ExpreS2ion Biotech Holding AB (publ)

Welcome to today's event where we have the pleasure to present expression biotechnology. To help us through today's event we are joined by CEO Ben Fransen and CFO Keith Alexander. Today's topic your H1 report fresh off from the press and of course some focus on the breast cancer candidate after you had your CTA earlier this month. As always you're very welcome to ask questions in the box down below. We will have a sharp deadline nine at 10 30 but uh we will see and get so many as christian in as possible so do feel free to ask down there but uh for now i think i will have the call over to you bent thank you very much michael and thank you ht anderson capital for hosting this webinar uh in connection with our quarterly interim financial report released today 15 august

I'm joined by Keith Alexander, CFO. My name is Bett Fransen. I'm the CEO and I'll go through an update of our business first, followed by Keith going through our financial results. We're happy to take questions and answers in the end. So quite a lot of things have actually happened here since we had our last quality webinar. uh announced the payment of the of the dividend portion of 22.5 million sec to expression through our 34 owned the associated company at that bank this was in connection with the phase three completion milestone payment from the very nordic that they paid to adapt back in connection with the covet 19 vaccine phase three completion very nice for expression and our cash position We followed this up with announcing a rights issue, and we have concluded a 30 million SEC cash raise in gross proceeds, including two warrant schemes called TO10 and TO11, which are exercisable here at the end of this year and end of 2025, very much correlated with the progress on our lead pipeline asset. We have also announced a US patent issue, which is great. It's also awesome, always awesome if you can get even an agency like the US Patent Office to validate your inventions. And this we have for our null FLYCO modified cell line. And this is strong, something we work with. And now we have this stamp from the US Patent Office. The biggest milestone that we have, and I'm gonna dwell more on this in my talk is that we filed a clinical trial application, a CTA. We did that last week on the 6th of August. It's a key milestone in our pipeline. Now we are really on paths towards the first clinical trial with our lead assets, the breast cancer vaccine project that we call ES2B-C001. Finally, we've also actually spent some time on updating our website and branding. So we bring a new visual identity to the table here. You may already have noticed that with our new logo and our greenish site. And we are very pleased with this update. And this is to clarify our value proposition, both to customers and partners and investors alike. If you look at our pipeline, it's led by our therapeutic breast cancer vaccine candidate, ES2B-C001, followed by ES2B-I002, which is our protocol for the CMV, the cytomegalovirus vaccine project that we do in collaboration with the Danish biotech company, Evaction. And we have further exploratory research in our pipeline. And I'm very, very pleased with ES2B-C001 that we have actually progressed. Updated the bar here. We have now submitted the clinical trial application on 6th of August, and we are approaching the phase one stage as we speak. Furthermore, on the CMV project, we are approaching animal testing. We'll do immunogenicity testing to test how we can raise antibodies with the potential candidate that we're looking into. As you know, this takes time and this is a discovery effort that we initiated in December 2022. I'm very pleased that we have actually some candidates now that we can take into clinical trials here in the next year. But let me dwell more on ES2B-C001. This is really a breakthrough breast cancer vaccine, and it's based on technologies that we have already validated. If there's clinical proof of concept and there's a phase three validation because it's exactly the same technologies that were applied in the COVID-19 vaccine that was sponsored by very Nordic on the license from that. So we take the same technologies and apply them in years to BC 001. and the good thing about this acid this is a protein we're making which is not mutating it's the same protein it's very clear cut and we make a full length protein which makes a polyclonal response this is important because existing standard of care treatments like monoclonal antibodies like her septum and pajetta which generate billions of dollars to rush They actually target only one domain and with this we believe we have a potential very effective therapeutic breast cancer vaccine candidate. The VLP concept that we apply here has actually also been validated or used in approved vaccines such as the HPV vaccine for cervical cancer and HPV vaccines against liver cancer. So the concept as such is in existence in commercial vaccines. With the VLP technology that we include here from AdaptVac, we can make a highly immunogenic vaccine, very efficacious vaccine that's able to generate a very strong polyclonal antibody response. And we can also say it has a very safe profile. We know it from the COVID-19 project, but we've also seen in our preclinical setting, long-term non-human, primate test data, which are very encouraging in terms of safety. We can say that it's a long immune response and we're able to break self-tolerance in this connection and we can combine it with standard of care even. So at the end of the day, we can apply this on top of existing lines of therapies or maybe even use it as a standalone and eventually an off-the-shelf, scalable, and cost-effective therapeutic opportunity. We've had significant progress, as I mentioned. We have carried on with the manufacturing of this. We made the drug substance there in the spring, and approaching the summer, we were able to manufacture and release the drug product. This is a very important step because it's a product that will be used in the clinical phase one trial. We could then carry on with a very important process of making the investigational medicinal product dossier, IMPD, which is a very important document for the regulatory authorities scrutiny, as well as the investigators brochure, which is the document which the clinical collaborators will use in connection with carrying out the clinical phase one data. We have selected the clinical trial setup. We are going to work together with Medical University of Vienna and their clinical colleagues. We're very pleased with this setup. It's very well known in the field, very experienced clinicians taking care of this. So I'm super pleased we have reached a collaboration agreement with Medical University of Vienna on this. We have in July had a very important scientific advice meeting with the regulatory body of Austria, and this was very encouraging. So we have a backup to proceed with the plans that we have set up in our protocol. And one of the key factors is actually that it also includes HER2 low patients. I'll get back to this shortly. So we were able to finalize the protocol and we submitted that on the 6th of August with all the documents and we're now in a waiting position. So the first in human phase one clinical trial, the protocol title is as mentioned here, first in human phase one, open label dose escalating trial to assess the safety, tolerability and immunogenicity preliminary anti-tumor activity of ES2B-C001 without Montonite and HER2 expressing breast cancer. This is the title of the phase one safety trial that we are going to conduct once we have the approval in place. The primary objective of this study is to determine the safety, tolerability, and maximum tolerated dose for the product alone or in combination with Montonite. Montanite is an adjuvant which has been used extensively in various clinical studies. In fact, more than 200 clinical stage studies have been carried out with Montanite. So it's strongly validated by regulatory authorities around the world to be included as an adjuvant. And an adjuvant may facilitate the immune response. well-known component in vaccines. You had them in many approved vaccines. One of the exciting characteristics of the COVID-19 vaccine was that it didn't need an adjuvant because the COVID-19 vaccine with the VLP raised a strong immune response itself. So here in this setup, we are going to look into a combination of with or without montanite to test for that. The secondary objective is to investigate the immunogenicity exactly in combination with the montanite adjuvant. And we have exploratory objectives as well. If we can determine the preliminary antitumor activity, that would be great. Bearing in mind, this is primarily a safety study and the antitumor activity readout will be an exploratory endpoint. The design is set up as an adapted three plus three design. This is very standard in the field of making early clinical trials in the oncology field. This is the same setup we're doing with a three plus three design. We'll look into two treatment groups and have patients amounting to about 18 patients in this setup. And the study duration is estimated to be around 20 months. We look into have some readouts during 2025 that can show some safety aspects of this study. The estimated study start as we announced it last week is in the first quarter of 2025. And our strategy to market is really, we take responsibility of the early research and development. We've done that so far. We have had the infrastructure to carry out the early research, including this phase one trial. And the aim is to license the asset out once we have the right clinical evidence for preferably a bigger pharma partner to take it over and carry out the phase two, three trials. the upscaling and the commercialization. We have some upcoming events where I'm going to detail more about this. So this is going to highlight events taking place in Denmark, in Aarhus, 2nd of September, in Stockholm, 12th of September, and in Copenhagen, 17th of September, where we'll be presenting more of our business and not least ESOP C001 and its progress. That said, I'll take some more questions around this later, but now I'll hand over the word to Keith. Keith, please.

Thank you, Ben, and thank you, Michael. As Ben mentioned, I'm Keith Alexander. I'm the CFO of Expression Biotech. On the coming slides, I'll talk about our financial results for the second quarter and first half of 2024. In the second quarter of 2024, Expression generated operating income of 2.4 million Swedish krona which is an increase of 16% compared to the prior year quarter. Our net profit in the quarter was 2.5 million compared with a net loss of 30 million in the second quarter of 2023, and drove a profit of 5 EUR per share, or 2 EUR on a fully diluted basis. At the end of June, Expression had 69 million Swedish crowns in cash. I'll dive into the key drivers of these figures and others in more detail in the coming slides. Starting with operating income, we experienced a 16% increase year over year in the second quarter to approximately 2.4 million Swedish kronor 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 a webshop. They were well below the long-term average in the quarter, reflecting the transition to a pipeline strategy. However, in the chart on the right, we show other operating income, that is grant-related income. which was the highest it has been since the fourth quarter of 2020, driven by both our newest grants, including the Vichy Disease and Mucovex Consortiums, and old grants, including Indigo. Moving to the cost side, which is much more significant than the income side, operating costs in Q2 amounted to approximately 23 million sec, a decrease of 35% compared with the second quarter of 2023. The decrease is driven by external R&D costs and cost savings from the restructuring announced approximately a year ago. Here, we've illustrated the two largest components of operating costs, starting on the left with 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 45% lower in the second quarter of 2024. 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 costs to calculate an underlying personnel cost. The underlying figure is approximately the cash cost of personnel. It peaked in the first quarter of 2023 and decreased by 35% compared to the year-ago quarter. The decrease primarily reflects the cost reduction program enacted last August. Note that personal cost is sensitive to wage inflation and FX since we reported Swedish crowns and paid wages in Danish krona. Moving to the net profit and loss for the period. After financial expenses and taxes, we had a net profit of approximately 2.5 million Swedish crowns in the first quarter, compared with the net loss of approximately 30 million in the year-ago quarter. We showed the year-to-date comparison on the right. For the first six months of 2024, the net loss was 10 million, an 82% decrease from the 56 million loss in the first six months of 2023. Our next slide shows 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. Cash burn from operating activities has been approximately 13 million. The net cash inflow from investing activities was 21 million. primarily reflecting the dividend paid by AdaptVac APS following their receipt of the milestone payment from Bavarian Nordic for completion of phase three activities for the ABN Co2 COVID-19 vaccine. Financing and effects reduced cash by approximately half a million combined. Putting this all together, at the end of the quarter, the company had a cash balance of 69 million Swedish crowns, which was an increase of 11 million SEK year to date. It's worth noting that these figures do not reflect the rights issue completed after the end of the quarter, which contributed approximately 30 million Swiss crowns in gross proceeds. On the next slide, we show the trend in our cash balance, which ended at 69 million in the quarter. As mentioned, we received gross proceeds of 30 million Swiss crowns. It's not reflected in this chart. This balance enables us to initiate the phase one clinical trial of our lead asset, the breast cancer vaccine. subject to approval of the clinical trial application submitted last week. Looking forward, we have two warrant subscription periods planned for the fourth quarter of 2024 and third quarter of 2025. The TO10 warrants have a subscription period from November 20th to December 4th, 2024, with each warrant being exchangeable for one new share for a price of 70% of the volume-weighted average price during the first 14 days of November. It's subject to a cap of 1.5 per share and a floor of the company's quota value of approximately 0.11 Swedish crowns per share. The T-11 warrants have a subscription period from September 18th to October 2nd, 2025, with each warrant being exchangeable for one new share for a price of 70% of the volume rate average price during the first 14 days of September next year. It's subject to a cap of 1.75 per share and a floor of the company's quarter value. In both cases, a maximum of approximately 30 million new shares will be issued. We do hope our investors will invest alongside us in the development of the groundbreaking breast cancer vaccine and Expressions future development pipeline. With that, I'll pass it back to Michael for Q&A.

Perfect. Let's jump into it. I know we're busy. The first one, when do we expect start for phase one breast cancer vaccine candidate? Did I understand you correctly that you expected that Q1, 25? Was that correct, Bent?

That's correct. And the definition for start in that connection, actually the first patient, first dose. So that we are expecting in the first quarter of 25. We just initiated a process now with the clinical trial application, which is going to take a while. So we expect a dialogue with the author and authorities before we actually get an approval to carry out the study. And even when we have that approval, it's going to take a little while before we can actually enroll a first patient and get the first patient dosed. So Q125 is the estimated starting time.

then there's a question i don't know whether you give this information the cost of the full phase one program an estimate of that and of course the question are you financed with with the warrants what you have gotten in your cash balance right now to run a full phase one program and should i take that one yes sir

We haven't disclosed the exact cost of the phase one program. What I would say is it's much less expensive than the phase one we were looking at a year ago at this time. I would say also that the reason why we're not disclosing the cost is that things can change as you go through the study, so of course the cost can be a bit variable. But I would say that we've been very diligent on trying to keep the cost very much under control. while making sure that it achieves the objectives that are important for expression and for the phase one study. Regarding whether we have enough cash to finish the phase one study, which was the stated objective of the rights issue, it really depends on how the warrant series go. It is possible that we have enough to finish, but we really need to see how things go. And that'll be subject to our share price and frankly, how the market values our progress as we proceed through this. I mean, entering the phase one should be a very, very material value inflection point, but we need the shareholders to reflect that in our short price.

And then there's a question also, are you seeking, will you seek, for example, direct issue, larger investors besides the potential for candidates? Are you looking at this, maybe getting in some It's a bad word, smart money. Something that can go a little bit deeper in and look at your technology. Is that something you're looking at other sites or is the roaring programs the main part where you are expecting to get the sourcing from?

Keith, would you also like to?

Sure, I think I'll take that in pieces. First, we have no direct plans for an additional rights issue at this time. Second, we would very much like to have some institutional investors on board. who are committed to the long-term development of the program. So it's something that's very much on our minds, especially right now, you could say.

And then a very big question and having to you to look into the future. If you look ahead three to five years, what company do the shareholders own? Is it a broad based with more candidate? Is it a company focused solely on what you already have in your pipeline and trying to run a license deal? There are some thoughts from you, Ben, and I know this is It's almost impossible to look into the future, but I'll ask you to try.

Yeah, well, the good thing about being in expression is that we have a clinical phase three validated technology platform. So that's very awesome. And it validates in many aspects our pipeline endeavors. We are now focusing on the breast cancer vaccine assets. We have also the CMV project, as I've alluded to. before the end of 2025 expression, we have the right to select the lead candidate. And then we have to find out how to develop that onwards. So that would be a direct consequence of that asset. In our exploratory projects, I've mentioned it a couple of times. I can't disclose details at this point. I think we have some super interesting preclinical projects going on there, even getting some animal data. But we have to validate it before we can actually go out and say, hey, we have actually really something potentially very valuable here. And then, of course, we had to find out how to proceed with those.

Perfect. Well, at that point, we see more milestone payments from Bavarian.

That is a no. So the phase three completion was it for the COVID-19 project in the hands of Bavaria Nordic. I think they've been very clear in their communication that they're not going to proceed with that. So as a consequence, I don't foresee any milestone payments on that project to adapt back.

Then the question, do we have the organization you need when going into human clinical trials? It's a step up. Do you have the organization or have you outsourced it from the outside? I think you kind of alluded to your presentation here.

Well, we are now in tight collaboration with clinical researchers in Austria. helping us out on carrying out the phase one study which is going to take place in in vienna and in addition to that actually since we have been in a transition one year ago we have retained consulting experts when needed so that's the way we've been handling that And I think it works fine. It's not as risky to hire in experts and we can handle it like with the consulting experts as we do. So that's the good thing about that.

Then this question, how far do you expect to take the ECB C001 yourself? I think you alluded to it on the slide there, but if you can tell a little bit more.

The strategy is really to take it to the clinical proof of concept, which would be actually getting output from a clinical phase two trial. That's going to take a lot of years and demand a lot of money, and I cannot sit here and say that we can carry that out. So that's why we take a business approach of talking with potential partners already at this stage if they can support the development. it's a pro and con process because you want to maintain the project yourself as long as possible to gain as much value to shareholders as possible in principle it would be great to carry it out to clinical proof of concept but in reality we we have to look at how we can proceed all the time

Then regarding the malaria, what are the possibilities in the projects? Is inspection part of the project of larger or smaller size? You mentioned negotiation in the report.

Yes, on malaria projects, which I didn't cover in this webinar, but it's actually very exciting that University of Oxford are carrying out many clinical studies across four different malaria projects, all applying our express production platform. And these clinical trials are taking place in phase one and even one in phase two. So that's great. University of Oxford have been very good in being awarded non-diluting funding to fund their clinical efforts and expression. We don't carry any cost on this ourselves. So we're just very pleased that they progress constantly. And eventually we get into a scenario where it may become commercially malaria vaccines, not caused by them. That's an upside to expression.

And then let's finish with this one. And I thought there was more, but we need to cut sharp. Could your technology platform potentially be partly outlicensed to fund your own development activities, you know, as a broad umbrella or something like that?

Well, we've been successful in licensing out for the last decade or so, but it's actually used in research laboratories with a license fee, which is based on scientists using it as a research platform, not really taking it into a pipeline asset. And so the challenge is actually to bring it to that stage. And that's what we're trying to do ourselves with our pipeline efforts. So it's going in the right direction, at least.

Unfortunately, we are running out of time. There's a question here. Why do we don't do it in Danish? You know, most of the shareholders are Danish, but I don't know how far Keith has come with learning to speak Danish. So it's not trying to alienate anybody. It's simply so Keith can participate. Here we are. We are doing it in English, of course. I hope it was OK. I answered that one.

I would just add that half of our shareholders are Swedish and some of them have asked us to do it in English as well. But yes, I'm more comfortable in English for sure. Perfect, perfect.

Unfortunately, we didn't catch all the questions. We will see you again at some point in time, and I will see if we can get answers to some of the questions. But thank you for taking us to the results and the trial set up for the breast cancer candidate. And thank you for people for listening in and asking a lot of questions.

Thank you. Thank you.