Research

Fri, 13 Sep 2024 14:59:47 GMT

Transcript: MOB-015 North American Phase 3 Study Results Call (Provided AS IS RAW)

Anna Ljung, MOB.ST

Thank you, and welcome to this telephone conference following the press release this morning, and this call will be recorded and uploaded on our web page following completion. So with me today, I have our chief medical officer under President and our chief scientific officer, Amir tabakov. And before opening up for questions, I would like to provide a short summary on the information that we received this morning. So in essence, we received information about clinical cure in a subset of patients for our North American phase three study for mode 15 against Omicron mucosis, and the number of patients who have achieved clinical cure in this blinded subset of patients is lower than our expectations. And clinical cure, that's the physician's assessment of the amount of affected nail area for a patient for clinical cure, this has to be zero, perfectly healthy, looking male, without any abnormal disease. In total, there are three parameters clinical cure, negative fungal culture and negative microscopy together that make up the complete cure, which is the study's primary endpoint, with the item that FDA will look at, all three need to be met. So a low clinical cure means that complete cure also have to be low. The information that we have received is blind, then we don't know if a patient has received drug or not, and also don't not know the percentage of patients receiving drug in this sample. However, the total number that we have achieved a complete cure in this subset, it's lower than our expectations, and thus the risk of the study not meeting its primary endpoint, complete cure has increased. Therefore we assess the risk of not being able to commercialize mog 15 in the US based on this study has significantly increased, which requires us to send this press release. Our priority is to protect the integrity of the study data, both when it comes to using the study results in discussions with the regulatory authorities, but also, since there are patients with ongoing treatment. In this study, when it comes to implications for a product on the market in EU, we have an approved product that has a different dosing. This approved product works as documented in previous clinical trials. We don't expect any consequences from from this trial. We will not speculate on possible outcomes or what this means for the future potential of mock 15, and we need to await top line results to avoid drawing premature conclusions. Once we get these top line data, those, of course, will be analyzed. We expect to get to be able to get top line date in December, and final data to follow thereafter, and only then we will be able to analyze the situation of our company for the different markets, and we will get back to you as soon as we can. With that summary, I open up for questions,

Moderator, MOB.ST Call

of course. Thank you. If you'd like to ask a question via the telephone lines, please dial star followed by one on your telephone keypad. If you choose to withdraw your answer, please press star followed by two when preparing to ask a question. Please ensure you're unmuted locally as a reminder that's star followed by one on your telephone keypad. Now our first question comes from Jacob Rowe of Road Fund LLC, Jacob, your line is open. Please go ahead.

Hi, sorry about that. Were there, was there any impact to mycological cure rates, and is this going to have any impact you believe on future patent extensions?

Anna Ljung, MOB.ST

So we have only gotten a subset of all the data, and we have not achieved any data on mycological cure, so only on clinical cure. So it's premature to draw any conclusions when it comes to to future patentability, since we're lacking key components, we only have one of these three components that make up The complete cure in the trial.

Okay, thank you.

Moderator, MOB.ST Call

Thank you. Our next question comes from Dakota. Quint who's a private investor Dakota, your line is open. Please go ahead.

Dakota, Left Field Investing

I just have one question, seeing as the odds to positively affect the change to the label. Been reduced. Is there any consideration for pulling forward the European launch? Thank you.

Anna Ljung, MOB.ST

So I think there are, there are two parameters that set the timeline for the European launch. We obviously wanted to have stronger claims coming from, from this ongoing study, and we we still want to see the results in the ongoing study, but I think more importantly, we also need that approval of a turban affined supplier before launching in Europe. And given the timelines, we expect to get approval by end of this year, and then there is a delay from when we get the approval until when we can actually get the product on shelf, since the pharmacy chains have have their decision meetings, I would say roughly six months before they actually put put the product on The shelf. So whether it's possible to put the product on the shelf during next year. That will depend on when we get this approval. But we can already now see that given that the high season starts in q1 if you want to launch the product during the high season, it's really high season 2026, and on not 2025

Moderator, MOB.ST Call

thank you as a reminder, if you'd like to ask a question, please dial star followed by one on your telephone keypads. Now that's star followed by one to ask a question. Our next question comes from gang Lu, who's also a private investor, gang, your line is open. Please go ahead. Gang, your line is open. Please proceed with your question. We have no response from Yang's line, so we'll move on to the next questioner. Our next question comes from Theo kiriku, who is also a private investor. Theo, please go ahead.

Hi, Anna. I just wanted to check, is the EU approval? Is it EU launch affected? I know you just touched on it, so I just want to clarify, is the EU launch affected by the US phase three data? And are any of the milestones with buyer attached to the

phase three data? Thank you.

Anna Ljung, MOB.ST

So if I start with the regulatory piece we we don't see that the regulatory piece in Europe will be affected since, since we have an approved product that has, you know, a different dosing than the dosing that that we tried in in this ongoing study. So, so this approved product in EU. It works, as documented in previous clinical studies, when it comes to actually launch plans for for Europe. It's, of course, a collaboration between us and Bayer, and I think it is premature to draw any conclusions based on on this press release if that is affected, because we need to see the top line data, and once we have received the top line data, we will, of course, engage in this dialog with all our existing partners. So

thank you.

Moderator, MOB.ST Call

Thank you. As another reminder, if you'd like to ask a question, please dial star followed by one. Our next question is from Chris vail of Pier One capital, Chris, your line is open. Please proceed.

Morning. Anna, can you tell me, does this affect the launch in Canada at all?

Anna Ljung, MOB.ST

I would say it's the same reply as for the launch in in Europe once, once we have the top line data, we will, of course, have a dialog with all our partners. But I would say that my expectation is for Canada, as for Europe, we're relying heavily on the already approved drug in Europe and that file.

Moderator, MOB.ST Call

Thank you. Our next question comes from Hugo moggart of bravado, Hugo, please go ahead.

Hi, Hannah, a couple of questions my end. The first one is, can you confirm about like the requirement for applying to the FDA? Was there an expectation of like, a statistical difference on complete cure rates with that second.

A second trial. And the second one is that, in the communication you mentioned below expectation, can you give a bit of more color on what were the expectation from mobik side? Thank you.

Anna Ljung, MOB.ST

Yes. So, so what we have communicated previously is that FDA requires two studies that where we show superiority, and we have one of these studies already in place, and our goal is that this current study will provide that second study that is needed. And our communication today, earlier today, this morning, tells that we see that the likelihood that we're being able to commercialize the product in the US, based on this study, has significantly increased, decreased. So so we're not saying whether we can or cannot register and launched the product based on this study, we're just saying that the risks that we will not be able to do it based on this study has increased.

Moderator, MOB.ST Call

As a final reminder, if you'd like to ask a question via the telephone lines on today's call, please dial star, followed by one on your telephone keypads. Now, our next question comes from Alex sack, who's also a private investor. Alex, your line is open. Please go ahead.

Thanks very much. Hi, Anna. Just two questions from me. First of all, I was wondering if you could, I guess, in some way, quantify what you mean by significantly decreased. Do you think the chances of approval in the United States, given the data you received this morning, do you think they're still above 50% or are they below 50%

And my second question is, would you launch another test to see whether a, perhaps a more frequent application of the ointment of the topical would meet the clinical cure objective and and whether and how long would that test take, and how much would it cost? Thank you.

Anna Ljung, MOB.ST

Yeah, yes, so if I start with the first question. So I think going back to, you know, an addition to what I already said, that, you know, we see that the risk of not being able to commercialize has increased, but we cannot really speculate on possible outcomes. And you know, percentages, it's it's premature, and we have to wait for, for the actual readout of the data. Sorry, but I didn't fully hear your second question, so could you please repeat that?

Yes, I'm sorry about that.

Just let me switch. So the second question was, you know, you you tried a different way of administering the topical where there would be a frequent application followed by an infrequent application, and that has not achieved the clinical cure. So I guess the nail is still somewhat dry after that, at least what you've received at the from the data you received this morning, would you be willing to try another set of clinical trials where there would be something in between, such as, you know, frequent and then less frequent application, and then ever even less frequent application, or would that take too long and cost too much?

Anna Ljung, MOB.ST

I think, for starters, we're not at the position where we would say that, that we have a clear conclusion on the results in the study. We're we're still saying that the risk has increased, and that's really what we need to to in the form the market about. But we only have, you know, a limited set of data. So it's a subset of the total data. It's one out of three parameters that makes up the complete cure, and it's blinded data, and we as a company have not fully controlled this data, so that makes it very hard, where I would say impossible, to draw conclusions based on this so we cannot really tell whether our hypothesis with the whitening of the nails are correct or incorrect in in this instance. So so therefore it's not possible for us to speculate on next steps. We just have to wait for for the final data and analyze that we would, of course, also want to look at nail photos and mycology data. None of that is available.

Okay. Thank you.

Moderator, MOB.ST Call

Thank you. Our next question comes from Douglas, home of Samson, Douglas. Your line is open. Please go ahead.

Hi, yeah.

If this study does not show good top line results in the end, what's the path forward in Canada? Does Canada require two studies for approval, or would you submit your previously completed European phase three trials for approval in Canada? Thank you.

Anna Ljung, MOB.ST

Thank you. We believe that the European dostia is sufficient to file in Canada, so we don't think that this outcome of this study will be necessary in order to file in Canada.

Moderator, MOB.ST Call

Thank you. Our next question comes from John copper, G who's also a private investor, John, your line is open. Please go ahead.

Hi, thank you. Could you

please let us know what the n of the subset of data is? So the study is something like, I forget 378, or 386, participants in total is the subset, meaning it's like only some of those, and if so, how many of those people is the subset drawn from?

Anna Ljung, MOB.ST

Yeah, so, so I'm going back to that. It's an absolute priority for us to protect the integrity of the study data, and for that reason, we have decided, after looking into the regulatory issue, not to disclose details about number of subjects. It's a sufficiently big data set so that we feel comfort that this data is accurate, and we need to send out this press release, but we're not disclosing the numbers.

Okay, thank you.

Moderator, MOB.ST Call

Our next question comes from David Jafari of AXA Capital Management, David, your line is open. Please go ahead.

Thank you. My question was just answered by the previous person. So I have no question. Thanks,

of course, thank you.

Moderator, MOB.ST Call

Our next question comes from Heder Miller, who is also a private investor. Header, your line is open. Please go ahead.

Hi. Thank you. I was wondering

if this phase three

trial fills. Is there any other way that we can get an FDA approval based on the previous regimen?

Anna Ljung, MOB.ST

I think it's too early to answer that. I don't know the answer to that. I

Moderator, MOB.ST Call

Our next question comes from Diego tremit Farah of North Shore, capital, Diego, your line is open. Please go ahead.

So I have two questions. Question number one would be, if we exclude the US, what? What other geographies around the world? Can you use the European study for approval? And I'll ask the second one afterwards.

Anna Ljung, MOB.ST

Yeah, so, so that's, you know, difficult question to answer. I think there are many geographies where, where European data can be used as a standalone or with a local study, but it's but it's hard to give, you know, a general answer. I think, for for the markets where, where we have partners in place, for for Israel and for Canada, the standalone European data is deemed to be sufficient, without any local registration. For other territories such as China or Japan, we would expect local studies to be required. So it really varies between territories,

okay, but in the case of, for example, China and Japan, how long would the process take in order for you to find a local partner and then require local studies?

Anna Ljung, MOB.ST

So the demands on local studies can can also vary a lot, so I think it's hard to give a general answer, but of course, there is, regardless of which country you're looking at, there is a local registration procedure, and the timing of that varies greatly. So I think there is a great advantage in us having approved. Land, starting countries in EU already in place, and also having partners in several territories in place.

So I appreciate that. And I'll move into the second question, which is obviously the vast majority of the answers that you guys have given so far have been quite generalistic and in some sort of way, almost very conservative, of mildly pessimistic. So, you know, if we take a step back, and if you look at your company right now, and if we look at the next, you know, several years, and the opportunity that you guys have with your product, what are you really

optimistic about? And says, you know, investors like, what should be really, realistically optimistic about?

Anna Ljung, MOB.ST

I think it's the fact that we do have approval in Europe, and we do have a very successful first launch in Sweden, where we managed to become the market leader within almost immediately, and we have now taken more than 40% of the market share in Sweden during this launch.

Thank you very much.

Moderator, MOB.ST Call

Thank you. Our next question is a follow up from Jacob Rowe of Road Fund LLC. Jacob Ulan is open. Please go ahead.

Hey again, so are you guys expecting a sales impact in Sweden? I understand that the launch is based off of past studies, but I'm assuming that

this study going poorly will impact sales. Just curious about your thoughts on that. And then I have a second follow up question that I'd love an answer to after.

Anna Ljung, MOB.ST

Well, I don't see a direct link. I must say, if we look at the Sweden being an OTC market, and I think we have a really strong, strong proposition in the Swedish market, so I would not see an immediate link, and we still don't know what outcome in the study will be. So, so I don't, I don't foresee any change in the way we look at the Swedish market.

Okay, I'm actually just going to skip my second question. Thank you.

Moderator, MOB.ST Call

How Our next question is another follow up, and it's from Hugo Mogar. Hugo, your line is open. Please go ahead.

Yes. Thank you. Like given what has been commented so far, and

as you mentioned, Anna, the lack of real answers that we have from this subset of data. What was motivating the PR that you released this morning? Was it legal? Driven? Did you have a constraint that led to that? Because it feels that the impact on the company's evaluation has been tremendous, as opposed to what you're saying, meaning we have very limited knowledge about what the impact will really be from the study. Thank you.

Anna Ljung, MOB.ST

Yes, so, so you're absolutely correct. This is, this is legally driven, and as part of the process to prepare the database closing, we received the blinded data on a portion of the patients, and that was unexpected to us, and unfortunately, we had to act on that information.

Moderator, MOB.ST Call

Thank you at this time, we have no further questions or apologies. We have had a late question registered from Guillermo Infante, who is also a private investor, Guillermo, your line is open. Please go ahead.

Hi. Thank you for taking my call. So

my question is regarding the number of patients in that sub sect of the data, I know you, I don't think I fully understood how relevant this is, are we talking about the majority of the data, minority, a small section, any cuts in any way, anything that you could give us?

Anna Ljung, MOB.ST

Yeah. So, so we, we really want to protect the integrity of the study, and for that reason, we have decided not to disclose that the numbers or values of these this subset also since it's blinded, so it's hard to judge, but the subset of data is substantial enough For us to lower our expectations.

Okay, thank you.

Moderator, MOB.ST Call

Thank you. Our next question comes from Felix Lindbergh, who's a private investor, Felix, your line is open. Please go ahead.

Thank you. I was just wondering if I don't quite get the rationale for not pulling the EU launch.

Forward, given that the rationale for pushing forward was to improve the label. Could you provide some more reasoning for that?

Anna Ljung, MOB.ST

Yes, we had two reasons for pushing the EU launch. The study was one, but I think the most important one was that, as you might recall, we did not get our terbaness in supplier approved when we got the approval, so we only have very limited amounts of terbaness in the active substance in mob 15. And for that reason, we could not launch in several countries. We had only sufficient drug to launch in Sweden and in parallel, we have been working trying to get a new urbanafine supplier approved. And we actually have two tracks there. We have one company which we have filed an application and expect approval by by the end of this year, and we also have another company that we're collaborating with, where, where the substance have been produced, and stability studies are ongoing so that we will be able to

so is that the main bottleneck now? And if you would finish that, say, by q1 25 would you be able to launch earlier, or would you still wait for 2026 and in that case, why?

Moderator, MOB.ST Call

Unfortunately, we have lost connections to the management team. Please stand by while we reconnect their line. You

Anna Ljung, MOB.ST

so my apologies for for breaking out now we're back.

Moderator, MOB.ST Call

Perfect, lovely, Felix, your line is open, if you'd like to proceed with your question.

Yeah, I was wondering then if the I interpreted correctly that now the main bottleneck for launching in the rest of the EU is the supply question. And

as I understand it, then you're basically online to finish that by end of this year, maybe early next year. And if that's the case, why wait for the launch in the EU until 2026

Anna Ljung, MOB.ST

Yeah. So, so once we have the approval, the new turbine asset supplier approved, then there is, there is a selling period towards the pharmacy chains. So, so the pharmacy chains will not accept a new product that cannot guarantee that we can deliver the product in time, basically. So if I look at those timelines, they're typically up to six months. So So in practice, if we get the approval by year end, and you have, this is a highly seasonal product where you have the majority of sales in q2 so you really want to hit the market in q1 and you also have limited Windows when you can enter the market. It's typically two to three times a year when when you can put a new product on the shelf. So that put, you know, logistics limitations, since we don't want to launch during off season. You think that does not promote long term growth. You want a successful launch. That's rather important. So for that reason, if we want to hit the peak season, then it's peak season 2026, and not peak season. 2025,

thank you.

Moderator, MOB.ST Call

Thank you. Our next question comes from will Pruitt, who's a private investor. Will your line is open. Please go ahead. You.

Great. Thank you. Good morning, good afternoon, everyone. Thanks for the call. Anna, I had two questions. The first one is, you know, it sounds like you guys are going to wait until you have all the data before making a call on how to proceed with potential further studies. But could you just confirm what did the p3 in the US actually cost.

Anna Ljung, MOB.ST

I don't think perhaps disclosed that information.

Okay? And then the second question is

a previous caller asked about other markets which could potentially still be open with the European dossier, and it's going to vary by country, but just to ask about three, in particular, South Korea, Germany and the UK. Could you give us some idea of whether or not those would still be potentially open markets with the dossier as it stands right now?

Anna Ljung, MOB.ST

Yeah. So if we take, if we start up with South Korea, that we have a partner in place. So, so with that partner, we were currently, you know, we're awaiting data, and then we'll, we'll have discussions with what is required when it comes to the UK after Brexit, that it's a totally separate process, but they're rather similar process to the European approval process, but it's a separate process, and I think this is really driven. UK is an interesting market we had to prioritize. So us and Bayer prioritized the the the European countries that belong to European Union, and where we could keep the same process. But we expect, you know, in the future, tools include UK, for Germany, it's part of the European Union, so it's part of the countries that we can add to the process. So our European approval is 13 countries. Right now, we have plans to add additional countries. We're not disclosing, you know exactly when and in what order. It's, you know, a city decision that is taking, together with with Bayer, the timeline for adding additional countries to the existing file in Europe that's also dependent on other items that affect the file, because you cannot change several things. Certain changes cannot happen at the same time as you're doing other changes. So for example, this turbine film supplier that we need to get approved in Europe, you cannot have a process where you do that type of change and at the same time add additional countries. So this sets the timeline for adding more countries within the European Union.

So great. Thank you very much.

Moderator, MOB.ST Call

We now have a follow up from Diego. Trama, Diego, your line is open. Please go ahead.

Hey there. Thank you for taking my follow up question. So first follow up question is, I understand you guys don't want to disclose the subset of patient data, but how does that compare the clinical cure compare with peers currently

compared with I didn't quite hear your question. Sorry about that. So how does the result of the subset of patients compare in terms of the clinical care versus peers,

Anna Ljung, MOB.ST

yes, so, so, as I was saying, we were disappointed with the data, and that's the reason for for the press release, and we will not comment on on the level as such, but, but I Think it's sufficient to say that it's disappointing.

Okay, question number two, so if we just focus on Canada and then Europe, my understanding is that the news company are focusing on starting around peak season in 2026 so that would be the beginning of the year 2026

assuming that that's basically launch date, how long do you think you you need in order for you to get profitable?

Anna Ljung, MOB.ST

I think if we, if we looked at the Swedish launch and the excellent rollout, our expectation is that this product is strong enough for us to have, you know, quick roll out throughout. Our goal is basically that every market where we decide to launch this product will be the market leader. I'm not sure we will succeed in every market, but that's definitely our goal.

I understand. So if we look at kind of like the Swedish launch, that would be, I wouldn't say.

Base expectation, but that would be kind of like the modus operandi that you would like to have in all the different countries within Europe.

Anna Ljung, MOB.ST

Yeah, I think the Swedish loans each it's an excellent example of a successful loan.

Fantastic. So and the last question that I that I want to ask management is if, basically, management is willing to commit a good portion of their compensation as share compensation in order to show commitment with the future launch of the product, both in Europe and Canada and hopefully in different countries around the world

Anna Ljung, MOB.ST

It's not the typical way you act in Sweden, I will consider your question.

Thank you very much for that, and thank you for taking my questions.

Moderator, MOB.ST Call

Our next question is another follow up, and that's from Guillermo. Infante Guillermo, your line is open. Please go ahead.

Hi, Anna, a final question from me. It's regarding the buyback potential, given the cash balances that you guys have in the recent share performance. Anything that you could comment on that? Thank you.

Anna Ljung, MOB.ST

So first of all, we need to analyze the data before making any kind of decisions of financial nature. So so we will wait the top line data in December and final data, and only then we will be able to analyze the situation for the different markets and whether we have investment opportunities or whether there are possibilities to distribute funds. So we'll get back to you.

Moderator, MOB.ST Call

Our next question comes from Simon valen, who's also a shareholder. Simon, your line is open. Please go ahead.

Hello, Lana.

It's Friday the 13th today, as we can see. So we're down 65% Yes, unfortunately, I noticed, yeah.

So we're down 65% Do you have any words or anything you want to say to us shareholders, about this situation?

Anna Ljung, MOB.ST

I think the situation is extremely regrettable. It's an awful position to being when you're when you're having a listed company, you get this information, but you don't get the full information, and I'm legally obliged to give this information to the market without being able to really tell what it means for for the long term, for the long term for the company. So I'm sad that this has happened, but we're working towards doing the best of the situation. My first and foremost priority is the data integrity of the subject and getting us to top line data as quickly as possible.

Okay, I understand. So it's kind of like your hands are side, behind you, back in a moment. You only had the responsibility to report these findings, but you can't really argue with it, because you don't have additional data and patience is

the key,

if I understand you correctly.

Anna Ljung, MOB.ST

Well, the patients are all patients are recruited, but there are still patients that are treated. So, so both,

Anna Ljung, MOB.ST

patients, is that? Yes, yeah, I think that that's a key component here to to await the final data. Of course, we, as a management team, we will look at different scenarios, and we will do our utmost for preparing the company for for for this data that is to come. But, yeah, it's right now. Very little we can do as management, except then continue running the study and making sure that we keep data integrity and that we keep timeline.

Thank you.

Moderator, MOB.ST Call

We have another follow up from Diego tramifara. Diego yolan is open. Please go ahead.

I hope you don't take this personally, but it's just because we are shareholders of the company and I'm a client of your product as well. So that's why I'm asking these some other questions. But by the end of the year, basically, so, you know, we'll get the results by the end of the year is that anything they mentioned can do, in order for, you know, the company, to signal some positive news around, you know, the study the Pro, the Pro, the product itself, the rollout of the product, in order for us not basically sit on this until the end of the year without.

Any news, and given the lack of data disclosed so far today, you know, we are forced to basically assume not very good things.

Anna Ljung, MOB.ST

I'm not really sure I understood the question.

So the question is, is there anything that you as a company and that management can do over the next couple of months before we get the full results of the study to signal positive news around the product and the company and the development and the rollout of the product in the different markets in which it operates.

Anna Ljung, MOB.ST

I mean, we will, of course, continue to work towards our goal to make mob 15 the leading product within only common causes in as many markets as possible. Right now, we're in a little bit of a limb this situation, I would say, given that we have this data that we have shared with you, but we don't have the full picture. And I think the full picture will impact how, how we target the different markets. So, so we will continue to work on I think, as I mentioned before, the key here is to to make sure that we keep the integrity of the study and to make sure that we execute as best possible and get the data out to to all of you as quickly as possible.

Moderator, MOB.ST Call

Thank you. Thank you. We have no further questions registered by the telephone line, so I'll hand back over to Anna for any final or further closing remarks.

Anna Ljung, MOB.ST

Thank you operator, and thank you all for calling in. I wish the circumstances were better, but I appreciate you taking the time. And I would also remind everyone that the recordings of this call will be published on our web page shortly. Thank you all for listening in, ladies

Moderator, MOB.ST Call

and gentlemen, concludes today's call. Thank you for joining email. Disconnect your lines. You.

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