Vivoryon Therapeutics N.V. (VVY) Q2 2026 Earnings Call Transcript

Good morning or good afternoon, everyone, and thank you for joining us today for Revoirion'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 Revoirion's website at www.revoirion.com. On the call with me today are Frank Weber, our Chief Executive Officer, Markus Ersfeldt, our Chief Financial Officer, as well as Michael Schäffer, 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 Vivorian's core platform, 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 viral gluten-free kidney disease. I will then hand the call over to Michael, who will share some new preclinical data, which provides further insights into the mechanism of action, underlying the compelling data we have seen with Raghudam's 13 clinical studies. Frank will then share details on the growing momentum behind our strategic partnering discussion. He will be followed by Markus, who will review the first half 2026 financial results before we conclude with Frank. Following the prepared remarks, we will open the call and we'll 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 Varagutamstad 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 Neurology in Japan, further validating glutamine uocyclases as promising targets in diabetic kidney disease in Schwartz and KDs. We previously showed in the Phase 2, Viviat and VivaMent studies that varagutam studs 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 varagutamstas has a beneficial effect in those patients with the highest risk of or already impaired kidney function. These data continue to support our Rational 2 as a next step in development, pursue a dedicated phase TB study in advanced BKD where there remains a significant unmet need for therapies that can stabilize or improve kidney function. As many of you know, Varagutam-STUD 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 data set around Varagutam-STUD'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 Virgo Dumpstat's role in collagen maturation and in reducing reactive oxygen species. As a reminder, if you would 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 effect of Virgo Dumpstat on endothelial cells. These cells are a crucial important part of the kidney saturation 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 varoglutum studs' potential to be a game-changer for kidney disease. The target molecules of varoglutum studs, the glutamine cyclases, play an important role in a number of pathways related to diseases of the kidney. Our continued progress in understanding how varoglutum studs support and potentially resource kidney function further strengthens the link between its mechanism of action and the exceptional clinical results observed to date. And we have already seen this deeper understanding support our discussion with potential partners. Finally, based on our current planning, we maintain the expectation that our cash-on 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 our good and to realize the next phase of value creation. And with that, I would like to hand the call over to Michael.

Thank you, Julia. So welcome, everybody, also from my side. Yeah, well, as we have been reporting in the past, we are continuously analyzing data from pre-explicative activities to deepen our understanding of molecular mode of action of glutamine recyclate inhibitors. And we have informed you also in the past about the comprehensive scientific validation showing that the downstream actions of our glutamine recyclate inhibitors are predominantly mediated by reducing the activity of pro-inflammatory of inflammatory prophylactic molecules, ultimately residing in reduction of inflammation as well as tubular interstitial fibrosis and glomerular sclerosis. Now, we report here new findings. A further analysis and RNA profiling from CKD animal models showed that in addition, while gritom stuff is improving endothelial self-function via the HIF pathway activation. HIF, or hypoxia-inducable factor, is a transcription factor that, when activated, kicks off a cascade of events, including metabolic reprogramming and modulation of innate and adapted immune cells, both residing in cellular protection and metabolic integrity. So, let us get this all into the framework of our current MOA overview. Next to the downregulation of inflammatory and fibrolytic signals report earlier, we now must add a third layer here for virulent stat effects, which is the activation of the protective HIF pathway. Some of the expected benefits of HIF pathway activation include reversal of capillary refraction, by promoting the growth of new and healthy endothelial cells to rebuild the capillary network in the kidney. Oxygenation and survival by activating the vascular endothelial growth vector of the EGF and the 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 scaring. So to sum up, it is really worthwhile to note that in the entire scientific community, the full understanding of the HIPP pathway induced changes on immune cell metabolism and associated changes in cell function is still somewhat in its incidence. However, at the same time, it's true that HIF is a rather new but already validated therapeutic drug target. GSKs, Genubroc, and Actibia's Vavseo are just two examples of FDA-approved HIF activators which are prescribed for anemia associated with chronic kidney disease. And with this I'd like to close and now on to Frank for an overview on current activities. Thank you Mick.

Thank you Julia. So I will talk about the strategic imperatives and priorities of Ivorion. 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 the best interest of Vivorion and the other involved parties. So let's go into details. Vivorion follows multiple tracks to secure development of Vavagutamstad in kidney disease. The company Vivorion is currently in advanced term sheet negotiations for a licensing agreement for Vavagutamstad 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 where the gluten starts potential in kidney disease for a potential investment. Also here we expect the updates and the conclusion within the next couple of weeks. Additionally, further discussion at various stages with additional strategic parties are ongoing to maximize the full potential of the QPCTL 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 Markus.

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 euros compared to 2.8 million euros in the first half of 2025. The reduction of 1.1 million euros was largely attributable to a decrease in clinical development costs of 0.6 million euros related to study research and the reduction of associated testing and consulting fees of 0.2 million. We have seen a decrease in GNA expenses with costs of 1.7 million euros for the first half of 2026 versus 2.8 million euros for the first half of 2025. The decrease of 1.1 million euros was largely attributable to lower non-cash-attective share-based personal 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 euros compared to 5.5 million euros for the first half The company has 2.4 million euros in cash and cash equivalents as of June 13, 2026, compared to 5.6 million euros as of December 31, 2025. We have maintained our cash runway into Q4, 2026, which does not include any funds from the standby equity purchase agreement. Our spending range continues to support the kidney disease strategy and we continue to actively pursue additional financing and partnership. Before we come to the Q&A, I would now like to hand the call back to Frank for a wrap-up.

So let me summarize where we are today. And the strategy is to develop new therapies with an 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 the 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 by the Guttamstatt, both clinical and preclinical. We have a differentiated mechanism of addiction targeting pro-inflammatory and pro-physiotic pathways and make sure today a new avenue of a pathway where we also positively affect endotelial function in kidneys. We are targeting to be the first oral agent to show improvement and long-term stabilization of kidney function. Altogether, Vivorion and Valoglutamstad is an attractive opportunity with defined value creation steps. There's a substantial market creating a blockbuster potential, and we are in advanced partnership negotiations, which are ongoing, and 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. And I'm sorry about this. Thank you.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. One moment for our first question. and this question comes from the line of Shushila Hernandez from Falna Schott Kempen. Please go ahead.

Hi, so this is Anna on for Shushila. Thank you for taking our questions. So you've already elucidated the mechanism of action of varic gluten stat and it would be great if you could just give some color on the mechanics and specifically on whether the HIV VGF activation acts as a direct driver of the anathedial benefit or more of a downstream consequence of the broader effects? And 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 questions, unfortunately. So it is localized to the kidney, yes. And there are, of course, multiple factors in the HIF pathway, VGF, the VGF receptor, TIE2, there are other molecules we've been looking at where we found activation of those. Again, there's pretty new findings also, so we are still about to elaborate this question because I didn't get really the first part. More if you have further needs for information.

Thank you. And 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 focus investor will materialize and would you draw the SEPA deal to extend your runway?

Maybe I'll take this one. we are confident and I think we have good progress in advance. but there is never certainty because these events are in the future and nobody can predict the future. So that can always happen, a thousand things. But the strength of our approach is that we are working on multiple layers and multiple opportunities, and we believe that at least one or two of those should bear success in the next couple of weeks.

Okay, thank you.

Thank you. We are now going to move to our next question, and this one comes from Joseph Hedden from RxSecurities. Please go ahead.

Joseph, you are very faint. We can barely hear you. A little bit better.

I 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 happening disease space?

So we will not do any further comments than those, because from all those can be drawn conclusions. And I think these are good and valid questions. In the interest of the company and the shareholder and the green confidentiality with other companies, we do not commit further here. Sorry about this but I think it is a very favorable setting for the company overall so 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. We are now going to move to our next question and this one comes from Tom Rosenfeld from Intron Health research. Please go ahead.

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?

I mean, mutually exclusive means, well, we will only do one year for the drug to several companies at least not in the same region there may be regional considerations but one drug for one company but we thinking about financing and other strategic collaborations which then would not include Varadutamstad directly but more the QPC TL platform or our company and that can be different parties Thank you, I think I was maybe not quite clear there so I'm more asking whether you see any future fundraising being contingent on you having signed a licensing deal We have decided on this because we are still negotiating the deal so So there have been no planning for future fundraising, capital increasing. This is neither a yes nor a no. It is just not decided yet. Sure.

And then one on the specialist kid, he's a 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?

Well, we are in discussions with investors, and there have been mentioning of a larger funding. But let's see step by step. The assessment is ongoing. These are clearly new aspects which we have not yet covered. so 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 thank you as a reminder to ask a question you will need to press star one and one on your telephone keypad that is star one and one to ask a question we have one more question at the moment and this one comes from

Sasha Barash from Paros Investment AG please go ahead 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 migrations which are ongoing. My question is who did this analysis, and what is the estimated peak sale potential of the drug?

Can you take this?

Sorry?

Yes. So, I mean, 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.

And Blockbuster means more than 1 billion sales, peak sales.

Yeah, sure. That means more than 1 billion peak sales.

We have in US, I mean, when you look into the current standard of care in diabetic kidney disease, all drugs which are currently used and patent protected or have been 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 so we are very confident that when the drug makes it to make to the market we will have a very substantial sales okay thank you one for us one

follow-up to the strategic kick investor if you like then in competition to the potential farmer company financing or closing license agreement or I know the question was asked before in a different kind of way, but I wonder, you know, if you have two parties now, both wanting it, you know, what makes it be a site for A and make it to the site for B?

I think we try to structure it to make it complementary, and we see it this way, and And we have discussed with the parties the corresponding potential strategic avenues we have taken, and that's very transparent, and that's okay. And then we see how it goes on. I mean, at that stage, as we go on, and we have said that before, we always pursue multiple avenues to secure the future and the best outcome of the company and 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 okay okay so there is always more than two yeah okay good luck then thank you thank you we are now going to take our next question and this one comes from

Tom Roosevelt from intron health research please go ahead hi thank you one more question from me and 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 and do you have clinical trial material ready or would you have to manufacture new material?

So I start with C, clinical trial materials ready. B, scientific advice. We have discussed the study design with multiple international experts, both in Europe and US. And we have narrowed down the signs. And A is the protocol ready. It is ready in the sense of an extended synopsis, which we can hover to our CRO who completes the study protocol once we have committed the resources.

Thank you, and then just one follow-up on the CTM, is there a shelf life on that? Is what? Sorry, on the clinical 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 one-year duration.

Perfect, thank you very much.

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

Okay, great. Thank you very much.

Thank you. There are no further questions for today. I will now hand the call back to Julia for closing remarks.

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.