ExpreS2ion Biotech Holding AB (publ) ($EXPRS2)

Welcome to today's event where we have the pleasure to present ExpreS2ion Biotech. As you can see on the front page, the Q1 report is, of course, the reason for today and the main topic for today, and of course, the pipeline news. So to go through today's presentation and answer our questions in the end, we are joined by CEO, Bent Frandsen; and CFO, Keith Alexander. As always, there's a box down below, where you can ask questions. If you do it in Danish, I will try and translate to the best of my ability. We have a firm stop at 10:30, so I will catch as many questions as possible, but we have a firm stop at 10:30. So I will not take any more time and leave the word over to you, Bent.

Thank you, Michael, and good morning, everyone, and welcome to ExpreS2ion's Q1 '26 webcast. I'm Bent Frandsen, CEO of ExpreS2ion Biotech. And with me today is our CFO, Keith Alexander. I'll first walk through the key development across our pipeline and platform activities during the first quarter and particularly progress in our HER2 breast cancer immunotherapy project as well as our grant-funded infectious diseases programs before Keith takes over and goes through the financial results. And of course, we'll take questions in the end. We'll try to go through this quickly to allow for that. During Q1 2026, we continued to advance both our clinical program and broader platform activities. Across the quarter, we reported progress in financing activities, ES2B-C001 clinical development, platform validation through partnered programs, manufacturing advancement in the Nipah virus project and continued strengthening of our IP position. Most notably, we reported encouraging preliminary immunogenicity observations from the ongoing Phase I trial of ES2B-C001. Subsequently, we reported drug-specific antibody responses across all evaluable patients and continued progression of the program following an independent data safety monitoring board review. We selected Northway Biotech as a manufacturing partner for the Nipah virus vaccine program. We highlighted additional Oxford University-led malaria clinical data supporting the platform validation and scalability, and we announced a rights issue supporting continued clinical execution towards the planned Phase I readout. Overall, Q1 reflected continued execution across both our clinical pipeline and platform ecosystem. This slide summarizes the core elements of ExpreS2ion's investment case, which is shown across 3 pillars. First is ES2B-C001, our proprietary HER2-targeted immunotherapy program, currently advancing through Phase I clinical development. Supporting this is the ExpreS2 protein expression platform, which has now demonstrated scalability and clinical applicability across multiple partnered vaccine programs. This has been validated in clinical Phase III and is, in fact, the foundation for all our pipeline and partnering activities. Thirdly, our ownership stake in AdaptVac provides continued strategic exposure to VLP-based immunotherapy technologies. Together, these elements position ExpreS2ion as a clinical-stage biotech company supported by a validated and scalable vaccine technology platform. Now turning to ES2B-C001. This remains our lead proprietary development program. The ongoing study is an open-label Phase I dose escalation trial being conducted in Austria in patients with advanced HER2-positive and HER2-low breast cancer. The study evaluates 3 escalating dose cohorts using a 5-dose intramuscular treatment regimen with objectives focused on safety, tolerability and immunogenicity. We have now completed the first 2 dose cohorts at 50 and 150 micrograms and initiated dosing in the 450-microgram cohort. And importantly, based on observations to date, we continue to see no safety signals of concern. On the immunogenicity side, we continue to observe drug-specific antibody responses across all evaluable patients. Titers are increasing across successive dosing visits and remaining elevated at later follow-up. Based on the data so far, we have also updated the planned clinical pathway. Rather than introducing a separate dose expansion stage before Phase II, we now intend to continue the Phase I program into a maintenance phase, evaluating booster dosing and longer-term immune responses, potentially in parallel with future Phase II development, subject to regulatory alignment. We believe this updated approach strengthens the overall clinical data package while preserving the planned end 2026 Phase I readout timeline. Overall, the program continues to progress according to plan. This slide outlines our strategic development pathway for ES2B-C001. Our immediate focus remains on completion of the Phase I and continued maturation of the immunogenicity and safety data package through 2026. In parallel, we are evaluating the design of a focused and capital-efficient Phase II proof-of-concept study in breast cancer. The objective of such a study would be to further characterize clinical activity and support the program's next stage of development. As clinical data mature, programs in the HER2 field may create opportunities for strategic dialogue and potential partnering. Importantly, our approach remains disciplined, generate robust clinical evidence, progress the program systematically and preserve strategic optionality as the data set evolves. Turning to malaria, one of the world's most significant infectious diseases. Our ExpreS2 platform continues to support a broad portfolio of Oxford-led malaria vaccine programs. As shown on this slide, there are now 11 trials ongoing or completed across Phase I and Phase II development, including Phase IIb studies expected to read out during 2026. Importantly, several programs continue progressing through later-stage clinical evaluation across multiple geographies. A key milestone for us remains the licensing agreement for RH5.1 and R78C entered into with the Serum Institute of India, one of the world's largest vaccine manufacturers. This partnership provides further validation of the scalability of the ExpreS2 platform, the manufacturability of these vaccine candidates and the continued commercial interest surrounding these programs. And importantly, these activities remain largely grant-funded and partnership-driven, allowing platform expansion without significant capital burden to ExpreS2ion. Beyond breast cancer and malaria, we continue advancing several externally supported programs within the VICI-Disease consortium. The Nipah virus vaccine program continues progressing and is now in the GMP manufacturing stage and remains fully externally funded through completion of clinical Phase I. During the quarter, Northway Biotech was selected as a contract manufacturing partner, while analytical method development and manufacturing optimization activities continue. Within MucoVax, work continues supporting next-generation mucosal influenza vaccine concept and associated GMP-compatible manufacturing tools. And finally, the INDIGO Influenza Consortium concluded during Q1, following which we are evaluating low capital pathways to preserve future optionality from the program. Collectively, these programs continue validating the ExpreS2 platform while contributing non-dilutive funding and external collaboration opportunities. This provides an overview of the broader ExpreS2ion pipeline. At the top is ES2B-C001, our fully owned and internally sponsored oncology program. Alongside this, we continue supporting multiple partnered infectious disease programs, including malaria, Nipah virus and influenza-related initiatives. Across the pipeline, the programs are powered by the ExpreS2 ExpreS2ion platform, and in several cases, combined with VLP technologies through AdaptVac. Overall, the pipeline reflects a balanced structure consisting of one proprietary oncology program, multiple externally funded infectious disease collaborations and continued platform validation across several indications. This slide highlights the experience supporting execution of our clinical and strategic objectives. Across management and Board, the company combines deep experience in oncology, vaccine development, clinical execution, manufacturing and partnering. We're also pleased to have strengthened the Board recently with the addition of Michel Baijot, who brings extensive international vaccine and biotech leadership experience. Collectively, the organization is well positioned to support continued clinical progression toward proof of concept. Looking ahead, we see a steady flow of operational and clinical milestones across both oncology and infectious disease programs over the next 12 to 18 months. For ES2B-C001, the primary focus remains continued maturation of the Phase I dataset, including maintenance dosing, durability assessments and progression toward the planned end 2026 readout. In parallel, we expect continued business development and Phase II preparation activities. Within the Nipah virus program, upcoming milestones include continued CMC manufacturing activities, toxicology and IND-enabling studies and preparation for the future Phase I initiation. And within malaria, we expect additional clinical readouts from the Oxford-led and the Serum Institute of India supported programs across the coming quarters. Overall, we believe the company is positioned for multiple staggered development catalysts across both oncology and infectious disease programs. With that overview of our pipeline and strategic programs, I will hand over to Keith to walk you through our Q1 financial results. Keith...

Keith, I think you are on mute maybe.

Thank you. I just got started anyway. Thank you, Bent. I'm Keith Alexander, CFO of ExpreS2ion, and I'll take you through the Q1 2026 financial results. As Bent described, this was a quarter defined by clinical progress. My job is to show you what that looked like in the numbers. Starting with the headline figures. Operating income came in at SEK 6.9 million, up 132% against Q1 last year. Operating loss narrowed to SEK 11.9 million, a 6% improvement year-on-year. The net loss for the period was SEK 9.6 million, down 16% from SEK 11.4 million in Q1 2025. On cash, we closed the quarter at SEK 21.8 million. That's the pre-rights issue position. After the quarter end, we completed the rights issue with initial proceeds of around SEK 31.8 million before transaction costs, which materially strengthens our near-term liquidity. I'll come back to that. The R&D spend figure, SEK 7.1 million, was up 158% year-on-year. I would like to address that directly. A significant portion of that increase relates to VICI-Disease CMC, which is 100% grant-funded and fully offset in income. I'll show you that clearly on the next slides. Looking at income in more detail, the left chart shows total operating income per quarter since 1Q '24. The step-up in 1Q '26 to SEK 6.9 million is substantial, up 132% against Q1 2025. That growth is from the grants line. CRO net sales were SEK 1 million, down 22% from Q1 2025, reflecting lower CRO activity in the quarter. That's a fluctuation we expect given the project-driven nature of that business. Other operating income, the grants line was SEK 5.8 million, up 259%. As you can see from the callout on the right chart, this includes VICI-Disease income relating to CMC costs sitting in R&D, which net to 0 with the corresponding income. Costs. The Nipah vaccine project has developed momentum that is grant-funded, but I want to be clear that the revenue comes with a corresponding cost. Turning to costs. Total operating expenses were SEK 18.8 million, up 20% year-on-year. The left chart shows the quarterly progression. 1Q 2026 is elevated, but not dramatically out of pattern once you understand the composition. R&D costs were SEK 7.1 million, up 158%. As the call-out states, this includes VICI Disease CMC, 100% grant-funded, fully offset in income. Strip that out and the underlying R&D trajectory primarily reflects continued ES2B-C001 clinical activity. Personnel costs were essentially flat at SEK 7.4 million versus SEK 7.5 million in the prior year quarter. We had 19 full-time equivalents, a stable headcount and disciplined allocation of costs. What the headline OpEx number doesn't immediately show is that other external costs fell 34% year-on-year from SEK 4.4 million to SEK 2.9 million. These costs were lower in the first quarter of this year due primarily to higher external business development costs and costs for new ES2B-C001 IP in the prior year quarter. The net loss for the period was SEK 9.6 million compared with SEK 11.4 million in Q1 2025. That's a 16% improvement. The right chart breaks down the drivers. The operating result improved by SEK 722,000. Net financial items contributed a further SEK 190,000 improvement, primarily lower FX-related costs versus the prior year period. And the R&D tax credit accrual increased by SEK 938,000, up 61% year-on-year, which reflects the higher qualifying R&D spend in the period. Those 3 factors together account for the SEK 1.9 million improvement in the net loss. So it's not a single driver. It's a combination of better operating performance, financial items and the tax credit mechanism working as intended. This waterfall chart shows cash development from December 2024 through to March 2026. We started 2025 at SEK 81.5 million. Operating cash outflows throughout the year reflected continuing investment in ES2B-C001 and grant-funded program activities. We closed Q1 2026 at SEK 21.8 million. The largest single movement in Q1 2026 is the operating cash outflow of SEK 25.5 million. That's higher than the comparable quarter last year, primarily driven by working capital timing across both ES2B-C001 clinical development and VICI Disease CMC. As noted on the slide, after the quarter closed, the rights issue completed in May 2026 with initial proceeds of SEK 31.8 million before transaction costs. The closing position you see here is not where we stand today. Pulling it together on the cash outlook. Q1 2026 closing cash was SEK 21.8 million pre-rights issue. Post-period proceeds of SEK 31.8 million before transaction costs strengthened our near-term liquidity position. In addition, the TO13 warrants have an exercise period running from August 20 to September 2 of this year. If exercised, they could provide potential additional proceeds subject to exercise level and share price at the time. Our capital allocation remains focused. The primary use of proceeds is completing Phase I of ES2B-C001 and supporting the targeted end-2026 primary readout. We are managing our costs with discipline, actively evaluating non-dilutive funding opportunities, and we will communicate transparently as plans develop. So that covers the financial section. To summarize the quarter in one sentence, income is up strongly on grant activity, our underlying cost base after VICI and ES2B-C001 is approximately stable and the rights issue completed after period end strengthens our position as we continue to execute on ES2B-C001 and our other priorities. I'll now hand over to Michael, who will moderate our Q&A session. Michael?

Perfect. The first question coming in, have you seen more partner interest after the first set of data has been released or the first data sets has been released on the ECE?

Yes. It's positive for sure. We have consistently here in 2026 announced data from the ES2B-C001 clinical Phase I trial, demonstrating very nice safety, of course, but also on the immunogenicity, which is very interesting. And from a partnering perspective, obviously, this improves our package, if you like. So that's good.

Perfect. The change of the study design of ES2B-C001, what more data does that give you?

Well, it -- you mean the clinical Phase II?

No, you changed the study design of picking up more data and changed the Phase I here. What more data does that give you? Anything talking to partners? Or is it more so you better can design the Phase II?

Yes. This maintenance phase that we are looking into after having completed the dose escalation phase. And bear in mind that dose escalation is the first part where we test all 3 doses and look into safety, tolerability and immunogenicity. But then, the maintenance phase allows us to follow these patients as they progress, providing a booster dose and looking into the durability of the response. The whole point with this program is to document that this is a durable treatment. As you know, the existing treatments, monoclonal antibodies and antibody drug conjugates are really not long-term therapies, and we aim to demonstrate that. So moving into a maintenance phase will allow us to do that. And in parallel with this, we will actually be initiating a Phase II study, where actual clinical benefit or clinical efficacy can be demonstrated. That will eventually show the clinical proof of concept, but that can be done in parallel with looking at the maintenance phase.

But can I add just one comment on there? In addition, for the Phase I, so far, we've been evaluating immunogenicity through antibody titers and also safety, but we're also adding 3 new sets of bioanalysis, including further information about mode of action, potential early efficacy and polyclonality. So there'll be a lot more data in the data package for potential partners coming this year as part of the Phase I readout.

And then there's on the Nipah, and I think you actually maybe showed, is there a realistic path to first in-human in 2027 on Nipah? And what would that mean for AdaptVac milestones payment to ExpreS2ion? If I remember your slide, I think it was put in the Q2 '27 potential start. So is that how we should think about it? And is there any potential milestone payments to ExpreS2ion -- to AdaptVac if that happens?

The Nipah virus vaccine project is fully sponsored by an EU Horizon Europe grant. And so it's a research and development collaboration under that consortium being grant sponsored. There are no licensing between the parties in this consortium setup. We all aim for developing this through clinical Phase I. And then, we have a very nice Phase I stage package on the Nipah virus, and we'll see where we take it from there.

Then including the warrant program, do you have the capital to end Phase I?

Bent, I can take that one. So the warrant program, we don't know what the outcome of that will be. That's subject to the subscription level, and of course, the share price at the time of the warrant exercise. We have money to reach the warrant program. And then, beyond that, it really depends on the outcome how far it will take us. So we are, I suppose, cautiously optimistic that the warrants will provide us with sufficient capital to reach all our Phase I objectives.

And then there's a question. Is it still your expectation that Phase II on ES2B-C001 could be partner financed?

I think we can look into many partnering scenarios on this pending our ability to fund the clinical development going forward. I'm quite sure we can have a partnering scenario here with our Phase I package. Obviously, as it is with development projects in this field, the more they mature, the higher value they achieve. You de-risk the program as you go along. So in a partnering scenario where we do this in the clinical Phase I stage, the partner will take some risk because we don't know if it has the efficacy you will get in a clinical Phase II, and they will sponsor clinical Phase II. But obviously, in such a partnering scenario, ExpreS2ion will not have to fund the Phase II. So it's a balance.

And then, there's a question here on the money. I think you've shown that very clearly on the slide, Keith. How do you view the strength of the immune response so far with the highest dose yet to be tried, good, so-so, too early to tell?

We are encouraged by the data we have announced so far. We have announced data from the first 2 cohorts, and the third cohort has just initiated. We saw the first patient in the third cohort being dosed with the highest dose, had no safety signals of concern. And from the 2 first cohorts, we've seen both very nice safety readouts as well as immunogenicity readouts. We have actually seen that in 9 patients who are evaluable, we've seen very nice dose responses, immune responses across them all. So that's encouraging.

And then a more broader question on vaccine immunotherapy companies. Eli Lilly's recent acquisitions actually paying well off for acquisitions of the 2 companies here. Any thoughts about that, Bent? Have you given it any thoughts? Do you don't comment on other transaction? Or are you seeing any signs that maybe vaccine will be picking up?

Yes. And I think it's a very nice good thing in our field in the infectious diseases and immunotherapy field, immunology field, that you see a big pharma company like Eli Lilly taking a step where they acquire several early-stage companies, which may be comparable to the stages where AdaptVac and ExpreS2ion are at. So, of course, this is nice information.

Perfect. And then I think we can catch the last one, I waited with that. A little bit about the value. Do you think you can reach the old value and a little bit? If a buyer came out by this afternoon, what would you price the company? I waited with that, Bent, so -- because I probably know the answer. So -- but any thoughts about this?

Keith?

Oh, me. Okay. Yes. I mean, we, of course, can't speculate on that kind of thing. What we can do, I think, is maybe point to some of the other transactions we've seen in the space and say that they provide us with good comparable transactions to look at. But, of course, it needs to be something very close to what we're discussing with a potential buyer if that were to happen. But I really don't want to encourage speculation there.

And we actually just have one question we can catch. Any thoughts about a reverse stock split like you did last time, any speculation? There's a question here, whether you could think about doing a reverse stock split? Or was that a special situation when you did that in the past?

It's not something on top of mind right now. Of course, it could be at some point in the future. What I would say is that the experience that we had before was that we expected it to be something that should be perceived neutrally because fundamentally, a reverse split has no fundamental impact. However, we saw different kind of trading behavior around the split. And so we take that into consideration if we were to think about something like that in the future.

Perfect. I think we catched all through our [indiscernible] line, 1 minute left. Of course, if anybody has more questions, I will just publish your investor mailbox, where they can send it to you any further questions. So if anything should come up, then everybody is very welcome to send any questions to that. But thank you to you, Keith and Bent, for taking us through your results and answering questions. May everybody have a nice day.

Thank you, Michael.

Thank you, Michael.