Thank you all for having me here today. My name is Keith Alexander. I'm the CFO of ExpreS2ion Biotech. Over the next 10 minutes, I'll walk briefly through breast cancer and what a terrible disease it is, a potential solution that we have for it, and also telling you a bit about our company. So starting off with this terrible disease, I think it's something that has probably affected everybody in this room in one way or another. I can tell you that personally, one of my best friends lost his wife to it, and it really is a terrible thing to watch through the progression. There are about 700,000 women each year who are newly diagnosed with breast cancer, and it's, sorry, 2.3 million and about 700,000 deaths each year. And that number is expected to rise as we approach 2040.
That's expected to go to 3 million and 1 million deaths per year. What's interesting in the space that we're focused on is that HER2-expressing tumors are prevalent in 80% of cases, and that's where we're going to focus, and I'll explain that in a moment. Up to 50% of patients with HER2-expressing breast cancer relapse because they develop a tolerance to the prevailing medications that are available, and that there's also a rising incidence in younger women. It's now the number one cancer for women under 50, with incidence up nearly 80% since 1990, so terrible disease. Let's focus on HER2 expression on the right-hand side from where you're sitting. A normal breast cancer cell will have some HER2 receptors. HER2 is throughout the body, and it is normal to have HER2 receptors. What the HER2 receptors do is they send signals for the cell to grow and divide.
On the bottom side, or in the bottom illustration, you can see an abnormal HER2-expressing breast cancer cell. It is doing what is known as overexpressing HER2 receptors, and it's coated with HER2 receptors. That causes it to grow and divide more quickly. What we've developed is a therapy and immunotherapy, which is illustrated here on your left-hand side. At the core of it is a virus-like particle, and what this is, is an empty capsid shell which to the body looks like a virus, and so what it does is it triggers a strong immune response, a very strong immune response. However, it has none of the negative internal workings of a virus, so it's harmless to the body. What we do is we put around it antigens, and these antigens trigger a very specific immune response targeting the HER2 receptor on the cancer cells.
What we try to show here is that we're targeting four extracellular domains of the HER2 receptor, and what's important here is to say that that's different from what the standard of care does. They trigger or they target one domain each. Herceptin, that's Roche's drug, it's targeting just one receptor, and so is Perjeta. That's also Roche's. They can sometimes be combined to target more than one. We're targeting the entire extracellular domain of the HER2 receptor. This is what's known as a polyclonal antibody response. We're generating antibodies in the body to go fight these cancer cells. The virus-like particle is a proven technology. It's in the HPV cancer vaccines, and so those are blockbuster drugs. As a result of this approach, we expect to have a broader and longer-lasting response.
There's a lot of data, but I've only got one data slide, so please bear with me. On the top left-hand side of the slide, what I want to show is that we've triggered antibody response of all the HER2-specific antibodies that are important. The red line is showing that after our vaccination, we're inducing the antibody response. That's what's important. It's the same across all of them. In the bottom left, what we've done is taken breast cancer cells that are normally resistant to the standard of care to Herceptin, and so the white boxes are the control, and what you see is that over time they're developing colonies of cancer cells. The blue lines are those cancer cells treated with the standard of care trastuzumab, also known as Herceptin, and so they're also developing colonies of cancer cells.
Then the four red, orange, yellow, those are when they're treated with our vaccine, and there you can see the development of cancer cells is much less. Okay, on the right-hand side, what we're showing is a couple of illustrations in mice, and the top right one is illustrating survival when treated with our vaccine. In the control, which is the black line, within approximately 60 days, none of the mice are tumor-free. The green is treated with our vaccine on its own, and the red is our vaccine with adjuvant, and that's what we're actually running through clinical trials right now. What you can see is that after 600 days, there have been, they're 100% tumor-free, so there's been no tumor growth in these mice that have been vaccinated with our vaccine. 600 days is the lifespan of a mouse, so that's as good as it gets.
The bottom right is showing tumor growth inhibition. It's just another way of looking at it. In the control, you can see that the tumor cells grow to about an average of two cm3 , whereas there's no growth when treated with our vaccine with adjuvant. Where are we right now? We're in the phase I study where we get the first human data, and in fact, just a few weeks ago, we published some very initial data on the first patient. It's very early, but what we saw was that there was a significant increase in these HER2-specific antibodies in our first patient, and that's as good as it gets for where we are in the process. We're happy with that. We hope to get more data in the coming months. In December, we actually hope to have the full treatment curve for that first patient.
Why is that important? It will show us whether the level of antibody protection or antibodies induced remains at a high level or if it tapers off, and that means that's a sign of the durability of the protection. Just for taking it back to the world that we know, COVID-19 vaccines, the ones from Moderna and Pfizer, they last for about 10 months and then are at 25% level of antibody protection. We're hoping that stays at a high level. Next year, in the mid of 2026, we expect to have the phase I- A data. That'll have a readout for safety. Is it safe when it's been given in humans? We should also know what level of dosage we want.
So what we're doing is we're starting at a very low level so we don't have any, to lower the risk in terms of safety, and then we increase it to a higher level so we can get a higher immune response, but also see at what point, if any, we trigger some kind of safety issues. By the end of next year, we'll have the end of the phase I-B study. There we should have early signs of efficacy in a broader patient group. So by the end of next year, we should have data from 27 patients. Then we decide on the phase II design in collaboration with potential partners, and a licensing opportunity may open. It'll be very early at that point. Then we do the phase II Proof of Concept study.
Potentially, we go into gastric cancer because that's also a HER2-expressing cancer, so we could expand the market there, and then reach a potential target licensing event. We're targeting licensing after the phase II Proof of Concept. It's also possible that we'd have early approval there if the data was so strong and could skip a phase III trial. If not, we go into phase III, and then we have registration, and we target launch in 2032, 2033. But we don't plan to do the phase III study. We target licensing to a bigger partner after the phase II Proof of Concept study. Another way of looking at this is the marketplace. We start off in HER2 overexpressing breast cancer, then HER2- low and ultra- low, and potentially gastric cancer. Breast cancer alone is a EUR 27 billion market, and it's growing at around 7% per year.
Focusing on the HER2 space specifically, that's around EUR 11 billion per year, and some of the bigger drugs have made over 7 billion per year a peak. Growth drivers are expanding into other lines of treatment and international expansion. Based on all of this, we estimate our market addressable market at being over EUR 5 billion per year. Here are the deals that we've tracked over the last 10 years in this space, and we go a bit further back to show the large acquisition of Genentech by Roche, which included pertuzumab and trastuzumab. It has been an active deal space, mostly focused on monoclonal antibodies, ADCs, and tyrosine kinase inhibitors. What you can see is it's happening at various stages, some as early as phase I and II most recently, and all the deals are fairly large.
The smallest is 40 billion in terms of - or 40 million in terms of upfront payment, and then multibillion in milestones plus royalties. So these are big transactions that we're talking about, and it, of course, depends on what geographies are covered. A bit about us as a company. We have multiple assets in our pipeline. It's only the breast cancer vaccine that is 100% ours. We've co-developed with the University of Oxford a series of malaria vaccines. They have 11 clinical trials that are ongoing right now, one in phase II, which we expect to have data for next year, several in phase I we expect to have data for this year. We also have two influenza vaccines that we're working on. All the stuff except for the breast cancer vaccine is mostly grant funded. I'm just going to - our team is great. I'm going to skip to the end.
We have a large unmet medical need. We have a differentiated therapeutic approach, strong Proof of Concept data. We have catalysts coming up with the data that we expect in the coming months and year. Large market experience team, and I didn't get to say, but we're extremely financially prudent. Our burn rate is about 5.5 million SEK per month.
Let's start by talking about the breast cancer. Is this a first-line therapy, and do you plan to add on to existing HER2 therapies?
Yeah, the way it works is that we have to start with metastatic patients, and that's what we're focused on in our phase I trial. So these are patients who have tried the monoclonal antibodies and ADCs and are looking for just something that can help them.
We are approved for testing along with ADCs, so that takes us up a little bit earlier in the line of treatment, but eventually we do want to go earlier stage.
There's also a question here. It's a much broader question, but you mentioned that the number of younger women getting breast cancer is increasing. Do you know why that is?
I'm sorry, I don't.
No. It's just something that's it's something that's happening.
It's something to be aware of just because it does affect the case. Yeah.
And in terms of market, we have a question here of whether or not Asia is of interest to you.
Yes, Asia. The whole world is of interest. I mean, we want to help as many people as possible.
When it comes to gastric cancer, one thing that's really interesting is that we notice there is a higher prevalence in Asia, so that could make an obvious partnering case for us with an Asian partner down the road.
You have signed a letter of intent with WuXi Vaccines.
Yes.
Could you quantify the potential of a collaboration like that?
So WuXi is one of the largest partners that we could have in China from a manufacturing perspective and taking things further through into commercialization, and so right now we're just trying things out. I think it's a little premature to talk about the potential there, but we are working with them on several things and seeing where it can take us.
It's an ongoing process.
It's an ongoing process, yeah.
Do you consider bispecific or even trispecific constructs on your platform?
That one I'd like to defer to our scientists for.
I was going to say, is this something you ask a CFO?
No. Sorry, I'm not the PhD.
That's quite all right. You've also signed an agreement with the Technical University of Denmark to gain access to the Computerome 2.0. What's the aim of that?
Sure, so this is a supercomputer at the Technical University of Denmark , which is just down the street from us, essentially, and using a supercomputer is pretty interesting in early-stage drug development. We've had AI engagements with partners in Denmark before, and this gives us access to accelerate drug development in the future.
I think that's everything for the questions. Thank you so much.
Thank you.