Good afternoon, and welcome to this presentation and Q&A with Curasight. With us today, we have the full management team. 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 to start the presentation. Your line is now open.
Thank you, Anas, and thank you for having us here today. My name is Ulrich Krasilnikoff. I'm CEO and CFO, and together with Andreas Kjær, Co-Founder and CSO and CMO, we will take you through this presentation, also, and the update of our strategy, besides also and, yeah, what we are looking into in the future. We have prepared a small presentation for you, first, with a disclaimer. What we would like to touch today is a short update on Curasight for all the new investors with us, with us today. Furthermore, we will touch on the financial results from the last year, 2023, and then we will look into the highlights from Q4, and afterwards, also here in the new year. Then we will go deeper into the company strategy, which we recently have announced we will update.
Furthermore, also, that we are raising money right now with a rights issue, more about that structure. Finally, in the end of this presentation, we have a Q&A.
Yeah. And just to remind everybody about Curasight, where we come from and where we stand today. So we are a late-stage clinical company, founded in Copenhagen some 10 years ago and based on 10 years of research prior to that, within the theranostics field. I come back to that. We have raised more than EUR 20 million over the years, and we believe that we have come far with that investment. We are leveraging on understanding of uPAR, which is a marker expressed on cancer in both diagnosis and treatment. And what we have is first-in-class imaging with uTRACE and first-in-class treatment with uTREAT. That's targeted radionuclide therapy, I come back to that, a form of radiation therapy, which is supposed to give more gentle and better treatment of an array of cancers.
We currently focus on brain and prostate, but with the updated strategy, which we'll cover later, we actually are looking broadly at different solid cancers. The reason for this is that the target we have chosen, uPAR, is expressed across solid cancers. So for that reason, we want to take advantage that our technology is not only working in one cancer, but in different cancers, and pursue a parallel strategy. In imaging with uTRACE, our technology has been tested in nine phase II clinical trials, investigator-initiated trials, which have included more than 400 patients. So we have really proven the technology is safe, and we have also shown the large percentage, 85%, 90%, 95% of these patients, that would be eligible for being treated with uTREAT as they express the target.
The cancers, and I come back to that, we have worked within now brain cancer, prostate cancer, head and neck cancer, neuroendocrine tumors, breast cancer, as well as lung cancer. So, the space of radiopharmaceuticals, so that's radioactive drugs, both for imaging and therapy, is an extremely rapidly growing market, estimated to be $35 billion in 2031, but foremost, growing with 35% year- on- year these days. The technology we'll describe for you, we hold strong IP protection around it, so we have issued patents both in the U.S., EU, and also many other jurisdictions, also jurisdictions not mentioned here, as China. And on the next slide.
Yeah. Then I will take over about the results from last year. Last week, we announced and published the annual report for 2023, and just some highlights from the report here and the figures. I will only focus on the full year. So, what is reflected here is that we have a gross loss amounted up to around DKK 25.7 million, compared to around DKK 11.4 million last year, and the difference is due to the increased activities in the company. Curasight is still a development company, and we don't have any income yet that is reflected in separate. If you look at the loss before tax amounted, it amounted to around DKK 33.2 million compared to DKK 19.4 million .
Also, it's the same, which reflects here, that, that the increased activity in the development activities in general. And on the bottom line, we have a loss, including the tax, in recommendations. It sums up to around 26.1 compared to DKK 18.3 million last year. The total assets is amounted to around DKK 38 million, compared to around DKK 60 million last year, and the main difference is due to the cash position, which has decreased. And about the cash position, by the end of the year, 2023, it sums up to around DKK 20 million, compared to DKK 50 million last year.
Looking at the highlights from Q4 and also afterwards, then in October, we were able to report and announce that we have demonstrated a preclinical proof of concept of uTREAT in treating of non-small cell lung cancer. Which is also the reason that we are now making this updating for the clinical platform uTREAT therapeutic platform, and Andreas will come back to that. Furthermore, in December, we were able to announce that we have signed an agreement with the CRO, ABX-CRO, to run the phase II study, which is comprising the uTRACE clinical phase II trial with prostate cancer, which is a part of the Curium partnership.
Furthermore, we have announced that we have submitted a clinical trial application for EMA, also comprising the same study, which is comprising of the Curium partnership. Recently, two weeks ago, we announced that we want to accelerate and expand the clinical therapeutic strategy with uTREAT, and that has to be conducted as a phase I/II-A clinical trial within five cancer types in parallel, in a so-called basket trial design. But Andreas will come back to that and explain more about that. And the same day, we announced that we also want to increase the funds and make a capital raise in the company in order to execute the strategy.
So the existing shareholders, and we will also touch base on that later in this presentation, where we, with all, shares and new shares is exercise expect to give us around DKK 51 million, before transaction costs. Then I will hand over to Andreas about the company strategy.
Yeah, thank you, Ulrich. And the company strategy, which is also part of why we are now doing a rights issue, is really an acceleration of our therapeutic strategy. And the background is, as I briefly touched on in the beginning, that we have a technology that is quite unique in the way that it works across solid cancer. So uPAR is expressed in 85%-95% of all solid cancers, and for that reason, we can actually use our technology in many different cancers. And so far, we approached a more sequential strategy, so going into brain cancer with therapy, then into the next cancer. But we believe this would be a missed opportunity because we can test it at the same time in many different cancer types, what is called a basket trial.
And not only because this is the major driver for us, do we want to help cancer patients across the different cancer types, but it also immensely increases our probability of entering into partnerships, because different pharma companies have different focus on indications. And with data from many different cancer types, the likelihood of a strategic fit is much higher. And basically, what you do is that you include probably around 20 patients in each of these different cancer types: brain, lung, neuroendocrine, head and neck, and pancreatic cancer. And then we will get data from each of these indications. It will apply our uTRACE and uTREAT compounds at the same time, which means we will check whether the patient has high uptake.
What you see is what you treat with uTRACE, and only the ones with high uptake, which is typically 90% or more, will be included in the trial. With this accelerated strategy, we expect to dose the first patient in the very beginning of 2025, and have an expected first readout of efficacy data in 2025. For partnering discussions, this, of course, is of an immense value. You take the next, Ulrich? So, we might, we'd like to remind you about the technology and how it works. So we have a two-minute video just showing the core of our strategy. So if you could start the movie, then...
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 1 mm, 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, and if you go to the next slide. So basically, what this showed was our technology, the theranostic platform of uTRACE and uTREAT. And the only thing in this video that is not fully up-to-date is that we will not start with brain cancer in therapy, but we will go broadly in this basket trial. On the next slide, we just have shown here, what you see is what we treat. So this is uTRACE in a patient with a brain cancer. You can see MRI on the left with the whitish tumor in the middle, and you can see to the right where uTRACE sit. Why is this important? It's important because one to one, that is where uTREAT will sit. So you can see the red area, that's where the therapy will sit and irradiate with only one millimeter range.
Whereas in the rest of the brain, that is dark, purple or black, there's almost no uptake. So this shows how precise and how gentle the therapy is likely to be. If you go to the next slide, you can see the principle. What you're seeing on this drawing on the right is basically what you saw on the previous image. It sits in the tumor, but not in the surrounding brain. Whereas on the left in this illustration is how it works when you do traditional external radiation therapy. You get a lot of irradiation to areas of the brain, all the yellow and green parts, which is harmful.
So very often, irradiation of healthy tissue restricts how much radiation you can give to the tumor, and this is why targeted radionuclide therapy has the potential both to be more efficient but also more gentle and less toxic. On the next slide. So our updated strategy can also be shown in three pipeline diagrams. First of all, uTREAT shown here. We now are pursuing these five indications at the same time: glioblastoma, non-small cell lung cancer, that's the most common type of cancer, lung cancer, neuroendocrine neoplasm tumors, head and neck cancer, and pancreatic cancer.
We want, as you can see, to perform this phase I/II-A trial, basket trial in these cancers, and will produce, during 2025 results, early efficacy results in all these indications on the updated strategy, with the potential then to partner and move further into later stage studies. On the next slide, is uTRACE in prostate cancer imaging only, and this is where we partnered with Curium. This is the non-invasive biopsy that shall be used to patients with localized prostate cancer, to, in a more reliable way, follow them and decide whether they should receive therapy like prostatectomy or not. This is where we partner with Curium, and, Ulrich, will come back to that.
On the last slide, we just give the overview of where uTRACE and investigator-initiated studies already has been tested, and here it has been tested in the majority of the indications we now go for. In essence, it has shown to be expressed, in a large part of all these cancer types. And this data forms the basis for going forward into uTREAT because we know the high amount of patient that express the target. Yes. So, so we are very excited. We are accelerating the strategy because the field is accelerating everything. And we used to have a slide here showing the last five years of transaction in this space, in the radiopharmaceutical space. We have now replaced that with a slide of last month activity.
If you just look over the last couple of months, you can see what we show here, that Eli Lilly, Roche, and BMS, all major large pharmaceutical companies, have entered into the radiopharmaceutical space, where they weren't before. So, so it's booming, and the reason for that is, my personal prediction, in 10 years, this technology, theranostics, will have replaced almost all of external radiation therapy because it's more gentle and more efficient. So on the next slide, not only is it very active in transaction, but it now also went into newspaper headlines, and this is from last Wednesday in The Wall Street Journal, Heard on the Street, where they covered that drug firms go nuclear to fight cancer.
And the background for this is they describe, the, the company's Eli Lilly, BMS, and, and, Roche, as we, we just described, but in particular, they describe that two smaller companies, Fusion Pharmaceuticals and Perspective Therapeutics, are up in, since September last year, 400% or 120%. And basically, what this shows is the companies out there in this space that are still available, they, they see an immense increase in share price. And of course, this is not the case right now for Curasight. It's also because we are on a small stock exchange that can easily be overlooked. But we believe with the data and going into clinical stage company, we have a bright future and people will, see Curasight and see the partnering opportunities that we represent. On the next slide.
You are muted, Ulrich.
Sorry. This is just to emphasize that the strategic partnerships is still a part of the company strategy going forward. And why is that? Yeah, there are some obvious benefits from that. First of all, it validates our technology, a proof of concept. First, and besides, it also provides some financial support during the development phase as non-diluting funding. And furthermore, it also strengths and speed up the market access to the market as we gain resources and support from a bigger organization that can help us to bring the product to the market. And finally, also, we have in additional competencies and knowledge about the development and regulatory processes.
That is the first partnership we enter, was actually announced in May last year with Curium, a deal that only relates to one indication within imaging radiopharmaceuticals and related to prostate cancer. So it's only a corner of the portfolio we actually are developing right now. And just to put some flavor on the partnership we did last year with Curium, it's structured in that way that Curasight is responsible for the development of the product in order to obtain regulatory approval in EU and U.S., and with Curium as responsible for the manufacturing and commercialization.
About the deal structure and also the size of it, then we, Curasight will be eligible to receive up to $70 million in development and commercial milestones, as well as a double-digit royalty on the sales on top of that. SEB, which among others, we have a commissioned research with, has estimated the total deal value of Curasight and of this transaction to sum up to around $3.8 billion over 10 years, accumulated over 10 years. So a very attractive deal, I would say, for both parties. But what is more important is that it supports our strategy and also to make, to bring product to the market, and we find that Curium is a very competent and also one of the largest within this field in the world.
As stated in the bottom of this slide, we have also ongoing discussions with other partners. So, this yeah. But we will see what the future will bring in that respect. Just some milestones from what can be expected from this year. Right now, we are working on in order to accelerate the therapeutic platform uTREAT. And then, finally, we also here in the first part of 2024 expect to be able to dose the first patients in the clinical trial under the Curium partnership with uTRACE in prostate cancer. And we also expect by that to receive another milestone payment for the enrollment of the first patient in that clinical trial.
Looking in the second part of this year, we expect to have some preliminary efficacy data from this trial, also part of the Curium partnership. And then, and not least, in the second part of 2024, we also expect to get some feedback from a Pre-IND meeting with the FDA based on the basket trial and the design that Andreas already had, have, explained. Then in connection with that, we also have announced that we want to strengthen the capital, the funds in the company by a rights issue. So I'll just put some flavor on that also, and how it's supposed to be.
It's a rights issue, which means that it's only related to the current shareholders, and all existing shares in the company really entitles to one new subscription right. And it requires seven subscription rights to subscribe a new one share for DKK 18, and that is, yeah, in the offer right now. And this was at last Friday and the twenty-third of February, and we're on until the seventh of March. The net proceeds from the rights issue is expected to be shared up in meaning that around half of it will be used for the initiation and also planning and enrollment of the patient in this basket trial with uTREAT.
Furthermore, we will use some of the proceeds from further development with uTREAT for clinical development, and also to support the trial under the current deal. Finally, we need to increase the working capital in general, and also for other corporate purposes to increase the business development and accelerate the value creation in the company. Very shortly about the timelines. Right now, all shareholders have received some subscription rights, and they are tradable, able to trade those, either sell or purchase the subscription rights from now and onto March 5. Furthermore, there have been prepared an information memorandum, which was published last week, February 22. This information memorandum is also to be found on the company's website.
The subscription period for new shares is settled from 23rd of February until the 7th of March, but a lot of banks want you to do it as fast as possible because they also need some handling and administration time internally. But hopefully, we will be able to announce in the middle of March, around 12th of March, the estimated publication of the outcome of the rights issue. That was the presentation, and then we hope you will have some questions or answers that we will be able to answer. Thank you.
Perfect. Thank you for that, both, Ulrich and, and Andreas. Let's move directly into the questions and take them from the top here. So the first question is from Tobias. It is, "Dear Ulrich and Andreas, could you please touch on your feeling, knowledge as to the, this rights issue being a success? Do you have any takers for any rights that may not be exercised in this issue here under the rights that you yourselves will not use, and the rights that private investors will not use?
Yeah. First, I will say, it's rather restricted how much we can comment on the process right now because it's running. So, what our feelings is or whatever, we are not able to say anything about that. But if you are not able to utilize your own subscription rights, then you can either sell them on the stock, or you can offer them to other external new shareholders or existing shareholders. That is the case in very short. And yeah.
The next question here is from an anonymous investor: "If the stock continues to trade below DKK 16 or below 18 DKK, then do you have a plan for getting investors to buy into the DKK 18 in the capital increase?
What I can say is, that's right, right now, the stock price is below the strike price what is in the rights issue. But if you only buy the shares on the stock, then it will you will just handle internally by with another investor. That will not support the company, and that will not support the funding of the company, and by that, also the value creation in the company. So the best way you can do is actually to utilize your rights to subscribe, even that it might be a little bit higher what the current stock price is. But I would say it will not support the strategy, and that by that, you will either not protect your investment.
So that is what to say for that.
The next question here is from another anonymous investor: "Why haven't the company released the result from the awaited uTREAT results in head and neck and neuroendocrine tumors yet?
Yeah, I can take that. So, so basically, the uTREAT technology has, has been validated. We have communicated to the market once we did it in in lung cancer and in brain cancer. We have previously academically performed it successfully in colorectal cancer as well as prostate cancer. So in my view, it, it basically works, and we, and we know it works across cancers. For for applications and filings, we are behind the lines looking into other cancer types, but we will not do it one-to-one in all of these, and that's why we have not been, been very eager on communicating this. Because once it's shown in four different cancer types, we know they all express uPAR, nothing depends on that.
It's not like we want to see and release the preclinical data in head and neck before we move into the basket trial. The background for moving forward on the basket trial is the combination of knowing that uTREAT works preclinically in many different cancer types. They all express, and we all know that in, or we know that in cancer they express uPAR because we know that through the nine investigator-initiated uTRACE trials in humans. So basically, if I was out there, I would not say it's not a thing that should be awaited with excitement. It's more like bread and butter work that we want those check marks. Expect it to work across all cancer types.
Normally, in cancer research, if you can show something for two different cancer types, it's already perceived as a general concept.
Okay. And then we have the next question here: How would you rate the chances of a future partnership and/or buyout of the company?
I would say it will definitely increase by conducting this strategy because as Andreas also explained, we will now run five studies or indication in parallel and not sequential. So we will very fast have proof of concept in five indications within the therapeutic path with uTREAT®, and that is definitely increasing the chances for partnerships or buyout.
The same person here: When do you expect to need funding again after this round of funding?
If all the subscription rights are utilized, then it will first be somewhere in 2025. Unless we do not get other funding or partnerships or whatever, or soft funding or whatever, then it will last at least until the last, I would say the middle of 2025.
Could you please elaborate on the reason to suddenly add pancreatic cancer to your uTREAT pipeline?
Yeah, definitely. Happy to do that. I think I will even expand a little bit on the answer, because we are looking into the basket, into five cancer types. We could have looked into even more. I mean, this is a compromise between budget and what is important. So we made a very meticulous process previously, but also again now, where we go through every cancer indication, look for the unmet need. Eventually, what we want is to help cancer patients and Curasight, and so we look at what is the unmet need. If you take brain cancer, for instance, what's out there doesn't really work very well. In other cancer types, let's say breast cancer, the therapies that are out there are quite okay, so the need is, need is lower.
So, this is the positioning. It also depends on do you use uTREAT potentially very early, or are there so many relatively well-working therapies that you are very long down the line? And when that is said, we arrived at these five indications, which actually falls in two groups. Glioblastoma, brain cancer, the aggressive brain cancer, and pancreatic cancer are two of the poorest cancer types regarding prognosis, and two cancer types where nothing really breakthrough has come over many, many years. They are also both rare diseases, so both of these indications, there are large unmet need. There is different programs that can accelerate your interactions with the authorities, so Breakthrough status, accelerated review, orphan disease. So that's the reason for taking these two indications and therefore, pancreatic cancer.
I should say a lot of it is also input from the pharma companies we on a running basis interact with. So also knowing when they approach us and saying, "Why are you not testing it in this cancer type?" So it's also based on that input. The other group is the non-small cell lung cancer, that's the most common cancer type, the lung cancer type, where you can also get through smoking, and head and neck cancer. These two cancer types are very common cancer types, so here you have a large volume, a lot of patient we can help, hopefully, but also where you want more gentle therapy.
And in the head and neck cancer, when you do external radiation therapy, in many cases you irradiate through the jaw, and you kill the teeth because the roots of teeth cannot tolerate radiation. So the teeth will rotten, so therefore, you prophylactically very often extract all the teeth, and then you need a prosthesis afterwards. So, by giving targeted radionuclide therapy, it goes into the tumor and not the jaw, and it only irradiates with one millimeter. So this problem would totally be circumvented by a targeted radionuclide therapy concept. And then the last indication is neuroendocrine tumor. It's a little bit in between because it's a rare disease, so we can get Orphan drug designation, and also some of the fast tracks.
It carries a somewhat better prognosis, but these patients already today receive one of Novartis' two products, named Lutathera, that targets a receptor called somatostatin. But unfortunately, this receptor is lost once the cancers get very aggressive. And we know once they get very aggressive, because that was studied in one of the uTRACE studies, they have a very high uPAR express. So we can go in this area where they are used to use the theranostic principle, targeted radionuclide therapy, but they have a large amount of the most aggressive patient that are not eligible for that therapy, and we can hopefully provide an offer for them. This is important because it's a disease group, patients and doctors, that are used to applying targeted radionuclide therapy, so they have the setup, they have the treatment rooms, they have everything.
The doctors that do a scan and say, "Unfortunately, we cannot offer you Lutathera," would be very happy if they then could say, "However, since you are uPAR positive, we have something else to offer you." That is the thinking behind selecting these five indications as first wave of indications in our basket study.
Are you done developing the uTRACE category alone on the specific cancer types other than prostate?
Yeah.
Will you then only proceed with the uTRACE as part of the theranostic platform?
Yeah. Another good question. First of all, the reason we now run the studies in parallel, that we do not do imaging first and then add the therapy, is that through the Curium collaboration, we actually finalized the uTRACE product, so it's ready for use in clinical trials. So we don't have to do any further work on the chemical development or the GMP production of uTRACE. So we accelerated that. It's basically ready for entering all these studies. And then we need it anyhow, as a companion diagnostic. So this is why we now have tied them together. It doesn't mean that we are not still looking for imaging-only positioning of these, for instance, for prognostication.
But the data we will get through this therapy study, added to the investigator-initiated study, where we already have studied with 50, 100 patients included, already provides the data to position it when we discuss partnering. And we also discuss partnering within imaging. So, it is very likely that you would see more diagnostic partnering, as you have seen with Curium, not only in therapy going forward. So we have not skipped going for imaging only. We just do it at the same time.
Then, Niklas has a question around the rights issue as well. "You two own half the company and will get 10 million rights. Almost all will not be exercised of you in the rights issue. What will happen with your unused rights?
They will be utilized or offered. They will be offered, let me say it in that way, to other potential investors, and also, if there are existing shareholders who want to subscribe more shares than they are actually able to do right now with the subscription rights that they have received, then they can contact Nordic Issuing for handling that you are able to oversubscribe. And there is actually a form on the website also, if you want to oversubscribe the new shares, then you can utilize that form to inform Nordic Issuing how to be contacted also.
With all the interest in this field, how actively are you working with establishing partnerships and connecting with potential partners to make them aware of you?
We are utilizing all the efforts and all the channels and tools we have. And of course, what Andreas also explained in the presentation, all the awareness is first now for real, the big pharma is waking up. Also, first of all, they can see the value of the nuclear medicine, but also now they're actually... we are actually able to handle the logistics behind them. That is also why we entered into the agreement with Curium, because they already have demonstrated how to handle nuclear tracers like uTRACE, in general and in practice with very high success. So, now they are not...
hesitating into stepping in this field because, you know, all the matters about the isotopes. There is a procedure for how to handle that, also in daily practice.
Then, Niklas has a follow-up question here, and it is quite long, so I will read most of it, and then you can answer the best that you can, based on that. "You say that existing shareholders will help the company by exercising their rights instead of buying the share, which is way below DKK 18 . There's a big hole in your reasoning. It's like you expect investors to be philanthropists and not interested in making money in a transparent company. Right now, the rights issue is up in the air, and I am afraid of it to be a failure. I would like you to convince me with your best argument in investing, because right now I feel it's like buying in the blind." Do you have any comments to Niklas around that?
The only thing I can say, I don't hope that they feel that the strategy that we have presented today is up in the air, but it's actually adding value to the company. But that also requires new funding. So purchase the shares on the stock market right now, that will not support the company in gaining the capital. We need the capital in order to execute on the strategy. So that is my answer to this question.
Perfect. Then we actually made it through all the questions, so thank you, Andreas and Ulrich, for answering all the questions from investors and potential investors here.
Thank you.
Before we end the webcast, I will just hand over the word for you, if you have any kind of final remarks.
Only that I will say thank you very much to all our loyal shareholders, and also that we hope that they, that they will utilize this offer to support the company and also be able to create value in the company with this accelerated strategy within the therapeutic field, because it's very exciting times we are in right now. Also, what happens in general around us, and especially with big pharma stepping into this field. So with that, I will say thank you very, very much for your supporting.
Thank you everyone for listening in here. We are now done with the webcast, so we'll see you next time. Bye.
Thank you. Bye.
Thank you.