We will now proceed in our schedule here. The next company is ExpreS2ion Biotech, and we have CEO Bent Frandsen here to present. The scene is yours.
Thank you very much. Thank you to Aktiespararna for again returning here to beautiful Stockholm and present ExpreS2ion Biotech. My name is Bent Frandsen. I am the CEO of the company, and I will emphasize ES2B-C001, as it says here on the first page, which we boldly say will revolutionize breast cancer treatment. It is approaching the first clinical trial, and I am going to describe that much more to you. Just briefly about the company. ExpreS2ion Biotech Holding AB is the publicly listed company on Nasdaq First North Growth Market here in Stockholm. It 100% owns ExpreS2ion Biotechnologies ApS, which is the Danish subsidiary where all operations take place. That is where we have our technology platform that we call ExpreS, and where we work on our vaccine pipeline, and we also have a CRO services business.
Importantly, we own 34% of a company called AdaptVac that we co-founded back in 2017 as a spin-out from University of Copenhagen. They hold a technology called virus-like particle technology or VLP technology, and that is a very important component of the breast cancer vaccine asset that I am going to describe to you shortly. The ExpreS2 platform already has considerable proof of concept across all development stages in R&D. We are extremely proud that it is actually Clinical Phase III validated, as shown to the right. We developed a COVID-19 vaccine that was fully outsourced to Bavarian Nordic, and they met the primary endpoint in a clinical Phase III trial. It showed non-inferiority to COMIRNATY, the COVID-19 vaccine from Pfizer-BioNTech, and thereby it validated the technology platform from ExpreS2ion as well as AdaptVac, because it was also a combination of ExpreS2-made antigen coupled to a VLP.
We furthermore have University of Oxford working on several different malaria projects using our ExpreS2 technology. They are in clinical phase I and II, and last month, in October, we announced a term sheet with Serum Institute of India. They take an interest in two of these malaria projects and want to develop them to the market, sponsor the phase II and phase III trial, and so on. That is the world's largest vaccine manufacturer, so we are really happy that we have a foot in the door of that huge company. Furthermore, we work in earlier phase projects, and I am going to highlight the ES2B-C001, as I mentioned here. Earlier than that, we have some infectious diseases projects as well, which I will not have time to cover in depth at this event.
When you look at our core pipeline that we fully control or semi control, we show it like this. It is in that sense, quite simple. We have a breast cancer vaccine asset approaching phase I. We filed the CTA, the Clinical Trial Authorization, a few months ago, and we are eagerly awaiting the feedback from the authorities to get approval to start the first clinical trial. We have a cytomegalovirus project, a CMV project, that we do in collaboration with another Danish biotech company, Evaxion, which is in the discovery phase. We have spent time the last two years to come forward to a stage where we can select a lead candidate and bring this forward. We have exploratory research, where we take our scientific expertise and patent when we can, and hopefully can take something out here to expand on our pipeline.
All of these addressing multi-billion euro markets. We have a very strong leadership team. Each leader has several decades of experience working with R&D, scientific affairs, and progression of products in the medicinal industry, even into the market. We have a Board of Directors, which is headed by Dr. Martin Roland Jensen. He was one of the founders of the company. Together, the leadership team and the board, we have more than 300 years of experience in bringing vaccines from the lab bench all through to the commercial stages. We also have a very important oncology scientific advisory board in this context, consisting of six high-level key opinion leaders in the field of cancer research, and I want to emphasize Professor Rupert Bartsch from this group.
He is working at the Medical University of Vienna and has paved the way for us to file the Clinical Trial Authorization to the Austrian authorities, and that is where we are going to conduct the phase I trial when we get there. Speaking of breast cancer, it is a terrible disease, and it can affect one in eight women during a lifetime. There are concerning statistics around diagnosis, and even deaths in this disease area. In 15%-30% of cases, the disease is characterized by a protein called HER2. When HER2 is overexpressed in your body, it can lead to an aggressive state of breast cancer, and it can lead to higher recurrence rate and increased mortality at the end of the day. HER2 is the target of the vaccine that we are working on.
Across HER2 cancers, we look into a market with 1.7 million patients every year. We are, in first instance, looking at HER2 positive cancers, but we also have in discussions with the authorities from Austria, the right also to work on HER2-low cancers, which is good. We have seen some preclinical evidence that we can also target gastric cancer, where HER2 is also highly prevalent, especially in Asia. Looking across HER2 positive, HER2-low gastric cancer, that is how we envision we are going to expand the market potential with this. There are other HER2 expressing cancers that we can target into. Then in the long term, we are talking about a therapeutic vaccine in first instance, so patients will have been diagnosed with the disease, and then we use our vaccine to hinder recurrence, or resistance to standard treatments.
In the long term, we hope for prophylactic vaccine using this approach. Our vaccine is designed exactly as we designed our COVID-19 vaccine. We make the antigens, which are shown here on the surface of this structure in our ExpreS2 technology. We couple these antigens on a virus-like particle using this technology from AdaptVac, thereby we have a unique form, which is very easy to produce and very consistent. Basically, we have seen evidence that it works. The concept of using a VLP like this is already in commercially available vaccines. HPV vaccines, which I am sure you are familiar with. There are vaccines called Cervarix and GARDASIL from big pharma. They use the same concept. As I mentioned, it makes a vaccine very efficacious, highly immunogenic.
It is highly safe in this manner, and there is a longevity parameter, which is very important that we can show an effect that is long-lasting. You can combine it with standard of care and basically have an off-the-shelf scalable and cost-effective vaccine. We have, over the last couple of years, made a compelling preclinical data package. This is just a snapshot of some of the preclinical data that we have, where we have investigated the outcome in mice. To the left, you see a therapeutic mice model where these mice will be inoculated or challenged with tumors from day 0. Then we see how it evolves in three groups, where they get our vaccine with an adjuvant, as shown in the red or without an adjuvant, as shown in the green. Combining it with an adjuvant is very normal and standard in the vaccine. Vaccines apply adjuvants.
In this case, we see when applying an adjuvant, we have basically zero development of tumors, looking at these mice in that group. Whereas if you do not use our vaccine, you will see the mice getting strong tumor growth. To the right, you see actually a preventive mice model where these mice are transgenic, so they are disposed for development of tumors. In the control group, they will die at day 60. But those who actually get our vaccines with an adjuvant, they survive across 600 days, which is remarkable considering the lifetime of a mouse is less than two years. This is what we cling our hopes to, so to speak. We find it very compelling and we look forward to evidence this also in a clinical setting. Looking at it across competition, there are monoclonal antibodies, antibody-drug conjugates, and tyrosine kinase inhibitors.
These are the standard of care treatments against breast cancer today. They come with some drawbacks on the safety side. The first five rows here show various safety issues with the known standard of care treatments. We have not observed any of this in our preclinical setting, and of course, that is what we also are going to look into in our clinical stage. Standard of care resistance, very important. Up to one third of patients may develop resistance, meaning they will not get any benefit, and the disease may recur. We have actually seen very strong preclinical evidence that we can hinder recurrence. Furthermore, we have seen the long-term effect, and it is very easy to administer, and it is VLP based and very cost effective.
Going forward, as I mentioned, we spent some years doing the non-clinical package so far. We are now on a very important point where we filed the clinical trial application a few months ago. We are awaiting the feedback from the Austrian authorities as we speak. As we announced when we filed the CTA, we expect the trial to start in Q1 2025. That is certainly still the case. Going forward, we already have to look into what goes on after a phase I trial where we have documented the safety. Then you want to obtain a clinical proof of concept showing efficacy as well. That is also my reason for talking about this, both to investors and to potential partners, because we want to have that value-creating milestone when we get the proof of concept in a clinical setting.
We want a partner to take over when it comes to the phase III and the commercialization of this asset. We see some very important milestones here in the short term. Right now, obviously, we are approaching the year-end. We are also approaching getting that CTA approval. It is a critical milestone in terms of regulatory approval, so we can start the clinical trial. During 2025, we, of course, will investigate how it works. I am sure we will be able to provide some updates on the clinical phase I trial. It is a trial that will last 12-18 months. So we expect the trial results to come in 2026, which can be a gateway, as we call it, to licensing or partnering activities.
It is always good with clinical evidence when you move into business development on such an important asset. It is also important for us to move into the clinical phase II going onwards. Right now, as we speak, we have a TO10 warrant subscription window going on. It started here on November 20, and it ends on December 4. If you find this interesting, of course, I encourage you to look into our warrants and get some shares for the current price of SEK 17.91. There is another one program. Both of these are part of the rights issue that we did earlier this year. The TO11 will be triggered in September, October next year. We see this as a way of financing our clinical activities and the company going onwards here to address the future value drivers.
I would also like to emphasize that the value in this is immense. It is really high value market we are talking about. We have seen deals in this space which are multi-million worth of euros, and that is the space we are stepping into, getting into the clinical phase now. So just to summarize, we are developing a HER2 VLP vaccine. We call it ES2B-C001, and we are targeting HER2-expressing cancers, and in first instance, breast cancer. This is actually a EUR 27 billion market with high growth over the coming years. We have a very strong preclinical data package, and it has all been submitted to the authorities. So now we are waiting for the approval to start the clinical phase I trial, and we are very committed to getting this further ahead so we can get into the high-value phase of our clinical phase II. Thank you very much.
Thank you so much for the presentation. Just as a first question here, you have a, let's say for a small company, maybe a broad portfolio of different candidates. Is it hard to manage them all as a CEO, or how does it work?
Well, we focus on one oncology asset with multiple indications granted, and then several infectious diseases vaccines. Most of the infectious diseases vaccines, which I didn't have time to present here, we're talking about malaria, influenza, and Nipah virus. They are more or less funded by non-diluting funding from grants from the EU and other sources, and they are coordinated in various consortium, which really doesn't require a full CEO attention, to be honest. So it's managed in these research groups. My main focus is really to bring the breast cancer vaccine forward.
That is the-
... pinpoint focus, so to speak.
Regarding, as you mentioned as well, you first submitted your clinical trial application for breast cancer here. Can you tell us more about the milestone? Any timeline in place right now, or can you give us some more detail there?
Yeah. Well, I think the time started when the 6th of August, we submitted the clinical trial authorization to the authorities in Austria. That coincided with their summer break, and they need to validate if it follows the right format. We use a so-called CTIS format, which is a new EU system for filing such documents. They returned 2nd of September to say, "Okay, you fulfill the criteria for submitting a CTA." So that's when the clock started in reality. Then the phases where authorities, usually, it's very standard. They have some requests for information, as they call it.
Yeah.
We've had that in three instances the last couple of months here.
Yeah.
When that happened, the clock stops, and then we have a certain period to respond to them. There's nothing unusual in any of these questions, so that's why I'm very comfortable in this reaching to an approval.
Yeah. Sounds good. You mentioned here when we started talking about malaria a little bit, you communicate a pretty big milestone here, that you reached an agreement with the Serum Institute of India. Regarding this, can you give us any more deep insight to that collaboration, what you hope it will generate for you and-
Yes
Yeah.
Yeah. Well, first of all, it is a term sheet that we announced. Right now, we are in a phase so we can make a definitive agreement, a final agreement on this. It basically grants Serum Institute of India the right to use our ExpreS2 technology platform to manufacture and commercialize these two malaria projects out of that. As I mentioned, the Serum Institute of India is the world's largest vaccine manufacturer, and they have a presence in more than 170 countries around the world, including U.S. and the EU. They actually produced and distributed more than 2 billion COVID-19 vaccines during the pandemic. I am really excited that we have a foot in the door with that company. Of course, the agreement is within malaria.
We have communicated, we will get some milestone payments, and we will get some royalties, but we have also communicated it is lower milestone payments and it is small royalties of sales. That is how it works.
Yeah.
I think the most important thing is the blue stamp from getting an agreement in place. That will make us very proud, and we will see. Then we have-
Yeah
... a dialogue with them and if we can-
Yeah, exactly. It might work as a door opener for further more-
Yes
business and so on.
Yeah.
Yeah.
Exactly.
I think if I've seen correctly, you communicated that you were at the BioStock talking to potential partners or something. Can you give us some insight there? How was the receiving from the other partners there?
Sure. That's correct. I was recently at BIO-Europe, one of many events that we go to every year, to describe what we do to potential partners. It's a big company dating market where you have your profile as a company and with your assets described, and there's a good opportunity to match with companies who fulfill the same criteria. That's how it works. I can say that I'm able to raise eyebrows with what we work on, right? That's why I'm eagerly wanting to get this into the first clinical phase so we can start generating some clinical data on the breast cancer vaccine asset, because then it becomes more partner-ready. But I've also said the highest value, and that's really for any biotech company, you want to have the clinical proof of concept, which is the end of clinical phase II.
But you have to face reality-
Yeah
and see if there's discussion and an attraction from the big pharma company or whoever the partner could be to buy into such an asset at an earlier stage, and maybe it's worth it.
As you mentioned a little bit, you raised capital in summer, if I remember correctly.
How long are you funded right now? You also talked about the warrant offering right now. How long are you funded, and how long will the money take you, so to speak?
Yeah. You can never really comment-
No
exactly on the one way. I cannot do that. The TO 11 warrant program, which is exercisable in September, October next year, also fell into this. But we have money to get far with the phase I trial.
Thank you. Just a finishing question here. Why should an investor take a closer look at ExpreS2ion Biotech as a next potential investment?
Well, we've discussed here or presented a revolutionizing breast cancer vaccine asset. It's a one-of-a-kind vaccine approach that can hinder resistance and potentially give the long-term treatment to breast cancer patients. That's a very strong one. Then we have the malaria vaccines, which are being out-licensed and can generate future revenue with the world's largest vaccine manufacturer. I haven't really touched that much on our platform and the exploratory research, where we're working on also exciting things in our labs that are unique as well.
I think our message then is, if you are more interested, check in their website and read more about the other products as well. Thank you so much for presenting here today and answering our questions, and we will be excited to follow you.
Thank you very much.
Thank you.