ExpreS2ion Biotech Holding AB (publ)

to today's event where we have the pleasure to present Expression Biotech. So that was today's presentation. We are joined by CEO Ben Fransen. Today's topic, of course, the Q1 results, but I think maybe more the news flow that you have have sent out in this quarter and actually also rather large snoops after the quarter's end. So I think that will be the main focus of today's events. As always, you can ask questions in the box down below. We have already got a lot in advance, but do feel free to ask him. Do feel free to ask him in Danish, and I will try and translate to the best of my ability. But for now, I will hand the call over to you, Bent.

Thank you, Michael. My name is Bent Fransen. I'm the CEO of Expression Biotech. i'm pleased to be reviewing the status of our company in business and pipeline today may 15 in connection with the release of our interim report for q1 so the agenda for this meeting i'll first go through our strategic and financial review, you will notice that Keith Alexander, our CFO, is not present today. As usual, he is out on some travel commitments. Then I'll cover the ESOP C001 or therapeutic breast cancer program and where that is, and then the remaining pipeline with respect to infectious diseases before we go through Q&A here. so as a starting point just to highlight where we are with respect to our strategic focus so as you know expression is a vaccine focused company with a pipeline of cancer immunotherapies and infectious diseases vaccine projects and we have focused our strategic areas across four different areas here as highlighted here on our pipeline it's a key focus to progress on our esvb c001 of therapeutic breast cancer vaccine and i'll go into this in detail later in this presentation secondly we have a couple of very important infectious disease vaccine programs which are all more in collaboration with organizations that are sponsored by non-diluting funding including university of oxford from the beach disease consortium for nipa virus university of copenhagen for influenza and the so-called mucolax program and the other influential consortium that we call indigo thirdly we aim to achieve proof of concept for new vaccine candidates and enhance our platform technology and we have made extra efforts here to enhance our ip and have a very strong patent strategy to support our intellectual property and this is also the basis for our exploratory pipeline development that we keep progressing on in the early stages And as well as our platform, the Express S2 technology, which is basically competent proteins and which is the underlying platform for all of what we do. Fourthly, we have our service activities that we will continue to advance and we are actually reinitiating the proactive marketing of this service. And a very recent example of that is the Wuji vaccines that have been just announced a few weeks ago. I'll get into detail on this as well, and also increase on partnering activities revolving on glyco-modified S2 cell lines, which come with properties that can make even enhanced immunogenic vaccines. So across these points, we've had a number of important updates here during the Q1, during the first quarter of 24. Sorry, it says Q4 here. It's, of course, during Q1, but also in the prolongation of Q1. On the leadership side, we have promoted Max Circle to our CSO in connection with the Retiring. The good thing is that Feshat, he continues to be engaged with expression in the form of a senior strategic advisor vaccine R&D role, which is good, taking his four decades of the vaccinology experience in consideration. Max has been with expression for more than 13 years and is instrumental in our technology platform and early R&D efforts. We provided an update on the 1st of April regarding our pipeline, where we updated on the vaccine phase one trial that we have just initiated this quarter and further review of the CMV vaccine program, which we decided to hold. I'll also spend a minute on that later. We announced the Wuxi vaccine's letter of intent. We are very happy that University of Oxford and the malaria programs going on there continue to patients across numerous vaccine trials progressing well. And as we have announced in the autumn of 2024, we made a term sheet with Serum Institute of India and we are progressing with the definitive agreement. As you know, these processes take time and this is still ongoing. Very important, we have just announced only two days ago, May 13, that we are inventing a protocol, our protocol for the breast cancer vaccine. And this is to enable our therapeutic breast cancer therapy with antibody drug conjugates or ATCs, as well as to expand the study sites. Most lately, we have just yesterday seen from our associated company ADAPMAC, which Expression owns 34% of and which hosts the important VLP, the virus like particle technology that they have published in Nature, a very exciting new scientific article about a modular mRNA platform. So this is in essence a new technology platform for ADAPAC that combines mRNA technology with the unique BLP technology. Very exciting. So just going through the financials, I want to highlight the operating income. We experienced a 90% increase year over year in the first quarter. and had an income of approximately 3 million Swedish kronor and this was due to primarily progression of grant projects. In the middle chart we focus on net sales which reflects revenue from projects and licenses increased 44% compared to Q1 2024. In the chart on the right we show other operating income that is grant related income and that remained on a high level driven primarily by the Indigo and Mucovax grains with a significant contribution from Vici as well. Moving to the cost side, operating cost in Q1 amounted to approximately 16 million SEK, a decrease of 1% compared with the first quarter of 2024, reflecting on close cost controls. In the middle and right charts, we illustrate the two largest components of operating costs, starting on the left with external R&D costs. These peaked in the fall of 2022 due to the preclinical development costs at the time for the breast cancer vaccine project, and they have decreased since then. Compared with the one year ago quarter, these costs were more than 50% lower. Costs in this category are large, volatile, and primarily driven by our pipeline activities. Moving to the chart on the right, we have removed the cost of share-based compensation from personnel cost to calculate the underlying personnel cost. And this underlying figure is approximately the cash cost of personnel. It peaked in 2021 of 2023 and was essentially flat compared to the year-ago quarter. Note that personnel cost is sensitive to wage inflation and foreign exchange currencies since we report in SEC and pay wages in Danish krona. So moving to the net loss for the period after financial expenses and taxes, we had a net loss of approximately 11 million SEC in the first quarter compared with a net loss of approximately 13 million in the year-ago quarter. In Q1 2025, we started the year with a cash position of 81.5 million SEK. During the quarter, we utilized 12 million SEK in operating activities, reflecting ongoing investments in our key programs, including the ES2B C001 trial. Additionally, we experienced a negative borrowing exchange impact of 3.2 million SEK due to currency fluctuations. As a result, our cash balance at the end of March 2025 stands at 58 million SEK. While this decline is in line with our planned spending trajectory, we remain focused on optimizing our cash systemization as we progress through 2025. Looking at our cash balance over the past eight quarters, you can see the impact of several significant effects that provided a boost to our cash reserves. In Q1 2024, we received an upfront grant payment providing a notable increase in cash. In Q2 2024, we recognized a dividend from ADAPMAC, which further supported our liquidity position. In Q3 2024, we executed a rights issue, reinforcing our cash balance to support ongoing programs. In Q4 2024, the cash balance was further strengthened through the water subscription, causing us to end the year with 82 million SEC. Entering 2025, our cash balance decreased to 58 million SEK, reflecting Q1 spending on operations and foreign exchange currency impacts. However, looking forward, we expect our burn rate for the next three quarters to be much lower than it was in Q1, extending our cash runway into 2026. So moving onwards with our pipeline activities led by ES2P C001, I'll give you an update on that. We, as you know, got an approval from the Austrian Authority to start a phase one safety trial at the end of last year, and we initiated Q1 with moving into a patient enrollment phase. This is a study which is A dose escalation trial where we start with 50 micrograms with adjuvant and move up to 450 micrograms with adjuvant. And a data safety monitoring board decides whether the study can progress to a higher dose. Primary endpoints are safety. Secondary endpoints are immune responses and signs of clinical efficacy. And all the applications you can see here in the bottom are really the typical efficacy endpoints in standard cancer trials that we also include for the secondary endpoint measurements here. The dose escalation will be carried out in three cohorts of three patients with advanced metastatic breast cancer whose cancers express HER2. This will take approximately 48 weeks from first patient, first dose. Subsequently, additional patients will be those to confirm the recommended phase two dose. That's the important trial. So we can say that we are now initiating patient enrollment, and we have just this very week, as late as two days ago, made an announcement about the recruitment and the amendment to the protocol that we are now doing. ADCs are Antibody Drug Conjugates. It's a type of therapy that has been launched in the last couple of years. And Inherto, for example, is a huge brand that is already a blockbuster despite having been launched only a few years ago. We are amending our protocol to ensure that we can combine our ES2B-C001 therapy even in the phase one trial with, for example, HER2. So this will also allow for further uptake of patients in the trial. We are also expanding the number of clinical trials to boost enrollment. And all this protocol amendment approval we expect to have a conclusion of here in the quarter following this summer. We are making this phase one trial in Austria and we have already, of course, a strong collaboration with Medical University of Vienna. where the principal investigator for the trial is also situated. And we have now agreements with further five oncology clinics in the capital neighborhood that can refer patients to medical literature. So this will also expand the potential for recruitment of patients in this. so on the timeline side we are still on track as we are right now with the phase one expectations for enrolling patients and getting the outcome of this potentially preliminary outcome before the end of this year further outcome in 2020 and The expected timeline is still to be able to start clinical phase two proof of concept trial in the beginning of 2027. So this is important, of course. The start of the phase two depends on the outcome of the phase one. If the outcome of phase one is successful, we can move straight into a phase two randomized trial. If the outcome is not optimal, we will go through phase two where we look at a direct comparison study. So in all cases, we still expect a timeline with the conclusion of a clinical proof of concept trial around 2029. Depending on the business development and partnering side, we will license this out for co-development partner to take over on the large scale development going forward. On the infectious diseases side, we have quite a number of clinical studies ongoing in the malaria fields. All of these are being handled by the University of Oxford who have done an excellent job applying the S2 system to make the antigens for all these vaccines. We're talking about four different vaccine programs which are being run in more than six different clinical studies. Two of these are actually in clinical phase 1-2, having an interest of Serum Institute of India, which we have announced a term sheet around in the fall of 2024. And we are in progress with making a definitive agreement with Serum Institute of India to get these programs further developed. And Just as with the malaria programs so far and with the other infectious disease programs, they are largely sponsored by grants. We have the MUCOVAX project, which is about research into a mucosal influenza vaccine together with the University of Oxford, where we got a grant solution from Innovation Fund Denmark a few years ago and are progressing on that and also getting some interesting data from our ligamodified cell lines in that project as well. We have for five years been engaged in the Indigo Influenza Consortium, which is an EU-sponsored project, and it's about to be concluded here this year and has an interesting preclinical candidate that might be taking onwards. On the Nipah virus vaccine, this is in collaboration with ADAPMAC and other consortium partners. This is sponsored also by the EU, and we with the COVID-19 project back in the days during the pandemic. Finally, on the CMV vaccine, the cytomegalovirus vaccine that we have been collaborating for a couple of years with the vaccine around, we have now discontinued this following a strategic review As you may recall, in December 2022, we announced this collaboration with Evaction, combining Evaction's AI platform and Expressions protein production platform. And after two years of discovery efforts, we still see quite a distance to a lead candidate. And in order to focus on Expressions side, we have decided to discontinue this project. so our pipeline essentially looks like this as we speak that led by the breast cancer vaccine project on top which is now in clinical phase one then we have the malaria the infectiousness the influenza and the nipah virus vaccine projects going on all more or less sponsored by non-diluting funding and in the bottom you'll see The COVID-19 project, which came to phase three, sponsored by Bavaria Nordic, who decided to shelf this project due to the pandemic and their view on the commercial outcome. But after all, we met the primary endpoint in the clinical phase three. So it's a very important project for saying that both our express technology and AdaptMax VLP technology have been clinical phase three validated. Finally, looking forward, we continue to progress on the clinical side with recruitment efforts on the year to BC double one safety trial and expect to get read out on this even before the end of the year, depending, of course, getting the first patient on board. We will also be looking at immunogenicity and early efficacy signals. And then we have There are fault malaria trials, which are continuing and will also support the express platform as well. And we are moving onwards with our good discussions with Serum Institute of India to get the license agreement concluded on that. Looking further ahead, we are filing IP. successively and have important innovations revolving our platform and other important vaccine innovations. And as I've said that before, I'll get back to this when we can put some more words on what that is around. And we continue on validation of through the grant grant grant funded projects led by Mucovacs and Indigo and Vita disease. That said, I'll be happy to take some questions from the audience. Thank you.

Perfect. Then let's start with one. It's a little bit the first one is regarding a little bit your share and so on. And then we will get into all the pipeline use. Have you done anything to to attract larger investors since we last spoke with you?