone in and studied the pharmaceutical technology, seen how it works, and they have seen a very important application for them in this product that they now have as a major market sale, so to speak, and that they have not covered the license agreement now, It's about a normal risk mitigation from their side. Let's make this less crazy before we sign the license agreement. For me, it's completely natural that they want to do that. As I mentioned earlier, for me it's a good start. It's a good start in such a collaboration around that specific product. All my expectations are really that we will come in a reasonable future to a situation where we write a license agreement with them. All these MTAs, Material Transfer Agreements and Feasibility Studies, aim at a license agreement. It is not a large company, no other partner company that started if they do not have that aim. And here I would like to say, here we have a really sharp situation.

When we talk about the Norwegian-Norwegian cooperation, a lot is happening there, there are some organizational changes. Is there anything that affects your cooperation?

It is actually hard to say, I would say. It does not affect directly. But of course it is... Yes, it is being redone a little. We have a new CEO. We know that changes are taking place in the organization in the USA. We see that changes are taking place in the R&D organization. Schindler had to leave and we have... Martin Holst Lange, who was the former head of development, will take over. But it's on a very high level, so I don't think it should affect it.

Could you describe the most important steps in the development plan for NEXT 2022? What preparations have been made and what is waiting for the next phase? Is the goal still to start in 2025?

I'll probably have to refer back to the same question as before. It's a bit of a discussion with the partner company to manage the timeline. But in general for GL-PETR, liraglutide or whatever, it is a dose escalation up to to a clinical level that stands as the next step. It is a dose-escalation study, a PK phase 1. And then there is a pivotal bridging study, also a phase 1 PK study. And then there is an effect study. a limited-effect phase 3 study. And that's really what connects the entire clinical program to an NDA, an application for market approval. So that's what it looks like. But in the near future, we have prepared with this new formulation of Liraglutide so that it is ready.

You have 40 million SEK in the cash register. How sure are you that it will take you all the way until you have the other cooperatives in place?

I can never guarantee anything, but I can guarantee that we work extremely intensively and have done so for a long time, but even more intensively now from spring and during the summer and now in autumn. My big hope and my best guess is that we get a long-term financing from contracts and not from any other way to finance the business.

As a summary, what do you most look forward to in the second half of the year?

Yes, that is probably to end the discussion with one or more of the companies that we are now discussing with. So that we really put an emphasis, an agreement forward. Nothing that I can guarantee, of course, but we work hard on it.

We get to mark your news flow. Yes, you can do that. Then I would like to thank you who have watched and also you who have contributed with questions. And a big thank you to you, David Westberg, for participating today.

Yes, but thank you very much. And thank you for all the questions.