Good afternoon, and welcome to this presentation and Q&A with Curasight. With us today, we have the CEO, Ulrich Krasilnikoff, and the founder, Andreas Kjær, both of Curasight. First, there will be a presentation, and afterwards a Q&A, where the management team will answer questions submitted via Stokk.io. There have already been pre-submitted questions on Stokk.io, and the Q&A is still open so that you can submit questions live as well. I will now hand over the mic to Curasight for the presentation. Your line is now open.
Thank you for the introduction, Anders. My name is Ulrich Krasilnikoff, and I am the CEO and CFO of the company, and I will, together with co-founder, CMO, and CSO, Professor Andreas Kjær, take you through this presentation, which highlights the Q3 interim report and also what is the current focus we are working with. Thank you, Andreas. Just a short disclaimer about the statements we are coming with, forward-looking statements that will be for your own positioning. We have prepared an agenda for you. First of all, we will take you through the financial results from the year to date, which comprise Q1 to Q3 this year.
Then we will look at the highlights from Q3, and afterwards, and also what is the current focus right now, and also we will look at the milestones for the rest of 2023. Yes, thank you. If we look at the financial results, I will only go through the figures comprising the Q1 to Q3 year-to-date figures, meaning that first of all, if you look at the nature, we are still a development company, means that we don't have any revenue yet. Look at the gross loss amounts to around DKK 20 million compared to DKK 6 million compared to last year, means also that we are increased the development activities quite a lot.
If you look at the loss before for the year amounts after tax, it sums up to around DKK 20 million compared to DKK 10 million last year. If we look at the total assets amount, it's around 42 million, compared to 69 million last year, and the difference is mainly due to the cash position. And also, if you look at the cash in by the end of Q3, it still sums up to around DKK 28 million, compared to DKK 56 million last year. So still we have fuel on the engine, and which also will last into the next year. Yeah. Then I will hand over to Andreas about the highlights from Q3 and also take you through the current focus afterwards.
Yeah. Thank you, Ulrich. Yes, and I'll take on the development, what has happened in Q3 and our plans going forward. So, two major milestones in Q3 and afterwards was that, in September, we announced the results of the investigator-initiated Phase II studies in brain cancer, in aggressive brain cancer, were presented as a talk at the World Molecular Imaging Conference in Prague. And I come back to what the data showed. And then on October eighteenth, we also could announce that Curasight had obtained positive preclinical data demonstrating proof of concept of uTREAT in treating non-small cell lung cancer. And these data come on as an addition to the previously released data, where we also showed uTREAT.
So our treatment option worked well in aggressive brain cancer, in glioblastoma. So you could say for the brain cancer, we both came out with the imaging studies in patient and with the treatment studies preclinically, and now we added also the non-small cell lung cancer. And by the way, non-small cell lung cancer is the most common type of lung cancer. So to dig a little bit down into this, and this is the press release on the right. So the positive results from the Phase II study in uTRACE and brain cancer was released twenty-ninth and was given in September in Prague. And it showed that it concluded that the majority of the glioma patient were uPAR positive. And what does this mean?
This means that it confirms our idea that uTREAT can be applied to the majority of these patients. Also, we showed that high uPAR expression predicted worse outcome. So the higher uPAR is, the poorer outcome. Why is this important? This is important because uTRACE can be used to stratify these patients into high and low risk, but it also demonstrates that the higher the uPAR level is, the worse the disease and potentially the better our therapy will work. So the higher uPAR is expressed, the better our therapy should work and the more it's actually needed. So everything comes together in this indication. When we said most of the tumors were positive, it was actually 94% of the glioblastomas, which is the most aggressive part.
So in essence, it's all of these patients that are, potentially eligible for uTREAT therapy.... So, definitely we will move forward in this indication, as we also communicated earlier. So where does this lead us with the current focus? You might remember, this, this figure that shows that we are currently, our strategy is pursuing uTRACE and uTREAT in four different indications: brain, prostate cancer, neuroendocrine tumors, and head and neck cancer. And where we decided in prostate cancer to do it as uTRACE only as a step one, and you might recall that this is where we did, close a, a commercial agreement, a development agreement together with Curium on uTRACE. In the three other indications, it's both imaging uTRACE and therapy uTREAT.
What's shown in the bottom here is that we also have strong uTRACE data from breast cancer and lung cancer, where we basically shows that the majority of the primary tumors are uPAR positive. So when... And also, maybe before we go further on, it's worth to remember that uPAR is expressed in all these solid tumors. So it's not that every indication here needs one compound. It's the same compound, it's the same drug that works across the cancer types. So our development of the drug itself is spread out of several indications, and once we have gone into the first indication, it's much easier to broaden out to the next indication. Maybe also just a short reminder about why targeted radionuclide therapy is probably the radiation therapy of tomorrow.
First of all, more than 50% of all patients with solid tumors will receive external radiation therapy at some time. But the drawback of traditional radiation therapy is the irradiation of healthy tissue. On the other hand, by uPAR Theranostics, it's given into the bloodstream, it binds to the tumor, and it's more gentle because more radiation will be delivered to the tumor and less to healthy tissue. We come back with the principle later in this presentation. So I think this is where we have a short movie demonstrating the principle and just reminding you about the target uPAR, how it works across cancers, and why the Theranostic principle is the way to do radiation therapy in the future. And I think we will get help, so the movie will be shown now.
More than 50% of all cancer patients will, at some time, receive external radiation therapy. However, traditional radiation therapy also irradiates healthy tissue, leading to serious side effects. This limits the use and impact of the therapy. Curasight has developed a new type of radiation therapy that solves this problem. Curasight's technology builds on the principle called targeted radionuclide therapy. Here, the patient is not irradiated from the outside, but instead a compound is injected into a blood vessel from where it automatically seeks out the cancer and any metastasis, and from there, sends out radiation. The range of the radiation is just one millimeter, and therefore only the cancer and not the healthy tissue is irradiated. In contrast to traditional radiation therapy, Curasight's method can also be used to treat patients with widespread disease. Our compound targets uPAR, a receptor expressed in cancers but not in normal tissue.
But how can we know if the therapy reaches the cancer? The answer is: with imaging. Using the exact same uPAR targeting compound as for therapy, but modified for imaging, we can exactly predict where the therapy will work. This is called the theranostic principle. By starting with imaging, only patients with a clear tumor uptake will proceed to targeted radionuclide therapy. This is personalized, tailored therapy. Although uPAR theranostics can be used in most tumors, we will start with glioblastoma, an aggressive brain tumor, as a first indication. Glioblastoma has a poor prognosis, with half of all patients dying within one year. 10% of these patients are children.
Yes. So, so this wrapped up a little bit around the, the theranostic platform we have and, and why this is the new way to do radiotherapy. So just, to sum up again, we have a diagnostic part, which is called uTRACE, and a therapeutic part called uTREAT. The only difference between the two is the kind of radioactivity attached. So uTRACE exactly predicts where uTREAT will go. This can be used for exactly knowing where the therapy reaches. We call it what you see is what we treat. For both uTREAT and uTRACE and uTREAT, the compound is injected into a blood vessel, then it goes to the tumor where it binds, and because it's expressed on cancer cells, but not on normal cells, it irradiates primarily the cancer cells, and the range was 1 millimeter or below.
And again, uPAR is cancer specific, but not cancer type specific, and it's expressed at least in 80, probably in 90% of all solid tumors. So what you see is what we treat. So this is a uTRACE scan from a real patient, and what you see here is on the left, an MRI scan of a patient with an aggressive brain tumor, a so-called glioblastoma. And on the right, you see how uTRACE is distributed. When it's red, it's very hot. So you can see a lot of the tracer sits in the tumor. When it's black or dark blue, purple, then it's very low. So you can see in the normal brain tissue, there's almost no uptake. So in this way, what you get is very little radiation to healthy tissue, but a lot to the tumor.
uTRACE can be used really to predict where our therapy goes. We now sit on data of more than 400 patients, from nine different studies in a multitude of cancers, where we see that there is uTRACE uptake. What does this tell us? It tells us that these patients are eligible for uTRACE therapy once we go into testing of this, because we know that our drug reaches the tumor. In the studies we are to perform, and remember that I said 80%-90% of the patients will be positive for uPAR, but the few patients that are not positive on uTRACE, they will not be included into the trials, and thus we can also increase the likelihood of being successful in our studies.
A thing that very often is a problem in cancer studies, you will see that they fail, but they actually worked in a subpopulation of the patients. By having uTRACE, we can be sure, uTRACE as a gatekeeper, that we only include patients that are positive on uTRACE. That's patient where we know our therapy will get to the tumor. So this is basically the principle, and we do this in a personalized way. By the way, the difference by injecting radiotherapy is also that it not only can be used on one solid tumor, but it can also be used on patients with widespread disease. So if there's metastasis all over the body, the uTRACE and uTREAT will seek out all those cells, bind there, and do irradiation locally.
If you have widespread disease, there's no way you can apply external radiation therapy, because you would deliver so much radiation to healthy tissue that you would basically kill the patient before you have affected those. So when we say more than 50% today get external radiation therapy, we can replace external radiation therapy by our technology and other vendors doing targeted radionuclide therapy. But we also open the possibilities for additional patients that today are not eligible for external radiation therapy. So it might be 70% in the future of patients that can receive radiation therapy because it's theranostic way to do it. This is just a drawing of the difference in the concept. On the right, you see the way that targeted radionuclide therapy works, that uTREAT will work.
But on the left, you see the way external radiation therapy targets the tumor. It's done by irradiation from different angles. The most radiation is delivered to the tumor, but a large amount, and that is what you see in green and yellow, and orange, is actually delivered to healthy tissue. And it's very often the side effects to healthy tissue that will limit the dose you can give. In this very example, you would harm the eye, but you would also harm normal brain tissue. So, this is the technology. We are as excited as ever about the technology. We believe that all the data we have been collecting up till now, all the data that are coming out, only supports the concept that we have pursued from the beginning, and this leads to very exciting future.
The milestones in 2023 can be summarized here. So if we start out with the milestones we already came out with, that was the Phase IIb study in brain cancer, in glioblastoma. We then also completed and reported the efficacy of uTREAT in a model of human brain cancer in mice. We also reported positive results from lung cancer on therapy preclinically and then also the interim readout. So that's the readout when we had the first 12 patients in the lung cancer study in patients with uTREAT that also showed that all of these cancers lighted up. So it also seems a very promising indication. Then we are now completing studies in other cancer types apart from small cell lung cancer.
Then we will report here in the second half our thoughts about an accelerated development strategy of the therapeutic platform based on the data we are acquiring. Then finally, before year-end, we will file the clinical trial application in EU and US for the study in prostate cancer. The study we performed together with Curium and the collaborative and commercial deal we went into with them in this single indication within imaging. Yeah, so this was basically the news. We are very excited. We think we are adding to the story, and we are really ready to embark on the therapeutic part of Curasight's journey. Thank you.
Perfect. Thank you both, Andreas and Ulrich. Let's move directly into the Q&A. We have a lot of questions from investors here. So the first question: In the presentation at Okonomisk Udvalg in June 2023, there was a question about the liquidity of the stock. Management said that they might look into either move to Nasdaq in Sweden or possibly a dual listing. Is there any new information about this?
Yeah, maybe I should start with that. That is right. One of what we are aiming for, as a company is, of course, to get more liquidity in the stock in general. So that is of course also something we are continuously looking at. Are we still on the right platform, Spotlight Stock Market, or should we change the platform? But that, that's all what we can say right now about that. But it is a part of the agenda, I would say, for the company of Curasight also going forward. Also, as a part of that, we also want to strengthen our institutional investor base, and they very often most like that we are listed on Nasdaq, but that's all what we could say right now.
Yeah, perfect. And then the next question: Previously in 2023, you have mentioned that you are looking on how to secure funding for next year, in second half of this year. How is it going with that work, and are you in talks with larger investors as well?
That is also a part of the daily work. I would say both, we are talking with institutional investors and also with industrial players, and that is the puzzle we are trying to lay right now to find out what would be the best strategy for Curasight going forward. But, also what Andreas mentioned in the presentation, we are looking for how we can strengthen the funding also, as we want to accelerate the therapeutic path of the pipeline with uTREAT. So that is a very exciting, I would say, also for the coming year. It will be a very exciting year for Curasight.
Yeah. And then the next question here: Could you talk a bit about the possibility of expanding the current pipeline, considering results in both breast and lung cancer?
Yeah, maybe I can take that. I think it's a very good question, and I think it also points exactly to what is the strength of Curasight as a company, because what we have is inherently a platform, since our technology targets in essence all solid tumors, which is the majority of all tumors. So, we are at a strategic internal work to see how we can maximally leverage on that, on the fact that we can actually pick between indications. At the end of the day, it will be looking into the technology we expect will work across the cancer types, but the positioning also is dependent on unmet need. How large is the unmet need?
One good example is brain cancer, whereas as in essence, nothing happened for more than 15 years on therapy. People live for 1 year, approximately, on average. And so, of course, how many patients can it serve? Brain cancer is a relatively small indication, whereas some of the other ones, breast cancer, lung cancer, are very large indications. How is the positioning, also the study you need to do? Is it a third-line therapy, or is it a second line, or do you want to make a randomized study as a first-line therapy? It has different costs, but also different upsides, of course, relative to patients. So all that, together with actually the regulatory pathway, some of the pathways, because as I mentioned in brain cancer, nothing really happened over 15, 17 years.
There's also quite some help regulatory-wise of, what you have to prove, how large the, studies can be, must be, because everything that is better than what is out there will be helpful. So this is a mix of, of the different possibilities, and that's what we're actually looking into, both on the single indications and how we potentially, can combine it.
Yeah. Could you tell what is the status of the Phase III study in prostate cancer?
Yeah. So what we are doing now is that we are moving forward together with Curium a path to get uTRACE out for use in prostate cancer patients. And as you also know from the press release, we have uTRACE in two variants. And we are going for the copper-labeled variant, because that can be centrally distributed, and in particular for prostate cancer. It's very important because if you go for brain cancer, it's highly specialized. There's only a few centers in each country that are doing these, treating these patients. Prostate cancer is in the other end of the spectra, so it's in particular in the U.S., it's also done in private clinics in smaller entities.
So we need something to distribute that is ready to use, and that is what we are pushing forward right now, together with Curium. And we will file the protocols for this. Everything is in the preparation, and we expect the first patient during the first half of next year into the study. So that is the status. It's basically moving forward as planned.
Yeah, perfect. Redeye talks about another phase II trial in prostate cancer before moving to phase III. Could you touch on this as well?
Yeah. Basically, what is meant there, and it's always a little bit a question of definition, what you call two and three. Basically, we are now on a path together with Curium that would take it to the market. We also have commercial milestones, so the project ends with a new drug application and hopefully an approval. So that timeline is intact. The reason Redeye talks about another phase II is basically because we are going for the copper-labeled version. So the data we have is with the gallium-labeled version.
It's the same binder, but we just need to do a little bit of repetition, but it's relatively few patients, and it should be seen as a whole that will bring us to an approval and offering in the patient at the timeline we have kind of communicated earlier.
When do you expect the first payment from Curium?
That will be in the Q1 next year. In 2024, we expect to receive the first payment.
There's a question about coverage here. Are you satisfied with the coverage from SEB? Any plans of additional coverage from other major investment banks?
Yeah, I can start. I would say, probably we will not never be fully satisfied by the coverage, but in general, we are satisfied with the initial coverage that SEB have conducted. And also we expect them to come up with a more comprehensive update very soon, based on the plans we are looking into. And furthermore, I would like highlight that we also have initiate coverage with Redeye in the beginning of this month, in November. And also, we are also looking into the next year.
We are considering or would like to have some major investment banks to cover Curasight, but that will probably be in connection with, if we are changing the stock market platform from Spotlight to another platform.
Yeah, perfect. Then there, there's a bit of a long question, but I will read it all so you have all the context. Do you plan for a combined study in glioblastoma with both uTRACE and uTREAT, and also same partner to support both uTRACE and uTREAT? If so, could this also be a strategy in other indications with a cancer partner who covers both uTRACE and uTREAT in same indications?
Yeah, I should start with that one, Ulrich? Yes. I mean, we have the luxury of having many indications and two products, basically. One for imaging and therapy. And I think, again, we should underscore the deal we did with Curium was only on imaging and only in one indication. So, and also, SEB calculated the potential value of that deal, which is quite large, and that's just on what I would call a small corner of what we are sitting on. We interact with partners and big pharma on what we have and the indications and see how the patchwork can be optimized for Curasight.
So, definitely, when you go for therapy, you also need the imaging ligand, but the interest of some of the partners are more on the therapeutic part, some are more interested in the imaging part, and some are more interested in certain indications. And this is also the reason why we are exploring the different indications, because the likelihood of a match- I mean, we believe together with the academic studies, we have now shown that it works in four different solid cancers. And since we know uPAR is expressed in all solid cancers, personally, I would take this as an indication of we don't need to show it much more. It works in all the solid cancers. But then there's a strategic match that depends on other pipeline compounds the different pharma companies have.
So we could think of any of those different ways it's put. It might also be that some pharma partners would have options or exclusivity to an array of cancer types. So that is basically where we stand, and we are very focused on keeping our most options open and how that we can optimize the outcome. Of course, for Curasight, but at the end also for the cancer patients, to make the technology available in as many cancer types as possible.
Then the next question here: What are your plans for the indications in lung cancer and breast cancer?
Yeah, I think maybe if I take that, we... I think we already covered that a little bit. They are, since we have the imaging data and we know that more than 90% of these tumors are positive of UPA, it's two indications that can be pursued, and we are taking this into our strategy discussions internally, together with the other. Even though they're not mentioned on our four indications, it's part of our strategic discussions, actually together with other cancer types. And we will make some conclusion about that that we will communicate in due time.
Then there's a stock-related question here: What do you expect the stock value is in the end of 2024?
That's a good question, I would say. So, you should be very careful about predicting what the stock value will be, especially what the time is right now. But I would say if the results we're expecting to disclose the coming years should also reflect in the stock value, then it would hopefully be at a higher level. Yeah, your opinion about that is as good as ours. But we definitely expect that we will have some good results, and hopefully that the market will also recognize, and yeah, those results in the coming years. So, yeah, let's see.
Yeah, I totally agree. A lot of value and potential value inflection points coming up, and moving it more into therapy. And maybe, like we could say, I mean, any opinion is as good as... but we know that SEB says-
Yeah
... it should be 2-3 times fold higher even now, not end of the year.
Yeah.
That is their fair value right now. So, let's see if we can catch up on that.
We hope.
How long would you need to follow patients for uTREAT®?
Yeah, that's a very good question. It depends on the indication, and what you are going for. So basically, to put it very simple, there are two ways to look at if a cancer therapy works, and one is what is called objective response rate. It's basically seeing whether a tumor shrinks on imaging. And that is a very common and very often sufficient measurement. Typically, you can start seeing that after three months, or and almost always after six months. The other readout you may do, which is even harder, is to follow what is called progression-free survival, so the time the patient survives without the tumor growing, and then finally, overall survival, if people live longer. And there are different...
For those two last two measures, it's totally dependent on what tumor you are studying. You could say it's very unfortunate for the patient with a brain cancer that has a very poor prognosis. They progress very rapidly, and they die very rapidly. On the study side, that translates into that you don't have to follow for a very long time, so you will be able to see a benefit much earlier. If you have a cancer like breast cancer, where on average, patients will live much longer, you have to follow it for longer. It's dependent on the cancer type.
Hopefully, you will go for an objective response rate, and what sometimes is accepted is that you will be able to go to the market on those initial data, but you will then have an obligation to follow the other endpoints even after it's marketed to collect those data. So there won't be one number on this, but if we start out with brain, it would be six, 12 months. That would be the follow-up on the hard endpoints here.
... And then we have the last question here: Can you disclose a timeline for the start of Phase 3 in prostate and Glioblastoma?
I think, I think we have communicated something about uTREAT earlier. I think the fair thing is to say that we are right now looking into how to optimize uTREAT in the different indications. Brain will be part of the first thing. I think it would be wise to say that that will come back very soon on that, on the exact timeline. I think we could say that what we said on the milestones that we will come back on is an accelerated strategy. So, maybe that tells a little bit about what we expect.
Yeah, perfect. That was actually all the questions. Before we end the webcast, I will just hand over the mic for you if you have any kind of final remarks to end with here.
I would just say thank you for all our our shareholders that continues on supporting Curasight. And also, I think it's a good time to be continue being a shareholder in Curasight, also what we are looking into in the near future. So, that's what I would say is the message from my chair right now. So yeah, thank you very much.
I can only echo, echo that. Thank you for having us. Thank you to all shareholders, and exciting times in the near future.
Yeah.
Thank you to everyone who has listened in today and will listen afterwards. Thank you, and thank you to Ulrich and Andreas for being part of the webcast. Everyone, have a nice rest of your day.
Thank you.
Thank you.