Moberg Pharma AB (publ)

Good afternoon and welcome to the Moberg Pharma telephone conference. My name is Charlie and I'll be coordinating the call today. If you'd like to ask a question at the end of the presentation you can do so by pressing star 5 by 1 on the telephone keypad. I will now hand over to our host Anna Young, CFO, to begin. Anna, please go ahead.

Thank you and welcome to this telephone conference following the press release this morning. And this call will be recorded and uploaded on our webpage following completion. So with me today, I have our Chief Medical Officer Anders Bredesen and our Chief Scientific Officer Amir Tavakol. 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 3 study for MOB15 against onychomycosis. 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 sufficient assessment of the amount of affected nail area for a patient. For clinical cure, this has to be zero. you are perfectly healthy looking male without any abnormalities. In total, there are three parameters, clinical cure, negative frontal culture, and negative microscopy, together that make up the complete cure, which is the study's primary endpoint, the direction that Tessier will look at. All three need to be met. So a low clinical cure means that complete cure also has to be low. The information that we have received is blinded. We don't know if a patient has received the drug or not, and also do not know the percentage of patients receiving drugs in this sample. However, the total number that we have achieved of complete cure in this subset is 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 MOB15 in the US based on this study, has significantly increased, which requires us to fund 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 regulatory authorities, but also since there are patients with ongoing treatment in this study. When it comes to implications for our products on the market in the EU, we have an approved product that has a different dosing. This approved product works as documented in previous clinical trials, so we don't expect any consequences from this trial. We will not speculate on possible outcomes or what this means for the future potential of MOD15, and we need to rate top-line results to avoid drawing premature conclusions. Once we get these top-line data, those, of course, will be analyzed. We expect to be able to get top-line data 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.

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 keypads now. Our third question comes from Jacob Rowe of Rowe Fund LLC. Jacob, your line is open. Please go ahead.