Welcome to today's presentation, where we have the pleasure to present ExpreS2ion Biotechnologies. Today's coverage, of course, the full year report, fresh from the press this morning, but maybe also besides the financial results, some of the many milestones achieved, I could see in the news flow in this quarter. To help us through today's presentation and answer questions in the end, we have Bent Frandsen, CEO, Keith Alexander, CFO. As always, there's a box down below. Do feel free to ask questions during the presentation. We will keep most or almost all of the questions at the end, but do feel free to do it now. Do feel free to ask in Danish, but I will try and I will try and translate to the best of my ability.
I think for now, I will hand the call over to you, Bent.
Thank you very much, Michael. Good morning, everybody. Welcome to ExpreS2ion's Q4 and full year 2025 results webcast. I'm Bent Frandsen, CEO of ExpreS2ion Biotechnologies, and with me today is our CFO, Keith Alexander. Today, I will walk you through the key updates across our pipeline and partnerships, particularly progress in our HER2 breast cancer immunotherapy and our grandfathered infectious disease programs. Before Keith takes you through the financial results, we'll begin with the pipeline updates and key milestones achieved through the Q4 and early 2026, and then Keith will present our financial performance and cash position. Finally, we'll open the call for questions. Q4 was a highly productive quarter across both our proprietary pipeline and partnerships.
On the financing side, we carried out a TO11 warrants program exercise with 88.5% subscription rate, bringing in approximately SEK 10.4 million and strengthening our capital base. Within the pipeline in breast cancer, we reported updated immunogenicity data from the first three patients and received a Data Safety Monitoring Board, DSMB, recommendation to progress to the next dose cohort. In malaria, Oxford-led trials using our ExpreS2™ platform advanced through a- across multiple clinical phases. We entered a definitive licensing agreement with the Serum Institute of India for malaria vaccine development and commercialization. In Nipah virus, the vac- the VICI Disease Consortium finalized its antigen selection and moved into the production phase and selected Northway Biotech as manufacturing partner. Overall, Q4 demonstrates both clinical momentum and strategic execution. Let's turn to our lead program, ES2B-C001, our HER2-targeted therapeutic cancer vaccine.
This phase I study includes up to 27 patients with advanced HER2 positive or HER2-low breast cancer, post second or third line standard therapy. The study is conducted at three clinical centers in Austria, and the design includes five intramuscular doses, three escalating dose levels, and optional combination with an antibody drug conjugate. Primary objective is safety and tolerability. The secondary objective is immunogenicity, specifically induction of anti-HER2 antibodies. Now to the progress, we are actively enrolling in the dose escalation part. Several patients have completed all five doses at 50 micrograms, and patients are now receiving 150 micrograms. Most importantly, no safety signals of concern have been observed. We see strong induction of drug-specific immune responses. Titers remain elevated at later time points, which is consistent with a durable, vaccine-like immune profile.
The geometric mean titer curve shown on the slide illustrates a clear rise across dosing visits and sustained levels thereafter. Of course, these are still early phase I data, but they are encouraging and consistent with our beliefs in this asset. Phase I-A data are expected mid-2026, and phase I-B data by the year-end 2026. This slide outlines our strategic development pathway. We think about value creation in four structured steps. Step one, safety and early signals. That's where we are today. Step two, clinical proof of concept. That's via Phase II in breast cancer, with potential parallel exploration in gastric cancer. And step three, partnering, where we target licensing opportunities as clinical data mature. And step four, patient launch. Importantly, our business development efforts are already ongoing, and there are multiple potential partnering windows.
After strong phase I immunogenicity signals or current phase II proof of concept, or potentially earlier, if compelling data emerge. Our goal remains clear: advance towards phase II to reach key clinical milestone that may enable partnering discussions. Turning to malaria, one of the world's most pressing infectious diseases. Our ExpreS2 platform supports a broad portfolio of malaria vaccine candidates, led by the University of Oxford. There are now 10 trials ongoing or completed across phases I and II, including phase II-B studies expected to read out in 2026. Some key highlights, multiple phase I-A and phase I-B studies are fully recruited. Phase II-B data are projected through 2026 and 2027, and two vaccine candidates, RH5.1 and R78C, are now licensed to the Serum Institute of India, one of the world's largest vaccine manufacturers.
This partnership validates the scalability of our platform and the commercial relevance of these malaria assets. Importantly, these programs are largely grant-funded, meaning they expand our platform footprint without significant capital burden. Beyond breast cancer and malaria, we continue to advance three major grant-sponsored programs. Nipah virus vaccine, the VICI consortium, it's 100% grant-funded through phase I/II-A. The lead antigen is selected. We're preparing for GMP manufacturing, now supported by a manufacturing partnership with Northway Biotech. MukoVac, mucosal influenza vaccine project. It's approximately 67% grant-funded. We have development of GMP-compliant cell line tool. This continues. We're evaluating alternative antigen-presenting platforms for next generation mucosal vaccines. The Indigo Influenza Consortium, this is fully grant-funded, focused on improving seasonal and pandemic influenza vaccine performance. This program is nearing conclusion of the current grant cycle, with next steps under evaluation.
Together, these programs validate our ExpreS2 manufacturing platform, they generate non-diluted funding, and they expand our IP and global collaborations. So this slide summarizes our diversified pipeline. At the top is ES2B-C001, fully sponsored and owned by ExpreS2ion. Below that, you see the malaria programs licensed to the Serum Institute of India and collaborations with Oxford. Influenza and Nipah virus programs are consortium-driven and largely funded externally. All programs are powered by our ExpreS2 insect cell-based expression platform, often combined with AdaptVac VLP technology. This gets us one high upside proprietary oncology asset, multiple externally funded infectious disease programs, and platform validation across indications. It's a balanced and capital-efficient pipeline architecture. Looking ahead, we have multiple value-driving readouts. For breast cancer, ES2B-C001 in the near term, we have expanded safety and immunogenicity data, continued dose escalation.
Next, we move into the phase I-B expansion part and potential early efficacy signals. Later, we will move into Phase II initiation, potential parallel gastric cancer study, and licensing opportunity across breast and gastric cancer, becoming opportunity, subject to funding and partnering success, of course. In malaria, the Bio002 phase I-A data will occur. Additional phase I-A/B readouts comes in Q3, and we see phase I-B, II, and II-B data occurring before the end of the year. In the Nipah virus project, the CMC manufacturing starts this quarter. Manufacturing expected to be completed this year, so the Tox study and phase I initiation can start after that. In influenza, the Indigo program completed here in Q1, as strategic decisions will be taken about what we do post-Indigo. In summary, we have multiple shots on goal with staggered catalyst across oncology and infectious disease.
With that overview of our pipeline and strategic progress, I will now hand over to Keith to walk you through our Q4 and full-year financial results.
Thank you, Bent. In this section, I'll walk through the results for the full year and fourth quarter of 2025. 2025 was a year of increased grant-backed activity, combined with a lower cost base, resulting in improved underlying performance. 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 Q4 2025 was SEK 3.5 million, which is a 62% increase year-on-year. For the full year 2025, total income reached SEK 12.2 million, up 56% from 2024. Both the CRO business and grants boosted our revenue base. Drilling down into full-year income components, net sales, which included revenue from our CRO services, license fees, and reagent products, were SEK 3.7 million in 2025, about 21% higher than last year. Other operating income, primarily grant funding, was up 78%.
The increase reflects higher activity across our grant-funded programs and collaborations, particularly within Vici, MukoVax, and Indigo. These grants allow us to advance key programs without relying solely on equity financing. Moving to the cost side, we've maintained strong expense discipline in the quarter. Having completed several high-cost R&D activities last year, such as key preclinical studies and CMC manufacturing work for our lead therapy, ES2B-C001, our external R&D spend in Q4 was much lower than a year ago. In fact, about 59% lower than in Q4 2024. You will notice an uptick in external R&D costs compared to the previous quarter as we advanced the phase I trial, adding a few more patients and analyzing samples. The phase I trial protocol limits how many patients can be on treatment at once, which in turn naturally caps how fast trial expenses can grow.
In short, our R&D costs are naturally linked to development activities, and we prioritize spending on key value-driving milestones. Overall, total operating costs in Q4 were about SEK 14 million, which is 37% lower than in Q4 2024. The two largest expense components are broken out on the right side of the slide. The top chart shows the external R&D costs discussed a moment ago. You can see the sharp year-on-year decline. The bottom chart shows personnel costs. Personnel expenses in Q4 were about 15% lower than the same quarter last year. This reduction in staff costs reflects changes in personnel, parental leaves, and careful management of salaries and hiring. Turning to the bottom line, our net result for Q4 2025 was a loss of SEK 8.2 million.
This outcome was in line with our expectations as we continue to invest in our lead program and other pipeline projects. Importantly, Q4 net loss improved by about 46% compared to the fourth quarter last year. The reduced loss reflects the higher income and lower costs we just discussed. On a full year basis, our net loss totaled approximately 38 million SEK, which is 6% higher than the reported net loss for full year 2024. However, it's crucial to put that figure in context. Last year's full year result benefited from a significant one-off gain in Q2 2024. We received 22.1 million SEK in a one-time payment from our associate company, AdaptVac, related to a Bavarian Nordic milestone. That one-time gain materially reduced the reported 2024 net loss.
If we exclude that one-off item, the underlying net loss for 2024 was around SEK 58 million, and against that normalized baseline, our full year 2025 net loss of SEK 38 million represents a significant improvement. Our focus remains on aligning spending with key value inflection points. This slide illustrates how our cash position evolved during 2025, focusing on the most recent quarter. We started Q4 with approximately SEK 37 million and ended the quarter with SEK 48 million, an increase of roughly SEK 11 million. The primary use of cash during the quarter was operating spending, reflected in our operating cash flow. This was partly offset by an R&D tax credit refund of around SEK 8 million. In addition, we received approximately SEK 11 million in proceeds from the TO11 warrant exercises, while foreign exchange movements had a negative impact of around SEK 1 million.
Overall, the cash development in Q4 was in line with our expectations, and we continue to manage expenditures carefully as we progress the phase I program. Here we provide a broader perspective on our cash balance over the last eight quarters, along with key financing events. Most recently, in Q4 2025, we received net proceeds of SEK 11 million from our TO11 warrant exercises. Each of these steps has helped strengthen our balance sheet. As of December 31, 2025, we had SEK 48 million in cash on hand. Based on our current operating plan and budget, and assuming no additional funding beyond what is already secured, this cash position positions us toward the next phase I clinical milestones and interim readouts targeted in 2026. To conclude the financial section, I'd like to highlight a few upcoming opportunities to meet us.
In early March, I will represent ExpreS2ion at the European Life Science CEO Forum in Zurich, where we will engage with both investors and potential biopharma partners. Later in March, I will also present at a life science investor conference in Copenhagen, hosted by Økonomisk Ugebrev. In May, Bent will present at the BioStock Global Forum in Lund. We look forward to connecting with stakeholders and shareholders at these events. In summary, 2025 reflected higher grant-supported income, a streamlined cost base, and improved underlying performance, while maintaining a cash position that supports continued execution towards our next phase I clinical milestones in 2026. With that, I'll conclude the financial update and hand it back to Michael to begin the Q&A section.
Perfect. Let's jump into the question. I think you already mentioned that in the start of the presentation. Just to clarify, is the timeline with tolerability data in mid-2026 and Phase I-B immunogenicity data by year-end 2026 still on track? I think you alluded to it in the start of the presentation, but-
Absolutely, it is. That's on track. We are having our current pipeline, or the ES2B-C001 program timeline, as I just mentioned, and that you just mentioned. So we'll have some interim data coming out from the first part, the dose escalation phase, by summer, and before end of year, we'll have the dose expansion part, covered as well. That's still the case.
Perfect. And then there's any news on the WuXi deal?
No, not at this point. We have our relationship and have been exploring various initiatives, but so far, I think it's on a co-marketing level. I can't be more precise than that.
Check. And then maybe to Keith, in general, I think if you take out the tax refund, it seems like your cost base is kind of around where we have seen the last three quarters and your cash outflow. Is there anything, and I know you don't guide on it, that we should look at either going up or going down in 2026? Or is that a good level to think about going into 2026?
... Michael, good question. I'll take that in two parts, the historical and then the guidance part. Historically, I'd say your assessment's correct. It's been very fairly consistent over the last several quarters, and if you look at it, taking out the R&D tax refund, it is on a very consistent basis. Looking forward, what I'd say is that there's not a material change to what we've guided previously, so it's remaining very consistent with what we've said previously and in what I said in my prepared comments.
Perfect. Then a little bit about the Nipah virus. Do I actually pronounce it correct? I think I do. There's a lot of questions and, of course, because of the headlines starting to show up in the end of the year, which you also noticed, what value are you expecting from the Nipah virus? And maybe more, how big is the Nipah virus market?
Well, first of all, Nipah virus vaccine project is fully sponsored by an EU grant on the so-called Pandemic Preparedness scheme. So the Nipah virus is on the list of WHO's potential pandemic threats. So far, it's been emerging primarily in East India and Bangladesh, and so far it's not been a serious infectious disease burning out like COVID-19, but you never know with these types of diseases. There's certainly been precautionary actions in Asia to test people at airports, because it is potentially very contagious infectious disease. It's a bat-borne disease, and it can lead to influenza-like symptoms. And yeah, ultimately, it can also be very grave.
Now, with respect to the Nipah virus consortium, the VCD consortium, this is a group of collaborative researchers, which include ExpreS2ion Biotechnologies, AdaptVac, our associated company that we own 34% of and which host the VLP technology platform, as well as other European partners, including Radboud University Medical Center. This is actually the same constellation which was backing up the COVID-19 vaccine initiative six years ago when the pandemic broke out in early 2020, and we also received a fund back then from the EU. You all know the story behind the outbreak and the pandemic and how it eventually- ...
Bavarian Nordic, they acquired a license and, in fact, later sponsored a clinical phase II and phase three, and it, it's super nice for both ExpreS2ion Biotechnologies and AdaptVac because our platforms are clinical phase III validated. And by the way, the same technologies, ExpreS2ion's production technology and AdaptVac VLP technology, that's exactly the same platform in our ES2B-C001 breast cancer vaccine asset. So, we have a very good way to start the Nipah virus vaccine project.
We know the platform works, and it's fully funded, and we have just been at this very crucial step of having selected a lead antigen, and we have chosen a contract manufacturing partner and have announced that this is Northway Biotech, which is a Lithuanian production company with factories both in Lithuania and main Europe, well, as in the U.S., and a very capable manufacturing partner to scale this up to commercial scale, and not least to make the clinical supply for the preclinical safety studies and the phase I trial that we're going to conduct, and which is also part of the fully funded project so far. So it carries some prospects to be prepared for a potential pandemic.
The commercial potential at the end of the day may be in the form of stockpiling, when we have an asset that works, and the EU will have a first right to purchase this type of vaccine.
Yeah, and I guess the reason why you don't put out a market size is that there is no treatment right now. So, I guess it's—it must be hard to estimate what could be the market size. And I guess because it's this em—it's probably emergency use that is going to be used, so how much are people going to stockpile? I guess, is that why it's hard to quantify maybe a market size? </transcript
It is. And just imagine with the Mpox from Bavarian Nordic, they developed this 20 years ago in a similar type of project. And who knew what that disease could emerge into? So yeah, it's about preparedness, and I think we're in a good spot on this project with that.
There's also a question: how much is... how long is it funded? You mentioned this Horizon funding. Is that where, how long does that take, this study, actually?
It's a four- or five-year funded project, which includes the clinical phase I study. So, we'll get some clinical evidence in this project as well.
Check. The next question, have you had any details into why the sixth patient didn't show drug-specific immune response?
... I'm not sure. Can you repeat the question?
Yeah, have you had any details into why the sixth patient didn't show drug-specific, immune response?
We have seen drug-specific immune response from the patients.
Okay.
We've seen five out of six patients have reacted positively. You have seen in the slide that I just showed on the geometric titer score, that there's a very nice increase over time across the patient visits. In the first doses, we see a dose response and then kind of a plateau at the end. So this is very consistent with what we actually want to see.
Perfect. There's a question: "What about the SII upfront?" Any comments on that, is the question. I don't think I can detail it more. Do you have any comments on that?
Not, not really. It's, it's been paid.
Yeah.
I don't think it shows up in our books for 2025, right?
Okay.
Yes.
Then there's a kind of a broad question, and I guess you, I don't know how you comment on it, but anything on the cash run rate, do we expect new emissions in or capital raises in 2026?
I can comment on that. I think as we've always said, we've, you know, or as I said earlier, our runway has not materially changed from what we've previously stated. We're always evaluating the best ways to access additional capital, whether it's non-dilutive or dilutive funding, with a preference to non-dilutive funding.
Check. Then there are some of the patients in the ES2B-C001 study on combinations, products?
Well, these patients are, first of all, late stage cancer patients, and they have tried other medications, including non-targeted therapies, but also the two targeted therapies such as monoclonal antibodies and antibody drug conjugates. It's a bit of a mix. Some of them have also concomitant medication, like antibody drug conjugates, so we're looking into that. But what we are reporting on this geometric titer graph, that is a very specific antibody that is raised due to our vaccine, so not being interfered with the standard of care treatment. So that's why we are thrilled with that graphical output so far.
Perfect. I will just check, but I think that was the last question. Thank you to you, Keith and Bent, for taking us through your results, the news flow, and of course, the financial reports. And thank you for answering questions, and thank you for the audience listening in.
Thank you.
Thank you.