Vivoryon Therapeutics N.V. (VVY) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Vivoryon Therapeutics 2024 Full Year Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Anne Doering, CFO. Please go ahead.

Thank you, Nadia. Good afternoon, and thank you for joining us today to discuss the company's Full Year 2024 Results And Operational Updates. This morning Vivoryon issued a press release reporting its full year 2024 financial results and also provided an update on our progress for the reporting period and year-to-date, which was marked by a strategic shift into kidney disease, creating a robust body of evidence for varoglutamstat's beneficial effect on kidney function as well as significant progress both on the preclinical and clinical front as well as on the corporate development side. This press release is posted on Vivoryon's website at www.vivoryon.com. On the call with me today are Vivoryon's Chief Executive Officer, Frank Weber; and our Chief Business Officer, Michael Schaeffer. I will begin today's call with an overview of the key highlights from the reporting year and post period updates and will then walk you through the financial results for 2024 and 2025 year-to-date, providing details on corporate and financial updates, including our recently announced SEPA facility; I will then hand the call over to Michael who will give very positive updates on the data front where we have new preclinical information as well as news on our IP strategy; Frank will conclude our presentation with a summary and details on varoglutamstat's unique and beneficial effects on kidney function and strategic outlook. Following the prepared remarks, we will host a Q&A session. Before we start, I would like to remind you that during this conference call we will present and discuss certain forward-looking statements concerning the development of Vivoryon's core platform, the progress of its current research and development program, and the initiation of additional programs, as well as results of operations, cash needs, financial conditions, liquidity, prospects, future transactions, 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. 2024 has been a truly transformative year for Vivoryon as we have successfully navigated the strategic shift towards a focus on inflammatory and fibrotic diseases, in particular on kidney disease. In the reporting period and year-to-date, we have built a robust body of clinical evidence for varoglutamstat. We have concluded 2 independent randomized, double-blind, placebo-controlled Phase II studies, and analyzed the results extensively, individually for each study and in a meta-analysis. This has shown highly consistent, statistically significant, and clinically meaningful improvement of kidney function for varoglutamstat versus placebo. We have designed an efficient clinical program. The Phase IIb DKD study will be a small and focused study aimed to deliver results as quickly as possible in the target patient population. This has been based on a thorough statistical analysis and has been shaped in lockstep with thought leaders in the space. All along we have had close dialog with key opinion leaders, and we have hosted events to provide others access to their views. We have created a viable commercial strategy for our lead asset, varoglutamstat. This includes new data that we will show you today on the potential synergistic effect of varoglutamstat with standard-of-care in kidney disease. We also have strengthened our IP position and are sharing exciting news with you today on the recent notice of allowance for a new varoglutamstat composition of matter patent in the U.S., providing us with significantly longer potential exclusivity. All these steps are bringing us closer to realizing the full potential of varoglutamstat in this area of significant unmet medical need. At the same time, prudent cash management has enabled us to extend our cash runway. And through the recently announced standby equity purchase agreement of up to EUR 15 million, we have gained additional financial flexibility. As of May 1, 2025, we will be expanding our executive team with the addition of Dr. Julia Neugebauer taking on the newly created role of Chief Operating Officer and heading Investor Relations. All of this marks yet another extremely active reporting period, with lots of updates on all fronts for us to cover today. Here we have an overview detailing the robust body of evidence generated for varoglutamstat in kidney function that underpins our strategic shift towards advancing varoglutamstat in DKD. This quarterly breakdown clearly shows the clinical and preclinical progress from the initial VIVIAD readout to where we stand today, including oral presentations at the most prestigious medical conferences, the American Society of Nephrology in the U.S. in the fourth quarter of 2024 and coming up this June at the European Renal Association Conference. Both Frank and Michael will go into further detail on the clinical and preclinical progress in our webcast today. We have decided to touch upon the financial results and corporate progress earlier on in our presentation today to also address our recently shared news on the SEPA facility. Overall prudent spending and resource management has allowed us to achieve the strategic turnaround towards kidney disease while reducing cash utilization. As for the 2024 key figures, research and development expenses amounted to EUR 14.1 million versus EUR 17.6 million in 2023. The decrease is primarily attributable to lower third-party expenses, mainly due to lower clinical and manufacturing costs following the ramp down of the VIVIAD study. We have seen a decrease in general and administrative expenses, with costs of EUR 6.9 million in 2024 compared to EUR 8.6 million in 2023. This EUR 1.7 million decrease was largely due to a decrease in personnel costs and costs for nonexecutive Board members, driven largely by a decrease in share option expenses relative to 2023. All of this resulted in a net loss for 2024 of EUR 20.6 million, compared to EUR 28.3 million for 2023. The company held EUR 9.4 million in cash and cash equivalents as of December 31, 2024, compared to EUR 28.6 million which includes cash and cash equivalents and term deposits within financial assets as of December 31, 2023. Cash utilization in 2024 reflects the intensive investment period in VIVIAD and VIVA-MIND, especially in the first 6 months of the year as well as investments to support the advancing of the kidney program, some of the newest results of those efforts we are sharing with you today. Costs from VIVIAD and VIVA-MIND are largely completed. However, spending continues to occur on preclinical studies and evidence supporting the kidney strategy. This brings us to an updated financial guidance. We are very pleased that we have been able to navigate 2024 successfully, with a positive outlook also for 2025. As a result, we are extending our cash runway given the improved outlook, now expecting our cash and cash equivalents being sufficient to fund our operating plan for the full year 2025 and into January 2026, provided there are no unforeseen circumstances and without taking into account potential additional financing transactions, if any. We have been diligent in spending and have invested where we believe it makes strategic sense to strengthen the kidney disease strategy. During this period, we have built the clinical evidence of varoglutamstat and its impact on kidney function. We have expanded the pipeline with the progress of our new molecule VY2149, and we have also strengthened our IP position. We still have our planned Phase IIb study and DKD insights for which we will need further funding and/or partnership. Now I would like to move on to the Standby Equity Purchase Agreement with Yorkville Advisors, which we just announced last week. The SEPA is one piece of our financial strategy towards starting our Phase IIb DKD study. It is with Yorkville Advisors and provides us with access to additional capital of up to EUR 15 million over 36 months. We can use this facility at our discretion, and there are mechanisms in place that provide a level of control over the amount and timing of tranches. We have not yet issued a tranche under the facility. The program can be stopped at any time. Strategically, it allows us to keep open the various potential paths we see going forward. Importantly, the SEPA does not pose any restrictions on other fundraising or partnering options, meaning that we can continue the active pursuit of the optimal solution to fund the Phase IIb DKD study. We have always been and continue to be fully committed to doing what is in the best interest of our shareholders and the patients we strive to serve with the medicines we are working tirelessly to develop. I'd like to conclude my remarks with an exciting announcement. We are very happy to welcome Dr. Julia Neugebauer to our executive management team. Julia will join as Chief Operating Officer on May 1, a new role within Vivoryon. She brings to the company nearly 20 years of experience in the biotech industry. Many of you will know Julia from her long tenure at MorphoSys, where she spent over 10 years in R&D before transitioning into Investor Relations, most recently as Vice President, Global Head of IR and Sustainability of MorphoSys. As Vivoryon's COO, Julia will be heading Investor Relations and Communications activities, spearhead our market analysis and lead other corporate functions. As a seasoned industry expert, combining scientific expertise with business acumen, she will be an excellent addition to the company's management team to support Vivoryon in executing its strategic goals. And with that, I will hand it over to Michael.

Yes. Welcome, everyone, also from my side, and thank you, Anne, for starting us off. So now let me continue with some details on very exciting recent findings and developments in the preclinical space, as well as some significant progress we have made on the operating level related to new intellectual property. Starting with varoglutamstat's mode of action and QPTC/QPTCL inhibitors in general. As a reminder, Vivoryon's groundbreaking discovery underlying our most advanced development program is that inhibition of the glutaminyl cyclase QPTC and QPTCL reduces kidney inflammation and fibrosis and can significantly improve kidney function. Varoglutamstat is a potent and selective inhibitor of glutaminyl cyclase, QPTC and QPTCL, which I will refer to as QPTC/L from hereon out. These 2 enzymes are the only ones in the human body enabling pyroglutamate formation in the substrate proteins and peptides. This pyroglutamate formation is per se a physiological event that we all need for our bodies to function normally as it leads to stabilization and/or full potency of the glutamine-related substrate protein. However, in disease conditions, disease relevant molecules, including glutaminyl cyclases, are overexpressed. Increased levels of pathologically relevant proteins cause additional or accelerated pathological changes like inflammation and fibrosis, ultimately leading to kidney function decline. Now glutaminyl cyclase have a rather broader number of substrate proteins, many of which are involved in fibrotic events, extracellular matrix remodeling and inflammation, like the ones you see in this illustration here on the right. For example, several chemokines and collagens, in addition, M1 macrophages are recruited to the site of inflammation and stimulated to polarize into proinflammatory status by CC chemokines, again, out of which some are also substrates of glutaminyl cyclases. Thus, inhibiting glutaminyl cyclases strongly reduces pyroglutamate formation on these inflammatory and fibrotic effectors, making them less active and ultimately leading to reduced inflammatory processes and fibrotic responses for which, for example, [indiscernible] marker and the reduction of kidney injury for which KIM-1 would be a marker here. Importantly, it also leads to an improved glomerular filtration rate, which is indicative of improved kidney function. In this context, I'd like to highlight that QPTC/L inhibition is modulating substrate activity rather than completely blocking it, which is just one of the several major differences to earlier anti-CCL2/CCR2 antibody approaches, for example. I'm making this clear distinction here because it is important to understand that this modulation of the activity of many different key inflammatory and fibrotic players with a beneficial trajectory is very different from a full block of just one more or less dominant disease pathway. So taken together, varoglutamstat and QPTC/L inhibitors have a unique and new mode of action, which also makes them in addition to be used as monotherapeutic agent, a very interesting component to be tested in combination with existing therapeutics. And I'd like to highlight on the next slide for you why this is of special importance in the kidney space. For that, let us have a look at standard-of-care in DKD as it is laid out nicely in the recent KDIGO guidelines. KDIGO stands for Kidney Disease: Improving Global Outcomes, a nonprofit foundation with a mission to improve the care and outcomes of people with kidney disease worldwide through the development and implementation of global clinical practice guidelines. In the KDIGO guidelines, we see that SGLT2 inhibitors, which prevent glucose reabsorption in the kidney, are now defined as a standard-of-care in DKD. SGLT2 inhibitors are now recommended very broadly for CKD/DKD patients with eGFR equivalent above 20 milliliter per minute. And to date, 3 SGLT2 inhibitors are improved and recommended for use in DKD. Nevertheless, the risk of disease progression is only reduced at best by 34% under SGLT2 treatment, still leaving a major need for approaches that can effectively halt or even reverse disease as a single agent or acting on top of SGLT2 inhibitors. With this in mind, we believe understanding the potential additional benefit of QPTC/L inhibitors on top of SGLT2 inhibitors is essential for development and commercial success. This has prompted us to investigate combination treatment of varoglutamstat with SGLT2 inhibitors, namely dapagliflozin. And I'd like to show you some of the exciting results we had in preclinical models. But before I go into the data, I'd like to briefly introduce the model I was speaking about today. The adenine-induced animal model of chronic kidney disease, ADI CKD model for short, is well established in the industry. At the same time, it is also known to provide a high hurdle for showing efficacy due to the manner in which kidney inflammation is triggered here. In the [ ADI CKD model ], a specific metabolic product, 2,8-DHA, accumulates and crystallizes in animals fed with an adenine-rich diet, ultimately leading to kidney inflammation. To investigate potential combination effects and also compare once-daily versus twice daily dosing, we conducted a series of experiments in several groups, including dapagliflozin alone and dapagliflozin with once or twice daily dosing, varoglutamstat on top. Treatment duration was 3 weeks and readouts included a broad panel of blood parameters and immunohistochemistry markers in kidney samples to analyze inflammatory and fibrotic events in kidney function. The most exciting outcome is that we found quite impressive synergistic effects for the combination treatment of [indiscernible] dapagliflozin and varoglutamstat over a broad panel of markers. You can see here on the graph on the right side that the combination treatment, which are the green columns, achieved statistically significant improvement versus dapagliflozin-only treatment group, which is the purple color. Just as examples here, on top is CD11c, which is a known surface marker for the proinflammatory M1 macrophage subpopulation and indicates beneficial impact on inflammation. In the middle, strong collagen 3 reduction shows the strong antifibrotic effect exerted by the combi treatment. And on the bottom, you see clearly reduced plasma cystatin-C levels, which are indicative of increased kidney function. Moreover, when comparing the dark green column, which is the combination of varoglutamstat twice daily and dapagliflozin with the control in light gray, you see that the combination nearly normalizes pathology for these domains. And furthermore, comparing both green columns, which is once daily versus twice daily dosing, you see they are quite similar, in particular, the domains of fibrosis and kidney function. This clearly supports the once-daily investigation of varoglutamstat in our planned clinical study. I'd like to reiterate that the efficacy bar in this model is pretty high. So all this is extremely encouraging and once again makes varoglutamstat and QPTC/L inhibitors a very attractive development program in the kidney space, both as a standalone therapy in its own right and also in combination with SGLT2 inhibitors. To provide further proof points, we are currently investigating additional animal models, including a DKD model, and results will be presented in one of our upcoming reporting events. So taken together, these exciting findings paves the development path for QPTC/L inhibitors in combination with SGLT2 inhibitors and the effect observed on top of standard-of-care SGLT2 inhibitors could substantially derisk our DKD clinical development program. Based on this outstanding effect, we very recently also have filed patents for the combination of QPTC/L inhibitors with SGLT2 inhibitors. And this leads nicely to the next topic I'd like to update you on today, and this is how we are protecting our findings and strive to extend our leading position in the field. So now I'd like to give you a brief update on our IP strategy and patent status. Let me start off with the most exciting news here in light blue. The accelerated examination process we have been applied for in the U.S. regarding the new composition of matter patent for the active polymorph in the drug product of varoglutamstat has been completed, and this was a positive outcome many months earlier actually than expected. We've received the notice of allowance just recently, and I'm very happy to report that the examination process went extremely smoothly, and the investigators had only very few minor formal remarks. We have completed all final administrative steps on our end, and we expect the final [ grant ] letter to arrive in the next month. The nationalization phase to the rest of the world will be due and starting by end of this year. In addition, we have filed further patents on medical use, dosing regimen, as well as the combination therapy of varoglutamstat and SGLT2 inhibitors, covering not only varoglutamstat, but also our follow-up candidate, VY2149, as well as other QPTC/L inhibitors and all of the polymorphs, which actually provides additional layers of protection. In line with the potential application of QPTC/L inhibitors in a broad range of diseases, we also have secured a large number of medical use patents in other indications, as you see here in the dark blue section. And as of today, overall, our patent portfolio is comprised of 22 patent families, over 400 patent applications and issued patents, with composition of matter patents on QPTC/L inhibitors representing [ the clear majority ] thereof. So now what does this mean in terms of timelines regarding the IP protection of our assets? As you see, varoglutamstat is now protected until 2044 with a potential extension under the Hatch-Waxman Act to 2049, which obviously is a major added value on top to the natural runtime to year 2031 under the original patent. Patent filings for dosing, medical use, and combination add a year on top of that. And as I said before, if granted, will provide an additional layer of protection from competition for varoglutamstat and also the follow-up candidate, VY2149, and other QPTC/L inhibitors of our portfolio. So I'd now like to conclude my remarks today with a quick summary of where we stand with varoglutamstat. And let me point out here, very importantly, what you see is not an [ aspiration list ]. These are statements reflecting the body of scientific and clinical evidence we have generated to date about the profile of varoglutamstat to demonstrate that this compound has the potential to become a convenient new treatment option to fill the existing gap in kidney diseases. So varoglutamstat is a single-agent oral compound with additional preclinical evidence for highly synergistic effect with SGLT2 inhibitors. Rooted in a first-in-class mechanism of action, addressing key pathways in inflammation and fibrosis, varoglutamstat treatment has proven to result in a statistically significant and clinically meaningful improvement of eGFR in 2 independent double-blind placebo-controlled Phase II studies with an effect size substantially larger in the diabetes versus nondiabetes population. Frank will go on into the clinical data in more detail shortly, outlining the clearly differentiated profile with above 70% of patients showing improvement on post stabilization of eGFR in the diabetes subgroup as well as the excellent safety profile consistent across 2 years of study duration. And finally, I have just updated you on our important recent success on the IP front, putting us in an excellent position with not only varoglutamstat, but also our other product candidates. And with that, I'd like to hand over to Frank for the clinical data deep dive. Frank?

Thank you, Michael. Thank you, Anne, for this very nice presentation. This is a special day for Vivoryon. It's about 1 year ago that we announced the first time that we had fantastic data on improving kidney function. And now we have a year behind us, and I will shortly review where we are today and give you an outlook where -- what is happening in the next year and where our ambitions go. Next chart, please. Chronic kidney disease is a very severe and unreversible progressive disorder, where there are treatments out like SGLT2 inhibitors to which Michael spoke before, but GLP-1 agonists, which do not reverse the disease, but just slow it down. So there is a huge unmet need to change the trajectory of that disease. And there is currently nothing out there, which looks as promising, I would say, as varoglutamstat does with the data we have seen in the past and by Michael and which I will present to you. Our evidence is based on 2 clinical studies, which we were running in the year '21 to '24, one is the European VIVIAD study and one is the American VIVA-MIND study, both double-blind placebo-controlled randomized studies that initially targeted an early Alzheimer's population with [ prospective ] measurement of kidney function. And what we saw that there is, on the next chart, consistent, highly significant improvement of eGFR in both studies, independently replicating the positive effects on different continents with different CROs with different investigators. So we have a very robust finding for our drug based on these 2 clinical studies. And to give you some idea, the effect size you observe here in the total population we studied is 3x higher than compared to SGLT2 and GLP-1s observed versus placebo in diabetic patients. Now that is a conservative statement because in diabetic patients, our effect size is much higher than in the total population as can be seen in the meta-analysis on the next chart. We conducted the meta-analysis, and we compared the effect of diabetes patients with nondiabetic patients in those 2 studies. And what you can see is that the bar charts are much wider away from the 0 line in the diabetic population than they are in the nondiabetic population. Both are significant, but when you compare then the effect size, you come, of course, much higher than threefold to what you have observed so far for the SGLT2s and GLP-1 inhibitors. While that are all statistical models, we have, I think, so far never shown the observed case MMRM by visit data. And these are the pooled observed data from baseline to last visit for VIVIAD and VIVA-MIND. And you see here in the pink line, the active compound, and then the placebo is in orange. And what you can see is that, as we always said, varoglutamstat increases slowly over 6 months or 24 weeks and then has a plateau of efficacy always clearly above the baseline value. And what you see is that the patients treated with placebo have a mild decline. The efficacy is clearly maintained over 2 years, and the effect is highly significant in the population -- in the total population. When you move to the next chart, we have also done the same chart for the diabetes population. As you can see, for the diabetes subpopulation, the active is in the blue and the placebo is in the yellow color. And the placebo is a little bit noisy because there are very few patients in the placebo arm. There is only 16, 14, [ 30 ]. But what you can see clearly is that the drug effect is very consistent and maintained over 2 years, again, starting at about 6 months of treatment. And the effect size actually is larger in diabetes patients than is in the total population. And it is a little bit confusing here, and I apologize for this, but the scales are a little bit different. So this is a smaller magnification scale. So the effect size seems to be small in diabetes patients, but actually it's much higher because. Because when you look at the real numbers, of course, the difference is much bigger than in the previous chart [ and is corrected just ] for the scale of the presentation. So overall, we have a very consistent and very meaningful effect in the total population and even more in the diabetic population, which we then analyzed as well, whether it comes from only a couple of patients or the majority of patients [indiscernible]. And we did a responder analysis. And in the responder analysis, we can clearly show that at the high dose, 72% of the patients had a sustained improvement of at least 2 milliliters above baseline, whereas that effect only occurs in 24% of patients in placebo. So we can state that about 3/4 of the patients using our drug at 600 milligrams twice daily have a sustained improvement of kidney function as measured by eGFR above baseline. And these are data so far, I think, haven't been presented scientifically or in a presentation at that stage in that length and that robustness. So it's a unique finding. And efficacy is one part of it. The safety is another part of it. And while you see big differences in efficacy, there are only very minimal differences in safety. There are -- some patients have more gastrointestinal or have more skin and subcutaneous side effects, but these are very small and these are minor, and they don't lead to drug discontinuation or to SAEs. So the product is very well tolerated. Beyond these safety data from the Phase II studies, we have also a large Phase I study. We have completed an [indiscernible] study. We have done our long-term safety tox studies of 6 and 9 months in rodents and mammalians. So we have a very complete and safe data package for the use of the drug in diabetic kidney disease and kidney disease. Then in 2024, we already started designing the next study. And the objective is now also forward-looking to bring the drug now to patients with chronic kidney disease and diabetes stages 3B and worse. Those patients which progress relatively fast to end-stage kidney disease, those patients which then require either transplant or dialysis, are in dire need of additional treatments, improving their outcome. And with the data Michael showed today, we are very confident that we can add substantial benefit on top of the current standard-of-care of SGLT2 in this patient population. Let me conclude now with our situation of Vivoryon in 2024. And what we did is we had completed in time and in budget 2 clinical trials with about 400 patients, around 370 patients. We created robust evidence of efficacy for improving the kidney function, and we designed a specific study. From now onwards, we will focus on ensuring that we have a clinical and commercial viable product in the market. And with the new composition of matter, which have a letter of allowance for the largest pharmaceutical market in the world, the U.S., we are quite confident that we can get there. We also filed additional medical use patents and the data with SGLT2 inhibitors in combination not only provides a huge opportunity, they also derisk the development program and the next clinical studies, making it much more likely that we see success in the future studies. We also, which hasn't been mentioned so far, were busy in the last year completing the characterization of a novel follow-up compound with improved characteristics, which can follow the pathway of varoglutamstat with a few years of delay. Finally, with those facts, we want to point out that our values and the way we operate is based on strong scientific foundation. In the year after we saw the first kidney data, until today, we provided a huge amount of scientific, intellectual, and also organizational evidence and competence to move the product to chronic kidney disease. And QPTC/L inhibitors are likely to become a cornerstone in chronic kidney disease, something which was not imaginable 12 months ago. We have a clearly defined commercial strategy. We have a large population with a huge unmet medical need. We have only limited competition in that space with a unique product profile, an oral simple administration, with a huge IP runway, and a very attractive time to market because we are a mid-stage clinical development company. There is not decades to come. There's a couple of years to get to the market, but it's not decades like in an early-stage company. And then, of course, we want to secure the value of the shareholders and the companies in our future pathway forward, moving the product now to patients with diabetic kidney disease and chronic kidney disease. For that, the part of that strategy to improve our financial situation was the conclusion of the SEPA agreement with Yorkville, which allows some additional flexibility if needed. We additionally, and don't misunderstand us, pursue additional financing and partnership opportunities that will be the cornerstone of the next months coming forward. And we, of course, in parallel, enhanced the management capabilities and breadth. With that, I want to also welcome personally Julia, looking forward to working with you. And not forgetting, of course, the team of Vivoryon who has carried forward that program in their brains and hands and hearts and bring the product where they are today. With that, I want to thank everybody for listening, and we're ready for Q&A. Thank you.

[Operator Instructions] And the first question comes from the line of Joseph Hedden from Rx Securities.

Congratulations on the IP and the new preclinical data. I guess I was just trying to dig in a little bit more onto any of the partnership discussions you may have been having recently. Maybe from the perspective of you've got this quite solid data in kidney disease now. You've compounded the preclinical package. The IP is important. You seem to be getting a lot of things in place. So I'm just wondering, is there anything else you see that a potential partner might be looking for that is still yet to come? Or do you now see yourself in a very solid position?

Well, we always commented that we can't comment on ongoing due diligence and discussions, and it's a principal policy. And also, I don't know what is in the brain of the people looking at our data. They may say something, they may think another thing. What I think we can say is that we have now, as you thankfully also mentioned, I think, a very solid case for any partnering and collaboration in the future because how usually things get looked at is by net present value and the net present value, so that the value which the compound has in the future for the commercialization period. And that depends largely on the market exclusivity of the compounds. And with the IP allowance letter, that period in the largest market in the world, of course, is much longer which, of course, increases the net present value in each calculation of a company looking into our portfolio. It gives us also a little bit more time to go to the market. So we are not so stressed whether we lose a year or not because the net present value still will be fantastic, and we have a very long market exclusivity. So for us, that is one of the homework we had to do, and we got very successful very fast, I have to say, and I want to thank the team for this outstanding effort and the result. We are much more confident that we can do something reasonable in terms of moving this forward into the clinic, to the patients, and into the market. And let's see how others see it because, of course, the partners is a partner decision and not our decision only, whether we do something with them or not.

And then perhaps just one on the equity line. So you talk about it providing you more strategic flexibility. Are there any obvious wins perhaps that you -- anything left that you can kind of get the Phase IIb trial in a better position for? What's the position with the manufacturing of the drug product? Can you remind us, is there anything left over from the VIVIAD and VIVA-MIND programs? Or are you needing to run a manufacturing campaign for the next trial? And is that perhaps something this [indiscernible] can help?

Thank you for the question. So we have drug product available for the study we have outlined in this presentation. So that is available and can be packaged and shipped. We don't need a new production campaign for this. Of course, if you do much, much larger studies, much, much longer studies, at a certain point in time, we need to restart production, no question. But for that study outline or for a small- to medium-sized study, we have material available. Yes, I don't know. Did I miss another part of your question or...

No, really, it was just on how might the equity line be used to get towards that Phase IIb trial?

The equity line was primarily not directed to financing the Phase IIb study. As you've seen, it's about a EUR 15 million max over 3 years. That doesn't help to finance the DKD study or any Phase IIb study, which we previously announced to cost probably around EUR 10 million alone. So when you do the numbers, it didn't help. But as you see, the markets have been really stable in the past couple of months. It's a little bit of turbulent environment, and we thought it is good to secure the operational basis of the company with that standby agreement in case we would need it. But the primary purpose is not to use this to largely or finance our future studies. For that, we need additional financing as laid out by Anne, or alternative partnership. And that's now on the to-do list for the next period.

Now we're going to take our next question. And the question comes from the line of Sushila Hernandez from Van Lanschot Kempen.

This is [ Sam ] calling for Sushila. There are 3 from our side, if we may. And the first one is, if you could remind us how much funding you would need for the Phase IIb trial in DKD. And on the financing agreement with Yorkville. Has Yorkville already requested a tranche? And on the meta-analysis to be presented at the ERA in June, is there anything new compared to the data disclosed in January this year?

So I'll start with the last one, I’ll leave the Yorkville one. The meta-analysis was submitted and based on the data we have presented. But, of course, the scientific presentation will always add a little bit of color here and there. It is not the same, let's say, high-level presentation as we usually do for investors. The scientific presentation goes always more into details and more into science. And the purpose here is clearly to get feedback and get into interaction with the scientific and clinical community with our drug. So that is not totally new data because the meta-analysis, of course, done. And it's also -- the data are submitted in the abstract submission. So the data won't change. But, of course, the granularity and scientific rigor in the way we present will be different. Regarding the clinical study, we have in this presentation, and we portrayed before, we have settled as a reasonable potential size of the study around 90 patients to be randomized and to be treated for about 30 weeks based on the meta-analysis and the current knowledge and also with the SGLT2 data. And we have always said it's about EUR 10 million to EUR 12 million cost for the study, and that didn't change either. And then I leave the middle question of Yorkville and the requesting of tranches to Anne to put that in a...

So just to make sure we have the same understanding. We actually -- Vivoryon actually submits a request for the tranche. So we can actually proactively do -- we would proactively do that. And no, we have not yet issued a tranche under the facility. I hope that addresses your question.

So for us, it's important that we get the message across. It is a management security safety belt we have put with Yorkville into place. And we steer it and not -- this is not an automatic trading system, which you have with some other providers, where shares get dumped [ regularly ] in the market. That's not our purpose. We will let use consciously, if needed, very carefully in bridging or special situations. For us, important to have it in place because it's a little bit of lifeline if needed, but that's not our primary financing strategy to make it very clear.

Dear speakers, there are no further questions. I would now like to hand the conference over to the management team for any closing remarks.

Thank you for listening and joining us in this year of birth of the chronic kidney disease program. And I think the baby is born, it's alive, it's kicking, and we want to keep it healthy and growing in the next years, and yes, make the program a successful program and with the objective to help these patients who have progressive kidney disease and no other treatments available. That's what we want to achieve and hope you join us in that effort. Thank you.

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.