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

Ladies and gentlemen, thank you for standing by. Welcome, and we are delighted to have you join InflaRx's conference call today to discuss yesterday's news about the emergency use authorization of Gohibic. [Operator Instructions] Please note that today's call is being recorded. The presentation will be followed by a Q&A session where you may ask written or audio questions. Please note that you can ask questions online only. I would now like to turn the call over to Dr. Niels Riedemann, CEO of InflaRx. Niels, please go ahead.

Thank you so much, Laurie, for the kind introduction. Ladies and gentlemen, a warm welcome from the entire InflaRx team to all today's press call. My name is Niels Riedemann. I'm the CEO of InflaRx, and I have the pleasure of taking you through the call today. Before I go into the presentation, I would like to have you take note of all important notices and disclaimers on the next page, please. As a public company, we would like to attract your attention and direct your attention to this page. Next slide, please. On our call with me today, I have the pleasure to have my co-founder, business partner; and dear friend, Professor Renfeng Guo is our Chief Scientific Officer and founded the company with me. Our great Chief Financial Officer, Thomas Taapken, who is an industry veteran, both on the finance side as investor and also in different executive roles; and also our excellent Vice President, Head of Regulatory Affairs, Derval OCarroll, who very recently joined us from Amryt Pharma. We will be answering your questions after the presentation. So can I have the next slide, please? So Gohibic was yesterday authorized by the U.S. FDA for the treatment of coronavirus disease '19 in hospitalized adults initiated within 48 hours of receiving invasive mechanical ventilation or extra corporal membrane oxygenation, ECMO. This is for us a great milestone company, and I will take the time to go through this presentation to direct you to some important information related to this authorization. The authorization is granted based on results from the Phase III clinical trial, including the ill mechanically COVID-19 patients, in which the treatment with Gohibic reduced the mortality significantly by 23.9% versus placebo. Gohibic is the first authorized therapeutic targeting C5a, the complement factor C5a. C5a is part of our immune response in severe COVID, and it is also present in other severe diseases, and this can result in severe tissue and organ damage. Gohibic development is based on over 2 decades of research by InflaRx team and founders. And I do want to point out that this was originating from the University of Michigan Research in the laboratory of Dr. Peter Ward, a very well-known complement specialist that Renfeng Guo and I had the pleasure of being post docs in his lab. Next slide, please. So I want to inform you that the U.S. Food and Drug administration issued this EUA for the emergency use of Gohibic for treatment of COVID-19 and hospitalized adults were initiated within 48 hours of receiving IMV or ECMO. Gohibic has not been approved. The emergency use of Gohibic is only authorized for the duration of the declaration that circumstances exist, justifying the authorization for the emergency use of drugs and biologics products during the COVID-19 pandemic under Section 564B of the U.S. Federal Food, Drug and Cosmetic Act, unless the declaration is terminated or authorized revoked or the authorization is revoked sooner. So that means there is no timestamp on this authorization, unless the underlying circumstances do not exist anymore which justify this. Next slide, please. So where does Gohibic fit in? And I want to remind you with this slide of the disease progression in COVID-19 when patients progressed to severe or a very critical disease. So obviously, in the healthy population, there are vaccines. This is before you have an infection, but patients that get infection in the early time in the early stage of the infection where the virus replicates and you find viral loads peaking, sometimes patients are asymptomatic or have mild flu symptoms. Now during the time, and this is just an approximation year after week or so, some patients develop intermediate to severe stage. So that means pulmonary symptoms, maybe the need of oxygen and the need of being hospitalized and that is at that stage when being required hospitalization and oxygen need is called severe disease. Now some patients are unfortunate and their inflammatory response that is part of this initial severe stage get stronger and stronger, and there is a development of a viral sepsis where patients then progress into very critical status and can progress there with the need for invasive mechanical ventilation. So at that stage, we assume a very strong inflammatory response, which drives also the organ and tissue damage, leading to the need for invasive mechanical ventilation. It's exactly there where Gohibic has its place of treatment. I do want to flag out that there are other anti-inflammatory treatments, which include this patient population. But our development has been focused specifically on these patients that have the highest risk of death. Obviously, some patients do die and this is still unfortunate that of those patients that get into this ventilation -- invasive ventilation status, have actually a grim outlook, and approximately half or more still die when they reach this disease stage. So there is a high unmet medical need in our view. And then some patients recover if they don't die in this stage, and that is also an important phase. So next slide, please. So in our Phase III PANAMO trial, we established a mortality benefit when patients have been treated with Vilobelimab, Gohibic. And you see here the Kaplan-Meier survival curves over 60 days. Keep in mind, the primary endpoint was 28 days, but we also assessed a key secondary endpoint, a 60-day mortality. Now important to note is not only the 23.9% relative reduction at day 28, but that this has been achieved on top of standard of care. So the majority of patients received corticosteroids and anticoagulant treatment. And then approximately 20% also receive concomitant or prior immune modulator treatment with, for example, tocilizumab or baricitinib. And that results into 1 additional life was saved for every 9 treated Vilobelimab patients at day 28 and even every 8 treated patients at day 60. Next slide, please. So what are the key facts of the PANAMO trial? I want to flag that this is 1 of the largest one-to-one randomized, double-blind, placebo-controlled, multinational trials here with 369 randomized patients in this patient population of invasively mechanically ventilated patients. It poses great difficulties. These trials are not easy because these patients, as you can appreciate, are not conscious, so they need to be ethically enrolled. And that is all very cumbersome, especially in a pandemic situation where patients have just been integrated, and this is an emergency. The results showed that Vilobelimab treatment showed a significant survival benefit at day 28 and also at day 60, and this is published in the Lancet Respiratory Medicine. The PANAMO study for us confirms 20 -- more than 20 years of research on the mechanism of action of C5a induced organ injury, an acute inflammation and sepsis and demonstrates the potential of a targeted C5a inhibition in contrast to upstream complement inhibitors. Next slide, please. So just briefly key usage and safety facts. It is important to note that the administration is an IV infusion over 30 to 60 minutes. We are giving Vilobelimab, Gohibic here up to 6 doses of 800-milligram over the time course of 22 days. Please also take note of important safety information. There are limited clinical data available for Gohibic. So we may still see serious unexpected adverse events, which may occur and have not been previously reported. There were serious infections and also hypersensitivity reactions associated with the use of Gohibic A.nd you can also find the detailed information on common adverse reactions in the fact sheet and here on this slide, on the website of www.gohibic.com. And I also want to flag that health care providers have the responsibility to report our medication errors and serious adverse events to the appropriate sites also mentioned here on this slide. Next slide, please. So this is an important slide for me because -- and for our team, because we all understand that the -- thankfully, the pandemic, the COVID-19 pandemic has slowed down. But the bad news is for patients that are incubated, there is still a high death rate. And that may also be reflected in the overall reported death rates per week here. This is from the center for disease control taken yesterday. And you see this is about approximately over 1 year from April 6, 2022, to end of March. And you do see that there is some fluctuation, but it is really in the range of 2,000 or even higher over this -- stable over this whole year, so that these patients still die. We assume that a majority of these patients are treated in hospitals and may be ending up on the ventilator. And with these reported death rates, we believe this is a very important indicator that there's still a high unmet medical need, especially when patients reach this most critical status of being invasively ventilated or in need of even ECMO treatment. Next slide, please. So just a few points here to the mode of action and to the importance of this. So the complement factor C5a is part of our innate, inborn immune system. It is actually 1 of the fastest reacting parts and a very potent part. See how they can activate white blood cells known as neutrophils, and they actually are known to contribute to severe inflammation. Importantly, these cells can release mediators, enzymes and make oxidative radicals that can actually damage your own tissue. And C5a level in critically COVID-19 patients were extraordinarily high. You see here on the right side, the graphic of the C5a levels from our PANAMO Phase II trial. This is all published by now. So these patients compared to healthy donors have a very, very high C5a level in the plasma. Vilobelimab here is the monoclonal antibody that binds and particularly specifically blocks C5a. So the mode of action targets the inflammatory response really. It does not target the virus directly, and this is important to understand relating to the mode of action. So just to the background, C5a and C5a-receptor inhibition has been researched extensively preclinically in other viral settings before COVID came along. And this includes also preclinical models that indicate that C5a is a major player or has a major role. For example -- and these are just 2 examples. In influenza-induced lung damage, specifically here, we tested that with our drug, Vilobelimab in age 7 and 9 induced viral pneumonia. And then also from another group with pneumonia in the Maersk coronavirus infection. So that being said, this mode of action has been extensively tested before COVID-19 appeared. And last but not least, C5a-induced neutrophil activation is the major pathogenic event here in this viral sepsis as we call it, that leads to our tissue damage and organ damage in our own organs. Next slide, please. So further steps, initial supply of the drug is available and additional manufacturing capacities have been secured by the company. We also have additional manufacturing already as we speak. So that is important to know. We are assessing all options to bring Gohibic to hospitals and patients as soon as possible. We are continuing discussions with the FDA related to a biological license application. This is also our ongoing responsibility when you have an EUA and the FDA is monitoring progress here. Next slide, please. So to summarize today's key messages here. EUA was granted by the FDA for these very critically ill COVID-19 patients. It's the -- Vilobelimab is the first authorized drug to specifically block C5a. The EUA is for the treatment of COVID-19 in certain hospitalized adult patients, which we believe have a high unmet medical need as we demonstrated also with the public available death rates. And the EUA is based on the Phase III PANAMO data, which show a significant survival benefit. I also want to mention that part of our work here has been funded by the Federal Ministry of Education and Research in Germany. With that, I'm at the end of our public presentation. I would like to hand over to the Q&A session back to Laurie. Thank you so much.

[Operator Instructions] Our first question will be from Yatin Suneja with Guggenheim.

Can you hear me?

Yes.

I have a question. Congratulations to the team on this big milestone getting drug approved, getting an EUA. Couple of questions for me. Niels, you mentioned that this initial supply is available. So could you articulate for us how much supply you have and what you are doing to secure additional supply? So that's the first question. Second one, if you can comment a little bit on the cost or the price, how you are thinking. And then the final question I have is -- everybody is trying to sort of understand what the market potential could be. And I wanted to sort of understand how we should think about it. I mean we looked at Gilead which, I think, is guiding for [ EUR ] 2 billion in sales for remdesivir in this year. So a significant market for remdesivir. So just curious to understand, how should we take that into account and understand what the market potential will be?

Yes. Thank you so much, Yatin. Thanks also for the kind note. So I think these are important questions. So I want to start with the first one, the supply. As I mentioned, we have drug supply immediately available and already manufactured additional suppliers. So this together will be enough to treat several thousands of patients, which is meaningful for us. We have also secured additional manufacturing with our manufacturer. That means we have contracts already in place, which allow us constant manufacture on a monthly basis. This is also important to then further the needs as we see the demand go up. The second question was related to the pricing. We cannot give you a final pricing figure yet, but this question somehow relates also to your third question. You mentioned rightfully so that there is still for some drugs, a significant market. Now I'll start with the pricing question. You know that remdesivir is priced in the range of several thousand, so it's a 4-digit figure. And that, of course, is a much broader patient population that are hospitalized patients, for example, and patients not hospitalized, but at risk of developing severe COVID. So this is a much broader population. However, we have conducted extensive market research with U.S. payers already, which has turned out to be very favorable for us. So we do not have a concrete price for you yet, but we have a good picture and expectations that this will be definitely a 5-digit figure. And it will not have a 1 as first figure as far as we expect it to be. So this is certainly, for us, a life-saving approach here, which was much appreciated in the payers' interviews, so that is important because, as I mentioned, we have a smaller patient population that we can address because only those that get to this very critical status, but we do have a life-saving -- potentially life-saving medicine here. And that, of course, puts us in a different trajectory related to, I would say, also sensitivity of higher prices with payers. So these are our expectations without being able to give you a concrete number today, and you can expect us to have these negotiations following very, very soon.

One more question, if I may, and then I'll get back in the queue. How quickly you would be able to have the drug available on, let's say, on the formulary for the hospital? Just trying to understand that you just got it approved, probably some work that's needed to be done that you put labels on. So just curious, the timeline in terms of availability.

Right. Yes, this is a question I cannot fully answer as of today, because we are assessing all options to get it as fast as possible. As I mentioned, we have drug available. And as you mentioned, since we got the label yesterday and we need to still label the drug, and of course, we need to open all channels for distribution, that means we have to have negotiations. This is very focused on large university hospitals and tertiary ICU carrying university or other big hospitals. So it's a very exclusive market, if you will, as it is not even all hospitals, but really those that carry intensive care units taking care of these patients. And so we are assessing all options, which include not, of course, only stand-alone options, as you can imagine. And depending on which option we have to go, and as you can appreciate, we are certainly working as Plan A on a stand-alone, but we are exploring other plans as well. So that may very much also determine the speed. All I can do today is assure you that we are working with the entire team on finding the best or the fastest way to get it to patients.

Our next question is from Ed White with H.C. Wainwright.

Can you hear me okay?

Yes, Ed.

Great. Well, congratulations on the approval. Just a couple of questions. First, can you give us your thoughts on potential for stockpiling? Has there been any government interest on building up an early supply and sign the contracts?

Yes. Thanks for that question, Ed. Certainly good question. So as the pandemic has been not much on radar anymore for government, the initial stockpiling is probably not as active anymore. We are exploring this as 1 of the options we are exploring besides others. This has been -- the stockpiling, as we understand, has been now under the umbrella of ASPR. And certainly, bringing the drug fast to patients -- a life-saving drug fast to patients is generally within the mission of ASPR and maybe also other governmental-related bodies. But we cannot today tell you whether or not this will be applicable to us. So all I can say is that we are assessing this.

Okay. And just wanted to -- you had mentioned about your sales effort and potential partnering. How should we be thinking about the ramp-up of your sales and marketing efforts here?

Yes. So I think I'm going to turn this question over to Tom. Tom, do you want to [indiscernible]?

Yes, sure. Happy to do that, Ed. Nice speaking to you. Yes. So as Neil has indicated, given the fact that we have received the approval yesterday or the authorization yesterday, we are, of course, still in an early situation with regards to the discussions, for example, for stockpiling purchases, the discussions with potential distribution partners and the potential to set up our own distribution at least to the tertiary centers that Niels was mentioning too -- was mentioning just now. So basically, I think it's fair to say that we should not expect an immediate ramp-up of sales in any meaningful way. We're not a big pharmaceutical company. We need to have the product first getting to be known by the physicians that are going to use this as well. So we're ramping up our efforts in the medical affairs world and trying to present the scientific data that has been generated with Vilobelimab to physicians, so that they understand the value that Gohibic can bring to their patients. So if one is realistic, I think we will start seeing commercial sales towards the second half of the year rather than immediately off the bat. And please keep in mind also that we as a company -- as a development-stage company, we want to continue the efforts that we are undertaking in other indication areas like our start of the clinical trial in the PG field, which is also very important for us. And we will not take our eyes off that very important target.

Yes. Tom, maybe to add to that, Ed, we have initiated already outreach and medical affairs work within the company. We have gathered external and internal professionals that are professionals in market access. We're working with consultants on the market efforts. So there are considerable efforts inside the company to do that as fast as possible, just to add to Tom's comments.

Great. And my last question is just on the future of the drug and future approval. So you had mentioned that European approval, I just wanted to get your thoughts on any timelines there that we could be thinking about availability in Europe? And also, you've mentioned that you're going to be speaking with the FDA on working towards full approval. Have you set up a meeting with the FDA yet, and any thoughts on timing for full approval in the U.S.?

Yes, thanks so much. These are important questions, which I would like to also hand over to our very experienced VP and regulatory affairs, Derval. But before I do so, I just want to add that we are in active discussions with the FDA on that topic. And we are definitely -- we definitely will set up additional meetings with the agency. But I hand over to Derval to give you more color also on Europe.

Yes, sure. Happy to take that. Thanks for the question, Ed. So from a European perspective, we've already had pre-submission meetings with the European Medicines Agency. And they've been very encouraging. So now that we have the EUA authorization, we'll be going back to those discussions. And the timeline for an MAA submission, our plan at the moment is the second half of this year. And then, of course, that process takes approximately 12 months. So that should probably give you the timeline in terms of Europe. It may be quicker depending on the type of discussions we have and the type of approvals that we are -- that we can discuss with the EMA. And in terms of the FDA, as Niels has mentioned, we are in constant discussion. I think -- we've had a couple of interactions -- formal interactions, and we will be working towards our pre-BLA meeting with the agency over the coming months.

Do you think that you'll need further studies to apply for the BLA?

So again, yes, they are part of the discussions that we've been having with the agency. I think you'll see from the authorization that the data that we have is fairly solid, but we haven't had those discussions yet. And so we're certainly open to having those discussions with the FDA and seeing where that goes. Niels, I don't know if you want to make a comment from the clinical side.

No, I think that's exactly right. I mean obviously, right now, intensive care trials are extremely challenging because they're not really enrolling or have stopped. These are generally very difficult even under conditions where there are more patients. And that's something that I think the FDA is generally aware of and we have made the FDA aware of. So we -- and the FDA has indicated that they want to discuss this further with us. So we are in these discussions, and we have to basically ask you to bear with us until we have more conclusive outcome. But our hope is, of course, and our wish is to get to a real BLA with this. We just cannot make projections if and how and when that happens, but we will work on this diligently and in short time here.

Our next question is from Steve Seedhouse with Raymond James.

Great. Congratulations to the whole team, and thanks so much for taking my questions, and you can disregard what I submitted online. Glad to ask them live here. First, just on marketing the drug, I mean, it really seems like finding a strategic partner with the prevailing COVID medicine even to market just in the U.S. would be an option on the table to sort of maximize efficiency and market uptake here. So you just got the approval yesterday or the authorization. I'm curious if this is an avenue that you think about pursuing and just to sort of expedite the path to revenue here.

Yes. Thanks, Steve. Also, thanks for joining in. Great questions. So happy to tackle that. So first of all, when we mentioned we're exploring all options, this is certainly an option that we are also exploring, because we have a key interest to get this potential life-saving drug to the patients at need as soon as possible. We do believe that this is a credible market. We've always said that. It's hard for us to predict right now how that market -- how large that market will be. But as long as there are patients that need and you have a life-saving drug and you can ask for a reasonable high price, I believe there is a market. So we would not exclude this option. We must be relatively opportunistic as we're a biotech company. And again, if the idea is to get the drug to patients ASAP that would not exclude a partner who can do that faster than we do. But again, we are working in parallel on the stand-alone just so we have that. And we have already prepared for that, as I alluded to.

Yes. Understandable. And then just on the mechanism here and its potential broader applicability to ARDS, I'm curious, in your view, what's the feasibility of running now that you have this authorization? The mechanism has been validated by the FDA. What's the feasibility of running a study or a pivotal study in ARDS broadly and ultimately affording a label that is expanded to include ARDS beyond COVID, either initially or down the road? Just curious if that's a feasible study to run.

Right. That's an excellent question. I mean as I have shown in the slide deck, the research actually came from other viral research, right, when COVID hit. So the mechanism has been researched extensively in different sepsis settings, including viral sepsis setting. So from the mechanism of action, we believe that such research would make sense and it would also -- I would say, be positively seen by the medical community to do such research just because of the data we generated already in COVID-19. Now obviously, there are different ways to look at it. These studies are never easy. I flagged this is a real challenge to do an ICU study of this kind. And of course, there are seasonal flu waves every year, every winter. But then on top of it, you may have new outbreaks in certain areas. We are right now seeing some concerning first cases of the new avian flu that is actually not only killing different species, but have now also swapped to first humans. So if something like this happened, we would certainly try to gather intelligence and look into this if we can afford it a small company, for 2 reasons. A, because we want to study, and we believe it makes total sense to study it in other viral diseases; and b, for the reason that you mentioned as well, Steve, that if we could have discussions with agencies either in the U.S. or also in Europe, that such an attempt would lead to a broader label or could lead to a broader label. That would be also of course, of interest for the company.

And then just if I could just ask, since we had you lastly, you're, of course, developing a C5aR targeted all molecule in parallel with Vilobelimab. And I'd be curious if you could update on sort of when the initial data from Phase I could be coming. And if you think ultimately you can establish improved PK and improve drug properties relative to, of course, the approved version of that mechanism of avacopan.

Yes. Thanks so much, Steve. Excellent question. I mean this is another really important focus for the company, the new 904, INF-904 molecule, small molecule that is currently in Phase I. We are running a single ascending dose, followed by a multiple ascending dose, and we made public that we expect data of the final multiple ascending dose in the second half. We may have the single ascending dose data earlier than that, and you're right. So the trial is running well. We are on track with the timing of the trial. We will be able to have this data in the second half. We may have single ascending dose data earlier. That remains to be seen, whether we want to already showcase them, but the trial has been set up for exactly that reason. Our preclinical data suggests that the drug has best-in-class potential. And it has been developed for over 5 years, real scientific effort here of Renfeng and his whole team. And the preclinical data are very convincing to us. If -- and we have set up the Phase I, such that a one-to-one comparison to the only other drug, which is now a marketed drug, avacopan, can be made. So that means we have same dosing are similar intervals, and we certainly can make at the end of these trials, an educated decision whether we see a different PK and whether that reflects in different ability to block the signal. So please take -- yes, look out for these data to come here during this year for sure. We are very excited about this drug because again, we actually originally researched the C5aR in much more detail. And Renfeng and I, this was actually the main part of our work. So we are very familiar with the receptor. We like that target as well. So if this plays out, we have 2 very powerful tools. We have Vilobelimab for life-threatening and more acute or very devastating semi-chronic diseases, and we have a drug that addresses the same pathway with I-904 that we then could develop in a more chronic and autoimmune space. So I hope that addressed the question. So trial's running well, and we expect data this year for sure.

Thanks, Steve. Just 1 thing to add here for the -- we actually have extensive PD analysis to assess 904 just to get a big picture of this drug compared with the market.

Yes. Thanks for adding that, Renfeng. I should have made that more clear that the PD parts of the blocking part of the signal is, of course, part of that [indiscernible]. Thanks for adding.

[Operator Instructions] Our next caller is Tim Lugo with William Blair.

Congratulations on the EUA. That's a major accomplishment for the team. And Niels, as you mentioned, PG is still an area where the company will focus. Is there anything on the interactions with the authorities around COVID-19 that maybe state your views on how to proceed clinically in PG? I assume the agency is obviously comfortable around the safety profile. But maybe did you glean anything in your interactions?

Yes. Thanks, Tim, for the question and joining the call. No, we don't have any new information that would let us believe that this would disturb or anyhow influence our PG work. In fact, we -- so from the regulatory perspective, in fact, the 1 new information we have is that the pricing we envision for the COVID scenario, which, as I mentioned, is a 5-digit expectation with not a 1 in front of it, that this pricing that we kind of discussed not be directly, but that we did in the external independent market research that, that fits very well to the much higher dose and price necessary to make a commercial case in PG. So we were very happy because, as I said, we expect those pricing, which is in all likely hood what will happen, and that fits very well to the very differently dose 2 diseases and the need for a higher drug price to make good revenues in PG. So that's the new learning from COVID. But regulatory-wise, we don't have any new concerns or any new insights that would jeopardize the PG program.

Our next question is from Will [indiscernible] with SVB.

Can you guys hear me okay?

Yes.

Excellent. Again, I'll add my congratulations, really exciting. So just to start off, I guess, how, if at all, is the expiration of the federal public [indiscernible] have on the EUA? Is there a possibility that it could be revoked at some point? And I guess, could you just remind us again the different variants that were included in the Phase III study?

Yes. Will, thanks for joining the call, and thanks so much for the question. I will tackle the second question first and hand the first question happily over to Derval again. So the second question is on the variance and Renfeng please chime in. But the mode of action, as I explained, is directed at the immune response to the virus, and we do not have a mode of action that addresses the virus directly. So we believe that this mechanism is independent of the viral variants. Now we have not tested during the pandemic study we conducted the viral variants, but we have conducted it throughout different waves in different countries with different predominance of different variants. So we and the entire development has been agnostic to the viral variant and the mode of action is actually not directed at the virus, which is why we believe it's independent from the variant. I hope that kept just the second question, and I hand over to Derval for the first question related to will the EUAs cease to exist when the public health emergency is revoked.

Yes. Thank you for the question. So I think, firstly, just to reiterate what Niels said during the presentation, which is that the duration of this EUA is not limited. The public health emergency, which is under what's called Section 319, that expires if it's not extended. And so as you've seen that the plan is that, that will expire in -- on the 11th of May of this year. But EUAs are under a different section, and they will generally continue. So the EUA declarations, they're distinct from and they're not dependent on the PHE declaration. And so therefore, the EUA will remain in effect beyond the duration of the public health emergency declaration, assuming all other statutory conditions are met. And they are the statutory conditions that we have met in terms of the assessment by FDA and the authorization of Gohibic under this EUA. So in effect, the EUA isn't impacted by the public health emergency declaration expiring. I hope that answers the question.

Great. And then just a quick follow-up here, if I may. In light of the EUA here and the obvious investment required for commercialization, how are you guys thinking about kind of cash runway? Please provide an update there.

Yes. Thanks for the question. I'm happy to pass that over to Tom. This really is his domain. Tom?

No, happy to say this. So as you might have seen, the last reported cash figure was EUR 83.7 million at the end of the year. And we had indicated cash runway into H1 2025. Now we are taking a conservative approach for the time being, because as I mentioned earlier, we cannot make any credible predictions at this very point in time as to when and how many -- how much revenues to expect from product sales. So therefore, we're sticking to that projection for the time being. But of course, expect that if we start selling commercial product, that this will, of course, help the financial situation of the company, knowing, of course, that this has also an impact on the cost structure if we have to set up the distribution ourselves. I hope that not answering the question did answer your questions.

Our next question is from Sam Slutsky with LifeSci.

Congrats on the EUA. Just 2 quick ones for me. So you mentioned the regulatory discussions where they're out in Europe. But can you just remind us where your China partner is at with your regulatory discussions in China, and then what's the terms of that partnership? And then second question is just regarding the grant with the German government. How much money is left on that? What's needed to unlock the rest of that amount? And then are they helping with distribution chain manufacturing, anything of that sort?

Yes. Thanks, Sam. Thanks for joining our call and also thanks for your questions. So I will tackle the one and -- with the Chinese partners. So we have announced this partnership late last year right before pre-Christmas. And so we've given certain rights in China to the partner also with relation to a potential authorization of their drug, which is a drug derived from our cell line under a license. We don't have any insights to any details of that discussion. We do, however, expect that the U.S. authorization may have a positive impact, but that's pure guessing. So I just want to make that very clear. We don't have concrete insights. But we know that this -- that the partner and we believe that maybe also the Chinese FDA will watch and will take a look at what Vilobelimab is doing here in the U.S. So that's for that. And I will hand over to Tom for the second part of the question.

Yes, certainly. So first to reiterate what the scope of the grant really encompasses. So the grant financed a lot of the clinical regulatory work, et cetera. But one big part of the grant also was dedicated to the setup of a commercial manufacturing process. So all the activities that led to getting to a robust manufacturing process that can be used for commercial purposes has been part of this grant. And we're very happy to say that we have been able to get almost to the point of full validation for this process. So we expect to complete these activities in the first half of this year. And as we have indicated in our recent annual report, there is around EUR 15 million still available, so which is a bit more than USD 17 million, still available potentially for being reclaimed. The way it works is that we incur the cost and the government basically picks up 80% of the bill. So that means everything we can get accomplished by June 30, by mid this year, which is the end of the grant will be subject to this reimbursement situation. So we're trying to really get to the point where we have all the manufacturing-related activities completed by then, which would be a great success and that would bring up the number that we were able to claim from the government in the range of EUR 35 million to EUR 40 million.

Sam, you're on mute. Do you have other questions?

Just -- yes, only other one, just remind us on the terms of the partnership with the China partner. What's the royalty rate on that, and is there any milestones involved?

Tom, do you want to just continue since...

Sure. The royalty rate is for the COVID-related indications is 10%. So basically, we will be eligible for 10% of sales in China from our partners product in China in case they get the approval in the COVID indication. For all other indications, as you might remember, the agreement was in place even pre-IPO already. For all other indications, the royalty rate is 5%. And no, there are no major milestones. The only situation that we have agreed with them or additional feature we have agreed with them is that we are able to requests from our partner to make a USD 7.5 million investment into the company if they get approval at a premium to the prevailing share price of 20%.

We've gotten several questions in the written Q&A regarding the company's financing plans.

Yes. Since Tom has a flow here, I'll let him speak.

I mean it's quite obvious that, as I said earlier, that we do have a good cash balance or a healthy cash balance for the time being, However, we will, of course, consider opportunistic possibilities to finance going forward. As you can imagine, yesterday's event was certainly 1 of these events that has brought up this question whether or not there could be a possibility, but we have not made any public statements to that effect and we will monitor the development of the investor interest quite carefully to make a determination whether this is appropriate or not. What is clear is that we want to have funding for the additional developments in 904 and PG. And this is, as I said earlier, a very important element of the equity story of the company that we will make sure that we finance appropriately and that's why we keep monitoring, as I said, investor interest and see how opportunities arise to consider financing.

Okay. And we have a question related to, are there any plans to study the medication in pediatric patients?

Yes, I'm happy.

I won't answer that one.

Happy to tackle that one. So there are no ongoing studies in pediatric patients, and we have not studied the drug in pediatric patients. I'm assuming that the question relates to studying this in pediatric patients with COVID-19, in this case, critically ill COVID-19 patients. So this is an extremely rare event, and we are assessing ways to address the pediatric population by all sorts of needs. But currently, we do not have a study and ongoing in the pediatric public. It will probably be extremely difficult. As I mentioned, it's a rare, rare event. So therefore, that has not been the focus right now.

Okay. And we have, I believe, a follow-up question from Yatin Suneja.

Sorry about that. Actually, I'm good.

We have also received a -- sorry. We've also received a question -- a written question about the current size of the global market.

Of the global market in severely sick intubated COVID-19 patients?

I believe so, yes.

We would not be able to answer that question currently. We do know that these patients exist in the U.S. We do know they exist in Europe. We do know that there are still a lot of these cases in China right now. And I think it also relates to the ability of the different countries to vaccinate -- or having vaccinated patients effectively. So we know that there are still significant numbers of patients dying from COVID, but I could not give you a better picture on the global market. I mean, so far, for us, being a small biotech company, we are focused on the U.S., and we are focusing on Europe. Beyond that, there's very little insights into any, I would say, current market situation.

And we have a follow-up question from Ed White.

No, I didn't have a follow-up question.

Okay. That was easy. All right. And I think we have maybe 1 last question before ending, and this has to do with -- and sorry, if this has already been answered. If you expect the government -- the U.S. government to do a bulk order of the drug.

Yes. I think we've gotten a similar question already, Laurie, earlier whether we think that stockpiling is an option. We are assessing this option. The original stockpiling situation has changed but we're still assessing this option. But at this point, we cannot make further comments as to whether there will be a purchase or not.

Okay. I think that is it in terms of Q&A. So I will hand it back over to you, Niels.

Well, thank you so much. Yes, not much to add, great questions. I just want to convey the last message here. We are extremely excited about this. We are proud and honored. We've worked hard on this. And I think that we are continuing to work towards the steps that we have indicated here. And I thank you so much for your attendance and the great questions. Have a good day.

Thank you.