Vivoryon Therapeutics (Euronext:VVY) Q2 2026 Earnings Call

0:00 Good morning or good afternoon, everyone, and thank you for joining us today for Vivoryon's first half twenty twenty six results call. Earlier today, we issued a press release reporting our first half twenty twenty six financial results and business update, which can be found on Vivoryon's website at www.vivariant.com. On the call with me today are Frank Weber, our Chief Executive Officer Markus Erstfeld, our Chief Financial Officer as well as Mikhail Schafer, 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 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.

0:59 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 twenty twenty six as we continue to advance our strategic priorities and strengthen the body of evidence for vargumentumab in kidney disease. I will then hand the call over to Michel, who will share some new preclinical data which provides further insights into the mechanism of action underlying the compelling data we have seen with raglutidem in clinical studies.

1:46 Frank will then share details on the ongoing momentum behind our strategic partnering discussion. He will be followed by Markus, who will review the first half twenty twenty six financial results before we conclude this plan. 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 twenty twenty six. Throughout the reporting period, we have seen growing momentum and increased strategic interest around veragutamstat 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.

2:44 Frank will provide a more detailed strategic update in a few minutes. On the R and 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 glutamate cyclases as promising targets in diabetic kidney disease in short CKD.

3:10 We previously showed in the phase two Gilead and VivaMAN studies that vargutam had a greater beneficial effect on kidney function in elderly participants with diabetes than in those without diabetes. At WCN, we build 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 vargutemstat 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.

4:01 As many of you know, vorablutinib 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 twenty twenty six, our science team has continued to expand the preclinical data set around voradustat mechanism of action in kidney disease. Previously, we had shared work that we have done to better understand the molecular mechanism, including data highlighting mirabegrandamstad'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.

4:50 In a pathway analysis, we have now investigated the effect of raglutamstat on endothelial cells. These cells are a crucial important part of the kidney 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 raragglutamstat's potential to be a game changer for kidney disease.

5:14 The target molecules of baragglutamyl cyclases play an important role in a number of pathways related to diseases of the kidney. Our continued progress in understanding how baragglutamstat supports and potentially restores 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 runway will extend into the fourth quarter of twenty twenty six, 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 Veragutemstadt and to realize the next phase of value creation.

6:05 And with that, I would like to hand the call over to Miguel. Miguel? Thank you, Julia. So welcome everybody also from my side.

6:16 Yeah, well, 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 glutaminolyticase inhibitors. And we have informed you also in the past about the comprehensive scientific validation showing that the downstream actions of arbutaminergic cyclase inhibitor valvulotemstat are predominantly mediated by reducing the activity of pro inflammatory profagdolic molecules, ultimately resulting in reduction of inflammation as well as tubular interstitial fibrosis and glomerulosclerosis. And now we report here a new finding.

7:01 The further analysis and RNA profile from CKD animal models showed that in addition, valvulotomstat is improving endothelial cell function via the HIT pathway activation. If 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 adapted immune cells, both resulting in cellular protection and metabolic integrity.

7:36 So let us get this all into the framework of our current MOA overview. Next to the deregulation of inflammatory and fibrotic signals reported earlier, we now must add a third layer here for varietalum sub effects, which is the activation of the protective fifth pathway. Some of the expected benefits of fifth 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, improved oxygenation and survival by activating the vascular endothelial growth factor 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 scarring.

8:43 So 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 associated changes in cell function is still somewhat in infancy. However, at the same time it's true that HIF is a rather new but already validated therapeutic drug target. GSK's Genubroc and Akcevia's Varshio are just two examples of FDA approved GIPP 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.

9:31 Thank you, Mick. Thank you, Julio.

9:37 So 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

10:01 of the communications and negotiations with other parties, which is in the best interest of Vivoryon and the other involved parties. So let's go into details. Vivoryon follows multiple tracks to secure development of avagutemstat in kidney disease. The company Vivoryon is currently in advanced term sheet negotiations for a licensing agreement for valagutamstat with the pharmaceutical biotech company.

10:39 We hope and expect that these negotiations will continue and be successfully completed in the upcoming weeks. We also are in evolved with a specialist kidney investor who is independently assessing valglutamstat's potential in kidney disease for a potential investment. Also here, we expect 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.

11:26 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 will hand over to Markus.

11:48 Thank you, Frank. I will now walk you through the financial figures for the first half of twenty twenty six. Research and development expenses in the first half of twenty twenty six amounted to €1,000,000 compared to €2,800,000 in the first half of twenty twenty five. The reduction of €1,100,000 was largely attributable to a decrease in clinical development costs of €600,000 related to kidney research and reduction of associated patent and consulting fees of €200,000 We have seen a decrease in G and A expenses with costs of €1,700,000 for the first half of twenty twenty six versus €2,800,000 for the first half of twenty twenty five.

12:34 The decrease of €1,100,000 was largely attributable to lower non cash effective share based personal costs and a decrease in video costs.

12:44 All of this resulted in a net loss for the first half of twenty twenty six of €3,400,000 compared to €5,500,000 for the first half of twenty twenty five. The company held €2,400,000 in cash and cash equivalents as of 06/30/2026 compared to €5,600,000 as of 12/31/2025. We have maintained our cash runway into Q4 twenty twenty six which does not include any funds from the standby equity purchase agreement. Our spending plan continues to support the kidney disease strategy, and we continue to actively pursue additional financing and partnership opportunities. Before we come to the Q and A, I would now like to hand the call back to Frank for wrap up.

13:36 So, me summarize where we are today. And the strategy is to developing 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 four, and the primary goal of our new treatment

14:19 is to stabilize and improve kidney function long term. We have compelling data with our lead program by the guttemstat, both clinical and preclinical. We have a differentiated mechanism of action targeting pro inflammatory and propathologic pathways, and MYC showed today a new avenue of a pathway that will also positively affect endothelial function in kidneys. We are targeting to be the first oral agent to show improvement in long term stabilization of kidney function.

14:54 Altogether, Vivoryon and valglutamstat is an attractive opportunity with defined value creation steps. There's 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 and 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 11 on your telephone and wait for your name to be announced.

15:41 To withdraw your question, please press 11 again.

15:47 One moment for our first question. And this question comes from the line of Shushila Hernandez from Van La Schott Kempen. Please go ahead. Hi. So this is Anna on for Shushila. Thank you for taking our questions. So you've further elucidated the mechanism of action of valroxenstat, and it would be great if you could just give some color on the mechanics and specifically on whether the HIF VEGF activation acts as a direct driver of the endothelial 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?

16:33 Thank you. I did not get all of your questions, unfortunately. So it is localized in kidney, yes. And there are, of course, multiple factors in the hidden pathway, VEGF, VEGF receptor, type two. There are other molecules we've been looking at where we found activation of those molecules. Again, although this is pretty new findings also, so we are still about to elaborate this further. I don't I'm not sure now whether this answers your question because it didn't get really the first part or if you have further needs for Yeah. For me.

17:24 No. Thank you. And just to also circle back to the cash runway into q four, how confident are you that the licensing deal or the financing from the kidney focused investor will materialize? And would you draw the CEVA deal to extend your runway? Yeah, maybe I'll take this one. So, 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, 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.

18:24 Okay. Thank you. Thank you. We are now going to move to our next question, and this one comes from Joseph Hedden from Rx Securities. Please go ahead. Good afternoon. Thanks for taking my questions. It's exciting to see you talking about advanced negotiations on a central licensing deal. Joseph, you are very faint. We can barely hear you. Sorry. Hello. Can you can can you hear me now better? A little bit better. Hi. So it's exciting to hear you talking about advanced discussions regarding a potential licensing deal. I appreciate confidentiality prevents you from saying too much. But just broadly in terms of structure, is is this a deal that would allow you to conduct the phase two b study as planned, or would it then be completely in the hands of the partner?

19:22 And just on that, is the potential partner experienced in the kidney disease space? Thank you. We will not do any further comments on 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 we do not commit further here. Sorry about this, but I think it is a very favorable sit setting of the camp 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.

20:11 Okay. Thank you very much. Worth a try. 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 valglutamstat. I mean, 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.

21:12 But we're thinking about financing and other strategic collaborations, which then would not include valglutamstat directly, but more the qPCTL platform or our company, and that can be different parties. Thank you. I 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 haven't decided on this because we are still negotiating the deal. So, there have been no planning for future, fundraising, capital increasing.

22:03 This is neither a yes nor a no, and this just not decided yet. Sure. And then one one on the, 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 two 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.

22:53 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 11 on your telephone keypad. That is star one and one We have one more question at the moment. And this one comes from Sascha Buresh from Taros 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.

23:46 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? Maria, 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.

24:41 And this is obviously also then the basis for our discussions with the potential partner. And blood plasma means more than 1,000,000,000 sales. Yeah. Sure. That means more than 1,000,000,000 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 1,000,000,000. 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.

25:35 Okay. Thank you. And one follow-up, one follow-up, to this, strategic kidney investor. Is he, like, 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, you know, if you have two parties now both wanting it, you know, what makes you decide for A and make you decide for B? No. I think we we 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.

26:35 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. Mhmm. 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 then good luck. Always more than two. Yeah. Okay. Good luck then. Yes. We need thank you. Thank you.

27:20 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. 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'll start with clinical trial material is ready. B, scientific advice. We have discussed the study design with multiple international experts both in Europe and U. S, and we have narrowed down the the signs.

28:15 And a is the protocol ready. It is ready in the sense of an extended synopsis, which we can hold it to our CRO who completes the study protocol once we have committed the resources. Thank you. And then just one follow-up on the on the 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 that you're working towards? Yeah. 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.

29:02 Perfect. Thank you very much. The drug is very stable and we have no shelf life issues which 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 Yulia 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.