Good morning, everybody, and welcome to today's event with Curasight. With me today, I have the CEO, Ulrich Krasilnikoff, and founder and CSO, Andreas Kjær. This event will be presented in English. You're more than welcome. Yeah, welcome to the audience as well, and you're more than welcome to write your questions in Danish, and I will pass them on to management. With that said, I would like to hand over the word to Ulrich. Welcome, Ulrich and Andreas.
Thank you, Claus, and thank you for having the opportunity to present this interim report and also give you an update on what has gone on for the last four to five months. Just a short disclaimer about the forward-looking statements. What we will highlight today is the Q1 financial results, and then we will give you a flavor on the highlights until now, and also what is the current focus. We also will touch the milestones for 2023, rest of the year. Very shortly, about the financial results, we are still a development company, meaning that we don't have any net sales yet. This means that we have an operating loss amounts around DKK -6.2 million, compared to minus DKK 4 million last year.
If you take the bottom line of this quarter, we have a loss, amounts around -DKK 4.8 million, compared to DKK 3.8 million last year. That reflects also the increased activities in the company. If you look at the total assets amounted to around DKK 54 million, compared to DKK 74 million last year, and that's mainly reflected to the cash position. The ratio, equity ratio is around 96% compared to 97%, that's very unchanged. The earnings per share is, has the increased a little amount.
Most important here is to emphasize that we have a cash position around DKK 44 million, compared to DKK 63 million last year, but still very good position as what we look into in the coming year. At least, as the budget is lined up right now, this will at least meaning that we have a good position until the beginning of next year within the cash position. Some highlights. The highlights here stated is only reflecting the official announcements from the press releases, but that's not means that anything has happened in Curasight. A lot of things is happening. Unfortunately, not all of they are ready to be released, but at least one major release was announced previously this month, in the first of May.
This is the Curasight and Curium agreement that we announced that we have entered into a global partnership for uTRACE in prostate cancer, and only in prostate cancer, for imaging with Curium. That is really a huge step up for Curasight, as this also validates and blue-stamp the technology that we are able to enter it, in such an agreement with Curium, as Curium is one of the leading company in the world within radiopharmaceuticals. The agreement comprise, among others, that they will support us in order to obtain regular approval in EU and USA, and Curium will be responsible for manufacturing and also the commercialization afterwards.
In manner of financials, this is also important and a very good agreement for Curasight, as we will be eligible for around $70 million in development and commercial milestones, as well as a double-digit royalty on the sales afterwards. Around about the sales, I would say, we have not put any figures on that, but I will just recommend to dig into the SEB report, and also hopefully other reports. The annual peak sales is amounts around DKK 2.8 billion, when we are full in the market.
This also emphasize that we are able to conduct the strategy we announced for a year ago, that we are able to go into partnerships like this, and hopefully, this will not be the only one, but also other partnerships will coming up in the future. This is very briefly just to give you a flavor on who is Curium. They are a global company. They have more than 6,000 global customers. They are 100% focused within radiopharmaceuticals, and they are present in more than 60 countries. Besides, they also have 4 manufacturing sites in different places in the world. I will hand over to Andreas, who will take you through the current focus and also the milestones we are looking into in the future.
Thank you very much, Ulrich. Indeed, as Ulrich said, it was quite a milestone to enter partnership with Curium. If we look at our pipeline, the different indications, as you all remember, probably, the target we have, uPAR, is expressed in almost any solid cancer. We have the privilege or luxury of being able to pick several indications, but we have, for now, due to the bandwidth, focused on the four shown here: brain cancer, prostate cancer, neuroendocrine tumors, and head and neck cancer, based on where the unmet need is. What we have now entered into agreement of with Curium is as Ulrich lke said, uTRACE, so the imaging in one indication, prostate cancer.
You could see at the numbers of this very attractive collaborative agreement, and then you can think this is only a small corner of what Curasight actually has in the pipeline. We are very excited about that. This is basically where we are pursuing today, mostly talk the main focus among these four is brain cancer and prostate cancer. Just to go a little bit back and remember everybody about the technology and why we believe it's so exciting, is that what we develop on the therapeutic part is a more gentle and targeted radiotherapy.
Instead of, as shown on the figure on the left, irradiating from the outside with accelerators, the common radiotherapy, what we are developing is an injectable radiotherapy or so-called radionuclide therapy. It seeks out the cancer and all parts of the cancer, and in that way, you get treatment of the cancer, but very little radiation to the surrounding tissue. I come back to showing that on a figure a little bit later. We do develop, and that was the two colors, the green and the orange. You saw orange for uTRACE and green for uTREAT also on the pipeline. This is, we do develop theranostics, and that is a combination of therapy and diagnostics.
The same compound basically comes in two flavors, one for imaging with harmless radioactivity on for PET scans, and one with harmful and efficient radioligands bound for the local therapy. Of course, the idea is that you can predict where your therapy will work. I come back to that also. The target is uPAR, and this is a very validated biomarker. It's expressed on cancer cells, but not almost not in normal tissue. This is how you can get. For diagnostic purposes, of course, you can see the cancer, but for therapy in particular, you get the therapy directed to the cancer and not the healthy tissue, and this is how this radiotherapy will be very gentle.
50% of all patients today receive some kind of radiation therapy during their course of disease management. The potential for injectable radiotherapy is, of course, immense. It's one of the pillars of cancer therapy. This is the target, again, it's unique in the way that it's cancer specific, but not cancer type specific. This is why once fully developed, the technology can be applied on many cancer types, and this is, of course, a big advantage. The pairing of imaging and therapy is what we have. We have the kind of headline on what you see is what you treat. What you see in this image is uTRACE applied in a brain cancer patient.
You can see the white tumor on the MRI scan to the left, you can see the very hot area, the red area, that uTRACE gets in there. What this tells us is that if we then go into this patient at a later stage with uTREAT, this is where uTREAT will sit, because it's the same binder, the same peptide, but just armed for therapy. In this way, you can tailor and personalize medicine. If this had been a patient, there are not many of them, but where we had no uptake of uTRACE, it would also be a patient where you would not try to treat with uTREAT. This is very individualized, and it also increases the likelihood of the studies we perform being successful, because we only include the patients where we know the therapy will get to the tumor.
Again, a little bit just a high level, uTRACE, which is the imaging part, it seeks out and visualizes the cancer. It can be used in two ways. It can be used either as we want to use it in brain cancer and the other indications as a pair, where we can predict whether the therapy will go to the cancer. It can also be used as a standalone technology, is what we pursue together with Curium, where uPAR is a marker of aggressiveness, and therefore, we can evaluate how aggressive a prostate cancer is, and in that way, save a lot of patient, hopefully, from unnecessary therapy like surgery, where a lot of the patients, 70%, become impotent or, and or urinary incontinent.
We can predict which patients should just be followed and which should be managed aggressively through this non-invasive imaging biopsy. On the therapy side, it's uTREAT, the same compound with more aggressive radionuclide attached to, and this sends out radiotherapy that has a range of approximately 1 millimeter. In this way, it's not irradiating a lot of other tissue. When it sits on the cancer, it's the cancer it irradiates, and applicable across cancer types. This is, of course, still in the preclinical development phase. A schematic demonstration just of how it works in the brain, how it's predicted to work. On the left, you see how with a linear accelerator, normal traditional external radiation therapy is done from different angles.
In that way, it sums up in the red area in the tumor, but all the green, yellow, and orange parts of the brain you see here on the drawing, they get still a substantial amount of radiation, and very often, that's actually what limits how much dose you can give. On the right, an illustration of how we foresee uTREAT works. When you give it goes into the tumor and sits there. Is this just wishful thinking, the drawing on the right? We don't think so, because you just saw the real-life image of uTRACE with the red hot spot in the dark blue brain.
I think.
... This is the way it works. We are very excited about the technology, as excited as we have ever been.
So-
Just to say very briefly what is coming up in the near future of milestones, still within this H1 year.
Can you take over, like?
Only being one month left.
Yeah.
We expect
There's a couple of questions about.
Um
... your capital needs, listing on different stock exchanges. Maybe you could address that until Andreas is back, Ulrich?
We are right now pursuing two tracks. First of all, we are, of course, try to leverage our strategy as like we did with the Curium, by getting non-diluting funding through partnerships. We don't know when we have those agreements in place, in parallel, we also seeks to get some heavy investors on board. Of course, we need to secure the funding also for the next year activities. What we are planning for is to see how we can get new funding by the H2 of this year, even that we have a very good cash position.
Yes.
Funding is essential for also for companies like Curasight, and definitely as the stock market is right now.
Yeah, and as you mentioned, Ulrich, you know, the Curium agreement is specific regarding prostate. You mentioned early on before this deal that you were seeking out capital in this year, beginning 2024, there's nothing new in relation to that, Ulrich?
No, no. As I mentioned before, that you cannot rely on one track, you have to pursue both options.
Mm.
Of course, this Curium deal is de-risking the case considerable, both for financial perspective, but also investor perspective. We are achieving quite a good interest in to look deeper into Curasight. This is definitely an important step for us, this agreement. For a financial, we did that also for years back. You always need to look to secure the finances for the activities going forward. When it also had to be the right, the timing also had to be right in place, when you need to get the new capital increase. What we are going for is right now, by the end of this year, hopefully.
How much? We don't know any yet, because it also depends on what would happen. Will we be able to close another partnership agreement or whatever? I cannot say anything about that yet.
No, that's fair enough. Ulrich, you mentioned in the beginning that the Nordic Investment Bank made an research report on you, and you talked about peak sales. Is that peak sales for for this indication, the prostate cancer?
Yeah
When is the peak year? There's a question here about how does financials look in five years? That's of course, a very good question, but we could address this.
Hopefully, within five years, we will be a cash positive company, with a very good, position. With, either we will, yeah, have different partnerships agreement, based on the royalties. I think we will be a profitable, company within five years.
Mm-hmm.
Again, it's five years ahead, a lot of things can happens. There are also the risk that we will get an offer from one of the big pharmas because they are also considering this technology as the technology of both diagnosing and also radiotherapy as radiate for cancer treatment be the methods for tomorrow. We have not showed the how the market is expected to increase, but actually, it's expected to increase sixfold within the coming 8 to 10 years. That is due, among others, due to the new tracers like uTRACE and uTREAT, and also the wider use of radionuclide medicine in general within the cancer treatment. This is.
We are in the right place right now, I will say, but also there's the risk that there will come an offer for a takeover.
Oh, for sure.
Yeah.
Yeah.
Yeah.
Good. Thanks a lot, Ulrich. Nice to have you back, Andreas Kjær.
Yeah.
Please carry on from where you left.
Yeah, I will. I understand, what's the last slide you saw?
I think the last slide was actually.
The, the one-
With the two brains. Yes, this one.
Yeah, this one. Is that correct?
Yeah, that's correct.
Yeah. Okay, I just have to see. Are you seeing it now?
Yes.
Yes. Okay, yeah. What you see is what you treat. Basically, we can see there's a uptake with the tracer in the tumor that glows red, and therefore, we also know that the therapy will get there. Just to wrap up on uTRACE, it's for imaging as a pairing to predict in glioblastoma, for instance, whether the therapy will go there, as I just explained. It can also be used as a standalone technology, which is what we pursue together with Curium, because it's a biomarker of aggressiveness. This is this non-invasive biopsy in prostate cancer, where we can actually see who should be operated on or who shouldn't. As you might remember, operation is not trivial because 70% will become impotent and/or urinary incontinent.
We want to save the patients that should not be spite. This is actually the goal together with Curium. On the therapeutic side, we arm the same compound with radiation that has a penetrance of 1 millimeter. In that way, it only treats the cancer where it sits on and not really the surrounding tissue. Much more gentle way, a way where also spread disease can be treated, which is not possible with external radiation therapy. This is basically a drawing of the difference. On the left, how you do radiation therapy today, you irradiate from different angles. Yes, you get the most radiation in the tumor, which is red. You can see all the green, yellow, and orange areas, that's healthy brain tissue that becomes irradiated.
Normally, irradiation of the healthy tissue will set the limit for how much dose you can deliver. On the right, you see a drawing, how it works and how we predict it works with uTREAT when we inject it. Is this just a thing, wishful thinking that we believe? No, because I just showed you the uTRACE image of a real patient with the dark blue brain and the red hotspot. It's actually how it works. It goes to the tumor but doesn't sit in the rest of the cancer. We're still very excited, very convinced about the technology, getting new data on it all the time, all the imaging data. In the near future, some exciting things will happen. Still, expected to be in H1, so that's a month to go yet.
The top-line results of the Phase IIb study in glioblastoma and also the treatment study in glioblastoma with uTREAT in the animal models of human cancer. In the H2 , we expect results from therapy studies in additional cancer type, on the regulatory side, filing of applications both in the E.U. and the U.S. for the prostate cancer study. With that, I hope... Sorry for the technical issues, but I hope you got the whole presentation.
Thanks a lot, Andreas, and thanks a lot, Ulrich. Let's take a couple of questions up. There's actually a lot of questions. If we start top down with the pipeline, there's some questions about both indications, whether you see any delays or extension, and also if you see any other indications of interest for your, you uPAR and uTREAT projects. Maybe you could take that, Andreas.
Yeah. No, I don't. I mean, we don't see it as a delay, really. I mean, we started out with glioblastoma. We are still pursuing that. That was the, in the last part, the capital raise was for. Now we have accelerated prostate cancer with this collaboration with Curium, of course. So that is pretty much as we planned it. Yes, other indications, in theory, many, but we picked neuroendocrine tumors and head and neck cancer, and when we pick indications, it's always based on unmet needs. So cancers where the therapy works, let's say, relatively well, that's not a challenge, will not be as obvious as the ones where there are really holes to fill, where something better is needed.
That is the reason for those indications. We also know from preclinical studies that uTREAT works in colorectal cancer, so that might be another cancer to pursue. Also, there's ongoing an imaging study in lung cancer. So that is also, that's also a potential indication down the road. With our bandwidth and financial position, we go for the four indications as a step one that was shown on the pipeline slide.
Thanks a lot, Andreas. If we then dive a little into the uTRACE and the phase III study, could you elaborate a little on how many patients are you going to roll in the two studies? A little about cost and timing, you know, when do you expect to see some kind of readout on phase III? It's of course, depending on-
Yeah
... on the study, could you elaborate a little on that, Andreas?
Yeah, yes. We are talking about the uTRACE in prostate cancer.
Yes.
Yes.
Yeah, glioblastoma also.
Yeah.
Both the brain cancer and prostate cancer.
Yeah. The interesting thing, I don't know whether Ulrich covered that while I was away at spring.
No, no.
People might have overlooked an important part of our press release. Of course, it was nice with Curium and to get some milestone payment. What was not less important in the press release was actually that it also stated that we had a pre-IND meeting with the FDA. Where we filed a very extensive briefing package and got their response and their view on our development plan. This means that there's a relatively clear way to get to hopefully get to approval in prostate cancer. Exactly how much is needed until you really get the approval is not. That depends, of course, on the data you get on your way.
The study that is planned to start, that we will file the application for end of the year, will be a study of approximately 150 patients. In glioblastoma, we have not had the interaction with the FDA. We are drafting the protocol, so we have our own view on how that should be positioned. It's likely that it can integrate, hopefully, imaging and therapy, and it will on the therapeutic part, be a smaller study. These studies are typically because it's also an earlier stage study, and such a study is likely to be 30, 40 patients. There's also built-in dose escalation, so you increase the dose to see how much, how effective it is on the different steps.
Let's say a very low early dosing is effective, then you end up having included less patients than if you have to go through many steps. It's, of course, a safety issue, yeah, that you cannot just start out with what you think is the final dose. You have to be cautious. On imaging, there's no side effects of the therapy or of the imaging, so there you don't have to go in these steps to see what is tolerated.
Yeah, it's fair to say, Andreas, that prostate is a much bigger cancer type.
Yes
Brain cancer. Yeah.
Exactly.
Uh-
There are more than half a million new cases in the U.S. and EU, every year. If you go for high grade, for the glioblastomas, there are around, 30,000 new cases a year. It's a different game. Of course, it's also, glioblastoma, as you might remember, is a very severe disease.
Mm
...With an expected survival of one year only, from diagnosis. There's really a need where we hope to be able to help these patients, that today have such a poor outlook, and even 10% of the patients being children.
When we look at Now, you mentioned the two studies, and talk about, if we talk about uTREAT in brain cancer and in prostate cancer, and the stepwise approach you're going to choose. Is there any difference in the substance itself, or is it the same substance you use?
That's actually the beauty, I think, from a company point of view and also from a patient point of view. It is exactly the same compound. It's not tweaked or done in any way. It might be that in imaging, it's exactly the same dosing, it's the same compound. It might be for therapy in different indications, it might be that the dosing ends up being a little bit different, but that will still be dosing with exactly the same compound.
Yes. Yeah, that's quite important. A small question here, it's probably, yeah, it could be you, Andreas, but maybe Ulrich as well. How far do you expect to take uTREAT before you start working on potential partners? Of course, the longer you can drive it on your own book, the higher value you get. That's normally the businessmanship. Are you already in negotiations, or could you elaborate a little on that?
I think, Ulrich can take that.
I would say that this Curium deal definitely have got some awareness also, and definitely also on the uTREAT part. Of course, we will gain more value if we first enter into a partnership when we have the first dose in patient. We have some interesting discussions with different partners, but that's all what we can say right now.
Okay. I think on a general level, you can say that, yes, it's advantageous to take it a later step. You still need to keep potential partners aware of what is happening. Even if they are not jumping, or you don't want them to jump on right away, you have to kind of keep them informed, so they are ready when we are ready.
Yeah.
Thanks a lot. Thanks a lot, gents. I don't know if there's any more questions. The time is 11:00 A.M. now, but if there's any final questions for management in Curasight. Doesn't seems like there's more questions coming up. By that said, both Ulrich and Andreas, thanks a lot for participating in this event. Well, we will probably very soon meet you again because you have some milestones coming up. Let me see. It's already there. There's just one question coming in here. Let's see. Okay, there's a That's maybe a good question about radionuclide therapies. There's some more competitions coming in. How do you think your potential market share will be? I hope it's all right I put this question in the end.
I think there will be many radionuclide therapies. This is the new big wave. I think it will. Personally, I think it will replace all external radiation therapy maybe over the next 10 years. There's plenty of room for, not everybody will be treated with uTREAT, so I actually see it as an advantage for the whole field. The two drugs that are out there right now, both are limited to a single indication because they go for a target only expressed on one, on one cancer. I think just as you have many types of chemotherapy, I think there's plenty of room.
I think we have something that is unique because it goes for this aggressiveness marker, that is not limited to one cancer type. I don't guess you expect us to put numbers on the market share?
Oh, no. Fair enough, there actually is a final question coming up for Ulrich. I think we already answered this question, but just touch it again, Ulrich. It's about, are you looking for dual listing? What are you thinking right now in terms of other markets?
Yeah, of course, that is something we are considering, when the time is right. We are very satisfied with to be on Spotlight right now, but in, when we are also want to strengthen institutional investor base, then we have to look into the Nasdaq platform, other the First North or the main market. That will not be right now because you have to plan that in, yeah, well, in advance, when you conduct it. Definitely, that is also something we will look into, and yeah. When, I cannot say that yet.
Thanks a lot, Ulrich. You got the final word there. With that said, once again, thank a lot, Ulrich and Andreas, for being here with us today. Thanks a lot to the audience for all the very good questions. With that said, I would close the event and hope everybody will have a sunny day. Thanks a lot.
Thank you, and thank you for having us.
Yeah, thank you.