ExpreS2ion Biotech Holding AB (publ)

Welcome to today's event where we have the pleasure to present expression biotechnology. And to help us through today's presentation, we are joined by Ben Fransen and CFO Keith Alexander to take us through your Q3 results. But I think maybe more the very last news flow we have actually had lately on some deal making and some interesting data on the CMV. As always, you can ask questions in the box down below.

very welcome to do it during the presentation we will take the main part of the questions in the end but for now i think i will have the call over to you all right thank you very much michael uh my name is ben franston i'm the ceo of expression biotech i'm joined by keith alexander who will come on board in a minute to go through our q3 report in first instance i'll go through the key updates we've had in this corner And to jump straight into major news that we've had. In the beginning of July, we announced the growth proceeds from the rights issue that we did, raising 30 million SEK in proceeds, including having two warrant programs, the TO10 and TO11. The TEO10 is having an exercise winter now between November 20 and December 4. We'll get back to that in this presentation. Later in July, we got a US patent issued on our Hymanose cell line. This is part of our GlycoX S2 cell line, another cell lines that can improve immunogenicity that we are right now exploring in our labs. We filed the CTA, very important milestone in August regarding our ES2B-C001, the HER2-VLP breast cancer vaccine asset that we have. We also announced our updated website and branding to clarify our value proposition to customers, partners, and investors. Most recently, we have announced a term sheet with the Serum Institute of India Very important step here that I'll also get back to later in this presentation. On the 21st of October, at an extraordinary general meeting, there was a resolution involving the reverse share split. And that came into fruition on the 31st of October, when the shares were reverse split by a factor of 40 to 1. And this very week, a few days ago, we've just presented at Vaccine R&D Summit in Boston, new preclinical data from our CMV project that we do in collaboration with Evaction. So if you look at our pipeline as we depict it with our core assets that we control, we have our ES2BC001 as the major asset. And as I mentioned, I'll get back to where we are in the process of the CTA submission that we did in August. And then, as I mentioned, most lately, we have announced new clinical, sorry, new preclinical data on the CMV project. From the standpoint of our Express platform, we've shown this depiction before. We have a clinical phase three validation of the platform through the COVID-19 vaccine that Bavaria Nordic brought all the way through and including a clinical phase three. This is wonderful for a biotech company like Expression that we actually have a clinical phase three validated platform. And then most lately, we're also very proud that not only to University of Oxford conduct clinical phase one and two trials using our platform to make the active ingredient in the malaria vaccine projects, but Serum Institute of India take an interest in this as well. And we have earlier proof of concepts as well that I'll allude to briefly in this talk. Focusing on ES2B-C001, this is really a groundbreaking breast cancer vaccine. We make the active ingredient, the HER2 antigens in our express platform, and these target all four extracellular subdomains, which is important because we can provide polyclonal response based on this vaccine. You have to compare that with the monoclonal antibodies that dominate the market, which really target only a single epitope. That's a very important distinction. These antigens are presented on a virus-like particle using a technology from ADAPMAC, which Expression owns 34% of. And this unique presentation of the antigen of the surface of a VLP provide for highly immunogenic vaccines. The concept is already commercially validated through licensed or approved vaccines against HPV, for example, against cervical cancer. Here you have Cervarix and Gardasil as known brands that use the same concept. And as I mentioned, these make very highly immunogenic vaccines, and they're also very safe. And we've seen that also from the COVID-19 project where more than 4,000 subjects were enrolled in this clinical phase three trial. And from the breast cancer vaccine project point of view, we have done non-human primate monkey studies, which have also shown complete safety. And also the longevity is very important in this respect. We're really the only vaccine in the COVID-19 field that has shown 12 months protection. This is astonishing, actually, and something that we also built into the breast cancer vaccine. And it can be combined with standard of care and become an off-the-shelf scalable and cost-effective vaccine. And I want to highlight where we are at the moment. Back at the previous quarterly update, we announced the August CTA submission, very important milestone for the company. We are on path towards the first clinical trial for this important asset. And we're still on the same plan that we will start the trial in the first quarter of 2025. So what happens in the meantime? Well, an important process starts. First of all, you need a validation from the authorities. In this case, we have submitted the application to the authorities in Austria. They have gone through the documents that we sent. And this is not a trivial package. It's quite a vast document under the clinical trial information system, the new CT system that the EU introduced a few years ago. So those authorities need to validate that this is correct. And they got back on the 2nd of September and said, good, you have the right application submitted. And that's when the clock actually started. So then comes a review by the authorities, both from a scientific and ethical point of view. And this is what can last up to 60 days. And what happens in between is that authorities will post questions. They call it request for information, RFI, as it's abbreviated here. And whenever there's an RFI coming into a company, you will stop the clock. In our case, we've had a couple of these RFIs and very recently actually in these very weeks where the latest is due today and we actually submitted the response to that yesterday. This is all standard procedures and goes along with the dialogue that any company that submits a CTA will have with the authorities, right? And then we have a decision coming up and our Latest estimate is that we'll likely have a decision here in December, probably in the beginning of December. From then on, there will of course still be a lot of preparation which can take some time. Why? The Q125 for the initiation of the clinical trial still stands as it is today. We define start of the trial as the first patient being dosed in the first trial. We're looking very much forward to that and we're comfortable that we're getting there. I've showed the protocol before. I just want to say that as a result of the dialogue with the Austrian authorities, we've just amended the protocol title with the metastatic. So we have a protocol, which is the basis for the trial of first in human phase one, open label dose escalating trial to assess the safety, tolerability and immunogenicity. and preliminary antitumor activity of ES2B-C001 with or without montanite in HER2 expressing metastatic breast cancer. So that's clear now. It's still the same objectives. It's a safety study. So the primary objective will be to determine the safety and tolerability and maximum tolerated dose for our vaccine ES2B-C001 with or without the adjuvant montanite. And the secondary objectives and the exploratory objectives of seeing immunogenicity and maybe observe some tumor activity remains in place. Now, turning our attention to malaria, this is what we have shown before. This is an update on the four different vaccine candidates that the University of Oxford have been conducting over the years, where they have a license to use the express platform for that. Now, Serum Institute of India, they have come uh very recently and have a strong interest in two of these projects namely they are at 5.1 and there are 78 c both so-called blood stage malaria vaccine candidates The RH5.1 is being run in Phase 2, as we speak, and the RH78C is being run in Phase 1, as we speak. And as I mentioned, Serum Institute of India wants to acquire a license for these assets. And of course, expression is very excited. Serum Institute of India is not only the world's largest vaccine manufacturer, they have a presence in more than 170 countries, including the US and Europe. They've also this year been included in Time's most influential companies. It's a great step for expression to get along with this. We expect a definitive agreement to take the time it takes. It's not a trivial document to make a definitive agreement, but we are in pass for that and comfortable around that. We have some upcoming events where I will talk more about this. The first one on the 18th of November is the LSX Investival event where Keith is actually present and we'll give a talk about where we are. And then comes two events in Sweden, the BioStock event, the 21st of November, and the Stockholm event by Aktiesparne on the 27th of November, where I will be giving a talk. And I'm looking very much forward to interact with shareholders at these events. That said, I will give over the word to Keith, who will go through our financial results for the quarter. Thank you.

Thank you, Ben. I'm just making a few adjustments here. All right. Thank you, Ben and Michael. As Ben mentioned, I'm Keith Alexander, and I'm the CFO of Expression Biotech. In the third quarter of 2024, Expression generated operating income of 1.7 million Swedish crowns, a decrease of 9% compared to the prior year quarter. Our net loss in the quarter was 10.5 million compared with a net loss of 22 million in the third quarter of 2023 and drove a loss of five spot 32 sec per share or two spot 82 sec on a fully diluted basis. At the end of September, Expression had 76 million Swedish crowns in cash. I'll dive into the key drivers of these figures and others in more details on the coming slides. Starting with operating income, we experienced a 9% decrease year-over-year in the third quarter to approximately 1.7 million Swedish crowns due to the progression of client and grant projects. In the middle chart, we focus on net sales, which reflects revenue from projects, licenses, and our webshop. They were well below the long-term average in the quarter, reflecting the transition to a pipeline strategy, as well as an increase in emphasis on grant-driven projects. In the chart on the right, we show other operating income, that is primarily grant-related income, which remained at a high level driven by the Indigo Grant with significant contributions from both Vici and Mucovax as well. Moving to the cost side, which is much more significant than the income side, operating costs in Q3 amounted to approximately 23 million, a decrease of 38% compared with the third quarter of 2023. As a reminder, we announced a restructuring in the third quarter of 2023, which has been a driver of cost reduction since then. On the next slide, we have illustrated the two largest components of operating costs, starting with the left, which is external R&D costs. These peaked in the fourth quarter of 2022 due to preclinical development costs for the breast cancer vaccine and have decreased since then. Compared with the year-ago quarter, these costs were 59% lower in the third quarter. Costs in this category are large, volatile, and primarily driven by our pipeline activities. Moving to the chart on the right, we removed the cost of share-based compensation from personnel cost to calculate the underlying personnel cost. This underlying figure is approximately the cash cost of personnel. It peaked in Q1 of 2023 and decreased by 37% compared to the year-ago quarter. The decrease partially reflects the cost reduction program enacted last August. Note that personal cost is sensitive to wage inflation and FX, since we report in SEC and pay wages in Danish crowns. Moving to the next slide, which is net profit and loss for the period. After financial expenses and taxes, we had a net loss of approximately 10 million Swedish crowns in the third quarter, compared with a net loss of approximately 22 million, in the year ago quarter. We show the year to date comparison on the right. For the first nine months of 2024, the net loss was 21 million Swedish crowns, a 73% decrease from the 78 million loss in the first nine months of 2023. On the next slide, we show how our cash balance has developed in 2024. At the start of the year, the company had a cash balance of 58 million Swedish crowns. Our cash burn from operating activities has been approximately 28 million Swedish crowns. The net cash inflow from investing activities was 21 million Swedish crowns, primarily reflecting the dividend paid by ADAPT back in April. Financing increased cash by just over 25 million, driven by the rights issue completed in early July. Finally, FX reduced cash by approximately half a million. Putting this all together, at the end of the quarter, the company had a cash balance of 76 million Swedish crowns, an increase of 19 million Swedish crowns year to date. On the next slide, we show the trend in our cash balance, which ended the quarter at 76 million, an increase of around 8 million in the quarter. Looking forward, we have a warrant subscription period commencing on November 20th for the TO10 warrants and another subscription period in the third quarter of 2025 for the TO11 warrants. In the following slides, we'll cover the recent ongoing corporate actions, including the reverse share split and the TO10 warrant subscription. Starting with the reverse share split, which had a record date of the 31st of October, we've received many questions about the rationale for the split and what it means for the fundamentals of investing in expression. We have addressed these in recent investor events and posted these presentations to our investor website. In addition, Bent made a video which we posted on our social media channels. To reiterate, we believe there was a good reason for the reverse split as it could remove potential psychological and limit-based concerns with the previous share price. Furthermore, the cost was immaterial and upcoming year clear changes would make such a split more difficult in the future. Prior to deciding to execute the split, we did confer with our financial advisors and saw that many similar companies which had done a reverse split were able to do it without an impact on their share price. This only makes sense as reverse split has no fundamental impact on the company. Essentially, if you own two slices of an eight-slice pizza before the reverse split, you would own one slice of a four-slice pizza after the split. There's no change in the size of the pizza. On the next slide, moving to the TO10 warrants, today is the last day of the pricing period, and the subscription period starts next week on November 20th, continuing until December 4th. The price will be set as 70% of the volume weighted average price during the period from November 1st to the 14th, including today. So we'll have the price after the close today. Following the reverse split, 480 warrants entitles an investor to subscribe for one share at the price that is calculated later today. If you'd like to participate, please look for corporate actions or emissions on your broker's website or contact your broker directly if you have questions. Alternatively, a subscription form will be available on Expressions' investor website, as well as on the website of our financial advisor, Beta Securities. We hope our investors will invest alongside us in the development of our groundbreaking breast cancer vaccine and Expressions' future development pipeline. We encourage you to participate early as some brokers have different processing times. With that, I'll pass it back to Bent to present what has us excited for the future, and we'll stick around for the Q&A.