As always, you can ask questions in the box down below. Feel free to do it in English and Danish. If in Danish, I will try and translate to the best of my abilities. But I think for now, I will hand the call over to you, Bent.
Thank you very much, Michael. My name is Bent Frandsen. I'm the CEO of ExpreS2ion Biotech, and I'm joined by Keith Alexander, our CFO. As Michael mentioned, we'll of course cover the Q1 report, which is the purpose of this webinar. We released it this morning, but we'll also take the opportunity to update you on our general business, the progression here, and, not least, also the rights issue that we announced, shortly. First, the usual disclaimer, we'll let you read the details when we publish this, on our webpage later. So basically, so far in 2024, we've had some very good news. In fact, we have been rewarded with cash through our associated company, AdaptVac.
Back in February, AdaptVac announced the phase III completion milestone payment from Bavarian Nordic for Bavarian Nordic's completion of the COVID-19 phase III study. So this led into, ExpreS2ion receiving, DKK 14.5 million, approximately SEK 22 million, which we have, just received there in the beginning of the second quarter, which is very nice for our runway. And also here in April, very importantly, we have completed the GLP safety study for the ES2B-C001, our breast cancer vaccine asset, a very important milestone for the company. And then lately, only, shortly here in May, we have announced a rights issue to raise approximately SEK 60 million through, a rights issue. If you look at our vaccine pipeline and the assets that we control, it's led by ES2B-C001.
This very important asset, we have an outstanding preclinical package now, which documents both the efficacy and now also the safety. We completed the safety package in non-human primates here very recently. Basically, we are in a clinical trial application-enabling phase as we aim to progress into clinical phase I here within the next year. Furthermore, we have the CMV asset that we call ES2B-I002. This is in collaboration with Evaxion Biotech, applying their AI platform and using ExpreS2ion's expertise in making the appropriate antigens, and this is in a lead optimization phase. Then we have exploratory research on some exciting discovery projects that we are right now looking into the IP positioning and progressing on that as well. Common denominator for these assets is they're tapping into market sizes of multi-billion values. ES2B-C001, we are very excited about.
It's a therapeutic breast cancer vaccine. It taps into an unmet medical need, and it's a HER2 positive breast cancer, the most common cancer, and unfortunately, a disease that takes more than 600,000 lives every year. The market size, in fact, the obtainable market, we conservatively estimate to EUR 2.8 billion, so it's a blockbuster potential we're looking into with this asset. And a very nice thing about the technology platforms that we apply in this asset is that they have been clinically phase III validated, most recently, as these are the same technologies that have been used in Bavarian Nordic's phase III stage COVID-19 vaccine. That's a very good thing.
And also, of course, we have a very strong team backing up this asset, both at management board of directors level, and importantly, also having a scientific advisory board with very strong oncology key opinion leadership. ES2B-C001 progresses across all the important stages of a, an asset like this. We have done the GLP safety study. We have the CMC manufacturing in place. We've done the drug substance manufacturing actually here in May, and are progressing with the drug product manufacturing. And then we have the clinical supply ready, basically. We are in the middle of designing the clinical phase I trial right now, and in fact, pending selection of a trial manager and the important Investigator's Brochure, an important document needed in this process.
But we are on path for making the clinical trial application here in the next quarter. Business development, we have initiated business development initiatives here. We have a consultancy supporting us in opening doors to potential partners, so we are now actively marketing this product across the market. On the CMV side, ES2B-I002, also a project on track together with Evaxion, and we have done the antigen discovery, having identified potential targets, and we are in the middle of assessing preclinical work on this and continuing. The aim is to select a lead candidate by next year, where ExpreS2ion has the first right to select this and carry on the work under a license agreement. Our platform, ExpreS2, has been validated now across many assets.
I think it's important again to highlight the COVID-19 asset. It has been validated in clinical phase III. We have seen long-term efficacy. In fact, as far as we know, the only protein-based COVID-19 vaccine with more than 12 months protection from COVID-19. In terms of other clinical stage validation, University of Oxford, they conduct several malaria clinical trials, and all using ExpreS2, the ExpreS2 platform for the antigens. And earlier, we have, as I mentioned, the HER2 breast cancer, which we are now focusing on, in ExpreS2ion, to carry that on. And then we have the CMV project and other earlier stage projects, which are all grant-sponsored, two within influenza and one within Nipah and filovirus vaccine.
With respect to the malaria vaccine candidates, as I mentioned, these are actually all sponsored by University of Oxford. They have been super good in obtaining non-diluting grants to support their clinical development. This was lying still during the pandemic, where, of course, even at University of Oxford, they were focusing on COVID-19 vaccine research. But I'm super pleased that since last year, they have really accelerated the work on the malaria vaccines. So in fact, these six different trials that I mentioned here cover four different malaria vaccine projects, all in or moving into a clinical stage, and some even at the phase II level, which is important. And of course, we do everything to support University of Oxford in their endeavors to continue on these important works.
That's a brief introduction to the business and where we are with our R&D. We have some upcoming events here in the short term, where I will cover much more on this. So tune into the BioStock event on the thirtieth of May, as well as H.C. Andersen Capital Life Science seminar on the fourth of June. ExpreS2ion will present as well. I'll then hand over to Keith, who will go through our financial results and the rights issue.
Thank you, Bent. As you mentioned, my name is Keith Alexander, and I'm the CFO of ExpreS2ion Biotech. In the first quarter of 2024, ExpreS2ion generated operating income of SEK 1.6 million, a decrease of 40% compared to the prior year quarter. Our net loss in the quarter amounted to SEK 12.9 million, which was 51% lower than in the first quarter of 2023, and drove a loss of SEK 0.25 per share, or SEK 0.23 on a fully diluted basis. At the end of March, ExpreS2ion had SEK 60 million in cash. I'll dive into these figures and others in more detail in the coming slides.
Starting with operating income, we experienced a 40% decrease year-over-year in the first quarter to approximately SEK 1.6 million due to the progression of client projects. In the middle chart, we focus on net sales, which reflects revenue from projects, licenses, and our webshop. They were well below the long-term average in the quarter, reflecting the transition to a pipeline strategy. In the chart on the right, we show other operating income, that is, grant-related income, which remained at elevated levels compared to history, but was lower than last quarter. Moving to the cost side, which is much more significant than the income side, operating costs in Q1 amounted to approximately SEK 16 million, a decrease of 52% compared with the first quarter of 2023.
The decrease is primarily driven by external R&D costs, which I'll dive into in more detail on the next slide. Here, we have 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 followed a downward trajectory since then. This item is large, volatile, and very much 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 an underlying personnel cost. This underlying figure is approximately the cash cost of personnel. It peaked in Q1 of 2023 and has since decreased by 37%. The decrease partially reflects the cost reduction program enacted last August.
Note that personnel cost is sensitive to inflation and wages. Wages are set by the market for talent and FX, since we report in SEK and pay wages in DKK. Moving to the net loss for the period, after financial expenses and taxes, we had a net loss of approximately SEK 13 million in the first quarter, a decrease of 51%. We show the full year comparison for 2023 on the right. Last year, the loss decreased 19% as compared to the 2022 result to SEK 96 million. Our next slide shows how our cash balance developed in the first quarter of 2024. At the start of the year, the company had a cash balance of SEK 58 million.... Net cash flow from financing activities was negligible, as was cash flow from operations and investment activities.
However, this does not reflect the underlying dynamics in which we received a large upfront payment related to a grant, which offset our operating loss. Note that the grant payment factors into cash, but only the realized portion is part of the operating income. As we complete the funded activities, we will realize the income in our income statement. Finally, we realized a SEK 2 million gain from currency changes. Putting this all together, at the end of the quarter, the company had a cash balance of SEK 60 million, an increase of SEK 2 million in the quarter. The next slide, we show our trend in the cash balance, which ended the quarter at SEK 60 million. We received a dividend of approximately SEK 22 million from AdaptVac after the end of the quarter. This balance should carry us into 2025 under the current budget assumptions.
However, additional capital is required to initiate a phase I trial of the breast cancer vaccine asset. This leads us to the rights issue launched on May 2nd, which I'll cover on the next two slides. The company's lead asset, the breast cancer vaccine, will soon be ready for clinical trials. As we've stated in many recent presentations, the phase I trial will require additional capital. We're exploring various sources as well as partnership opportunities, preferring not to dilute investors. Those other sources take time, as does establishing partnerships, and both are uncertain until terms are signed. While they may bear fruit in the future, the board decided to launch a rights issue now to prevent delay to the initiation of the phase I trial. The rights issue targets a capital raise of SEK 60 million.
As shown on this slide, approximately 65% of the targeted proceeds will fund clinical development of the breast cancer vaccine. 10% will fund continued development of the CMV vaccine, 5% will fund grant-sponsored projects, and 20% will fund working capital, including discovery and platform development. We have secured subscription intentions and guarantee commitments from insiders and investors, amounting to approximately 50% of the targeted amount, or SEK 30 million. The rights issue includes two warrant series, with subscription periods in Q4 2024 and Q3 2025, which we hope will result in additional funding. So how does the rights issue work? Investors who hold ExpreS2ion shares as of June 10th will receive seven unit rights for each existing share. Every six unit rights will entitle subscription in one unit in the rights issue for SEK 1 per unit.
Each unit consists of one share and one warrant in each of the two warrant series. Looking at the timeline below, the key dates are the start of the subscription period, June 12, and the end, June 24. Participating investors must subscribe their unit rights during that period, and ideally near at the beginning, as some banks' cutoff period for subscription may be shorter. This is unfortunately outside our control. After the subscription period, the outcome will be announced on July 1st, and the conversion to shares and warrants will occur around July 22nd. With that, I'll pass back to Michael for Q&A.
Perfect. There's a lot of questions, so we will jump right into it. There was some question coming in on an email. I have put those in, but let's start with the first one. There's also a question here. You have mentioned that you were seeking partners to this breast cancer vaccine, that you were looking for it, that that was the road you were going to, because that was the only possibility without the right issue. Now, you have decided to raise a new equity.
Can you comment a little bit on these discussions you have had there, so maybe we can get a feel on whether it's always going to be rights issues or a new equity that is going to fund you, or you have a feeling that it should be possible later on to fund it more with partners?
Yes, I can answer that. So with respect to business development, as I mentioned, we have actually retained a professional consulting agency, specialized in this work, and it's very nice that at this very preliminary stage, we've had a few meetings, even with well-known pharma, but it's too early to say that this can progress. Generally, processes like this can take quite a long time. And of course, it's great that we can present the compelling package that we have made preclinically, but clinical data really count. And that's why it's good to have presented this initially.
It's good to actually be able to inform that we're progressing, and that under this rights issue, that hopefully we can move into the clinical phase I trial and progress on that, generate the data that will ensure that the partners get back to us and actually potentially can move into some deal agreement discussions. So that's kind of the stage.
There's a question regarding that: How long will the first human trial on the breast cancer candidate run before potential data readout? Any indications? I know you have indicated, I think, 12 months from when you get the money, you will start the trials, and how long do they run afterwards there, before there could be potential some kind of a data readout anybody could see or you could negotiate with?
... Yeah. Well, ideally, if everything goes well, we have data before the end of 2025. But I have to say that, as I mentioned earlier, we are actually in the middle of designing the clinical trial setup and are looking into several different clinical solutions. And so actually, it's important to look at all parameters when we look at this. The clinical support that we will get have different assumptions for patient recruitment rates, different assumptions regarding timelines and setup. So it's not such a clear answer on this. But in the best of cases, we could have some data before 2025, but it's also realistic to say that, hopefully in the beginning of 2026, we have actually a phase I data package.
Hopefully before that, of course, we will make some initial observations. Those are also data points, but... That can come probably earlier in 2025. Yeah.
Perfect. Then there's a question, and I don't know whether you can comment on other companies. What are the activities that go on in AdaptVac, and could there be further dividends in the future? I think they kept some of the cash to progress their projects over there. So I don't know whether you can comment on other companies, but...
Well, AdaptVac is also a vaccine-focused company, and they own the VLP technology that ExpreS2ion has in-licensed for the breast cancer vaccine asset, and which Bavarian Nordic in-licensed for the COVID-19 vaccine asset. Both of which coincidentally also apply ExpreS2ion's ExpreS2ion technology, so. But AdaptVac, they actually nowadays project the pipeline with ExpreS2ion's breast cancer vaccine as their lead asset, so that's already out-licensed to ExpreS2ion. Their further research work revolves malaria. They have another malaria research set up, which is coordinated by University of Copenhagen, and they have non-diluting funding for that, so that's good. They can progress on that as well. As far as I know, they also perform the research, applying the VLP within gonorrhea vaccine. It's an early research phase.
Of course, they also have some operational activities they need to carry on. Some of the dividend, of course, or some of the proceeds from the phase III completion milestone payment is retained in AdaptVac to secure that they have funding well into 2026. But it's a very nice setup, all this. I want to comment that because it's exactly what we set out to do when we established AdaptVac back in 2017, that together we could build novel vaccines. We showed that with COVID-19, and Bavarian Nordic carried it through to clinical phase III and paid a very sizable EUR 10 million milestone payment for that work. Of course, we can build further on that.
Perfect. How far can you take the ES2B-C001 in clinical development based on the assumption of a gross proceeds of SEK 30 million, which is the guaranteed amount, and SEK 60 million from the rights issue?
We hope to gain the maximum of SEK 60 million or approximately up to that level, because that will ensure that we can complete the phase I trial. That means that we will have cash into the beginning of 2026, where we expect the phase I trial to be completed. If we only get secured level of SEK 30 million, it will help us still, but we will risk not having the finance to completely complete the phase I trial, and we will look into other sources of cash, of course. Actually, we are very active on looking into non-diluting funding and have some processes going on for that.
But that's, of course, also risky processes that you never know if you can get awarded a grant, although we have a very nice track record in that sense. And of course, in parallel with this, we continue with the business development and letting potential partners know where we stand and continue the mutual discussions there.
Perfect. Will you seek external funding when you have chosen the lead CMV candidate? I think the 10% of the proceeds was going with that, and you indicated that if you might be able to choose a leading candidate there in 2025.
Mm.
I guess that's where the funding takes you to. Is that enough to seek external funding, non-dilutive funding, grants or, or something like that, or, or just to go a little bit further on? I know we are in 2025, and it's hard to to guess about the future, but, but any thoughts about that?
I mean, once we are at that stage where ExpreS2ion can select the lead CMV vaccine candidate, then we know we have actually a compelling preclinical package, and we can use that to apply for non-diluting funding going forward. Or, maybe even, take some partnering discussions, to co-develop it, taking it onwards. But you're right, at that point in time, either it may be stalled, could be a pity because we would have a compelling preclinical package, or we are able to sponsor it in other ways.
You return again, Keith, because I think now there are some questions for you. Can you disclose which project the grant payment in Q1 is linked to? You had some cash flow effect, and I think the next question also covers this. How much of the grant for the Nipah virus, I don't know whether that was the grant you got, do you expect to book this year in your P&L?
Well, I, I'm afraid I can't provide much disclosure here. It gets a little bit too specific for public disclosure.
Good.
You can probably... You can look at the grants that we're involved in, they're all publicly disclosed, and maybe make a guess based on that. We don't give forward guidance, so I'm not gonna tell how much we expect to realize through the rest of the year.
Perfect. That was a clear answer. Then there's, how much will the cost rise from the levels here in Q1 when you start the clinical trials on the breast cancer candidate?
Again, that's forward guidance, but and we don't want to provide that. We could have provided something on that in the Q1 report, but it's not according to our IR policy to provide forward guidance. And it also very much depends on which clinical program we decide to pursue. As Bent mentioned a couple of times on this call, it's there are several options that we're looking at right now, and the cost will vary depending on which one we select.
Then there's a little bit of questions on. Yeah, you are again asked, Bent, to comment a little bit on other companies, but can you comment on the Novavax sale of the COVID vaccine last week? Why can others see value in the Novavax vaccine and not the ES2B-C001 or COVID-19 vaccine.
As long as that agreement exists between AdaptVac and Bavarian Nordic, it's Bavarian Nordic's rights. And they've decided to shield it as it is at this point in time, so it's lying there. And that's Bavarian Nordic's sole decision. Yeah.
And then the second question was, I asked you to comment a little bit on the Novavax deal that was out there. I don't know whether you want to comment on that, any signals in that, on the vaccine front or something like that. I don't know how much you know about that.
I think, Novavax is a very interesting company, seen with ExpreS2ion classes. They work with vaccines, they work with other insect cell-based expression systems, they work with VLP. So there are some synergies in that company. So I always find it interesting to follow them, what they do, and it's inspiring. So good luck. If they can progress, that's good for all of us working in this field.
Then there's some questions about the malaria vaccine. Is there anything special about your research regarding the malaria vaccine? Is there something you expect something extraordinary for in terms of resistance, and is there a market for another malaria vaccine? So if I have studied well, there has been a malaria vaccine. So maybe I think the questions are regarding, are there actually a market for another one, and is there something special in your approach to this?
Yes. Apparently, the antigen that we produce in our ExpreS2 platform shows the highest immunogenicity. There's been even clinical studies conducted with antigens made in our ExpreS2 system, documenting very high immunogenicity. That means a high level of protection. And that's a clinical study that has been performed in infants, which are the most vulnerable population of malaria. All this is being sponsored by University of Oxford, and it's good. So they keep on using our technology platform for making antigens for this. Now they run actually four different projects that's slightly different in terms of the antigen targets. And it's good that they keep the options open and continue to fund this with the grants that they can obtain.
It appears that, ExpreS2ion with our technology has a very important position in the malaria field, and we are very thrilled that University of Oxford, they continue to progress on these activities.
Then there's a question regarding the mechanics in the rights issue. Is the guaranteed commitment also secured if the rights issue exceeds the minimum expected amount? So a little bit about those guarantees.
Sure. Well, I hope this will explain it in a clear way that is understandable. There are two types of guarantees. There are bottom guarantees, and there are top guarantees. The bottom guarantees are what we have right now, and what they do is they secure a minimum amount that we raise. So you can consider it almost like insurance on the rights issue. A top guarantee would be on top of whatever else is raised in the rights issue, and obviously, that's more attractive, but it also comes with a much, much higher cost. So it's much more expensive insurance, and it's not always available. It's just like any kind of market. Sometimes things are for sale, and sometimes they're not.
We all are aware of the challenges in the biotech fundraising market right now. We have bottom guarantees in this rights issue.
I know, we are a little bit over time, but one last question, and then I will let you off the hook here. I know you needed to go 10:30, so sorry. Will you need additional animal data once the GMP version of the CO01 vaccine is established?
No, the animal part of this asset is done. We have the functional data that we've documented multiple times, and then we have the preclinical safety package in non-human primates. That's it. So now it's onwards towards the first in-human clinical trial.
Perfect. You answered short. That's good. I know I had two minutes over. Sorry for that, guys. I know I needed to let you go. Thank you for taking the questions, thank you for presenting the results, and thank you for people for listening in.
Thank you.
Thank you.