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

Dear, ladies and gentlemen, welcome to the conference call of Vivoryon Therapeutics N.V. At our customer's request, this conference call will be recorded. [Operator Instructions] May I now hand your call over to Manuela, who will start today's conference. Please go ahead.

Thank you, Cheryl. Good afternoon, and thank you for joining us today for Vivoryon's conference call to discuss the company's full year 2021 results and operational progress. This morning, Vivoryon issued a press release, which is posted on the company's website at www.vivoryon.com. On the call with me today are Ulrich Dauer, Chief Executive Officer of Vivoryon; and Florian Schmid, our Chief Financial Officer. Also with us on today's call and available for questions is Michael Schaeffer, our Chief Business Officer. We will begin today's call with opening remarks from Ulrich on Vivoryon's approach to overcoming the challenges of Alzheimer's disease drug development and our progress for 2021, and then Florian will review the financial results. Following the prepared remarks, we host a Q&A session. Before we start, I would like to remind you during this conference call, we will present and discuss certain forward-looking statements concerning the development of Vivoryon Therapeutics' core technologies, the progress of its current research and development programs and the initiation of additional programs. 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 the date hereof. With that, I will now turn the call over to Uli.

Thanks, Manuela. Good afternoon, everyone, and thank you for being here with us today. 2021 was an important year for all those people around the world whose lives are affected by the devastating reality of Alzheimer's disease and dementia, currently, without a chance of being cured. 2021 saw the U.S. approval of aducanumab as the first potentially disease-modifying treatment for Alzheimer's disease. While aducanumab is currently not broadly available to patients outside of the clinical study setting, this approval after nearly 20 years of disappointments in the space was an important signal to the community and the markets. Nevertheless, uncertainties remain around the potential regulatory path to approval for other Abeta-antibody-based approaches. An extremely high unmet medical need remains for safe, effective and widely available treatment options. We, at Vivoryon, have an important message to all those waiting. We are fully committed to making a real difference to all of you affected by this merciless disease. Our approach to treating Alzheimer's disease is very different from antibody-based approaches and from those that focus solely on the amyloid aspect of the disease. I'd like to briefly share with you why this is the case and why we believe that this will allow us to become an important part of the solution to end the Alzheimer's crisis. At Vivoryon, we specialize in developing medicines to block the misguided activity of certain enzymes that either cause diseases or allow them to progress. Our most advanced medicine in development, varoglutamstat, is a differentiated shaded small molecule designed to overcome challenges of Alzheimer's drug development. Varoglutamstat is in clinical Phase IIb development, and it has a unique dual mode of action that is truly differentiated from other approaches in clinical development, which is shown in the graphic on the right-hand side here. Firstly, as you can see in pink on the left, varoglutamstat blocks the enzyme glutaminyl cyclase, or QPCT for short, and this prevents formation of neurotoxic N3pE amyloid, a toxic Abeta variant shown to play a pivotal role in the development and progression of Alzheimer's disease. Importantly, this happens way upstream of other approaches, which means that varoglutamstat can also have an impact on other downstream pathologies such as tau pathology, neuroinflammation and synaptic impairment. There's a second important pathway on which varoglutamstat acts, which is shown here in right in dark purple. Here the isoform or variation of glutaminyl cyclase, or QPCTL, up-regulates or boosts the proinflammatory signaling molecule CCL2 by turning it into pE-CCL2.So by blocking QPCTL, we are able to reduce neuroinflammation. Moreover, CCL2 is also a promoter of the tau pathology, meaning that we can also address this pathology via both elements of varoglutamstat's mode of action. So varoglutamstat is modulating all important pathological hallmarks of Alzheimer's disease, Abeta pathology, neuroinflammation, tau pathology, and therefore, can protect synaptic function. What I want to stress here is that varoglutamstat is the first small molecule, and to our knowledge, the only project in clinical development selectively targeting the de novo production of neurotoxic N3pE amyloid. We've carefully designed our development program with a clear regulatory path in mind towards bringing it to patients in need as soon as possible. With antibody-based therapies in Alzheimer's disease, safety of the patients is one of the main concerns. We've already characterized varoglutamstat broadly and our development strategy is rooted in promising Phase I and Phase IIa results, where varoglutamstat was well tolerated and showed statistically significant changes in working memory after only 3 months of treatment in patients suffering from Alzheimer's disease. Another important benefit of our approach is that, while many drugs in development in Alzheimer's disease are antibodies that have to be injected or infused, we focus on small molecule medicines, so varoglutamstat can be very conveniently administered as an oral pill. Our research and development efforts are protected by a strong IP estate with potential market exclusivities beyond 2035. 2021 was a truly outstanding year for Vivoryon, marked by a number of hugely important achievements in the clinical development of varoglutamstat. Despite the pandemic-related challenges, we have met the recruitment objectives for our European Phase IIb VIVIAD studies and initiated our Phase IIa/b study, VIVA-MIND, in the U.S. as planned. Clinical development in the U.S. is further supported by the fast track designation the FDA has granted for varoglutamstat last December. In addition, the regulatory achievements for our Chinese partner, Simcere, enabling near-term clinical development in China, broadens the tremendous opportunity we have to make varoglutamstat available to as many patients as possible. It's, of course, crucial that we have enough varoglutamstat for these activities. So in 2021, we've expanded our manufacturing capabilities for API production to ensure sustainable steady drug supply for ongoing and future studies. This also increases our flexibility to react to global challenges such as the ongoing pandemic. Further substantiating the rationale for evaluating varoglutamstat in combination with monoclonal antibodies to treat Alzheimer's disease, in October 2021, our team, together with our collaboration partners, published data providing strong preclinical evidence that treatment with a combination of varoglutamstat and our N3pE amyloid-specific antibody, PBD-C06, has an additive effect on reducing brain Abeta pathology in transgenic mice. The data published in the International Journal of Molecular Sciences support the hypothesis of a potential benefit of a combination therapy that simultaneously targets 2 different and independent molecular pathways, namely reducing N3pE amyloid production by QPCT and QPCTL inhibition and clearing existing Abeta deposits through anti-N3pE immunotherapy. While we are currently focusing on developing varoglutamstat as a monotherapy, we see great potential in further investigating this approach in the future. In terms of additional opportunities for clinical investigating varoglutamstat, I'd also like to briefly point to our recent regional strategic licensing deal in China with Simcere, which was one of the corporate development highlights last year. Simcere has acquired a license to develop and commercialize varoglutamstat in China and an option to do the same for our antibody PBD-C06. We are excited about this because we believe that Simcere is the ideal partner for us to access many Alzheimer's disease patients in China as possible being able to benefit from our medications as soon as they are successfully developed. Commercially, we've agreed on combined upfront and future milestone-based payments of up to USD 565 million, plus double-digit royalties on sales. On the management side, I'd like to highlight that we have strengthened our team with the addition of Florian Schmid as Chief Financial Officer as of April 2021. And I'm happy to share that we plan to expand and diversify our nonexecutive Board this year, and I look forward to introducing 2 outstanding candidates to you soon, whom we intend to propose for nomination at our Annual General Meeting. Through 2021, we've significantly expanded our patent portfolio with a total of 55 additional patents granted for our small molecule inhibitors and antibody-based medicines in development to treat Alzheimer's disease and other diseases with exceptionally high medical needs. And earlier this month, despite the current market conditions, we were able to successfully raise EUR 21 million in a private placement. This will enable us to reach a number of key milestones and inflection points we are looking towards in the remainder of this year, which we believe will further substantiate the potential of varoglutamstat in Alzheimer's disease. In the context of our capital raise supported by a number of high-quality institutional investors from Europe and the U.S. as well as executive and nonexecutive members of our own Board, we are extremely grateful to these investors and to all of our shareholders for their continued support. On the banking side, we'd like to acknowledge Hauck Aufhauser Investment Banking, who acted as sole bookrunner for this successful transaction. We are following a diligently design development strategy without cutting corners. We've completed preclinical work, shown here on the left in pink, building the foundation for our development by showing the effect of QPCTL blocking on cognition in well-known Alzheimer's disease mouse model. In Phase I completed clinical trial in 205 healthy volunteers here in yellow, we've shown that varoglutamstat is well tolerated, and we also got important information on dose response and target occupancy. We are extremely pleased with the progress of the development activities in China, led by our partner Simcere, which are planned to add important data to the profile of varoglutamstat from a Phase I trial expected to start within the first half of this year. Our first trial for patients with Alzheimer's disease, the Phase IIa SAPHIR study, shown here in dark purple, not only met the primary objective of obtaining important safety information, but we were also able to show first evidence of the disease-modifying activity of varoglutamstat, most importantly, with statistically significant changes from baseline in working memory as an important cognitive ability after only 12 weeks of treatment. These Phase IIa results guided the design of our ongoing European Phase IIb study VIVIAD. And as mentioned before, we are enrolling patients into our U.S. Phase IIa/b study, VIVA-MIND, which is intended to complement the results of VIVIAD. Both trials are designed to align with the draft FDA guideline, which supported the more frequent interactions we can benefit from, due to our fast track designation, may provide further regulatory opportunities such as breakthrough designation and accelerated approval. This is, of course, contingent on the outcome of our studies and also the relevant criteria in this context has to be fulfilled. Before we move to the financials, I want to provide an overview of the upcoming clinical milestones for the remainder of 2022 and the first half of '23. For VIVIAD, we are on track for a very important data point, which is the interim safety analysis planned for mid of 2022, where we will obtain key safety and tolerability data. And based on at least 90 patients treated with varoglutamstat for 24 weeks or more, the independent data safety monitoring board will select the final dose. We can then move forward with for the remainder of the study, gearing up to final readout in the second half of 2023. As mentioned before, VIVIAD is well on track with 22 active sites in 5 countries, and I'm truly grateful to everyone involved in the study for their outstanding efforts to meet the challenges all clinical studies around the world have faced over the past 2 years. And the same goals for VIVA-MIND, the U.S. study we initiated in September last year, which is run by the ADCS and supported by an NIH grant. Despite the pandemic and also weather-related challenges in the U.S. during the winter, the study is open with 11 active sites and randomizing and treating patients in the ongoing Phase IIa part of the study. VIVA-MIND is on track for interim futility analysis in the first half of 2023. If predefined criteria are fulfilled in this analysis, the trial will pass a stage gate into the Phase IIb part. As mentioned, additional milestones we look forward to are expected from our partner, Simcere's investigation of clinical development for varoglutamstat in Greater China in the first half of this year. So in summary, we are looking at several key milestones in 2022 and '23, and our overall data set is intended to support a clear path to approval for varoglutamstat. And with that, I'd like to hand over to Florian to review our financial results. Florian?

Thank you, Uli. And I will start with some KPIs from the P&L statement. So in 2021, we have disclosed a gross profit of EUR 9.2 million. This figure is the result of revenue from our licensing deal for the region Greater China. We have signed this deal in June with our partner Simcere. Our revenues include licensing issue fees of USD 8.8 million and USD 4.0 million for the first milestone related to the start of the first clinical trial in China. In our cost of sales, we have included 10% Chinese withholding tax and an intermediary fee. Due to technical requirements of IAS 12 and our receivables from the licensing deal, we had to report expenses from the recognition of deferred tax liabilities for the first time this year. However, we expect that this position will be significantly reduced or completely reversed over the next 12 months, leading to identical tax income. For the rest of our operations, we report cost increases in both R&D and G&A compared to past -- to the previous year. The additional expenses of EUR 4.2 million in R&D are mainly attributable to 3 areas: manufacturing with EUR 2.3 million, preclinical activities with EUR 1 million and share-based payment expense with another EUR 800,000. We have expanded our API manufacturing capabilities by initiating a second line of manufacturing with an additional partner to ensure sustainable study drug supply for VIVA-MIND beyond the ongoing Phase IIa. Compared to 2020, we had more preclinical activities with regards to Meprin technology that we have acquired in 2020 and also in the area of backup profiling. A cost increase of EUR 800,000 for share-based payment results from a grant issued in December 2020. An identical grant and the same cost increase was also reported in G&A. The remaining cost increase in G&A is mainly due to increased legal, consulting and audit expenses of EUR 1.7 million, which basically relates to our preparation for a secondary listing on NASDAQ. In this context, we also have capitalized EUR 1.8 million capital raising costs. This brings us to our overall net loss for the period of EUR 12.7 million, which was EUR 3.9 million lower than last year. On this slide here, let me highlight some items from the statement of cash flows, and thus, also our cash position. Our operating cash flow was EUR 2.8 million better than in 2020, although our operating spend was higher than in 2020. The reason for that lies in the licensing payments that we received in 2021. The investing cash flow was EUR 0.6 million lower than in 2020 because we acquired Meprin licenses in 2020 for approximately EUR 0.6 million. Our financing cash flow shows an inflow of EUR 1.1 million from the exercise of 75,000 share options. This was compensated by capitalized capital raising costs of EUR 1.8 million. These developments and also FX effects on cash and cash equivalents, leads to our cash position of EUR 14.7 million at the end of 2021. As outlined in our annual report, we have increased our liquid funds with a capital increase on April 1 this year. Following this capital raise, our cash runway will last at least through May -- end of May 2023. This guidance does not include potential for the milestone payments from development partnerships or licensing agreements as far as such milestone payments have not yet been recognized in revenue. It also does not include any additional financing measures. And with that financial overview, I will now turn back to Uli for a brief concluding remark.

Yes. Thanks, everyone, for joining us today. I'd like to conclude by emphasizing that we are laser focused on progressing varoglutamstat through clinical development in Alzheimer's disease. The time is now, and we are extremely encouraged by our progress in 2021 and the first month of this year and excited for all that lies ahead for the remainder of 2022. With varoglutamstat, an oral agent with the encouraging results already available to date, especially the effects on memory and synaptic function, we believe that we are on the right track to deliver a treatment to patients that can change their lives. And thanks again to our shareholders, many of which have been following our progress for many years now, for their continued support, and welcome to all new shareholders. We look forward to keeping you all updated on our progress, and we will now open the call to take questions. Thank you. Cheryl, can you please open the session?

[Operator Instructions] Our first question comes from Joseph Hedden from Rx Securities.

Congrats on the recent fund raise. Just one on the Simcere's deal, please, or a couple. Is the Phase -- do you know if the Phase I trial with Simcere you're intending to initiate is in healthy volunteers or in Alzheimer's patients? And then has the company said anything about the expected regulatory pathway in China? I note that recently Eisai have said that as far as Lecanemab development goes, they're including 100 patients into the ongoing pivotal trial there, the global pivotal trial that's expected to fulfill a Chinese approval.

Unfortunately, we haven't got the first part of your question, acoustically. In terms of the regulatory path. So what currently is on the agenda is a Phase I trial just to make sure that we can kind of reconfirm the pharmacokinetic profile of the compound in -- yes, in the Chinese ethnia, so to speak. So that's going to be the first step. And Simcere has guided for the start of this Phase I trial in the first half of this year. So the communication with the authorities, to our understanding, is still ongoing. And further to the announcement of the Phase I trial, we can't give any further information at this point in time. So Joseph, may I ask you to repeat the first part of the question again?

Yes. Sorry. So the first part was, is the -- do you know if the Phase I trial is in healthy volunteers? Or is it in Alzheimer's patients?

It's in healthy volunteers. It's a classical Phase I trial in healthy volunteers, not in patients.

Okay. Great. And then if I could just ask one on the finances in regards to Simcere. The accounting treatment of that first expected milestone, could you just confirm the accounting treatment? I think that you've already booked as a revenue last year because you're reasonably assured that you would achieve the milestone. So is it are we purely expecting the cash to come in when the trial starts? Or is there something else?

Yes. I mean from our financial report, you can see that we've already recognized approximately EUR 11 million in revenue from an overall potential of approximately USD 565 million. And we certainly will continue to report on further revenue from this partnership once recognized. But at this point and in agreement with our partner Simcere, we can't provide a further breakdown of the milestones and associated payments.

Okay. But just to confirm. On the cash runway guidance, you stated that obviously that doesn't include further milestones that you might achieve, but it does include the first Phase I entry milestone.

It does. Yes.

Our next question comes from [ Mark Kosanik ].

Well, actually, my question was already addressed by Joseph. I wanted to ask if you could give us a little flavor of what we could expect in percentage as your partner, Simcere, is obviously going ahead very fast in their efforts. If you could give us a little flavor in percentage, how much we could expect within the next 12 months and how much is rather back-end loaded?

I mean, again -- and I think we've also indicated that in the answer to the question of Joseph. I mean, as far as the regulatory path forward in China, a couple of things are still in flux, so to speak. It's really difficult for us to be more precise on what I have stated already. Again, we've recognized currently -- or in '21, EUR 11 million. We have an overall potential of USD 565 million. And it's part -- or it's the nature of these deals that the more substantial the downstream milestones get, the more substantial the payments will be. That's all I can comment at this particular point in time.

Our next question comes from Chris Redhead from goetzpartners.

Yes. Just a quick comment on the trial in terms of what's going on with the other guys and in the space. Lilly, for instance, they've sort of slowed their development in the sense of having to go into a full Phase III. So they sort of abandoned the accelerated development. So in principle, you could leapfrog those products or at least your program could -- you could get an approval at the same time or even before they do. Is that the case?

First of all, I think that the change in the approval strategy of donanemab is due to the CMS decision. So the reimbursement authorities in the U.S., which kind of have said that they obviously are not prepared for a full reimbursement of antibodies -- Abeta antibodies on the basis of their plaque removing potential. So they kind of obviously try to avoid what has happened to aducanumab. Now we have designed our development strategy in a way which is aligned with the draft guideline of the FDA, but is not necessarily jumping on this surrogate of plaque removing potential. So we see really a couple of other options, which we believe are closer to functional and cognitive improvement. As to when our drug can be approved, at this point in time a bit too premature. So we understand that Lilly will come up with the complete Phase III data set in the next year and whatever that would mean then for the approval time line. But it's really difficult for us to comment on how we would fit into this time line.

Yes. But basically, you -- potentially you could have caught up in a way that you wouldn't maybe have anticipated before they made that decision to not go through accelerated approval, right? So it's a -- it is -- it must be an advantage for you guys that they've accelerated to the Phase III.

Yes. I mean, generally speaking, what we've seen over the past months is obviously the kind of challenges that the Abeta antibodies are still having and the kind of medical need that this creates, which we believe we can ideally meet with our approach and especially with varoglutamstat in terms of safety, but also with respect to efficacy.

Yes. So you basically get -- your time line for approval is much more similar potentially than it was. And equally, the data that you've got already with the antibody -- the studies that you've been doing suggest that the trial -- even though the other products may be around, that you can use them in conjunction, in combination with those products and make them more safe potentially by reducing the dose? Is that -- that's case, isn't it?

Yes. Absolutely. And this is what our preclinical data, which I've mentioned, is pointing to. So we are obviously able to significantly reduce the amount of the therapeutic antibodies in combination with varoglutamstat, but still preserving the plaque removing potential. And this could be a way to manage one of the main limitation of those antibodies, which is the ARIA side effects, which is clearly dose-dependent. Absolutely, right. I mean, as to the approval, just let me emphasize that we believe what it needs at minimum is the completion of both trials which we're currently running, the European trial and the U.S. trial, including the Phase IIb arm. So that is what is required in our view. And since we have not guided as to when the Phase IIb data may be available, it's really hard for us to assess on a particular point in time.

No, no, I appreciate that. The other -- yes, just a quick -- another question to clarify on the licensing of the other programs, the non-AD programs. Do you see any prospects of licensing deals on those? Or are you not going to be drawn on that?

I mean with our team's expertise and our technology platform and our compounds in development, we know that we have really strong assets that have great potential beyond Alzheimer's disease, including in oncology. And both in-house and through preclinical partnerships and licensing, we've generated, I believe, encouraging, very encouraging data. So we know that we have huge potential on this front. And we will make a conscious decision as to the specific assets we are open to partner. And of course, the stage in development at which we feel such partnering could have the biggest value for Vivoryon and its stakeholders. And you know we are a lean organization. So it's crucial for us to really allocate our resources in the most efficient way possible. And for the time being, this is clearly the clinical development of our lead candidate, varoglutamstat, in Alzheimer's disease. And with what has happened in the space over the last 12 months, it's clear that the time is now to leverage the full potential here. So we will be focusing exclusively on this for the time being. But obviously, we will continue to be opportunistically evaluating opportunities for other indications, also oncology, in which our approach has great potential. But again, now we are laser focused on progressing our clinical development with varoglutamstat.

We have a follow-up question from [ Mark Kosanik ].

Regarding oncology, my question would be how potentially could the safety readout that we are expecting mid of this year also be a positive trigger as it seems there has been safety issues, especially around this oncology deals that we have seen. Could this also be a trigger for you to be successful in signing an oncology deal when safety data is supportive?

I mean, of course. I mean, any data that adds to the profile of varoglutamstat or in this case to our QPCTL inhibitors in general is of advantage. But having said that, please bear in mind that the safety issue, you're obviously referring to, in the Gilead trials was due to a combination of a immune modulator with another drug. And it is not clear what really caused this side effect. And the other point I have to make clear is that we are talking generally about QPCTL inhibitors, so not necessarily only focusing on varoglutamstat or PQ912. But again, any data point that adds to the profile of our QPCT and QPCTL inhibitors may be supportive here.

Could you maybe let us know is there any expected time when we will know whether it was the mode of action or the antibodies themselves that caused the problem?

So we are not -- we do not have any particular insight here. So we are dependent on public information here. And as far as we know, it's still pending.

And our next question comes from Alexander Galitsa.

I apologize if that has been asked already. I only joined later. Regarding Simcere, can you remind us how long will it -- I understand that they have started Phase I trial. Can you remind us how long will it take them to complete this trial? And then the second question is whether they will be able to go right after into Phase II trial?

To be clear, we haven't started yet with the Phase I trial in China. So the guidance is that we expect to start in the first half of this year. It's going to be a trial with 40 patients and -- yes. Allow me to hand over to Mick for going into the specifics.

So -- I mean, we are in constant discussions with Simcere. And that's what I can confirm, that this runs all very collaborative here. But it's all moving targets a bit. So that's why -- so the -- it is currently the plan that this Phase I trial -- and again, this would be healthy volunteers that would be around 60 individuals, also placebo-controlled. So very state-of-the-art standard kind of Phase I trial. But what I can comment is that, of course, it's not like you usually plan, like you do the Phase I, look at the outcome and then start to plan for the Phase II. So this all goes currently hand-in-hand. We are planning both. And I think it's fair to assume if anything runs as planned, that there will be sort of a seamless ongoing from a Phase I into a Phase II.

Okay. And then maybe to the extent you can actually answer with regards to milestones, what are the -- kind of what is the triggering event for the first milestone? Is it really meeting some end points of the trial? Or really it could be even the start of the trial. And if so, again, to the extent you can comment, when is the kind of first milestones scheduled Phase I, Phase II, Phase III?

Yes. I mean it's both really in general. And again -- I mean, we've reported that in our financial report that we already recognized approximately EUR 11 million out of the overall potential of USD 565 million. And yes, the only thing I can repeat here is we will continue to report on further revenues from this partnership once it's recognized. But again, in agreement with our partner, with Simcere here, we are not able to provide a further breakdown of the milestones and payments.

Fair enough. And the EUR 11 million you referred to, that's the upfront payment, I presume, right? Or is it really...

Yes, basically, that -- yes, it's the upfront. Yes.

Okay. And then I have another question on sort of enrolled -- patient enrollment. We've seen that some other companies are struggling to enroll patients for their drugs, even the ones that run Phase III trials from smaller developers. Could you maybe provide some context or color how your Phase IIb trial has been enrolling patients in Europe and maybe also with regards to Phase IIa in the U.S? How does that look?

Yes. So that's Michael. That's certainly a very, yes, important question you bring up here. In that times -- we are now in a pandemic situation. For some companies that have looked maybe into Eastern countries, Ukraine situation and so on. So that's certainly a big topic now for many companies which run trials. And I would say in many points here, our strategy to mitigate risk a bit and diversify pays out a lot, actually. So the recruiting into the VIVIA trial goes as planned, let's say. So we -- as we have guided, we are along the time lines. And so the -- well, I can give you some closer background even here. So I think we are very close to the sites we are working with and try to support them also in any way we can. And one important point -- actually, for example, to just give you a small point, which pays out big maybe in the end. Well, I'll do it differently. So actually today is my fifty-fourth birthday. And so there are actually many people globally which are around that age, like many of you on the call. And they are indeed affected by Alzheimer's disease in that age. And actually, our VIVIA trial is one of the very rare trials currently that also allows people from 50 years age onwards into the trial. So there's kind of an unfortunate trend actually in the Alzheimer's world to rather go to elder populations. But again, also younger people are affected. So this is one small point which probably also helps us to stay very much aligned with the recruiting at the moment. You want to know for the VIVA-MIND as well?

Absolutely. Yes.

So that's also, yes, ongoing very smoothly. So we have the first patients in the study. And we are continuously opening sites here. So we have already a number of very known sites open and recruiting. So like the Banner Institute in Arizona, for example, which is again also a country where many elderly population is present. So we are kind of, yes, very much on track here also to be in the framework we have guided at this point of time.

Thank you. And presenters, at this time, I show no further questions in queue.

Okay. So once again, thank you very much for participating in our earnings call today. We highly appreciate your attention and questions. Have a nice day, everyone, and bye-bye.

Ladies and gentlemen, thank you for your participation. You may now disconnect.