Ladies and gentlemen, thank you for standing by. Welcome and thank you for joining the Vivoryon Therapeutics Q3 Results 2022 conference call. Throughout today's recorded presentation, all participants will be in a listen-only mode. The presentation will be followed by a question-and-answer session. If you would like to ask a question, you may press star followed by one on your touchtone telephone. Please press the star key followed by zero for operator assistance. I would now like to turn the conference over to Manuela. Please go ahead.
Thank you, Timo. Good afternoon, thank you for joining us today for Vivoryon's conference call to discuss the company's third quarter 2022 results and operational progress today. This morning, Vivoryon issued a press release reporting its third quarter 2022 results, 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, as well as Florian Schmid, our Chief Financial Officer, and Michael Schaeffer, our Chief Business Officer, who will be available for questions. We will begin today's call with opening remarks from Uli on Vivoryon's approach to overcoming the challenges of AD drug development, our strategic focus and progress, and a review of the financial results for the third quarter of 2022. Following the prepared remarks, we will hold 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 Therapeutics support technology, the progress of its current research and development program, 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 day hereof. With that, I will now turn the call over to Uli.
Thank you, Manuela. As we head into the end of the year, I would like to capture our progress from the last quarter and provide an update on our clinical development plans for varoglutamstat. As many of you know, the Alzheimer's disease landscape continues to be challenged by regulatory, safety, and efficacy hurdles. At Vivoryon, we are fully committed to making a meaningful difference to all of the people affected by this devastating disease. Our expertise in creating small molecule medications enables our in-depth understanding of pathological pathways has led us to develop the pipeline we have in place today, and we are incredibly proud of the advances we have made as we work hard to improve the lives of those who are affected by the disease.
By modulating the misguided activity of enzymes involved in disease onset and progression with small molecule inhibitors, we are able to disrupt the treatment landscape for indications where the unmet need remains incredibly high. Our approach to targeting Alzheimer's disease is very different from antibody-based approaches and from those that focus solely on the amyloid plaque-removing aspect of the disease. We are acutely focused and committed to making a difference for all patients affected by this disease. With a specialized approach, we feel that we are at the cutting edge of innovation within the landscape of consistent challenges. As a reminder, varoglutamstat blocks the activity of glutaminyl cyclases, QPCT and QPCTL. The inhibition of QPCT prevents formation of neurotoxic N3pE-Abeta, a toxic Abeta variant shown to display a pivotal role in the development and progression of Alzheimer's disease.
Importantly, this happens way upstream of other approaches. QPCTL fully activates the pro-inflammatory signaling molecule CCL2 by turning it into pE-CCL2. By blocking QPCTL activity, we are able to reduce neural inflammation. Both CCL2 and N3pE-Abeta are promoters of the downstream tau pathology, meaning that we can also address this pathology via both elements of varoglutamstat mode of action. The varoglutamstat is modulating all important pathological hallmarks of Alzheimer's disease, Abeta pathology, neural inflammation, tau pathology, and therefore can protect synaptic function. To our knowledge, varoglutamstat is the first small molecule and only program in clinical development selectively targeting the de novo production of neurotoxic N3pE-Abeta. The benefit of a small molecule in this disease setting continues to be evident as we observe strong safety results across both of our clinical trials for varoglutamstat.
VIVIAD, the phase II-B trial in Europe, and VIVA-MIND, the phase II-A/B trial in the U.S. We have thoughtfully designed our development program capturing regulatory parameters and specifications as we think about the late-stage advancement of varoglutamstat while factoring in recent developments within the Alzheimer's disease treatment landscape. Today we are announcing key updates to the development program for varoglutamstat, and we strongly believe that these changes put us on the optimal path For potential approval and ultimately addressing the unmet need that remains for patients with Alzheimer's disease. At the beginning of Q3, we reported data from VIVIAD showing that varoglutamstat is well tolerated at doses with high target inhibition.
Importantly, both the total number of SAEs and the discontinuation rate were considerably lower than the respective numbers at the 800 mg twice-daily varoglutamstat dose in our completed Phase II-A substance. By carefully designing VIVIAD based on earlier clinical results, we are able to achieve improved tolerability for varoglutamstat without significantly sacrificing target engagement. The highest dose investigated in VIVIAD, 600 mg twice daily or BID, selected as the final dose, it is important to understand how we can best leverage this information to improve design. Factoring in the highly encouraging safety data as well as the recent data report from both lecanemab and gantenerumab, including insight from parameters such as readout time points and treatment duration, we have selected to adapt our clinical status.
We've carefully crafted a well-defined clinical development strategy. We are pursuing a newly regulatory path to potential approval for varoglutamstat with option for surrogate markers reflecting patient benefit beyond the simple endpoint of plaque-removing potential. This entails a few new factors. We are looking at the combined results of both of our ongoing phase II studies to offer novel surrogate endpoints. For VIVIAD, we are looking at a composite evaluation of attention and working memory as primary endpoint. In VIVA-MIND, we have selected CDR sum of boxes, the known approval endpoint, as a complementary primary endpoint. As we are conducting clinical development in a field that has historically been characterized by a number of setbacks, we have ensured that both VIVIAD and VIVA-MIND studies have been set up as informed studies.
What we mean by this is that the design allows for a certain degree of flexibility to adapt to the overall therapeutic landscape evolving based on insights from our own and external data readouts. How did we arrive at these new changes? We've evaluated both our own studies and have taken key learnings from the results and challenges of our peers to determine the best path forward for varoglutamstat. We've identified what we believe are three critical success factors for an Alzheimer's disease drug. Firstly, patient recruitment and retention in the studies. Despite the COVID-19 pandemic, thanks to the careful design of VIVIAD and the close relationships we have built with the study sites, we have had zero COVID-related discontinuation.
Overall, the study discontinuation rates are very low, around 6% to date, with the study running over 2 years already, which makes us confident that VIVIAD will achieve the necessary statistical power. In addition to the above-mentioned factors, we believe that this is also attributable to the fact that as an oral drug, varoglutamstat requires less time in which participants are hospitalized during the study compared to antibodies, and that the study sites and personnel were extremely well trained to ensure comfort level and quality standards in managing the specific elements of the study, like for example, EEG or CSF data collection, which are not standard and therefore need to be established at every site.
Recruitment was comparatively slow in the first 12 months of the VIVIAD study. We are currently seeing a similar pattern with recruitment into VIVA-MIND being slower than anticipated over the last week, coinciding with ramp up and training at the study sites, in particular, in the context of frequent staffing shortages and personnel fluctuation in clinical study sites across the U.S. As it is our intention to allow for the highest possible degree of flexibility to the VIVA-MIND study, in addition to the primary endpoints, the design includes data collection for a large number of analytics, cognitive measurements and secondary endpoints, which in turn makes the study more complex in its initial stages. This poses an extra burden in times where the staffing situation at many sites in the U.S. is compromised. Secondly, endpoint selection.
Looking at endpoints in Alzheimer's studies, the question is always, what does therapeutic success look like in terms of memory, which is why we are evaluating a composite memory endpoint as well as individual cognitive endpoints. The second element of relevance when looking for potential approval endpoints is the question of how the quality of life of patients improves, which is why we have selected a functional endpoint that is, to our knowledge, the most sensitive and meaningful in enabling us to assess real-life improvements. In addition, by employing EEG, we have added an endpoint which is not subjectively assessed by study doctors or personnel, but is an objective assessment of parameters described to correlate with cognitive decline in Alzheimer's disease. We are also adding sophisticated analysis of neuronal networks to contribute to the overall understanding. Finally, balance between safety and efficacy.
600 mg twice daily has been selected as final dose and have been reached in VIVIAD by slow up-titration from 50 mg once daily to 600 mg twice daily or BID over the course of 12 weeks. The most important learning from VIVA-MIND in its initial stage is to understand if 600 mg BID can also be safely administered when following a more aggressive uptitration regime, starting at 150 mg BID and going to 300 mg BID and up to 600 mg BID over the course of only 8 weeks. Such a quicker uptitration regime would fit better into clinical routine as compared to the slower regime we've been using in the VIVIAD trial. Turning now to more specific updates for each trial.
For VIVA-MIND, more than half of the 600 mg BID cohort has been treated with varoglutamstat with no adverse events of special interest observed to date. Based on the encouraging safety data, we have decided to treat all 180 patients in their trial for at least 72 weeks. With this adjustment, we are shifting focus of the study to better prepare for potential transformation into a phase III study in the event that this would be required for Accelerated Approval. We have high degree of confidence to move forward with the 600 mg BID initial dose, and we look forward to observing longer term follow-up for all patients up to 72 weeks. This change enables all patients in the phase II portion of the study to receive longer treatment than the originally planned 24 weeks.
On this basis, we expect to have key data in hand to make even more informed decisions about next steps for the program, as well as having a more informed trial by taking into account learning from VIVIAD as our European study progresses through its final stages. To summarize, all 180 patients included in the phase A portion of VIVA-MIND will now be treated for 72 weeks to increase quality and robustness of data and allowing the seamless transfer into potential confirmatory phase III study. This prudent adaptation is designed to increase the probability of success of the VIVA-MIND study for potential approval. Consequently, we are no longer guiding thoughts on interim utility analysis and stages for a stage gate decision. We intend to provide a status update on the study in the first quarter of 2023. Now regarding VIVIAD.
As a reminder, this is a state-of-the-art phase II-B study conducted in Europe and designed to evaluate the safety, tolerability, and efficacy of varoglutamstat in subjects with mild cognitive impairment and mild Alzheimer's disease. We are very happy to report that we have completed recruitment into the study as planned. VIVIAD is now fully enrolled with a total of 259 patients. We've designed this trial with study protocol flexibility to optimize treatment duration. As Alzheimer's disease is a slow-progressing disease, longer treatment duration is expected to help data quality and facilitate observation of treatment effects. We are now aiming to allow all randomized patients who have not completed 96 weeks of treatment to have their last visit up to year-end 2023, as opposed to stopping all data collection to the last patient 48 weeks visit, estimated for October 2023.
This step will allow us to collect additional data, improve overall data quality, and increase the average treatment duration for patients. This means that over 100 patients will be treated for 96 weeks, and over 200 patients will be treated for at least 72 weeks to the mean treatment duration of approximately 82 weeks. All of these are estimates based on the current discontinuation rate, which as mentioned, are particularly low at only 6% in VIVIAD. It is important to note that this will be among the longest treatment durations for such a comprehensive study in the Alzheimer's disease field, and we are excited to be at the forefront of this effort.
In addition to the final follow up visit in the second half of 2023 we had previously guided to, we now expect reporting of full data, including additional follow-up data in the first quarter of 2024. I'd like to note that to date, we continue to be incredibly encouraged by the results observed from varoglutamstat thus far, as it was well tolerated in our phase I clinical study, and we've gained important information on dose response and target occupancy. As mentioned before, our first trial for patients with Alzheimer's disease, the phase II-A VIVA-MIND study, met not only 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 3 months of treatment.
Both our VIVA-MIND US and VIVIAD EU studies are designed to align with the draft FDA guideline, which, supported by 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, provided all further relevant criteria in the context of our studies and their outcomes are fulfilled. In summary, our overall data set is intended to support a clear path to approval for varoglutamstat, and we strongly believe that the updates to its development plan that we've announced today further support this path. We look forward to providing further updates on our progress. I would like to thank the patients, the families and caregivers and all supporting staff at our clinical study sites for both VIVIAD and VIVA-MIND, and with this enabling advancement of science in this very important field.
I would now like to give an overview of our financial results for the 9 months ending September 30, 2022. The company did not generate any revenues in the 9 months ending September 30, 2022, whereas in the first 9 months of 2021, revenues amounted to EUR 10.8 million, deriving from a strategic regional licensing partnership in China. From January to September 2022, our research and development expenses added up to EUR 16.1 million compared to EUR 13.6 million in the first 9 months of 2021. This increase was mainly driven by EUR 1.9 million higher expenses related to our advancing clinical trial VIVIAD.
General and administrative expenses totaled to EUR 4.2 million, an increase of EUR 1.0 million compared to the nine months ended September 30, 2021, mainly resulting from higher expenses for share-based payments following new share option grants in 2022. Net loss for the period ended September 30, 2021 amounted to EUR 80.9 million compared to EUR 7.3 million for the same period, 2021. The company has EUR 19.8 million in cash and cash equivalents as of September 30, 2021. Please note that the proceeds of the private placement entered into on September 30 are not yet included in this cash number. Total equity summed up to EUR 20.1 million on September 30, 2022, compared to EUR 16.6 million as of December 31, 2021.
With that, I would like to thank everyone for joining us today. We've already remained in a strong position as we head into the end of the year, and I would like to reiterate our enthusiasm around the new development changes for varoglutamstat announced today. We have a clear opportunity to address all pathological hallmarks of Alzheimer's disease by modulating QPCT and QPCTL activity. We are at a critical time in Alzheimer's disease research with multiple wins with setbacks occurring throughout the industry. Ultimately, our primary mission is to address the continued extreme unmet need for these patients and to meaningfully ameliorate the global Alzheimer's disease crisis. I would once again like to thank our shareholders, many of which have been following our progress for many years now, for their continued support, and welcome our 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, Timo.
Ladies and gentlemen, at this time, we will begin the question and answer session. Anyone who wishes to ask a question may press star followed by one on their touchtone telephone. If you wish to remove yourself from the question queue, you may press star followed by two. If you are using speaker equipment today, please lift the handset before making your selections. Anyone who has a question may press star followed by one at this time. One moment for the first question, please. The first question is from the line of Joseph Hedden with Rx Securities. Your question please.
Good afternoon. Thanks for taking my question. First one on VIVIAD. Could you just expand a little more, please, on the decision to essentially lengthen the trial? Is that from observations that you've been making in the literature? Is it KOL input? Is there something intrinsic about the trial design you weren't quite happy with? Just a little more on the rationale, please, would be great. Thanks.
Yeah. Thanks, Joseph. Welcome to the call, and thanks for the question. I think first and foremost, I mean, we're carefully observing what kind of peer data is appearing in the, you know, recent months. What we are particularly referring to is the observation that we see a meaningful separation between the development of placebo outcome parameters or clinical endpoints, and those with active drug separate at a later time point as the consensus expectation was. This is an observation we made with lecanemab in particular. That was one trigger point where we decided to use the flexibility of the study protocol to treat the patients longer as originally planned.
As you know, usually the last patient completing 48 weeks of treatment would have determined the treatment stop of all patients in the trial, and we have decided to alter that and let the patients continue treatment so that they can have their last visit still in the year 2023.
Okay, thanks very much, Uli. If I could have one on VIVA-MIND too. Obviously the design's changed a fair bit there, allowing potential to go into phase III. What should we expect at the Q1 update? Is there gonna be a decision at that point whether you know, instead of it becoming a phase II-B, go into phase III? I noticed that the wording in the press releases, phase III if required. Is there some kind of regulatory interaction happening soon where you're discussing the potential for an accelerated pathway? I'm not sure, you know, quite what the statement, if required, it means at this point.
Yeah. Also thank you for that question. I mean, first of all, what did we do in VIVA-MIND? We decided instead of having this stage gate decision after 24 weeks of treatment based on the first 180 patients, which would have led to treatment pauses, essentially, we decided to treat all 180 patients for 72 weeks. That was the first decision we took. As to your question, what are the, or what is our anticipation as for regulatory requirements? You might have followed that there's a discussion also led by lawmakers in the U.S. as to what should be the criteria for an Accelerated Approval.
Obviously, there was some kind of frustration about the fact that some companies have used the Accelerated Approval and to slow down their confirmatory phase III trials post-approval. There might be a situation where there is a requirement to have a decent enrollment already achieved in a phase III trial prior to an Accelerated Approval. That might be a situation that may arise. It's not decided yet, but in anticipation, we just thought it's prudent to kind of increase optionality for VIVA-MIND and have a seamless transition into phase III again, if it is necessary. As to, you know, what you can expect in, as an update in the first quarter, if we knew that, we have given that. We just have to be adaptive to the situation.
What we've made clear is we will further, we will give further guidance in the first quarter, as to our further plans with respect to VIVA-MIND.
Okay. Thanks, Uli. That's clear. Thanks very much.
The next question is from the line of Dominic Rose with Intron. Your question please.
Hi, this is Dominic from Intron Health. Thanks for taking my questions. I have two. My first question is, in your opinion, is there any read-through to Vivoryon from the gantenerumab readout? That applies to either varoglutamstat or to your antibody. Question two is, can you give us an update on your latest thinking on licensing varoglutamstat outside of China? I'm thinking not so much for the U.S. here, as well the rest of world regions. Thanks.
Yeah, thank you. Thank you, Dominic, for your questions. As far as gantenerumab is concerned, which clearly was another disappointment in the field. However, we are not at all discouraged by the outcome of gantenerumab. I think there's an important difference between gantenerumab and lecanemab. Lecanemab obviously is acting more upstream with respect to the aggregation cascade of Abeta. Lecanemab obviously is binding to soluble aggregates of Abeta, whereas gantenerumab is more downstream in this aggregation process and focusing on already established insoluble aggregates or plaque. In that respect, it's similar to aducanumab, and therefore, it's not necessarily a surprise to us that there was a different outcome in the gantenerumab trial versus lecanemab.
If there's a cross-reading, I would say, it's important to act upstream in the process, and we are even more upstream than lecanemab because we are preventing the formation of toxic elements in the, in the Abeta aggregates rather than removing them once they are established.
Thanks. That's very helpful. On the licensing.
Yeah, I mean, our thinking on licensing is that it's an important part of our strategy because the more downstream we are developing our programs, the less particular value we may be able to add. This is why partnering is, you know, a key priority in our business strategy. However, I think it's important for us to be able to achieve the important value inflection points in both of our trials, and we wanna make sure that we are able to do that. Yeah, I think in terms of the future of the program, it's gonna be very important to have the VBR data available.
I think we have tried to point out today that, we have a study here with very high integrity, with very low dropout rate, high compliance of the patients, and, we are quite sure that the data will speak for itself. Does that answer your question, Dominic?
Sorry. Yes, that's very helpful. Thank you.
Thank you.
Thank you.
The next question is from the line of Alexander Galitsa with Hauck & Aufhäuser. Your question please.
Yes, thank you. Can you hear me?
Yes, we do.
Okay, very good, because I wasn't sure. I was struggling with my microphone here. I just wanted to ask around the sort of value capturing possibilities in your key Alzheimer's assets. If maybe we'll start with varoglutamstat, could you broadly talk about kind of your strategy, how you see it around whether you would be looking to partner prior to the marketing authorization being received or would you be looking into doing that right after? That would be first one, and then I'll follow up.
Yeah. I mean, this is kind of similar answer to the last question. Again, I mean, partnering is an incredibly important element in our business strategy. Yeah, of course, we want to be positioned as well as possible with our trials, with our data. First and foremost, it's important to us to make sure that we are able to achieve the next or the potential value inflection points in our clinical trials. As the time point of when we are able or when we want to enter into a partnership, we're quite a kind of, you know, opportunistic and, of course, it also depends on the match of the economic potential of what we might be able to offer to the market.
Thank you. I continue with the N3pE antibody. What one can expect here, are you looking to partner it already now, or are you still planning to do some work internally before you will consider partnership? In connection to that, I think you mentioned earlier that you will be running another combination trials preclinically. If you could update us on that, whether they are undergoing and when can one expect any kind of readouts or results from those?
First of all, we are working on our antibody. We are expanding the base of data which we are able to show with respect to this antibody. In terms of combination which you were mentioning, we are much more focusing on varoglutamstat here because we believe that this is a very attractive additional opportunity to position this drug on top of a monotherapeutic setting, which is of course what we have in mind in the current development strategy. We believe given the safety profile and the combination data that's already available, that we have an additional attractive option or opportunity to position varoglutamstat also in a combination setting with the antibody.
For the, for the antibody and the partnering strategy, similar things apply as I, as I mentioned before. We are exposing ourselves here. We are opportunistic and, at the same time are, adding to the profile of this antibody.
Thank you. Then maybe briefly on the oncology opportunity. Right now you're basically in a situation where your focus is on Alzheimer's, and the organization does not necessarily have the bandwidth or funds to further develop the immune oncology franchise. Naturally, one would expect you to partner license the IP. I'm wondering sort of from today's standpoint, what is sort of the major roadblock, so to speak? Is there a lack of interest from the big pharma? Is that the IP is too early in its stage, or there's anything else?
Okay. Thank you, Alex, for this question. Understood. I mean first and foremost, and you've mentioned that we only have a limited operational and financial bandwidth, and currently we are laser focused on progressing varoglutamstat through clinical development as we explained today. Now having said that, what we have to acknowledge in the field, especially of CD47 SIRPα signaling, is that most of our peers have advanced clinical data. Of course, they are based on antibody approaches, but this is clinical data. It is obviously challenging to compare pre-clinical or research data with advanced clinical data.
In terms of strategy, what we are looking into is possibilities through partnerships or other measures to make sure we can progress this concept into clinical development and kind of backing our claims, which we have been making on pre-clinical basis, in clinical settings. I think that's the key to success. We are absolutely excited about the opportunity we have in hand here. We are continuing to make sure that we exploit the full potential of this asset.
Thank you. The last for me is regarding KKR, sort of engagement so far. Have you noticed their sort of activist angles since they have made the investment, or is it still too early to tell anything?
I mean, the activist angle sounds a little bit kind of negative to us, but what we can confirm is that they have broad network, and they have the preparedness to make this network available to us, and we are very excited about the collaboration with KKR. Of course, it's early days, but we already had very interesting interactions, which we will continue over the next, yeah, couple of weeks, and we are really excited about this new partnership.
Yeah. Thank you. That's the way I meant it, really leveraging their network.
Yeah.
which will help potentially
I thought so.
development. Not necessarily in a negative sense. Thank you.
Thank you, Alex.
Ladies and gentlemen, if you would like to ask any further questions, please press star followed by one at this time. The next question is from the line of Chris Redhead with goetzp artners. Your question please.
Hi, guys. just in terms of the... You know, you're extending the treatment time, right? For the trial. It... Because the data suggests, other data suggests from... That was from other antibody trials, right? That there's-
Right.
a greater divergence between drug and between, yeah, between control and drug in those trials. How big that, you know, how much that is? What is the kind of difference in magnitude of the divergence? Because clearly, you know, that's gonna be pretty significant. That could give you accelerated pre-approval, couldn't it? Because if you get a much larger effect in that, at that time point, you could get Accelerated Approval or indeed become a much more attractive licensing target. Could you sort of kind of give us a little bit more color on that?
Yeah, I mean, what we can't give you is a very, you know, a precise benchmark. What we have seen is obviously that the treatment duration is a critical success factor in Alzheimer's disease. You obviously know that there's also kind of discussion around speed of progression between different genetic settings, for example.
Mm-hmm.
We really wanna make sure that with the treatment, duration in this very important trial for us, we kind of exhaust the flexibility which we have, within the given, study protocol. This means, again, that we are expecting to have an average treatment duration in this trial of 82 weeks, which is substantially longer than most of the standards which are focusing on, 72 weeks data.
Okay. Okay. Fine. No, no, that's fine. Thanks.
The next question is from the line of Gilbert Gerber with Belsize Asset Management. Your question please.
Yes, good afternoon, Uli and everybody. I was just wondering, in fact, Joseph already touched on that question. I'd like to have a bit more color on that. It's about, you know, the transition to phase III. In terms of, you know, what would it look like in the first place? You know, have you been in, let's say, in interaction with the FDA about, you know, what these conditions would be? Would it be really realistic to, let's say, make a decision on that before you have the European trial data? That's this whole complex I'd like to have still a bit more explanations.
Gilbert, welcome on the call, and thanks for this question. I mean, again, as I stated before, what we have to deal with currently is the draft guideline situation. We cannot 100% be sure what will be the situation when we have the data available. What the amendment or what the alteration of the trial design of VIVAMIND is meant to, first of all, avoiding that we have treatment pauses in a slowly recruiting trial, which would have been a risk if we would have to assess all 180 patients at 24 weeks of treatment. Secondly, to increase optionality. In that we treat seamlessly all those 180 patients for 72 weeks, that can mean different things.
That can mean that we would be able to add additional patients while we treat those 180. That can mean that we adjust our statistical modeling once we have the read-out of VIVIAD available. That could mean that we extend the trial beyond the treatment of 24 weeks of the first 180 patients. All those options are possible, maybe even additional ones, but the goal really is to create optionality and especially to be able to have a more seamless transition from this phase II trial in a phase III trial, if regulatory environment is requiring that.
Okay, thank you. Maybe the second one, it's concerning the antibody, as you probably would have guessed. You know, it is as much a statement as it is a question. You know, Eli Lilly has leapfrogged their follow up antibody to donanemab. They must still have problems remembering remternetug from a phase I to a phase III. Yes, you know, from an investment point of view, it makes sense to focus everything on the small molecule. I always just wanted to, you know, for the record, make sure that all options are evaluated in order to, you know, bring that program, which in my opinion is the best in class, forward as soon as possible. That's about it.
Yeah. Thank you, Gilbert. really acknowledged. We are also happy with the kind of focus that Lilly is putting on N3pE-based approaches, which is also kind of a endorsement of our approaches. Both approaches, the small molecule one and the antibody one. I really acknowledge your statement, which we are perfectly sharing with you. I think it's a great asset and deserves to be developed.
Thank you.
Ladies and gentlemen, another reminder, if you would like to ask a question, please press star and one. The next question is from the line of Albrecht von Witzleben with von Witzleben Asset Management. Your question please.
Yeah, thank you. You haven't said anything on the China developments in your note this morning on Simcere. Could you update us on the preparation for phase I and maybe any likelihood of a 2023 payment or milestone payment?
I pass on this question, if you allow, to Michael Schaeffer.
Yeah. Hello. Yeah, we are certainly continuously in discussions with Simcere how to design and pursue the clinical development in China best. That's an ongoing process. You might be aware of the fact that we are in a phase where we are have changed a bit the plans in terms of where to put the study in terms of the phase II part. Do it in sort of a parallel extra cohort within the European trial, which we changed towards the U.S. trial, which just has the, you know, kind of approvable endpoint with the CDR sum of boxes. That makes, made certainly much more sense.
Since we are looking here into a little bit of flexibility how the U.S. trial is designed in the future, there's certainly just, you know, room for, or need for discussions and for being flexible. We cannot at the moment guide to any, you know, time point where Simcere, because it's a complete decision of Simcere to kind of start the clinical phase I, if you will, which would be a pretty requisite for the phase II, obviously, when this will happen. Again, we are, of course all sides are very interested. I mean, Simcere took this license because for a reason also.
We are all very interested to move this forward, as soon and also as diligent as required.
Right. Do I understand you right, that you're still in a planning phase and you haven't identified any patients yet?
Well, actually, for the phase I part, the patients would be kind of available, if you will, because Simcere has, you know, kind of established phase I units. So that would not be a, you know, like a, like a bottleneck or something like that.
Okay. Payments then for 23 are very unlikely then, from what I hear you saying.
I'm not sure, whether I got you right. I mean, they have to do the Phase I to have the optionality to whatever do in a Phase II. I think they are appreciating that, and we expect that they are committed to starting Phase I. I think there's another aspect which we should mention, and this is due to the COVID policy in China. I think that's also an element which has a certain impact, as to their ability to move quickly with clinical trials in China.
Yeah. Just repeating, likelihood of any milestone payments for 2023 is rather unlikely, correct?
If they, if it proceed according to plan, I think it's likely.
Yeah.
Okay. Thank you.
Welcome.
The next question is from the line of Alexander Galitsa with Hauck & Aufhäuser. Your question please.
Yes. Thank you. Just 1 follow-up. Could you just explain why have you decided to go ahead with the adaptive dose finding part instead of dosing all patients with 600 mg, given that you have kind of cleared the safety hurdle with just interim safety readout?
Alex, to be clear here, I think we communicated that today. Our assumption is that we feel we have high safety potential at a dose level of 600 mg. This is underlined by the fact that we have already enrolled 40% of the 600 mg cohort in VVS and in VIVA-MIND, excuse me. There's a lot of evidence that lets us believe that this is gonna be the dose for all 880 patients, which we are treating for the 72 weeks.
Okay. Thank you.
There are no further questions, and I hand back to Uli for closing comments.
Yeah. Thank you very much, Timo, and thanks everybody for joining our call today. Yeah, I'd like to again thank you and, yeah, please stay tuned, and we look forward to talk to you at the next occasion. Thanks very much. Bye-bye.
Ladies and gentlemen, the conference is now concluded, and you may disconnect your telephone. Thank you for joining, and have a pleasant day. Goodbye.