CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Good afternoon, everybody. Welcome to the first CytoDyn Investment Community webcast. I'm Ana Berry, and I'll be your host today. Stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications and is holding its first investment community webcast today. So CytoDyn will present for 30 minutes and 60 minutes will be dedicated to live questions and answers. Now during the company's presentation today, you can submit questions through the webinar module and Cytodyn may attempt to address as many of these as possible at the end of their presentation. Now this webcast will be uploaded to the Emerging Growth Conference YouTube channel so subscribe youtube.com/emerginggrowthconference. And just a few notes for those attending, this is a live continuous event it begins now and it runs until approximately 2 30 p.m. Eastern Time. So if you do experience downtime for more than a minute or 2 just refresh your browser. And our platform does work best on Google Chrome. So if you're watching from an apple device, you have to hit the play button to start the session. One last note. After today's event, you'll be redirected to the registration page for the conference, which is tomorrow. So please stay on. All right. Today, joining us, we have Dr. Nader Pourhassan, the President and Chief Executive Officer and Head of Business Development. We have Dr. Scott Kelly. He's also the Chief Medical Officer and Head of Business Development. We have Dr. Nitya Ray, Chief Operating Officer and Chief Technology Officer; and Dr. Stephen Rechner and the Senior Executive VP of Clinical Operations, Welcome, gentlemen.

Thank you, Ana. Great. Thank you, Ana. Thanks, everyone, for being on this presentation. We will be covering quite a bit of forward-looking statements. And we will start with leronlimab as usual. The only molecule that CytoDyn had since we acquired that we are developing is leronlimab. When we bought it, it had 1 indication. Now we are pursuing 31 indications. I simplified this 31 indications to 5 areas. The last area is -- we haven't started anything in autoimmune disease. So four areas that covers the 31 indication is what I want to just talk about briefly. In regards to HIV, we have got a product that had that Progenics had spent 12 years, developing it to the point where the FDA had allowed them to do a Phase IIb in combination therapy. That's just a combination therapy. The market size for that combination therapy was only $30 million to $50 million and is MDR market, which is multidrug-resistance market. Now that wasn't something very appealing to us. So we try to talk to other key opinion leaders, get everybody else's opinion. And we try to modify that MDR to a different combination therapy, which was for two class resistance with limited treatment option. That indication could be about $1 billion at that time, now probably smaller than that even. But that's not the path we wanted to go forward because FDA in 2009 had told Progenics you have 3 weeks of efficacy of leronlimab you're not ready for Phase III. You need to do Phase II in the same trial that they wanted to do, which was substance app use population combination therapy. We did not do that. We actually talked to a lot of key opinion leaders that realize that there might be a chance to go after monotherapy, a market size of $5 billion. Now, this dollar amount that we're throwing around, these are all backed up by reports, independent some of ambitious like BioVia report, the seniors report. And we put those in the website. So monotherapy was very challenging, but we took that on and we thought that the company can benefit tremendously if we go for that indication. Within 8 or 9 months from beginning of that monotherapy to where we got enough results to go to FDA, FDA saw that we did 12 weeks -- we had 12 weeks of efficacy of leronlimab. And FDA said, well, we're going to let you have a Phase III pivotal combination therapy. In parallel, you can do monotherapy. But then they said your monotherapy is very different than anything they had ever seen. And here's a letter from FDA. Here's the minutes that FDA sent us. Look at the bottom of it that I just highlighted with the box -- purple box. It says, FDA said, if you are successful CytoDyn, this may lead to additional BLA submission in the future. They were saying, you have to be successful. If you are successful, it will lead to another label expansion for monotherapy, but what is it that they were talking about, what success? Well, they said it before that, the ultimate goal would be to identify those subjects who are best suited to PRO 140 monotherapy. So what was a result when we went there with the CD01 with the first 40 patients have been monitored. Well, here it is. They said the FDA say we're in 25% of enrollees remain biological suppress at more than 2 years, but the remaining 75% experienced virologic failure. How do you -- how do you go forward and you have 25%, you need 90%. We're able to accomplish what we did, which was getting to 90%. So we had to do a lot of work. I hope shareholders appreciate the team that we brought and were able to accomplish what we did, which was getting to 90%. But we had to go to a different dosage and a few other things that we will talk about it in a minute. But then that wasn't the only thing. We also wanted to expand the HIV itself to where we perhaps can go for prep, prophylaxis and prevention. That market size is $3 billion. The only thing for credit that was out there in a few years ago was Truvada. Now they advanced Truvada to product Descovy, which is much better than Truvada. But the patients have to take pill, and not the patient, the individuals who have risk of HIV, have to take those pills. We believe leronlimab could be once a month prep prevention, and we're going to be following with that also. So with all of that, we didn't stop with HIV. We realized that put a trial that now we have results from there could be potential for this product in cancer. So we started a Phase II, a IIb/IIII , a trial that now we have results from compassionate use protocol and this Phase IIb/III, and that data is allowing us to file 2 breakthrough designations, which we haven't yet filed the first one, and we are going to talk about that a little bit today. But we also have a basket trial, which was very unique for us to be able to go for 23 indication immune trial. And that results from that trial also, we are analyzing that. And that we will talk about it also when we get to that, but we have results from that front also. We are analyzing that. But meanwhile, COVID-19 happened and when COVID-19 happened, we realized that we could have potential in their ViiV Because Dr. Seethamraju, our hero doctor from Montefiore called FDA and emphasized that he believes on the literature that was published that leronlimab could have effect and definitely, it did have an effect according to him for his patients, and that started the road to COVID-19. But he wasn't the only one, Dr. Harish Seethamraju from Montefiore led the way, but then Dr. Otto Yang from UCLA got a hold of that and he enrolled quite a bit of patience in emergency IND, I believe over 30 patients. Then we've got Dr. Nicholas Agresti, who said I had 4 patients that would never made it and he gave leronlimab to them. And we have another hero doctor in Philippine, who really believes in this product, Dr. Randy Nicolas and he led the way in Philippines, saying that this product works. Now that was paper published by this gentleman and others even and Dr. Harish Seethamraju published his findings in a peer review journal. Dr. Otto Yang published and Dr. Nicholas Agresti, he published papers. We, therefore, win and also signed licensing agreement with BIOM, pharmaceutical in Brazil and with Karo Pharma in Philippine. Now these are extensive tasks to accomplish. This is not something you can do overnight. This takes time. But we pursued aggressively while we did not let HIV or cancer be left alone, we continue with that. There comes NASH. Now this NASH study, I have to give all the credit to Dr. Chris Recknor. When he told me about it, I laugh because that's a common. NASH will take forever to enroll. This is not with me. And I couldn't second-guess him on that because he already had proven me wrong in previous COVID-19 when he enrolled patients in the pace that I've never seen. he also led us to a whole new path in regards to our CRO realizing that there are things that we need to do better. Therefore, he led the way to find another CRO that we're going to talk about. But with NASH, we have now 350 milligram arm that we've been looking at some of the data, and they are very exciting. We're going to be talking about that soon. Dr. [ Regina ] led this study of NASH from beginning to the end, personally, he's responsible for this success, and I cannot thank you enough. And it was the fastest enrollment what we hear that nobody involved 90 patients in NASH in that pace. Again, shareholders perhaps don't recognize if you're not involved with that kind of trial, you don't recognize how powerful this has been, but he has done an unbelievable job. And then autoimmune diseases, I mean we had animal study in MS, multiple sclerosis that was very strong. Just like we had animal study in NASH that showed the fatty deposits to reduce. We had the animal study in cancer. That shows the 97% reduction of metastasis. So those -- we take it very serious now because we see that the human data matches those humanized animal studies. And long-haulers data, Dr. Chris Recknor again did a fabulous job, it was his idea to start the long color. I never thought it's going to happen this quickly. He did it, and the results were strong enough to get a Phase II and hopefully becomes Phase II/III could be an adaptive trial. And that trial, we went through FDA, and we talked with them and modify the protocol, and we are going to start the China. We're ready to start. We're going to be announcing that also because we're clear to start. So what is the market cap -- I mean I'm sorry, the market size of these potential indications. So I put these links in my code here in our code, I'm sorry. And in those codes, you can click on those links and see where I'm coming up with these dollar amounts, $30 million for combination therapy we can see other product that is very similar to antibodies, not just ours, but antibodies, the IV infusion, they're reaching those market sizes. Monotherapy, $5 billion, it was in the report. PrEP, there is a lot of report on that $3 billion, Truvada sold for that much. So we say we went from potential $30 million in HIV alone to potential $9 billion for MDR population multi-drug resistance for monotherapy for prevention. Now these are all amounts that you will realize post launch, perhaps 2 or 3 or 4 years after that. But these are very large numbers. And cancer, again, there are links here so people can check for themselves, $158 billion market size even if we realized $50 billion, that would be huge. COVID 19, a few billion. We don't know how large that is yet with long-haulers, Dr. Scott Kelly will talk about in a minute. And NASH, the same thing and -- with autoimmune diseases, we haven't started any of those indications, but we will -- but we like to get our first approval before we get any more indications because we got our hands full with all the work that we have been doing. Now if you look at it and say, was this really impressive or not, look at the other companies, how they dealt with leronlimab. Progenic had this drug in 12 years, they had 3 weeks of efficacy of leronlimab, within 10 months, we got much more. And if 7 years ago, I would have told shareholders that in the next 7 years, these are the number of trials that we will be conducting in setup having 12 years and 160-or-so trial that they did at Progenics, 168 patients -- enrolled 168 patients for 3 weeks of efficacy. If I would have told everybody less than 12 years, in 7 years, we will enroll 100 -- I'm sorry, 1,445 patients. They would tell me it's too good to be true. It's not right. It's not going to happen. They did tell me that, a lot of people. And if I were to say that while we do all of this, we would generate $400 million potential value for our product, that's how much commercial product -- commercial grade is a whole different volume than clinical grade. People who are in CMC would appreciate that. And we're going to use $400 million to get there we're going to raise that fund. I don't think people would have believed it. Now in regards to HIV, we had a primary endpoint. We do have our monotherapy and we want to go forward. We have a protocol synopsis, I agree to be Dr. Chris Recknor, Dr. Nitya Ray, we all met with Dr. Scott Kelly. And we are going to submit that protocol to FDA and get that moving, not only in United States, but in broad in Brazil, perhaps. All of our extension trials have been not transferred to other CROs. So I'm going to ask Dr. Chris Recknor, you have moved the extension trial data all over to Synbio. Can you talk about that, Dr. Recknor, please?

Sure. We have the data that we are migrating over to their systems from the Snap that we did during the study. They're having to rebuild the database, and we're looking in good shape. Very excited about getting the trials tidied up and ready for the BLA. And I guess while we're doing that, you're going to be telling them about the BLA submission then.

But 1 question I like to have you answer for the shareholders' sake. So what was the problem with the data that was over there at Amarex? Did we have all the data in an organized way in EDC, electronic data capture? Was there problems that you wanted to move out of there because of tell us why, please?

Well, I mean, we've been trying to work with them on the BLA for a while. And I just don't think they had the experience to do the BLA. To do the BLA, we've gotten new people in, new staff and new consultants and making a lot of progress. I mean regarding the data though, it's important that proper procedures are adhered. When you're looking at the data and working with the sites. And at 1 point, maybe the CRO had done a good job with us on the prior studies. And we just felt that changing with these extension studies, we could get it cleaned up faster to get the BLA submitted.

One of the things that I always ask of them is if you have 40 patients in extension going 3 to 4 years, 7 years for 5 patients, and more patients in extension about 4 years long in the CD02. If all of these patients are in extension, which was a larger number, and if there were 566 patients that was using leronlimab as monotherapy. Did any of these patients get COVID-19? Did any of them get cancer? Some of these patients were in HIV for 20 years, where is the data? That data, it was driving me very much crazy, not to be able to get them. And after Recknor says he's going to move it to a place where we can get those things left and right and be able to understand that, that was huge. And he looked at quite a bit of stuff in that recourse. And am I correct, Dr. Recknor about that?

Absolutely not. That's the main thing. Once we have all that and we're working with another CRO to get that cleaned up and to go to the sites.

And then when we go to BLA, biologic license application, there was quite a bit of stuff that was not happening. And let me just ask Dr. Ray first, who's taking care of this receptor occupancy, which was a problem. And it was a joke that some people would say that they had made the receptor occupancy. It was never like that. But Dr. Ray like tell us the status of the BLA in regards to those things.

Yes. So our plan is to submit the nonclinical and CMC module next month, this in November, and we are on target of doing that. And the clinical module will be submitted in the first quarter of 2022. Area that we are really working on is that the receptor occupancy study, and we are working with a major CRO on the bioanalysis on the receptor occupancy. We do have the method, but we have to validate it before we make a submission. And right now, we are working on the method validation.

Great. Appreciate it. And Dr. Kelly, while you and I saw what's happening with Amarex and all of these tasks moving from CRO, perhaps you can explain how difficult that was, that Chris -- Dr. Recknor did a fantastic job. Dr. Ray is now really helping great way. But tell us your view about that.

Yes. No. I mean it was a tremendous challenge and Dr. Recknor stepped up to the plate as well as Dr. Nitya Ray, I mean they really, really took over and really putting us in a position to succeed going forward.

We always hear that do not move from your CRO because it's very difficult and they also knew that, and they perhaps hold the data as a hostage in our opinion. But now we are going to be able to really take off with the new CROS. Synbio will be for HIV. We are talking to other CROs like PPD, pharma, product development and so forth. But now let's move to cancer. What do we do in cancer? This report that you see here was going to be used to incorporate to an application for breakthrough designation. But Dr. Nitya Ray has been really investigating this data, and we realize that we have to go actually instead of 30 to 28 to emergency in the patients were taken out. And these numbers that you see in the bottom, 980% maximum amount of benefit compared to the standard of care if the circulating cells are low after 1 injection of leronlimab, now is changed to over 3,000% when we took those 2 patients out. So we are fine-tuning this breakthrough designation. And Dr. Ray, could you tell us where we are with the breakthrough designation?

Yes. We are working on it, we do have the first draft, and we are reviewing it internally. And also the KOL in that area of reviewing this reviewing this draft. So we believe that the first breakthrough designation application will be submitted in the next few days. Definitely by next week, if not this week.

So when Dr. Ray say, if not this week, next week, we said before, we're going to do it this month. But Dr. Ray also found out that some of these patients, 1 or 2, maybe 3 were on monotherapy for 1-year monotherapy. This is a cancer patient leronlimab. Dr. Kelly tell us about the monotherapy patient, please.

Now there's been a few actually, some can't tolerate chemotherapy or other standard of care treatments. And so we've had a patient in bladder cancer, for instance, that has been taking monotherapy and responded quite well. So we're very excited not only about synergistic opportunities with leronlimab, but also the potential for monotherapy and a subset of the population that can't tolerate traditional standard of care.

Let's talk about our COVID-19 program. These are the data that we have shown in the past in our press release, some people mentioned to us that the same table on the top, we wrote first dose injected at day 7, but that's not correct. It was injected -- injection happened at day 0, 7, 14 and 21. Analysis of the data at day 7 revealed that the survival benefit of leronlimab arm versus placebo was 78% after 7 days. At day 14, which was after 2 injections, the survival benefit was 82%. And then we didn't give leronlimab anymore, so then down to 50% and 31%. Now this 31% also was 24% before, but once we clean the data, we realized that, that number was a little bit higher. So what do we think is going to happen in Brazil that's our prediction. That doesn't mean anything right now unless you have that data to show. But having the same kind of progression of getting better with 4 dosage, we believe that this is the kind of data we're going to generate, and hopefully, we will be able to hit our primary endpoint, God willing. So with a long-haulers, Dr. Chris Recknor again, did a fantastic job. What we had was 56 patients, 100% better clinical outcome and 24 symptoms lumped up together was seen. The symptom improvement was 16 in leronlimab versus placebo 8. P-value was not hit with 56 patients, obviously, 28 in each arm, we didn't expect that. But now we have -- we are ready to do our next trial, and there's a lot of people waiting. Dr. Recknor, please tell us about that.

Well, we've got the protocol completely done. We're working with building the EDC with the new CRO. We've used everything that we've discovered with the biomarker lab with the prior studies and with the prior long-hauler study, and also let searches to come up with a new protocol. I'm real pleased with it. There's a waitlist of already about 500 people, currently have it designed for 225 people. It's a 1:1:1 ratio. So we're trusting 700 versus 350 versus placebo. And I really look forward to getting these people some help.

And the good thing about it would be 2 out of 3 patients will get leronlimab, which is very good for us. And Dr. Kelly, the market size for long hauler, nobody knows. Dr. Chris Recknor, I think, is leading the way for this kind of trial with the FDA. They're figuring out what to do with the trial. But please tell us.

Yes. I mean the market potential for this is overwhelming. I mean you have over 245 million people that have been infected with COVID-19. And conservative estimates are 10%. So if you have 24 million on a conservative estimate, but it could be as high as 72 million or more of people that don't have treatment options that need help. So obviously, this is a tremendous opportunity for CytoDyn and to shareholders and for patients alike.

Thank you. And we have a great news that Dr. Recknor went back and forth with the FDA and our regulatory team have cleared us to start the trial. And Dr. Recknor will start that. There is a group of people waiting. I'm going to time him when he injects the first patient to the last patient. And I want to see if it's a world record because it's incredible the way -- I mean, I'm used to the past people that we had, Dr. Kelly, you know that, Dr. Ray you know that. We enrolled 1 patient or -- no, 0 patients in 11 months, and then we enrolled 1 patient. It was incredibly painful. And we always have to figure these things out. So we solved that problem and that problem solver is Dr. Recknor. Okay. So now let's talk about Philippines, quite a bit of publicity we have seen out of Philippines. These are the number of sites that was put in the public domain by people from -- who are familiar with leronlimab in the Philippines. We have a group of 39 patients and a group of 17 patients that the data is being put together. And it's a very strong data. We met with one of the Chiral pharmaceutical people who came to United States and we've met with him yesterday. All of us, the whole team, all 4 of us and we are very excited about what he was saying. I don't know why these slides are changing by themselves. Okay. In regards to Philippines, we expect to have revenue, and we expect this to increase. Now let's talk about Brazil, same thing with Philippines. As we can see, the numbers are rising, number of orders, the quantity of the orders. But in Brazil, everybody is telling us, why is nobody enrolled yet? So we need 612 patient, severe population. We don't think we're going to hit our primary endpoint at interim analysis. I don't think so, maybe we will, some scientist think. But with CD16, we think we're going to hit our primary endpoint very nicely at the interim analysis, which is 127 patients. We enrolled the first patient on both trials, but why is it so slow? Well, the pandemic has gone down but we are now, unfortunately, hearing the rise of this new virus that is making more patients being sick. And we are setting the hospitals for severe and critically ill. If there is a wave and if there is problems that we saw -- we have seen in the past, this enrollment of 127 patients could happen very quickly. But we have to be cautious because we need to have that to see that happen in order to be able to enroll quickly. And the hospitals, they are adding continuously. All the product has been sent to them and ready to go. So we will update everybody as much as we can. In regards to NASH, it's -- the trial is over in regards to this first 60 patients who are double blinded. The 350 milligram, which was again, Dr. Chris Recknor's idea of after looking at the mechanism of actions, he taught 350 milligram would also be very nice to the look at, and he was absolutely right based upon the 3 results that we're seeing so far. And we're very excited about it. But obviously, we have to be cautious to see more data, and we will be announcing those data. But Dr. Recknor, do you want to tell us whatever you like about this trial?

Well, we're already designed the [ 2B ] for biopsy and can get that started within the next -- either into this quarter or beginning of next. Based on what we've learned, the biomarker lab has come in handy very much with this trial. And I think we've got a solution for the NASH problem that patients have. And Dr. Kelly, you can comment on the prior animal studies where we believe we're going to be seeing the same thing with...

Yes. So those are immunized mice and what we saw was a threefold reduction in NAFLD or fatty deposition. And I think what's unique about this is, not only could you be using in this sort of monotherapy, but there's also a lot of pharmaceutical partners that are looking to combine this in a synergistic approach as well. One of the fortunate things about leronlimab is the mechanism of action with binding the stellate cells at CCR5. Stellate cells are what produce the scar tissue. So there's a lot of the different -- whether it's PPAR inhibitors or [ THR ] beta selective and all the other different potential mechanisms of action. This is a very unique thing, and then it's once a week that we don't expect to see drug-to-drug interaction. So I think as it opens the door for a lot of opportunity, not only as a monotherapy, but it as a synergistic component. And we really believe our mechanism of action is unique and that it addresses the actual problem, which is the formation of scar tissue by stellate cells.

Thank you, Dr. Kelly and Recknor. So the manufacturing, Dr. Ray, has done a fantastic job with this. We have seen what he was able to do, getting us commercial product. And Dr. Ray, we're going to be using Samsung for our first BLA, am I right?

That's correct.

And the BLA, the run that we have, the next year run, that would be the one that you're probably going to use for auditing the site for BLA?

Yes.

Okay. Perfect. So we are set with Samsung being the manufacturing for the BLA. Before it was different. It was AGC and Dr. Ray have changed it, then we are very happy with that change. Now in regards to our fundraising, people have to realize we're not asking for 200 million shares to be authorized because we're going to go and sell those next week. We were very, very careful with what we have done with our fundraising. And I really like to see people look at other companies, if they don't mind, [ OTCB ] and look at how they raise money and how did they -- how much dilution they were able to absorb, what they were raising and compare that to our numbers. I think the people will be impressed. As we said before, there are 4 different ways to raise money for us. There are other ways. But main 4 ways for us was always tied to [indiscernible]. So with that said now, I'm going to ask all the shareholders to please make sure that you go and vote. And please note that when you hear from people that this company is going to get 200 million shares because they want to give it to their executive team, that's not correct. And if you check the percentage of what I own and the shares of the CytoDyn, less than 1%. Usually CEOs after 12 years, 9 years, they get to get 10% or 15%. So it's not happening the way people are telling you. We need your vote so we can conduct the business by having 200 million shares, which would make us look very strong to the pharmaceuticals. Dr. Kelly, you want to talk about that, about business development?

Yes. No, I think it puts us really in a position of strength, as Nader said, this is not shares that's going to go for the executives. This is -- as some group has said before, this is just simply not true. So all of our stuff is done from a third independent party in terms of compensation. We really believe that we can explore new opportunities for the shareholders and for patients and also be in a position of strength because we would look -- we are looking for pharmaceutical partners.

Thank you. So to summarize everything, let's look at the 4 areas that we are targeting in the last 7 years, and let's see what we have done real quick. HIV, we have new CRO, thanks to Dr. Recknor. Already Dr. Ray is looking at that very carefully and hiring very key people. He already has hired some really strong people that we will be introducing to the shareholders. CD01, 02 or 03 extension study to move that to another CRO was a very difficult task. It's completed and is still being worked on. BLA is on track now. Dr. Ray is completely in control, nonclinical section and CMC will be submitted in November, and the clinical section is, as we said, first quarter of next year. Monotherapy new protocol, this is very important for us. We want to make sure that that's ready to go and hopefully get approval for that as a label expansion at some point. And the BLA submission in other countries, we have worked on that. Cancer program. Breakthrough designation for mTNBC, breakthrough designation for mTNBC with patients who have brain metastasis. We have 7 or -- 6 or 7 patients that have brain metastasis, and that's the progression-free and overall survival has been impressive, and we're going to file that. And we also have breakthrough designation for basket trial that we are analyzing the data. We think if the data is as good as mTNBC, we will find that too. We also are studying -- we're going to be starting negotiation with our CRO at Brazil to do a cancer trial with it. With COVID-19 situation, CD17 enrolling, CD16 is enrolling. Long hauler new trial is set to begin now. We're ready to go. No CRO is selected by Dr. Recknor. Regards to NASH, we have data from open arm. It's very strong in our opinion. It's just only a few patients. We will announce those very soon and potential breakthrough designation if the results are coming out as good as we've seen so far. And in regards to autoimmune disease, we haven't done anything. So all of this is this, is this too good to be true? That's what we've been hearing. Speaking up on other article 1 time is really too good to be true. Well, I think we can answer that, right? PRO 140, leronlimab was purchased with $3.5 million down payment. CytoDyn has only 1 molecule in development. That's the leronlimab and our market cap is now at $1 billion. Is that too good to be true? If I would tell you, 7 years ago, we're going to buy this for $3.5 million and our market cap would hit $1 billion and sometime we also had 3.5x larger than that. So if that's the beginning of very, very good things to happen, it's because of the hard work of last 7 to 9 years to have not dropped the ball in any of these areas in my opinion. With that, Ana, can we please go to Q&A?

Absolutely. Great job, gentlemen. Just a few questions on here. I'm just going to start from the top. So on the last call, Dr. Ray says BLA resubmission is ready to begin. On previous calls, you stated that resubmission has already been initiated. Please clarify.

So the -- you're talking about the BLA submission, correct?

Yes, the resubmission.

So the BLA submission is going to be happening rolling review in November. We have to hear back from FDA. FDA asked us to give time lines, and we gave our time lines. And as soon as we hear from FDA, we can submit that. Dr. Ray, am I correct to say that?

Has granted rolling review, that means that when we start submitting other nonclinical and the CMC, they will start reviewing those sections. However, the approval of the day, that don't begin until we submit the last section that is -- the clinical section. That will happen in the first quarter. And then the review clock will start from that. At that point, the FDA is going to -- and it will take about a couple of months for FDA to tell us whether they'll accept it or not. The last time we got a refusal to file. And this time, I think that our BLA is strong enough that, that is not going to happen. And then they are going to give us the PDUFA date from that point. Whether do we get a priority review or it's a normal review, we'll know that after we submit the BLA.

And one thing I would like to add, if I may. Dr. Ray was in charge of submitting the CMC section of the BLA. It's not the most important one. Big pharmas sometimes get complete response rejection because of the manufacturing problems. So when he says we are going to submit a much different package, the history of what he has done in CytoDyn has been tremendous. And the nonclinical portion also, we didn't have that much problem, but there was quite a bit of work that Dr. Recknor was involved with other people to get it done to update it with all the new information. So those will be done and the clinical section under Dr. Ray will happen, in our opinion, in a very solid way.

And the CMC and nonclinical are extremely important for all of our other indications going forward. So I want everybody to understand, it's really the foundation. All we got to do a show efficacy, and we can get multiple indications and multiple approvals.

And the other confusion may have been that we filed a draft dose justification with the FDA. We asked them for guidelines on the submission and along with asking about the receptor occupancy, that's what we submitted to the FDA. And based on that core permits and working with them over a period of months, we're now able to submit the actual BLA starting with the nonclinical in November.

Okay. Thanks for that. Amarex is no longer analyzing test data. Does CytoDyn have a means now to get the new data analyzed? And what is the name of the replacement company?

So not only we will have CROs in place, which we have Synbio, we have other CROs that are talking to us. They have sent us their MSA, master service agreements, but also we are hiring. Dr. Nitya Ray is hiring top professionals from big pharmas to be our bioanalytic person. We have already hired -- he already hired biostatistician, very top person from pharmaceutical. Dr. Ray, can you talk about the biostatistician background?

Right, right. So we have started to strengthen our team here at CytoDyn. I mean we got our new CRO, it's not only that the CRO will do the job, but we need our own team, our internal team, who can manage what with are CROs and manage them. And we were lacking in that respect, particularly on the clinical side of the CMC. When I joined CytoDyn, I built our own team. We have a small group of CMC with a core competency. So therefore, the CMC package, so far, we have been very successful working with Samsung and having that amount of drug in our inventory. So we are focusing on the clinical. And we have just hired, actually, he joined yesterday, a biostatistician with 30 years of industry experience. He was at 25 years with GlaxoSmithKline and also 5 years with the [indiscernible], who is a big CRO. So he just joined and we are working with him, and we are going to be sending out request for proposals to multiples CROs. And we will select the CROs based on their strength in their respective areas. It's possible that we might -- we have more than 2 or 3 CROs. And 1 CRO will be working on oncology, 1 will be in infectious disease, one will be on the NASH. NASH, I believe, we already have a CRO that Dr. Recknor has selected. So -- and then on the bioanalytical person that we are, right now, she has not joined yet, but will be joining in the next few weeks. And she is also coming with that experience from Pfizer and other pharmaceutical companies and the biotech companies. And we believe that we need that person to manage all our bioanalytical work, including biomarkers as well as PK. And we are in the process of hiring a clinical regulatory person. We hired a CMC regulatory person, Dr. Srinivasan, and we are in the process of hiring that as well as strengthening our clinical project management group.

Thank you. So we have hired a very strong regulatory person for CMC. We have hired bioanalytic person that's going to be hired, and it's almost ready to sign for us. And Dr. Ray, we also have -- got the biostatistician. We will also bring a regulatory person for clinical and project manager, and we will be overlooking everything the CRO will be doing for us from here on, and we will not have the problems that we saw before. Dr. Recknor, anything to add to that?

No. But definitely overlooking everything and making sure that we stay on time.

Perfect. Thank you. Go ahead.

When will GvHD start moving forward again?

So the GvHD, when we first started that trial, we had humanized mice through that study that we were supposed to give to FDA. As the study went forward, there was a couple of other product got approved. So there was no longer -- we could get breakthrough designation. However, going forward, with the market side of something that was $200 million, $300 million, that was something that was draining us. Our CRO was not the right CRO also. But besides that, we believe that the product had to -- our chances to go into cancer and other areas is so much larger market size, and we didn't want to put too much effort anymore in GvHD. So the GvHD is on hold right now, and we will not start GvHD. We will need to get approval for one of these indications that we are going and then everything else is there for expansion.

Have you filed a patent application in Brazil?

Our patent, Dr. Kelly, could talk about this. In 57 different countries, and it's over 80 or maybe even more in our patents. So Dr. Kelly, do you want to add anything to that?

Yes. We're going to be looking at -- and we're -- really strengthen our patent portfolio with multiple indications all over the world. That's all I can say about that.

Yes.

So do you believe long-hauler syndrome is mediated by the fractal and pathway?

Dr. Kelly, Dr. Recknor, do you want to comment?

No. [indiscernible] comment on that.

Yes. Our biomarker lab is picking up some different things that are going on with these patients. And I mean, the one thing we do agree on is that they really need a lot of help. There's a lot of people suffering out there.

Right.

This next question is for Dr. Ray. A most likely scenario of approval based on your thoughts, the combination therapy, COVID Brazil or mTNBC. What is the likelihood to get an EUA by the end of next year for any of these?

So this question is for who?

Dr. Ray.

So I should perhaps address that first and then Dr. Ray can add to that. Emergency use authorization for Brazil, the interim analysis only can happen if we have 127 patients. It won't happen if we don't have that patients. So providing we get that -- we believe we will hit our primary endpoint. Why? Because the similar indication endpoint in our CD12 as a subpopulation was analyzed, and that was patients walking out of the hospital when they were on ventilator. 166% better the results in leronlimab arm versus placebo. So is it possible to get approval in the next 12 months or by the end of next year? We said absolutely it's possible to get approval in the next 6 months. Now that might be very aggressive, but I'm counting on leronlimab getting breakthrough designation in cancer, breakthrough designation in NASH and having emergency use authorization. Am I being too optimistic? We will let the results talk for itself, and I don't think we're too far away from that. Dr. Ray, do you want to add anything to that?

Yes. I think on the mTNBC, we do see a similar pathway that sacituzumab govitecan got approved. When they got approved, they had a breakthrough designation that what we are submitting the application or submitting by next week. So it will take FDA for about 60 days, we'll hear from them. And there is a good chance that we'll get the breakthrough designation on that. And the regulatory pathway for our sacituzumab was that they did a 1-arm trial. It's a Phase I, Phase II trial. And based on the trial and just based on the objective response rate, they were -- FDA granted them accelerated approval pathway. So based on that 1-single trial, that -- it was approved. I mean that was delayed because of the CMC issues, but they were and they were approved based on 1-single arm trial. And then post the approval, they completed Phase III trial, that -- it was -- is a placebo controlled, not a placebo controlled, it's a 2-arm trial. The standard of care versus sacituzumab, and they got a full approval. So I think that a very good chance that we would pursue that regulatory pathway for mTNBC. And based on the data that what we have seen and what Nader was leading to that significant difference that we have seen, even for the patients who responded after first dose on the circulating tumor cells, these patients were manyfold better what we have seen. Always a small number of population than sacituzumab. So much even C4 -- sacituzumab is about 3x better than the standard of care chemotherapy, and we are seeing much better results compared to the sacituzumab. So we are very optimistic and very hopeful that this is the pathway to see that.

And that product sacituzumab and standard of care have similar side, I think, Dr. Ray. Am I right?

Yes. Actually, the side effect in sacituzumab is greater than like chemotherapy. It has blackbox warning for neutropenia and that's worse than the standard of care. And we believe that, based on some of the data that we have seen on the monotherapy, we will do a Phase II. I think that would be -- I think we are still planning. We'll a 2-arm trial, 1 with a monotherapy, 1 with leronlimab, with [indiscernible] of physician choice. And monotonically, we believe that, that is, by itself, I figure they be in the similar efficacy data, we got approved because of this less side effect.

Thank you so much. Great explanation. Go ahead, Ana.

The mTNBC data is in combination with chemotherapy. So how can we know the relative contribution of leronlimab versus chemotherapy in the study?

So the historical data, we talked about that before. Historical data is like over 12,000 patients have taken a look at the data. And when that large number of data shows that the average overall survival, for example, is 4 months or 5 months or whatever that is, then we use that number. And we do the same thing with progression-free historical data. We did that with monotherapy, and we're going to FDA for monotherapy for HIV with -- based upon historical data of what happens to HIV patients if they don't take their medication. So we have data from -- for the placebo on that we would say, which is the standard of care. Dr. Kelly, do you want to add anything?

I think that's fair. It's based on historical data. And also remember, we've had some monotherapy patients as well. So [indiscernible] a small subset of the population. But I think in terms of side effects and everything that we have a distinct advantage.

Yes.

Okay. Is the HIV monotherapy possible with a once-a-month injection?

I don't think so.

I will add one thing about that, Nader, is we have looked into some things about modifying the antibody, and there's the potential to make it a much longer-acting monoclonal. That is very possible to believe the molecule is stable enough to do that. So it's very interesting for the long term, but maybe not so much in the short term.

This is very good at what you're saying, Scott, because people just have to realize once you touch the molecule and change it just a little bit, you got to go to Phase I. That means it's going to take us time. But Dr. Kelly has been working in coordination with Dr. Jonah Sacha, we are seeing some very strong results that we've been modify certain part of this molecule, if it could be once every 3 months even.

That's correct.

Those are the things are all going to be post approval. We've got to get the first approval, show to everybody that this product can be in the hand of the people for the population that we get approval for.

Why did you select 225 as the number of patients for long haulers? Why not more?

Dr. Kelly, I mean Dr. Recknor, please?

So it's based upon our prior experience with CD15, the original long-hauler study that we did and also the endpoints that we're selecting for the new study, CD18. So it's calculated out. And we actually have an interim analysis at 90 patients.

And let me just add this. When Dr. Recknor says 90-patient interim analysis, that means with the 28 patients in each arm -- 27 and 28 patients in each arm, only 56 patients, our p-value was 0.269. So 0.27. So if you increase that by twice or 3x, which is 90 patients, then you could have primary endpoint of -- I mean 0.05. So the result that he generated gave us tremendous guideline of what to do now. And to that 225 is much more than what we need, we believe. But we will see what happen at the interim analysis.

Any more information on the recent academic research organization collaboration? And are you planning on using AI to analyze the data?

So we do not want to talk about it, right, Dr. Kelly?

Yes. In terms of academic, I can tell you that we're in -- not only have we been in agreement with 1, but we're in contact with multiple different academic institutions that are interested in a lot of different things with leronlimab, not only cancer, but many different things. And in terms of planning on using AI to analyze the data for the clinical trials, that's not necessary. But we have been contacted, for instance, by a major academic institution about using AI to help us with the mechanism of action studies.

Is the CytoDyn agreement with Samsung Biological (sic) [ Samsung BioLogics ] still in effect for the same projected unlimited number of leronlimab vials?

Dr. Ray, you want to please explain?

Yes. In 2019, so it -- we [ test ] like 6 years of the commercial production, and then we can extend it. So it doesn't say that it's unlimited production, but it has a minimum number of batches per year. So we have already fulfilled that for the first 2 years. And then we do the forecast. We provide 5 years of forecast and then a number of years at the binding. So we are already -- that is the program that we have in place and we correlated Samsung over time, is that we do have manufacturing schedule for next year as well as 2023. And these are all binding and we have forecast for future years. And then if we need -- Samsung has a huge manufacturing capacity, but they are also very busy, and we realize that. So we have to think ahead before we book a slot at Samsung. And some of the raw materials because of the supply chain constraint and more so because of the pandemic, some of the raw materials, essential raw materials, it takes like 6 to 9 months just after ordering that -- at the time that they will receive the raw materials. So yes, and also Samsung is expanding their facility. So they will have the -- I think, they are more than 60%, they're going to expand the capacity in the next year or so. And we have a very good relationship with Samsung, and we don't believe that will have any issue in terms of drug supply going forward.

This is very important for everyone to understand. When 2.5, 3 years ago, we went to the Board and we asked them that we're going to spend $30 million, $40 million to get our technology transfer. All the Board members were questioning why, and we had to raise. We had to use shares and raise money by selling those shares. And we are in the position of 1 million vials because we sacrificed, during these 3 years, spending and raising money and being very careful with dilution. But now that we are at this point, we also still have to have -- we have to raise money because what happens if we get emergency use authorization in Brazil. 700,000 was go -- already -- and then -- the -- we follow the Philippine EUA. If we get Brazil to follow, then you don't have any more vials after that. So we have to keep our date that is assigned to us. If we don't, we lose a year, it goes to the next year. So when we say we need 200 million shares more to show strength with -- pharmas are also -- we're going to use some of that, I don't know, 30 million, 40 million, 50 million shares in the next several months to make sure that we have product. If we don't, it will be a disaster when we have approval and we don't have product. Go ahead, Ana.

Another question about Samsung. Some investors online have pointed out Samsung not being mentioned in the most recent 10-Q. Could you put that speculation to rest and discuss why there's no mention of them?

Yes, we can put it to rest right now. There is a lot of talk from these other people that I don't know why they sometimes say all this negative thing. Dr. Ray did an incredible job getting us into Samsung. And no, let's put that to rest right now.

Okay. Great. How come Seenu Srinivasan has not been introduced to the investors?

Well, we have our executive team here right now that were talking about the things that they are in charge of. Dr. Ray is in charge of the -- as a Chief Operating Officer, in charge of all these activities. Dr. Seenu is one of the people that he brought in to help with the regulatory portion of manufacturer. We have about another 10, 15 people that we work with, and we just can't bring everybody to the -- any meeting. We just have the executive team talking about what they are doing.

He's, right now, he's very busy with the BLA. So we are submitting our CMC next month. So we're all extremely busy to finish that section of the module of CMC, yes.

Recent Philippines newspaper stated Merck COVID pill would probably receive PH EUA after receiving U.S. FDA EUA. Is that your understanding of the process? And what are your expectations?

We don't have any expectation because we don't know the stories. I mean Dr. Kelly, and Recknor, and Ray, can talk about it if they like, but we don't concentrate on those for critically ill population. There is nothing out -- patients who are dying, there's no approved drug that I know, but I don't know if Dr. Kelly have anything that he wants...

I mean that's [indiscernible] process in the Philippines, but I think it's unique in terms of what Nader said in terms of the critical population. I think if we do our interim analysis and have strong results, it's very, very possible to get an EUA.

Yes.

If HIV combination therapy market is no longer a top target for CytoDyn, would you consider partnering with an established player in the HIV space to both move the BLA forward and have an established sales force?

So everything is priority. There is nothing here that's not priority, that's why we have extensive team now. And we -- whenever there is a let down on something, we try to bring somebody who can do a better job and different organizations. BLA has been #1 priority always. And let me just explain if we did not have monotherapy, if we did not realize that we actually can inject patients with 2 shots, 700 milligram, which is twice the amount that Progenics had these were optimal. Their optimum was 324 milligrams and it was 2 injections. They believe that you will need 4 injections to administer 700 milligram. When we were able to overcome that and gone through a lot of hard work to get to that, and thanks to Dr. Jake Lalezari for that also. And when we got to the 2 shots with 700 milligram, we realized that our cancer trial without 700 milligram wouldn't be as good as it is. We wouldn't be able to discover that monotherapy can be approved for 90% rate post induction period of time. Everything was dead. So we found something very spectacular, but that delayed us because when you have vials of 175 milligrams, now you have to make vials of 350 milligrams, that's not at the 1 year, 1.5 years of going through the manufacturing, further stability for a year and so forth. So at the price of getting delayed with the BLA with that, but we discovered so much more things for ourselves. And at this time, the BLA is very crucial for us. Dr. Ray, as he explained, we will be submitting a very strong application under Dr. Ray's leadership.

And I'll add just one more thing. We do have a partner already in HIV combination therapy with an established sales force.

What CRO are you using for the long haulers trial?

Dr. Recknor?

Synbio.

What is the regulatory pathway for long haulers?

Well, if we have -- the data comes out as strong as we hope to come up, we will definitely talk to the agency and see if we need to do Phase III or if we could get breakthrough designation. If all of those pads will open up, if the data comes out, and we know what the data is.

Were tropism studies done on all patients in the BLA or just the [ RO ] studies?

So when we say tropism, I hope everybody understand. There are certain patients that cannot take leronlimab in HIV setting, not in cancer, but in HIV because the tropism that we're talking about, it's going to recognize whether the virus is R5 or X4. If there is X4 virus, then leronlimab does involve. Naive population that means patients with HIV haven't taken any product are 90% or more R5. As they get resistance more and more, this percentage goes down to 50% or sometimes you have 40%. That's an MDR. That's multidrug resistance. That's the combination Progenic was going after and it's a very small population. But with monotherapy, we checked the tropism. With the combination therapy, we checked the tropism. That's a requirement. FDA would not let us enroll a single patient without that. Our -- or a receptor occupancy is a whole different thing. We're trying to add that to recognize the patient's receptor occupancy with leronlimab.

Can you discuss the competition in the NASH space?

I discussed that before, but I'll tell you, again, I think that people are looking at a variety of different potential mechanisms of action in NASH because it's an immense opportunity help a lot of people. And people are looking at PPARs and FXR agonists, et cetera. We believe that the reason that people develop scar tissue because of stellate cells. And we know that stellate cells are little bit CCR5. So we also have animal studies to support the reduction of NAFLD. So we think we're in a unique position, not only from limited side effects and potential synergistic opportunities and less drug-drug interactions, but also a once-a-week subcutaneous monoclonal and that's very unique in the space.

So Ana, we have heard from all of our investors that 1.5 hour question is a little bit too much. So let's go to the last couple of questions, and that's it.

Okay. Last couple of questions. Let's see. We have some questions about MD Anderson. So how long is the CytoDyn MD Anderson collaboration is supposed to last and talk more about that academic partnership and the long-term vision there?

Yes. I can't -- we can't talk too much about the specifics with different partnerships. What I can tell you is that the academic partnerships are continuing and some really, really unique things are happening that we're very excited about and we'll announce that when appropriate.

Okay. And can you share if there were any acquisition proposals rejected by CytoDyn?

Dr. Kelly, did you reject anything?

No. We can't talk about different potential synergistic opportunities with other pharmas until we announce it publicly and bring in the shareholders to vote.

So in September, you mentioned on a call that the CD10 and CD12 manuscript is prepared and will be submitted for publication within 2 to 3 weeks. Has that manuscript been submitted and which journal?

So they're working on that. There are 4 top people that we have. Dr. Kelly, do you want to talk about where we are with CD10 and CD12 manuscript?

Yes. And Chris, you can weigh in, but we basically completed the manuscripts. We can't announce which journals we're submitting to and we can't talk much about that, and the fear that they wouldn't publish them for that reason. So we're moving forward on all fronts. And actually, we have multiple other manuscripts that we're working on as well. Chris, do you want to add anything to that?

Sure. The long haulers was submitted for CD15. And the next 1 that our focus was on is CD02 for the pivotal HIV.

And CD10, I don't think we're going to really worry about that one at this time, but we -- it's not our highest priority. CD12 is and our Dr. Recknor is working with the key opinion leaders to get that published very soon.

Question for Dr. Recknor. Why did you choose to work for CytoDyn?

I chose to work for CytoDyn after being very sick with COVID in the hospital. My physician requested an emergency use for leronlimab. And I got the drug and felt so much better. I was in on a Friday and discharged on a Sunday. I've been having a lot of problems. I was a long hauler at that point in time. And so the passion from what that did for me, I want to try to make sure that the drug is able to be provided for other people so it can help them.

And one thing that shareholders should know they keep saying, why does the insiders don't buy shares? Dr. Recknor invested in CytoDyn also right away. And he's been a blessing for us, and I'm going to give the credit to the person who brought him to us, and that's Dr. Scott Kelly.

Great. Thank you, gentlemen. What was a lab that was used on the HIV receptor occupancy analysis that was not even validated?

I didn't get the question. Sorry about that. Can you repeat it, please?

Okay. They're asking, what was the lab that was used on the HIV receptor occupancy analysis that was not validated?

It was Dr. Bruce Patterson and not only it wasn't validated, but the assay that he used for the -- previous to that is CD12 was not validated. We asked for validation. He never gave it to us. He always says he well, but he didn't. And also we had problems with a lot of different things, but God bless everybody.

Okay. And there are different molecules for NASH in Phase III. Will you be able to compete?

For NASH?

Yes.

Absolutely. But I mean, look at our animal studies that we've done in the humanized mice. So perhaps with that, we can go to the last question, if you don't mind.

What obstacles do you anticipate in importing data from the Brazil trial to the U.S. FDA? And the proposed issuance of 200 million shares will dilute shareholders' equity stake by 25%, how can these be valuable? Last question.

So first of all, 200 million is not 25%, of 1 billion. So this is 20%. But we're not saying we're going to dilute anybody. We keep saying that, I mean, I don't know how many times we should repeat that. But we have 200 million shares authorized, that means you will be sitting in a bank, perhaps -- that -- and we're not touching that. We are only raising money when we need money to get more product. So when we get to the point where we have to have product sell, we have it. We're also going to use -- if we raised the funds to support all of the clinical trials. All these trials cost quite a bit of funding, and we are going to need to have those shares to support that. We're not going to be using that in a wild way, and our record of what we have done in the past speaks for itself. So you have to recognize as a shareholder, do you want us to stop working, everybody, and not have any money right now. Don't approve the shares and we won't have anything. We can all go home and just say goodbye to everybody. We have to have shares to raise funds, to get manufacturing, to support the clinical trials. Ask the FDA, the agency has data out there. It costs about $1 billion to get 1 product approved. We've got 31 of them. So we need to have funds, and we have been very, very frugal with all the shares that we have used. So please vote so we can continue this process and we are very close to approval in many things. So let's go forward. So with that, let me just give the last statement, if you don't mind, and conclude the call today. So I don't know if somebody can actually go and find out if there is anything close to what we are, we have looked at 31 indications. We have not dropped the ball in manufacturing and have product to be able to sell right now if we get approval. We have been doing all of these in a very difficult time at some point where we had a change of leadership. So we had to change our vision. The new leader didn't want to go to [indiscernible]. They didn't want to go to NASH, so nothing. We changed that. Dr. Scott Kelly and myself were very much adamant that we got to go in that path. We did that. And now we have all these multiple things that everybody can talk about. Long haulers, we're going to be starting a trial. This is amazing. We did our trial. Dr. Recknor did it and we showed the FDA that there is potential for this product, clinical outcome. So we have a long-hauler trial, which we will start as a Phase II. And hopefully, if we could adapt to Phase III. We have NASH trial that we are very optimistic about based upon the animal studies that we had, and these new results that we are seeing a little bit at a time. And we have -- BLA finally figured out to do it in the right way. It was difficult to have 2 different trials for 1 indication. You don't do that. That was new. For FDA that was new. They had to actually go to advisory committee to get a vote to allow us to do that. I mean they did that. We were very happy that allow us to use our safety data from monotherapy. So all the stuff that we have done so far to get us that many opportunities is getting closer and closer to some very crucial stage. Do not make a mistake by not looking at the fundamental. Look at the fundamental. Do we have anything fundamentally that we have achieved that is very, very close to some solid ground? And if it is, then let's continue going forward and let's have the votes and please vote immediately. There's only 2 more days left. We need the vote, and we need the 200 million shares to be able to survive. If you want us to continue this performance that we have and if you're happy with us, please vote. Thank you, everybody.

Well, thank you, gentleman so much for this great presentation. And we certainly hope to see you back on the Emerging Growth Conference very soon. And yes, please vote. All right. So this is it for us today. Lots of questions still for you, so we'll send them to you, gentlemen. But on behalf of all of us at Emerging Growth, we want to thank the CytoDyn executives for such a fantastic and informative presentation. Now everyone remember that in just a moment, you're going to be redirected to the registration page for the next conference, which is tomorrow, so stay on to reserve your spot, if you would like. As always a complete replay of this event will be made possible on the Emerging Growth Conference YouTube channel. Also follow us on Twitter. That's @EmergingGrowthC. We post all information there first. I'm Ana Berry and on behalf of myself and everyone on this team that made this event possible, we wish you all a great day and a very successful week, and we'll see you tomorrow at our Emerging Growth Conference. Thank you, everyone.

Thank you.

Thank you.

Thank you.

Thank you.