Hi, everyone, and welcome to today's question-and-answer with Spermosens. My name is Jacob Lundgren, and I am with Sandbrook Capital, a corporate finance firm supporting Spermosens with its investor relations and capital markets communication. I will be moderating the session today. Please feel free to submit your questions in the chat, and we will address them after Tore's question-and-answer walkthrough here. With that said, Tore, I will leave it over to you. The floor is yours. Thank you, Jacob. I am not sure. Do we have everyone here? Is there someone who can send a chat message to Jacob so that we are sure that everybody is into the webcast? I can at least see that people have joined. How do I If anyone can hear us, maybe send just a confirmation to Jacob that you are in the meeting. Yeah, it works. Excellent. Just want to make sure. So hello, everybody. My name is Tore Duvold. I am the Chief Executive Officer of Spermosens, and thank you, Jacob, for the introduction. We have these question-and-answer sessions right after our quarterly reports to inform and take questions and have a free and open discussion. Just added this disclaimer here. I prefer that we have as open discussion as possible and that you get my perspectives on the situation now and how I look at the future. So, of course, there are no guarantees. We are working in a development phase, and there are things going on, but you get my best view on things and our plans going forward. There are no direct news, so it is related to what we have already communicated. I have actually got quite a lot of questions, and I appreciate that. Very good questions. It also shows me that people read our reports and our press releases very carefully. So thank you very much for the questions. I have divided it, as I did last time, into sort of the clinical or could also be technical, and then on the more commercial side, and then financial sides, and then there are a few other type of questions. When we come to the end here, it is also a possibility for you to submit additional questions. I will answer the question to the best I can. So again, very warm welcome. The first question we received was, what specific clinical performance would you consider a successful outcome for the Generation 3 study? More importantly, what results would be strong enough for potential commercial partners to move forward without requiring another major validation study? So first part of the question is what is the success criteria? As you may know, we run this in a large clinic in Malmö, and we recruit patients that are diagnosed for so-called unexplained infertility. So all the parameters on the female and the male side are normal, yet they have to undergo a fertility treatment. What we are looking in these patients, some of them successfully get pregnant and others do not. It is a little bit a black box why this happens. So we have this population, and what we are doing is we get a sperm sample the day they do the incubation with the egg, and we get the leftover sperm for that day. We take the sperm and we test it with our JUNO-Checked to see how the sperm binds to the egg, how strong is the binding. Then we correlate with the outcome, and the outcome that we look at is how many of the mature eggs are fertilized in percentage. So what the goal here is to establish a correlation between the binding strength of the sperms to the egg and the fertilization outcome, so the percentage of fertilized eggs. So what we here want is to find a statistical significant correlation so that we can determine what sperms have a high probability of fertilizing and what sperms have a low probability of fertilization. Later on, that can be used to decide what type of treatment these patients should go through. Because now we may, for the unexplained, have an explanation why they cannot conceive. So what would be strong enough? I think this is already very strong that we can find a parameter which is currently not measured, and that it can distinguish poor sperms versus good sperms. That is exactly what the partners are looking for. That was the first question. Second question, the Q2 report mentions a second clinical site as a potential next step. What would that add? Is it something you are actively pursuing? As you know, when you have a medical product, a diagnostics or a medicine, you generate as much evidence as possible. The more evidence you have, the stronger your position is. The study we are doing is to prove the diagnostic value. Of course, having more clinical data is always good. One thing which is extremely important here is to have an external validation. We are in contact with clinics outside Sweden, and we are pursuing this very actively, and it is very concrete. We haven't decided when to start such a study. What we are looking for is actually a study where the clinic is doing this, what we call pro bono. We are not paying for a clinical trial, but it is clinics who want to try our product. I think it is not going to happen this year, but the discussions and the preparation, we are currently actively pursuing this. We go over to commercial and licensing, and there we have quite a lot of questions. Maybe they overlap a little bit. You have stated that partnership discussions have broadened and deepened. Without disclosing confidential information, could you clarify what concrete milestones still need to be achieved before one of these discussion could turn into a binding commercial or licensing agreement? Do you believe such an agreement is realistically achievable before the end of 2026? Yes, they have broadened and deepened. Maybe first focus on how they deepen. We have announced that we have a memorandum of understanding with Sapyen and RSI, and we also have a Japanese company. I would say that Sapyen and RSI, we are deepening the discussions, and I think I will come back to it a little bit what that means. We are also attracting other companies who have showed a very clear interest and have signed confidential agreements so that we can discuss freely. Whether I think it is realistic, I think it is a possibility that we can sign an agreement this year. As you know, these are negotiations on terms, so there is no guarantee that it will be materialized in 2026. It is our clear ambition that we can have agreements this year as we have communicated earlier. Do not think that we are failing if we do not have a signature before Christmas. I think it is to really drive us towards the commercial goals of having partners, which is important here, and that we have progression and that we have several alternatives. I think how it is going, I feel optimistic that it is a possibility, but do not say whether it is end of this year or into next year. It does not really change when the product would reach the market. Next question. It is a little bit along the same line. I think it is from the same person. I appreciate that certain aspects of ongoing partner discussions may be confidential, but any additional context you can provide around these questions would be very helpful in assessing the company's progress and the remaining risks on the path toward commercialization. I think it is important to say here that even if we have some clear leads in who we are talking to and we are deepening, I think it is important that we also bring in other players. That also helps us to negotiate the terms in the best possible way. The company in Japan that we have been discussing with, they have been very thorough scientifically, but they have not been very specific on the commercial side. I know I have been in Japan a couple of times. It takes a long time, and it is also good to have a physical presence. I am happy to say that now we have two persons who are traveling and one living in Japan, helping us to establish these contacts because Japan is a very important market. Right now, our progress has mainly been in the U.S. and Europe. It is, of course, very difficult to be as specific as this, confidential and also tactical in terms of negotiations, but I do my best to share how this is progressing. Hopefully we will have deals. I think there could be deals like exclusive agreements on territories or non-exclusive. Right now, the most interest is to have exclusivity over territories, and also type of agreements. What I have said many times, that sort of our base case is an outright license agreement of our asset and our intellectual property, bringing upfront milestones and royalties on net sales. There are other types of business models which would imply that there is a certain commitment from Spermosens, in terms of regulatory work and in terms of manufacturing. There are different types of business models and companies, they have different capabilities. For us, it is very important that we have not fixed ourselves into one model, but that we can be open to different type of models. The most important, I think, when we look for partners, is to see their capabilities. Is this a company that is ambitious? Are they growing? Do they have good sales channels and things like that? That is very important for us, because then we know that they will prioritize it and there is more or less a plug and play. Next question. You mentioned discussions with potential partners for manufacturing and supply. That is a good catch in my Chief Executive Officer comments of the last report. Why is that a separate track from your commercial partners, and how important is it for the overall plan? It is true that it is not something that we have talked about before because we are focused very much on sort of the commercial agreements, but it is very important for the partners that the product is real. It can be produced, it can be produced at the right quality, and it can be supplied to the market. That means that we take care of transportation and all these things. We have good contacts in the manufacturing environment, to see also how can we do this efficiently because when we are scaling this right now, we can probably supply at a small scale for a launch, but we aim higher. Potentially we need to produce thousands of sensors. That's why we look for manufacturing partners to supply the product so that we have this readiness. It is a little bit a separate track. Some of the big companies, they might want to do this themselves, but it is a hurdle if you have no idea how to do large scale manufacturing. We are front-loading that part. Still commercial and licensing. In December 2025, you published timeline specifically included signing partner and/or license agreement in second half of 2026. Is that milestone still part of your current timeline, or should investors now expect commercial agreements to come later? If you look at the latest report, and I think the two quarterly reports we have this year, we have introduced the major milestones, and the signing of a license agreement is still there in the second half of 2026. I have to emphasize that it's not a guarantee that it will happen within the next few months, but it is clearly our ambition. I think you shouldn't be surprised if it happens before end of this year, but it might also be a little bit later, because we have all the clinical results coming towards the end of the year. Whether that would be sufficient to complete and sign an agreement with all the legal work, I don't guarantee it. It is an ambition, and we're working hard to make that come true. Beyond demonstrating that JUNO-Checked works clinically, what evidence do you currently have that fertility clinics or commercial partners are willing to pay for the test at a price that supports an attractive commercial business model? We have discussed this with quite a lot of partners, also partners or organizations that not necessarily partners, but to find out what is the market, and based on the feedback, it's very clear that all the sperm tests that you have today, they are not very predictive. If we can show this, the feedback we've had, in Europe, in Asia, and in the U.S. and Australia, is that if you can show this to work, that it has that diagnostic value, that is very attractive for the markets. Then, of course, it depends on how much evidence you have. Is it going to be widely used, or is it becoming a niche product? I think our vision is that it's going to be routinely used in the future with high volume. I think the first introduction of the product will, of course, be in more smaller segments until you can expand and get sufficient data to support your claims. I'm not going in to speculate about pricing, but you can check yourself how much a sperm test, the standard sperm test, costs in the U.S., Japan, and Europe. You all have AI to help you. That doesn't necessarily give you the right answer, I can tell you. We're talking about potentially several hundred dollars per test, at least in the U.S., and above EUR 100 per test in Europe, condition that it works as it is designed. That's a very clear feedback that we've had from many discussions that if we can prove it, then it has a very high clinical value, and high clinical value means high commercial value. How advanced is your most advanced commercial partner discussion today? Are you already discussing concrete commercial terms and agreement structure, or are the discussions still primarily technical and exploratory? How advanced our discussions are today. There are two types of discussions, maybe three types. One is those that we have discussed for a long time, who have followed our development last year and this year. With these companies, we are, of course, discussing beyond technical specifications and clinical results. We are discussing how to go to market. What is the appropriate regulatory pathway? Are there any possibilities to make this shorter or in two steps? How do we supply, as I talked about before. All these aspects are on the table with those we have discussed for some time. There are a couple of companies that we have those type of discussions. Other that we brought in more recently under a CDA, we are more explaining the clinical results, our plans, and trying to understand their business models and their interests. It is more like on an advanced dating level, I would say. The third one is that we are scouting for a new one, reaching out, trying to get hold of the right decision makers and so on. There are three levels here. Partnership discussions have broadened, including new geographies. Without naming anyone, can you say something about what a relevant partner for JUNO-Checked actually looks like? I think there are different types of relevant partners. Maybe I would just like to take offset in Sapyen that we have had many discussions with, and also maybe RSI Reproductive Solutions. Sapyen is started in Australia, and they run their business out of Delaware in the U.S. and have a presence in the U.K. and trying to expand to Europe. They have a service, I would say, based on a transportation medium. They can send this kit to the patient. The patient can prepare the sample at home, saving time and embarrassment maybe, and send this to the laboratory or the clinic. That means that the clinicians will have the results before the first visit. It also allows more people who are in doubt to get tested. This company is widely recognized of having the best service for home kits, and they are growing and they are very innovative, not only in terms of product, but also in terms of their business model. I would say that is an interesting partner. We also discussed with other partners having similar services, but we believe that Sapyen has a very good profile. RSI Reproductive Solutions is a little bit different. They work on products to work up the sperms, the quality of the sperm optimally, have a very good network into key opinion leaders, clinics, and so on, and they want to complement their portfolio with innovative products. I think they are both good examples of good companies. Of course, then you have the large ones like Hamilton Thorne or Vitrolife in Sweden. Of course, they would be interested in increasing their services. Those are very interesting, but sometimes it is faster with the small, agile, and innovative companies, as compared to the big corporate structures. Both are relevant. Yes. I cannot come closer. I think Sapyen is a good example. But of course, we also talk to the big ones. There are several possibilities. The next question, if the ongoing Generation 3 study delivers the result you expect, what concrete steps will remain before the first clinic can routinely use and pay for JUNO-Checked? What will be required? Of course, there is some sort of regulatory work and quality work that we have to do. There is some testing and validation. What we think is in at least in some markets, you can go to the market without a full regulatory approval, but run the product under their quality management system, which means that it has to be validated in their quality management system. But once that happens, the product can be used, and then you can have the full regulatory approval on a later stage. That is not valid for all markets, but in the U.S. and also in Japan and the U.K., that is possible. There is regulatory work to do, and then we have to establish whether that is the partner taking care of it or we take care of it. I think our working hypothesis now is that we are actually quite good at manufacturing these sensors because, as you know, we insource this, and we have our laboratory in Lund. We can produce quite a lot of them, at least for a first launch or a soft launch. Manufacturing and supply is also important. How we do with pricing, and also communication to the market through key opinion leaders to make the right noise around the product. I think those are some of the key steps that need to be done before the product can be commercially launched. But there are different ways of going to market, and we're discussing this. You can go to market as a soft launch, and you can go more aggressively to the market. Soft launch would be faster than the other. These are things that we are considering in our discussion with partners. You previously stated an ambition to convert partner discussions into formal agreement during 2026. Is that still your expectation, and has your assessment of the timing first commercial licensing agreement changed? I think I already answered a similar question on this. As we have communicated, and based on the discussions we have, it's our ambition to have formal agreements or at least one in 2026. I don't think that I ever said that it is a firm expectation. It is an ambition, and it is possible. I think it's realistic. But the assessment has not changed. I think we're in a good place. We have recruited patients faster than expected. We completed the development of the Generation 3 in April as we planned. We're on plan, and of course, if we change the plans and if there are significant delays or things, that will be communicated. But I think the key message here, we're on plan, and we maintain the same ambitions without guaranteeing exactly what is going to happen. Yes. We have a few questions on the financials. Following the recently drawn capital facility, what is your current estimate of the company's cash runway? I take that one first. We had capital until end of August as we communicated earlier. No deviation there. We have been on budget. We've even been a little bit under budget. For those reading this carefully, you will see that we have a monthly burn rate of between SEK 700,000- SEK 800,000. That brings us some time into 2027 with this capital alone and will allow us to advance partner discussions and also to complete the clinical study. Then under your base case operating plan, do you expect Spermosens to require additional equity financing before reaching a commercial partnership or generating meaningful revenue? A good question. That is the ambition that we have, is to have agreements that involves an upfront payment that can help the company to be less dependent on raising external capital. But it also depends on the type of business model and our commitments. Therefore at the årsstämma, we have the permission to take in strategic investors. What are strategic investors? Because you may all be strategic in a way, but strategic investors would typically mean players in this field who can help bring JUNO-Checked successfully to the market. We have that option of a directed issue to strategic partners if that is needed. I think it is also worth mentioning here, maybe it is coming in the next question, that we have the TO6 warrants coming up in November. What needs to happen between now and then for warrants holders to find it attractive to exercise? Of course, you are the best ones to answer that question. But what I think is that if we can show that we have a steady progress on the clinic, our partnering discussions, there might be other positive things happening, and that we are coming closer to a situation to increase the probability to succeed and have a product ready for the market. I think those elements will be positive. At least I see it as positive, and I hope investors will see it as positive. If we got a good exercise of the TO6 warrants on a good level, that of course can bring us capital, in the best case, until mid-2027 or at least sometime in quarter 2 2027. TO6, it is very difficult to say how much, but last time in the TO5 it was fully subscribed. I hope that we can deliver and that the shareholders will appreciate our progress and will find it attractive. Then I had two other questions, and then we can start with a chat. This is a long one. Why does Spermosens not make its question-and-answer webcasts available online afterwards? Making recorded investor presentation and question-and-answer sessions available on demand is common practice among listed companies and allows all shareholders to access the same information regardless of whether they can attend live. Would you consider publishing recording of these sessions going forward as part of making your investor communication more shareholder friendly and accessible? Absolutely. I fully 100% agree, and actually, all these webcasts are recorded, and they can be found on our webpage under Video in Media and Press. I think one thing I can do better is to just put a note in our press releases and our LinkedIn posts that these webcasts are available on our webpage. Last question. Spermosens is listed in Sweden, but the company currently communicates primarily in English. Many Swedish-listed companies that use English as their main corporate language also provide their regulatory communications in Swedish. Why have you chosen not to communicate in Swedish as well, particularly considering your Swedish shareholder base? I fully understand this question, and we have had this discussion internally and on the board level. The truth is that we are a small team, and we are very conscious about how we use our resources, and dual language takes resources if you do it properly. Everybody can just make a rough translation by AI, but when you do this on a regulatory basis, you need to put work into it. It takes resources. I agree it would maybe be ideal, but English on the other hand, is the natural choice given that our partner collaborators and the markets we are targeting are all international. At the same time, we do provide our annual report and the AGM or the årsstämma material in Swedish. Also be sure you can always send questions in Swedish under this question-and-answer. That is not a problem. I believe this is how we have prioritized, that we put all our efforts into the clinical technical work and our business development and partner discussions and keeping a good communication, of course, but not overdo it. We have chosen to use English to prioritize our resources. I hope that everybody can bear with that. I have heard it before, but not many times. That is how we see it. I think that was the last question. Thank you very much, Tore, for that thorough walkthrough. We now open up for questions from the audience. If you have any questions, please write them in the chat, and we will address them. In the meanwhile, Tore, I actually have one question. You mentioned that there is some work with the regulatory and quality validation before the commercial launch. Could you put a timeframe on that, or is it hard to do that at this point in time? I think we have mentioned that in the quarterly reports. It depends. We have an ISO certification, so we are audited every year. I can also tell you, I did not communicate this, but we went through the audit in April, and very exceptionally, I would say, we had no remarks. I think we have a proper quality system. But a full regulatory approval in the U.S. and in particular in Europe, that is a very heavy procedure by making a pivotal clinical study. You also have to do extensive testing and validation, and that is why we consider going through a lighter version of this in some markets, which would require local clinical or local technical validation under the quality management system. I do not know exactly how long time that would take. It depends a little bit on the capability of that clinic or laboratory. There are different ways of doing it. Also in Japan, we are exploring whether there is an easier way to do it. We know exactly what it takes to have a full approval in the U.S., for example, and that is quite extensive work. As we have communicated before, this is not something that we will do alone. This is something that we will do in collaboration with a partner, because competence and resource-wise, where we are today, we do not have the muscles to do this alone. That is how we see it. Perfect. Thank you. We have a question here from Marcus. Regarding the upcoming commercial launch, what are the expectations of competition from similar products? Yes. I think there are no similar products. I think it is very important. There are other companies working on see how they can measure this binding, but there is no product on the market measuring the sperm function when it comes to its ability to bind and fertilize the egg. You have to compare it with the standard parameters, whereas it is like sperm counts and how they move and so on, the standard parameters. I think we are not trying to replace any of those ones. We are extending the toolbox, because I think it is dangerous to say that this is the only parameter that matters. I think we have to bring all the sperm parameters on the table. That is very important, because if you want to knock out some of the currently used methods, that is tough. I think it is much better to say, this will bring more knowledge and will bring better decision tools for clinicians. That is how we look at it. Whether that will be part of the first run of testing or it is a test coming after, that depends a little bit how much evidence you have, and all clinics have their way of doing it. There are no common guidelines for this. I think, the stronger our results and the more noise we can do through key opinion leaders, the better we can position the product and get the right uptake. Thank you, Marcus. Thank you, Tore. Do we have any further questions? Last chance. If not, then I will thank you everyone for joining and thank you, Tore, for the presentation. Thank you, Jacob, and thanks to everybody for attending, and I will make sure that this is uploaded. It may take a couple of days, but it will be available on our webpage, and I will make a note of that in the future press releases. So thank you very much for excellent questions, and I hope that my answers were sufficient. Thank you. Thank you.
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