InflaRx N.V. (IFRX) Earnings Call Transcript & Summary

Hello. Thank you for joining us today for our presentation on the top line results from our Phase III Panama trial of Vilobelimab in severe COVID-19 patients. A replay will also be available on our website following the live event. Before we begin, I'd like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These beliefs are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for more details. Our agenda today will include an introduction of key messages, a review of the Vilobelimab mode of action in COVID-19, the Panama trial design and Phase II results review; and finally, the Panamo Phase III trial results. We will conclude with a live Q&A session for which I will give instructions at the end of the presentation. Today, I will be joined by our CEO, Professor Niels Riedemann; and our Chief Clinical Development Officer, Dr. Korinna Pilz. I will now hand over the call to Professor Niels Riedemann, to get started. Thank you.

Thank you, Jordan. Welcome, everyone, to our today's press call. I'm excited that we will be presenting to you the top line results of the Panama study. Please allow me to make a short introductory statement before I go into the summary here. This is an important moment for InflaRx because the company has been funded based on research that was originally conducted 20 years ago at the University of Michigan Ann Arbor in the U.S. And also based on the strong belief of the founders that C5a plays a crucial role in infectious organ disease and life-threatening organ injury in sepsis. Now based on this belief, we founded InflaRx, and the last 15 years of research, we feel may be validated today by the data we're presenting since we believe that the data show a robust effect and suggest that Vilobelimab, the first-in-class C5a inhibitor has lifesaving potential. So with that, I would like to right go into the key messages. Please next slide. So the primary endpoint was the 28-day all-cause mortality. And you may know that this is kind of the toughest endpoint for intensive care studies recommended by the FDA and other agencies around the world. The clinically meaningful benefit was detected for Vilobelimab, and we will go into details in a minute, but we missed the statistical significance level that we put up using the prespecified analysis method. However, we had prespecified different analysis that show significant improvement in the 28-day all-cause mortality. I want to put your attention specifically on the significant treatment benefit in a predefined subset analysis of the Western European patients which made up for more than half of the patients in the trial and in which we showed a 43% relative reduction in 28-day all-cause mortality. We also showed a significant treatment benefit in all 3 predefined subgroup analysis of patients with higher disease severity at baseline. Now this was based on our knowledge, our research and also on the Phase II data that suggested that severely sick patients may show a stronger benefit from our drug. We also will show you a continued robust improvement in all-cause mortality up to the day 60, which was the end of the study. And finally, we will show you data related to a favorable safety profile for Vilobelimab confirmed in this critically ill patient population. Next slide, please. So before we come to the data, I just want to very briefly review what we have done before in COVID-19. Next slide. So this was -- our hypothesis really derived from in-house knowledge on other work but from the Phase II data of the Phase II/III PANAMO study. We published this work in the Lancet Rheumatology. And really, what we found is that C5a seems to lower mortality by impacting neutrophil activation besides other factors. We know that neutrophils secrete tissue factor. They are very much involved in the organ damage. In this case, in the endothelial cell wall damage and we are [ apotheosized ] without going into all details that the microangiopathy with thrombosis maybe influenced strongly by C5a. And there were certain signals in the Phase II study that we alluded to. But I do want to point out that today, there's additional evidence from other studies that suggest that some of these hypothesis specifically on tissue factor release and coagulation have already been proven through with other research. Next slide, please. Next, please. So just briefly to recap the design. So this study is -- the Phase III study is really about critically ill intubated patients with COVID-19-induced pneumonia. And they had to have additionally ARDS criteria. The primary endpoint was the primary -- and it was the 28-day all-cause mortality. And we had key secondary endpoints, especially the 60-day all-cause mortality, but also the 8-point ordinal scale improvement, the kidney dysfunction and renal replacement need, and, of course, also the safety aspect. Now the Phase II study was a small open-label but randomized study, where we only researched 15 patients in each arm. And we did learn about the PK/PD profile. We also learned about the intubated patients showing a stronger signal. And this is why we designed the Phase III part of the study based on this prework. And I just want to remind you, in the Phase III part of the study, we did administer 6 doses of 800-milligram IV Vilobelimab in the first 28 days, and then we followed up the patient up to day 60. Next slide, please. So the Phase II study results, we originally started with an exploratory primary endpoint, which was also pre-discussed with authorities here in Europe and it looked at the oxygenation ratio, which is one part of the ARDS criteria that is used. However, we found a very high variability. And this seems to be not a very suitable endpoint, not even a good surrogate because it's very dependent on patient positioning and other effecting factors. However, the key secondary endpoints showed a pretty substantial lower cost, all-cause mortality rate. We also showed other signals, especially less renal impairment and a faster reversal of blood lymphocytopenia which is a hallmark of COVID-19 disease, amongst other effects. Next slide, please. So without further ado, we would like to go now into the Phase III top line results. So the first slide here looks at the 28-day all-course mortality given the Kaplan-Meier curves. And what we've seen here is a 23.9% relative reduction of mortality. This is the full analysis set and you see that we reduced mortality from 41.6% to 31.7%. So as you see, we slightly missed the prespecified primary endpoint with a p-value of 0.09. And among -- besides this, what we've seen and what we really like about this is that there is an early separation starting as early as day 4 and a consistent separation of improvement in the Vilobelimab arm. So when you calculate that into how many patients you need to treat, we have one additional life saved for every 10 Vilobelimab treated participants compared with the Placebo arm. Next slide, please. So just briefly that the Cox regression approach that we principally chose for the analysis of the primary end point we feel is definitely the right approach. And I want to remind you that all the Cox regression analysis here is adjusted for the one factor that is known to affect mortality, which is age in COVID-19. However, we used in the final version of the statistical analysis plan, a stratification by site to be included in the Cox regression. And this was then the prespecified primary endpoint. And as we said, it slightly missed the statistic significance level of 0.05. However, the original suggested one was the non-stratified version and this would have resulted in a p-value of 0.026. Now we did change this based on recommendations of regulatory authorities, which we felt were justified. And therefore, we changed it. However, we looked at different other ways that are usually used to look at Cox regression. One of the so-called frailty model. Please keep in mind, this is a post-hoc now. This assigns random effects and random treatment effects in the sites. And also then, I want to point your special attention here to the stratification by country where we saw an even stronger p-value effect. And there are certain reasons for that, that I will explain in a short while here. But even if not applying the Cox regression approach, but the simple kind of group comparison, if you will, with the log-rank test, even in that test, we would have hit statistical significance. Next slide, please. We did use various prespecified ways to look at sensitivity analysis. And what that does is you look at the patients that are live, you see them the table upfront. And then you look at the missing values because some patients may withdraw consent or leave the study for other reasons. And it's always a question how do you impute this and that, therefore, you use sensitivity analysis. Now it just so happened that we have 9 patients missing in each arm, which is around 5%. This is a relatively low number, and we are happy to see that. And so what you do is you impute those missing values. The worst case in favor of placebo is when you basically say all missing patients in the Vilo arm would die and all missing patients in the placebo arm would survive. And we did not expect to see statistical significance given the trial power and the size of the trial. However, what is important is that even in this worst-case scenario, we still have the signal, the risk difference here with minus 5.4% in the right direction. Now if you just treat both groups similarly like all alive, this is what you usually call last observation carried forward or all dead, then you would still yield a clear statistical significance. Probably the most valuable way of imputing missing data is the multiple imputation model. This was also prespecified in the statistical analysis plan. And this is really accounting for the data you know from the study, but also signing additional random effects to basically mimic real life. And here, what we see is an even stronger p-value, which further makes us believe that the data are robust. Next slide, please. Next slide, please. Thank you. So looking at 60-day all-cause mortality, this is the same set of full analysis set, now looking not only at 28 days, but further to 60 days. The same effect principally was seen. We still have a 22.7% relative reduction in mortality and similar hazard ratio. Again, we used the final stratified -- site stratified Cox regression analysis, and you see a p-value of 0.08. And next slide, please. And we did the same analysis using the same originally per protocol analysis with no stratification or the other models that I explained just before. And we have a similar effect, all the other p-value show statistical significance if they had been chosen as the primary. Now so that is important for us because the 28-day data do not seem to be a chance finding, but are really carried forward the effect of saving lives to day 60. Next slide, please. So now I come to one of the most exciting slides here in the slide deck. This is a prespecified analysis of the European patients. Now the reason why we prespecified this is we knew that we would likely have a large amount of European patients, but we also know the sites here. This is the Netherlands, this is Belgium, this is France and Germany, and we can assume relatively similar treatment algorithms and also equipment in these areas. And so what we've seen here is an all-course mortality reduction at day 28 or 43% relative reduction. And when you look at the Kaplan-Meier point estimates, we have reduced the mortality in the placebo arm wiht 37.2%, down to 21.2%. So these were also statistically significant from p-value 0.0142. And you see on the right side that this effect was just as present when carried forward to day 60. Now this brought up the question, why was this effect so strong and we looked at the different regions, and we also prespecified for other regions. And before I show you, I just want to remind you, this would project here in Western Europe that one additional life was saved for every 6 patients at day 28 and for every 7 patients at day 60 who were treated with Vilobelimab versus placebo. Next slide, please. So when looking at the prespecified other regions, one thing becomes relatively clear. Now these are not the same numbers as you see, it's 209 patients in Western Europe. This is more than half of the trial. So you expect more variability in lower numbers, obviously. But there is a clear trend towards improvement in Western Europe as well as in the, what we call rest of world, South Africa, Russian Federation. However, in South America, this effect was much lower. And South America, he means Brazil, Mexico and Peru, where we recruited patients. And without being able to tell you all the data yet because there are still analysis ongoing, one thing we can already share is that we have identified quite substantial baseline differences in that patient population compared to the Western Europe one. And so the effects seems to be clearly impacted by the region of the world, and there may be various reasons for that. Next slide, please. This is also exciting really because these were prespecified analysis in patients that have a higher baseline mortality. Now -- sorry, a higher baseline severity and looking at 28-day all-cause mortality. Now why is this important? Again, our earlier research, also the Phase II data showed kind of a more substantiated effect in the most severe patients. So we looked at 3 ways here to save baseline severe patients. One is the ordinal scale. So an ordinal scale of 7 means that next to being intubated, you have to have 1 additional organ support that could be vasopressors or other organ support like renal replacement. And these make up for roughly 100 to 130 patients per group. And then the second one was the ARDS severity criteria. So we looked at patients that have oxygenation indexes below 100. So this would be severe ARDS. And last but not least, we looked at patients with impaired kidney function using the estimated glomerular filtration rate. And all 3 prespecified analysis show a clear benefit and reached statistical significance. You see that on the right side. So with these forest plots and the variability really not reaching one. So these were very convincing data that showed that the drug seems to be working even more -- even stronger in patients that are more severely disease. Next slide, please.. So the -- we're coming now to the other secondary endpoints. One of them was the change in the ordinal scale. And what we found is that the change in the ordinal scale at day 15 and day 28 follow the 28-day baseline mortality rates. So we did not see an effect where patients would be earlier out of the ICU. But in a way, this is also not to be expected because patients who survive a near death situation are usually known to have some longer stay on the ICU. So we do see a shift, but this really follows mortality, clearly. Next slide, please. Now another secondary or 2 secondary endpoints dealing with kidney function. This was the proportion of patients developing acute kidney failure. Now surprisingly -- and this was kidney failure derived from data that were entered at prespecified time points in the data set in the [indiscernible] analysis. And so patient reaching criteria for acute kidney failure were only 8 patients in the Vilo arm and 12 in the placebo arm. Now these are clearly less patients in the Vilo arm. But of course, as you can see, these are very low numbers. So not to be expected that statistical significance can be reached with that few patients going into acute kidney failure. However, next slide, please. In the next slide, we used -- looked at the proportion of patients free of any renal replacement therapy within the 28 days of randomization. And used to the fine and gray model to look at hazard ratios. And this shows you a rather nice separation even though acute kidney injury was detected only in a few patients, the need for renal replacement therapy using this model was really showing a nice separation. The p-value almost reached 0.05 limit with 0.696. Next slide, please. So just coming to safety, there are 2 slides looking at safety. This is really the overview. Just looking at all treatment-emergent adverse events. And you see on the left side here, any treatment-emergent adverse events. They are equally distributed. There is any related treatment emergent adverse events. And then serious any serious TEAs -- as any serious related TEAEs and any fatal. And you said that overall, there is of course, a really good distribution, so no peaking out signal. And of course, for the fatal TEAEs, it's actually lower in the Vilobelimab arm. Next slide, please. Now another prespecified look was focusing on infections. And these are the MedDRA high-level group terms that you see here. These are pre-fixed, so to speak. They are not invented by us. And also here, we see a very even distribution between Vilobelimab arm and the placebo arm nothing really peaking out. Obviously, we have to keep in mind that we had significant more patients -- number of patients surviving, so being longer in the hospital because they survived. And when you're in the hospital, specifically when you're in the ICU, principally, you have a higher chance to catch a fungal or viral infection or bacterial infection. And even though the numbers here show really very small differences, if at all, there will be additional analysis following to also look at that, for example, looking at that per treatment days applied. Okay. Next slide, please. So I come to the key learning and the summary again. So the primary endpoint of 28-day all-cause mortality showed a clinically meaningful benefit in the Vilobelimab arm, but missed the statistical significance level here with a prespecified analysis method. Now prespecified and post hoc analysis both suggest a robust reduction in mortality for both day 28 and day 60 in the entire treatment set. The trial analysis set for the Vilobelimab treatment compared to placebo. In the Western European patients, we saw a significant treatment benefit. This was a predefined analysis I just want to recap that. And we saw 43% relative reduction in 28-day all-cause mortality. Similarly, in the 3 predefined subgroup analysis of most severely diseased patients, we saw also a significant treatment benefit comparing Vilobelimab to placebo. The safety profile really does not pose any concern for us and really confirms that Vilobelimab seems to be safe and well tolerated in this critically ill patient population. So we are excited about presenting this data and the company clearly plans to discuss these results with regulatory authorities and then to learn how next steps could be, and we will definitely update the public once we are there. So with that, you see a happy founder and a happy team. And I would hand back now to Jordan to go into the Q&A session.

[Operator Instructions] Our first question comes from Yatin Suneja, Guggenheim. Yatin, the line is yours.

So a couple of questions. With regard to the change in the statistical method, which regulatory agency asked you to change it was it the U.S. or the Europeans? And then in terms of the Western European, can you just comment a little bit more on what might be driving that difference? Is it more aggressive use of SoC or standard of care or there is somehow changes or change in the patient population, maybe they have different virus strain or morbidities, just to these 2 questions. And then I have another follow-up.

Niels take it away.

Yes. Thank you, Yatin, for the 2 questions. So I want to start with your first question. So just I want to clarify, we have not been asked to change. So it's not that this was -- you should change it. This was a recommendation, and we looked deeply into this recommendation. It was the U.S. FDA making this recommendation. I think we can share that -- and we chose to take that recommendation. So it was not really an ask to change. It's important for us that we make that clear, it was a company decision based on that recommendation. The second question was how can we -- can we further allude to why we see this relatively strong effect in Western Europe. As I said, we have not fully concluded yet the analysis. There's numerous analysis going on. we do see quite substantial baseline differences. They are pointing to the -- especially the patients being admitted in Brazil and in Peru, which make up for this effect mostly that these patients may be significantly younger and maybe also less severely diseased and we have to further look into this. We can't make definitive statements today. So this analysis is still ongoing. But I would say it really peaked out that especially in the 2 countries that drove this effect, we seem to have looked at the different patient populations. We can't fully comment on the viral strains because we didn't test for each wireless strain in each patient. Obviously, we can match that work that's ongoing, we can match the time and the reported strains and strain dominance per region. But that, of course, carries a certain uncertainty whether that is true for each individual patient. We do, however, have concluded the study patient reported. And so we do and strain dominance per region but that, of course, carries a certain uncertainty whether that Is true for each individual patient. We do, however, have concluded the study with the last patient being enrolled in October last year. So this was before the Omicron variant was reported. And so we do anticipate that most of these patients carry delta and other variants, but not necessarily Omicron variant.

Got it. And then in terms of, again, focusing on the Western European, what -- were there any significant differences in the ICU stay or acute kidney failure in that subgroup relative to the overall? Just trying to get a sense of how supportive some of the secondary endpoints were in invest in European? And then just talk a little bit about your next step for COVID for this particular indication? Are you going to engage -- focus mostly on the Western European, like which regulatory agency are you going to sort of try to hone in on? Just give us a little bit more color there.

Sure. Yes. So for your first question, Yatin, this work has not been yet concluded on the detailed difference. This is something that will be ongoing and we hope to report further in upcoming conferences. And also, we have not yet the full analysis, right? These are just top line results that we went through. And so we will probably learn more about that, and I cannot share more than we have as of today, obviously. And so please stay tuned. We're going to look into this in great detail. The second question is who are we trying to engage like in terms of regulatory authorities, I mean, the obviously, for us, important regulatory agencies would be the European EMA and the FDA. Now we can't make any representations if these agencies will be open for a submission or how they're going to view the data. But I do think we have it here and also in the press release, we plan to have these discussions with the regulatory agencies and see how they view the data and whether we will be encouraged to submit or encouraged to have further discussions. And as this plays out, we will definitely update the public.

Your next question because it's relevant, it comes from the written questions. I am Anupam Rama from JPMorgan, who just wanted to just be clear, we'll be meeting with regulators globally versus EU only. And that is correct. Anupam, as Neil has indicated, we will be meeting and engaging with EMA on the EU side as well as FDA in the U.S., given we had engaged the both these agencies in the beginning and want to follow the next steps with both. So hopefully, that answers your question there. The next question comes from the phone line Ed White from on H.C. Wainwright.

So just a couple of questions. In general, can you make any comments on the standard of care in Brazil and Peru versus the rest of the world? When it comes to COVID patients.

Yes. I think -- I mean, Jordan, I'm just going to take the question and Korinna, please chime in. I mean this is a difficult question because obviously, it's very difficult. And we are not really in the position to say on detailed level what the standard of care looks like. Obviously, what we have done, we have done an in-depth feasibility study before we started, and we have selected trials that are both from the equipment standard as well as from their standard of care principally in the same, I would say, legal in the same arena as centers here. That is not true for all the centers in Peru, but there are centers, specialized centers that treat these patients and we have really tried to be very careful in selecting centers that principally have the same equipment have similar guidelines. And however, as you know, I'm an intensive care physician background and ran a large ICU here. And I must say that this is known and intensive care transits it's always a big problem because even though you may have the equipment, even though you may have similar guidelines standard of care can differ substantially depending on local, I would say, use of the guidelines, and that's not necessarily something that you can fully capture. So to really make like a substantiated statement on standard of care as per the sites, that's going to be extremely difficult. I mean I think we've done what we could to confirm that these sites operate on a similar level. But I know that, that standard of care differs a lot. And that's why we prespecified the regions for the subgroup analysis. I don't know, Korinna, if you had something to add here, please feel free.

The only thing I could maybe add here is that we do have information about the COVID-specific standard of care that was introduced over the time. And here, we do not see any differences between the regions. But as Niels alluded, we don't have a full picture of the, let's say, ICU linked standards. And we have also not a real grasp on it in the pandemic situation if all units were operating under their optimal conditions during the waves they experienced as well.

Okay. And do you have any guidance or any thoughts at all on the timing to the meetings with the FDA and EMA.

Niels, I don't know if you have any comments on that?

Yes. I think we cannot concretely guide. I think at this point in time, there is still a rather rapid response. So we don't anticipate that we usually -- that we would meet on a usual 3 months kind of pre-notice schedule, but rather faster, but I can't make representation. I know in Europe that can work within several weeks, and the same thing is true for the U.S.. It's going to be difficult for us to understand whether that changes currently or whether they are fully operating under the same time schedules. At this point, we anticipate it will be faster than usual, so not in several months, but rather in several weeks, but I can't make clear like representations, if that's going to be the case, but we're definitely going to be trying that.

Okay. And my last question is just from a strategy standpoint, you're developing Vilobelimab for several indications. If you are if the agencies request that you do another large study, is it worth to you to do that large study? Or would you focus your resources elsewhere?

Yes. Thanks, Ed. I guess I'll take that one and pitch it to Niels and Korinna. I think it's difficult to know what they're going to say, but I would say that given this data, it really opens up evidence to suggest this works in the critical care setting. This is the largest data set for us in one study, and it is really encouraging. And so we would certainly consider how to pursue Vilobelimab in this general area. I think what we do a specific COVID-19 study, I think that's something that we would have to seriously consider given where COVID is moving and it's a moving target as we see every day in different regions. And so I would say that, that's still dependent on what we hear from regulators. Any other comments, Niels?

No, nothing to aggregately join you. You captured that perfectly. Obviously, what we have done, maybe just one aspect, but we have done -- we have vetted with both the U.S. and EMA whether principally one trial in this area that is adequately powered would be seen as appropriate for potential approval, and we did not get a know from either one of them. So always, it depends on the data robustness, but if they came around and said, you need another trial, we need to see what they concretely say, what they're suggesting, how the trial would look like. And -- this took a look from our team. This is the largest drive we conducted. It's a true global study for us. And it really -- I think no one else has in a randomized fashion in these intubated patients like used more in a study with new -- with a new agent. And so it is not easy to conduct this large study in an ICU setting. So we would definitely wait what we see and hear back to make a decision on that one.

The next question comes from the on the written portion from Will [ Skogen ] from Leerink. And a number of questions. The first was, how do you -- how do these data change your strategy moving forward? I think we briefly commented on that we had come out with a press release statement on -- based on the COVID data, we would review kind of our corporate strategy and moving forward. And I would say, Will, that's still under development, but what we are promising is that we're going to take this data to find out next steps with these programs. And as Neils has indicated, we hope that won't take very long. And certainly, we are going to utilize this in conjunction with what we're going to do in our other indications. So I would say that, that is -- that strategy is going to come [indiscernible] whether pretty quickly. And we will certainly inform the public as soon as that is developed. I don't know, Neils, if you have any comments on that?

No, not really. I mean our principal focus is here immunodermatology we have voiced that. And obviously, this opens a second chance here to look into whether that drug can help really patients ad hoc or relatively acutely [ here ] in COVID. And we're going to have these discussions and see whether there is step moving forward. And based on that, we will determine the COVID situation. But I would say, as of today, we haven't changed our focus. We're doing this review, and we will come back as soon as we can here.

Great. Thans Niels. Also, Will, you mentioned reviewing the government funding and how this would impact that and the structure of this, as you can recall, we had announced government funding approximately up to about EUR 43.7 million. In the way this works is in tranches that we will be reimbursed up to 80% of kind of prespecified expenses. And if we continue to progress the program, we will continue to be reimbursed. So if we decide to continue this and start additional activities, including manufacturing, et cetera, this will continue. It's not contingent on some data points. So hopefully, that's helpful for that. Anything additional to add to that, Neils?

Perfect. Nothing.

And then in terms of financing for this indication moving forward, I think this is something that -- and we don't fully have what next steps are until we meet with the regulatory authorities. And we would come back to the markets to understand what additional capital would be needed. But we do have significant capital as we covered in our quarterly -- in our annual press release and definitely, we have enough money to continue to pursue some of these near-term objectives. Thank you, Will. Our next call comes from the line Ryan Deschner from Raymond James. Ryan, the line is yours.

Just curious if you could comment on the feasibility of a potential U.S. EUA given the lack of study sites there and what else may be required from the FDA in that case. And then also, how much of the grant from the German government has been used and what IP considerations are associated with it?

Niels do you want to answer the first question?

Yes. So it's always difficult to comment on what the regulatory authorities would say. So I would say this was operated under an IND. And so this was also pre-discussed in the U.S., and we made significant efforts to recruit patients in the U.S. as well and had sites ready to recruit. So at least that door and that is open, and we have, from the beginning, focused also to recruit and to be in dialogue with the FDA. So whether or not the FDA will comment or look at the fact that there are no U.S. patients in is something that is really difficult for me to comment on. We don't know that. From an ethnic kind of background standpoint, we have covered quite a substantial area of the world from South America to up to South Africa, Russia, Europe. So from a patient perspective, that should not be a problem. But -- we -- again, we cannot comment on how the FDA will view that. That was the first question.

And I think the second question, Ryan, you had was around the amount of funding we've received from the grant from Germany. And we put in our annual report as of December 31 of last year, we have received EUR 8.3 million of the grant funding. And I don't know your question was around intellectual property. What was that referring to?

Question about any sort of contingencies or restrictions on IP in Germany or elsewhere associated with that grant.

Yes, to my knowledge, Niels can confirm that there's no intellectual property restrictions based on this.

Yes. That's also my knowledge. I mean all the IP rights we have were generated completely independently, even our filed patents in the COVID arena. So from that point of view, our generated IP that we're operating under was even basically constructed completely outside any funding. So there's not a link to the funding as well. And I'm not aware of any additional restrictions.

Our next question comes from the written section, Sam Schotsky, LifeSci Capital. What do you anticipate the FDA will say on these data? Do you think they will suggest running another study? Or is there precedent for a data set like this to result in approval without additional studies? And I would say Sam, as Neils had indicated, we don't know yet. I think we -- the best we can do is kind of present the data. What we did was initially engaged them, and they gave us some feedback, which we clearly, on the statistical method decided to follow but we will go to them. And certainly, there's been other COVID drugs that have gotten approved and under mutancy used authorization and then full approval for things. So we will have to see. We don't know quite yet. But Neils or Korinna, you may want to comment additionally.

Yes. Maybe Korinna has additional thoughts. For the U.S., again, it's difficult to say also for Europe, I think when you look at presidents the anakinra anti-IL-1 receptor antagonist was recently approved to be also -- authorized to also be used in COVID-19 on a data set that was not as substantial, not as large and did not have mortality as the prespecified primary endpoint of the studies to my knowledge. So I think there are areas where an approval took place. But as I said, we are not here to make any representations of [ orange ] what the agencies will do I do think there's general interest also on the European side for our data, and we will just have to go and discuss and we will update the public as soon as we know more. Korinna, I don't know if there was something you wanted to add.

Actually, no, you said everything. Yes. [indiscernible] .

I think our last question was in reference to when we would see a presentation on the full data set. I don't know Neils or Korinna, do you have any comments on that?

So if I may take this one, Niels. So actually, yes, we will try to get as soon as possible out to a conference, which is a good target or which will be represented with a good target audience. We have not entirely decided which one, so as soon as possible.

Great. And we'll take one more from the written questions to be our last question. Given this encouraging results in COVID-19 sepsis, are you considering to also to address sepsis patients from other pathogens. Neils, why don't you -- considering this is your research area, why don't you take this one?

Yes. Let me -- that's a great question. And let me just start by saying like I mean sepsis has been an extremely difficult field to be developing drugs in. And despite that, we always said this structure work. Now we had difficulties funding this, even though we had a small encouraging early study. And when COVID came back, the evidence was just so overwhelming. And it looked like even though this is viral sepsis that these patients kind of have a different pattern that, first of all, you have one agent -- one virus, maybe some variants that drive it. And on the other hand, it looked like these patients develop a pretty severe disease, but relatively slowly compared to some of the other [ subsidies ]. So it opened the window for us to prove that the drug works and also to prove that it works best in very severe patients. Now I think these data robustly suggest that the drug may have activity, and that's really encouraging. Now running a larger study in sepsis is an endeavor that I would say, from where we are right now today, that's not a plan that the company has, maybe in conjunction with a strong partner that feels strong about the data, that's a different story, and that's something that, as always, is up in the air for a smaller company to discuss and to see whether that comes to play. But I'm very cautious and I'm very optimistic on the other hand because even tougher than in sepsis, the history of ARDS, viral ARDS has been one of the toughest spots to develop. And the data we have here are from a scientific point of view, probably the most substantial Phase III data to date on 28-day mortality with a new agent in this disease area. So we feel pretty encouraged, but that doesn't mean that we are like jumping to the conclusion that we are starting a huge sepsis [ Trianex ]. So we wouldn't do it. But if the company grows and we have the funds or partner available to look into this, I think we have now substantial proof that there could be an alley towards that endeavor.

Thank you, Neils. And this brings us to the end of our event. Thank you for your interest in InflaRx and for everyone's questions. Today's slide deck and a recording of the event will be available on the website in the Investor Relations section of the Events and Presentation of our website very shortly. Thank you, and have a great day.

Thank you.