I'm pleased to introduce ExpreS2ion Biotech to you. My name is Bent Frandsen. I'm the CEO of the company, and the main focus of my pitch here is actually our breast cancer vaccine asset, as was just alluded to. We call it ES2B-C001. It has a very strong preclinical package, and we're just on the verge of bringing this into the first clinical phase I study as we speak. First, some words about the company. We are listed on Nasdaq First North Growth Market since 2016. We are operating in Denmark. The Swedish holding company owns ExpreS2ion Biotechnologies ApS, where all operations take place. We have all our lab facilities and development operations in Denmark. This is also where we have our protein expression platform that we brand ExpreS2. This is what was the reason for establishing the company back in 2010.
It's been used tremendously, with more than 100 clients for the first 10 years of the company's lifetime, and we're now using that in our own vaccine development pipeline and still maintain some service business around this platform. Furthermore, we own 34% of a company called AdaptVac. We co-founded that company back in 2017 with a group of researchers from University of Copenhagen. They had invented a proprietary virus-like particle technology, and it's important to mention here because it's also part of the breast cancer vaccine asset that I'm going to talk more about. Our ExpreS2 platform has been used, as I mentioned now, for 15 years, and we have strong proof of concept, also clinically. I'm very pleased that we have actually a phase III clinical validation of this technology.
It was an integral part of the COVID-19 vaccine asset that Bavarian Nordic, they brought all the way through to clinical phase III last year. For commercial reasons, they shelved the asset, which is a pity for us because we were looking into some commercial milestones just around the corner. Bavarian Nordic is a huge vaccine player. They need to focus on their mpox business and bringing a COVID, sorry, chikungunya vaccine to the market shortly. Anyway, as a biotech company, we have a clinical phase III validated platform. Not many biotech companies have that, and that's great. ExpreS2 is also used by University of Oxford in several clinical stage malaria assets. Four different projects running in phase I and phase II, all sponsored by University of Oxford and their grant awards.
Then we have the preclinical stage, but now actually in a phase of being approved for the first clinical trial, the HER2 breast cancer that I'm going to speak more about shortly. We have earlier in our pipeline, various infectious disease vaccine projects in CMV and influenza and Nipah virus as well, more or less funded by non-diluting funding from various grants. But HER2 breast cancer is where we focus. Breast cancer is, of course, you know, a devastating disease. It can affect up to one in eight women over a lifetime, and more than 600,000 patients die every year from this disease. In 25% of breast cancer cases, it's caused by overexpression of a protein called HER2. HER2 is a protein that we all carry, but this overexpression can lead to, yeah, at the end of the day, fatal breast cancer cases.
This is the target of our vaccine approach. We call it ES2B-C001, and it is made of antigens that are being produced in our ExpreS2 platform, and we couple it to a virus-like particle, the VLP technology that I described earlier. The good thing about the antigens made in ExpreS2 is that we actually target all four epitopes of the HER2 protein. This is actually an advantage if you look to existing standard of care monoclonal antibody treatments which target only one epitope. The fact that we can couple this or display it on the surface of a virus-like particle means that when you administer this drug to the body, the body will effectively, in theory, induce an immune response to get HER2 antigens to handle this disease. We see the VLP concept already in a commercial setting.
It is also a VLP concept in HBV and HBV vaccines from big pharma. As I mentioned, it is a very efficacious platform, very safe, and provides also a durable immune response, which we saw in the case in the COVID-19 vaccine. We also expect here to overcome resistance with a durable effect. It can be combined with standard of care and basically is an off-the-shelf, scalable, and cost-effective treatment opportunity. We have a very compelling preclinical data package that we have generated over the last three years. This is just a snapshot. A lot of this has been published in a 2022 scientific paper. We made this together with University of Bologna, which has state-of-the-art mice models in the breast cancer vaccine field.
The short of the matter is, if you follow the red curve here, which is our vaccine versus the other control groups, you can see a complete inhibition of growth of tumors in a mice setting. Even actually 100% survival if you inject this vaccine in mice that would otherwise develop breast cancer. That is extremely encouraging to us, and we have seen this again and again over the last three years. Now we hope we can translate this into clinical evidence as well. If you look at it from a competitive point of view, this is a table that shows monoclonal antibodies, antibody-drug conjugates, and tyrosine kinase inhibitors in the first three columns. These are standard of care treatments in this field today, and you can see other vaccines as well as our vaccine, ES2B-C001.
We really believe that we have an edge here across existing standard of care and even other vaccine approaches. This goes even when it comes to side effects. It is actually known that monoclonal antibodies, in up to 8% of cases, can cause cardiovascular side effects. We do not believe we will experience that. We can overcome the resistance. In up to 30% of cases, patients will actually develop resistance, so they will not benefit from a monoclonal antibody treatment. We have also evidence, which I have not time to show you here, that we can overcome this resistance with our vaccine approach. It is an easy administrable therapy, and then it is VLP based, as I mentioned. We believe it is very cost-effective. We can produce gram per liter material both with the antigen and the VLP. It is looking good.
Going ahead, we have now financed the non-clinical package over the last couple of years, and we are right now in a waiting position because one month ago, we filed the clinical trial application to conduct the first clinical trial, and that's a very exciting waiting time. We expect to start the trial for real in the first quarter of 2025. We have just closed a financing round and received other financing earlier this year that can bring us ahead with this clinical phase I trial. Of course, next steps in the future will be to actually demonstrate clinical proof of concept, because eventually, as a biotech company, you always have the ambition to actually get a clinical proof of concept after clinical phase II. That's the highest value.
Facing reality, we are actually already in dialogue with various potential partners about this concept and the preclinical data that we have so far. So depending on the ability for a partner to progress on this asset going forward, we'll see. It depends on what kind of financing there is in this. We have other indications also on this, going forward, when it comes to broadening beyond breast cancer. For example, HER2 also is very prevalent in gastrointestinal cancers as well. Very shortly, we have more than 200 years of experience in our management team and at the board. We have a very strong oncology scientific advisory board.
I'm just highlighting the three of the key opinion leaders below, and I want to acknowledge Dr. Rupert Bartsch to the lowest left corner, who is a professor from Medical University of Vienna, and that's exactly where we're going to start the first clinical study here soon. When it comes to financing, as I mentioned, we've just concluded a financing round. This actually includes two warrant programs that are exercisable here around 1st December this year and around 1st October next year. So look for news coming from us here in the near future. Of course, we are going to inform about the status of the clinical trial application, and then look into starting the first-of-human trial and seeing some observations and results coming out here in the very near future. Just a summary of this, and that said, I'm ready for questions.
Thank you so much because I think you have interesting questions to answer. Please come and join me here in the center. First question, how do you intend to position ES2B-C001, did I get that right, in the breast cancer treatment landscape?
I think we are inspired by the big pharma companies who are marketing the VLP vaccines such as Cervarix and Gardasil against cervical cancer. Commercialization strategy, we will look into that. As I mentioned with that table, looking at the advantages versus competitors, that also goes into our positioning as well. All these thoughts of course, we are thinking about.
Mm-hmm. Looking to enter phase I with the ES2B-C001, you are already looking for a partnership. Why is that so early?
I think as a biotech company, you need to present the data at scientific congresses and at investor events like this, and then partnership conferences as well. I think you need to start as early as possible to show the evidence that you have. I have close to 30 years of experience in the life science industry and have been responsible for business development and partnering activities for decades, and you need to start early. That doesn't mean that you immediately can make a deal, but it means that you get some notion and thoughts triggered at the right companies early, and then they want to follow you. That's important. Then we are in a dialogue, and then we will see what happens.
Is the ES2B vaccine better than existing HER2 antibodies? Will the vaccine replace monoclonal treatments?
That's a very good question. At the end of the day, of course, we have the ambitions for being first-line treatment. Of course, who wouldn't have that ambition? It's a very established field, the breast cancer field, especially with the monoclonal antibodies out there. We can, as I mentioned, overcome the resistance, so we can actually bring this therapy on top of existing treatment. We'll see if we eventually can actually replace it.
Mm-hmm. What will pricing be when HER2 biosimilars?
That's a difficult question. There are so many factors into a pricing estimate. Of course, looking at monoclonal antibodies that can cost more than $100,000 for treatment, we're looking into a high price because of the premium advantages of this vaccine approach.
How much have you thought about this, or do you think it'll come after a while?
I think we are forced also to think about these things from very early on.
Setting an exact price, of course, we also make our business cases and develop our own net present value models based on estimates of this, so I'm not going to disclose our details on that one. It's going to be competitive.
I can understand that you can't disclose it here, but is there a number internally already?
Yeah.
Mm-hmm. Great. What interest have you seen in the project and your platform so far? That will be the last question.
Yeah. As I mentioned, we also go to scientific congresses where we actually present the preclinical data package in a scientific setting, and we get a very good dialogue. That is both across events in North America and Europe as well. Our Chief Scientific Officer, Dr. Farshad Guirakhoo , who is mostly handling these, he is keeping himself busy on that front. That is actually also kind of business development in a way.
Mm. Thank you so much for answering our questions and for your presentation.
Thank you.