ExpreS2ion Biotech Holding AB (publ)

Welcome to today's event where we have the pleasure to present the 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 large 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. You are 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 hand the call over to you Ben.

All right, thank you very much Michael. My name is Ben Fransen, 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 quarter and to jump straight into major news that we've had. In the beginning of July we announced the growth proceeds from the rights issues that we did raising 30 million SEC in proceeds including having two warrant programs the CO10 and CO11. The CO10 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 high mannose cell line. This is part of our GlycoX S2 cell line. You know those cell lines that can improve immunogenicity that we are right now exploring in our labs. We filed the CGA, very important milestone in August regarding our ES2B C001, the HER2VLP breast cancer vaccine cat acid 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 revolving 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. This very week, a few days ago, we've just presented at a vaccine R&D summit in Boston, new preclinical data from our CMV project that we do in collaboration with the faction. If you look at our pipeline as we depicted with our core assets that we control, we have our ES2B C001 as the major asset. As I mentioned, I'll get back to where we are in the process of the CTA submission that we did in August. Then as I mentioned, most recently, we have announced 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 company like Expression that we actually have a clinical phase three validated platform. Then most lately, we're also very proud that not only do 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. 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 ADAPTMAC, which Expression owns 34% of. 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. As I mentioned, these make very highly immunogenic vaccines, and they're also very safe. We've seen that also from the COVID-19 project where more than 4,000 subjects were enrolled in this clinical phase three trial. From the breast cancer vaccine proactive point of view, we have done non-human primate monkey studies, which have also shown complete safety. 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, and something that we also built into the breast cancer vaccine. It can be combined with a standard of care and become an -the-shelf scalable and cost-effective vaccine. 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're on path towards the first clinical trial for this important asset. We're still on the same plan that we will start the trial in the first quarter of 2025. 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 CTAS system that the EU introduced a few years ago. Those Austrian 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. 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. What happens in between is that authorities will post questions. They call it request for information, RFI, as it's abbreviated here. 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. 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. And 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, and 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 very happy to see some of the results that we're getting there. I've showed the protocols 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 monotonype 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 monotonype. And the secondary objectives and the exploratory objectives of seeing immunogenicity and maybe observe some tumor activity remains in place. Now turning our attention into 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 very recently and have a strong interest in two of these projects. Namely they are at 5.1 and they are 78C, both so-called blood stage malaria vaccine candidates. They are at 5.1 is being run in phase two as we speak and the R78C is being run in phase one 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 times most influential companies. So it's a great step for expression to get along with this and 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 we'll talk more about this. The one on the 18th of November is the LSX Festival event where Keith is actually present and will give a talk about where we are. And then comes two events in Sweden, the Biostock event on the 21st of November and the Stockholm event by Akjes Barne 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, Bent and Michael. As Ben mentioned, I'm Keith Alexander and I'm the CFO of Expression Biotech. In the third quarter of 2024, expiry rated 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 the net loss of 22 million in the third quarter of 2023 and drove a loss of 5.32 sec per share or 2.82 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 web shop. 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 Vichy and Mucovacs 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 have removed the cost of share-based compensation from personnel costs 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 personnel costs 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 -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 -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 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 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 a 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 at 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, 4D 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, Vader 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 have different processing times. With that, I'll pass it back to Ben to present what has us excited for the future and we'll stick around for the Q&A.

Thank you very much, Keith. All right, let me conclude with looking forward while we are highlighting many significant milestones that we're we are very much looking into the decision from the Austrian authorities, which can happen here very soon. So we can initiate the phase one trial in Q1 2025. And we have completely on pass for that. The definitive agreement with the Serum Institute of India is also a key milestone coming up. And as I mentioned previously, it will take some months, but we are working definitely towards both parties. We expect in 2025 to select a CFV lead candidate, which is a result of the discovery collaboration we've had with the faction for two years. And we're looking into some interesting lead proteins that potentially can be brought forward by expression. And furthermore, we have exploratory research going on. And we are also doing all our efforts to extend our IP protection with these efforts. And we have further validation of our platform technologies through the grant sponsored projects, one of them being a MOOCVAX, one of the influencer projects where we also are including our driver modified cell lines with very interesting research results. And then lastly, but not least, data from the year two BC001 project is coming. Hopefully we can announce that during 2025. But the study as such is expected to go into 2026. But we expect to have some interim data during the trial. That said, I hope you get an idea of where we are. We have a very exciting future ahead of us. Both Cheese and I are here now to take any questions you may have.

Perfect. Let's jump into him. Congratulations on the great assaults, CMV partners. When can we expect the partnership with malaria to finally fall into place? And can there be milestones already in the start of phase three? You indicated a couple of months. Is that your not best guess, but your answer?

I have been in this industry for three decades now and have made deals like this for 20 years. And it's very, very good with a term sheet. That's obvious, because you have the main aspects in place. But I've just come to realize that making a legally binding document, which is 10 to 20 times larger than a simple term sheet is very time consuming. And it takes the time it takes and it can take months. So I don't want to promise something just around the corner.

Perfect. And then can there be milestones already at the start of phase three?

That's meant to be so. Yes, but I cannot comment on any evaluation.

Can you give a little more detailed timeline for influenza and the nipah?

Yes. Those are influenza activities and our nipah virus activities are being sponsored by grants. I want to highlight the Mukovacs influenza project, which is in collaboration with the University of Copenhagen with key professors there, including Professor Alan Rathum Thompson, whom I'm sure you all know from the COVID-19 days. And the idea with this influenza project is to develop novel vaccine platforms that can address a mucosal delivery for a novel influenza vaccine. And we have sponsorship from Innovation Fund Denmark for five year project. And this started last year and we have kicked it off. And we're now looking into the targets and progressing on that. And as soon as we have some good data, we'll of course announce any of that. With respect to nipah virus, it's also a grant sponsored project on the Horizon Europe grant. This is in collaboration with ADAPTMAC and other European academic partners. And the fact that it's in collaboration with ADAPTMAC mirrors a little bit the COVID-19 grant sponsored project that we had in 2020, 2021. It's a bit of a similar setup. In this case, nipah virus, if you don't know it, it's a disease that has become emerging in India and Bangladesh. And there's a concern that a disease like this may break into a pandemic. So the reason we got this grant is to prepare for a pandemic. And so we take the best of both worlds, just like the COVID-19, where we take the express system from Expression and make antigens for the nipah virus antigen and couple them to the VLP. Just as we have experienced with COVID-19 and now also with breast cancer. So it's kind of exciting.

And then the last question here in this one, or not the last question in general, but by this person, what are the upcoming share price triggers in the next three to six months? I guess you don't want to call it share price, Tigers, you want to call it news flow. But can you put a little bit on what we can expect in the next three to six months? What of these milestones?

I already alluded to it in this slide looking forward. Obviously, the breast cancer vaccine project getting that into a clinical phase one phase is very important and is a high evaluation trigger. We can see that in other biotech companies that have gone from pre-clinical stage into the phase one stage, that that triggers a lot of value increase. In fact, we've seen statistics that document valuation increase that is relatively higher than when you later go in from phase two to three. So we expect something to get out of that for sure. Of course, also getting the definitive agreement in place with the Serum Institute of India is important. That's really the validation of expression also in the malaria field that we have a defined collaboration agreement with the world's largest vaccine manufacturer.

Perfect. And then there's a little bit questions around the malaria vaccine. I'll see how I can put them together. Do we expect to have some, have one or perhaps several products ready that you are ready to put in production on the Serum Institute and how much revenue you expect from this one? And there's a little bit a question also whether the virus, sorry, the royalties is normal. And there's a question also, when can you actually expect a malaria product in the market? So let's start there. And I know this is far out in the future, but maybe the earliest point where you are now and where could the earliest point be that you could be ready to put a product into the market together with all your partners, of course.

Of course, it will be highly dependent of Serum Institute of India and their ability to fund this project going forward. And it's still a few where grains are important also in the future. And I know Serum Institute of India also take part even in grain projects. And by the way, just like expression has had a strong collaboration with the University of Oxford, so has the Serum Institute of India. Serum Institute of India also is dominating the malaria fields. They already have a license to R21, which is one of the two recommended malaria vaccine by WHO, which has emerged just very recently here and within the last few years. So they're the right partner to bring this forward. I cannot comment on timelines and anything related to financial aspects at this point in time.

That's fair enough. Maybe also to help us better understand, as you said, I think MuscoRix is the one on the market already, two are being recommended. What sets you apart? Is there something or is there just a very broad need for more malaria vaccines? Is that the take here or is there something that could set you apart show up in your scene in the data or something like that? Normally on a pharmaceutical market, you need the way into the market. I don't think you do that with malaria vaccine because it's so undertreated. But is there something sitting your part that makes this interesting also why your partner has decided to join up with you? Is it cheaper to produce something like that?

Well, there's a high unmet need in this area. More than 600,000 people die every year. And actually people, I mean, the majority of these are children below five years old. Right. And so that's where you want to give a vaccine that can provide the right level of protection. And we've seen with the University of Oxford's preliminary clinical data, and they've also shown some publications on this, that we have an edge on the effect, the protection level, safety and dosing regimen as well. So all of these are factors that are important to get a product that stand out if you like.

So no nothing in your data. I think is it five times you need to give the shot or something like that? And that is what new products are hoping. Is that the deliverance or maybe the immunity and so on that could be a little bit stronger? I know it's pure speculation here at the point of time, but just you're thinking of

it. Absolutely. I mean, just getting less dosing, especially in many of these countries where going to the doctor or the hospital is really complicated. So you don't really want a vaccine. You need to take five times over some period of time. But we'll get back to that. Yeah, we get

back to that. Perfect. There's a lot of crazy surrounding that, but I think I understand that before you have to sign documents, you are very limited in what you can say. Then there's you do a lot of these conferences you already showed us here. Any talks to partners on any project that is progressing and whether you can actually say anything about that, I doubt. But any thoughts about that? What is your feel? Do you meet partners out of these conferences? Some are investors, some are of course the medical conferences and the interest for you in general. Can

I respond? I already responded to it in last part last week when I attended by Europe and there's a video Q&A interview with me on LinkedIn that you can see, which was a very fruitful event and which is really important that we start taking initial dialogues and present what we have in our pipeline and get into a discussion with appropriate partners. Again, these discussions takes a long time and also many partners, especially big pharma partners, they really want clinical data. Why? Especially when it comes to the breast cancer vaccine. Now that we're moving into phase one, it's important to keep that dialogue. But I'm fully aware that the most value we can get out of this asset is to partner after we have clinical proof of concept, which would mean after clinical phase two. This is years in the distance, but we may actually want a partner to put a proposal on the table before that, which we cannot say no to.

I think you already answered the question about how you think about the partnership for the HER2 vaccine and what are your expectations for milestones and royalties? It's probably a little bit too early, but as I understand it, you have these two. The earlier you will get funding for it, the later you will get higher royalties. So that is what you need to balance. Is that how I should understand your answer, Sven?

I think it's a fair comment, Michael.

Then there's a, can you disclose anything on the topics raised by the Austrian authorities in the RFI, stosing, testing, healthy participants, anything on the ethics? I don't know whether you can disclose anything or what they have been asking and so on, whether it showed up any larger problems, I guess, with you keeping the timeline not.

Well, apart from the protocol title, which is the basis for the clinical trial that the authorities wanted us to include metastatic in the description of this type of breast cancer, which of course is relevant. We also have a feedback that we should prioritize HER2 positive patients. That's not to say that we cannot also include HER2 low patients, but the latter we will do later. So we will take the most advanced deceased patients and start vaccinating them and see how the safety comes out. Bear in mind, it's all about safety in this first phase one trial.

And then there's the question ending and maybe it's a little bit too early, but I will ask that as the last one here and then I'll let you off the hook. When do you expect to provide a clinical trial plan? Phase one, there's two design longer term position and partners plan for the breast cancer vaccine. There was a lot of question in this one, but any thoughts about what needs to happen before you will present those plans?

I think we have alluded to that phase two could start a couple of years down the road. I would say in 2026, if everything goes well and is planned. And phase two trial is going to include many more patients, probably around 100 to 120 patients. We're looking into that and that is also something we're discussing here to get the right picture.

And some thinking about the longer term positioning with this product. Is that still the same as you always have wanted to that it's for the patients not being treated well?

In the very long term, we may the fact that this is a vaccine, we and we've seen some preventive mechanisms or effects in the preclinical setting. We would of course also like to test that in the future, but in first instance, it's a therapeutic breast cancer vaccine. So it will be administered on top of standard of care. And the idea is to prevent resistance of the standard of care, which is the case in up to 30% of cases.

Perfect. That was the last question. Thank you to you, Ben and Keith for taking us through the results and achievements in the third quarter and a little bit beyond. May everybody have a nice day?

Thank you, Michael. Thank you very much.