Welcome to today's broadcast with Guard Therapeutics. We will begin the presentation here, and afterwards, there will be a Q&A. You can send in questions in the form to the right side on the screen. You can also call in, and if you're calling in and want to ask a question, please press star nine to raise your hand and then star six to unmute yourself when given the word. With that said, I'll leave over the word to you guys. Thank you so much. Good afternoon, everybody, and welcome to this web conference. We host this web conference because of the press release that was announced this weekend addressing the top line results of our phase 2B dose finding study called the POINTER study. The purpose of today is to address the main findings of the study and, of course, the implications of some of these study results. With me today, I have our Chief Medical Officer, Michael Roesch. I also have our Chief Financial Officer, Karin Botha. Thank you so much for taking the time to be here and listen, and let's get started. I'll give it over to Michael to start digging into the data. Thanks, Tobias. Before making you familiar with the main study results, just a short reminder on the study background and the rationale for the study. The setting we are studying is open heart surgery patients who are at elevated risk for acute kidney injury, a population very similar to the previously designed AKITA study. The intervention we are looking at is recombinant human alpha-1 microglobulin known as RMC-035, again the same formulation as used in the previous AKITA study. The design of the POINTER study and the concept of the POINTER study was based upon evidence of efficacy seen in the AKITA study, where we showed improved kidney function in terms of estimated glomerular filtration rate, eGFR, and also reduction of severe kidney injury expressed as major adverse kidney events, MAKE. Also, post hoc findings showed that biomarker data were consistent with the key efficacy results. Based upon these encouraging findings, we designed the POINTER study with the following objectives: number one, to confirm the beneficial effects seen in the AKITA study, and secondly, to identify the optimal RMC-035 dose to be carried forward for future phase three development. Key endpoints in the POINTER study were the estimated change from baseline in eGFR, estimated eGFR change from baseline, which is an endpoint directly linked to chronic kidney disease progression as well as end-stage renal disease. Also, in interaction with the FDA, this phase 2B endpoint was considered as an appropriate dose finding endpoint. We also studied as secondary endpoints the occurrence of MAKE-90 events, so those MAKE events occurring at day 90. This is the anticipated regulatory endpoint for approval by the FDA, and it represents significant loss of kidney function, death, and need for renal replacement therapy. The POINTER study design was very similar to the AKITA study design. Patients were randomized to three different dose arms: 30 mg, 60 mg of RMC-035, and placebo. We used a two to two to three randomization scheme, ending up in the number of treated patients as shown here: 47, 50, and 73 in the corresponding treatment groups. The dosing was given as three infusions: one prior to surgery, the other one six hours, and the third one 24 hours after the first dose. Patients were followed up after the hospital period at day 60 and day 90 for the primary endpoints as well as for the key secondary endpoint, again eGFR and MAKE. Out of the 170 patients treated, 76 were treated and cared for in the European Union, and 24% were recruited in Canada. Now, the key efficacy and safety results. While I explain this, we are having only those key top line results in hand. Full analysis datasets are expected to come later in two weeks' time. What we see on the key top line results is that number one, in terms of eGFR change from baseline, this primary endpoint was not met. We saw a net change versus placebo of minus 2.76 milliliters per minute, which was not statistically significant. Also, if we looked into single doses, 30 mg and 60 mg, no statistically significant improvement was seen with any dose. Clearly, these findings in eGFR change from baseline are inconsistent with what we had previously observed in the AKITA study. Also, for MAKE-90, there is no significant benefit seen. We have seen a relative risk of 0.89, which is not statistically significant, numerically favoring RMC-035. However, also here, no statistically significant improvement was seen with any dose. Particularly, the findings for the eGFR decline component of more than 25% decline were inconsistent with the AKITA results, where it was the main driver of the MAKE outcomes in AKITA here in POINTER study, this is not the case. The safety profile is nothing remarkable. It's reflective of the underlying condition, and no safety concerns were identified at this stage. Allow me a couple of comments on the dose considerations because from the questions raised up front, we learned a lot that those were circulating around whether we have met the right dose or exposure. I think my message here clearly is the exposure we have observed in the POINTER study is clearly aligned with the target levels which we had looked for when designing this study. This means the 60 mg dose achieved levels of RMC-035 in the blood comparable to the lower and most efficacious dose in the AKITA study. Also, the 30 mg dose was associated with numerically better efficacy outcomes than 60 mg. In terms of the dosing frequency, based upon the preclinical findings, pre-surgery and the six-hour doses are the most critical doses, critical for efficacy, and that's where POINTER and AKITA are aligned. When designing POINTER, we removed the 48-hour dose compared to the AKITA study in order to optimize the safety ahead of phase three, reason being that we wanted to have a dosing which is associated with a clean safety profile in POINTER, and that necessitated the removal of the 48-hour dose. If we look at dose and exposure considerations, our conclusion at this stage is that the exposure observed in POINTER is consistent with target levels and with a safe AKITA exposure. We also think that the removal of the 48-hour dose is unlikely but cannot be fully excluded as a contributor to the efficacy outcomes and the study failure. However, I have to emphasize again, from a clinical point of view, the 48-hour dose was associated with an unacceptable safety risk in AKITA and therefore could not be advanced for future or potential phase three study. That is why we removed it in the POINTER study. In summary, basically what we have to convey today is that eGFR and MAKE-90 do not carry any benefit in the POINTER study, which is in contrast to the AKITA findings. Also, the preliminary data with further analysis ongoing tell us that we have a full dataset review to be done in the coming weeks. We will look into pharmacokinetic and pharmacodynamic relationship relating basically exposure to efficacy and look at the effect of potential confounding factors on the study results. However, even if we take these all into consideration, these uncertainties, our interpretation at this stage is the findings are not expected to change materially with a full analysis, which brings us to the situation where we have two clinical studies with conflicting outcomes, which carries elevated risk for further development if we think about it. That is why we think at this stage RMC-035 development in heart surgery is likely to be discontinued. However, we will, in the coming weeks, assess the strategic value of both the RMC-035 range as well as the GTX platform for further potential implications and then get back to you. I'm sorry that I have no better news for you today. You all saw it from the press release, and I'm now happy to take questions and try to address them as much as possible. Thank you so much for the presentation. As you mentioned, now we will carry on with the Q&A. Just a short reminder, if you're calling in and want to ask a question, please press star nine to raise your hand and then star six to unmute yourself when given the word. The first caller here that we will give the word is Philip Lindquist from Renaware. You have the floor, Philip. Thank you, and thank you for taking our questions. You mentioned the removal of the effort data or dose may partly explain the negative outcome in the POINTER study. Besides, how do you explain that AKITA could deliver such strong data? Was it maybe that AKITA reflects a chance finding or maybe a combination of the two? At this stage, I'm not in a position, unfortunately, to deliver the full explanation why there is such a difference between those two studies and whether which of the confounding factors or any other implicating factors is driving those results. I think that that's all I can say at this stage. We are looking, as I told you, in several perspectives at the data, but at this stage, it's too premature to make any conclusions. Okay. Do you have any reason to believe that there may have been any deviations or irregularities during the POINTER study, such as issues with the vial handling, labeling, or administration? We have investigated this, and we have no indication that this would be a systematic cause of error in the study. Okay. How does the POINTER results change your outlook when it comes to the preclinical GTX platform? I think with regard to the mechanism of action, we still believe that the mechanism of action is valid based upon the preclinical findings and also supported by the clinical results from the AKITA study. There is no reason for us at this stage to refute the validity of this mechanism. Yeah, and maybe to just add to that question, obviously, as we discussed in the press release, now we look strategically, review both the RMC-035 data, the full data package coming through, and also the GTX platform. I think the wealth of the preclinical data we have supports this program, both in the acute as well as in the chronic setting. I think also the purpose of the GTX peptides is being delivered in a completely different setting, in a non-acute setting. At this point, we're not in a position to dismiss that or consider this not to be a validated target. Of course, this will be subject to strategic review in the coming weeks. Obviously, once we have a more clear view of how to proceed with either RMC-035 or the GTX peptides, we will, of course, communicate that to the market. Yes. I'm sure you will await all the complete data before making any decisions on the future. If you find nothing, maybe the next step could be a delisting and distributing remaining cash to shareholders or a reverse takeover. Even if this ultimately is a question for the board, could you share your view on this? No, I think it's really too early because, as pointed out here, we think we have a very sort of solid background package before going into the POINTER. I think we're all very surprised. This is not really the results are not in line with what we expected and hoped for. I think we really need to make a more thorough assessment of the results that we have before we can actually comment on the next step. As you said, I think it's too early to really speculate about delisting and reverse merger and things like that. That would really come once we have made a more scientific and scientifically based assessment of the totality of the data that we have, both for RMC-035 and as well as for the GTX platform. That's clear. A final one from me. If you could elaborate on the cash position and your cost expectations for Q3 and Q4, will, for example, some study costs spill over into Q4? Yeah, so briefly, we haven't yet published the Q3 report. By the last Q2 report, we have about SEK 100 million cash. Obviously, we will have some spillover in terms of study cost that goes into the Q3. We still expect to have a relatively solid cash position also when the POINTER study is being fully paid off. Since we're actually immediately halting a lot of the ongoing work streams towards the phase three start and I think the phase three planning, that also brings us essentially to have a cash runway which extends throughout the next year in 2026. I think strategically, this gives the option of really making a thorough assessment. I think both from a scientific standpoint and of course in terms of preserving shareholder values. I think that's exactly the conversation we will have now in the coming weeks. Earlier, you expected cash to reach summer 2026. Do you expect to extend that period? Yeah, as indicated, we are now comfortable to say that that can be extended since we have a very small team in principle and we have very low running costs when we're not executing clinical studies. Obviously, there are high CMC costs which are attached to development work and also manufacturing of clinical trial materials. All those work streams will now be paused, which of course brings additional cash and extends the runway comfortably into the end of next year. Thank you. That's helpful. That was all from me. Thank you so much, dear Philip. We will now carry on with the next caller here. It's a cell phone number that ends with 858. Please, you have the word. Hi, [Ramaria] here from DNB Carnegie. Thank you for taking my question. A lot of good questions before, so I'll keep it short. The strategic review that you have talked about, can you tell us anything about the timeline of that? How long do you think it would take? Which alternatives are you considering if you can give us a bit more detail on that? Thanks. Yeah, obviously, this is not something we expect to finish in a year's time. We fully understand that this is something which needs to be accelerated and executed as quickly as possible. I think, as Michael alluded to, the full data package from the phase 2B POINTER study will come in in approximately two weeks. Of course, we have a couple of weeks before we have the full insights in what happened in the POINTER study. We need some additional time to work through that material. We need to do a lot of the analysis, as pointed out by Michael, the PKPD modeling being one of those efforts. I think realistically, we need at least one or two months to make a thorough assessment and look at all the possible sort of angles from this and make a decision on the path forward. If that can be expedited, we're happy to do so, and we will communicate as soon as we know more. I think that gives you a reasonable ballpark on how we think right now. In terms of options, I think we commented on that already, but from now, we need to first understand the data. We need more assessment of the totality of the data for both RMC-035 as well as the GTX platform. Then I think we can discuss the more conservative options in terms of just looking at reverse mergers and other solutions for the company going forward. Yes, okay, thank you. Speaking of the full dataset on the study, what level of detail can we expect that you're going to publish? If you can tell us something. Once we had full insight into the full dataset, including doing additional potentially exploratory analysis triggered by the data themselves, we are planning to publish these in a manuscript. We are committed to scientific rigor. We take the time which is necessary in order to have a good understanding of the results and to explain the findings here. A publication will be coming along in a scientifically peer-reviewed journal. All right, thank you very much. That will be all for me. Thank you so much for the questions, dear. We will now carry on with some questions that have been sent in to us. There have been several questions on the dosing. Could you again briefly summarize the rationale for the doses and frequency of dosing in the phase 2B POINTER study? Yeah, the rationale for the doses in terms of setting the doses, one principle was not to exceed the dose which carried safety risk in the AKITA study. We were oriented towards the lower dose in the AKITA study to achieve comparable exposure, which was perfectly the case in the POINTER study. That was the 60 mg dose. We did the 30 mg dose based upon pharmacological considerations and extrapolations. That was with regard to the doses and dose amounts. With regard to the dosing frequency, as pointed out before, our principle was to maintain as the critical dosing time points the surgery or close to surgery dosing, as well as the post-six-hour dosing, and include a third dose, which in this case was a 24-hour dose. The removal of the 48-hour dose, as mentioned before, was not deemed critical for efficacy. However, we can't exclude it, but was necessary for safety-related considerations that would have implicated a safety risk not viable for being carried forward into phase three. Thank you so much for that. I will now shift language to Swedish here. [Foreign language] Hur skiljer sig patientpopulationens riskprofil i POINTER från AKITA? Kan en friskare baseline ha minskat möjligheten att uppnå signifikans? Okay, I'll take the freedom to translate. The question in English is, is there a difference in terms of baseline characteristics comparing the AKITA and the phase 2B POINTER study? Would it make a difference if, call it, relatively healthier patients from an eGFR standpoint would have been included in the phase 2B POINTER study? Yeah, thanks. I understand the question. The data we have so far are showing that our population is very comparable to the population we had included in the AKITA study, both with regard to the basic demographics and baseline characteristics. Of course, there are other risk factors potentially driving risk for kidney injury, which are post-randomization factors. We will have a careful look at them with a full dataset. At this stage, I can only say there's nothing in the baseline demographics and characteristics which points to these strange findings. Thank you so much for that. Another one in Swedish here. [Foreign language] Kan den biologiska mekanismen A1M fortfarande anses validerad trots POINTER-resultaten? I think I get the point of this question. I think, as pointed out before, by mechanism of action, based upon the preclinical pharmacology results as well as based on the AKITA results, we think that the mechanism of action is still valid and viable. The purpose of the ongoing analysis of the full dataset, as well as additional analysis, will be to explore why this mechanism wasn't successful as we planned in the phase 2B POINTER study. The take-home message at this stage today is our conclusion is that the mechanism is still viable based upon the evidence I just talked about. Thank you. Moving on to the last question here. [Foreign language] Planerar ni att offentliggöra mer detaljerad PKPD-data innan ASN-presentationen i november eller först vid kongressen? Do you get the gist of the question, or I'll translate if there are any English listeners? I would appreciate it if you could shortly translate. Yeah, the question is, are we planning to publish or release the outcomes when we have more PKPD modeling results, which is going to follow? I think the second part of the question... Was it before the ASM presentation in November or on the Congress? Effectively, I think we will not have the full insights. I think, as explained, we don't have the full data package on time for that. In due course, as again, we're committed to scientific rigor. Of course, we want to be transparent to the scientific community. We think there's a lot of interest, I think not only in the study design but also to the mechanism. We will plan and inform more about PKPD modeling outcomes. That will take a little bit more time. I think we just need to hold off until we have the full dataset to do that type of work. Thank you. We actually received one more question here. [Foreign language] Hur mycket kassa bedömer ni att ni kommer ha kvar i slutet av detta år? As alluded to, we will release the Q3 report. We'll provide more information that comes relatively soon in November. As I said, in terms of cash runway, we are now comfortably in, you know, we have a runway towards the end of 2026 based on these results. The Q3 report doesn't provide any major surprises. In principle, we need to wait for those results. We need to also look at some of the tails of the costs attached, and also for some of the additional work that we are committed to do from a scientific standpoint, although that may not change the outcome of the study. Thank you so much for presenting here today. Thank you all at home for sending in questions. We wish you a pleasant day. Goodbye.