Moberg Pharma AB (publ)

Good morning all, good afternoon all, and welcome to the Movericks Family Conference call. My name is Adam and I'll be your operator today. If you'd like to ask a question in the Q&A portion of today's call, please press star followed by 1 on your telephone keypad. I'll now hand the call to Anna Young to begin. So Anna, please go ahead when you are ready.

Thank you, and welcome everyone to this telephone conference following the press release yesterday evening. Please note that this call will be recorded and will be made available on our webpage. With me today are our Chief Medical Officer Anders Bergessinger and our Chief Scientific Officer Amir Tavakol. Today, we will provide an important update on our ongoing efforts related to our product MOB15. We understand that there is a significant interest in the progress of this program, and we aim to be as clear, transparent, and forthcoming as possible. Our objective is to address not only the applying results from our North American Play Treats study, but also preliminary statistics strategic implications that arise from the data. However, I want to emphasize that this is top-line data that we have just received, and both we and our partners need time to thoroughly analyze and digest the information before making conclusions. I will begin with an overview of the study, key results, and our reflections on what these results mean for our business strategy going forward. After that, we will open up the floor for questions. So, turning to that overview of the study, The North American study was conducted at 33 study centers across the U.S. and Canada, including a total of 384 patients. Two starts of the patients received MOB15, while the remaining starts received a vehicle. To maintain consistency, we deliberately kept key elements of the trial the same as in our previous studies. This included using the same investigators, CRO and mycology lab, while also providing comprehensive training to ensure good compliance. This study differs from previous studies with MAD15 by reducing the dosage to 8 weeks of daily dosing, followed by a weekly maintenance treatment for 40 weeks. The previous studies, which are the basis for drug approval in 15 EU countries, had a daily dosing throughout the entire treatment period. Our goal was to evaluate whether this dosing adjustment could deliver comparable or better efficacy by offering the advantage of less frequent dosing. A few words on the selected dose regimen. Our formulation and dosing regimen worked well in previous studies, and it is reflected in our European approvals. However, given the very high mycological cure rates seen in the previous studies, we also expected better clinical outcomes. We believe the results of the previous studies were confounded because of whiting and overhydration of the nail plates for our effective formulations. This interfered with the investigator assessment of the nail and likely the clinical cure process of the nail appearance. Already at week 12 in the previous studies, 70% of patients showed checks of whitening and overhydration. The current phase 3 was therefore designed to reduce the frequency of replication and dosing through 8 weeks of daily dosing, like a loading dose, to allow fungal killing, followed by once per week dosing to avoid nail overhydration and whitening effects, while at the same time maintaining fungal erodiction. It is a combination of primary tests that led to the exact dosing in the study, including analysis of patient photos by key opinion leaders from our previously completed phase 3 trials with the first cases of VIC-12, photos from earlier time points, such as 4 and 8 weeks from vehicle data, and mycology data at different time points. And also the biopsies at 24 weeks showing a concentration of sorbinafilm with daily treatment that is 40 times higher in the nail bed to what is known levels with oral treatment. So in line with previous communication on September 13th, the results now confirmed that the primary endpoint was not met. The primary endpoint defined as the proportion of patients achieving a complete cure of their target soulmate at 52 weeks. was achieved by 1.5% of patients receiving MOP15. No patients in the vehicle group achieved complete cure. It is important to note that complete cure is a composite endpoint requiring both a completed CRNA and mycological cure. For the three secondary endpoints, the results were as follows. For mycological cure, we achieved 25% of patients receiving MOP15. Treatment success. as assessed by the investigators, was achieved in 11% of patients. Regarding nail whitening, while not a formal endpoint, we did see an improvement compared to earlier studies. Previously, about 70% of patients showed whitening at 12 weeks, according to Clear Opinion leaders' review of photos in both studies, as well as looking at the number of nails scored at increased affected nail area by investigators at 12 weeks versus baseline. We have just received the data, so no formal review of all totals has taken place by external key opinion leaders. However, our internal experts have reviewed the data and also shared some of the pictures with key opinion leaders. As expected, whitening seems less frequent after 12 weeks compared to the previous studies, also indicated by SS-affected nail area by investigators. where 49% of patients were scored as having a worsening, so increased effect of malaria, by investigators as 12 weeks versus baseline. The corresponding number for 8 weeks was 54%. Thus, comparing to previous studies with about 70% of 12 weeks, this indicates that fewer patients develop worsening with the new dosing, and that the worsening seen as week 8 is reduced by switching to weekly treatment. Turning to the mycology data, mycological cure was 25% after 52 weeks and only achieving 16% at 12 weeks. This is way lower than the numbers seen in our previous studies, starting at 37% to 47% at 12 weeks and gradually increasing to 76%. The difference between the groups at 12 weeks is that instead of getting daily dosing for the full 12 weeks, Patients in the news published got eight weeks of daily dosing, followed by four weeks of weekly dosing. The drop in mycological cure indicates that eight weeks of daily treatment is insufficient to kill off the fungus, and while we see some improvement of mycological cure throughout treatment, levels remain low and show that although weekly treatment may be sufficient to prevent the infection, we were unsuccessful in killing off the fungus to start off with. Whether another, longer daily treatment period might have been helpful is impossible to tell. Unfortunately, the only way to know is to conduct length and extensive clinical trials, as patients need to be followed until health in a regrowth. We still believe that there is a balance between delivering sufficient drugs and avoiding the hydration, worsening effects on the nail, where there is an interference between this worsening effect of the nail and the clinical cure assessments. We have managed to reduce whitening, but at the expense of not supplying sufficient amounts of drugs. The patent application builds on the hypothesis that new lower dose would result in a higher complete cure rate. Unfortunately, the data from the study does not support this, so new data has to be generated for the patent application. We also have granted patent protection until 2032. Following these data, we and our partners will further analyze the results and determine the best way to move forward. Given that the study did not meet its primary endpoint, we do not have the data package required to file for regulatory approval in the U.S., as FDA typically requires two successful superiority studies. We have also investigated the possibilities of taking an OCC route in the U.S. Provided that data supports RX approval, an OTC route for a topical onychomycosis product in the U.S. is possible, but takes time. We have no immediate plans to do another U.S. study with the original dosing or another dosing, given the timeline and costs involved. Our original strategy was to combine direct sales in the U.S. with strategic partnerships in other team territories. In light of the top-line data, we are reassessing our plans for the U.S. and shifting our primary focus to Europe, where the regulatory approvals are already in place and where we see the greatest opportunity for growth. During this late autumn, Bayer had conducted an extensive review of its pipeline, and we have together decided not to continue the collaboration due to strategic reasons and the top-line data received. So therefore, we have... expressed a mutual intent to terminate the license agreement, and whereby we regain the full rights in the EU and retain milestone revenues already paid by Bayer. For Mobut Pharma, this represents both a challenge and an opportunity. We remain confident in the competitive profile of Mob15, as seen in the successful launch in Sweden. By regaining control of Mob15 in Europe, Mobut Pharma can secure a larger share of the value chain and play a more active role in commercialization. This includes brand ownership and better margins. Following the subset of data communicated in September, we have been working with multiple scenarios, including a shift in focus towards EU being the greatest opportunity. Mobile Pharma is now in discussions with potential partners in Europe to identify an optimal path forward. Our intention is to update you once our business plans have been detailed and negotiations have progressed. We see great opportunities in Terclara for the 13 approved countries in the EU and with more to come. Terclara is already the market leader in Sweden and has grown the market by 44%. Having a 76% mycological cure, daily dosing is outstanding for topical onychomycosis scars and the success in Sweden confirms that the marketing message and claims of the product resonates well with consumers. I'm looking forward to updating you on our plans and progress forward taking Terclara to market. In summary, the North American Phase III study for MOB15 did not meet its primary endpoint, and its mycological cure rates were lower than those seen in previous studies. The reduced dosing regimen decreased male whitening, but came at the cost of lower mycological cure. The strategic implications of these results are significant. The findings confirm that sustained daily dosing over a longer period, as approved in EU, is essential for effective treatment. As a result, mobile pharma will shift its commercial focus away from the U.S. and towards Europe, where the original dose in regimen is already approved. Stands for direct sales in U.S. have been put on hold, as FDA required two successful superiority studies for regulatory approval, and the current study fails to meet its primary end point. A key development arising from the data is our shared decision, together with Bayer, to stop the collaboration due to strategic considerations and top-line results. As a result, we will regain full rights among 15 in Europe while retaining milestone payments previously made by Bayer. This is also an opportunity to capture more of the value chain in Europe by taking a more active role in commercialization and brand ownership. Discussions have been initiated with potential partners in Europe to support this strategy. RS4 EU product, marketer Teclara, provides a strong market opportunity. Teclara has already become the market leader in Sweden With the product achieving 76% mycological cure under the daily dosing regimen, we plan to use Terclara as a star brand in Europe, with the potential to expand to more EU markets. The strategy may include acquisitions of complementary brands to create a broader product portfolio, similar to what was previously achieved in the US market. And with that, I open up for questions.

As a reminder, if you'd like to ask a question on today's call, please press star followed by one on your telephone keypad now since the queue. When preparing to ask your question, please ensure you're head to fully plugged in and unmuted locally. Star followed by one on your telephone keypad. And our last question comes from Decatur Queens. Decatur, your line is open. Please go ahead.

Hi, Anna. Thanks for taking the call. So, you know, obviously you weren't getting the label outcomes you were looking for with this trial. You were able to reduce the whitening. And this is kind of a question for at least Amir or Anders. Reading about turbinifine, well, or gestural deficiency, it weakens the cell membranes. And, you know, consideration for past things Amir has said about the excess hydration that was unrelated to that composition. I'm wondering if that whitening is cell death. I know it's preliminary and, you know, unfortunately, that would just be something that, you know, you're just getting punished for having a good topical that works well because, you know, it's just causing all this excess cell death to occur continuously with continued applications. And, you know, just in the spirit of market access and what we've seen of the good work we've seen Alderma do with capturing all of that market, you know, I'm just wondering if they could take, if that would be sort of your ideal partner of choice for Europe. And I would be interested in hearing back if there's, any validity to that possibility from the opinion leaders, like Amir. Thank you.

So if I start with a question that I believe was directed towards me, whether Alderma would be our partner of choice, I would say that we have dialogues with several partners, and we aim to... get back to you as soon as we have clarity on the road forward. But we definitely see a road forward where we control a larger chart of the value chain, but we won't do it all by ourselves. So we will definitely have a partner involved in the conversation going forward. And Amir, perhaps you want to address that other question?

Yes, I just hope I understood the question. I think you are correct in the fact that terbinophene obviously inhibits the enzyme squalene and further down the stream inhibiting production of the cholesterol, which is the cholesterol required for membrane assembly. I think this is pretty specific to antifungals, in this case terbinafine. I'm not really quite sure the VHL would have such a potent biological activity to inhibit cholesterol production or lanosterone production. Is that what you're asking?

Well, it's just your... MOB15 gets a lot of turbinosine into the nail plate and the nail bed, way more than systemic oral therapy. And it does so very quickly, which is what's been observed in the past. So I'm just wondering if, you know, it's possible this excess hydration you've referred to in the past could be cell death. And, you know, if that's the case, well, I mean... moberg pharma is just being punished for having an ill topical that works really quickly i i know it's like really preliminary and you know it's it's it's it's our data was just unblinded 12 hours ago um but i i was just curious to hear your thoughts on that um idea uh just because you know um it's it's an oddity for sure right no i i i hear you so

Yes, so I'm really doubtful that that is the case. As you know very well, the live or viable fungus resides underneath the nail plate in the nail bed. That's actually where the size of infection is, which often kind of goes unnoticed. So the discoloration or the whitening that we see is really very superficial, is limited to the nail plate, The formulation, which is, as you know, again, contains amounts of urea, lactic acid, and propylene glycol. These are really non-moisturizers, non-hydration kind of excretions, and they're used widely in the industry. So my belief is that it's really just a superficial effect. I don't really think that it would it is a overdosing and killing the cells these are keratin they're dead on the surface and I don't think it would really affect the vibe of the fungus which is way underneath the male plate in these kind of spaces but it is an interesting idea yeah I was just thinking about the excess hydration you've referred to in the past because you said it doesn't come from the composition to my understanding so I was curious about that but okay thank you I appreciate you no actually it does come I'm sorry maybe me missus folks I doubt but it really actually the cause of hydration over hydration is the excipience because we see the same if you like phenomena in both vehicle treated as well as mob 15 treated so and that is that is expressively because of the acceptance and as Anna just nicely alluded to by lowering the lowering the frequency of dosing will reduce the hydration whitening, but then that came at the expense of delivering less dose of the active drug. But they are very closely linked.

Gotcha. Okay. Thank you for your time. And congratulations to Alderma. Alderma, you knocked it out of the park with that launch. And, you know, you deserve everything that they're telling. Because, you know, they earned their stripes for that launch. And, you know, this is just me hoping, Anna, but you should give them more of your help if you can. Okay. Thank you.

Thank you. We're really pleased with the collaboration with Anzalan, of course.

The next question comes from Johan Holmström. Johan, your line is open. Please go ahead.

Hello. My name is Johan Korn from Sweden. I'm a private shareholder. You already announced that around this time of year you will announce a new supplier of Terbimaskinen. I wonder how is that proceeding? That is my first question. And then, as a shareholder, I'm interested to know more about the business plan and the rollout in Europe. When do you expect to enter the first country, and what will the situation be in 12 months, 24 months, and 36 months, if you can give us some kind of information about that? Thank you.

Sure. So, if we start with the carbon F10 question. So, as we announced in the quarterly report, we have answered the questions from the Swedish MPA regarding the application, and we are waiting for the agency's decision. So, we have no new information, but we really do expect approval shortly. And, of course, the carbon F10... Supply, that's also linked to the rollout plans because we need that suburban supply to be in place in order for us to roll out in more countries. As I said, we think it's from the corner, but we're waiting for approval by MTA. And I would say that the timeline of the rollout is not really affected by this decision. Our goal remains that we will launch in the approved countries in 2026. So it's not really a change of plan when it comes to that. When it comes to the details around the launch in every country, well, now we have ongoing discussions with potential partners, and we need to get that in place and come back to you with an updated business plan.

Okay, thank you. May I ask you, when you talk about 2026, Why are we talking about 12 to 24 months from now? Why does it need to take so long time to do the first launch in the first country outside Sweden?

Yes, so the reason for that is that we don't have approved drug substance to the extent that we need in order to launch in more countries. So we need that approval, and just assume that we will get that tomorrow, then that's excellent. But that approval, then you need to produce the drug. And more importantly, the pharmacy change needs to put the drug on their shelf. And unfortunately, there are typically windows when they accept new drugs. So if we take our 3D fluid as an example, there are basically three windows in Freedom where you can enter... a drug into the shelf, and it's February, it's March, and it's October. And when we entered in February last year, then that decision was made by these chains in August and September the year before. So the timelines for the decisions for the chains, that's really the critical time point here. And we want to enter at high season. And the reason for that is not so much that we want good sales to start off with, but we want to be part of the change campaigns. And they only have the campaigns while at high season. So we typically have a foot campaign following the high season. So that's super important in order for us to actually enter all the chains at the same time. We were successful in Sweden, so we now have coverage on every pharmacy chain in Sweden. And that's, you know, if we're going to spend money on advertising, of course it's crucial that the pharmacist has the product on the shelf. So entering at peak season is, critical, I would say, for us to do a really good launch, so that we get acceptance by the chains, so they will take in the product ahead of the peak seasons, and then we will do combined marketing with the chains over these peak seasons. So, that explains your timeline, I hope.

Okay, that's good information. Thank you. May I ask another question? Sure. So, What I read also is that you have increased the market in Sweden with 40% since you launched the product, which is an amazing feature. May I ask you, what size is it on these 13 countries where you have approval of the market in euro, so to say? Can you give us an approximate number of that?

I would prefer not to, because I think they're really different markets. They, of course, have similarities, but I think that I'd rather come back to that when we have a thorough analysis of exactly how we will approach each market. Because even if we say that our goal is to take a larger market share ourselves, I don't expect that we can do that in every territory. So, margins and so on will vary between countries. The structure of these countries are rather different. So, you know, in Italy, it's really down to covering the different pharmacies, and it's very, very local. It requires a lot of foot on the ground, but it's a really interesting market. Whereas you have the chain-based, the pharmacy chain-based markets in Northern Europe. So Europe is rather, well, it's talking different markets. And they all look slightly differently. And we think we will have, you know, different market share in these different markets. And we have different views on markets. to what extent we can grow these markets, how mature they are. But we do think that this product has the capability to become the market leader in each of these 13 countries. So that's really our goal.

Okay. Thank you so much for good information, Anna.

Thank you.

The next question comes from Dan Carroll. Dan, your line is different. Please go ahead.

Hi, thanks very much for taking the call. So a couple of questions. I'm very excited to hear that the European launch timeline has not been affected. That's wonderful news. I was just wondering if you could talk to, given the changing situation with Bayer, whether you regard yourself as being fully funded to pursue that rollout? as you think about it today and that you're efficiently capitalized for that. The second thing I would like to explore a little bit is the conversation around the U.S. market. I think you said that there was an immediate plan to run another phase three trial. but that there might be the possibility of going OTC. I'm wondering, that would probably require a different concentration of terbimethine and whether such a trial might be put in place or what the approval process might be or whether you're just thinking about putting such trials off for a few years until Europe is rolled out. Those would be my questions.

Okay, so if I start off with the US question. So right now, we have investigated the possibilities of taking an OTC route, and we have also investigated the monograph route and concluded that monograph route is not possible. But the OTC route might be possible. And the challenge with OTC, Ralph, is that today there is no onychomycosis drug that is approved OTC in the U.S. today. So the drugs that you find in the shelf in the pharmacies, they're not really for onychomycosis. They're for athletes and so on. And they're labeled in a way, so you might think that it's for onychomycosis, but it's not. So for me, it was important to understand if this is doable or not. We think it is doable. It takes quite some time. It's a three- to five-year exercise. Of course, there is a price tag associated with it as well. But I think that the key question in U.S., regardless if it's RS or OTC, we need the FDA to approve our clinical data. And basically what we hear is that you need to have two studies showing superiority. Today, we only have one study showing superiority. So if we are to proceed in the US, the conclusion is that we need to conduct one additional study. And given the time and cost associated with that, I think for us, For the time being, we're focusing our efforts on Europe. We'll get back to you with detailed plans, but I would rather spend the excess cash that we have in the company on making sure that Europe is a great success. I think it makes much more sense. So you also asked about the financial situation. And as could be seen in our quarterly report, we have slightly more than 300 million kronas in cash in the company. So we do have some excess cash that could be invested both, I would say, in a direct-to-market approach in Europe and also potentially to acquire additional brands that would be a good fit together with Mob 15 or Techlara. So we have no plans for raising additional funds as of now. We're well capitalized. And, you know, I'm looking forward for things to naturalize so that we can talk about these potential partnerships, the partnership discussions that we have ongoing and present, you know, the full business case.

Thank you very much. I appreciate that comment. It's exciting to hear that there's certainly no likelihood in the near term of a dilution and that you're fully funded for the European rollout, which remains on track. One last question. I didn't understand the comment from earlier in the call about whether or not it would be possible to rerun a U.S. trial, if you chose to do so. Obviously, the timing is a different question. But just to rerun with the original label on a daily basis, if you could replicate the results of the first study, that would be sufficient for the FDA. Is that true?

Well, it's challenging to know on beforehand, if you do exactly the same study, will you end up with exactly the same results? That you never know. But I'm just repeating myself. If we provide two studies showing superiority, then I think we have a very good material to present to the FDA, and then ultimately it's the FDA's decision whether to approve a product or not on that data. But that is the data that we hear is needed for approval in the U.S.

Okay, but I'm just trying to understand the hypothetical, so If you were to rerun the same trial, probably it takes 18 months between recruiting and running the trial. And if you were to replicate the results of the first trial, there's no immediate reason to believe you wouldn't. That, in theory, would provide you with a sufficient data.

Yeah, but it is a four-year exercise. And it's been a good course, of course.

Well, thank you very much for taking the call. Very excited about the European rollout and look forward to hearing more from you. Thanks for taking my question.

Thank you.

As a reminder, that's star followed by one on your telephone keypad now to ask a question. We have a question from Guido Talbabi from Traders Partners. Guido, your line is open. Please go ahead.

Hello, thanks for taking my question. Question number one is about the strategy for the patent. I didn't really understand what the strategy is, if there is any. And the second one is about the other European markets. Now we are through April 13th, wondering if there will be more markets in Europe opening up and what's the timeline for those. Thank you so much.

Thank you. I'm not sure I got the first question. Could you please repeat that one?

Yeah. What's the strategy in terms of patent extension? Is there anything planned to possibly obtain an extension to their current patent?

Okay. Yeah. So I'll start with a timeline for additional markets. We do have 13 countries that are approved, and we do have an open file. We have the ambition to include more countries into the European file, and we could also potentially file in countries outside of the European Union that are looking at basically the same file. So UK, for example, would be a good example. If we are to add more countries, into the European file, which is our plan, but we have no fixed timeline for that. And the reason for us not having a fixed timeline is that we cannot have several variations in our file at the same time. So you really have to think about in the order to do things here. Right now, our highest priority is to get the new Turbinefin supplier approved. So that's already an ongoing variation with our files. So while that's ongoing, we cannot add another market. And our plan was potentially to change the label somewhat coming out from this study. That is probably not the case right now. But there might be other issues where we want to prioritize existing markets. For example, if we want to switch One or two of the RX markets into OCC, that's also a consideration versus including new markets into the existing five. So I'm not going to tie myself to a certain timeline, but we will, of course, think very thoroughly about in what order we're doing this when it comes to the European file and long term that's definitely the goal to expand it to more countries and then it was a patent question trying to remind myself and this is the ongoing patent application It builds on the hypothesis that lower dosing would result in higher complete cure rates. And the data from this study does not support that. So we have to generate new data for this patent application to be able to be transformed into a valid patent. But we do have granted patents. So we do have granted patents until 2032. We don't see any... possibilities to prolong those patents. So it's 2022. But of course, it's a priority for the company going forward to work with patent protection and I think equally important with brands. Because when we're talking about OTC markets, it's really just the brands that build the majority of value, I would say. So going forward, I think it's a really important outcome of of getting the rights back is that we now control our own brand in Europe so we can build value long-term connecting to the Terclara brand.

Thanks for your answers.

The next question comes from Guy in front there. Your line is now open. Please go ahead.

Hi, Anna. Thank you so much for this call. I want to ask a question about South Korea and Israel. You know, they don't come up very often. I know these are smaller markets, but have you had conversations with those partners? Are they still on board? Anything that would need to be done? Can you file with the positive daily studies that we did in the U.S. and Europe in those countries? Thank you.

Yeah, so, as you know, we just got some of the data. So, So, of course, we are in dialogue with all our partners, but both we and our partners need time to digest the data. So it's simply too early. We have to get back to you while we and our partners have, you know, revisited the business case and have a route forward. So I would expect that, you know, within our Q4 report, then we can give a good update to the markets.

The next question comes from David Bryce. David, your line is open. Please go ahead.

Thank you very much, and thank you for taking my call. It's David Bryce, private investor from Denmark. You alluded to, Anna, that you would be able to share a more detailed business plan in terms of the rollout in Europe. My first question is, when do you expect that business plan to be shared with our shareholders? The second question is just to remind us all what the market opportunity in Europe is. Not so much what we expect to get in the European market, but more what is the broad opportunity that we are addressing here. Thank you.

Yeah, so when it comes to the timing of an updated business plan, it's not really up to us, I would say. As it says in the press release, we are in discussions with partners, and it's hard to get a fixed timeline, but obviously we will inform the market as quickly as possible. And when it comes to the overall potential of the European market, I would actually go back to our old estimates on the market, the pricing of the market for home of 15, where we previously have said that it's between $35 and $50 million in annual sales potential for the product.

Thank you.

The next question comes from Fabian Becquia. Fabian, your line is open. Please go ahead. Fabian, your line is open. Please ask your question. We will move on. The next question is a follow-up from Johan Holmström. Johan, your line is open. Please go ahead.

Thank you so much. When we talk about the strategy, I wonder, you're talking about having your own feet on the ground in some countries to push for sales. Have you used that strategy before? Is that something that you, a material that you are well known to, so to say?

Yeah, perhaps. Did I use the word feet on the ground? Maybe I did. So typically, we have never employed feet on the ground, and we have no intention to do so either. We look back on what we were successful with in the U.S., what really we were in charge of strategic marketing, and then we hired personnel to be feet on the ground as needed. We're thinking something similar here, but I think, You know, this was a couple of years ago, and we really see a development in many European countries. So I think there will be much more digital focus and so on. We really see a trend in several European markets where the online pharmacists are taking a significant share of the market. So the environment is changing, and we're aiming to – to fit to the current environment and not the environment that we had in the U.S. with our previous products.

Okay, thank you.

Next question is from Felix Lindberg. Felix, your line is open.

Please go ahead. Hello. This is just a minor question. I could not read in the press release what the mycological cure rate and the treatment success in the vehicle are.

Yeah, so we only included, you know, the very top-line data, and all the data will be available via clinicaltiles.gov when all the data is released. But basically also the vehicle arm was lower compared to our previous studies, and I think that's a reflection of our vehicle not really being susceptible, but a vehicle, and a reflection of the lower dosage.

Thank you. Can you comment on whether there was any specific significance in the difference between the vehicle and the treatment arm for mycological cure and treatment success?

Yes. So I think they included the P values in the press release. So you have a good P value both for treatment success and for mycological cure.

Thank you.

Nothing further in the queue for the final reminder about staff led by Juan to ask a question instead. We have a follow-up from Guy Infante. Guy, your line is open. Please go ahead.

Ana, thank you so much. So one last question because I didn't fully understand. So we did not make primary endpoints in the U.S. study, but the p-value was basically successful for the mycological, and we had a complete cure above 1.5%. They thought that, you know, it's better than the zero from vehicle. So how come it did not meet its primary goal?

Thank you. So the primary efficacy parameter, that was complete cure, that was only achieved in 1% and 1.5% of the patients and none in the vehicle group. And that was not significant. but the key secondary endpoints, the mycological cure and treatment success, those both were, there was a significant difference between the groups to our advantage. And it's really the primary endpoint. We needed that to be significant in order to be able to use this study towards the FDA.

I think the one in that country is not enough. It would need to be a little bit higher for that. I do have some difficulties hearing you. Correct? You're breaking up a bit. Could you please repeat the question? Yes, what I meant to say is the complete share of the daily one was around 50 cents, and that one was significant, but this one is one and a half percent significant, correct?

Yes, so in the In the daily trial, with the previous U.S. trial, it was 4.5%. And that was significant versus vehicles. That was zero in the previous trial. In the European trial, it was not a superiority study. It was designed as a non-inferiority study towards another pharmaceutical, so towards Ticloperox, so PEMLAC in the U.S. So we met the primary endpoint in both two previous phase 3s that formed the basis of the approval in Europe with this very high mycological cure that now is, you know, an excellent way of promising the product. But in this study, the 1.5% was not good enough. And looking at the other parameters, so there was significant difference when it comes to mycological cure and treatment successes. As well, but if you look at the levels and compare between studies, I know you shouldn't compare between studies, but nevertheless, there is no doubt in my mind that we did not get the mycological cure that we saw in the previous studies. It's way lower. And as a consequence of that, it also meant that the complete cure became lower, and we did not get the primary endpoint.

Okay.

Thank you so much.

Thank you.

We have no further questions, so I'll hand the call back to Anna for some concluding remarks.

Thank you. And thank you all for calling in. The recordings of this call will be published at our webpage shortly. Thank you all and have a good day.

This concludes today's call. Thank you very much for your attendance. You may now disconnect your lines.