Thank you very much. Welcome all of you listening in. We are hosting this webcast since we yesterday evening published positive results from the interim readout from our ongoing phase III trial with our biosimilar candidate, Xlucane. I have with me today our Head of Clinical Affairs, Dina Jurman. For those of you who do not know me, my name is Martin, CEO of Xbrane Biopharma. Okay. If we can go to page number three to start off. Just to remind you all, Xlucane is a biosimilar candidate to LUCENTIS, and LUCENTIS is a drug used in treatment of several severe eye diseases, mainly age-related macular degeneration and also diabetes-related macular edema. These are diseases which leads to a deteriorating vision for the affected individuals. These are big diseases.. We estimate there to be some 18 million eyes affected globally, 5 million or so across Europe and the U.S., 13 million or so in the rest of the world. Important to note, a high fraction of affected eyes, those untreated due to the high pharmaceutical costs of the on-label drugs for these indications. We believe due to this, it's a great prospect to bring a more cost-efficient treatment alternative to this market in the form of a biosimilar to LUCENTIS. We can shift to page number four, and here I want to have Dina Jurman, our Head of Clinical Affairs, describe a little bit more in detail the setup of XPLORE, our phase III trial for Xlucane. Thanks, Martin. Hello, everyone. XPLORE is an ongoing study, during which we are evaluating efficacy and safety of our product, Xlucane, compared to Lucentis. We do this in patients with newly diagnosed neovascular AMD. About 580 patients were allocated equally to receive monthly injections of Xlucane or LUCENTIS for a duration of about one year, a total of 13 doses. At the time of this teleconference, 76% of patients have finished their participation in the study. The primary objective of the study is to show that Xlucane is equivalent to Lucentis. To assess the equivalence hypothesis, the primary endpoint in the study is the change in visual acuity at week eight compared to time point before treatment commenced, also known as baseline. When we speak about visual acuity, we talk about BCVA, which is a standardized way of assessing how well patients can read letters on a certain chart from a certain distance. The visual acuity assessors are staff at the clinics. They are trained, and they are certified centrally to conduct this very important assessment in a standardized manner, which ensure that we have a consistency in the way the results are gathered and then analyzed. Approximately 140 clinics in 15 countries contributed to successful completion of patient recruitment in November last year, despite the challenges due to COVID-19 pandemic. To date, the treatment schedule and assessments in the study have been in large maintained, and the majority of the deviations that we are seeing due to the pandemic are minor and not expected to have an impact on the interpretation of the data that we have collected so far. I understand that you're all very curious about the top-line data readout from the interim analysis that was done last week, and this analysis includes data up to and including month six visit for all patients on the study. Martin is going to tell you a bit more about this later. Important to note is that the study is still ongoing, and the last patient last visit is expected to occur end of this year, followed by complete study analysis shortly thereafter in January 2022. The trial is conducted in collaboration with Syneos Health. This is a multinational CRO with extensive experience in conducting trials in the field of ophthalmology. The trial is supported by a team of ophthalmologists at Syneos Health that are specialized in eye and vision care. In other words, very experienced and well-versed partner on this pivotal clinical trial. Martin, will you present the results? Thank you very much, Dina. If we move on to page five. This is now top-line data from the interim readout, which then includes data from all patients up to treatment month number six. We selected five endpoints for this top-line data. We are still awaiting data on remaining secondary endpoints in this trial, and some of them are listed in the bottom of this page. Also it is important to note that the 12-month data, which then is due in beginning of next year, is crucial for concluding the full study and for the authorities in terms of assessing biosimilarity. If we look at these five first endpoints, which forms part of the top-line results, and we selected these ones because we deemed them to be the most important ones. Okay. The primary endpoint was change in visual acuity measured in BCVA, best corrected visual acuity, from baseline to week eight. That is the primary endpoint. That was selected week 8 since that is the point in time where the change in visual acuity is the largest and therefore is the point in time where you most likely are going to identify any potential differences with a biosimilar candidate and the originator product. The statistical criteria set forward here was that the 95% confidence interval, if we speak about EMA, European Regulatory Authority, around the difference between the means of Xlucane and LUCENTIS respectively needs to fall within a predefined equivalence margin, which in this case was ±3.5 letters as agreed with both EMA and FDA. FDA worked with a 90% confidence interval, but EMA, it is a 95% confidence interval. Here, this is the most important thing, of course, we're very happy to announce that the trial met the primary endpoint, and that is to say the confidence interval around the difference was contained within this defined equivalence margin. That's very good of course, and that demonstrates equivalent efficacy with regards to improvement in visual acuity compared to LUCENTIS. We looked at the very important secondary endpoint, which is reduction in the retinal thickness. This is important since it's a crucial part with regards to the mode of action of these products. As you know, these are called VEGF-A inhibitors. They're injected into the eye, and they binds into a growth factor called VEGF-A which then inhibits the growth of abnormal blood vessels in the eye. The subtraction of these blood vessels can be measured via measuring the thickness of the retina, and that then leads to improvement in vision. This is a very important endpoint, which is on the causal pathway towards improvement in visual acuity. Some regulatory authorities, at least EMA also accepts this endpoint as a primary endpoint with regards to biosimilar trials in this field. This is an important endpoint, and here we're working with the descriptive statistics and the bottom line is that we cannot identify any clinically meaningful differences between Xlucane and Lucentis. This is very good. Next one here. As many of you know, typically in clinical development of a biosimilar, you first have to do a phase I trial where you compare pharmacokinetics of your biosimilar candidate to the originator in healthy volunteers, then you go on in a phase III trial where you compare efficacy and safety in the well-selected indication. Now, when it comes to biosimilars to LUCENTIS, it's not meaningful to conduct a phase I trial in that manner because, again, it's a drug injected into the eye and a very small portion of the active ingredient finds its way out of the eye into the systemic circulation. You cannot really measure the concentration of the API in the blood circulation in a manner so that you can compare it strictly statistically speaking. It's very low concentrations and the variability is very high. What we agreed with the regulatory authorities to do in this case was to go straight into phase III, but in a subset of the patients, 60 patients in this case, look at pharmacokinetics. Here also we work with descriptive statistics. We're looking at the maximum concentration at day one and at week 20. Also here we cannot observe any clinical meaningful differences between Xlucane and Lucentis. That's very good as well. We look at immunogenicity. This is essentially the body's own potential response to the drug itself. Here you measure anti-drug antibodies or neutralizing antibodies via blood samples across all the patients at all time points and compare the cases in which you find either anti-drug antibodies or neutralizing antibodies. Here as well, we cannot see any clinically meaningful differences between Xlucane or LUCENTIS. Of course it comes to safety profile, where we look at adverse events of different severity and different kinds. This is, of course, a crucial aspect of any phase III trial, but particularly in ophthalmology and intravitreal injected drugs, because it's very sensitive towards adverse events. Here we cannot see any clinically meaningful differences either between Xlucane and LUCENTIS. Overall, looking at these five endpoints, we come out positive. We met the primary endpoint and across the four secondary endpoints here listed, we see no clinically meaningful differences. We're very happy with this interim readout. It's encouraging. Again, we need to be clear on that there are multiple additional secondary endpoints for which we yet have not seen the data. We're going to receive the data and analyze the data in due time ahead of submission of the marketing authorization application. Also it's crucial, of course, that what we show here, we also see with regards to all these different secondary endpoints by the time of month 12, when all the patients have concluded 12 months treatment. That's really the key outcome of this interim readout. We can move on to page number 6 here and to look ahead a bit. We now confirm our previously communicated plans to proceed towards submission of the marketing authorization application to EMA in the third quarter this year and to FDA fourth quarter this year. In accordance to an agreement with both authorities, we make the submission on the basis of these interim results, then we complement the regulatory file with the 12-month data during the first quarter of 2022. Counting on the 12-month regulatory process, which I think we need to count on in a case like this, we expect to have approval in place second half of 2022, then allow for a launch of the product by our two partners, STADA and Bausch + Lomb. That is shortly after the patent expiry of the reference product in Europe, which is July 2022. Exciting times for us, of course, now. We expect the product to be on market in 18 months or so. It's very short time now ahead up until we can actually see the product on the market. It's very exciting, of course. We're very excited about the prospects for the product, both with regards to what we can do for the patients in this area and also the commercial prospects of the product. That was all from the formal presentation. Here we can open up for any potential questions. We can start with questions that come over phone, potentially. Thank you. We have a question from the line of Mattias Häggblom from Handelsbanken. Please go ahead. Mattias, if your line is on mute, can you please unmute yourself? Mattias, can you hear us? I don't believe Mattias is on the line. We only have Mattias, but I don't think we can get through. I'll hand it back, and then we can try again if Mattias registers. Sure. Thank you. I actually see no questions coming in over email either. I don't know. We should give it a couple more minutes, or maybe it was so clear that it doesn't result in any questions here. Yeah. No questions coming in really. I think that was really all from us, and we can probably conclude this call. Thank you all who listened in, and we are of course, as always, available. You can send any questions you might have after this call over email or give me a call and we shall be discussing any potential questions you have. With that, thanks a lot, and we can close the call.
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