ExpreS2ion Biotech Holding AB (publ) ($EXPRS2)

Hi, and welcome to BioStock Studio. Where today we will listen to a presentation from ExpreS2ion Biotech's CEO, Bent Frandsen. Welcome, Bent, and please take away.

Thank you very much, Cecilia, and thank you to BioStock for hosting this short presentation of ExpreS2ion Biotech. My name is Bent Frandsen. I'm the CEO of the company. And I'm going to focus primarily on our first-in-class HER2 immunotherapy, which is a novel breast cancer therapy. It's now in clinical Phase I, and I have also an important financing update in connection with this presentation. So briefly, our investment case. You can say we have our lead asset, we call it ES2B-C001. It's a HER2 immunotherapy against breast cancer, and it's in clinical Phase I now. It's based on a proprietary platform, the ExpreS2 protein manufacturing platform. And the wonderful thing about this platform is it is clinical Phase III validated. It's already been used in more than 4,000 people, and it demonstrates superiority in making proteins for biologics. Furthermore, we have a very important strategic position, namely the 34% ownership of AdaptVac, which holds an important VLP technology, which is also part of our lead asset. And we have a clear partnering strategy in the company going forward. So basically investing now, that's because we have a first-in-class HER2 immunotherapy against breast cancer. We have seen early Phase I immune responses already now and no safety concerns have been observed, and we have a clear path to value inflection and partnering. So what are we addressing with our lead asset? Well, there are limitations in breast cancer therapy today, resistant develops with current therapies, which are mainly monoclonal antibodies and antibody drug conjugates, and they have limited durability. Our ES2BC-001, HER2 VLP therapy is a full HER2 extracellular domain-based product, and it makes a polyclonal immune response, which is a very strong feature. So this is important to create memory in the immune system. And furthermore, it's comparable with HER2 therapies. So if you look at the current HER2 therapies, they are focusing on single epitopes, you require repeated dosing with these and it can create resistance. And we are overcoming all of these limitations with ES2BC-001, and it has the potential to provide durable immune control, and overcome the limitations and complement existing HER2 therapies. And so far, we've seen very exciting early observations. We are conducting a Phase I clinical trial. It takes place in Austria, in 3 clinical centers where patients with HER2-positive and HER2 low breast cancer are being enrolled. We are aiming for the first part of the study to be completed by mid of this year and the end of the study by towards the 2026 end. And it's a safety study, but we also have some important immunogenicity observations. And that's what you see in this graph where we demonstrate the raising of vaccine-specific antibodies, which is important. So far, we see no safety signals of concern. We have anti-HER2-specific antibody responses as shown in this graph. And you can see durability even as far as about 5 months after the last dosing, we still see a very nice antibody titer. So the early Phase I data show immune response in all evaluable patients in this study. The data so far are based on 9 patients. Eight of these have shown a positive response. No safety concerns have been observed to date. Going forward, we are right now making this Phase I study, as I mentioned, with the aim of completing it towards the end of 2026. And we have an important time point in regards to designing the Phase II study taking place afterwards. All along this time frame from now on, we are generating clinical data. So we are generating a partner relevant assets. That's important to mention, we see the Phase II trial as a potential collaboration with a potential partner. So the data we are generating now, which look promising, we see them as attractive for a partner to jump on board to support in the further development. We see industry precedents for making multibillion-dollar partnerships in this deal. Many HER2-focused oncology deals have been announced over the years. And I'm just showing a very recent deal by Novartis, which has acquired a HER2 asset in early clinical development for $3 billion, $2 billion upfront. So that's the numbers we're looking into with this asset. Now we are conducting a Rights Issue. We have just launched it. We are aiming to raise SEK 53 million. This is a Rights Issue, which is 60% secured. So we have commitments and guarantees amounting to approximately SEK 31 million. The subscription period are the last 2 weeks of April. And the structure of this is such that if you are a shareholder, 1 share will give you 47 unit rights, and you need 5 units rights to purchase 1 unit, and 1 unit will consist of 1 new share and a TO13 warrant. And those units will be priced by SEK 1.6 per unit. And the TO13 warrant program is a program that can be exercised in September, where you can purchase shares with a 30% discount. The proceeds from this Rights Issue are primarily going into completing the ES2B-C001, the HER2-focused breast cancer therapy clinical study that we're conducting now. Furthermore, we are strengthening our R&D efforts and also our business development efforts, and also looking into co-financing grant projects on this. But primarily, it's the ES2B-C001, which are driving the value here and where we're seeking financing to complete the Phase I study. With that said, thank you very much for this presentation.