Today's event where we have the pleasure to present ExpreS2ion Biotech. So it was true today's presentation, we are joined by CEO Bent Frandsen. Today's topic, of course, the Q1 results, but I think maybe more the news flow that you have sent out in this quarter and actually also rather last news after the quarter since. 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 them. Do feel free to ask them in Danish, but I will try and translate to the best of my ability. For now, I will hand the call over to you, Bent.
Thank you, Michael. My name is Bent Frandsen. I'm the CEO of ExpreS2ion Biotech, and I'm pleased to be reviewing the status of our company and business and pipeline today, May 15, in connection with the release of our interim report for Q1. 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. I will cover the ESGBC001, our therapeutic breast cancer program and where that is, and the remaining pipeline with respect to infectious diseases before we go through Q&A here. As a starting point, just to highlight where we are with respect to our strategic focus. As you know, ExpreS2ion is a vaccine-focused company with a pipeline of cancer immunotherapies and infectious diseases vaccine projects.
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 ESGBC001, our therapeutic breast cancer vaccine. 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 the University of Oxford for the Vigil Disease Consortium for Nipah virus, the University of Copenhagen for influenza on the so-called Mucovacs program, and the other influenza consortium that we call Indigo. Thirdly, we aim to achieve proof of concept for new vaccine candidates and enhance our platform technology. We have made extra efforts here to enhance our IP and have a very strong patent strategy to support our underlying intellectual property.
This is also the basis for our exploratory pipeline development that we keep progressing on in the early stages. As well as our platform, the ExpreS2 technology, which makes recombinant 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. We are actually reinitiating proactive marketing of this service. A very recent example of that is the WuXi Vaccines that have been sent that we just announced a few weeks ago. I'll get into detail on this as well. Also, increase on partnering activities revolving on our GlycoX-S2 cell lines, which come with properties that can make even enhanced immunogenic vaccines. Across these points, we've had a number of important updates here during the first quarter of 2024. 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 Serpo to our CSO in connection with Fajard Kouelakou retiring. The good thing is that Fajard, he continues to be engaged with ExpreS2ion in the form of a senior strategic advisor vaccine R&D role, which is good, taking his four decades of vaccinology experience in consideration. Max has been with ExpreS2ion for more than 13 years and is instrumental in our technology platform and early R&D efforts. We provided an update on the 3rd of April regarding our pipeline, where we updated on the vaccine phase one trial that we have just initiated this quarter, and a 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 Vaccines letter of intent.
We are very happy that the University of Oxford and the malaria programs going on there continue to recruit patients across numerous vaccine trials, progressing well. 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 amending our protocol for the breast cancer vaccine asset. This is to enable the evaluation of our therapeutic breast cancer therapy with antibody drug conjugates, or ADCs, as well as to expand the study sites.
Most lately, we have just yesterday seen from our associated company at AdaptVac ApS, which ExpreS2ion 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. This is in essence a new technology platform for AdaptVac ApS that combines mRNA technology with a unique VLP technology. Very exciting. 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 SEK 3 million. 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 that 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 Mucovacs grants with a significant contribution from Vigil as well. Moving to the cost side, operating cost in Q1 amounted to approximately SEK 16 million, a decrease of 1% compared with the first quarter of 2024, reflecting our 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 fourth quarter of 2022 due to the preclinical development cost 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. This underlying figure is approximately the cash cost of personnel. It peaked in Q1 of 2023 and was essentially flat compared to the year-ago quarter. Note that personnel cost is sensitive to wage inflation and foreign exchange currency 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 11 million in the first quarter compared with a net loss of approximately SEK 13 million in the year-ago quarter. In Q1 2023, we started the year with a cash position of SEK 81.5 million.
During the quarter, we utilized SEK 12 million in operating activities, reflecting ongoing investments in our key programs, including the ESGBC001 trial. Additionally, we experienced a negative foreign exchange impact of SEK 3.2 million due to currency fluctuations. As a result, our cash balance at the end of March 2025 stands at SEK 58 million. While this decline is in line with our planned spending trajectory, we remain focused on optimizing our cash utilization 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 DAPMAC, 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 warrant subscription, causing us to end the year with SEK 82 million. Entering 2025, our cash balance decreased to SEK 58 million, 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. Moving onwards with our pipeline activities led by ESGBC001, I'll give you an update on that. We, as you know, got an approval from the Austrian Authority to start a phase I 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. All the operations 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 dosed to confirm the recommended phase two dose. That's the important part of this trial.
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 Enhertu, 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 ESGBC001 therapy even in the phase I trial with, for example, Enhertu. This will also allow for further uptake of patients in the trial. We are also expanding the number of clinical trials to boost enrollment.
All this protocol amendment approval, we expect to have a conclusion of here in the quarter following the summer. We are making this phase I 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. We have now agreements with further five oncology clinics in the headquarters, in the capital neighborhood, that can refer patients to Medical University of Vienna. This will also expand the potential for recruitment of patients in this. On the timeline side, we are still on track as we are right now with the phase I expectations for enrolling patients and getting outcome of this, potentially preliminary outcome before the end of this year, further outcome in 2026.
The expected timeline is still to be able to start a clinical phase two, proof of concept trial in the beginning of 2027. 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. In all cases, we still expect a timeline with the conclusion of a clinical proof of concept trial around 2029. Of course, depending on the business development and partnering side, we will license this out for a 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 field.
All of these are being handled by the University of Oxford, who have done an excellent job at 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 I/II, having an interest of Serum Institute of India, which we have announced a term sheet around in the fall of 2024. We are in progress with making a definitive agreement with Serum Institute of India to get these programs further developed. Just as with the malaria program so far and with the other infectious disease programs, they are largely sponsored by grants.
We have the Mucovacs 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 glycomodified 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 lead candidate that might be taking onwards. On the Nipah virus vaccine, this is in collaboration with DAPMAC and other consortium partners. This is sponsored also by the EU, and we are looking into the same kind of setup as we've seen 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 Evaccin around, we have now discontinued this following a strategic review. As you may recall, in December 2022, we announced this collaboration with Evaccin, combining Evaccin's AI platform and expression protein production platform. After two years of discovery efforts, we still see quite a distance to a lead candidate. In order to focus on the expression side, we have decided to discontinue this project. Our pipeline essentially looks like this as we speak, led by the breast cancer vaccine project on top, which is now in clinical phase one. We have the malaria, the infectious disease, the influenza, and the Nipah virus vaccine project going on, all more or less sponsored by non-diluting funding.
In the bottom, you'll see the COVID-19 project, which came to phase three, sponsored by Bavarian Nordic, who decided to shelf this project due to the pandemic and their view on the commercial outcome. After all, we met the primary endpoint in the clinical phase three. It is a very important project for saying that both our ExpreS2 technology and AdaptVac VLP technology have been clinical phase three validated. Finally, looking forward, we continue to progress on the clinical side with recruitment efforts on the ESGBC001 safety trial and expect to get a readout on this even before the end of the year, depending, of course, on getting the first patient on board here. We will also be looking at immunogenicity and early efficacy signals. We have the Oxford malaria trials, which are continuing and will also support the ExpreS2 platform as well.
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 around our platform and other important vaccine innovations. I've said that before. I'll get back to this when we can put some more words on what that is around. We continue on validation through the grant funded projects led by Mucovacs and Indigo in vitro disease. That said, I'll be happy to take some questions from the audience. Thank you.
Perfect. Let's start with one. The first one is regarding a little bit your share and so on, and then we will get into all the pipeline news. Have you done anything 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. For example, both in Sweden and Denmark, there have been important events in that aspect where I've been able to promote ExpreS2ion Biotech as an interesting investment case. 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 share is trading around SEK 20 now. There's a question here. Could you think about doing a share split 1-10, meaning that it should go back to three of these crowns? 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 is 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.
There is a question regarding you are showing good progress. You have hopes for this company. Why not more insider buying? Why are not more insiders buying this year?
As you know, we are listed on Nasdaq First North Growth Market in Stockholm, and of course, we are obligated to report on any insider transactions through the Swedish Financial Institute. We do that.
When I say we, primarily myself and our Chairman of the Board, we have participated in any issue of new shares that has been there where we have acquired shares in the company. That has been a premise, of course. That is 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 is a question I could understand before the 1st of April. We have made a couple of announcements there, both 1st of April and here two days ago, 13th of May. Have a look at those announcements, and you will see there is an important update.
Most recently, of course, on the amendment to the study protocol, which would allow us to combine our ESGBC001 with antibody drug conjugate therapies, such as Enhertu, which opens up, we believe it opens up a lot of opportunities for expanding the potential of our therapeutic vaccine.
Perfect. I will jump a little bit in there because there is a question. Is it Enhertu and the success of this product that has actually maybe delayed you a little bit? Now when you do this combination, you actually think maybe you can accelerate things after the protocol. A little bit about the thoughts on this, besides, of course, the commercial opportunity, if you can do a combination product. A little bit here on the trials. Has it been delayed? Has it been harder to get enrolled patients because of this success?
Is that now why you expect maybe that when this protocol is amended, you actually can accelerate the take-in of enrollment?
I think there is a relation, and that, of course, motivated us to take this initiative. We do not know for sure, so it is a little bit speculative. We know that in Austria, Enhertu has been given reimbursement during the last year. In that respect, it is another dynamic than what we looked into last summer when we were drafting the study protocol. 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 Enhertu, 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 the patients in the long run. That is the importance here on this. 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. Actually, just to make you understand, because following you for the last couple of three years, you've been talking about the case that you have this huge market of existing treatments, and now something new is coming in. That does not change your business case, if I understand you correctly. All the new products are also only targeting one receptor. Is that correct?
That means, yes, there's a new generation of product that might take over a little bit from the older ones, but it does not change your business case or business case. You are being more a product that could actually go to market.
We are still a first-in-class opportunity with the breast cancer therapy. In that respect, we believe there's certainly a market adoption rate that can be very rewarding. In our estimates, we believe we will certainly have blockbuster potential and may exceed EUR 5 billion annual revenue once it's on the market. We strongly believe in this, obviously.
Okay. There are actually a couple of questions. As a resident Danish person, can you be in those trials in Austria? There's a little bit of a question. Where can you look for information and try to be 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, whether you as a Danish citizen could be included in these trials, if you pay everything yourself and so on. 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. As I mentioned, now five other clinics in Vienna will be referred to the Medical University of Vienna. I cannot say for sure.
It's a very good question. Yeah.
I think maybe should send you an email directly to ask you this. I think you can direct them to the right person maybe in your company that has a higher.
Perfect.
Can you give me an idea of stock 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.
That is where that is at the moment. Mucovacs, it's very much research-driven as we speak and supporting new technologies that we have from the ExpreS2ion side as well. I mentioned the GlycoModified S2 cell lines where we're generating data based on this mucosal influenza vaccine approach. On the trigger side, I cannot give you any specific milestone triggers for these as we speak, but I'll make sure to progress on them every quarter for sure to our shareholders.
Yeah. In general, I took out the slide here where you're looking forward. That is what you think investors should look out for, and then it's up to us to decide whether they could be share price triggers. Is that how I should understand you, Bent?
Yes. Have a look at the three times mentioning of ESGBC001 here.
That's obviously a very important trigger how that progresses here with the phase one safety trial. 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 peer-reviewed scientific journals. The fact that we still have our good discussions with the Serum Institute of India on a license agreement for two of those malaria assets.
Please, could you provide us with a rough estimate of the annual revenue and profits you could generate from the Wuxi deal from next year? Can this meaningfully extend your cash reach?
Very good question. We announced the Wuxi Biologics letter of intent here in April, one month ago. It's a super interesting discussion we have going on with Wuxi.
They are also one of the world's largest vaccine manufacturers and certainly a big player in the space of manufacturing recombinant proteins. We are very proud that such an organization, they actually reach out to us and find us and want to get our technology platform in-house for their clients' manufacturing needs. The idea with the letter of intent is that we first test it in a pilot study on one of WuXi's clients. Based on the outcome, we will then initiate a 12-month period to 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. It is too early to say anything about revenue projections on this.
Is it in your... Is it in the WuXi CRO business or in their production?
Is it in the CRO 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. It would be a nice simple setup in a way. Instead of ExpreS2ion actually spending resources on promoting and marketing of this, that we actually have Wuxi doing it for us. They have a huge infrastructure on the commercial side. 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 various presentations in that forum. 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 ESGBC001 study? Have you given some indications to market on first patient enrolled? 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. We must admit that here after a quarter, we lacked the first patient. Maybe it's related to the dynamics of the breast cancer therapy market and with the introduction of antibody drug conjugates like Enhertu here 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. We are also expanding the number of sites in Austria to ensure further patient enrollment.
Let's see here as we progress. We will, of course, give an announcement as soon as this is done the first time.
Perfect. Let's see. Yeah, there is something about this. An email has been sent to you, but yeah. Let's see. Do I have other questions? No, I think that was the final question, Bent. Thank you for taking us through your results and milestones achieved in this quarter. Thank you for the audience listening in.
Thank you.