Thank you, Madalena. Good morning or good afternoon, everyone, and thank you for joining us today for Vivoryon's first half 2026 results call.

Earlier today, we issued a press release reporting our first half 2026 financial results and business update, which can be found on Vivoryon's website at www.vivoryon.com. On the call with me today are Frank Weber, our Chief Executive Officer; Marcus Irsfeld, our Chief Financial Officer; as well as Michael Schaeffer, our Chief Business Officer.

Before we start, I would like to remind you that during this conference call, we will present and discuss certain forward-looking statements concerning future transactions, the development of Vivoryon's core platforms, the progress of its research and development programs, and the initiation of additional programs, as well as results of operations, cash needs, financial conditions, liquidity, prospects, and strategies. Should actual results differ from the company's assumptions, ensuing actions may differ from those anticipated.

You are therefore cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. As you can see on the agenda for today's call, I will begin with an overview of our progress throughout the first half of 2026 as we continue to advance our strategic priorities and strengthen the body of evidence for varoglutamstat in kidney disease.

I will then hand the call over to Michael, who will share some new preclinical data which provide further insights into the mechanism of action underlying the compelling data we have seen with varoglutamstat in clinical studies. Frank will then share details on the growing momentum behind our strategic partnering discussions.

He will be followed by Marcus, who will review the first half 2026 financial results before we conclude with Frank. Following the prepared remarks, we will open the call and will be happy to take your questions.

I would like to start by providing a high-level overview of our progress throughout the first half of 2026. Throughout the reporting period, we have seen growing momentum and increased strategic interest around varoglutamstat from a range of external parties, and we are aware of the market's focus on latest developments.

We obviously can't go into too much detail, but what we can share is that there are multiple strategic discussions progressing, including advanced term sheet negotiations for a potential licensing agreement. Frank will provide a more detailed strategic update in a few minutes.

On the R&D front, we continue to present and generate interest at important international medical conferences in the kidney space. In March, we presented a poster at the World Congress of Nephrology in Japan, further validating glutaminyl cyclases as promising targets in diabetic kidney disease, in short, DKD.

We previously showed in the Phase 2a Viviad and Vivamind studies that varoglutamstat had a greater beneficial effect on kidney function in elderly participants with diabetes than in those without diabetes. At WCN, we built on these findings by showing that the effect was maintained or even higher in participants with diabetes who had lower baseline kidney function.

This is extremely important because it shows that varoglutamstat has a beneficial effect in those patients with the highest risk of or already impaired kidney function. These data continue to support our rationale to, as a next step in development, pursue a dedicated Phase 2b study in advanced CKD where there remains a significant unmet need for therapies that can stabilize or improve kidney function.

As many of varoglutamstat is differentiated from other approaches in development in spanning multiple pathways that underpin inflammation and fibrosis, key drivers of kidney disease progression. Throughout the first half of 2026, our science team has continued to expand the preclinical dataset around varoglutamstat's mechanism of action in kidney disease.

Previously, we had shared work that we have done to better understand the molecular mechanism, including data highlighting varoglutamstat's role in collagen maturation and in reducing reactive oxygen species. As a reminder, if you'd like to learn more, there's a detailed scientific webcast on our website under the 'Our Approach' section.

In a pathway analysis, we have now investigated the effects of varoglutamstat on endothelial cells. These cells are a crucially important part of the kidney's filtration barrier, and their integrity is an essential factor in maintaining proper kidney function.

Michael will highlight some of the key findings, which we believe further support varoglutamstat's potential to be a game-changer for kidney disease. The target molecules of varoglutamstat, the glutaminyl cyclases, play an important role in a number of pathways related to diseases of the kidney.

Our continued progress in understanding how varoglutamstat supports and potentially restores kidney function further strengthens the link between its mechanism of action and the exceptional clinical results observed to date. We have already seen this deeper understanding support our discussions with potential partners.

Finally, based on our current planning, we maintain the expectation that our cash runway will extend into the fourth quarter of 2026, and we continue to actively explore strategic and financing options to strengthen our financial position. Overall, we believe we are in a strong scientific and strategic position to advance varoglutamstat and to realize the next phase of value creation.

With that, I would like to hand the call over to Michael. Michael?

Thank you, Julia. Welcome everybody also from my side.

As we have been reporting in the past, we are continuously analyzing data from preclinical activities to deepen our understanding of molecular mode of action of glutaminyl cyclase inhibitors. We have informed you also in the past about the comprehensive scientific validation showing that the downstream actions of our glutaminyl cyclase inhibitor varoglutamstat are predominantly mediated by reducing the activity of proinflammatory, profibrotic molecules, ultimately resulting in reduction of inflammation as well as tubulointerstitial fibrosis and glomerulosclerosis.

Now we report here new findings. The further analysis and RNA profiling from CKD animal models showed that, in addition, varoglutamstat is improving endothelial cell function via the HIF pathway activation.

HIF, or hypoxia-inducible factor, is a transcription factor that, when activated, kicks off a cascade of events including metabolic reprogramming and modulation of innate and adaptive immune cells, both resulting in cellular protection and metabolic integrity. Let us get this all into the framework of our current MoA overview.

Next to the downregulation of inflammatory and fibrotic signals reported earlier, we now must add a third layer here for varoglutamstat effects, which is the activation of the protective HIF pathway. Some of the expected benefits of HIF pathway activation include: reversal of capillary rarefaction by promoting the growth of new and healthy endothelial cells to rebuild the capillary network in the kidney; improved oxygenation and survival by activating the vascular endothelial growth factor, VEGF, and its receptor, supplying starving renal cells with necessary oxygen and nutrients; reduction of interstitial fibrosis by relieving chronic tissue hypoxia and breaking the cycle of inflammation and extracellular matrix protein deposition, which otherwise would lead to permanent kidney scarring.

To sum up, it is really worthwhile to note that in the entire scientific community, the full understanding of the HIF pathway-induced changes on immune cell metabolism and associated changes in cell function is still somewhat in its infancy. However, at the same time, it is true that HIF is a rather new, but already validated therapeutic drug target.

GSK's Jesduvroq and Akebia's Vafseo are just two examples of FDA-approved HIF activators which are prescribed for anemia associated with chronic kidney disease. With this, I'd like to close and now on to Frank for an overview on current activities.

Thank you, Mich. Thank you, Julia.

I will talk about the strategic imperatives and priorities of Vivoryon. It will be a very concise and short presentation.

The objective is to give you a correct update where we are as a company, but also keep the confidentiality of the communications and negotiations with other parties, which is in the best interest of Vivoryon and the other involved parties. Let's go into details.

Vivoryon follows multiple tracks to secure development of varoglutamstat in kidney disease. The company Vivoryon is currently in advanced term sheet negotiations for a licensing agreement for varoglutamstat with a pharmaceutical biotech company.

We hope and expect that these negotiations will continue and be successfully completed in the upcoming weeks. We also are involved with a specialist kidney investor who is independently assessing varoglutamstat's potential in kidney disease for a potential investment.

Also here, we expect updates and a conclusion within the next couple of weeks. Additionally, further discussions at various stages with additional strategic parties are ongoing to maximize the full potential of the QPCT/L platform in kidney diseases.

While we expect, hope, and believe that we can conclude those negotiations successfully in the next couple of weeks, I want to remind you that there is no guarantee that there will be success. With that, I want to hand over to Marcus.

Thank you, Frank. I will now walk you through the financial figures for the first half of 2026.

Research and development expenses in the first half of 2026 amounted to €1.7 million compared to €2.8 million in the first half of 2025. The reduction of €1.1 million was largely attributable to a decrease in clinical development costs of €0.6 million related to kidney research and a reduction of associated patent and consulting fees of €0.2 million.

We have seen a decrease in G&A expenses with costs of €1.7 million for the first half of 2026 versus €2.8 million for the first half of 2025. The decrease of €1.1 million was largely attributable to lower non-cash effective share-based payment costs and a decrease in legal costs.

All of this resulted in a net loss for the first half of 2026 of €3.4 million compared to €5.5 million for the first half of 2025. The company held €2.4 million in cash and cash equivalents as of June 30th, 2026, compared to €5.6 million as of December 31st, 2025.

We have maintained our cash runway into Q4 2026, which does not include any funds from the standby equity purchase agreement. Our spending plans continue to support the kidney disease strategy, and we continue to actively pursue additional financing and partnership opportunities.

Before we come to the Q&A, I would now like to hand the call back to Frank for a wrap-up.

Let me summarize where we are today. The strategy is to develop new therapies with the aim to preserve kidney function and prevent progression of kidney failure.

There is an important, significant unmet medical need in diabetic kidney disease, and that includes the latest portfolio events in other companies where we are sure that nobody is ahead of us with a similar or competitive data. There are many millions patients in US and Europe with diabetic kidney disease stage 3b and 4, and the primary goal of our new treatment is to stabilize and improve kidney function long term.

We have compelling data with our lead program, varoglutamstat, both clinical and preclinical. We have a differentiated mechanism of action targeting proinflammatory and profibrotic pathways, and Mich showed today a new avenue of a pathway where we also positively affect endothelial function in kidneys.

We are targeting to be the first oral agent to show improvement and long-term stabilization of kidney function. Altogether, Vivoryon and varoglutamstat is an attractive opportunity with defined value creation steps.

There is substantial market creating a blockbuster potential, and we are in advanced partnership negotiations which are ongoing. I have already commented about how things are and how they go forward, and due to the confidentiality, also in the Q&A, we cannot further elaborate on this.

I'm sorry about this. Thank you.

Hi, this is Anna on for Sushila. Thank you for taking our questions.

You further elucidated the mechanism of action of varoglutamstat, and it would be great if you could just give some color on the mechanics, and specifically on whether that HIF-VEGF activation acts as a direct driver of the endothelial benefit or more of a downstream consequence of the broader effects. Also related to that, do you have any early data or expectation on whether this is localized to the kidney or whether it could also be showing up systemically?

Thank you.

I did not get all of your question unfortunately. It is localized in kidney, yes.

There are of course multiple factors in the HIF pathway: VEGF, VEGF receptor, Tie2. There are other molecules which we've been looking at, where we found, yeah, activation of those molecules.

Again, this pretty new findings also, we are still about to elaborate this further. I'm not sure now whether this answers your question because I didn't get really the first part, or if you have further needs for information.

No, thank you. Just to also circle back to the cash runway into Q4, how confident are you that the licensing deal or the financing from the kidney-focused investor will materialize?

Would you draw the SEPA deal to extend your runway?

Maybe I take this one. We are confident, and I think we have good progress and advanced, but there is never certainty because these events are in the future, and nobody can predict the future.

There can always happen thousand things, but the strength of our approach is that we are working on multiple layers and multiple opportunities. We believe that at least one or two of those should bear success in the next couple of weeks.

Thank you.

Good afternoon. Thanks for taking my questions.

Exciting to see you talking about advanced negotiations on a potential licensing deal.

Joseph, you are very faint. We can barely hear you.

Sorry.

Hello, can you hear me now? Better?

A

little bit better.

Hi. It's exciting to hear you talking about advanced discussions regarding a potential licensing deal.

Appreciate confidentiality prevents you from saying too much, but just broadly in terms of structure, is this a deal that would allow you to conduct the Phase 2b study as planned, or would it then be completely in the hands of the partner? Just on that, is the potential partner experienced in the kidney disease space?

Thank you.

We will not do any further comments than those, because from all those can be drawn conclusions. I think these are good and valid questions.

In the interest of the company and the shareholder and the agreed confidentiality with other companies, we do not comment further here. Sorry about this, but I think it is a very favorable setting for the company, overall.

We try to preserve shareholder value and create shareholder value and company value with such an agreement, but I have to stop here.

Thank you very much. Worth a try.

Good afternoon. A couple of questions from me.

The first on the licensing negotiation and the equity investment, do you view these things as mutually exclusive or is one likely to be contingent on the other?

Mutually exclusive means, well, we will only do one deal for varoglutamstat. It's clear that we will not license the drug to several companies, at least not in the same region.

There may be regional considerations, but one drug for one company. We thinking about financing and other strategic collaborations, which then would not include varoglutamstat directly, but more the QPCT/L platform or our company.

That can be different parties.

Thank you. I think I was maybe not quite clear there.

I'm more asking whether you see any future fundraising being contingent on you having signed a licensing deal.

We haven't decided on this because we are still negotiating the deal. There have been no planning for future fundraising, capital increasing.

This is neither yes nor no, it is just not decided yet.

Sure. Then one on the specialist kidney-focused investor.

You mentioned that he's conducting or they're conducting an independent assessment of selected aspects of the program. Could you give any more color as to which aspects, and if they were to make an investment, would you expect it to allow you to fund the full Phase 2 program yourself?

We are in discussions with that investors, and there have been mentioning of a larger funding, but let's see step by step. The assessment is ongoing.

These are clearly newer aspects which we have not yet covered, we wait also for new information, and that should come in the next couple of weeks, and then we will look at the volumes and the timing.

Great. Thank you very much.

Yes, thank you for taking my question, and thank you for the update and that you are in advanced negotiations, which is reassuring. I wonder, you're talking about blockbuster potential for the drug, and I suppose you also had to analyze the commercial potential of the drug for the negotiations which are ongoing.

My question is, who did this analysis, and what is the estimated peak sales potential of the drug?

Julia, can you take this?

Sorry?

Yes. Obviously, we're always looking into peak sales potential.

I think at that point, as a company, it is a bit too early to comment on that. I think when we look into external sources, this clearly confirms blockbuster potential.

I think this is also what our analysts see if you look at their research, and this is obviously also then the basis for our discussions with the potential partners.

Blockbuster means more than $1 billion peak sales?

Yeah. Sure.

That means more than $1 billion peak sales.

We have in US, when you look into the current standard of care diabetic kidney disease, all drugs which are currently used and patent-protected or have been protected protected have reached, $1 billion. And, the magnitude of effect these drugs provide for the patients are lower than those in our target profiles and which we have observed in our current previous studies.

We are very confident that when the drug makes it to make to the market, we will, have very, substantial sales.

Thank you. One follow-up to this strategic kidney investor.

Is he then in competition to the potential pharma company financing or closing a license agreement, or I know the question was asked before in a different kind of way, but I wonder, if you have two parties now, both wanting it, what makes you decide for A and make you decide for B?

I think we try to structure it to make it complementary, and we see it this way, and we have discussed with the parties the corresponding potential strategic avenues we have taken, and that's very transparent and that's okay. Then we see how it goes on.

At that stage, as Vivoryon, and we have said that before, we always pursue multiple avenues to secure the future and the best outcome of the company.

Does this include the follow-up molecule you were mentioning, or would that be again a separate discussion?

This is probably part of the current discussion, but can also be separate.

Then good luck.

There is always more than two.

Yeah. Good luck, then.

Fingers

crossed. Yep.

We need, thank you.

Hi, thank you. One more question from me.

I wanted to ask about the Phase 2b trial and assuming you secure funding, how ready are you to start the trial? Has the protocol been finalized?

Have you received scientific advice? Do you have clinical trial material ready, or would you have to manufacture new material?

I start with C: clinical trial material is ready. B, scientific advice: we have discussed study design with multiple international experts, both in Europe and US, and we have narrowed down the designs.

A, is the protocol ready? It is ready in the sense of an extended synopsis which we can hand over to CRO who completes the study protocol once we have committed the resources.

Thank you. Then just one follow-up on the CTM.

Is there a shelf life on that?

Is what? Sorry?

Hi, yeah, on the clinical trial material, does it have a shelf life that you're working towards?

It has a shelf life. Every material has a shelf life, but it's sufficiently long to complete the study of at least a 1-year duration.

Perfect. Thank you very much.

The drug is very stable, and we have no shelf life issues which basically are creating issues of reproducing quickly and permanently.

Great. Thank you very much.

Thank you all very much for your continued interest and support. We appreciate your time today and look forward to speaking with you again soon.

Bye-bye.