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 presentation, we are joined by CEO Ben Fransen and CFO Keith Alexander. The topic, of course, you could see a report this morning, but I think more abroad, a very large news flow coming in the course on a lot of other than the financials as always ask questions in the box down below i'm speaking fast we have a firm deadline at 11 30 we will try and catch as many questions as possible but uh you will have joined a lot of events presentations here in in the coming days so i think people will have a good way a good possibility to ask questions later on but for now i have the call over to you bent thank you very much michael

Good morning, everybody, and welcome to Expressions' third quarter webcast. I'm Ben Fransen, CEO of Expressions Biotechnologies, and with me today is our CFO, Keith Alexander. We'll take you through our progress this quarter, how we are advancing our HER2 breast cancer immunotherapy, expanding on global vaccine partnerships, and keeping track on our financial position. We'll start with strategy and pipeline updates, focusing on clinical progress, collaborations and upcoming catalysts. And then Kies will walk you through the financials before we open for questions. This quarter has been about driving momentum across both pillars of our business. First, our proprietary HER2 cancer vaccine and second, our global vaccine collaborations. Together, these create a unique balance between high impact innovation and revenue generating partnerships. Our strategy continues to be driven by these four key pillars. From top left, we are advancing our proprietary pipeline led by our HER2 breast cancer vaccine, ES2B-C001. We're intensifying global vaccine collaborations, including projects with Oxford, Copenhagen, the Indigo Consortium, and the VGDC's Nipah Virus Partnership. We are innovating, strengthening our platform, expanding IP and exploring next-generation immunotherapies, and finally growing our crow business and platform licensing business, which provide recurring revenue and visibility. These pillars create a robust and diversified model, combining near-term income with long-term upside from our clinical assets. Q3. was a strong execution quarter. In our ES2B-C001 phase one trial, the first patient has completed dosing, and in the quarter, we received approval to expand the protocol, adding the opportunity to combine with standard of care treatments such as antibody drug conjugates, ATCs, as well as new clinical sites. Early data already show how vaccine-induced HER2-specific immune response occurs in the first treated patient it's an indication of the ability to break tolerance on the partnership front we executed a definitive license agreement with the serum institute of india yesterday for two malaria vaccines is 5.1 and r78c oxford now has 10 active malaria vaccine trials six in phase one four in phase two all supported by our technology in the vichy disease nipa virus consortium A lead antigen has been selected and at that bank in which we hold 34% secured at 4.6 million euro in new grain funding. We also strengthened our finances through warrant proceeds and we are broadening our investor visibility at multiple Nordic life science events. Let's take a closer look at our phase one trial. The study is regulatory approved to include up to 27 patients with advanced HER2-positive or HER2-low breast cancer who have already received standard of care treatments. It's taking place at the Medical University of Vienna and since our protocol amendment approval also at clinical sites in Linz and Kars. Each patient receives five intramuscular vaccine doses at escalating levels to establish safety and immune response. Some patients will also receive an ADC to assess safety of combination therapy. Our primary goal is to confirm safety. The secondary is to measure NTH2 antibody formation and potential tumor response. So far, the first patient has completed all five doses and four additional patients are in follow-up or ongoing treatment. The data safety monitoring board review is going to take place, we expect, before the end of this year. And pending approval from this board, we will increase to the next dose level of 150 micrograms. Assuming positive outcomes from the phase one trial, we are preparing for a phase two trial to begin in 2027. We have the potential for an accelerated design. Our long-term goal is to move from breast cancer into gastric cancer, where HER2 is also a validated target. From there, we have the potential to advance toward conditional approval and eventual registration. This potential roadmap allows us to progress diligently toward a pivotal partnership or licensing opportunity as we build clinical proof of concepts. Our malaria collaboration with the University of Oxford continues to deliver at scale. As I mentioned, there are now 10 active or completed clinical trials spanning Phases 1 through Phase 2b. The two new Serum Institute of India licensed vaccines, R5.1 and R78C, are fully recruited in early-stage studies, and several Phase 2b readouts are expected through 2027 and 2026. These programs exemplify how our express platform enables rapid, reliable protein production, supporting one of the world's most advanced malaria vaccine pipelines. And importantly, most of these programs are fully funded by grants or partners, reinforcing our non-diluted business model. Beyond breast cancer and malaria, progress continues across several major collaborations. In the Vichy Disease Nipah Virus Consortium, We've selected a lead antigen and are preparing for GMP manufacturing, fully funded through phase one. At the University of Copenhagen, our MucoVax influenza program reached important preclinical milestones, including progressing on a potential GMP-compliant siloed cell line, a successful proof of concept on tools to create a GMP-compliant high-main cell line. And in the EU-funded Indigo program, which targets a next-generation influenza vaccine, We're nearing completion and discussing next steps to translate this work into follow-on development. Together, these programs broaden our reach, validate our technology, and diversify funding sources. So this slide shows how our express plan platform underpins every program that we are involved in, both proprietary and partnered. At the top is year 2B-C001, our fully owned HER2 cancer vaccine. Below that, you see our partnered malaria programs, two of those licensed to Serum Institute of India. And you see the influenza projects, indigo influenza and VT disease, all funded through grants or partnerships. And even though Bavaria Nordic discontinued the COVID-19 program for commercial reasons, and successfully validated our platform in more than 4,000 study subjects through Phase 3, we maintain having it on this chart. Finally, here's a summary of our upcoming catalyst. On the clinical side, we expect initial Phase 1a safety and vulnerability data by mid-2026. followed by phase 1B immunogenicity data before the year end. We also anticipate several malaria vaccine readouts from Oxford and Serum Institute of India trials over the next 12 to 18 months. Under the strategic fund, we are filing new IP extensions to protect our technology and continuing grant funded validation work within Mucovax, Indigo and Avicii disease consortiums. These milestones provide continuous visibility, strong news flow, and clear long-term value drivers for expression. With that, I'll hand over to Keith, who will take you through our financial performance for the third quarter and year to date.

Thank you, Ben. In this section, I'll walk through the results for the first nine months in the third quarter of 2025. Overall, the story for Q3 is one of increased income supported by grants, disciplined cost control, and a strengthened cash position. Let's go through the key figures and charts together, starting with our income for the period. On this slide, you can see that our total income for Q3 was $2.3 million, which is a 36% increase year-on-year. For the first nine months, total income reached 8.7 million, up 54% from the same period in 2024. For a company at our stage, achieving this kind of growth with minimal marketing underlines how active our collaborations and grant funding have been in fueling R&D. In other words, our partnerships and non-dilutive grants are contributing to revenue and supporting our research. Drilling down into year-to-date income components, net sales, which includes revenue from our CRO services, license fees, and reagent products, were 3.2 million, about 33% higher than the same period last year. Other operating income, which is primarily grants, was up 69%. This growth was driven by progress in our supported projects, for example, the MUCOVAX and VCHE grant programs. They both contributed substantially. The takeaway here is that both the CRO business and grants boosted our revenue base. Grants are an important non-dilutive funding source to advance our pipeline while reducing costs to our shareholders, underscoring the strategy to leverage external funding for RMT. Moving to the cost side, we have maintained strong expense discipline in the quarter. Having completed several high-cost R&D activities last year, our external R&D spent in Q3 was much lower than a year ago, in fact, about 42%. You will notice an uptake in external R&D costs compared to the previous quarter as we advanced the phase one trial, adding a few more patients. Phase one trial protocol limits how many patients can be treated at once, which in turn naturally caps how fast trial expensive can grow. In short, R&D costs can be variable quarter to quarter depending on pipeline activity, but we strictly control them and only spend on critical development work. Overall, total operating costs in Q3 were about 12 million, which is 19% lower than the prior quarter. The two largest expense components are broken out on the right-hand side. The top chart shows the external R&D costs discussed a moment ago, and here you can see the sharp year-on-year decline. The bottom chart shows personnel costs, which were held roughly steady. Personal expenses in Q3 were about 3% lower than the same quarter last year. This small reduction in staff costs reflects a stable headcount and careful management of salaries and hiring. Turning to the bottom line, our net result for Q3 was a loss of $8.4 million. This outcome was in line with our expectations as we continued to invest in our lead program and other pipeline projects. Importantly, the Q3 net loss improved by about 19% compared to the last year quarter. The reduced loss reflects the higher income and lower costs we just discussed. On a year-to-date basis, our net loss totaled approximately $30 million SEC, which is 44% higher than the reported net loss for the first nine months of 2024. However, it's crucial to put that figure in context. Last year's nine-month result benefited from a significant one-off gain in Q2 2024, in which we received a $22.5 million one-time dividend from our associate company, AdaptVac, related to a Bavarian Nordic milestone payment. That non-recurring game actually gave expression a temporary net profit in Q2 of last year, greatly reducing the cumulative loss in 2024. If we exclude that one-off item, the underlying net loss for January through September of 2024 was around 43 million. Against that normalized baseline, our year-to-date loss of 30 million in 2025 represents a significant improvement. We remain focused on prudently managing our spending while progressing our R&D. This slide illustrates how our cash position has evolved quarter by quarter in 2025. Focusing on the most recent quarter, we started Q3 with about 49 million and ended for 37 million. So net cash reduced by approximately 12 million over the three months. The primary use of cash was our operational spend. In Q3, we used approximately $11 million in cash for operations. Roughly half of that went into R&D for our project expenses, funding the ongoing ES2B-C001 phase one trial, as well as supporting our malaria, Nipah, and influenza vaccine programs, the other early-stage research and platform, and other early-stage research and platform development. The other half of our operational cash flow covered our personnel and overhead costs to keep the company running. We had minimal cash flows from financing or investing activities in the quarter. We did, however, experience some negative foreign exchange fluctuations of 1.3 million due to currency changes. Taking all these factors together, the cash-burning Q3 was in line with our projections, and we continued to manage our expenditures carefully. Adding the quarter with 37 million in cash puts us in a position to continue executing our strategy in the near term. Here, we provide a broader perspective on our cash balance in the last seven quarters, along with key financing events. Most recently, after Q3 2025, we received gross proceeds of 11.1 million SEC from our TO11 warrant exercises this October. Each of these steps has helped strengthen our balance sheet. As a third quarter, we had 37 million in cash, which when we include the October warrant exercise gives us a pro forma cash balance of approximately 49 million sec. Based on our current operating plan and budget and assuming no new funding or inflows beyond what's already secured, this cash gives us runway into second quarter of 2026, carrying us towards our phase one readouts targeted in mid and late 2026. Moving on, we wanna update you on some shareholder engagement initiatives. In Q3 and into early Q4, we conducted a review of our investor relations and capital market service providers and decided to consolidate our partnerships for greater impact. The goal is to ensure we are reaching our investors effectively with high quality research coverage and events while also being cost efficient. As a result of this review, we are bringing on Redeye, a well-known Nordic investment and analysis firm in several capacities. Redeye will become a provider of sponsored research covered on Expression and will also host investor events for us. Moreover, Redeye will take over as our certified advisor in February of next year. We're excited to partner with Redeye given their strong life science focus and reach among Nordic investors. We want to thank our outgoing partners for their support and quality service over the years. To conclude the financial section, I'd like to highlight some upcoming opportunities to meet with Expressions Management. Later today, Ben is presenting at the BioStack Life Science Summit in Lund. Next week, Ben and I will host an investor seminar in Copenhagen, organized by Jose Anderson Capital. And on December 3rd, Ben will present at the Red Eye Life Science Day in Stockholm, which will also be accessible virtually. These events, whether in person or online, are great opportunities for investors to hear more about our progress, ask questions and engage with us directly. We encourage all investors or all interested stakeholders and shareholders to join us at any of these sessions that fit your schedule. With that, I'll conclude the financial update and hand it back to Michael to begin the Q&A session.

Perfect. The first question was actually how many patients are enrolled in your easy ES2B study. I think five was on the slide, so I guess that is the correct answer there. Is that correct, Ben?

That is correct. Five have been posted and ongoing at the moment. Perfect.

Regarding malaria, congratulations to the agreement. What is the time horizon for phase three and beyond? And why haven't you the third vaccine that is in phase two included in the agreement?

Well, if you look at our pipeline, we show four different malaria projects and not all of them are blood stage malaria projects. So CRM Institute of India takes a particular interest in the blood stage malaria vaccines that University of Oxford are developing. That's two of the three blood stage malaria vaccines. uh i cannot answer on the third one uh so that's the same institute of india's folio uh interest and the agreement we have entered into has the scope of those two at 5.1 and our 78c but i just want to like to add that we are of course very thrilled by having an agreement in place now with cm institute of india it's the world's largest vaccine manufacturer And it's a way to be engaged with them in this way. And for us in expression, just think about the world's largest vaccine manufacturer who is going to work with our proprietary S2 cell system. That's great. It's going to broaden the knowledge of working with S2 cells and its advantages in making vaccines and We're very thrilled about this.

And then to maybe round up the malaria, what is the sales potential? I know it's not a very well-known market, so do we have any figures or is it too early to kind of indicate what sales could be in the malaria market?

It's very difficult to predict and for sure the majority of malaria cases take place in Africa in low and middle income countries. Up to 600,000 die of malaria infections. and of course sierra institute of india they have a mission of providing affordable vaccines so it's up to them actually to decide the proper pricing so it's difficult to say anything about sales potential perfect then i read that i read that at that back has to be funding for another project you usually write a press release when that happens can you tell me more Well, if it's referring to a grant award that they received to actually sponsor another malaria development project, I believe we have made an announcement on that. In fact, that's the 4.6 million euro funding from a Japanese fund. That has been announced. So I'm not quite sure what this question is about.

And then when do you expect to receive the upfront and milestone payments from the recent licensing agreement with SII?

Well, an upfront payment in the near term since we have now signed the agreement and milestone payments which are dependent on progress on the clinical moving into the later stage clinical phases. Well, they should come here within the next one to two to three years as they roll along. We already alluded to Oxford-driven clinical trials, where some of them, including these two projects, I-5.1 and I-78C, progressing along in the next 12 to 18 months. So that should be good, but I cannot be more detailed than that.

Now, my next question was, there's a question how the upfront payment compared to the milestones and what might be triggered and you don't want to get into close to diesel there. Should I understand you that correctly, Ben? That is correct. There's a question here. How do you balancing pros and cons of a partner agreement after phase one versus phase two for the for the HER2 vaccine. Any comments, any thoughts you have made about that balancing act between later stage more value, earlier stage less funding needs?

Well, certainly our goal would be to drive the development towards a clinical proof of concept ourselves. That would mean concluding a clinical phase two trial. That would be awesome for everybody and all our shareholders because that's the greatest value inflection point. And of course, We'll see how we can get to that point. We talk about starting phase two in 2027. That in itself will also be a value inflation point, I suspect, but obviously not as high as when you actually have this clinical concept some years later. We have to look at this carefully, balancing our financing, looking for funding also through potential non-diluting funding sources, even for an asset like this. We're doing everything we can to cover all those areas.

Perfect. And then does the cash balance for Q2 include malaria, SII, upfront payment, I guess, the runway you indicated, Keith. Does this include malaria upfront payment from SII?

No, no, this was just signed yesterday, so this will all happen in Q4. I think I would like to just mention that without giving more detail than what we put in the press release, the split between the upfront and the other further milestones, it follows a typical licensing arrangement. So it's primarily in the further milestones just to set expectations.

There's a question about the Nipah. Is the Nipah vaccine with your technology? I thought that was a bit unclear. I need to be clarified whether it's Adaptvax or Expression or your technology. So a little bit about the Nipah.

Sure. It is actually a combination of Expression's antigen production technology and Adaptvax VLP technology. So in that sense, it's exactly the same setup as when we developed the COVID-19 as it started on that five years ago. And as you know, that was clinical phase three validated. So we know the combination works even in the clinical phase three setting. So what we have just described here recently is that the antigen that is being decorated on the surface of the VLP, we have chosen a lead antigen candidate so we can progress on scale towards GMP manufacturing and getting that into preclinical testing. But it's a combination, so both at that back and expression are deep in this particular project.

And then on the CRO business, it looks like you are again growing here, as you said, not with that much marketing. Are you putting more effort into kind of also create a funding, a big funding, but maybe a more focus on that and that could give you a little bit of the funding. So are you shifting a little focus to the CRO business?

uh both both yes and no it's always been there we have never abandoned it it's not been highest priority when we started on our pipeline focus strategy five years ago and the crow business alone will not be able to fund the pipeline activities going into more expensive clinical development expenses but nevertheless it again it's about expanding the knowledge of our important platform. And we have business development activities, which this year have been more increased and focused, including hiring of a director of business development. So I expect progression on that to happen as well there. And that can cut operational expenses, if not the project development expenses as such. Perfect.

I think we covered all the questions and got you off at a time where you can leave for your next presentation, Ben. So thank you to you, Ben, and Keith for taking us through your results and answering questions. And thank you for the audience listening in.

Thank you. Thank you.