All right. My name is Bent Frandsen. I am the CEO of ExpreS2ion Biotech. I hope you do not mind that I take this presentation in English. It is a very simple presentation, actually, with some very straightforward messages. We make innovative vaccines for a healthier world. We have the usual disclaimer, since we are listed on Nasdaq First North Growth Market in Stockholm, so I will be making forward-looking statements. You can read the full details when we make a copy of this presentation on our webpage. ExpreS2ion Biotech Holding AB is the listed company since 2016 on Nasdaq First North Growth Market in Stockholm. It is the holding company that owns 100% of ExpreS2ion Biotechnologies ApS, which is the Danish subsidiary, which resides in Hørsholm in DTU Science Park, just north of Copenhagen, where all operations of the company takes place.
Here we have the protein expression platform technology, which was the basis for the company's foundation back in 2010. We have the vaccine pipeline we focus on, and we also do contract research services at this facility. We have about 20 employees, and we also own 34% of a company called AdaptVac, which was a spin-out of University of Copenhagen, and it is an important entity in this connection because they have the VLP, the virus-like particle technology, which has played an important role in ExpreS2ion's story. Our management team consists of these four people. Myself, Bent, and our CFO, Kees, our Chief Scientific Officer, Farshad, and our Senior Vice President of R&D and Technology, Max. We have decades of experience in leading biotech companies, financially, generally, and of course, with respect to R&D. All in all, more than 100 years of experience in this.
Let me give you some details around our technology platform. We call it ExpreS2. The reason why we spell ExpreS2 as an S2, and why we have the S2 in the middle of our company name is because we work with so-called Drosophila S2 insect cells. We have a proprietary technology for production of recombinant proteins using these so-called fruit fly cells. There are two enablers using this technology. We can develop novel vaccines, and we can produce hard to express proteins. These are key important factors in this technology platform.
It comes with a lot of advantages, such as safety and immunogenicity, and not least versatility, which means that we can make these recombinant proteins for vaccines by applying adjuvants, which is a common component in vaccines, or apply them to a virus-like particle technology, which I will tell you more about shortly, or we can use them as standalone. Furthermore, we have advantages in terms of speed and high yields. We can make more than gram per liter yield, which is advantageous. It is very easy production technology, and they are very stable. We can work in room temperature with these proteins. The ExpreS2 platform has actually been validated all across the value chain when you look at drug development from early discovery through even to clinical phase III.
We are very proud that we met the primary endpoint in a clinical phase III trial last year with a COVID-19 vaccine project, which was sponsored by Bavarian Nordic, the exclusive licensee for this project. We can now say as a biotech company, which is early stage, but we can say that we have a clinical phase III validated technology. Not many biotech companies can say that. That is very useful in our discussions in terms of business development and in general, also speaking with regulatory authorities as we proceed. There are several projects, also in clinical phase I and II, handled by Oxford University, using our ExpreS system as the basis for the production of these malaria antigens. We have a preclinical stage, a HER2 breast cancer vaccine, which I am going to focus much more about.
We have a CMV, cytomegalovirus vaccine, influenza projects, and most recently, also Nipah virus project, where we also apply the ExpreS platform. In terms of delivery vehicles, this is another component that I alluded to in the beginning. We use VLPs, virus-like particle, because we know they are safe and they can enhance the efficacy of a vaccine. This is a technology that I described coming from AdaptVac, which we own 34% of. They come with also nice advantages, and the best thing is that we already know of approved vaccines in the market applying VLP technologies such as Cervarix and Gardasil, which are already approved HPV, human papillomavirus vaccines, which have been marketed for a number of years. Virus-like particles also come with a range of advantages such as safety, low toxicity, higher immunogenicity.
They are very cost-effective to produce, are also very stable, and have a right size in the sense that they mimic viruses but are completely safe. If you look at our pipeline in terms of what is controlled by ExpreS2ion, it is actually quite simple. We have a late preclinical stage oncology asset that we call ES2B-C001. It is a HER2-directed breast cancer vaccine, which as I mentioned, is in late preclinical stage. We have an infectious diseases program against cytomegalovirus, CMV. We call it ES2B-I002, this program, and it is in the lead optimization phase, where we expect to select the lead candidate within the next year. We have certain undisclosed projects which we are right now looking into the IP situation here. We have filing patent applications, and once we have those in place, I can disclose what those are all about.
We certainly take our skills and develop novelties here in the vaccine field. I want to deep dive more into the breast cancer vaccine asset, the ES2B-C001. The epidemiology around this is such that one in eight women may be diagnosed with this breast cancer during a lifetime. In more than 25% of cases, there will be an overexpression of HER2, which is a self-antigen that all people have, but due to the overexpression, it can lead into tumor development. Annually, it is assessed that there are 1.4 million patients in the top eight countries. These are data that we have from AstraZeneca. We look into an addressable market of about 1.1 million patients.
Deep diving further into the market size, we look into a serviceable, obtainable market, which at the end of the day may be 25,000 patients on an annual basis, which are eligible and targetable for getting a therapeutic vaccine based on our HER2 VLP. If we look at the very high prices that are in this space, we can actually calculate a market size of around 2.8 billion , which is a revenue potential that we look into not many years after launch. With the advantages that we have, we expect we can achieve a sizable sales revenue here. What is it that this breast cancer vaccine asset can do? We also know that with the common treatments on the market, monoclonal antibodies, that patients develop resistance. We have seen with our vaccine that we can overcome resistance.
Herceptin, also known as trastuzumab, is a well-known monoclonal anti-body treatment today. We have seen from early on that we can actually overcome resistance, and that's what we have demonstrated in this in vitro assay, where I think you can appreciate the pictures showing the development of tumors. If you look to the right side, you will see the application of our vaccine, where even in trastuzumab-persistent cells, as shown in the lower right, you have lesser development of tumors. That's unique and something we are very thrilled about. We have shown other proof-of-concept preclinical data in animals previously. The left one here, I highlight again because we've seen that we can completely inhibit the growth of tumors in mice, which are otherwise transgenically prone to develop breast cancers.
Furthermore, the newest data here on the right, here you can see survival data where the red curve shows our vaccine with an adjuvant. You actually see now in the course of 600 days that none of these mice, which are otherwise prone to develop tumors and will die within 50 days, as you can see on the control group with the black curve, they survive. So it's very astonishing, actually. Right now, we are in late preclinical stage, as I said. We have completed the preclinical safety study, and we are finalizing the report for this, which will be included in our clinical trial application package. On the CMC manufacturing side, we have initiated the drug substance production that will lead into the drug product production, which will be used for the clinical supply. That should take place here in the second quarter, so right around the corner.
Then we proceed with an investigator-initiated trial. The aim is really to get our clinical trial application in place this year, so we can initiate this clinical trial shortly. Furthermore, we have speeded up our business development activities to take partnering discussions to get a sense of the value of this asset in a licensing agreement. So across these aspects, non-clinical CMC, regulatory, and clinical, we are proceeding, as I mentioned, and things are going as planned. Moving gear from breast cancer to cytomegalovirus, just a one-page overview. This is a project that we initiated in December 2022 together with the Danish biotech company called Evaxion, where ExpreS2ion and Evaxion together performed the research to develop a novel CMV vaccine. ExpreS2ion has the first right to license that in and take it forward. We have progressed on the research. We are on track. We have the material ready.
We can test it now in vivo in animals. Again, a good place to be with this asset. It proceeds according to plans. Finally, I also want to highlight the so-called VICI-DISEASE Project, which is based on a grant through the EU Horizon Europe Program, which ExpreS2ion and a consortium of partners were awarded. It was announced here in December 2023. It is an EUR 8 million project, and more than 50% of the proceeds in this actually goes to finance ExpreS2ion activities in this setup, which is a four-year program, including financing of a clinical phase I trial, which we, of course, hope to lead into within the next four years. This is a busy slide, but it is to summarize over the course of the last four years since we actually initiated our pipeline-focused strategy in 2020, how the costs have evolved.
You can see the cost level here in euro millions, and you can see across our general activities and on our breast cancer vaccine asset, our CMV asset, and also on COVID-19 vaccine asset that we were engaged in, how we have proceeded. We have been able to raise the funds over the years to get the clinical phase III trial validation. If you look at the right side, we are now looking for partners and alternative fundings to progress on the breast cancer vaccine asset and moving ahead. Finally, as a last slide, turning again back to our cash balance at the end of December 2023. We had SEK 58 million in the bank. We restructured the company in the third quarter of 2023, so we have a significantly lower cost base now than we had when we started 2023.
We have sufficient cash to move into 2025, well into 2025. However, it does not include the cost for actually going ahead with the clinical phase I trial for the breast cancer vaccine asset. So that is the challenge we have to face this year, how we can proceed into this very important next step, getting into the clinical phase I with the breast cancer vaccine asset. As I mentioned, we are moving ahead on business development and alternative funding to get that in motion. That is it. I am ready to take some questions.
Yeah. Thank you very much, Bent, for your presentation. We can start off with the breast cancer vaccine. In your reports and so on, also now, you discussed the possibility of finding a strategic partner or something like that. How is that developing? What is the interest in the market for this opportunity?
Well, over the years, we have had some very preliminary dialogues with various potential partners, especially in the big pharma field. They take a great interest in both the target, but also the way we proceed with our antigen made in our proprietary ExpreS2 system, as well as the application of this VLP system, especially now that we have the evidence from the COVID-19 project, which use exactly the same technologies as we apply in the breast cancer vaccine asset. But specifically on business development, we are now actively retaining a business development professional consultant bureau to support us actually in these activities.
Yes, but the COVID vaccine is obviously a good selling point, I guess.
Indeed. As I mentioned, it's a clinical phase III validation. That's very good. The primary endpoint in the clinical phase III with the COVID-19 was met. We have also seen long-term data in the COVID-19 asset. That means that after 12 months, we could still see the same level of protection in the COVID-19. Bear in mind, that's really, according to our Chief Scientific Officer in this field, the only technology that has shown long-term protection in the COVID-19 field. We use the same technologies with the breast cancer vaccine approach. So we hope that we can show the same having a long-term protection.
The obvious question is then, how restless are you? Do you have a deadline when you decide that we need to go by ourselves and maybe raise more money to take care of this opportunity?
Ideally, we would like to continue with it ourselves to increase the values. I am sure if we can get a clinical proof of concept that would be in a phase I/II setting, we could increase the value significantly. We have to balance how it works in terms of potential funding or partnering in that connection.
How fast can you actually start the clinical trials for this breast cancer vaccine?
If we can-
In a good scenario, how fast can you actually?
Well, in a realistic scenario, we may be able to file the clinical trial application here in the second half of this year and initiate the clinical trial within a year.
Okay. Very good. You have a strategy based on several different areas, if I read you correctly. When it comes to this, your legacy is contract research, right? And you are going back to that as well, I guess. Are you looking for clients for that or what can we expect going forward from that?
It is a good description, our legacy business. It supported us well in the pre-pandemic times, and we had an increase of revenues back then of more than 30% per year over a three-year timeframe. We have not been able to put the same focus on the sales of these activities during the pandemic and post-pandemic. We are a pipeline-focused company, and we want to increase our market value by progressing on the pipeline activities. It requires a different funding level than what we can get out of the service business. We maintain the service business for strategic reasons because it is also a gate entry into various companies. We have still recurring clients that makes it a nice business still.
Yeah. The cost of capital has gone up, right? So it is more difficult to raise money. Does that affect anything of your strategy when it comes to that kind of research where companies come to you to help them research product?
No, not as such. In the service business, we can still honor any request that we get from potential clients. We have to be realistic on the timelines of servicing clients. In the past pre-pandemic times, we would try to get clients in as fast as possible and do the invoicing as fast as possible. Now we have to fit it into how we prioritize our pipeline activities.
Yes, of course. The malaria vaccine, now obviously that's a very good thing for the world as a whole. If that becomes successful, how is that financially affecting you?
Well, there will be a licensing element in it, so we would expect some milestone payments from getting a malaria vaccine on the market and royalties of sales, of course.
You will get a royalty for that as well. Okay. Very good. You write in your report that you want to capitalize on your platform going forward. Could you elaborate a little bit what you mean when you say that?
Well, we both have the ExpreS2 platform. We also have the 34% ownership of AdaptVac, which is a very interesting company with their own activities on various projects applying their VLP technology. That's a platform which may be monetized somehow. It's just speculation from my side-
Yeah.
...because we use it in our breast cancer vaccine assets. It's just another way of saying that there are various gems.
Yeah. You will try to look to realize value, right?
Exactly.
And if we go back to the breast cancer vaccine, you have said that you might look for a partner, you might go alone, and you might do an asset sale. But if you are going to sell the asset, you still want the clinical proof, right? Or could you elaborate a little bit about that?
Well, so far it is a vaccine approach. Again, we have seen phase III validation of the technology being applied here.
Yeah.
So it is interesting in itself, and it raises eyebrows among the right companies. So of course, it is a give and take of how much you need to take it into the clinical stage yourself or with a partner. So it is a constant discussion.
It is an open-ended question, right?
Yes.
Yeah. Thank you very much for coming here.
Thank you.
We need to move on.