What is Marinomed, and why it's interesting for investors? First of all, to hear our story, and second, to own our share. We are a life science biotech company located in Vienna, listed on the Vienna Stock Exchange. We have experienced management team, and we have done in the past product development that led to partnering with big pharma companies, including Procter & Gamble, Boots, Boehringer Ingelheim, and Reckitt Benckiser with our previous assets that we have recently sold. We have the know-how, we know the industry, and we know the field. And why we think we're gonna be successful in the future? We have a clinically proven, potential disruptive technology that deals with the solubilization of otherwise insoluble compounds.
That's not something that is far away in terms of development. Those lead assets that we've developed from this technology, those lead assets are already in partnering. Right now, we're in partnering discussions. We have involved an M&A advisor for that, and not only for one asset but for the top assets. We're doing that all with a lean and efficient business model. With the recent capital increase that we've done last year, and we plan also to be profitable, got profit from the sale of the assets of our Carragelose business . Having said that was also the basis for the future of the company as we came out from a restructuring procedure in 2024.
There is a similarity with Volatus, is that we also have skin in the game as management and founders, still have around a little bit above 20% of the company. That's the similarities as well. My wife and I, we've never sold shares since we went public or even before. We have quite some holding. We're listed on the Vienna Stock Exchange. You can see that under ATMARINOMED6. You can find our stock easily on the Vienna Stock Exchange. There's two individuals, Abdul Mohsin and Mohammed Al-Sheikhs. Those are early-stage investor, and they have invested as back as 2006.
Also from that perspective, you see that our seed investors are still on board. 71.4% are in free float, quite some free float as well. What are we talking about, and what is the business model about? We have two assets in the, in development. One is Budesolv, which is a solubilized nasal corticosteroid for the indication allergic rhinitis. That product has already successfully passed the clinical phase III, and Tacrosolv, a solubilized tacrolimus for the treatment of inflammatory eye diseases, has already passed successfully shown efficacy in a phase II clinical trial. Those are in-house project that we have developed until a stage where we can, we are currently in partnering processes.
On the right side, under the brand Solv4U, we have technology partnerships in place where we develop different products, client-sponsored products that are driven by customers. They simply want to leverage on our technology. What does it mean? Basically, it means that we solubilize the compounds, they develop the products, we give the technology license, and certainly, we plan and are currently also already collecting revenues, first of all, from the services we do there, and second, from the providing the license, we get payments. That's how it looks like. This is the business model. If you wish, we are an R&D boutique with in-house and client-sponsored projects based on our Marinosolv technology. That is also marketed under the Solv4U brand.
We have these in-house projects, of course, the idea is to generate upfront milestone and royalty payments. In client-sponsored projects, Solv4U project, it's a cost-plus model where we later get royalties, milestones and royalties dependent on the development of the project. Why is this so interesting for investors, why do we think we can move significantly here? The global market for nasal steroids has a systematic flaw. The existing products, they fall short of the patient's needs and the market opportunities. Why is this the case? They contain preservatives because all of these products are suspensions. Therefore, they are not sterile, have a slow onset of action, and requires a relatively high dose in treatment.
Of course, all, practically all of them face a generic competition. We consider those products represent something like the Nokia phone of the year 2000s. There is, of course, a need for an iPhone, and that's what we want to deliver to this market, and this market is huge. It's a if you take the market altogether, it's a double-digit billion US dollar market that is dominated by the antihistamines and corticosteroids. Those of you who are allergic already know that. The antihistamines, the main reason why their antihistamines are existing is because they have a fast onset of action, are active in a relatively short period of time, whereas corticosteroids, they may take time.
If you consider that the health authorities ask us when we ran our phase III clinical trial and had to do the non-inferiority to the competitor of marketed product, the health authorities ask us and said, "Okay, we know that these products, they don't work fast, so you treat the patients for a week, and then you do your head-to-head comparison." Just imagine that you have an allergy. Doctor prescribes you a product, or you buy it in a country where you can buy this OTC. You buy it in the, and then it takes a week until you have full efficacy. You probably are not satisfied.
That's the actual case in this market, and this market is growing simply because of price increases and the increase of allergic people everywhere in the world. On the right side of this figure, we have modeled somehow what it would mean if a new product enters that has a transformative potential. When we could replace this existing corticosteroid nasal sprays and compete with antihistamines and a combination product, the product would have a market potential of around $5 billion. Quite a significant market. What has to be done to go there and what has to be done to get that market share?
In our opinion, and also the opinion to the partners we are currently in discussions, it needs a compliant strategy to do that. You definitely need a superior technology, and you need an industry footprint, but this superior product, and that's what we have shown already, is you need, first of all, a fast onset of action, not days or weeks after the first dose. That's quite clear. We've shown that in the clinical trial. Of course, you need the data, the clinical data. You need the sterile product. You need it preservative-free. You need the low dose, and to protect yourself from immediate competition, you need an IP protection, and all that is there. But that's insufficient to get the revenues. A small company like Marinomed needs partners.
A partner with a carrier brand and marketing and regulatory know-how. It depends on the markets, especially in the regulatory, whether it's a switch to OTC is needed. Those partners, they need a winning marketing concept. We know it from the past, as I mentioned, when I entered from our previous products. It's not a given that if you have a superior product, it's sold. You need a winning marketing concept. You need the global rollout strategy, and very importantly, you need cost-effective production. Here we can really leverage our experience. We have more than 20 years of experience now with the production of nasal sprays. Here is significant differences in how you produce and how you produce them.
Cost effectiveness is key for the margins, and the margins determine our royalties and revenues later on. You need the regulatory expertise and the public relations or modeling. We need to transport the message to the customers that preservatives in these products are unhealthy. They simply, especially for the nose. There has been done a lot of work for other products in the past, so we can leverage on that. Communicating that the lower dose of the product is better for the patient should be part of the story, and also that less steroids are better for the environment should be given as well, but you need to tell it, and then you can grow the brand behind.
What is needed here to go there is to get the regulatory path cleared. Those who know us for quite some time know that the phase III clinical trial occurred some time ago. The reason why we are still discussing about partnering is that we had a stability issue after in the upscale of the large-scale production that we have solved. That stability issue really cost a lot of time because you only find it out after a certain time, and our stability problem was only after 18 months of storage. It's unacceptable for the market that the product has only a shelf life of 18 months. We need at least two years, as the originator has.
We are now working on, towards three years. We had to adapt the packaging and the formulation , which was different. It is now a little bit different to the clinical trial. First of all, we filed another patent. We had to clarify the regulatory paths. That happened last year. Last year, we also did our first partnership with a Swiss company. Now we are working with the Swiss company on the submission in Switzerland, including a small PK study. What does PK mean ? PK is a pharmacokinetic study.
Pharmacokinetics is basically you, to those who are not familiar with a procedure like this, basically, you take the product that was in the clinic, take the new product, spray the volunteers in the nose, and then look at the blood, whether you have the same levels or not. That's a very fast-forward study. That's planned for later this year, and t hat study triggers then, well, then we can do the approval process in Switzerland that we expect for next year. Then, in 2027, the product could be launched in Switzerland.
Important for us, for you as investors, we don't need to wait for the revenues to kick in until we have approval in Switzerland. A pharmaceutical partnering works a little bit differently. You get the partnerships in place well before the marketing authorization is there, and that's actually ongoing. Of course, I would be much happier to tell you or give you news today about the progress here. We have the partnering process for Europe, Asia, MENA, and others, and these others also include the US at the moment. I cannot give clear news here. I can report that there is quite some progress, but there's no news yet to be published.
Would be much happier and much more motivated. I'm motivated anyway, but much happier to tell you details of a deal. I can tell you that I'm pretty optimistic that we achieve our goals here and that we do it very soon . Once these deals are done, the work is not over. First of all, afterwards, post-deal, you have to work on approvals with the partners, and then we do, of course, additional partnering for the US and rest of the world, and then we work on the launches in those individual countries. The partnering now is key. We expect significant upfront payments here as well.
For those who know us longer, we have been able to generate upfront payments in our previous Carragelose business that had much smaller markets also in the mid-single-digit billion EUR. We expect that this is possible here as well. Given the size of our company, that alone would significantly help to finance us until the royalties, once the products are launched, kick in. On the way, typically these deals are structured like that you get upfront payments, but also, for example, an approval triggers the next milestone or launches another milestone. Here is quite some opportunity and not so much work to be done at Marinomed anymore.
Most of the work has happened, and the biggest part of the investment has happened here as well. We are quite busy in partnering here. That's about Budesolv, and then I want to give you an insight also into tacrolimus eye drops, which are the solubilized tacrolimus. This is also a big market, not only dry eye, but also the market for inflammatory eye diseases, which is dry eye, is also an inflammatory eye disease. By far, the US is the biggest market, and this market is also up to gonna reach around $10 billion in 2030.
There has recently been some approvals in the space that demonstrate that, first of all, the market is valuable. Here we plan to partner already at the stage that we have at the moment. We are also in advanced discussions with a couple of companies in advanced discussions. We're quite confident here that we're gonna reach an agreement here as well. To remind you what we've done here, just one slide on data, it's pretty important because those products on the market for treatment of dry eye disease, they happen to work only if you see clinical efficacy after something like a month or so of treatment.
Here is phase II data that shows that after an 8-day treatment, TOSS means Total Ocular Symptom Score. That is a combination of several ocular symptoms, which, when you compare it with a placebo, you see quite a difference immediately after challenge. That was an allergic challenge. When we take the higher dose in this phase II trial, we see a 26% reduction on day eight. It was quite, when we discussed this with key opinion leaders, they told us it's quite astonishing that Tacrosolv shows this level of efficacy on that low dose already after eight days, that they were expecting a month or so treatment. We even saw a reduction of the nasal symptoms of the patient on this date.
What are the next steps here? We work together with an M&A advisor here as well in the strategic evaluation. That means we are discussing potential strategic partnerships that may include a partial sale of the asset. This may include a typical upfront milestone royalty deal that may include a strategic partnership. It's currently not fully determined, but Marinomed itself will not invest in phase III trials alone. We're going to take that forward together with a bigger partner.
Not big because we don't like it, we don't believe in the project, but we are certainly fully aware that a phase III trial in that space requires significant industrial and marketing expertise and contacts to key opinion leaders around bigger jurisdictions than we have. And that's why we need a partner here. For investors, this could be interesting because it's a chance for near-term income and quite some potential upside later on the further of beyond 2027 and 2028. To summarize, yeah, we have near-term commercialization of our late-stage assets based on our proven technology. We do it with an experienced management team. It's potentially disruptive.
Disruptive means that we really could turn the market, especially when it comes to Budesolv and the allergic market, and together with, supported by an M&A advisor, we are working on partnering. As a shareholder, it's quite an interesting time because that news can come up anytime. It's very difficult for those of you who are know pharma companies or life science companies, it's always difficult to predict exactly when a deal happens. That's why the help of an M&A advisor ensures that at least the process itself is competitively timed and ensures that the potential partners are doing their job.
Yeah, we're doing it lean and efficient, and yes, from our from the finance side here, of course, those of us who know our history, it's it has never been easy once you come from such a restructuring process. The restructuring plan is currently fulfilled. We have profits from the sale of our assets, and we're looking forward to get more payments here from that sale. Having said that, I'm open for some questions from the audience.
Well, thank you very much for the great presentation, Andreas Grassauer. We do have a few questions coming in. We have still six minutes. Please, if you have more questions in the audience, please send it in the Q&A. The first question, which is very precise, is from Thomas. It says: Which markets can you address with the Budesolv with the Swiss approval? Which market will that open you?
It's a good question because Switzerland serves as a reference country for a couple of countries outside Europe , and that includes countries like Canada, UK, Singapore, Australia, New Zealand, and recently Brazil and South Korea joined. Most importantly for us at the moment, it's also clear that we can easily reach East also in the MENA region and a couple of Asian countries with the Swiss registration. Basically, we could address around 2 billion patients with that registration. That's quite a lot.
Absolutely. Next question, do you need to wait for full regulatory approval before the company can begin generating revenues from its product? That's a question that was asked by Matthias.
The typically, deals like the ones we're working on now typically have an upfront payment, then a milestone upon a registration. For example, if it's a bigger jurisdiction, it can be quite significant, even in the double-digit. It depends on the jurisdiction. The company plans to finance its operation from the upfront payments and milestone payments until the profits from the sale of the product in the individual markets kick in.
Okay, perfect. Another question, is the underlying technology protected by patents, or is there a risk that competitors could replicate the product?
We have patented the technology. The patent strategy, we have a basic patent for the technology, but we have additional patents for the individual product itself. Budesolv itself is then there is another sub-patent or a product patent that protects the Budesolv product itself. That's part of the strategy, that every single product that we develop gets an additional patent protection to maximize patent lifetime and maximize value.
Perfect. What is the current development and regulatory status of Tacrosolv?
Tacrosolv is a post-phase II asset. The status is that we are currently working with potential partners on the registration pathway in different jurisdictions, mainly in Europe and mainly for Europe. If there's an agreement on the regulatory way forward, but once we have a commercial agreement with them as well, we're gonna announce it to the public what the deal looks like.
Perfect. What is the competitive advantage does your nasal spray offer compared to current market leaders?
The competitive difference is that, first of all, you can reduce the dose by 86%. The second thing, you have an immediate onset of actions. You don't need to wait. The third thing is that the product is preservative-free, which represents a significant differentiation from anything else that is on the market.
Okay, perfect. Finally, because we're running out of time, if you were to sell one of your products, would you pay out the amount as a dividend or keep it for reinvestment in R&D or others?
That's certainly something as a shareholder, I'm always happy if there is a chance to pay dividends. Of course, our shareholders have been waiting quite some time until we show profits, so it's something, but certainly I would ask the general assembly because they are the final deciders whether or not we pay dividends.
Perfect. The time is up. I thank you very much, Dr. Grassauer, for being with us to present your company, Marinomed Biotech AG, which is traded on the Vienna Stock Exchange. We will be following the story and looking forward to the development in the next few months. Thank you very much.
Thank you very much, and have a good day, everybody.
Thank you very much.