Welcome to this web conference with Promore Pharma in connection with the company's report for the First Quarter of 2022. The company is today represented by CEO Jonas Ekblom and CFO Erik Magnusson. We will start by me having a discussion with the company, and we will have a Q&A session afterwards. Everybody listening is invited to ask questions. You can write them as we go along, and we will collect them, and I will read out the questions to the company at the end of the session. You can write your questions by expanding a control that's denominated with Questions or may be indicated by a talk bubble on the right side of the screen or the bottom of the screen, depending on what device you're using. I forgot to say my name, who will be the moderator. My name is Alf Riple, and I work at Västra Hamnen Corporate Finance. I remind you before starting the discussion that this session is being recorded and that afterwards you can find the recording. It will be on the Promore Pharma's homepage and on Västra Hamnen Corporate Finance channel on YouTube. With that, I would like to turn to you, Jonas and Erik. Hello. First of all, you have released your first quarter report earlier today. Could you describe the outcome of that first quarter and also what your financial status is at the moment? Yeah. As we said in the fourth quarter, the costs were temporarily down at that time, but we also said that we expected them to increase again in 2022, and that is what we have seen now in the first quarter. As you also can see, it's the commodities and supply bar that is rising, and that is of course due to the costs related to the clinical study that we're doing. Everything is very much going according to plan, not only the timetable, but also the costs. We are very happy that we can keep this pace in terms of cost development. The cash flow was also very much in line with the operating results, although we had a slight decrease in working capital. The net cash funds at the end of the period was SEK 36.4 million, which is also according to our plan. Again, the quarter quite undramatic and totally according to plan, financial wise. Thank you, Erik. As for your current activities at the company, could you perhaps maybe Jonas can take this. Can you explain what's going on at the company at the moment, in terms of activities? Absolutely. For those of you who follow Promore Pharma, you know that we are focused on therapeutic peptides. We have two programs where we're investing the majority of our funds and effort into. It's enseraptide that is a program where we're exploring the potential of this drug to prevent unfavorable scarring on the skin. We are right now conducting a clinical phase II trial on this program that is ongoing in Sweden. The other program, ropocamptide, is a peptide that is aimed for treatment of venous leg ulcers, which is the most common type of non-healing wounds on the legs. In this program, we're doing certain product improvements. It's a technical development that we're doing in that program. Those are the two main efforts we are engaged in for time being. I noticed in your report that you have a mention of widening applications. Is this something that you're actively pursuing at the moment or is that just something to keep in mind for the future? I should say that for the time, but we highlight the potential because we believe that in the future, there will be opportunities to go in several different directions with both programs, actually. At this point in time, we're trying to be as careful with our spending as feasible. Best approach in that case is for us to focus on the two initiatives that we're working on right now. Okay. Going back to enseraptide. Can you tell us more about the objectives and the plan for your clinical trial in skin scarring? Yes. These two clinical trials, the objectives fall into three tiers, I would say. The first tier and primary objective, of course, is to assess safety and tolerability of this treatment modality. We believe our peptide is very safe. We have seen that in prior clinical studies, but this is a new application we're onto applications on the skin to prevent scarring and, for any new application or indication, it's essential to assess the safety and tolerability. That's one important set of objectives. We have objectives related to the drug. We're studying how we best can apply this drug to prevent scarring, how it's applied to the skin, how it's used in conjunction with other bandage products and so forth. Thirdly, and perhaps most importantly, we're assessing the effectiveness, the medical effectiveness of the drug to prevent scarring. We're doing this with classical, visual grading scales, but we're also doing this with histopathology, where we're taking biopsies and studying with microscopy, very minute details of the scarring process. Three buckets, safety, tolerability, application process, and efficacy. Okay. I think it's also. Yeah. Sorry. Yeah, sorry. You also asked about the timeline, and I should add that we started enrollment into this program in February. At this point in time, we have fulfilled the recruitment goal. We have 24 patients in the study. The objective is that at least 20 of those shall complete the protocol. At this point in time, all patients have passed the first few visits, and we're awaiting the final set of visits where the patients will come in and we'll do biopsies. We are aiming for having last patient, last visit sometime in the early summer, and we will make a communication to the stock market about that when we reach that milestone. Then we will have a period of several months during the fall when we will be doing histopathology in this program. During that whole time, the program will still be blinded. We will not know which sample comes from placebo or from active, and we will be unblinding, if everything goes well, sometime in December, with the objective of having final study results, sometime around the turn of the year or the beginning of next year. That is our operating plan right now. The minimum number of patients in the study, like you said, of 20, that sounds of course very low, but I think it's worth repeating the point about each of the subjects being both test and control group. Could you just give a brief explanation of that? Yes, absolutely. That's actually very important. Each patient, or each study subject will obtain six small synthetic wounds. Instead of just 1 N per study subject, we get six. These six synthetic wounds will be randomized to receiving treatment with either placebo or active. This means that we will be having both placebo and active wounds from each patient. Each patient can be used as their own control group. This is important because there is a fairly large inter-individual difference. There are certain ethnic groups that have a high propensity for hypertrophic scarring, for instance. By being able to use each patient as his own control, we reduce some of the statistical variance that you otherwise would be seeing in a study where you would get just an N of one from each patient. Thanks. Moving on to ropocamptide side. Could you explain the objectives and the goals for your development activities there? Yes. In our previous clinical studies, we've done two clinical trials. We have used dual component products. The product kit at each time of application would have consisted of two syringes, one with a solvent and one with an active pharmaceutical ingredient. The contents of these two syringes have been mixed. You mix the contents of these syringes to get a homogeneous solution, and then you apply it to the wound. That works well or reasonably well in a clinical trial setting. We have all along known that that is unsatisfactory for a commercial product. In a commercial product, we wanna have a pre-mixed single component drug solution that can be applied directly. We're not really changing anything of the content of our product, but we're developing a new manufacturing process for this. That manufacturing process need to be robust, scalable, and provide cost effectiveness. We also need to have a pre-mixed product that is satisfactory from a product specification point of view, that it has the appropriate properties of shelf-life stability, that the viscosity is the same and so forth. To do these studies is a process that will take six to nine months, and during that six to nine month period of time, we will gradually retire risks related to the process development and to the properties of the product. Before the end of the year, our aim is to have a product that is stable, has the appropriate properties, and where we have a manufacturing production process that is satisfactory for the future that will hold all the way into the commercial phase of ropocamptide. Okay. Now you have spoken about the plans for the immediate future, 2022 and the period directly thereafter. If you look further out, what are your plans for your longer-term development? That's a very good question, and let me start by answering our thoughts for 2023. We believe at this juncture that we have a financial runway that will carry us through most of 2023. Our next step in both programs will depend very much on the outcome of the current activities. If we take the enseraptide activities in skin scarring, the outcome of the PHSU05 study will be very important. That data set will be instrumental in us selecting the preceding steps that we will do in that program, how another clinical trial can be done, our possibilities to do partnering, how long a study would need to be conducted, how many patients that would need to be in there, the cost and so forth. We don't know that and won't know that until we see that data set. In the case of ropocamptide, we are preparing for a phase III clinical study, but we are not conclusively finished with that. We are not absolutely finished with how a design of the next study would be. We have started the process of manufacturing some of the raw materials, but also in this program, it highly depends on our ability to reach a single component formulation or dosage form of the drug. Our intention is, as we get closer to this year, end of this year, we will have learned a lot in both programs, and in the beginning of next year when we get the PHSU05 data, we hope to make an intelligent choice of what our next step are in this program. We will make investments in the most lucrative opportunities that we see in either program. Since you mentioned the further development thereof ropocamptide, and also in your report you talk about an upcoming phase III study. Now, since your financial runway it will cover you up until the start of a phase III, but not through a phase III. I suspect that they are looking for a partner in performing a phase III study in, well, possibly in both pharmaceuticals. Do you have any wish list of partners to work with? Or if you can say anything about what you think the best type of company to work with in this relation would be? Yes. Of course we are consistently, constantly looking for the possibility of strategic partnerships. So far we haven't found an opportunity that we consider appealing enough to enter into such a partnership. Ideally, yes, a Phase III clinical study, if we could find a strategic collaboration partner or create a joint venture that could be, let's say, with a mid-sized company that has regional reach, that could be one opportunity, so that we take responsibility for certain regions and our partner take responsibility for other regions, that could be one way of doing it. We of course have explored at this stage if there is possibility to outlicense the program where we stand, but it turns out that in wound care, the vast majority of big med tech companies, they are keen on expanding by acquiring assets, but they are largely looking at really market-close assets. This therapeutic area is a little bit different than what you see in mainstream therapeutic areas in the pharma industry. Yes, we are absolutely constantly looking for possibilities to find partnerships that can reduce our financing burden and will help us strategically and synergistically to execute, let's say, Phase III program, for instance, in the ropocamptide program. Are you, is it a realistic prospect that you could perform any of Phase III in any of the candidates yourself? Well, the interesting thing is, I shouldn't comment on it very specifically because we're not done with the planning. It depends a little bit on the magnitude, the size of how such a clinical study can be done. Right now we're working with a range where if we're in the lower part of that range, it would absolutely be feasible for us to finance such a study alone. In the upper range, where we would look at a study with a very large study population to test, that is something we by necessity would have to do together with a strategic partner. Okay. All options still open as I perceive it then. Yes. All right. I will just repeat to the audience that it's still possible to write a question if you're really, really fast. Otherwise, I don't have any more questions on my list. It's been just a brief comment for our analyst side is that you seem to be following your progression plan very closely. We haven't found any surprises at all in the Q1 report. We will be writing a research update, but as we see it from the first reading is that there was little in terms of surprises there that would change our view. Do you think, in your own perception, is there anything that we should really notice in the report that would call my analysis so to speak? No, I think your assessment is absolutely right. We haven't been trying to hide anything between the lines. Actually it's a very undramatic report. We are tracking according to plan very closely, and the finances are robust, and we don't anticipate any significant deviations or surprises over the coming quarters. We're following plan. That sounds very good. I don't see any questions from the audience, and I don't have any more questions myself. I think I would just like to take the opportunity to thank you very much, Erik and Jonas for doing this interview, and best of luck going forward. Thank you for hosting, Alf. Thank you. Thank you. Bye-bye. Bye-bye.
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