Hi, and welcome to BioStock Studio, where today we will be doing a live Q&A session with Saniona. Saniona is, of course, focused on developing treatments for rare central nervous system and metabolic diseases. They have recently strengthened their financial position through a collaboration with Acadia. Today we will be talking about the strategy and the vision for the future. Before we do that, we have to set the format. We have 30 minutes, and we've had some questions by email already, but you can send questions in during the session through YouTube's chat function. I will see them here on the iPad. Do bear in mind that there is a short delay between you pressing send and me seeing it on the screen. I should also say that we have had a lot of questions already, so I don't think we will be able to answer all of them today. The questions that are left unanswered in this session will be addressed by Saniona at a later stage. With the format in place, let's turn to the two gentlemen who are here to answer your questions. It's CEO Thomas Feldthus and John Haurum, who is a board member and will be appointed chairman of the board at the next general meeting. Welcome. Thank you. Thank you. I thought, as we have you here, John, could you start by telling us a little bit about yourself and what attracted you to Saniona? Yeah, I've been following Saniona for many years, partly, of course, because Thomas and I go back. I started my career in the biotech industry as a Chief Scientific Officer in Symphogen that Thomas and I were co-founders of. We worked together for many years. Thomas, of course, in his tenure at Saniona, occasionally talked about Saniona. I followed it and been really excited about the company and bought some shares over the years. Last summer, I had some extra time and offered Thomas to join the board. I'm very pleased about that. He accepted? Yeah. Getting straight to putting you on the spot here, could you summarize Saniona's strategic priorities for the coming next three years? Yeah. We, on the back end of the deal with Acadia, now have a solid financial position. The main strategic objective of the company now is to prosecute our three leading programs, get those ready for the clinical trials or into the clinic, and then build value in those programs. They are in the ion channel area that Saniona is an expert in. We also have Tesofensine, which is also a strategic objective, of course, to prosecute. We'll be doing that by a careful focus on internal activities. We'll build our research activities with our partners and then use that to also continue our business development activities. Turning to you, Thomas, you've talked a lot about Saniona having a strong history of partnerships. Could you elaborate on how collaborations fit into your strategy? Yeah, this is a major partnership. It's a significant part of our business model. It's also part of our success story. The latest deal with Acadia is probably one of the 10 largest deals in Swedish biotech. It now provides funding for the next three years where we can take these programs forward. Over the years, we have raised income of SEK 750 million and actually made a profit of SEK 150-200 million through periods where we have followed this model. At the same time, this has enabled us to run five clinical studies and two preclinical programs, build our pipeline from scratch, and also create some significant valuable deals with future upsides. This demonstrates the effectiveness of this model, I believe, and also our ability to capitalize our science. This is a key element in what we are doing. If we look specifically at business development, what will the focus be there? In the coming period, I would say it's divided into three areas. First, we will focus our we will start with our internal pipeline discussions. The three programs we're developing, we will reach out to companies. The goal here is to create interest among companies so they are lined up when we have completed the Phase I study and the time for replicating the Acadia deal is there. I have a question here from an investor that has asked whether an exit within the next two to three years is a preferred strategy, assuming that the Phase I studies are successful, of course. I think this is you, John? On the exit question, it's important to understand that companies are typically not exited as being sold, but rather they get acquired when certain stars have been aligned. Therefore, for Saniona, that's not really a strategy for us to pursue an exit. Rather, the strategy is to really focus on building value, create value in the pipeline, and also create value through partnerships, which, of course, is sustained by the value created in the pipeline. Therefore, looking at exit, that's a shareholder objective. It's not really a company objective. Of course, as we build value, you can't rule out that someone would come along and be interested in the company as a sort of whole entity. As shareholders, we're not opposed to that. Of course, we're focusing on building value that potentially could create that opportunity in the future. It is not a company objective as such. Your focus is the partnership. Our focus is really on unleashing the value that we see in the platform and that we see in the individual programs that we have and drive those into clinic and through clinical development. Focus on Tesofensine also. We're reluctant to be specific about what will happen with Tesofensine because we have the major milestone that needs to happen first, the approval that we are expecting. Until we have that, we're reluctant to talk much about the strategy about tesofensine afterwards. Of course, that's part of our value creation story also. Yeah, because. I just want to go a little bit back to the business development because I mean, it's three elements and you only get one of them. The other one is that we also are, in the coming period, apart from the three internal programs for lining up interest, we have two programs for partnerships, Tesomet and SAN903. We are going to continue working on that. We also have the research platform. The point here is that right now, our entire research is fully funded through three research collaborations. As they progress, we will have a candidate selection. The partner will take over the program and take it through clinical development, and then we get all the milestones through that. This will also release internal resources at our end for new programs. Some of them could be in collaboration with partners. Therefore, we are still working on that. We have these three elements going forward. Really, what we want to do is that we want the steady flow of deals in Saniona. We are working actively on it. We have made many types of deals over the time. We have made research collaborations. We have made licensing deals. We have had regional collaborations. We have had spinouts, three spinouts in Saniona. Some of this, I've been talking a little bit about deals with John and I have made deals together before with Genentech in the US and Meiji in Japan. John has made some very external ideas, I believe, in his previous company. Maybe you could talk a little bit about that. Yeah, I'm happy to, yeah. In the years 2012 to 2019, I was the CEO of a British biotech company called F-star. There we did, during the time I was there, four deals that were all quite significant, either license deals or acquisition deals. Basically, we created asset-centric vehicles where we were then selling some of those programs that we had through equity deals and selling the programs in high-value deals that created a return to investors. Obviously, something similar can't exactly be copied into Saniona's model because we are a public company. The thinking behind looking at creative models for dealmaking is something that Thomas and I spent a lot of time talking about and that we want to continue. It's especially with a platform company, which Saniona is. It's a platform around the ion channels. It allows deals at different stages of pipeline value creation. Either early stage, as Thomas talked about, or later stage when they are into clinical development. The value package is different each time. This is something that we will have a lot of focus on going forward and use this kind of approach to also raise money for the company and through that create value for the shareholders. Turning to look a bit at your projects, we're getting quite a lot of questions about Tesofensine in particular, which is not even your lead project. You did release a press release yesterday that your partner, Medix, now see a clear path, I think the wording was, to in Mexico, hopefully towards an approval. We have an investor here asking if the information disclosed in that press release impacts your potential milestone and royalty payments in 2025 in any way. Yeah, maybe I'll start and then you can continue. Obviously, the communication with Medix reflects the relationship that we have with Medix and our understanding of the approval of Tesofensine. It's important for the shareholders to understand that we don't discuss the situation directly with COFEPRIS. Medix has the entire dialogue with COFEPRIS. We get reports from Medix about how they understand the situation with COFEPRIS. Some of the circumspection that there has been in our communication in the past, of course, reflects the fact that we don't know exactly how to interpret the messages from COFEPRIS. We do believe, after the latest communication that we've had with Medix, that the pathway for an approval now is very clear. COFEPRIS have requested a resubmission of the package in a certain format. There are some format aspects that they have requested to be amended in the resubmission. Medix has made it clear to us that they will do that submission in February. There is no guideline on the time for the subsequent approval. It is not possible to answer how much time it will take for COFEPRIS to then answer. We have a feeling or an expectation that it will not be too long. We are not talking about quarters. We are probably talking about months or maybe single, like maybe just one month. We do not know for sure. I do not want people to speculate too much on the timing of that, actually, because it is impossible to answer. It is definitely more likely now that we will have a certain income from milestone this year. Royalties on sale will only happen after the launch. There is a launch preparation phase that may push the actual sales into next year. It's impossible for us to quantify that time at the moment. That was good because you actually answered the most common question we've had, which was if there's an indication of how long COFEPRIS will take. That's impossible to say. I mean, there is no way for the particular phase that we're in right now, there is no guideline on it. Therefore, there is nothing formal we can answer on. It is only on our impression from hearing what Medix is saying. Therefore, it is a little hard to give specifics. Yeah, as I mean, Medix is very optimistic about the timelines. They think that also the agency has an interest in progressing this and that they will set aside resources. That is why they have some good expectation about that. We can only refer to them. That is what probably was why we can go. We also had a question saying that if Tesofensine is approved and launched in Mexico during 2025, what is your strategy for expansion? Right. Yeah, the next step will be to take a look at South America and Central America, where Brazil is absolutely the most interesting market. Because it's the largest market in the country. The size of it, the growth in value and people. Brazilian companies, they typically have sales distributions all over South America. It could be a regional deal in this context. We actually spoke, have been in contact with several of the biggest companies in Brazil and have ongoing discussions with them. The next step will be perhaps Southeast Asia. South Korea is a quite interesting market and could be a gateway for other Asian countries. We have been a couple of years ago, two times in South Korea, where we have talked with them apart from business development conferences. I think we could find a partner there who would be willing to make a bridge study to Asian populations. Now, Tesofensine has been tested in Europeans and in South Americans and also in Japan, actually, but that needs another bridge study. That will be a one-year study. You will map to new markets there. Finally, there is a significant change in the obesity market in the last couple of years. We are also considering this, both with Tesofensine and perhaps Tesomet also, to see how we could position these products in this market. I've actually had a question here from the chat. If you're thinking about Tesofensine in terms of the US market. Yeah, the US is particularly interesting because it's growing more than any others. The total world market has gone from almost nothing to expected to be $160 billion in a few years. I don't think this industry has seen anything like this before. There's no wonder that a lot of companies are, there's an explosion of companies coming into this field. The reason is that there's a significant rise in, of this rise is the success of the GLP-1 analogs, which have demonstrated efficacy, which both patients and doctors are excited about. They are not a one-size-fits-you-fits-all, I would say. They have also some problems. First of all, the mode of action doesn't work in all patients. People are becoming obese for different reasons, and GLP-1 does not address all this. The second part is that they come with side effects. There are some severe gastrointestinal side effects. People are vomiting or feeling sick. This leads to people stop using them. There is a big adherence problem in clinical practice. People are referred to data saying 50%-70% are stopping too early. They get on and wait again. That is an issue and much worse than seen in the clinical studies, which is actually quite good. Finally, there is a, it's not unnecessary healthy weight loss because 40% of it is lean body mass, muscles and bones. This has created some concern, particularly among elderly people or people with osteoporosis and something like that. There are limitations on adherence. Companies coming in with another GLP-1 analogs claim that they have 1%-3% more in weight loss than Lilly and Novo. It is a little bit, in my view, ridiculous when you see all the other problems. It is not really our game. What the market really needs is new drugs with a different mode of action, which can have a good side effect profile. You have long-term use on these drugs. It has to be effective on its own. They would also very well be good to combine with GLP-1 analogs. You have maybe tablets, a bit oral formulation instead of injectables. You can line up seven points of these things. The interesting with Tesofensine is that there are a few products out there where you can tick off all the boxes. Tesofensine does. That makes it interesting. We have some issues in raising we need to resolve. That is in relation to intellectual property and also some if it's a regulatory pathway for a combination product, which is a bit complicated. We are looking into this. We are working actually on it. We could potentially find, build a business case, which we think would be interesting for a potential partner. We did have a question here about Tesomet that you mentioned, saying that in a previous presentation, you stated that it was positioned for partnering in HO, excuse me, and PWS. Why not go after the broader obesity market? That has to do with some of the things that you alluded to here. Like you said, it's a massive potential, of course. This is what we, but it goes, and it's very good questions and try to respond there. But it's not only Tesofensine; Tesomet could also apply to Tesofensine in this context. I actually had a question here on the chat wondering if Medix is interested in Tesomet as well as Tesofensine. They have the right to it. I think that they want somebody else to bring it a bit forward for the next step. Let's see. Turning to. Only for this, again, only for the Mexican market. Right. The focus is very much on the Mexican market. We have some more questions. Mainly, I think, aimed at you, Thomas, about the rest of your pipeline. What makes SAN2355 a key part of the pipeline? SAN2355 has the potential to be best in class for treatment of a lot of patients, which an epilepsy patient who are refractory to the existing therapies. It has opportunities in major depressive disorders and also in bipolar disorders. It comes best in class because it's much more selective than the competing programs. It's more less side effect and potentially also higher dosing than creating potential for higher efficacy. We're now taking this into preclinical development. We hope we'll start Phase I about Christmas. We will have the Phase I data one year later. Over the next two, a little bit more than two years, we would hope to have this through Phase I studies. Also had a question asking you to share a little bit more about SAN2219 and SAN2465. A lot of numbers here. Yeah. San2219 is also positioned for epilepsy, but has also potential other indications in neurology and in anxiety and in pain and several others. We are taking this in just as we are doing with 2355. The goal is here to take it through Phase I over the next two to three years. When it comes to SAN2465, this is positioned for major depressive disorders. There is a backup indication or a secondary indication in a rare disease called DUP15q, which is a very severe disease in children. You actually can get a voucher where you can save for $150 million. We are taking this through in the Phase II studies where we initially focus on depression. We will look at biomarkers, which can help say in healthy volunteers whether this has a potential in this indication. That will be a major one for us in the Phase I study. We are aiming to improve Phase I also in the next two to three years. There are lots going on in terms of the pipeline. Right. Just had a question about collaborations with AstronauTx and Boehringer Ingelheim and how they are progressing. If you're looking at candidate selection in the near future. Yes, they are. I mean, the existing research collaboration has been extended several times. It's a very early program, right from concept. Could you just remind the viewers maybe what these. The program with Boehringer Ingelheim is positioned for schizophrenia and it's a complete new concept. Target has never been disclosed. That is a secret. We put it into lead optimization in, I think, in autumn. When big pharma companies do that, then there's more or most very often only a year. We see this could happen quite soon or within this time frame. This is why we know that there could be some resources which will be released over the next 6-12 months or so for other indications. I believe that they will run it out this term within March next year. Yeah. We can talk a little bit about milestones perhaps at the end, I guess. I just wanted to ask you one more question about Tesomet, which has come in here. That's regarding when the clinical trials will resume. On Tesomet? Yeah. There is an open IND for Tesomet in the United States, both in hypothalamic obesity and in Prader-Willi syndrome. We have conducted some proof of concept studies in here in Europe. There has been opened an IND back in 2021. These are still open. They could be started up this way to get a partner. It is not possible to. It's not something which we are achieving. It's quite expensive studies. In HO, we're talking about 100 centers around the world. That's a lot of. I think the important sequence of event here is that we will build the strategy around Tesofensine and Tesomet on the back end of an approval of Tesofensine in Mexico. Because until we have that, it's hard to, I think, credibly engage with a partner elsewhere on any of these assets. Once we have, hopefully soon, the approval, then the partnering efforts, both in the other emerging markets, as Thomas has talked about, but also our internal strategy development on how we will prosecute this particular part of our pipeline in the developed markets, like for example, in the U.S. and elsewhere, is something we're going to be much more explicit about. It will require partnering to develop these programs forward in the U.S., for example, because we're talking about an initial clinical development stage that will be quite expensive and also will need to be conducted together with whoever is going to subsequently be responsible for marketing the program in those territories. We can't do that ourselves. There is going to be some time spent on that. We will talk to the market about that in the future. We need to have the Mexico events clarified first. Once that's clarified, maybe we'll see you here again. We can look ahead to the emerging markets. As a final question then to wrap the session up, Thomas, what message do you want to leave with investors and stakeholders looking, well, 12 to 18 months? Yeah. First of all, we're a well-funded company now. We have the ability to take the company forward in the next three years and finance three internal programs where we can get them ready for Phase I and then take them from there and make a replication of the Acadia deal and bring them even further without necessarily going back to the stock market. We have a potential approval for Tesofensine this year, which is quite exciting. We do not consider ourselves as an obesity company, but I like the money coming from it. This is where we are looking very much forward to see whether the royalty can come over to the company over the next couple of years. We have potential two research milestones coming up. We talked a little bit by BI before. There is also another one with AstronauTx maybe. There we are talking maybe, I put it, but there's only two companies. Be a little careful what I'm saying here. There are sizable milestones coming potentially in relation to this. You know, 8, 12, 15 months from now, we will have maybe a start of Phase I or Phase II study by Acadia. This will provide a $10 million milestone to Saniona. We are working on business development. We are also in the operation. I would say we will stay lean, financial discipline in order to make this happen. We are working on business development. Some of these activities could also end up with a deal in the coming period. This is how I see the situation right now. I'm quite comfortable where we are right now. Sounds like exciting times ahead. Thank you. Thank you so much for coming here. Thank you, Cecilia. Thank you for all the questions that you sent in. I can see that there's a couple that we did not have time for. Like I mentioned, they will be addressed by the company at a later stage. Thank you so much for watching. Hopefully see you soon again.