We have ExpreS2ion, our CFO, Keith Alexander. Welcome, Keith. Thank you. Start your presentation. I will come back with some questions.
Great. Thank you everyone for having me here. I really appreciate it. The name of the company is ExpreS2ion Biotech, like protein expression. Today, I am here to talk to you guys about breast cancer, which is truly a terrible disease. It is one of the biggest killers of women globally. While there have been great advances in the treatment for breast cancer, a lot of women are left with resistance to the treatments. Therefore, they end up progressing through the cancer itself. It remains a very deadly, unmet medical need for many women globally. It is also a very large market. These medications that I talked about briefly are worth over $10 billion per year in terms of annual income.
It is a large market and makes it interesting for development of new therapies because there would be a reward at the end of that for investors. Today, what I am going to do is talk about our immunotherapy, which is a first-in-class design based on many decades of research that have led us to this point where we can come with this kind of immunotherapy. Then I will take your questions at the end. We have a disclaimer. We are publicly traded on the Nasdaq First North Exchange under EXPRS2. All the comments that I make today will be beholden to the disclaimer. Touching on breast cancer, over 685,000 women per year are dying every year because of breast cancer. Most of us in this room have known someone who has been impacted by it.
Personally, my best friend, he lost his wife to it. Each year, 2.3 million women are diagnosed with breast cancer. In the majority of cases, it is a type of cancer called HER2-expressing breast cancer. The women who have this, up to 50% of them end up relapsing. They get some effect from the prevailing treatments, the standard of care, but then they stop getting any kind of effect from it. They continue until they die. Furthermore, many people do not know this, it is the number one cancer in women under 50 years old. The number of cases there has increased by 80% since 1990. It is actually a growing threat for women under 50. The projections are that there will be over three million cases per year by 2040. Deaths will rise above one million unless new solutions emerge.
I have mentioned this word, HER2 expression, a couple of times. I just want to explain what that is. When you look in the middle, there are two charts or two diagrams there. The first one is a normal breast cancer cell. The cell has these receptors on the outside called HER2 receptors. Those cells, or the HER2 receptors, tell the cell to grow and expand and divide. HER2 overexpression is when you have too many of these HER2 receptors, as shown in the bottom diagram. That causes the cell to grow and divide more rapidly and uncontrollably. That is what HER2 overexpression is. We are going after those kinds of cases. On the right-hand side, we break it down by the different types of HER2 expression. HER2- positive on the left, that is when they are really overexpressed. There are really very many of them.
HER2- low is when they are overexpressed, but not to the same level as HER2- positive. It is a spectrum. It is not black and white. HER2- negative is when they are not overexpressing. You can see in the vast majority of cases, there is some degree of HER2 overexpression. That was the unmet medical need, the terrible disease, our villain, we can say. Here I want to touch on the market opportunity. Breast cancer as a whole is a EUR 27 billion global market with a 7% compound annual growth rate projected over the next five years. Focusing on the HER2 targeting segment, that is over EUR 10 billion of those EUR 27 billion each year. You can see some of the drugs there that have led the way, Herceptin and Perjeta from Roche.
At peak, Herceptin was over EUR 7 billion, and as the treatment has progressed, biosimilars have picked up there, and they have been over $3.25 billion in the last few years. Perjeta and HER2 are each worth $4.1 billion and $2.6 billion per year. On the left-hand side, you see our chart, which has it broken down in some of the key markets globally, broken down by HER2 overexpression, that is HER2- positive, HER2- low, and then HER2- ultra low, which is another way of segmenting it. On the right-hand side, we have HER2- positive gastric cancer. That is an expansion beyond breast cancer that we could go into with the same therapy once we establish safety and efficacy. Given this information here, we conservatively forecast or estimate our addressable market at over EUR 5 billion per year.
Just to show, and maybe this is a little bit too small print for this setting, but to show a few of the deals in this space, these are all HER2 expressing breast cancer drugs over the last 15 years. They are all for the most part, multi-billion dollar deals, depending on what stage they are treating and whether it is first or second line of treatment. They are all large deals comprised of upfront payments exceeding EUR 50 million or dollars, and then milestone payments getting up into the billions. On top of that, the royalties paid. What we are not aiming to do is take it all the way to market and to commercialize it. We are just 18 people north of Copenhagen. We aim to take it through phase I clinical testing and phase II, and then out-license it to a large biopharma partner.
At that point, we would get the upfront payment and be paid milestones along the way for our investors. Okay, so now I have spoken about the terrible disease, the market opportunity, and how we as a company can pay back our investors for developing the drug. I would like to talk about the drug itself for a little while. We have developed the first immunotherapy to target all four domains of the HER2 receptor with a virus-like particle. What does that mean? That is a lot of strange words. On the left-hand side, I have tried to illustrate it. We have a molecule that has in the center what is called a virus-like particle, it is an empty capsid shell that the body recognizes as a virus.
It trains the body to have an immune response to it, but it has none of the harmful inside of a virus, so it is harmless to the body. On the outside of that, we have attached antigens. These antigens are what trigger the immune response in the body. We have intentionally displayed it as four pieces, and these are four pieces that are targeting the outside of the HER2 receptor. In the illustration, you can see that each of these four pieces, they target a different part of it, domain 1, domain 2, 3, and 4. The leading medicines out there right now are targeting one part of it, and we are targeting all four. Why does that matter? If you target one part, you are just targeting one segment of the cancer cell.
If all of a sudden that cancer cell develops a tolerance to the way you are targeting it, then your medicine does not work anymore. Furthermore, it allows us to attack from basically all sides. If it is a very targeted attack with one domain, we are attacking from all sides with our, it is called a polyclonal attack, where we are generating antibodies to attack all four domains of the HER2 tumor cell. This allows us to overcome resistance to the prevailing therapies and also have a longer response. We hope. That is what we saw in the pre-clinical data, and we hope to prove that in the human data as well. Our approach has been proven before in other vaccines. For cervical cancer, the HPV vaccines, they are based on a VLP with antigens on the outside.
Those are very large drugs that are being administered broadly to young men and women around the world. I talked about the fact that we are trying to trigger an immune response by targeting all four domains of the HER2 receptor. I do not want to go into too much detail on the charts in this slide, but they all illustrate the same thing. Each one is an antibody response. So you have antigens, they trigger an antibody response. What we have shown is that our vaccine does elicit an antibody response in the four antibodies that target the HER2 receptor. What is different with monoclonals is they only trigger one. We trigger a broad polyclonal immune response.
What we also saw in our animal models is that the degree of response was much higher than it was for the monoclonal antibodies, so it is a stronger response as well. Again, we are attacking from all sides, whereas monoclonal antibodies attack from a very targeted, specific area. Now I am going to show you some animal data. First, I am going to show you on the left-hand side, it is human breast cancer cell lines in a serum, basically. These are ones that are specific because they do not respond to Herceptin anymore, the standard of care.
What we have shown is that when we treat these cells with our vaccine, that is the four orange ones, it brings down the growth of cancer cells. So it is much lower than it would be if it was left untreated, that is the far left-hand side, or if it was treated with Herceptin.
We are showing that we work when Herceptin doesn't work. The chart on the right-hand side, what it's showing is it's a mouse that will spontaneously grow cancer cells in its lung. That's what the vehicle is, that's the control. On average, they're spontaneously growing over 300 lung metastases. But when treated with our vaccine, they don't grow any. It had 100% efficacy in this test. We've demonstrated that in animal models, and now we need to test it in human. I'll show some more animal data now, the last two animal charts. The left-hand side shows Delta16 mice. These are mice that will spontaneously grow breast cancer tumors. The black line shows the percent that are tumor-free when left untreated. You can see that after 20 weeks, very few of them are tumor-free.
That's what we would expect because that's the way these mice are bred. What you can see with the red, that's our vaccine with an adjuvant. That's what we're testing right now. When treated, none of them developed any tumors. We prevented tumor growth entirely. The chart on the right-hand side shows another kind of mouse called FVB mice that you can inject tumor cells into, and looking at the black, that's the control again. They will spontaneously grow in volume. After approximately 70 days, the tumor volume is about two cubic centimeters. Again, the red is our vaccine with an adjuvant, and you can see that it blocks all growth of the tumor in these animals when treated the same way. Again, animal data looks very good, but we need to test it in human. We've started doing that.
In June of this year, we administered our vaccine to the first patient, and actually just two weeks ago, we released some data from that patient, showing that we had triggered the immune response that we were aiming to trigger. It was very significant and good data. Of course, it's based on one patient, and one patient does not a study make, so we need to show this in many more patients before we can say it's conclusive. But at that early stage, it was strong enough of a good signal that we wanted to share that with our investors. At this point, we've now dosed three patients, and we have a fourth patient in screening. We expect to have preliminary safety and dosage data in the middle of next year.
We may have data even before then if once we have the first patient going through all of their treatment, we'd like to show a curve of how their immune response has been, because we want to see if it stays high or if it tapers off, like with the COVID-19 vaccines, after 10 months, you only have 25% response. We want to see if we maintain it or if it falls, and so that there's a temporary response. That's the phase I-A study that's going right now. Then we'll have a phase I-B study, which will give us signs of efficacy. Are we able to stop tumor progression? Are we able to even have tumors shrink in size? We expect to have that for our full study at the end of next year, according to our current plan.
It is a very interesting time for us right now. We have done a lot of work over the last many years to come to this point, and now we are getting proof in human, for the efficacy and safety of our vaccine. So far, we have not seen any adverse safety signals. So it is looking good so far. But again, it is early stages. We need to see much more data in human. In terms of the actual study, the way it is broken up is we have nine patients to start with, where we are going three at a time on a tapered basis to increase the dose slowly. We want to make sure it is safe. We start a very low dose, and we want to make sure it is safe before we go to a higher dose.
The goal of these first nine patients is to find what is a safe dose where we are actually seeing immune response. Then we have up to 18 more patients where we find a dose, and we want to see that it is safe and demonstrating early signs of efficacy of stopping the disease progression. But that will all be at one dose. So that study will be completed by the end of next year, as I just mentioned. Taking a step back and looking at our plan more broadly. So you can see in the top left, we are in the phase I study with the first human data, which we aim to complete before the end of 2026. At that point, we will decide on the design of the phase II study, and actually that is when a licensing opportunity might open up for us.
We, from the beginning, have been talking to big pharma companies to understand what it is that they would be looking for in this type of immunotherapy. They will want to see the human data before they have any specific interest in it. But it could happen as early as after the phase I data is complete. When we enter the phase II, that is what we call a proof of concept study. That would be a much bigger study with 300 patients, at least, maybe 600 patients, depends on the design of the study. After that, we would have a definite licensing opportunity if the data is good and possibly even conditional approval. If the data is so strong, that the regulators deem that they want to get it to patients faster, then we could have early conditional approval.
In terms of licensing, that is when we would target a licensing event. We cannot take it through the phase III study ourselves. That is a huge study costing many millions of dollars. As a small company, we do not have the personnel for that. So we need to find a big partner for that. Then eventually we have registration and launch in 2032, 2033. So four steps, safety and early signals, that is what we are doing now. Then clinical proof, partnering, and patient launch. All right. I have now explained how our therapy works and what we are aiming to do to take it to market, and we would like to talk a little bit more about our company, just so you understand who we are and how we run the company.
It is called Big Shots and Small Waistline because what I want to get across is that we have multiple shots on goal. We are trying different approaches, and we are running a very tight ship. We are not spending a lot of money. We have a very tight financial control. I am the CFO, so I oversee that personally. We are a platform-based vaccine company. We have many different pipeline assets, although it is only the top one that we control 100%, the breast cancer vaccine. You can see here we have many malaria vaccines that we are working on.
Those are all in partnership with University of Oxford, and so Oxford is the one who is actually running these. We have contributed our platform technology, and we could have some monetization of that down the road through licensing agreements, but we are not doing any further work there. We are not spending any money on the malaria vaccines.
That is Oxford's project using our platform. We also contribute to a couple of influenza consortiums and a Nipah virus consortium. But we do these through consortiums with other players, and those are all grant-driven projects. The last one is a COVID-19 project that has been discontinued. It was out-licensed to Bavarian Nordic back in 2020, and it made it through phase III with strong phase III data, so we could like to think of it as having proof of concept. But it was not fast enough to market, and therefore Pfizer and Moderna won that game. To touch on our team very rapidly, we have an executive management team. There are three of us there. Our CEO has deep experience in life science. He also has a deep specific experience in business development and licensing deals, as well as a background in finance.
Our CSO, he has been working for many years in molecular biology, and he also taps into a team of about 16 research scientists from around the world who are supporting him in our efforts. Then finally, I have a background in finance for the last 24 years, working with companies like JP Morgan in New York, Danske Bank in Copenhagen, and Accenture was my first role out of college. We are supported by an extended leadership team that has experience starting in concept of drug development, taking it all the way to commercialization. So we believe we have the right people, and of course, we have a very strong team supporting us. Cost discipline. We have brought our costs down considerably over the last two years, reflecting the market realities of raising capital right now and of taking drugs through development.
Whereas before we might have been focusing on multiple assets, we decided to focus on our lead asset and to bring our costs down. You can see our R&D costs have come down considerably. I would say that those are very volatile and depends on where we are in our pipeline development, so they can go up and down quarter to quarter. Our personnel costs are fairly consistent. We brought them down in 2023, and since then they have been plus or minus the same area. We have income from our CRO business, our contract research service, where we develop proteins for other companies, for big pharma companies, or we license our platform to them. And we also get grant income related to the grant consortia that I mentioned earlier.
The way we see this is a way to develop our pipeline further and also to reduce the cost related to our pipeline development. So it helps us out a little bit. Our cash balance is around SEK 50 million. We have raised around SEK 91 million over the last 18 months. So if you were to average that out, that means that we have spent about SEK 5.5 million per month over the last 18 months. We have had a broad source of cash coming in from grant payments. We have a dividend from an associated company. We have had rights issue, and we have had warrants. Our runway right now takes us through the first quarter of 2026, and that does not include a warrant series that we currently have open.
To close, I would like to talk about why you should invest now, what plans we have in terms of capital, and also our risks. Why invest now? As I mentioned before, we have key readouts coming in 2026, with possibly earlier readouts happening before the end of the year. Each of these, we believe, is a significant value inflection point for the company because it is taking us from conceptual design for our drug to real proof in humans that it is working. Furthermore, the malaria vaccines that University of Oxford is developing, those are going through phase. There are actually 11 trials going on right now, and some are going to have phase I data this year, and then there is one having phase II data in the middle of next year.
Finally, one of our grants we are working on for Nipah vaccine, there should be a lead candidate selected this year, and that could be ours, or it could be one from our associated company. On the strategic and financial side, I just want to mention that we aim to finalize a malaria vaccine license in the near future. We could have new patents filed for further development with our grant projects, and then our CRO business could continue to grow. We grew 49% year- over- year in the second quarter. Right now, we have a warrant series that is up for subscription at the end of this month, actually, September 18th through October 2nd is the exercise period. The price is SEK 14.65. That is a 30% discount from the period September 1st through 12th. We hope that people would like to participate in that.
The TO 11 warrants are actually trading on the Nasdaq First North Growth Market, so you could purchase them there if you are interested. You can also come talk to me afterwards. I am happy to tell you more. Finally, our key risks, clinical trial risk, we could lose patients. Our recruitment rate could be not as fast as we would like, and of course, we could have data that does not tell us what we would like to hear. The way we mitigate that is by having more sites than one. We went from one to three sites, and we also have five referring clinics that are bringing patients in. We also have this dose escalation design where we start with a very low dose so that the chance of having a bad safety outcome is very low, and we go up slowly. Partnership dependence.
We are focused on partnerships for our external programs, and we are subject to their timelines there. We try to diversify this by having multiple programs with different partners. Then finally, on the funding and runway, our cash needs exceed what we need to take things through development. So one way we mitigate this is through warrant programs and other ways that we have raised capital in the past 18 months that I mentioned earlier. So with that, I hope you understand that the breast cancer vaccine is there to address a very significant and material unmet medical need, and that we are doing everything we can to push it through development while keeping our costs low. And that we hope you also find that we are an interesting investment at this point in time because of the data we have coming. With that, I will take any questions.
Thank you very much. Thank you very much, Keith. We do not have any more time, I am afraid. But thank you very much, and nice to listen to you. Thank you. Thank you.