Hi, everyone. Thank you for joining today and welcome to this Q&A webcast with Spermosens. My name is Jacob Lundgren, and I work for Sandal Partners. We are an investment banking firm based in the Nordics, and I will be your moderator for this session. Please feel free to ask questions in the chat, and I will make sure to address them to Tore towards the end of the webinar. With that said, Tore, I'll hand it over to you and yeah, please feel free to get started.
Thank you. Thank you, Jacob. Hello, everybody. My name is Tore Duvold. I'm the CEO of Spermosens. I'm sorry we got a little bit late. We had some technical problems here. It's the first time we do it, so please take my excuses for the delay. I would also like to thank you very much for very good questions.
I think I've had more than 50 questions the last days. We have organized it the way that we have because many of the questions, they overlap, so we have bundled it into different themes. I'm not going to present Spermosens because I can see from the questions that you have read our quarterly reports and that you know the company very well. That's good.
As Jacob said that you can also use the chat and Jacob will organize so we can try to address every question that you may have. I think we're ready to start with the questions. The first questions we have received. It's about the product and how we do manage this on the regulatory path.
The first question here is the product ready for commercial sale? The clear answer is yes and no. Yes, in the sense that we now have reached the commercial specification for the product. The product we have now, it's much faster, it's much simpler to use, and it's more robust, so it's more reproducible.
There are still steps that we need to follow in order to have the product on the market. The first step now, because we have almost completed the technical development, it's also to verify this, that the new version is also clinically relevant. As you know, we had very good clinical results last year where we showed a statistically significant correlation between the JUNO binding and the fertilization outcome.
That is something we need to demonstrate again. Then there are regulatory steps before the product can be approved by the relevant regulatory bodies. That was the first question. The next question is, what is the regulatory path for Generation 3.0?
We are following the regulatory path defined by FDA in the U.S. and EMA in Europe and also other regulatory bodies. There is a certain path for that that we need to follow, and we need to document the performance doing a test and validation program and also do clinical validation.
There are a lot of things that we need to be sure to demonstrate that the product is working as it is for the intended use and what it has been designed for. That's the regulatory program. There is a caveat to this, and that's called CLIA, which is a laboratory test use which can be implemented before the product has got the full approval.
It is possible to launch the product into a CLIA-certified laboratory, and they include the product under their quality management system. It is possible for us to launch in certain markets before we get a full registration. Next question, what steps remain before a clinic can use it?
It's a little bit the same question, but we've chosen it as a separate question because actually the clinic we're using, we're working with, RMC in Malmö, they are already using it. They're not using it as a decision tool, but there are different clinics that we're talking to who would like to try out and start to use JUNO-Checked in the clinic. Basically it's a matter of supplying the product, installing the instrument, and that can be done quite quickly. Next question.
What is the single largest remaining risk? Of course, when you develop a new product, there are different risks. There are technical risks, there are clinical risks, and there are regulatory risks, and there are commercial risks. I'm not trying to scare anyone, but I can say that we have de-risked the project a lot by having the clinical proof of concept from last year.
As I see it, the risk that we're focusing on now is to show that this product can do the same trick as version two, that we can reproduce the good clinical results we had last year with the new version. The regulatory risks, I think, just to say we have no reasons to believe it won't work, but we need to demonstrate it.
It's always exciting when you run a clinical study. We are confident, but it is of course a risk. The regulatory risks, I think they are quite minimal because you have to follow a program. It's a matter of maybe risk of delays. Of course the commercial risks is that, you know, how big a market can you target. I think we're in a much better position when it comes to risks than as compared with last year when we actually had no clinical evidence. Yes. I am going to the next category here. There were lots of questions about the commercial strategy and partnerships and licensing and things like that.
I hope I will have answered all of the questions coming in here. The first one is, why have no commercial agreements been signed yet? The simple answer to that is that we started last year having dialogues with several companies. Of course they were interested to see that we can prove this clinically. Also they were eager to see that we could develop a system which was easy to use and easy to implement. As you know, the product we had last year was too cumbersome for that. We needed to have clinical evidence, and we needed a product which is robust, fast, and easy to use, and that's why we haven't signed an agreement yet.
Please also note that there sometimes you see that deals are signed on a very early stage, but when you sign on a very early stage, the value is also much lower. The better product you have, the further you are in development, the better deals you can target. What is the status of the interest in Japan? Yes, I remember I've talked about Japan many times because we have several dialogues in Japan, and we signed an MOU with an undisclosed Japanese company last year. It's not me who wouldn't disclose it, but they wanted to be discreet. We still have contacts and dialogue with this company. They are very thorough and very careful as well.
As some of you may know that in Japan, things tend to take time. Still in dialogue in Japan, and it's a very interesting market also because there are very high incentives from the government in Japan, and the regulatory pathway is also simpler in Japan. Very interesting market, and a very high interest with JUNO-Checked then we're also talking to key opinion leaders there. Japan is interesting, still in dialogue with this Japanese undisclosed company. It's not forgotten. I've just not talked about it so much lately. Is it realistic to sign a commercial deal in 2026?
It's always tricky to say when you will sign a deal, but it's our very clear ambition to sign a deal in the second half of 2026. I cannot guarantee it, of course. It's also a question about, you know, how attractive is this? Is this the best we can do for shareholders? We have different dialogues open. I won't promise, but we are working hard to get a first deal in the second half of 2026. It may take longer time. There will be lawyers and negotiations. It is absolutely our ambition, but it's not a promise. Will agreements be exclusive or parallel?
I'm not completely sure what the question is, but I think that most of them, those we talk to, they would be most interested in a certain type of exclusivity. That type of exclusivity can be a territory. And it's also about different segments. There could be, you know, a segment for sperm banks, another segment for IVF clinics, another segment for mail-in testing. There are different segments that we can target and different territories. My best guess is that the deals we are targeting are some sort of exclusivity. Yes. Can you outline your current partner pipeline in terms of number of dialogues and stage early versus advanced?
I cannot reveal everybody we're talking to, of course, but as you see, we signed two memoranda of understanding with Australian-based Sapyen, which has a very strong presence in the U.S. and U.K. as well, and with the American company called RSI. These discussions are very close and very, you know, concrete and very positive. We have, you know, open data rooms and things like that, so very good dialogues with these companies, very innovative companies. We talk to their CEOs and so very good contact there. We also have a lot of non-disclosure agreements signed with different companies, so we are able to share more sensitive, confidential information.
We're talking to basically all the big players and also a lot of players that we didn't know existed. My best guess here is that we have about, well, we have four MOUs, and two of them are, you know, very active, and we have about 10 non-disclosure agreements and then a series of other, where we have had the first meetings. I would say that we are about having dialogues with 10-15 companies so far, and then we have reached out to many more. Why would a partner prioritize JUNO-Checked over alternative solutions? In my view, there are no alternative solutions. The normal semen analysis is to, you know, count them, see how the shape and how they behave, but this is not very predictive for outcome.
This is the first functional test, and there are no other tests like this, JUNO-Checked, that we have got confirmed from everybody we talk to, that this is really interesting, and there are no alternatives to measure how the sperms bind to the egg. We are the only ones doing this. That said, we are based on more than a decade of scientific research in this field, but we're the only one having a product. Do you have concrete feedback indicating likely adoption in clinical practice? Yes. The two companies we're talking to, they have ideas how this will be implemented in clinical practice.
RSI, they have innovative products to, you know, prepare semen samples for insemination and for IVF treatment, and they see this as a very good complementary product with their offerings. Sapyen, they have this unique service where patients can prepare their sample at home, and they have a technology that can preserve them up to 72 hours. Here again, JUNO-Checked fits very well in. We also have contact with sperm banks and hospitals who would like to test our system in their practice. Yes, there are a lot of feedback indicating how this can be implemented in clinical practice. Next questions. Financials. I think the first question was about the burn rate and, you know, how long the money last.
Our current burn rates, I don't know if you remember, but last year, or more when I came in in 2024, I reduced the operations quite a lot, and we basically insourced our development. We have a burn rate which is under SEK 1 million per month. It's actually a little bit better than the estimated burn rate. We have cash until sometime this summer or autumn and maybe we can stretch it a little bit if necessary. We have basically reduced our capital need a lot since I started and we got in new investors last year.
Very grateful for these investors who are more strategic and long-term and are looking at how this will, you know, how this investment will be a good investment for when we reach the market. We've had a stable financial situation and we hope that we're now closing in on commercial deals. We're fairly optimistic about how things will go. Cash will last until end of July approximately. Maybe we can stretch it a little bit more. Remember we have the warrants of the series TO6 coming up in November, which could also generate extra liquidity for us. The question is when will the first actual revenue arrive?
How we define revenue, when we talk about cash positiveness is, revenue coming from, licensing agreements, being upfront, milestone agreements, and, revenues from sales will obviously be when we can first launch the product. As I said, we have the possibility to do early launch in some territories and then wait for the regulatory approval in our other territories. Revenue, if we follow the plan and our ambition, could be in the second half of 2026, otherwise in the first half of 2027. Board and governance. One question we got was why hasn't the board bought shares recently? Yeah, that's not true.
The board bought shares twice last year in connection with the directed issue and also with the TO5 warrants. Some people say, "Yeah, why don't they buy shares over the market?" First of all, there are silent periods and there is a lot going on preventing from buying like this, but also because it's not really in the interest of the company because that's not giving more cash to the company. The board has always participated and also myself and the former CEO in rights issues and directed issues, so on. The board has bought...
There is only one who hasn't, but that is to prevent any conflict of interest with the clinic since she is involved in the clinic. Why this is important, I don't know if it's important. I think it's a good signal that we have skin in the game. We believe that this is also good investment. When the board participates, it also brings cash to the company. All in all, it's a good thing for the board to participate there, but there is no obligation to participate, and not all board members are professional investors. Because you're a board member, you're not necessarily a very wealthy person.
You don't force board members to participate. In practice, board members have participated in Spermosens all the way along. Will you sell the company or stay independent? I think we're in the business, so all possibilities are in principle open. Our strategy is to license out our products to different markets and share revenue from net sales. You know, if there is a larger company who want to have full control, there is a possibility for them to buy all rights to the assets.
I think the most realistic is that Spermosens will go on and also support these partners and share revenue and also have profit from upfront and milestones. That's the model. You know, everything here is for sale and for the right price. What dictates it is what is the best for the shareholders. I think that's how I will answer. You know, keep all options open, but with a clear strategy of what is your idea of going to market and how to make profit. Have you got any questions, Jacob, from the chat, or does it work? I don't know if it works.
No, I can tell you that I haven't received any questions here.
Yeah.
I actually think with this, I think we're ending the session.
Do you have any questions, Jacob? Is it something that you think we have missed?
We actually received one question here now.
Yeah.
What about rights issues is the question?
We have no plans for rights issues.
Are you gonna cover the cash flow with a license deal, or what are your thoughts, going forward, towards the summer?
Yeah. First of all, we have cash in hand, and we have a good liquidity and we have runway end of July. Maybe we can stretch it a little bit. Our ambition is to get license agreements and of course, we always have a good dialogue with major investors, so we are pretty confident that we can present how we'll finance this going forward. You know, the ambition here is to get license agreements, but we cannot guarantee when this will bring liquidity. But hopefully, and it's possible that could happen this year.
One follow-up question there that might be interesting to know is, when you estimate to be cash flow positive?
Yeah. I think it's a little bit the same answer. Our strategy, our commercial strategy is to get license agreements, partnerships, and we're working very hard for that to happen in 2026. That's of course not a guarantee because you always have to prioritize having also, you know, deals that make sense. It's the ambition and we're, you know, coming closer to a commercial situation.
Thank you. We have some questions coming in, possibly. I see that people are writing here. One question here is that what happens with the product if you run out of cash?
I don't think we'll run out of cash. I think also we've proved that we can find good solutions, and we have very strong support from investors, and there are also companies that would, you know, be interested in signing license agreements. I think I'm pretty confident that we'll find good solutions. And we are also careful in our way of dealing with it, keeping a very low capital need, and I think that's in the interest of the shareholders that we're very careful with money and that we are also careful in how we're raising money that we are not, you know, doing unnecessary dilution. I think that we have, you know, the first thing I did was not to search for more funding, but it was to reduce our cost base. Very diligent with money and resources.
Thank you. Another question here, what will you do to increase the valuation of the company, and be able to take in money on a higher valuation?
I think that it's a good rule that I don't comment on share value. I can of course have my thoughts about it. I think that the company maybe have had a little bit problems in the past of making expectations that couldn't be fulfilled. I think that the last two years we have done a good job to establish clinical evidence and a clear path for not commercializing ourselves, but doing this through partners and go international instead of targeting, you know, Swedish or Nordic markets alone. I think we made strategic changes, cost savings, and we brought clinical evidence and a product with commercial specification. I hope that people will see that we haven't overpromised.
We never give guarantees, but we try to keep and fulfill what we say. Things can go wrong, of course, but I think we have fulfilled all the milestones that we presented earlier. I think it's that we prove that we can move forward and that we can get agreements. I think that will be very positive for the company and for the shareholders.
Yeah. We also have a comment here that says you have a unique technology, which is very valuable. You must be able to create more value in the phase that you are in right now. Do you wanna comment on that, Tore Duvold?
I think it's a little bit the same comment. As I said, I'm not commenting on share value. I think that you know sometimes when share values are low it can be legacy or someone has been disappointed in the past and it has to prove trust through producing results. You know getting good commercial partners I think that will be very positive.
Thank you very much. I think that was it. There's one question about the warrants. When you will actually get capital from the warrants?
I think that now it's written everything on the warrants is written on the webpage. You can see it under Investors, and you see all the details about the warrants and so it's closing end of November.
All right. I think that was it. I thank you, Tore, and I thank everyone for joining in.
Maybe we should just mention that this is not a one-off. We plan to have this quarterly webcasts, so in conjunction with our quarterly report. Although this is in English, please feel free. I got a lot of questions in Swedish. No problems with that. I've worked in Sweden for many years. I am Norwegian, and I'm Danish, and have a French wife, so language is not a problem for me.
It's also here we chose to have it in English, because there are also foreigners joining, so that we don't have any problems with the communication. That's why it's in English. Please feel free. Swedish is a wonderful language, and we take all questions in Swedish, as well. Thank you very much for all the good questions and also the discussion in the chat, and I look very much forward to see you next time.
Thank you very much.
Thank you. Bye bye. Have a nice day.
Bye.