Good afternoon, and welcome everybody to this web conference with Promore Pharma in connection with the company's full year report for the year 2021. The company is today represented by CEO Jonas Ekblom and CFO Erik Magnusson. Your moderator today, that is myself. I am Alf Gustavsson. I work for DNB. We will start here today with a presentation for the company, and after that, we will have a Q&A session. All of you listeners, you can ask questions by writing them. There's a control called Questions, either on the right side or the bottom of your screen, depending on your unit. You can expand that and write your questions, then I will read them out, and the company will answer. Finally, I just want to say that this session is being recorded and that the recording can later on be found either on Promore Pharma's homepage or on DNB's channel on YouTube. With that, I leave the word to you, Jonas and Erik. Thank you very much, Alf. What happens in Promore Pharma? Well, we are a small biopharmaceutical company. We are focused on development of peptides. Our vision is to provide new solutions for scarring, tissue adhesions, and hard-to-heal ulcers. We have been on Nasdaq First North since July 2017. We have two main projects that we focus on, the Ensereptide and Ropocamptide, respectively. These are two human peptides. In the case of Ensereptide, it is a project where we currently are conducting a phase II clinical study, and we have conducted two prior clinical studies in this project. The phase I study preceding this one, and also another phase II trial that was conducted in hand surgery. I should incidentally say that the positive data from that phase II study we feel supports the mechanism of action and the proof of principle. We think we have better than average probability of being successful in this phase II clinical study. Primary indication here is dermal scarring, so to prevent scarring on the skin after an incision or a skin trauma. This is intended as a locally administered drug, and it's a single dose administration. One single dosing event. We estimate that the addressable market for this application is in the order of $10 billion annually. The next development step, well, that depends on the outcome of this phase II study that we're conducting right now, which is referred to as PHSU05, and I'm going to speak a little bit more about the status of that trial. The other peptide, Ropocamptide, is also a human peptide that naturally occurs in the skin. This is a peptide that is pro-angiogenic and pro-migratory. Our primary indication here is venous leg ulcer. That is the most common type of hard-to-heal leg ulcers. It represents an addressable market of about $3 billion. It is also a product aimed for topical administration. The next development step is a phase III study. What we are doing in the company right now is we are improving the dosage form, and I will speak also a little bit about that. Now, looking back at the operating year 2021, we are happy and satisfied with what we have managed to accomplish in the company. On the R&D side, and in regards to Ensereptide, we managed to significantly improve the supply chain of the study drug. We received a patent approval for Ensereptide in regards to scarring in the United States in May of last year. We have, during the fall, produced the investigational medical product that will be used in our clinical trial, PHSU05. In November, we obtained the regulatory approvals from the Swedish Medical Products Agency and from the ethical committees to conduct PHSU05. Now, drumroll, because today we actually managed to have the first patient in this clinical study. We started officially the study as of today. We're very happy about that. In the other program, Ropocamptide, as I mentioned, we're focusing on developing a single component product. In prior clinical studies, we have used a two-component product. That means there's been two syringes which have needed to combine its contents prior to application. In a similar fashion that you do with, let's say, a two-component glue. It works for clinical studies, but we know in the commercial setting it's important for us to have a single component product for user-friendly use. We are in the process of developing that, and I will also speak a little bit more about that. In December, we were pleased to obtain the patent approval for Ropocamptide in the United States. On the business side, the most important activity that we did, I think, last year, was in the first part of the year when we decided on a realignment and a change of the indication area for the Ensereptide program, where we changed from our prior focus, which was hand surgery, to prevention of the type of scars that occur on the skin. After that, we successfully conducted a rights issue where we raised approximately SEK 45 million after transaction costs. During the year, we dissolved certain warrants. These were warrants that previously had been issued to finance some of our R&D activities. Due to the strategic change in the Ensereptide program, those warrant programs became obsolete, and we decided to de-register them. Finally, during the year, we conducted a cost-effectiveness study in France for Ropocamptide, and we were very happy with the outcome because it supports the pricing assumptions that we have done for that product and its use in venous leg ulcers so far. Overall, the largest individual accomplishment during the year was the successful preparation for PHSU05, a phase II clinical study on Ensereptide. I would like to clarify a little bit why we made the change we did in strategy in the first quarter of last year. Ensereptide is a versatile product. It's a multifunctional peptide, and we see multiple medical uses. For those of you that have followed the company over the last few years know that we've had an important focus on tendon injuries and particularly tendon injuries in the hand. The type of scarring prevention or preventing scarring that cause tissue adhesions of tendon to the tendon sheath. During the spring, we decided to refocus our efforts on dermal scarring instead. You may ask why. Well, one reason is we deemed that this is a substantially significantly larger market opportunity. We also deemed that the production process that we have in place for the investigational product is particularly suited for making a product here. Also, in all fairness, we deemed that it's easier at the time being to conduct the type of clinical package that we have implemented in dermal scarring rather than conducting clinical trials in a surgical theater. That has been a challenge during COVID and most likely will continue to be that for a couple of years. There were a number of reasons why we chose to change direction here. This does not mean that we have lost our interest for these assets. We're continuing to review opportunities there. We're a small company, and we can only finance finite activities. We've decided to put our investment on what we consider to be the largest commercial opportunity in scarring. A little bit about the medical side of scarring. The vast majority, nearly all patients that have like a full-thickness incision on the skin will obtain a scar. It's also true that the majority of scars vanish over time. A proportion, and this proportion is deemed to be at least 10% of patients, will have a long-term or a permanent scar remaining on a body surface where you do not want to have it. That could be the face, the neck, the chest or bowel area or the arms, for instance. At the recent point, according to the World Health Organization, there's about 300 to 350 million invasive surgeries that are conducted every year worldwide. We're talking at least 30 million procedures where you have a permanent scar on an undesirable location after the surgery. subset of patients have a propensity to overproduce collagen during the healing. These patients get scars that are bulky, that they're raised up like small mountain ridges on the skin. This is referred to as hypertrophic scarring or keloids. People who have this propensity are much more likely than average people to remain or to develop permanent scars. In the order of 50% of incisions on the skin result in significant permanent scars on these individuals. Scars may be disaesthetic, like they may be aesthetically unpleasant, but hypertrophic and keloid scars also have the propensity to cause skin irritation or itching, pruritus. Currently, there are no effective treatments to prevent or to remove scars. That's why we see that as a very appealing opportunity for Ensereptide. During the year, we have significantly enhanced the production chain of Ensereptide. Perhaps most importantly, we managed to make an agreement with CDMO, which is one of the largest manufacturers of hyaluronic acid in the world. They produce our hyaluronic acid fiber, and they also help us with dispensing into syringes that are sterilized. They help us with the component production. Aside from that, we also have made improvements in our technical re-release procedure, and we have stability testing that is ongoing and supporting the strong stability of our investigational medical product. At this point in time, we have a process that is stable, that is quality assured, that is scalable, and that is appealing to us in terms of cost of goods. We've tightened all that together, and today I feel we have a process that will be able to bring us all the way to the market with this product opportunity. PHSU05, which is the study where we enroll the first patient today, is a phase IIa pilot study where we're intending to bring in 24 healthy volunteers. These volunteers will have seven visits where six visits are at the clinic, and the seventh last visit is a follow-up call that we will have with patients for safety reasons. On visit two, these patients will receive six artificial synthetic wounds that will be produced on the upper arms of the patients. These wounds will be randomized to be treated with either placebo or active. The neat thing about this is that each patient will be able to serve as their own controls. As I indicated in the prior slide, there is an inter-individual difference to what extent these patients produce hypertrophic scars. It's important to either have really large studies or be able to use the patients as their own controls in the way that we do. The overall follow-up period from this first visit. It's at this visit number two, where the patients receive the wounds, but they also will get the one single treatment, the Ensereptide or placebo. We follow the patients for three months. The objective is to have out of these 24, 20 patients that complete this protocol. We're doing this at one single study site. It's done at Akademiska sjukhuset, Uppsala University Hospital in Sweden. A little bit of information about the study timeline. We are going to have an inclusion period now during February, March, and possibly the beginning of April. There is a three-month follow-up period. We're estimating that the last patient's last visit will occur in the middle of the summer, so July, August timeframe. After that, we are going to conduct histological analysis, because after the last visit, the patients in the clinic, a biopsy will be taken. This biopsy will then be sectioned into very thin micrometer thick sections that will be stained for various, immunohistological and other histological preparation methods, and assessed both by professional histopathologists and by automated digital image analysis. Now, this is the most work-intensive part of the clinical study. It will take approximately 3 to 4 months to complete, so it is the most important determinant of the study timeline. During this entire period, in order to have full integrity of the study, all study data and the samples will be blinded. The unblinding will happen when the histopathology analysis has been completed, and it's after that that we will compile a clinical study report, a CSR. We are planning to make three announcements to the stock markets about the progress in this study. We intend to indicate with the press announcement when we have completed the inclusion period. In other words, when the last patient's inclusion has been reached. We are planning to communicate when we have the last patient's last visit of the study, because that means that the so-called live part of the study is completed. Then of course, we are going to communicate when we have unblinded and processed the data, and we anticipate that that will be at the very end of this year or the very beginning of 2023. Again, the overall determinant, which is actually a very complex day-to-day tight schedule with four organizations involved, is the histological analysis part that will happen between August and the end of November, unless we have any deviations. Sure. A few words about the other project, Ropocamptide. We are in progress with a development work to develop a single component product. We have strong indications that we have appropriate stability of a product that is mixed. But what we're working on right now is a manufacturing process for the single product, because that would look a bit more different than the current production of the two individual product components is. Then we need to assess that we fulfill all the product specifications that we have established and utilized in prior clinical studies. This is a work that will progress during the year, and we intend to make announcement when we have identified significant risks in this process. So far, it's progressing really nicely and according to plan, so we don't have any deviations. We have important process development experiments to be conducted during this year. In parallel with that, we have manufactured API for a future clinical study, and we are in the process of firming up a study protocol for a phase III study to understand how large such a study needs to be, what the duration needs to be, understand the cost ramifications, etc. With that, I'm going to hand over the financials to Erik to comment on the fourth quarter and the full year of 2021. Erik, please take it from here. Thank you, Jonas. Just one slide. You can see that the operating expenses are slightly down from last year, but on par with the third quarter. We have temporarily lower costs for purchases, et cetera. This is kind of a periodizing issue. They will increase again in the coming quarter. At the same time, we had a bit higher external consultancy costs in the fourth quarter, and they will be increasing in the coming quarter. Slightly higher costs in the coming quarters, but no major deviations going forward. We should also say that we have had a very good cost efficiency in the whole year, which means that we are slightly better than our own plan. On the cash flow side, it was SEK -6.8 million in the quarter. If you look at the full year, it's SEK 21 million, including the new issue that we performed in June and July. The cash position for the SEK 5.3 million at the turn of the year, some of these, there will be some. We are well-positioned for our 2022 activities. Slight increase in cost in some quarters, we are doing very well at the moment. Thank you. Thank you very much, Erik. To tie this together, our vision is to develop new treatment modalities for scarring and hard-to-heal ulcers. We feel that we have the product portfolio, we feel that we have the capital structure, that we have the finances, and we have an organization to be able to deliver on this process and this promise. With that, I wanna thank you so much for your attention and leave the word back to Alf for questions, please. Thank you very much, Jonas and Erik. I want to repeat to everybody who's listening that you can ask questions. There's a control called Questions. It's either on the right side of the screen or on the bottom of the screen. It might be indicated with a talk bubble. If you enlarge that, if you write your question there, I will read them out, and the company will answer. Just to kick it off, I just want to congratulate you, first of all, on having the first patient in the phase III trial on Ensereptide. Could you just give us a little bit of a flavor on how difficult or easy it is to get people to sign up for a study like this? Yes. In this study, we're utilizing healthy volunteers. In the big university cities of Sweden, it's normally not a problem to engage, for instance, students who are willing to do this on a part-time basis. The CRO that we work with, they have a target list of people that have a potential interest. I should say that the numbers on their list were lower than what you would see or you saw before the pandemic. For the selection of these 24 individuals, we had in the order of about a database with about 200 individuals that provisionally fulfill inclusion, exclusion criteria. Of course, you have a dropout during the screening phase where a fairly large number don't qualify because they're maybe taking a medication or have some other condition that is exclusive to participating in this study. In principle, we don't think that we will have a problem identifying the subjects to be included in the study. How important is it that you get a dispersion among the test persons, I think in terms of age, in terms of genetics, et cetera, and things like that? Well, this is a pilot study, and for that reason, we chose to have multiple wounds on each patient so that we can use each patient as their own control. We're a little bit less sensitive to, how should I put it, genetic and ethnic variance in the population. Of course, in a phase III clinical study, you wanna do that really broadly, where you have all ethnicities and skin types represented. In pilot studies, that's a little bit less crucial for us because we use internal controls, so to speak. If you look at the test material that you're using here, it's. Did anything come up in the manufacturing process that were important to note or and is this the final version of the product that will be the same product that you take to the commercial commercialization phase? I think that we have defined a manufacturing process that will be final, and we will use that all the way to the market. We have struggled, frankly, to be transparent, for years, particularly with the hyaluronic acid component of our study because it's a very viscous material. It's difficult to find suppliers that can produce that at the appropriate quality. It's difficult to find suppliers that can dispense small volumes of this highly viscous. To give you an idea, it's like mustard in consistency. It's really difficult to have industrial dispensing equipment that can very precisely allocate the appropriate volumes into syringes. But with our agreement and set up with Fidia, we solve those problems. They produce, of course, the world's best hyaluronic acid. They fulfill all quality requirements, they manufacture according to GMP, and they have the dispensing tools to do this at any scale, essentially, to meet our specifications. We're very happy about that. Yes, we have a process that is scalable, and we will be able to use in a commercial setting. Okay. A final thing about the trials there. I think I read between the lines that you're going to apply just a single concentration of the active molecule in the active arm of the study. Is this a common setup? Is it correct, first of all, and is this the common setup for a phase II trial? It's a terrific question. I should say that it's not unusual in a phase II trial, and particularly with per oral treatments, that you try several dosages. In our case, since this is a topical solution that we're applying, what's important is not the total amount that we apply on the skin, but the concentration. We've established the concentration very carefully, both in non-clinical studies, in animal studies, and also in our prior clinical studies where we've done dose and concentration ranging. We feel quite confident that we have narrowed in on an appropriate concentration. For that reason, we did not feel a need in this study to explore further concentrations. That gives us the possibility to put more statistical power on comparing the active versus placebo. If you have more doses, you either have the choice to increase the total number of patients or wounds that you analyze or to reduce the numbers per group, so to speak. But we feel quite confident about the concentration range and chose this two-arm setup. Okay. I have received a couple of questions from the audience. First one is, "What kind of company would be the best kind of partner for Ensereptide and for Ropocamptide, respectively? Yeah. I think the answer could be quite similar for both projects. We are in a border zone between large, fully integrated med tech companies that typically dominate the, let's say, the scarring and wound care with dressings and ointments and glues and devices. Certain pharmaceutical companies that have an interest in that have dermatology with presence in wound care, for instance, and may have an interest in a prescription pharmaceutical product for wound care or for scarring. I think those pharmaceutical companies that may have an interest in scarring, they're particularly interested in the non-aesthetic use of it. The use for patients that are particularly vulnerable to develop strong scars. Patients who have a tendency to develop keloids or hypertrophic scars. Whereas med tech companies, I think, would have a strong interest in both the medical and also the aesthetical side of it. Procedures, the utilization of this product after plastic surgery, for instance. I see. The second question here from the audience: "When do you expect to complete the development of the single-component product for Ropocamptide? That's a good question. It's not super easy to answer it firmly because we are working on the development of a manufacturing process. I think that the manufacturing process, we should be able to complete the definition of that one during the spring, so the next 2 to 3 months. The uncertainty lies in the stability of the product. Of course, we need to set up, once we have established this new manufacturing process, we need to verify that the product has long-term stability. That, for peptides specifically, requires real-time studies, which requires a number of months to verify that it doesn't behave different than the product when we had it contained in two different containers. The answer to that, we most likely will have that towards the end of this year. Okay. I assume that you, at the same time, you're looking around for potential partners for this project. How would you assess the mood among the eventual takers of this product? Is it easier to get in contact with people now that some of the COVID-19 restrictions are being scaled back? I should say, in general, it's been relatively easy to be in contact with companies during COVID. Perhaps even easier than prior to the pandemic, because all these partnering conferences have moved into a virtual format. You have the world in front of you in your laptop. I don't feel that there's been a barrier in reaching to companies. However, I felt in some of the discussions I've had, a large hesitation for entering into significant clinical studies committing to phase III programs with the uncertainty that has been in the world up to this point. For a condition like venous leg ulcers, these are elderly patients, many of them belonging to risk groups. I hope that now that society opens up a little bit, we will be able to move further into some of these partnering dialogues. Hopefully, supported by success in our development of the single-component product, to bring that into a setting where we can work with one or two companies, so we don't need to finance this on our own. To take the next. Do you think that it has held you back a bit in terms of progressing with partners talking this project, that everybody knows that it's very difficult to start off any phase III trials in the current conditions anyway? I cannot really speculate about that. We constantly over the last few years we continuously have a business development activities. We are in contact with companies. I don't feel there's been a barrier in reaching them, but maybe there's been some pent-up resources for clinical development, where a catch-up in the bottle will be reaching the neck, so to speak, soon, and that might be to our advantage. Going back to Ensereptide, you made a pretty good explanation on how you will do the biopsy studies after the close of the patient trial. What sort of endpoint are you looking for? How, apart from the biopsies, do you compile a list of observables in this project? There's three categories of endpoints in this study. The primary endpoint is safety and tolerability. It has to be, because it's a new medical application of the product, so that's by default. We have secondary endpoints that involve medical effectiveness of the drug. Here, we're using visual scoring scales, and we're using the standard scales that are used for scoring studies. It's the Vancouver Scar Scale and the POSAS. These are scales, visual scales that are combined, where both the treating physician and the patient, him or herself, will do the rating, and those ratings are combined into a numeric scale. Mm-hmm. We have a third layer of endpoints, experimental endpoints, the histopathology, and we think that in this particular study, the histological analysis is most likely the one that is going to be most information rich in guiding us into how to design and set up the next clinical study following the PHSU05. Thanks. I just have one final question. I guess it’s for you, Erik. It’s on the finances. You mentioned that the outcome now was you had a little bit lower costs this quarter than you had envisaged earlier. You said after publishing your Q3 report that you had made a reassessment of your costs going forward and that you had a longer financial runway now than you had seen before. Does this outcome, this the latest quarter, does that mean that runway is stretching even further at this point? I would say that nothing changed and all equal it has been prolonged a bit. Again, it also depends on what kind of actions that we decide to take. Not the least, depending on what the outcome of the PHSU05 study is. We're well-positioned all through 2022, and quite a considerable way also in 2023. We are sort of calm in the sense that we also have our own sort of. It's in our own hands a bit on how long the runway is. Mm-hmm. We are feeling rested and calm in that sense at the moment. Cool. I think your wording last time was that you had funding roughly six months beyond the final reporting of the basic trial. Is that the same message you're giving now? Yeah. All right. Well, that's the end of my questions, and I can't see that I have received any more questions from the audience. I think it's time for us to say thank you to everybody who has participated. Thank you, Jonas. Thank you, Erik. Hope to see you again in another three months or so. Thank you very much, Alf Gustavsson. Very well hosted, and looking forward to see you again in a quarter. Thanks very much. Take care. Thank you. Thank you.