Welcome to today's investor relations call. I'm Jenny Sundqvist, CEO of InDex Pharmaceuticals. I wish it was under happier circumstances we're holding this call, but that's the way it is. Today I'm gonna start with a short presentation, and then we're gonna open up for Q&A, and you will see a QR code with a Menti number on your screen. That's what you use to type in your questions. So please use that and type in any questions that you may have, and we will try to answer them. The team with me here today is the management team. So we have Johan, CFO and Deputy CEO; Eva, Chief Development Officer; Lotta, Chief Scientific Officer; and we have Jamie, who's gonna help us out in terms of the question, and he's in charge of communications. With that, I would like to start the presentation. This call is based on the press release we sent out last night, and we will try to shed some light on that, in this presentation, although we still have some unanswered questions. Forward-looking statements, you are used to these. So in case there are any new viewers today, there's quite a lot of people on this call. InDex Pharmaceuticals was founded in 2000, headquartered in Stockholm. We're listed on Nasdaq First North. Our focus has been development of cobitolimod in ulcerative colitis, and we had started a global phase III program. The phase III program looked like this: we had induction study one and the corresponding part of the maintenance study. That's what we had ongoing, and there were plans to start an induction study number 2 later on upon final results from induction study one. That's where we were in terms of our progress, and what we got the results from last night is the milestone called dose selection milestone. So that was a planned analysis. It was always planned to take place when 30% of patients had completed induction study one. The analysis was conducted by an independent external data monitoring committee, so there was no involvement from either participating clinics or us in the analysis. It included the first 133 patients, so 133 patients is the basis for the analysis that was made. Two-thirds of those received active treatment, cobitolimod. One-third received placebo. As part of the analysis, DMC performed what's called a futility assessment based on the primary endpoint, clinical remission, and a safety review. A futility assessment is performed to stop a trial if the chance for significant primary endpoint at the end of the study is too low. So if the chance of showing actually that we had an advantage over placebo in clinical remission was too low, then we would stop the study because it is not ethical to treat patients with a drug if you're not likely to show better efficacy than placebo. And again, I want to reiterate that only the Data Monitoring Committee had access to the unblinded data. InDex investigators, study personnel, patients, anyone else, remained blinded to all data. So nobody else has seen the database that the analysis is based upon and the recommendation from DMC. The recommendation, as was communicated last night, is that cobitolimod is unlikely to meet the primary endpoint upon completion of the study. So the DMC advises us to stop the study, and we will do so. And I want to point out that since it's a blinded study, there is no possibility for us to look into data unless we stop the study. Because if we would look into data, the study is no longer usable for, for example, using it for application to the FDA. So if you stop a study, we unblind the data, and then eventually we can look at the data. So we are following the DMC's advice, since it's not ethical, neither to patients, nor investors, to continue a study that is unlikely to meet the primary endpoint. So what happens next? No more doses of cobitolimod will be administered in the study of the CONCLUDE program. So from last night, investigators received information that the study is being stopped and to contact all patients, and no more doses are being given. Patients will, however, ever be followed up according to study protocol. That is a requirement. That's an obligation from our side. So we need to follow up patients, and the study needs to be closed in an ethical and regulatory compliant manner. Then we will collect all data, quality control the data, unblind it, and analyze it to try to understand what happened, because at this point in time, we have not seen the data that underpins the decision from DMC. What's important to point out, there's more information regarding next steps for InDex as a company will be provided once a thorough review of the data has been completed and we understand why this happened and how it happened. Otherwise, it's very difficult to comment on next steps. So of course, we're extremely surprised, disappointed. There were a lot of people who had hopes for this assets. Patients, everyone in the team who's worked on this, investigators, we've received a flood of messages during the day of people who are disappointed with us. The outcome confirms the complexity of the disease, and that there's a need for further research in this field. I wanna say that it, it's not uncommon that phase III trials fail. About 40% of phase III trials fail, but it's even higher in this area. So this is a complex area, and many of studies that we have seen, even with now approved drugs, have had extremely varying results. So there is something in the disease that we do not understand, that researchers don't understand. And in a lot of studies, the results have hinged on one or two patients making the difference. So it's a complex area. There's still a very high unmet medical need for moderate to severe UC, and that's why there was so much hope for this asset. Not only in itself on its own, but we had high hopes of it being able to be combined with something else, and that possibly could have helped patients with greater clinical remission, given the safety profile of our assets. So we are incredibly grateful to all patients, investigators, study personnel, for their engagement to date. Everyone has worked extremely hard to get us to the point that we are at today. And just want to reiterate that we are going to conduct a comprehensive analysis of all the data to understand it before announcing next steps. It will do no one any good to speculate why this happened until we actually know what the data looks like. So that is of no benefit to anyone. With that, that was a very short introduction, and we wanna leave plenty of time for questions. Again, there should be a QR code or a Menti number on your screen, which you use to type in your questions. They will then be sent to Jamie, who will pose them to us. Please feel free to ask any question that you have. Over to Q&A. Yep. So there's a few questions that have come in. The first one: "So the study was advised to be stopped because of the negative results of the futility analysis. So what does that mean? So a futility analysis means that if you have a like a very low likelihood of meeting your primary endpoint, which is being better than placebo, then you stop a study, because it's not ethical to continue a study where you give patients a drug that may not help them better than placebo. So that's what's happened here. Yeah, and I think leading on from that, "So, what will happen to the study and the company now? Why don't I let Eva comment around next steps for this study, and then I can comment on the company. Yes. So what will happen to the study is that, as Jenny also explained, patients are in the study, so there are patients in the induction study, but there are also patients in the maintenance study. So no one will be given cobitolimod doses any longer, and all patients will be asked to come to the clinic and have a termination visit, so a last visit. And of course, we will try to collect as much data as we can, so we can later analyze that data. But then this data needs to be entered, monitored, cleaned, and then the database lock will occur also for this data that were not included in the interim analysis. Because these are additional patients that have entered the study after the interim analysis was done or the dose selection analysis was done. In terms of the company, as I said, we will not make decisions on next steps until we have received the data in-house and analyzed it to understand what happens. It would be a hasty decision to decide something without knowing- Mm ... and being able to explain to everyone what has actually happened, so. In Swedish, I'll see if I can translate it. But, "How do you see the opportunity of distributing cash to create owner value, shareholder value? Yes. So I think the question is, are you considering liquidating the company and distributing the cash? Because we do have a healthy cash balance. That is one of the options that will be on the table for the company, but we haven't made a decision as of today, which option we're going with, but that is one option, yes. Another financial question. "Cash position and incurred cost for clinical trial program, debts, et cetera. So maybe, Johan, do you want to comment on that? Yeah, we have already communicated our cash position as of Q2. Next week, we will have the Q3 update with that report. In the meantime, we will, of course, control cash and cost and so on, and we will have all the cost for closing the study, et cetera, and all our other commitments. Once we have done and have the overview of that, we can also see where we will end up then, but that's too early to say. Yeah. I think there's a question in Norwegian as well now. "But can the phase III program be saved?" Is that the right translation? Yes, that's the right translation, yes. The phase III program that we had started, as such, cannot be saved, because once we stop a study and unblind it, you can't restart it.... What could be done is, of course, start a new phase III program, but you cannot, you cannot restart a study that's been stopped. Okay. How long will it take to reevaluate the design of the study? And do you know if both doses failed? Why don't I give that to you, Eva, if you want to answer it? Yes. So reevaluate the study data and know if both doses failed, that we will know when we have looked at the data that the Data Monitoring Committee looked at, which we will do that. And as I also mentioned earlier, we will look at more at the data and evaluate that. What we do know is that both doses failed because otherwise we would have been told to continue. Yes, that's true. ... but we don't know any magnitude or by how much, but we do know that none of them showed enough efficacy for us to be able to continue the study in this setting. Another financial question. How will you maximize shareholder value now when cash is worth more than double that of the market cap? Do you want- As I said, we need to understand our commitments and make sure that we then can honor them with the cash that we have, and then the next step will be, together with the board and potentially also the shareholders, what will be the next step of the company. So that's how we maximize the value. Okay, financial question. Redeye noted this morning the cash position will be valued at SEK 0.5 per share. Is that something we can confirm? Not asked or opine on that. Okay. When do you expect to have a final overview of why the study failed? Well, the final overview will be when all patients have gone into the study, and we have made these final visits, as I mentioned before, and then we will need to collect and clean the data. So it will take a few months at least. So I expect maybe early next year, first quarter, something like that, we will have all the data. Yep. There was another question on that as well. How long do you expect the analysis to take? I think you just answered that. Yeah. Thank you. Okay, a few more questions. Have you experienced anything similar in earlier studies in terms of dose versus placebo? Do you wish to comment, Lotta, on the historic? In the previous CONDUCT study, in the phase IIb study, we met the primary endpoint in the 250 mg dose compared to placebo, with the difference of about 15%. So we were, of course, very surprised and disappointed when we received this data, and we need to dig into the data in more detail to drawing more conclusions on why we failed on the futility of this study compared to that the previous study was successful. Another financial question: how much cash will you have after the study has been terminated? Too early to say. Okay, the questions are still coming in. So the question is, is the future for cobitolimod as a potential drug over? What happened? In that case, what happens to the company InDex and the shares? It's as we said, it's too early to say whether it's the end of cobitolimod as a drug. We will know that when we have analyzed the data to understand what has happened here. We, like many others, were quite surprised, since, as Lotta said in previous studies, we have shown efficacy. So the result is quite surprising. A bit what I mentioned earlier, this field as such is tricky. Same drug provides very different results in similar studies. So it's odd. We cannot necessarily say today that it's the end of cobitolimod. We don't know that because we don't know the reason for the failed futility. I think we need to wait for the data to come in and to have it analyzed before being able to answer that question. Yep. The same question again. When do you think the analysis of the data will be done? You've answered that a couple of times already, so... Okay, what would be the best type of outcome for when you analyze the data? Mm. We don't want to speculate on that now. There's a few more questions coming in. Is that one relevant? I guess the- It is a question, but probably mixed up with another company. Yes. I will rephrase it to make it relevant for us. Thank you. Does the negative result have any financial impact on your agreement with Viatris Japan? Thank you. I'll address that. Yep. That's something we need to look into together with the Viatris, what will be the outcome. With this outcome, what will be the next steps according to the agreement, but that's too early to say. We have scheduled a meeting with Viatris later this week to start a discussion, but too early to say. Are there any earlier stage programs behind cobitolimod? We do have other compounds in the portfolio, but not advanced to the point where we could see a return for shareholders in the near term. ... Again, the same question around estimated timeline, when to have a finalized assessment of the data and communicating that. I think you wanna say the answer that one more time? Yes, why not? I mean, we as everyone hopefully understands, we got this message yesterday evening. So right now, what's happening is that we are making up the plans and identifying how long will it take, how much time do they need, and so on. So we're working hard to get the shortest time plan we can to retrieve the data and analyze the data. That is what I can say. I said first quarter of next year, but I actually don't know exactly right now. No. But that is... It will take a few months at least. But what I can promise is that when we do have the analysis and understood it, we will communicate it. Yes. So that we can promise. Yeah. We just don't know the exact timing of when that will happen. Yep. And more, another type of question. How will you manage to keep the competencies within the company now with a highly uncertain future? That is a. It's a very good question, and something that we've already discussed last night and this morning, because there are some key competencies, and we have obligations as a company that, that we cannot choose to not do. So you have to close a clinical trial in, in a certain manner. You have to go through certain procedures. There's certain data that has to be filed with authorities, and that has to be done no matter what. So we will do our best to keep the people who are critical in that process. We need to, because to bring on new people to the company at this point would be highly difficult. But I'm convinced that we will. We have had meetings with all... everyone in our staff. Everyone is, is committed. We have a good team. Everyone is engaged and extremely committed, so we're hoping that that's gonna work out to the best. A little variation on the timing question, but do we know when we'll have access to the data? Well, there's, like, two parts of the data. One piece of the data is the DMC data, and that is already available, not to us, but that was available to DMC last night, so. And then we have the data from the remaining patients that are ongoing in the study. So those are two sort of data sets that can be looked at. Eventually, both of them will be looked at. Yep. A question about our commitments to Parexel. What are they? To our CRO, our commitments to our CRO? Yep. Well, I mean, our commitment to Parexel is that we are working together, so we had a plan together that we were going to, to do an induction study one and induction study two, and the maintenance study together. And of course, now we will need to revise those plans, so that is what we're also going to do right now. Finances again. Will you need to wait for the data evaluation before making a decision on what to do with the cash position? Yes. I would say yes. Okay, a little bit back to the other assets. Is there any ongoing work with other assets within the DIMS platform? Do you wanna come up answer that? You can answer it this time. Yeah, I mean, Jenny, Jenny, already answered that. I mean, we have other DIMS, but they are in very early stage compared to cobitolimod, so they have a long way forward. Yes. What was the reason for choosing 43 patients in each arm? Eva? Well, this was based on this probability analysis that you do. So there was this futility analysis, but then there was also the dose selection analysis, and that's all related to a probability analysis. What's the probability of this study, or what's the probability of this dose winning? The winning dose, for instance, then to win the study. And that was all in the plan. So this was all pre-planned before the study started. So we have just followed what was in the plan, really. Mm-hmm. But you can say that actually, a statistician looks at what's the minimum number of patients you need to have a certain decision. Mm-hmm. Exactly. So, so- Yeah. so 43 was- Mm ... is determined, and we have an extremely good statistician. 43 is the number that we needed to have a certain result. Yep. Not a certain result, reliable- Result ... reliable- A reliable result. That's a better English word. A reliable result. Yep. Okay, yep, a few more questions. Were there any significant differences in patient populations from the previous phase IIb trial to this induction study? Was there any obvious change in recruitment criteria? Well, I can answer that. No, it's the same patient population as we had in phase two. So it's moderate to severe ulcerative colitis, and it was defined the same way. We used the same assessments and methods to look at the disease progress, the efficacy and safety. Is there any chance that DMC may have made an erroneous conclusion? That's, that's one of many hundred questions we asked ourselves last night. And I think it's, it's part of the shock and the reaction. You wish that there must be something wrong with this because we don't understand it. The protocol that's been set up and the process that they followed is very solid. So it's highly unlikely they make a wrong decision. It's sort of a I think an instinct that you have to think that there something must be wrong. I know, I know we had the same thoughts initially when you're in shock, but that is highly unlikely. Yep. Have your biggest donor, Linc, indicated what they would like to see going forward? I've had discussions with Linc, and we have further discussions later this week, so we have an ongoing dialogue. Is the sample size of 2/3 of 133 large enough? I guess the question is, were enough patients on active drug? I guess that's the question. Yeah, but that was in the whole analysis. So that was, like you said, Jenny, that the basis for this statistical calculation was based on that 44 patients should be enough to determine the winning dose and then also look at futility. So that was the whole ground for this statistical analysis. What was the minimum delta for continuing the study? I think the question is referring to delta in clinical remission. Mm. And that, that's not how it's measured, but I leave to Eva to try to explain. Yeah. For continuing. That was not the ground for this analysis. I mean, the final primary endpoint, that was based on the data that was in phase two. So the results from phase two lay the grounds for how many patients we needed for the whole study. But then for this analysis, this was a different analysis, so it's a probability analysis that you do. Probability of a dose or probability of futility then for this study. The next step, is that a question for the board? Why are they not represented on this call? I mean, we have continuous discussions with the board. We had a board meeting last night. We have another one coming up. So there's continuous discussions between us and the board. We will get back, the next step are largely determined. The board's involvement and the shareholders' involvement is largely determined by what the next step should be. At this point in time, the main focus is to get the data in-house, and try to understand what happens. Yep, back to the study. Is six weeks clinical remission a short time for this complex disease? For many, it takes a longer time. Six weeks, is it short? I think the question is: Is six weeks induction enough to put a patient in remission versus other clinical trials who use, for example, twelve weeks? So maybe, Lotta, you want to comment on that? Yeah. We had the six weeks in the previous phase 2B study, and there we saw a significant result with the 250 milligram. It's true that some other compounds have later endpoints, but as we saw these good results in phase 2, we continue with the same design also in phase 3. What will your communication plan to the shareholders look like going forward? As soon as we understand the data, we will, of course, communicate. And as soon as we know about next steps, we will communicate. So we will do it in as soon as we know. I think that's been part of one of my priorities- Yes ... so clear communication to the shareholders, and we'll continue doing so. Yes. Are there any risk that mistakes were made, for example, mixing cobitolimod and placebo? Eva, do you want to take that question? Well, I mean, we have taken all measures that you do in a clinical study. So, I mean, placebo is manufactured and active drug is manufactured, and then follow all the rules and regulations that we have. So I would say you can never say that there is no risk, but of course, the risk is extremely low, that there is a mix-up between cobitolimod and placebo, for instance. Mm. I would say extremely low risk in this case. Yes. What was the lower bar for efficacy needed to meet in order to have a positive outcome in the futility analysis? So the... It was not an efficacy analysis. We did not pass futility because there were less than 15% chance that we would meet our primary endpoint. Was it the same type of evaluation in the phase 2 study? Yes. I mean, we have the same type of patients, and clinical remission is defined in the same way with the Mayo Score as it was in the phase 2. Have you considered whether competitors can affect DMC? Eva. Well, of course, we have considered that. That's sort of in the contract between us and the DMC, because it is us who contracts the DMC, but they are an independent Data Monitoring Committee. So we never have any relations to them. It's always Parexel, our CRO in this case, who delivered the data to them. And there is a very strict code of conduct in this, that you always need to declare your responsibilities or your, what is it called? Interests- Yeah ... financial interests. So in this case, I would say no. ... back to the finances. Do you have an estimated cost for closing down the study? Not yet, but that we will work on as soon as possible, of course. Were there any changes in how the dose was administered, in the patients between the former studies and this one? It's this still 50 ml enema. It is administered at week 0 and week 3, so that's the same as in the previous study. So I gotta... Yeah, I say this one anyway, it's just because it's nice to hear. So there's a person who says, "I'm impressed with your professional handling of the situation. Thank you for your commitment and clear communication. Thank you. Thank you. Thank you. Did DMC do the evaluation of phase two also? We had a DMC in phase II that evaluated safety during the study, but we didn't have a futility analysis in the phase II. It was a smaller study and a shorter study. No maintenance included. I just want to say that this milestone was put in because we were choosing a dose. If the phase three program would have been run with just one dose, you wouldn't put in this type of milestone in it. You would run the entire study and then... But we needed this analysis to be able to pick a dose. So there was no choice in that matter. We've actually got through all the questions that's been sent in so far. 46. Okay. So, if anyone has additional questions, now is your chance. Use the QR code or Menti number. If there's any more questions, please state them. Let me just see if... Yep, one more has come in. Comparing with Guard Therapeutics, who got similar DMC recommendation in phase 2 and then came to another conclusion in their own analysis, which findings could lead to that happening in our case? I think that's speculation at this point, 'cause we have no idea. I mean, of course, this happens all the time when studies fail, and then companies look into the data, and they find a subgroup where it works, or they find a reason. But, I mean, we can't speculate on what those reasons would be. We need to see the data first. It happens very often that study fails, and it happens sometimes that upon analysis, they find something that proves to be a path forward. And that is also the reason that we don't want to decide firmly on a path forward before having done the analysis, because that would be premature. Yep. I think we're sort of tailing off a little bit now, but a few more. Will you communicate the cost for closing down the study as soon as you have an estimate? In one way, I mean, we have the Q3 next week, and that's too early, but then we of course have the Q4 coming up in February, and might be the right time to have at least an overall estimate on that particular subject. Yep. There... All the questions have come in, we've answered. I don't know if there's any closing remarks or anything you'd like to say before we end the call. No. Sorry. It's not often I'm lost for words, but we are. So, we will get going as soon as we can to look into the data to understand what has happened. Communicate as soon as we understand that, and I think, by that, we close. Thank you. Thanks.