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.