My name is Bent Frandsen. I'm the CEO of ExpreS2ion Biotech. At ExpreS2ion, we tackle the deadliest threat to women's health, breast cancer, by developing a novel therapeutic vaccine. That is the focus of the talk that I have here. Every year, 2.3 million women are diagnosed with breast cancer, and up to 700,000 even are killed by this disease. In about 80% of cases, this is caused by a protein called HER2. If HER2 overexpresses, it can lead to the development of fatal tumors. Up to that, there are standard of care treatments against this, but in up to 50% of cases, patients may relapse. That is what we are addressing with our approach. Also, as incidence rises in the younger women population, this is clearly a high unmet need. Our approach, we call it ES2B-C001. It's a therapeutic vaccine.
We have spent years on developing this unique construct where we develop the HER2 protein by making the full-length protein that can address all four epitopes on the domain of the HER2 protein. By this, we can provide a broad polyclonal response. This is in opposition to the standard of care, which are mainly dominated by monoclonal antibodies or antibody drug conjugates, which are also monoclonal as such. As I mentioned, this provides a broad and durable immune response. We have seen that this can even be safe and scalable, and more importantly, also an ability to combine it with the standard of care treatments that are out there. This offers a lot of prospects versus the existing standard of care treatments. We spent three or four years, or more even, in preclinical stage and have compiled a lot of preclinical data.
This is just a snapshot. The short of the matter is that we've seen in preclinical settings that we can induce a broad immune response across HER2-specific epitopes. We can even suppress resistant tumor growth. There's something wrong with this. I need to press it backwards sometime. Forgive me for that. Anyway, we can also make tumor-free survival in mice, and we inhibit growth of the tumors. This is all very encouraging, obviously, now that we are starting the first clinical trial based on these findings. In the clinical development plan, we've just begun the first clinical phase I trial this year. It's a very exciting phase for us. We have started our first in-human safety trial in Austria at the Medical University Hospital.
Earlier this year, we obtained an amendment to our protocol so we can actually enroll patients in more clinical centers than in Vienna. We can also include patients that undergo standard of care therapy, which is important when we want to document that it's a compatible therapy we are developing. Going onwards, obviously, after phase I comes phase II. That's a very important phase because that's where we can develop the clinical proof of concept. That's our ambition to reach that goal. Also, we can broaden the scope by also moving into gastric cancer because HER2 is also an important protein in gastric cancer cases. In the phase I, we have dosed five patients now. That is great. We are on path on the first dose. We have seen initial immune response from the very first patient, which was very encouraging.
We saw in that first patient basically the right immune response and that we may have the potential to break tolerance, which is really the holy grail in development of therapeutic vaccines. Importantly, we need to have a data safety monitoring board meeting taking place so we can evaluate the first couple of patients here. That will take place before the end of the year. We can move to the second dose in this dose escalation trial. Going onwards, as I mentioned, we can broaden the scope of this considerably. Right now, we're looking into HER2 positive and HER2 low patients. We also have approval to include HER2 low patients, a very important group, which the new standard of care antibody drug conjugates are also addressing. We can also do that. Progressing down the road into gastric cancer as well.
That means broadening the patient potential considerably. Market-wise, it's a EUR 27 billion market with a high growth of 7% per year. The dominating standard of care treatments today, like Herceptin and Perjeta, which are monoclonal antibodies, and the new Enhertu, which is an antibody drug conjugate, those alone sell for more than EUR 8 billion per year. We believe that our vaccine, with the profile that we've seen in preclinical setting and the development plan we have for moving this on the clinical side, that we have a potential blockbuster on our hands that may be able to sell for more than EUR 5 billion per year eventually. HER2 is really a hot target in the oncology space.
There have been some multi-million dollar deals over the years, notably when AstraZeneca acquired the Daiichi Sankyo rights for the antibody drug conjugate Enhertu in a $7 billion deal. Of course, we are very inspired by all those deals and are looking into the same as we progress with our clinical phase I and II. Looking at ExpreS2ion's broader pipeline, it's led by ES2B-C001. That's really the lead project that we sponsor ourselves, that we have full control over. The rest of our pipeline is mainly in infectious diseases such as malaria and influenza and Nipah virus. Actually, all of these projects are more or less sponsored by having been awarded grants from the EU and the Danish state, etc. That is very good.
Most recently, on the malaria side, where there are four different projects which the University of Oxford are developing in clinical phase I and II, we've just yesterday announced a very nice licensing deal with Serum Institute of India, which is the world's largest vaccine manufacturer. They now have rights to proceed with the RH5.1 and R21 malaria projects. Not to forget, our platform, ExpreS2, which is the basis for all of these projects, whereby we make the antigen in our ExpreS2 production technology, is clinical phase III proven, as shown by the bottom, which is a COVID-19 vaccine asset, which Bavarian Nordic had licensing rights to and concluded even a phase III trial with. We have a very solid leadership team with more than a century of experience in bringing assets from the preclinical settings and even into phase II and beyond.
I'm very confident we can also proceed with our goal of getting a licensing partnership in place to make this being developed for the later stage clinical trials. In terms of financials, we have just today released our Q3 report. This is very hot news, I can say. We have SEK 37 million in the bank as of the end of Q3. In October, we concluded a warrant exercise, the so-called TO11 warrant exercise that brought in SEK 12 million. It was 100% subscribed, which was very nice. We now have a runway at least well into Q2 next year. Of course, we are fully focused on further non-diluting funding, strategic partnerships, and other means of getting funding for progressing on where we want to go.
This is just highlighting that we are looking into a large unmet medical need with our lead asset, having a differentiated therapeutic approach, strong preclinical proof of concept, and catalyst ahead for the clinical development. It is a huge market potential. Obviously, with the team we have in place, we are all set for moving on. Thank you.
Someone actually wants to get straight into the funding question there and is asking you to expand on the plans to secure funding after Q2 2026. It's a very specific question.
Sure. As I said, we have been reliant also for many years on non-diluting funding. We are very experienced in looking for sources even for that. That is actually a quite active plan that we have, even on the breast cancer vaccine. Many non-diluting funding actually target towards infectious diseases. We have some good sources for applying also for non-diluting funding for that. Obviously, we are quite active in that field as well.
Going back to the breast cancer, like you said, there's a lot of deals and so on and a lot happening in the area. How do you view the competition and your role in the landscape?
I think we bring on a very unusual attack on treating this disease with the broad polyclonal response that we see in preclinical settings and now also in at least the first patient of the phase I trial. I'm sure we'll see also good results on that front.
When do you expect the results to be?
We have a data safety monitoring board meeting here before the end of the year, where we'll look into the first patients that are being enrolled. We should get some data for those as well that we can release at that point in time. Before the end of the year, right? Back to the question.
Yeah, I'm sorry, I interrupted you. Yeah, how you view your role in the landscape of.
Yeah, this is a first-in-class therapeutic breast cancer therapy. I think we have a unique role in that setting. We can discuss with potential players who are in the field. We can combine our therapy with existing standard of care. I think it makes it very prosperous for bringing this therapy to market with such players and what we have as a product profile.
Thank you so much, Bent.
Sure. Thank you.