Good afternoon, everybody. Welcome to the first CytoDyn Investment Community Webcast. I'm Ana Berry, and I'll be your host today. CytoDyn Inc. on the OTCQB, it's CYDY, is a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, and is holding its first investment community webcast today. CytoDyn will present for 30 minutes, and 60 minutes will be dedicated to live questions and answers. 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. This webcast will be uploaded to the Emerging Growth Conference YouTube channel, so subscribe. youtube.com/emerginggrowthconference. 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. If you do experience downtime for more than a minute or two, just refresh your browser. 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. Please stay on. All right. Today joining us, we have Dr. Nader Pourhassan, the President and Chief Executive Officer. 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. Christopher Recknor, the Senior Executive VP of Clinical Operations. Welcome, gentlemen. Thank you, Ana. I appreciate it for having us. Well, we look forward to your presentation. Great. Thank you, Ana. Thanks, everyone, for being on this presentation. We will be covering quite a bit of a forward-looking statement, 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 had one indication. Now we are pursuing 31 indications. I simplified these 31 indications to five areas. The last area is we haven't started anything autoimmune disease. So four areas that covers the 31 indications is what I wanna just talk about briefly. In regards to HIV, we have got a product that Progenics had spent 12 years developing it to the point where the FDA had allowed them to do a phase II-B in combination therapy. That's it. Just a combination therapy. The market size for that combination therapy was only $30 million-$50 million, and it's MDR market, which is multi-drug resistance market. Now, that wasn't something very appealing to us, so we tried to talk to other key opinion leaders, get everybody else's opinion, and we tried 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. That's not the path we wanted to go forward because FDA in 2009 had told Progenics, "You have three 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 abuse population combination therapy. We did not do that. We actually talked to a lot of key opinion leaders and re-realized that there might be a chance to go after monotherapy, a market size of $5 billion. Now, this dollar amount that we throwing around, these are all backed up by reports, independent, some of them, which is, like BioVie report, the Sinews report, and we put those in the website. 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 eight or nine months from beginning of that monotherapy to where we got enough results to go to FDA saw that we did 12 weeks. We had 12 weeks of efficacy of leronlimab. FDA said, "Well, we're gonna let you have a phase III pivotal combination therapy. In parallel, you can do monotherapy. Then they said your monotherapy is very different than anything they had ever seen, and here's the 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, you know, label expansion for monotherapy." What is it that they were talking about? What success? Well, they said it before that. The ultimate goal would be to identify those sub-populations who are best suited to PRO 140 monotherapy. What was our result when we went there with the CD01, the first 40 patients in monotherapy? Well, here it is. They said, the FDA say wherein 25% of enrollees remained virologically suppressed at more than two years. The remaining 75% experience virologic failure. How do you go forward when you have 25%, you need 90%? 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%. We had to go to a different dosage and a few other things that we will talk about in a minute. That wasn't the only thing. We also wanted to expand HIV itself to where we perhaps can go for PrEP, prophylaxis and prevention. That market size is $3 billion. The only thing for PrEP that was out there a few years ago was Truvada. Now they advanced Truvada to call it Descovy, which is much better than Truvada. The patients have to take pills. Not the patient. The individuals who are at risk of HIV have to take those pills. We believe leronlimab could be once a month PrEP prevention, and we're gonna be following with that also. With all of that, we didn't stop with HIV. We realized that there could be potential for this product in cancer. We started a phase II, a phase I-B trial that now we have results from compassionate use protocol and this phase I-B/II, and that data is allowing us to file two breakthrough designations, which we haven't yet filed the first one, and we are gonna talk about that a little bit today. We also have basket trial, which was very unique for us to be able to go for 23 indications in one trial. That we will talk about it also when we get to that. We have results from that trial also. We are analyzing that. Meanwhile, COVID-19 happened. When COVID-19 happened, we realized that we could have potential in there. Why? Because Dr. Harish Seethamraju, our hero doctor from Montefiore, called FDA and emphasized that he believes in the literature that was published, that leronlimab could have effect. And definitely it did have effect according to him for his patients. That started the road to COVID-19. He wasn't the only one. Dr. Harish Seethamraju from Montefiore led the way, but then Dr. Otto Yang from UCLA got ahold of that, and he enrolled quite a bit of patients in emergency IND, I believe over 30 patients. We got Dr. Nicholas Agresti, who said, "I have four patients that would never made it," and he gave leronlimab to them. We have another hero doctor in Philippines who really believed in this product, Dr. Randy Nicolas, and he led the way in Philippines saying that this product works. Now, there was a paper published by these gentlemen and others even, and Dr. Harish Seethamraju published his findings in a peer-reviewed journal. Dr. Otto Yang published, and Dr. Nicholas Agresti published papers. We therefore went and also signed a licensing agreement with Biomm in Brazil and with Chiral Pharma in Philippines. Now, these are extensive tasks to accomplish. This is not something you can do overnight. These take time. We pursued it 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 laughed because I said, "Come on, NASH will take forever to enroll." He said, "Not with me." I couldn't second-guess him on that because he already had proven me wrong in previous COVID-19 when he enrolled patients in a pace that I'd 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 CROs that we're gonna talk about. 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 gonna be talking about that soon. Dr. Recknor led this study of NASH from beginning to the end. Personally, he's responsible for this success, and I cannot thank him enough. It was the fastest enrollment or what we hear that nobody enrolled 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. He has done an unbelievable job. 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 reduced. We had the animal study in cancer that shows the 97% reduction of metastasis. Those we take it very serious now because we see that the human data matches those humanized animal studies. Long haulers data, Dr. Chris Reckner again, did a fabulous job. It was his idea to start the long hauler. I never thought it's gonna 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 a adaptive trial. That trial, we went through FDA and we talked with them and modified the protocol and we are going to start the trial now. We're ready to start. We're gonna be announcing that also because we're clear to start. What is the market cap—I mean, I'm sorry, the market size of these potential indications? I put these links in my code here, in our code, I'm sorry. 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, IV infusion, they're reaching those market size. Monotherapy, $5 billion, it was in the report. PrEP, there is a lot of report on that, $3 billion. Truvada sold for that much. 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 would realize post-launch, perhaps two or three or four years after that, but these are very large numbers. Cancer, again, there are links here, so people can check for themselves. A $158 billion market size. Even if we realize $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. NASH, same thing. With autoimmune diseases, we haven't started any of those indication, but we will. But we like to get our first approval before we get any more indication because we got our hands full with all the work that we have been doing. Now, if you look at and say, "Was this really impressive or not?" Look at the other companies, how they dealt with leronlimab. Progenics had this drug. In 12 years, they had three weeks of efficacy of leronlimab. Within 10 months, we got much more. If seven years ago, I would have told shareholders that in the next 7 years, these are the number of trials that we will be conducting, instead of having 12 years and 160 or so trials that they did, Progenics did 168 patients, enrolled 168 patients in three and three weeks of efficacy. If I would have told everybody, less than 12 years, in seven years, we will enroll 1,445 patients, they would tell me, "It's too good to be true. It's not right. It's not gonna happen." They did tell me that, a lot of people. If I would've said that while we do all of these, we would generate $400 million potential value for our product. That, that's how much commercial product. Commercial grade is a whole different ballgame than clinical grade. People who are in CMC would appreciate that. We're gonna use $400 million to get there, and we're gonna raise that funds. 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 wanna go forward. We have a protocol synopsis agreed to with 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 abroad, Brazil, perhaps. All of our extension trials have been now transferred to other CROs. I'm gonna ask Dr. Chris Recknor, you have moved the extension trial data all over to Symbio. Can you talk about that, Dr. Recknor, please? Sure. We have the data that we're 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. I guess while we're doing that, you're gonna be telling them about the BLA submission then. Yeah, but the one question I like to have you answer for the shareholders' sake. What was the problem with the data that was over there at Amarex? Did we have all the data in a organized way in EDC, electronic data capture, or was there problems that you wanted to move out of there because of? Tell us why, please. 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, new consultants, and making a lot of progress. Regarding the data, though, it's important that proper procedures are adhered when you're looking at the data and working with the sites. At one 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 three to four years, seven years for five patients, and more patients in extension, about four years long in the CD02, too. If all of these patients are in extension, which was larger number, and if there was 566 patients in open-label 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 it. I mean, Dr. Recknor says he's gonna move it to a place where we can get those things left and right and be able to understand that. That was huge. He looked at quite a bit of stuff in that regard. Am I correct, Dr. Recknor, about that? Absolutely, Nader. 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. When we go to BLA, biologic license application, there was quite a bit of stuff that was not happening. Let me just ask Dr. Ray first, who's taking care of this, receptor occupancy, which was a problem. It was a joke that some people would say that they had made the receptor occupancy. It was never like that. Dr. Ray, like, tell us the status of the BLA in regards to those things. Sure, thank you, Nader. Yes, our plan is to submit the non-clinical and CMC modules next month, this year, November, and we are on target of doing that. The clinical module will be submitted in the first quarter of 2022. The area that we are really working on is that receptor occupancy study. 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. Right now we are working on the method validation. Great. Appreciate it. 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 Recknor, Dr. Recknor, did a fantastic job. Dr. Ray is now really helping great way, but tell us your view about that. Yeah, no, it was 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 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 hostage in our opinion. Now we are going to be able to really take off with the new CROs. Symbio will be for HIV. We are talking to other CROs like PPD, Parexel, and so forth. Now let's move to cancer. What are we doing in cancer? This report that you see here was going to be used to incorporate to an application for breakthrough designation. Dr. Nitya Ray has been really investigating this data, and we realized that we have to go actually instead of 30 to 28, two emergency IND patients were taken out. These numbers that you see in the bottom, 980% maximum amount of benefit compared to standard of care if the circulating cells are low after one injection of leronlimab. Now it's changed to over 3,000% when we took those two patients out. 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 reviewing this draft. We believe that the first breakthrough designation application will be submitted in the next few days, definitely by next week, if not this week. When Dr. Ray say, "If not this week, next week," we said before we're gonna do it this month. But Dr. Ray also found out that some of these patients, one or two, maybe three, were on monotherapy for one year. Monotherapy. This is cancer patient in 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. We're very excited not only about synergistic opportunities with liraglutide, but also the potential for monotherapy and a subset of the population that can't tolerate, you know, traditional standard of care. Excellent. Now 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 that same table on the top, we wrote first dose injected at day seven, but that's not correct. It was injected, injection happened at day zero, seven, 14, and 21. Analysis of the data at day seven revealed that the survival benefit of leronlimab arm versus placebo was 78% after seven days. At day 14, which was after two injections, the survival benefit was 82%, and then we didn't give leronlimab anymore, so it went down to 50%, 31%. Now, this 31% also was 24% before, but once we cleaned the data, we realized that that day, that number was a little bit higher. What do we think is gonna happen in Brazil? Obviously, that's our prediction. That doesn't mean anything right now unless you have that data to show. Having the same kind of progression of getting better with four dosage, we believe this is the kind of data we're gonna generate, and hopefully, we will be able to hit our primary endpoint, God willing. With the long haulers, Dr. Chris Reckner again did a fantastic job. What we had was 56 patients, 100% better clinical outcome on 24 symptoms lumped up together was seen. The symptom improvement was 16 in leronlimab versus placebo eight. P-value was not hit with 56 patients. Obviously, 28 in each arm. We didn't expect that. Now 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, lit searches to come up with a new protocol. I'm real pleased with it. There's a wait list of already about 500 people. We currently have it designed for 225 people. It's a one-to-one-to-one ratio, so we're testing 700 versus 350 versus placebo. I really look forward to getting these people some help. The good thing about it would be two out of three patients will get leronlimab, which is very good for us. 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 FDA. They're figuring out what to do with the trial. Please tell us. Yeah, 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%. 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 and need help. Obviously, this is a tremendous opportunity for CytoDyn and its shareholders and for patients alike. Thank you. We have great news that Dr. Recknor went back and forth with the FDA, and our regulatory team have cleared us to start the trial. Dr. Recknor will start that. There's a group of people waiting. I'm gonna time him when he injects the first patient to the last patient, and I wanna 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 zero patients in 11 months, and then we enrolled the 1 patient. It was incredibly painful, and we always had to figure these things out. We solved that problem, and that problem solver is Dr. Recknor. Okay. 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 Philippines who are familiar with leronlimab in 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 Pharma people who came to United States, and we met with him yesterday, all of us, the whole team, all four of us. We are very excited about what he was saying. I don't know why these slides are changing by themselves, but 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. We can see the numbers are rising, number of orders, the quantity of the orders. In Brazil, everybody is telling us, "Why is nobody enrolled yet?" We need 600 to our patients in severe population. We don't think we're gonna hit our primary endpoint at interim analysis. I don't think so. Maybe we will. Some scientists think. With CD16, we think we're gonna 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 that the rise of this new virus, which is making more patients being sick. We are seeing in the hospitals for severe and critically ill. If there is a wave, and if there is problems like we have seen in the past, this enrollment of 127 patients could happen very quickly. We have to be cautious because we need to have that to see that happen in order to be able to enroll quickly. 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 patient who were double blinded. The 350 milligram, which was again, Dr. Chris Recknor's idea. After looking at the mechanism of actions, he thought 350 mg would also be very nice to look at, and he was absolutely right based upon the three results that we're seeing so far. We're very excited about it, but obviously we have to be cautious to see more data, and we will be announcing those data. Dr. Recknor, do you wanna tell us whatever you like about this trial? Well, we're already designing the IIb for biopsy and can get that started within the next, either end of 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. Dr. Kelly, you can comment on the prior animal studies. We believe we're gonna be seeing the same thing. Yeah. I'd be happy to. Yeah. Those were immunized mice, and what we saw was a threefold reduction in fibrosis or fatty deposition. I think what's unique about this is not only could you be using this in a 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 to stellate cells and CCR5. Stellate cells are what produce the scar tissue. There's a lot of different, you know, whether it's PPAR inhibitors or, you know, THR-β selective and all the other different potential mechanism 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 interactions. I think it opens the door for a lot of opportunity, not only as a monotherapy, but as a synergistic component. 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. No, thank you, Dr. Kelly and Recknor. The manufacturing, Dr. Ray has done a fantastic job with this. We have seen what he was able to do, getting us commercial product. Dr. Ray, we're gonna be using Samsung for our first BLA, am I right? That's correct. The BLA, the run that we have, the next year run, that would be the one that you're probably gonna use for auditing the site for the BLA? Yeah. Okay, perfect. We are set with Samsung being the manufacturing for the BLA. Before it was different. It was HEC, and Dr. Ray have changed it, and we're 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 gonna go and sell those next week. We were very, very careful with what we have done with our fundraising, and I really would like to see people look at other companies, if they don't mind, OTCQB, and look at how they raise money and how much dilution they were able to absorb while they were raising, and compare that to our numbers. I think they will be impressed. People will be impressed. As we said before, there are four different ways to raise money for us. There are other ways, but main four ways for us was always PIPE, Reg D, note, and loan. With that said, now I'm gonna ask all the shareholders to please make sure that you go and vote. Please note that when you hear from people that this company is gonna get 200 million shares because they wanna give it to the executive team, that's not correct. If you check the percentage of what I own as shares of CytoDyn, less than 1%. Usually CEOs, after 12 years, nine years, they get to get 10% or 15%. It's not happening the way people are telling you. We need your vote, so we can conduct a business by having 200 million shares, which will make us look very strong to the pharmaceuticals. Dr. Kelly, you wanna talk about that, about business development? Yeah. No, I think it puts us in, really in a position of strength. As Nader said, this is not shares that's gonna go for the executives. This is a, as some group has said before, this is just simply not true. 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 are looking for pharmaceutical partners. Thank you. To summarize everything, let's look at the four areas that we attacked in the last seven years, and let's see what we have done real quick. HIV, we have new CRO. Thanks to Dr. Recknor, it is all ready to go. 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. CD001, CD02, CD03 extension study to move that to another CRO was a very difficult task. It's completed, and it's still being worked on. BLA is on track now. Dr. Ray is completely in control. Non-clinical 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 wanna make sure that that's ready to go and hopefully get approval for that as a label expansion at some point. BLA submission in other countries, we have work on that. Cancer program, breakthrough designation for mTNBC, breakthrough designation for mTNBC with patients who have brain metastasis. We have seven or six or seven patients that have brain metastasis, and that's the progression-free and overall survival has been impressive, and we're gonna file that. 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 file that too. We're gonna 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. New 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. in regards to autoimmune disease, we haven't done anything. all of this, is this too good to be true? That's what we've been hearing. Seeking Alpha had an article one time, is really too good to be true. Well, I think we can answer that, right? PRO 140, leronlimab, was purchased at $3.5 million down payment. CytoDyn has only one molecule in development, that's leronlimab, and our market cap is now at $1 billion. Is that too good to be true? If I would tell you seven years ago, we're gonna buy this for $3.5 million and our market cap will hit $1 billion. At some time, we also had 3.5x larger than that. If that's the beginning of very, very good things to happen, it's because of the hard work of last seven to nine years of the team that have not dropped the ball in any of these areas, in my opinion. With that, An a, can we please go to Q&A? Absolutely. Great job, gentlemen. Just a few questions on here. I'm just gonna start from the top. On the last call, Dr. Ray says BLA resubmission is ready to begin. On previous calls, you've stated that resubmission has already been initiated. Please clarify. You're talking about the BLA submission, correct? Yes. The resubmission. Okay. The BLA submission is going to be a rolling review in November. We have to hear back from FDA. FDA asked us to give timelines, and we gave our timelines. As soon as we hear from FDA, we can submit that. Dr. Ray, am I correct to say that? FDA has granted a rolling review, that means that, you know, that when we start submitting other non-clinical and the CMC, they will start reviewing those sections. However, that the approval date won'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. You know, at that point the FDA is going to, you know, and it will take about a couple of months for FDA to tell us whether they'll accept it or not. You know, 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. Then they're going to give us the approval date, you know, from that point. You know, whether they will get a priority review or it's a normal review, we'll know that after we submit the BLA. 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 one of the most important one. Big pharma sometimes get complete response letter, rejection because of the manufacturing problems. When he says we are going to submit a much different package, the history of what he has done in CytoDyn has been tremendous. The non-clinical 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. Those will be done, and the clinical section, doctor, under Dr. Ray will happen, in our opinion, in a very solid way. The CMC and non-clinical are extremely important for all of our other indications going forward. I want everybody to understand it's really the foundation. All we gotta do is show efficacy, and we can, you know, get multiple indications and multiple approvals. Yep. 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. Based on that correspondence and working with them over a period of months, we're now able to submit the actual BLA, starting with the non-clinical in November. Yep. Okay. All right. Thank you 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? Not only we will have CROs in place, which we have Symbio, we have other CROs that are talking to us, they have sent us their MSA, master service agreements. 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. We have started to strengthen our team here at CytoDyn. I mean, when we go to a new CRO, it's not only that, you know, the CRO will do the job, but we need our own team, our internal team, who can manage, work with the CROs and manage them. We were lacking in that respect, particularly on the clinical side. The CMC, when I joined CytoDyn, I built our own team. We have a small group of CMC with a full competency. That's why the CMC package so far, you know, we have been very successful working with Samsung and having that amount of drug, you know, in our inventory. 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 25 years with GlaxoSmithKline and also five years with Parexel, you know, the big CRO. He just joined, and we are working with him, and we are going to be sending out requests for proposals to multiple CROs. We will select the CROs based on their strength in their respective areas. It's possible that we may have more than two or three CROs, and one CRO will work on oncology, one will be infectious disease, one will be on the NASH. NASH, I believe, we already have a CRO that Dr. Recknor has selected. On the bioanalytical person that we are right now, she has not joined yet, but will be joining in next few weeks. She also coming with that experience from Pfizer and other pharmaceutical companies and the biotech companies. We believe that we need that person to manage all our bioanalytical work, including biomarkers as well as PK. 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. We have hired a very strong regulatory person for CMC. We have hired bioanalytic person that's going to be hired, he's almost ready to sign for us. Dr. Ray 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? 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 products got approved, so we could no longer get breakthrough designation. However, going forward with the market size of something that was $200 million-$300 million was something that was draining us. Our CRO was not the right CRO also. But besides that, we believe our chances to go into cancer and other areas is so much larger market size, and we didn't wanna put too much effort anymore in GVHD. 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. Thank you for that. Have you filed a patent application in Brazil? Our patent, Dr. Kelly could talk about it, is in 57 different countries, and it's over 80 or maybe even more now patent. Dr. Kelly, do you wanna add anything? Yeah, we're gonna be looking at really strengthen our patent portfolio, multiple indications all over the world. That's all I can say about that. Yeah. Do you believe long hauler syndrome is mediated by the Fractalkine pathway? Dr. Kelly, Dr. Recknor, you wanna comment? No. Okay. Chris, do you wanna comment on that? Yeah. Our biomarker lab is picking up some different things that are going on with these patients. 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. What's the most likely scenario of approval based on your thoughts, the combination therapy, COVID Brazil or MT-MBC. What is the likelihood to get an EUA by the end of next year for any of these? This question is for who? Dr. Ray. 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 those patients. 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 the leronlimab arm versus placebo. 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 six 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 wanna add anything to that? Yes. I think on the TNBC we do see a similar pathway that sacituzumab govitecan got approved. They got approved. They had a breakthrough designation on that what we are submitting, the application we're submitting by next week. It will take FDA about 60 days. We'll hear from them. Yeah. You know, there is a good chance that we'll get the breakthrough designation on that. The regulatory pathway for our sacituzumab was that they did a one-arm trial, the phase I, phase II trial. Based on the trial and you know, just based on the objective response rate, FDA granted them accelerated approval pathway. Based on that one single trial, it was approved. I mean, that was delayed because of the CMC issues, but they approved them based on one single arm trial. Then post-approval, they completed the phase III trial. It was a placebo-controlled, not a placebo-controlled, it's a two-arm trial, the standard of care versus sacituzumab, and they got a full approval. I think that a very good chance that we will pursue that path, you know, regulatory pathway for mTNBC. Based on the data that what we have seen and what Nader was alluding to that, you know, that the significant difference that we have seen. Even for the patients who responded after first dose on the circulating tumor cells, these patients were many fold better, you know, what we have seen. Always a small number of population than the sacituzumab. Much even C4 Sacituzumab is about three times better than the standard of care chemotherapy, and we are seeing much better results compared to the sacituzumab. We are very optimistic and very hopeful that, you know, this is the pathway to that, you know. That product, sacituzumab, and standard of care have similar side effects, Dr. Ray, am I right? Yes. Actually, the side effect in sacituzumab is greater than like chemotherapy. It has, you know, a black box warning for neutropenia. Wow. That is worse than the standard of care. I think. We believe that, you know, 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. Yeah. We have to do a two-arm trial, one with the monotherapy, one with leronlimab. Yeah With the chemotherapy of physician choice. Monotherapy, we believe that, you know, that is by itself, you know, if we get even the similar efficacy data, we'll get approved because of this less side effect. Thank you so much. Yep. Great explanation. Go ahead, Ana. The MT-MBC data is in combination with chemotherapy, so how can we know the relative contribution of leronlimab versus chemotherapy in the study? The historical data, we talked about that before. Historical data is like over 12,000 patients have taken and looked at the data. When that large number of data shows that the average, you know, overall survival, for example, is four months or five months or whatever that is, then we use that number. We do the same thing with progression-free historical data. We did that with monotherapy. We're going to FDA for monotherapy for HIV based upon historical data of what happens to HIV patients if they don't take their medication. We have data from the placebo arm that we would say, which is the standard of care. Dr. Kelly, you wanna add anything? No, I think that's very good. It's based on historical data. Also remember, we've had some monotherapy patients as well. I mean, granted, it's a small subset of the population, but I think in terms of side effects and everything, that we have a distinct advantage. Yep. Okay. Is the HIV monotherapy possible with a once a month injection? I don't think so. I will add, the one thing about that, Ana, 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. We believe the molecule's stable enough to do that. So it's very interesting for the long, long term, but maybe not so much the short term. No, 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 gotta go to phase I. That means it's gonna take us time. Dr. Kelly has been working in coordination with Dr. Jonah Sacha, and we are seeing some very strong results of if we modify certain part of this molecule, if it could be once every three months even. That's correct. Those are the things are all gonna be post-approval. We gotta 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. It was 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. It's calculated out, and we actually have an interim analysis at 90 patients. Let me just add this. When Dr. Recknor says 90-patient interim analysis, that means with the 28 patients in each arm, 27 or 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 hit primary endpoint of 0.05. I mean, the result that he generated gave us tremendous guideline of what to do now. 225 is much more than what we need, we believe, but we will see what happen at the interim analysis. Thank you. Any more information on the recent academic research organization collaboration? Are you planning on using AI to analyze the data? We do not wanna talk about that, right, Dr. Kelly? Yeah. In terms of academic, I can tell you that not only have we been in agreement with one, 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. In terms of planning on using AI to analyze the data for the clinical trials, that's not necessary. We have been contacted, for instance, by a major academic institution about using AI to help us with mechanism of action studies. Okay. Thank you. Is the CytoDyn agreement with Samsung Biologics still in effect for the same projected unlimited number of leronlimab vials? Dr. Ray, you wanna please explain? It signed in 2019, so it has like six years of the commercial production, and then we can extend it. It doesn't say that it's unlimited production, but it has a minimum number of batches per year. We have already fulfilled that for the first two years, you know. Then we do the forecast. We provide, you know, five years of forecast and then number of years of the binding. We are already, you know, the program that we have in place, you know. We coordinated Samsung all the time. We do have manufacturing schedule for next year as well as 2023. These are all binding, you know. Then we have forecast for the future years. Then if we need. Because Samsung has a huge manufacturing capacity, but they are also very busy, and we realize that. We have to think ahead, you know, before we book a slot at Samsung. 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 six to 10 months just after ordering, you know, the time that they'll receive the raw materials. Yes, and also Samsung is expanding their facilities, so they will have the. I think they have more than 60% they're gonna expand their capacity in the next year or so. We have a very good relationship with Samsung, and we don't believe that we'll have any issue in terms of drug supply going forward. This is very important for everyone to understand. When 2.5, three years ago, we went to the board and we asked them that we're gonna spend $30 million-$40 million to get our technology transferred, all the board members were questioning why. We had to raise money. We had to use shares and raise money by selling those shares. We are in the position of 1 million vials because we sacrificed during these three years, spending and raising money and being very careful with dilution. Now that we're at this point, we also still have to raise money because what happens if we get emergency use authorization in Brazil? 700,000 was gone already, and then it follows with Philippine EUA. If we get Brazil, Philippines will follow. You don't have any more vials after that. 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. When we say we need 200 million shares more to show strength with pharma, also we're gonna use some of that, I don't know, 30, 40, 50 million shares in the next several months to make sure that we have product. If we don't, it'll be disaster when we have approval and we don't have product. Go ahead, Ana. Okay. 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? Yeah, 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 these negative things. Dr. Ray did an incredible job getting us into Samsung, and 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 we're talking about the things that they are in charge of. Dr. Ray is in charge of the as the 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 manufacture. 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, you know, the executive team talking about what they are doing. He's right now very busy with the BLA. We are submitting our CMC next month, so we are all extremely busy to face that section of the module of the CMC. Yes. Recent Philippine 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 you know, 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 about. I don't know if, Dr. Kelly, you have anything that you know about. I mean, that's normal process in the Philippines, but I think it's unique in terms of what Nader said, in terms of critical population. I think if we do our interim analysis and have strong results, it's very, very possible to get an EUA. Yep. 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? 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 letdown on something, we try to bring somebody who can do a better job and different organizations. BLA has been number one priority always. Let me just explain. If we did not have monotherapy, if we did not realize that we actually can inject patients with two shots, 700 milligrams, which is twice the amount that Progenics said these were optimum. Their optimum was 324 milligrams, and it was two injection. They believe that you need four injections to administer 700 milligrams. When we were able to overcome that and gone through a lot of hard work to get to that point, thanks to Dr. Jacob Lalezari for that also. When we got to the two shots with 700 milligrams, we realized that our cancer trial without 700 milligrams 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. 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 another year and a half of going through the manufacturing, put it under stability for a year and so forth. At the price of getting delayed with the BLA with that, but we discovered so much more things for ourselves. 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. I'll add just one more thing. We do have a partner already in HIV combination therapy with an established sales force. Okay. Thank you. What CRO are you using for the long haulers trial? Dr. Recknor? Syneos. Syneos. 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 paths 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? 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 we're talking about, it's gonna recognize whether the virus is R5 or X4. If there is X4 virus, then leronlimab doesn't work. Naive population, that means patients who are 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 even 40%. That's MDR, that's multi-drug resistance. That's the combination Progenics was going after, and it's a very small population. With monotherapy, we check the tropism. With the combination therapy, we check the tropism. That's a requirement. FDA will not let us enroll a single patient without that. RO, receptor occupancy, is a whole different thing. We're trying to add that to recognize the patient's receptor occupancy with leronlimab. Thank you. Can you discuss the competition in the NASH space? You know, I discussed that before, but I'll tell you, again, you know, I think that people are looking at a variety of different potential mechanism of action in NASH because it's a tremendous opportunity to help a lot of people. People are looking at PPARs and FXR agonist, et cetera. We believe that the reason that people develop scar tissue because of the stellate cells, and we know that stellate cells are littered with CCR5. We also have animal studies to support the reduction of NAFLD. 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 this space. Ana, we have heard from all of our investors that 1.5 hour Q&A is a little bit too much. Let's go to the last couple of questions and that's it. Okay, last couple questions. Let's see. We have some questions about MD Anderson. So how long is the CytoDyn MD Anderson collaboration supposed to last? Talk more about that academic partnership and the long-term vision there. 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. 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 it to shareholders to vote. In September, you mentioned in a call that the CD10 and CD12 manuscript is prepared and will be submitted for publication within two to three weeks. Has that manuscript been submitted, and which journal? They're working on that. There are four top people we have. Dr. Kelly, you wanna talk about where we are with CD 10 and CD 12 manuscript? Yeah. 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 too much about that, and the fear that they wouldn't publish them for that reason. We're moving forward on all fronts, and actually, we have multiple other manuscripts that we're working on as well. Chris, you wanna add anything to that? Sure. The long haulers was submitted for CD15, and the next one that our focus was on is CD02 for the pivotal HIV. CD10, I don't think we're gonna really worry about that one at this time, but it's not our highest priority. CD12 is, and 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'd 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 wanna try to make sure that the drug is able to be provided for other people so that it can help them. 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. He's been a blessing for us. I'm gonna give the credit to the person who brought him to us, and that's Dr. Scott Kelly. Great. Thank you, gentlemen. What was the lab that was used on the HIV receptor occupancy analysis that was not even validated? I didn't get the question. Sorry about that, Ana. Can you repeat it, please? 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. Not only was it validated, but the assay that he used for the previous to that in CD12 was not validated. We asked for validation. He never gave it to us. He always says he will, but he didn't. Also, we had problems with a lot of different things, but God bless everybody. Okay. There are different molecules for NASH in phase III. Will you be able to compete? For NASH? Mm-hmm. Absolutely. I mean, look at our animal studies that we've done in the humanized mice. 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? The proposed issuance of 200 million shares will dilute shareholders' equity stake by 25%. How can these be valuable? Last question. 200 million is not 25% of 1 billion. Excuse me. It's 20%. We're not saying we're gonna 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 we will be sitting in a, you know, in a bank, perhaps. We're not touching that. We're only raising money when we need money to get more product. When we get to the point where we have to have product to sell, we have it. We're also gonna use that we raise the funds to support all of our clinical trial. All these trials cost quite a bit of funding, and we are gonna need to have those shares to support that. We're not gonna be using that in a wild way, and our re-record of what we have done in the past speaks for itself. 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, you know, data out there. It costs about $1 billion to get one product approved. We got 31 of them. We need to have funds, and we have been very, very frugal with all the shares that we have used. Please vote so we can continue this process, and we are very close to approval in many things. Let's go forward. With that, let me just give the last statement, if you don't mind, and conclude the call today. 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 had 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 change of leadership, so we had to change our vision. The new leader didn't wanna go to cancer, they didn't wanna go to NASH, nothing. We changed that. Dr. Scott Kelly and I, myself, were very much adamant that we gotta go in that path. We did that, and now we have all these multiple things that everybody can talk about. Long haulers, we're gonna be starting a trial. This is amazing. We did our trial, Dr. Recknor did it, and we showed 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 it will adopt 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. We have BLA finally figured out to do it in the right way. It was difficult to have two different trials for one 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. When they did that, we were very happy that allow us to use our safety, data from monotherapy. 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 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? If it is, then let's continue going forward and let's have the votes, and please vote immediately. There's only two more days left. We need the votes, 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, gentlemen, so much for this great presentation. We certainly hope to see you back on the Emerging Growth Conference very soon. Yes, please vote. All right, this is it for us today. Lots of questions still for you, so we'll send them to you, gentlemen. On behalf of all of us at Emerging Growth, we wanna thank the CytoDyn executives for such a fantastic and informative presentation. Now, everyone, remember that in just a moment, you're gonna be redirected to the registration page for the next conference, which is tomorrow. 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. We'll see you tomorrow at our Emerging Growth Conference. Thank you, everyone. Thank you. Thank you. Thank you.