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?

sure yes you can say we interact where it's possible and we can do that through various conference activities where the institutional investors as well i've been doing that more during the last year compared with previously so For example, both in Sweden and Denmark, there have been important events in that aspect where I've been able to promote expression biotech as an interesting investment case. So yes, there are efforts in that direction, but cannot be more detailed than that.

There's a question. You just made a reverse share split and your shares trading around 20. Now there's a question here. Could you think about doing a share split 1 to 10, meaning that it should go back to 2 Swedish crowns? So a little bit of thoughts about the using of the share split.

I think that's an interesting question. I think we would need to get back to where we were based on liquidity and trades in our share three years ago. And maybe that could be a topic for the board to consider. It's not an issue at this point in time. And I think a share price between 10 and 100 or more is certainly not unusual for traded shares.

And then there's a question regarding you're showing good progress. You have hopes for this company. So why not more insider buying? Why are not more insiders buying the share?

Well, as you know, we are listed on Nasdaq First North's growth market in Stockholm. And of course, we are obligated to report on any insider transactions through the Swedish Finance Institute. And we do that. We, and when I say we, primarily myself and our chairman of the board, we have participated in any issue of new shares that's been there where we have acquired shares in the company. And that's been a premise, of course. But that's how it is.

Yes, you are participating. Please could you elaborate what if any additional financing you may need to complete phase one, especially in case of further delays in recruitment? Thank you.

Thank you. That's a question I could understand before the 1st of April. We've made a couple of announcements both 1st of April and and here two days ago 13th of may look at those announcements and you'll see there's an important update most recently of course in the amendment to the study protocol which will allow us to combine or year to be C double one with antibody drug, can you get therapies such as in here to which opens up? We believe it opens up a lot of opportunities for expanding the potential of our therapeutic vaccine.

And I will jump a little bit in there because there's a there's a there's a question. Is it the answer and the success of this product that has actually maybe delayed you a little bit and And now when you do this combination, you actually think maybe you can accelerate things after the protocol. So a little bit about the thoughts on this besides, of course, the commercial opportunity, if you can do a combination product, but a little bit here on the trials. Has it been delayed or has it been harder to get enrolled patients because of this success? And is that now why you expect maybe that that when this protocol is amended, that you actually can accelerate the take-in of enrollment?

I think there is a relation, and that's of course motivated us to take this initiative. We don't know for sure, so it's a little bit speculative. We know that in Austria, Enherto has been given reimbursement during the last year. And in that respect, it's another dynamic than what we looked into last summer when we were drafting this protocol. So this is a learning and we see it positively for sure, because since our product opportunity actually is a first in class therapeutic vaccine and can offer a polyclonal broad immune response where you basically target all epitopes on the HER2 receptor as opposed to monoclonal antibodies or in HER2, which inherently only offer a single epitope approach. Our approach could be combined with those efficacious therapies to provide a durable, broad immune response, which will help patients in the long run. So that's the important thing on this. And we are very, very pleased that we are at this point now to amend the protocol. Of course, as I mentioned, we'll get back during the next quarter to see where we are in the protocol amendment.

Perfect. And then actually just to make you understand, you know, because Following you for the last couple of years, you've been talking about the case that you have this huge market of existing treatments and now something new is coming in. But that doesn't change your business case, if I understand you correctly. All the new products are also only targeting one receptor. Is that correct? And that means, yes, there's a new generation of product that might take over a little bit from the older ones, but it doesn't change your business case or business case. We're still being more a product that could actually go to market.

We are still a first in class opportunity with the breast cancer therapy. And in that respect, we believe there's certainly a market adoption rate that can be very rewarding. So we have in our estimates, we believe we will certainly have blockbuster potential and may exceed the 5 billion euro annual revenue once it's on the market. So we strongly believe in this, obviously.

Then there's actually a couple of questions. As a resident Danish person, can you be in those trials in Austria? And there's a little bit of a question, where can you look for information and try to be, you know, adopted in the trial? I know maybe it's a little bit outside what we should talk about financially, but maybe as a broad interest, if you have any information about this event. whether you as a Danish citizen could be concluded in these trials if you pay everything yourself and so on. And secondly, where can you look for more information about maybe being included in a trial?

It's a very good question and I will have to confer with my project colleagues just to make sure I get a right answer here. I'm not quite sure how it is with non-Austrian patients here to be enrolled. The Medical University of Vienna, they are the central study site as we speak, and certainly other patients from other sites. And as I mentioned, now five other clinics in Vienna will be referred to the Medical University of Oxford. So I cannot say for sure. It's a very good question.

Yeah. And I think maybe to send you an email directly to ask you this, then I think you can direct them to the right person, maybe in your company that has a perfect. Can you give me an idea of stocks triggers for the next six months? Could it be influenza and Nipah? If we just jump back to, I guess, this slide, and you're thinking maybe you actually went through the stock triggers here, but if you should focus on some of them, and could it be Nipah influenza? Is that also potential if you look six months ahead?

Yes, we are right, as we speak this year, we're getting the project on the Indigo wrapped up with the consortium and it's in preclinical stage and we are discussing how to proceed with a preclinical candidate. So that is where that is at the moment. Mucovax, it's... very much research driven as we speak in supporting new technologies that we have from the expression side as well. I mentioned the glyco-modified cell lines where we're generating data based on this mucosal influenza vaccine approach. On the trigger side, does that give you any specific milestone triggers for these

sure to progress on them every quarter for sure to our shareholders yeah and then in general it it I I took out the slide here we're looking forward that that is what you think investors should look out for and then it's up to us to decide whether they could be a share price tracker share price triggers is that how I should understood you

Yes, and have a look at the three times mentioning of year two BC001 here. That's obviously a very important trigger, how that progresses here with the phase one safety trial. And then also on the malaria front, where University of Oxford keep on progressing on the many different clinical studies going on and even making publications from time to time in the in peer-reviewed scientific journals and the fact that we still have good discussions with the Civil Institute of India on a license agreement for two of those malaria assets.

Then there's a, please could you provide us with a rough estimate of the annual revenue and profits you could generate from the VUXI deal from next year? Can this meaningfully extend your cash reach?

Very good question. We announced the WuXi Biologics letter of intent here in Naples one month ago and it's a super interesting discussion we have going on with WuXi. They are also one of the world's largest vaccine manufacturers and a big brand in the space of manufacturing recombinant proteins and we are very proud that such an organization they actually reach out to us and find us and and want to get our technology platform in-house for their clients' manufacturing needs. And the idea with the lead-up intent is that we first test it in a pilot study on one of Bushi's clients. And based on the outcome, we will then initiate a 12-month period take a further discussion about a strategic collaboration. Whether that strategic collaboration will be in the form of merely licensing or some kind of collaboration with further operational revenues, that remains to be discussed. So it's too early to say anything about revenue projections on this.

And is it in the Vuxy CIO business or in their production? Is it in the CIO where if clients want to develop a new product, they will actually say it might be smartest to do that on your platform? I know I'm trying to make it easier to understand and probably a little bit too simple, but is that how we should think about it?

That is correct. And it would be a nice... simple setup in a way instead of expression actually spending resources on promoting and marketing of this that we actually have wooshie doing it for us they have a huge infrastructure on the commercial side and you know we announced this letter of intent one month ago and they already after easter at the world vaccine conference in washington spent a lot of time even presenting our platform at the various presentations in that forum. So that tells us that that's a great place to be.

Perfect. What is the expected timeline for getting data when the first patient is enrolled in the ES2B001 study? Have you given indications to market on first patient enrolled, then everything else given?

What could the timeline be before preliminary data? Of course with the approval of the clinical trial application in place we expected patient enrollment to start and we must admit that here after a quarter we we left the first patient and maybe it's related to the dynamics of the breast cancer therapy market and with the introduction of antibody drug conjugate like in Herzog most recently in Austria. We don't know, but now at least we're doing something about it and can allow to enroll patients who are also on antibody drug conjugate treatment. And we are also expanding the number of sites in Austria to ensure further patient enrollment. So let's see here as we progress, we will of course give an announcement as soon as this is the first time. Perfect.

Let's see here. There is something about this an email has been sent to you, but yeah. other questions no i think that was the final question ben thank you for taking us through your results and and milestones achieved in this quarter and thank you for the audience listening in thank you