CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, and welcome to the CytoDyn investment community webcast. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Antonio Migliarese, Chief Financial Officer. Thank you. You may begin.

Hello, everyone, and thank you for joining us today. This is Antonio Migliarese, Chief Financial Officer of CytoDyn. Joining us on today's webcast is our President and CEO, Dr. Nader Pourhassan; our Chairman, Chief Medical Officer and Head of Business Development, Dr. Scott Kelly; and our Chief Operating Officer and Head of Clinical Development, Dr. Chris Recknor. Before we begin, it is essential that we provide you with important cautionary language related to certain federal securities laws. Our remarks during today's webcast will include forward-looking statements. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are difficult to predict. Actual results may be materially different from any future results expressed or implied by such forward-looking statements. These risks and uncertainties include, among other matters, statements regarding leronlimab's potential efficacy for COVID-19 and in certain immunology and oncology indications; the company's ongoing ability to raise additional new capital; that clinical trials may not commence or proceed as planned; products that appear promising in early trials may not subsequently prove to be viable on safety or efficacy grounds; products may not receive regulatory approval or market acceptance; competition may reduce the commercial potential of our products; we may experience product recalls, manufacturing issues or product liability; and our patents may be challenged or unenforceable. Although forward-looking statements help to provide complete information about the company, forward-looking statements may be less reliable than historical information. The company undertakes no obligation to update publicly these forward-looking statements, except as required by law. Please refer to our recently -- our recent quarterly and annual reports filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to differ materially versus our current expectations. I will now turn the webcast over to Dr. Nader Pourhassan.

Thank you, Antonio, and thank you for all the shareholders participating in this call. The presentation that we will have today will first have forward-looking statements, so the information given here will be forward-looking statements. So let's go to the first slide, which is Slide #3. So we are going to update you today in regards to most important immediate need of the company, which is COVID-19 long-hauler. While we go through that, Dr. Chris Recknor will also talk about a few studies in that regard that will be conducted, especially the Phase III that we are hoping to get FDA green light to do so. Then we will talk about the other trials, critically ill and severe in Brazil, what's happening in India and other countries. BLA submission for HIV will be discussed next and then cancer program, where we are with that. And then NASH, and then we'll talk about the stroke. So it's very important for everyone to know why we are going to present some primary endpoint hit in this trial that was not on the press release. The models used in this exploratory trial, very small trial, was a model that did not allow for repeated data for every day to be modeled for a p-value the way we wanted to account for repeating values because every patient recorded their symptoms every day, 1, 2, 3, 4, all the way to 56, if that's how long the event. So Slide #4 talks about the model. So I can be very clear that the model used was this, and that was not in our SAP. So this model will be used perhaps if we're going to do the Phase III, then that way, we can get credit for all of these. But nonetheless, let's look at the next slide, please, Slide #5. Let's go over this. When we use the model that we just showed on phase -- I mean for on page -- Slide 4, what we did. When we use that model, you have outcome of each patients at 56 days for 24 symptoms and the baseline. So you got 56 days and the baseline. How did the patient do when they come in? Were they on wheelchair? Do they have terrible cold? What do they have? And then how do they score themselves throughout the whole 56 days, at 56 days, what was it? And that's what you see in the screen is at 56, but the p-value that we wanted to get, we wanted to incorporate all 56 days for leronlimab and placebo, so we can compare the averages. When you do that, we crush the primary endpoint in joint pain and swelling by a p-value of 0.0001. It's a highly significant -- statistically significant. We did 28 patients in each arm, very important primary that we are very proud of it. So I'm going to talk about only 8 that we hit the primary endpoint for with this model. Now the p-value for this particular symptom, which is joint pain and swelling was also met in the prespecified p-value evaluation with that model, it was 0.013. So we are very excited that we've actually shown with that p-value of 0.013 that the patients on leronlimab enjoyed impressive improvement over leronlimab. And the percentage was calculated because every score was either severe, moderate, mild or none. The value would be 3, 2, 1 or 0. So you score it and you calculate the number of patients in that category by multiple with the appropriate number. That number came to be negative 23 for leronlimab, which means we went down 23. Where only placebo went down 5%, that comes up to be a relative delta of 360% better, 360% better in leronlimab. Let's go to the next symptom, next slide, Slide #6. Tightness in chest, p-value for average, if we use average 56 days, 0.0001, less than 0.0001, 3 zeroes. Highly statistically significant when you use for the average of the -- all 56 days. But if you look at the 56 data outcome outside that -- just that last day, how did they fare compared to the beginning? 171% better tightness in chest. We are very proud of this result. Next, tingling or numbness. P-value, again, when you look at the average, it's less than 0.0001, highly statistically significant. Percentage improvement, 156% more. Next symptom. Muscle weakness, 79% better, p-value statistically significant for the average numbers, which was 0.013. Next, sleep disturbance/insomnia, 68% better, p-value 0.01, primary endpoint hit. Next, headache, better. Leronlimab was 65% p-value, less than 0.0001 for the average value, not for this 65%, but the average value. So that was highly statistically significant. Next, shortness of breath, 57% improvement, p-value, 0.032, primary endpoint hits. Next, nausea, 20% better, p-value 0.028, primary endpoint hit, that's 8 of them. So we go to FDA and we want to be respectful because we want to know that we use different method. And we want to say we want to do a Phase III, [indiscernible] very clear at the very beginning. This is an exploratory trial. There's nobody is doing -- the long-hauler is an unmet medical need perhaps. So we're going to ask for breakthrough designation. And we think we have a wonderful result, and we want to explain to FDA, get guidance. We don't want to promise anything to anybody right now. We're just saying this is what we have. We are very, very happy to show that leronlimab is one step closer, in my opinion, than being immune modulator that truly it is. So I'm going to ask Dr. Scott Kelly to give us a little bit of background of all of this. Scott, could you please?

Sure. Absolutely. Thank you, Nader. So I want to begin by saying that I am very proud of our team. Our team has fully dedicated themselves to understand the pathophysiology to help lead our efforts in helping those patients with long-haulers or PAS. This is also known as post-acute sequela of SARS-CoV-2. I believe the results we've released today are very encouraging not only for PAS but for those affected by other post-viral syndromes. We are trying to look at every angle of pathophysiology, including viral toxicity, the role of immune dysregulation that is potentially causing lingering cellular damage and subsequent scarring, auto antibodies involved, other immune responses driving effects, the role of neuroinflammation, viral reservoirs and residual viral material. We are looking at this for multiple avenues, including clinical symptom improvements, biomarkers, what role imaging studies may play in assessing progression. We've also learned a lot about trial designs and establishing endpoints for future trials going forward for PAS, but also other post-viral syndromes. PAS is a difficult entity to define, but we are learning more each day from our work and the work of others. One of our advantages that we have now is that we believe in these patients early. And that has put us a unique position in that we have unblinded data in a placebo-controlled trial that we believe is compelling. So as of this morning, there has been approximately 180 million COVID cases. At the current rate of COVID-19 infections, global cases could exceed 200 million cases by the end of 2021. If the delta variant continues to flourish in certain places, and either vaccines are not available, people choose not to receive them or decline the second vaccination, it may be that this number is exceeded. We just don't know at this point. But let's just say that 10% to 30% of those infected will have persistent symptoms, leading 20 million to 60 million patients without effective treatment options. In addition, there happens to be up to 2.5 million patients in the U.S. alone with chronic fatigue syndrome and 50% to 75% of patients are unable to work or attend school. Recently, I've been in New York, San Francisco and London, discussing the role of leronlimab in everything from HIV, oncology, long-haulers and Alzheimer's. I will tell you there is no lack of interest in the importance of HIV PrEP, the potential for macrophage polarization in oncology and other indications, the role of neuroinflammation and how leronlimab might benefit these patients in PAS and Alzheimer's, and the role of leronlimab in various lung pathologies. We still have some work to do, but we have made tremendous progress in the right direction. Nader?

Thank you, Scott. And now I'm going to tell everyone that Dr. Scott Kelly is responsible for bringing Dr. Chris Recknor to our company. This man was a patient in the COVID-19. And then he's a principal investigator who helped the company, and then now, he's the person who designed the study. He put all his effort into this by making sure that design is fantastic for this small little exploratory trial. What he has done with our BLA submission that was now taken out of Amarex and with all the stuff that he has done for us, watching him work and we make personnel changes very quickly when we see that the shareholders are not getting what is they're supposed to get from each one of us at CytoDyn. And then Dr. Recknor came short time ago, the revolution that he has made, I am in debt to him. He has done unbelievable work. And I want to get his take now. Dr. Recknor, could you please tell us what do you think about this trial?

Thanks, Nader. I appreciate the comments. Well, the FDA was very clear, it's an exploratory study. And the key thing prior to about 3 months or so ago is we really needed biomarkers, not only needed biomarkers for the long-hauler trial, but also for NASH and looking at cancer. And so one of the things that we've done is to establish a biomarker lab, and that allowed us the ability to look at biomarkers at a cellular level in the cytokine chemokine level. We're still going through that information with the long-haulers, but it is clear when you look at several of the patients that they had fantastic results. Others did not respond as well. And so what we're finding by this biomarker analysis is really what's going on with the mechanism of action. And there was one patient in particular that didn't respond at all, which then led us to the really discovering what we think is going on in the long-hauler patient population. And the next step is now looking at genetically typing or sequencing why this patient didn't respond versus the other ones it did. And then we can take this to every single trial that we're doing such as NASH trial, we're incorporating this into NASH, so.

Thank you, Chris. Appreciate it. So when I look at some patients in this trial coming in wheelchair, saying that they had not been improved for so long, saying that they couldn't work anymore and realizing that they took leronlimab and have done what some fantastic improvement. And when I see the critical ill population in the past, when we did emergency IND, seeing so many patients saying that our lives were saved and the doctor is saying that, it makes me feel very proud to be part of this company. And it makes me feel very proud that we have given everything we have to get the company to this point. It's a very difficult road getting approval and we're doing everything to give the CytoDyn shareholder chance at the maximum possibility of benefit on everything that this product can give. 18 symptoms were improved. Now I don't know if how many products that are out there that can do that, but I'm very proud of this. So in the next slide, please, Slide #13. So COVID-19 long-hauler, plan is to submit the top line report, hopefully, within 2 to 3 weeks to FDA. Executive summary, hopefully, sooner than that, to not only FDA but to ANVISA in Brazil, to India, to Philippine. And we have now -- we are now working on South American countries and Middle East, which is covered by one company, and we are working to get some deals done over there, so we can get that to be covered. But the long-hauler would be pursued aggressively. We will ask FDA for breakthrough designation based upon these results. And whatever the agency said, we will follow through. Again cautious, all of our shareholders, please be respectful to the process of the agency. They are doing everything they can to give us whatever we can to go forward. 28 patients in each arm is a small trial, but heading primary endpoint with 28 patients each trial tells me that this is a potent product. That's what I believe, but we need to go through the regulatory procedure. In regards to critically ill population, Brazil is now hoping to have their first patient injected by the end of July. Things have been getting delayed some going through. ANVISA, we have got some of the approvals from other agencies through there, but the final approval, ANVISA, we are hoping to be able to get soon and have our first patient injected end of July. We are making a contract where we have asked for expedited everything where would allow both trials to be finished from beginning of first patient to the last in 2 to 2.5 months, and we hope to achieve that. We don't know if we will, but that's what we're shooting. Look, always, we will shoot for the stars and try to get whatever we can get. And with Philippines, things are going forward. And the other countries, again, we will update about that as it goes forward. But now I'd like to pass this -- the laboratory work, finding mechanism of action of leronlimab for each indication. Each indication must have its own dose. We are finding out that leronlimab, perhaps we should give high dose of 700-milligram for the first few weeks, but not after that. Now the reasons will come out at the right time. We are patenting there. We have to protect our shareholders by patenting everything. But the thing that Dr. Chris Recknor is revealing and coming up with the laboratory that is working, I would like for him to say a few words. I know we can't say too much but, Dr. Recknor, can you elaborate on what are you doing to find the mechanism of action of leronlimab for every indication that we're going to go for?

Well, we first started with the biomarkers with the long-hauler group. And then after we've seen what's going on with the long-haulers, we're now applying it to all other indications. Not going to go into the specifics on what the biomarker changes are that we're seeing, but we're taking a look at the cellular level and then applying it to cytokine and chemokines. What's really interesting with the leronlimab trial with long-haulers is that -- is the patients that got leronlimab did better, but the placebo group in almost all cases did worse. And in particular, fatigue is one of the most common symptoms. One of the secondary endpoints that was met was in terms of worsening of fatigue. And in these patients, we looked at when they came in, what their fatigue was and then how many days since that time did it worsen over the 56-day period of time. And fatigue was much worse in the control group versus leronlimab group. I think that speaks to a lot of what you were saying about the patients feeling a lot better, having more energy to go back and do work, thinking clearer. And we're still looking at the data for analysis. The next step is to then take those symptoms and ranking the patients and correlating them further with the signals that we've been seeing with the biomarkers. And then finally, going to the FDA, talking to them about this and getting their input, and they've been very helpful with us. So we look forward to working on the next trial with them.

Perfect. Thank you so much, Chris. So the next slide is Slide #15. Let's talk very quickly about HIV monotherapy PrEP and cure. And I'm just going to leave it a bit, PrEP, that's our main focus, once a month injection of 700-milligram for PrEP, which is prevention and prophylaxis use of HIV. We are working with the CRO in Brazil. They're fantastic. We would like for them to start that trial. And we also want India to start that. And we're also going to talk to Philippine folks, which we have not yet, but we will get to that. But monotherapy and QR, just we are following it as much as we can. The next slide, Slide #16, please. So let's look at the BLA HIV. Now this BLA got delayed. And the dosage of this product made us realize that there are a lot more into this product than anything. And that delay was painful. However, the dose justification, the major part of the problem that was for FDA for us to have submit will be submitted on June 30. Dr. Chris Recknor gets a lot of credit for being able to get these reports. We are doing it with outside of Amarex, with other folks. Amarex is also collaborating with us to give us whatever we need. And we are going to be able to submit that. The FDA will take that and tell us, yes, you're good to go or not and whatever we have to do and then get it back. We will be getting our full BLA submitted no later than October 15. That's what we believe, that's our guess, that's our prediction. But now we have something because we believe in Dr. Chris Recknor, the way he has set all his people to work. And I'm going to ask Dr. Recknor, do you want to add anything to that?

Sure. We have a fantastic team. And actually, Amarex sold to NSF, and they've been a great partner to work with. We really have a lot of people working on getting this submitted. The first thing though that we've done is really improved the communication with the FDA. And one of those was asking about the receptor occupancy study, talking about the dose justification. And because of this involvement with the FDA, we are submitting the key part of this BLA that has held this thing up all along. It's not that there wasn't a statistical finding in CD02. It's not that CD03 didn't look great. It's what dosed out of these 3, 350, 525 and 700 would -- do you think works fast. And at this point, now we have 48-week data, very excited about it, in addition to the 24-week data, and we'll be submitting the dose justification report in a draft form to the FDA, and they've made it available to go ahead and give us comments on that to help us with the BLA. So it's a very good working relationship, and we're encouraged by that.

So -- and one other thing I would like everyone to know is, when you say 350, 525, 700, some people will say, 700 is better. You got better results. But what we're looking at is we're looking at the monotherapy data. And if it goes to, for example, 24 weeks and 700 is better. Let's just say that. But then after 24 weeks, we're looking at the rest of the second half of the trial. What if after that, we don't see any difference? That suggests that the loading dose will be needed for 24 weeks. And after that, we don't have to give them that. We can give them 1 shot instead of 2 shots, 2 injection goes down to 1 and the material that we save is 50%. So these are fantastic things, and we get to launch. If we're successful, and we believe we will be, that's what we are taking our time. We're not sitting here and just waiting for anything to happen. We are making it happen, thanks to Dr. Chris Recknor and Scott Kelly and the team over here, especially Dr. Nitya Ray who manufacturing, carried the load for so long. So next slide, please, Slide #17. So let's talk about triple-negative breast cancer results. We believe we could get the results within 4 to 6 months, but we're going to have breakthrough designation meeting with the FDA, hopefully, sooner, pre-breakthrough designation meeting. In that meeting, we will talk about the results and talk about the applying for breakthrough designation. But either way, Dr. Recknor, another thing that he has done is he has got the triple-negative breast cancer trial back on track. Something the folks that we had in the past could not do, and they fail to enroll even 1 patient in 1 year, and we did not hesitate to separate ourselves from them. We immediately go to a different path till we find gold. Dr. Recknor is gold. Then so in triple-negative breast cancer, we hope to get that result. And hopefully get a breakthrough designation. Dr. Recknor, would you like to comment on cancer? And then maybe, Scott?

Sure. We're really excited. We've got a lot of great partners, academic sites that are working on this with us. We've finished the 350 dose, 525, and we're into the 700 dose. And after that, we'll have our main portion with what dose we think we need to do. And that's coming up just in the next week or 2 that will make that decision. Scott, do you have any?

Yes. Yes. And to Chris' point, I mean, I think for the first time, we've really crossed the bridge in terms of bringing in some major academic institutions that will give us a lot of credibility in terms of pursuing our oncology indications. And so this is something that we've been working very hard on and very excited to move forward with. And we'll be announcing that when appropriate.

Perfect. Thank you. And with NASH trial, I don't know if anybody really gets the magnitude of the NASH trial. How many companies have hit a primary endpoint in NASH? I think the number is 0. Peak Pharmaceuticals tried it and they failed. We now have 60-patient trial, which we believe we will reach 60 by next week. And we are -- Dr. Recknor, is going to add perhaps more patients to look at other things because he's very much aware of what leronlimab can do and all the ins and outs of these product's mechanism of action. So in regards to NASH, Chris, would you like to comment?

Sure. This is really a fast recruit for all these 60 patients, and we have more sites coming on board. We wanted to not alter release of this result, but add 2 to get some biomarker data, and we're submitting that to FDA. So I won't go into the details on that. But we'll still be able to see those 60 patients. It will be about 14 weeks after for those patients when they're -- from enrollment to end of treatment. And then we'll have some additional patients with biomarkers. And again, we've learned a tremendous amount of information from the long-hauler patient population, and there may be some differences to that. And we'll just see, but we're also looking for commonalities and trends. Another thing that we've done is then we have a central repository for all of our data basically from a biomarker standpoint. And so any endpoints plus biomarker data are going to a central repository. And this will help us with future development be able to see trends.

Thank you. And -- go ahead.

No, I was just going to say, I mean, I just think it's important that people understand what we've accomplished over the past 3 months, and I shared this with Dr. Recknor is that in my opinion, we've accomplished more in the past 3 months in terms of figuring out the mechanism of action and effects on subsets of immune cells and how this will be applicable to other disease process and how we can fill our pipeline. We've done more probably in the past 3 months since been done in years. And so I think people will be very happy once they realize the work that's being done behind the scenes to further just realize the potential of leronlimab.

And Nader, let me just say one thing, too. When we see the mechanism, and we see this in NASH, if we can relate this to a change in the CT1, that's the fibrosis score by MRI. And the PDFF is the MRI evaluation of proton density fat fraction. We think this trend, we're still -- we're seeing in long-haulers will also apply over to NASH. I mean but we will be able to know pretty much as the trials going on that we're having the effect if we're changing the biomarker that we think is causing the issue.

Perfect.

And that helps to set up things with the Phase III trial for long-haulers, too. And it may be that you take that and it's part of an inclusion criteria. We're totally speculative at this point in time, but it makes it easier to identify the patients that you're looking for that you know will respond to your medication.

And knowing the results that we know, we are going to try to get the Phase III and ask for breakthrough designation. Hopefully, by end of July, we should have all that cleared. But we're going to make, most likely those 8 symptoms that we had hit the primary endpoint on as our primary endpoint for Phase III. So we're very, very excited to see how that plays out. So I'm going to summarize everything. In 2021, we have less than 6 months left to go. BLA submission completion, we will have it done now. Finally, it's very difficult task with all the distraction of COVID-19 trials coming in and the cancer trial, we added and all the NASH and everything else. We still got everything back on track, thanks to Dr. Chris Recknor. Critical COVID-19 completion, the trial in Brazil will be completed, we believe, both of them the critical and severe to critical this year. Long-hauler Phase III results will be completed, we believe the trial will be completed this year. HIV PrEP, we believe we can initiate it this year. NASH trial results is this year. That's a huge result that we're hoping to have. Mechanism of action results with dosage finding loading versus normal dose and all of that, Dr. Recknor will have quite a bit of data to publish maybe 3, 4, 5 papers to publish with that data. He has his own lab right now in a well-known institute, and they are working full-time on lots of items, some of part-timers, but we have full-time staff also with it. And breakthrough therapy designation for triple-negative breast cancer, we believe that is now very close to being talk to FDA and see where we are without that. With that said, please, let's go ahead and go to Q&A, operator.

Go ahead, [ Mike ].

First question, what was the dollar value of the recent PO or POs from the Philippines?

So the reason we don't talk about POs or the value or the revenue from Philippine because this is just the beginning of some small orders. And we need to get revenue like getting these major things happening. Meanwhile, these things happen for us, and we bring it up, and we say what we have. But we like to focus on the big enchilada. And I think I give quite a bit of enchilada today. Go ahead.

What is the status of the Chiral Pharma purchase order announced 3 weeks ago prior to this webcast?

If there was any update, we will definitely talk about it. The Chiral Pharmaceutical is working on all of those. Our focus right now, long-hauler in COVID-19 is something that's going to be affecting millions of people for many years to come. And our focus is that, critically ill and severe is shifted to Brazil. We need to get those trials done. Philippines is a back seat for us right now. But we would submit the long-haulers to them. If we get orders and get flooded with the orders, trust me, I will be the first one to jump and tell the shareholders. But we don't have that. So let's focus on the major ones. But go ahead, please.

What are the company's revenue projections for the third quarter of this year?

Well, the revenue projection for the third quarter here, I would say, is very small because there is only revenue from the compassionate special permit. We are working with another company that might be able to make sales under the same conditions in the -- in South America and Middle East. But let's not talk about it until we get it. But Antonio, do you want to add to that?

Yes. So we currently do not provide public guidance on revenue expectations. As Nader mentioned, we're just too early in the building of these relationships and in the regulatory approval process to reasonably be able to do so.

Okay. Next question, what actions have been taken to create an independent board?

Scott, do you want to answer that? You're the Chairman of the Board.

Yes. No. We're actually currently in the process of reviewing candidate for being an independent member of the Board, and we'll continue to do so.

Okay. Next question for you, Scott. Who is on the compensation committee?

Dr. Samir Patel, Alan Timmins and Jordan Naydenov. And this is actually on our website. If you look under the Investors tab at the top of our website and then go into Corporate Governance, all the different members of the committees are on there, but it's Alan Timmins, Dr. Samir Patel and Jordan Naydenov.

Okay. Next question. It's been over 2 months since former President Estrada recovered. What has happened to the 28 we gave leronlimab to in our future distribution at -- with the Philippines?

As soon as we get any results from anything that we can talk about, we immediately turn it to the shareholders in our updates. That's one of the things that we always do. But we don't follow each patient. The ex-President of Philippines, thanks their family members -- thank us for the patient's life being saved. There were some VIP, other VIPs who thanked us, but that we couldn't talk about. But other than that, we just have to focus on the major things that we're working on.

How many people in the Philippines have received leronlimab treatment for COVID?

I don't have any update since last time, but once I get anything I will definitely can.

How will the Regeneron monoclonal antibody treatment affect COVID prospects?

Scott, do you want to?

Yes. I [indiscernible] every trial published on June 16. And versus the severe population who had not mounted an immune response. It's encouraging to see an antiviral work in later stage COVID, but it's also a different mechanism of action and that it binds the different sites of the spike protein. Obviously, that could be affected by further mutations. We'll have to see. We binded the CCR5 receptor. So we think that we are very agnostic in that. But again, just to Chris' point earlier and Nader's point, when you look at these trials, I think they had over 9,000, it's like 9,785 patients involved. And they had 6 fewer deaths for every 100 patients. So although it's encouraging to see antiviral work later in the stage, you will have to see how it continues and see our results as well.

Thank you. Why did the U.S. distribution partner end their contract with us? Are we going to sign other partners?

They did not, we did. I had asked our legal to do so in conjunction with Dr. Recknor and Scott and Nitya's collaboration. We decided four of us to do that. We believe our contract with big pharmas could happen in this year. And we believe if we don't have any pending contract like that is the best path for the company currently.

For the Phase III long-hauler trial, are we going to apply for NIH long-hauler funding?

No. We are going to go as fast as our shareholders expect us to guide the pace that we have they are used to us go. And with NIH, we had -- we couldn't go that fast. We are very close to major things that 18 symptoms getting approved is a major event for us, and we're going to build on that very quickly.

Okay. For the...

Nader, I would like to comment on that one thing.

Yes. Yes, please.

I want people to understand, this is not something that we took lightly. We knew about the funding. We looked at the things. We certainly thought in our opinions where we certainly thought we were stronger getting the data because we felt we were way ahead of the game. And in terms of going to have a big pharma partner, I mean, we wanted the data. I mean if you go to a big pharma and say, this is -- we have some interesting concept that we're thinking about. That's a little different than showing a correlation with biomarkers and clinical symptoms and a pandemic and then with the after results of the pandemic. So we thought we're in a better position for all things, whether we're looking to go to the NIH eventually or whether we're going to have a big pharma partner, we thought it was best to have the data first. And that was a decision we made. But to Nader's point, we want to move very, very quickly, and we want to be sure that our partner would move quickly, and that's the prerequisite for us.

Yes. Thanks, Scott.

For the COVID indication, have we filed an EUA with the Philippines?

No, we have not yet. They were in process of doing so, and we haven't had any updates from them. We will get that update pretty soon.

Along the same lines, have we filed a EUA with Canada or India?

So with India, we are in process of going forward. So we will update on that. But we don't have update. We are in touch with them. We are working with them. With the Canada, interim order were supposed to be completed in June. We couldn't because of all other items that we've been overloaded with. So that's delayed, but we will update on that time line also.

When are we going to start the COVID trials in Brazil?

We are hoping that the first patient gets injected end of July. That's our time line. The people over there are working very hard. I'm so impressed. We get time lines adjusted every week in case something gets delayed. They have every item listed. We have team calls twice a week. And every time we get the project manager go over everything. I am just very, very happy with the process with these folks.

Okay. The next question is related to Breakthrough Therapy Designation for cancer. You may have touched upon this in the deck. What is the status of the breakthrough therapy designation application with respect to cancer?

Pre-breakthrough designation meetings, what we are wanting to have. But meanwhile, we are generating results that we believe could form the basis of getting breakthrough designation. We hope to have complete results in 2 months or so. And we were going to ask FDA for meeting to be able to see, hopefully, show them the results and maybe even before that, because whatever we have right now, we'd like to put it in front of our FDA and get guidance.

Quick question on HIV PrEP. Will we get funding for an HIV PrEP trial?

Again, getting funding, then that will take time. We want to do a quick trial, a small trial. And if you show with the antibody that perhaps has very low level of side effects or toxicity in the trials that we have done, if you can, we believe that's a breakthrough designation because there is no antibody injectable which could be once a month, which would be very simple for people at risk of HIV. So this is a fantastic result that was published for animal data in that regard with Dr. Jonah Sacha. So we want to build on that, but not with going after getting money. We have funding right now. We want to use that to get all of these things done this year.

And Nader, I would like to add one thing on that. I mean I hope people understand that what we just published in Nature Communications is, we believe, a very big deal. And I think it's going to gain acceptance of HIV specialists over the world, especially the people that I'm talking to, it's very encouraging. If people remember, the U.S. said they had a goal of a vaccine from -- in 1997 within 10 years and here we are in 2021 without a vaccine. And I think that PrEP is the answer to that, and patients need a way to prevent transmission, that's once a month. And if we can provide that, I don't think that anybody wouldn't be interested in us as a company.

Next question. As an investor, several investors are concerned over several investigations. Can management comment on those?

So we can't comment on the pending litigation. But we -- as we always said, we will pursue this very aggressively. We believe we have all the situation -- all of these under control, and we will report to the public as any case gets resolved.

You mentioned that you sold 200,000 to 300,000 vials of leronlimab to Chiral Philippines over a period of 1 year. How much did you get from the sales? And did you get any sales? Or was that just publicity?

So that's a misquote of what we said. Antonio, do you have the exact...

Yes. So we did not state that we sold 200,000 vials to the Philippines. And what we have stated is that we have agreed as part of a distribution agreement with Chiral Pharma to allocate and provide them with up to 200,000 vials of inventory.

Thank you. Why do you continue to run COVID-19 trials in other countries when you did not meet your primary or secondary endpoints in the U.S. trials? Wouldn't it be better to spend your energies on getting approval of leronlimab for HIV, which you have completed Phase III trials?

Yes. So the potential of this product, we believe, is far more than just HIV and COVID-19 long-haulers result that we just announced and demonstrate some of that, in my opinion. And in regards to the critically ill and severe population, we didn't have a quite a bit of people in the world that needs that, we believe.

What's the...

Yes, Nader, one [indiscernible] here. Mike, I just say one thing. I think people should look at the numbers that we talked about today and please do run research and find out how big the critical population is in COVID or HIV combination therapy and what's in long-haulers. I mean it's just -- it's a tremendous opportunity to help a lot of people plus chronic fatigue syndrome, et cetera. And we think we're identifying the biomarkers to help these people and have the products. So that's what we're working towards.

Okay. What is the status of a possible EUA for COVID in Great Britain?

No update on that yet.

Okay. What's the status of the BLAs for HIV in Great Britain and Canada?

We are working with both of them, but we are focused on the other stuff that we just mentioned. So that has taken all of our time. We haven't updated on that yet. We will give you update when we are able to get to that.

If the HIV BLA is completed and submitted in July, would CytoDyn expect a PDUFA date in the first quarter of 2022?

So let's take it one step at a time. This is a major, major achievement to be able to get the BLA submitted completely. The first part, CMC, we said in July. The last part would be October. And we need to realize that this company needs to be careful how much money we raise, how we dilute the company. At the same time, have trials that show the potential of this product. Having coordinated all of those to give the smallest dilution as possibly we can and spend our money wisely on giving the most potential -- the most benefit to our shareholders from the potential of leronlimab is what we're doing.

If leronlimab is approved for long-haulers and the endpoints are similar to chronic fatigue and ME, will this drug also be approved for those other indications within the trial?

Scott and Chris, please?

Yes. I mean, I'll go first, Chris. And I think you would agree with this, but you'd have to have a separate trial for chronic fatigue and myalgic encephalomyelitis. The FDA would not grant this approval for those indications based on what we're doing. That being said, we will know about the immunological biomarkers and endpoints that we feel comfortable with in doing a trial for chronic fatigue syndrome.

Yes, I agree. And it's -- and there are similarities with patients with fatigue and COVID. There's similarities with many viruses as well. The key thing we're trying to do is look at the biomarkers and see, do we see a similar trend between all viruses?

It's noted that individuals with ME and chronic fatigue syndrome are reportedly dying at a younger age compared to the overall population. The all-cause mean age of death for this sample was 55.9 years. Would it be safe to say that leronlimab alleviating these symptoms will likely increase median age expectancy and dramatically improve the quality of life.

Scott and Chris, perhaps?

Yes. I'll answer that. I think that's an excellent question for a lot of reasons. And one of the things that we're realizing is how much these patients with chronic fatigue syndrome and myalgic encephalomyelitis are suffering. When you look at what are the major causes of death in this population, it's cardiac, suicide and cancer, and some of the theories behind the suicide is that their quality of life is so dramatically impaired, whether it's fatigue, financial challenges from their inability to work and everything else that affects every aspect of their life, and that's why we're so interested in trying to help them. There's also been some, obviously, some interesting literature in COVID that's available to the public from somebody outside of us that talks about inflammation and possible reoccurrence of cancer. There's been some stuff about cardiac manifestations, being that it's a multisystem disease. So we'll certainly be looking at a lot of these measurements and how we improve the quality of life. And it just goes to show you why we think that the data that we presented to you today is so important. Chris?

Yes. And so symptoms is a place to start. And you can identify those patients that are having issues, but other ways of looking at this or starting with patients where you're seeing the inflammation through MRI scan or other objective criteria. And so you're working back and forth through looking at cellular changes, inflammatory biomarker changes and then changes actually that we can visualize on an MRI scan, like as in NASH or in long-hauler patients looking at MRI or lung or a lot of them have a lot of pancreatic inflammation with exocrine pancreatic insufficiency. So that's -- and not all like you said, is really to help that person improve the quality of life. And fortunately, the patients that did get leronlimab, some of them have a dramatic change in quality of life, and I've seen some of the YouTubes on those patients. So it's really very rewarding that they're feeling better and have been able to get back to their life. It's given them their lives back.

Yes. And I think that people really need to realize this is a multisystem inflammatory disorder with COVID, and it's not just affecting one organ system. So it's not just lung fibrosis, but there's also -- there can be pancreatic problems, there can be cardiac manifestations. There can be liver problems. I mean it doesn't stop. And so that's one of the things that we're looking at and looking at best ways to measure that with our biomarkers and imaging studies.

And actually, the clustering of those symptoms may be related to clustering of changes on MRI. So for example, some symptoms present more with cardiac issues, chest pain, palpitations, et cetera. That sounds reasonable, but also the pancreatic issues or liver problems as well, too. So it is multisystem inflammatory.

Great. Thank you.

Related question. Will the 6-minute walk test have masked metabolic testing to see if the metabolism is working better to prove the efficacy in another way?

Scott? Chris?

Well, I think -- so there is another long-hauler study being done by a compound a [ YT 100 ] that's looking at pulmonary fibrosis issues. And I think the other issue is will fibrotic lung disease be a secondary endpoint. In the MRI study that we are looking at doing, the conditions of the lung from a fibrosis standpoint, along with heart and every other organs, can be looked at. A concerning thing is that in patients followed in the U.K., there's about 500, 600 patients being followed with long-haulers. They -- the hopes was that with their symptoms, even if their symptoms were getting less, that we would see a resolution on MRI. And surprisingly, what they're seeing is some increases in MRI findings, especially in the heart as much as 18%, 20%, I believe, but don't quote me on that, that are happening from months 6 to 12. So -- and the other things, too, in talking with physicians, just because patients are not having that many symptoms doesn't mean they don't have a lot of inflammatory issues going on in the blood that are causing problems potentially later on [indiscernible]. So we want to explore all these parameters with this long-hauler group as applied to chronic fatigue and other post-viral conditions.

No, I agree absolutely with everything Chris said, perfect.

Great. Thanks. Mike?

Will improvement in fibrotic lung disease be a secondary endpoint?

Scott? Chris?

Yes. So one thing about the 6-minute walk. So if you're looking at lung and pulmonary function, you're wanting to look at exercise and endurance. And this one group of long-hauler patients, they're really looking for those that have lung damage, and it may be from those that were hospitalized or not, that are having problems with breathing because of the lung, and so -- and I've done many functional studies looking at 6-minute walk. It's a difficult endpoint to have. I think it may be easier looking at MRI changes. But -- so that remains to be seen in those patients. But it would be great to see the 6-minute walk improve. Whether that alters the test or not or the metabolic testing, I don't really think so. The patients that are improving, if they are in that study, will have better oxygenation and better ability to walk a 6-minute time. And that -- and for people that don't know the medical, it's -- they walk up and down a hall, and the distance is measured over a 6-minute time period. We use that in myostatin and ACTR2 antibody studies. So we could be looking at fibrosis of lung, but we don't want to be just limited to any one organ. And then finally, the brain isn't really being discussed. Scott, you can talk about some of the stuff you're working with, with post-COVID. And in particular, they have certain cognitive issues that are going on, and our hope is to be able to look at that as well.

Yes. I mean, I think, to Chris' point, we're looking at the role of immune dysregulation, subsequent scarring in multiple different organs. And I think the easiest way to think about this from a pipeline perspective is imagine being the cardiologists and having patients that are post-COVID patients with cardiac manifestations, but really not having a great treatment option. Same being said for the neurologist, same being said for the GI physician, same thing to be said for the pulmonologist. So we think we kind of owed to these patients to look at each organ independently as well as in a combined approach. And it might be that there's a neurological manifestation that's causing other symptoms that we're looking at, and that's what I'm exploring with physicians. And I think that what we are seeing is that they're all very concerned that they don't have treatment options for these patients.

okay. Mike?

Have the unblinded long-haul results been submitted to the FDA? If not, do you plan to share the results with them? And what is the anticipated timing?

So we're hoping to have in the next 2 to 3 weeks, not only just the results that we just gave out, but more importantly, the biomarker results would be correlated to these results, which is a very powerful thing. And hopefully, we have an executive summary and top line report. We will definitely put those in the 8-K, so everybody can read every bit of the results for themselves.

The next question is related to the long-hauler trial. Can you please explain clearly how you evaluated these clinical improvements for the long-haulers trial? For instance, did you ask the patients to score like between 1 and 10, their experience for each of the symptoms?

So if they go to the slide that we presented, that explains it. Next, please.

Please provide the latest enrollment numbers for the NASH trial. Based on the previous enrollment numbers provided, analysts have been expecting complete enrollment in June.

The next week, we should have it, as Dr. Recknor has mentioned.

The FDA approved Aduhelm to treat patients with Alzheimer's disease using the accelerated approval pathway, under which the FDA approves a drug for serious or life-threatening illnesses that may prove meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit? This approval was based on the drug's effect on a single biomarker. Leronlimab safety record to date is far superior to Aduhelm's safety record. If completed analysis of leronlimab's effect on biomarkers are positive, will CytoDyn engage the FDA regarding possible accelerated approval for long-haulers?

Yes. We just said breakthrough designation, we will be asking FDA and then wait for their guidance. Okay. Go ahead.

Next question is related to Brazil. The sender of the e-mail cites a website related to global regulatory partners, clinical trials in Brazil, and he quotes in there that the review and approval process by ANVISA typically takes 18 weeks. Please let us know a realistic date for the start of the Brazil trial.

We're in touch with them very closely, and that's what we said, by end of July, we were hoping for a first patient injection, not 18 weeks from now.

And if I may, this is -- it's different for COVID. So Brazil has a problem with COVID. We want to get their patient population doing better. They're focusing on vaccines right now in addition to treatments. So they're really overloaded, but much faster time line than a standard drug to be developed.

Very good point.

On a somewhat related basis, also given that India and Brazil are improving fast, which is a judgment call, what are the chances that our prospects internationally will not become greatly diminished by the time these trials are completed?

So we are -- the long-hauler, we know that this is something that's solid. Now if a long-hauler trial Phase III is positive, not only long-hauler, but we're going to talk about post syndromes that people have from other viral diseases. And we will talk about getting involving much even bigger than that. But in regards to critical and severe, as we are going forward, obviously, it's getting better in some other parts of the world, but there are still enough patients to -- that for us to feel urgent and Brazil feels that way. So we're going forward as fast as we can.

Another follow-up question for Brazil. Why is the primary endpoint of the Brazil trials for moderately ill patients more severe than that of the critically ill patients? And also related, if moderately ill, we're supposed to be severely ill, the primary endpoint is still more severe than that of the critically ill patients. Is there a mix up here?

No, we don't make a mix up with the Albert Einstein Medical Research Hospital that is known and they just had wonderful publication in New England Journal of Medicine, where they got a lot of credit all over Brazil. So please give us credit for that. Next.

But if I can, looking at it from a scientific standpoint, here's why. So for patients that are -- that we call moderate in the U.S., we call severe, they'll call moderate. Those are patients that are hospitalized. Most of those patients are going to be discharged. And so these are 2 sister studies that are looking at patients who are hospitalized, non-intubated versus patients that are intubated. And those patients that are hospitalized, because the majority of them will be discharged, what we want to do is accentuate the split between the placebo and treated groups. We need less patients when we -- for that group that's non-intubated, look at how they will get worse if they mostly get better. In the patients that are critical, we're willing to look at it in the opposite direction for them getting better because they're very critical and high likelihood of mortality in those groups. Again, we're trying to accentuate the split, needing less patients. And what matter, Einstein has done 7 COVID trials of thousands and thousands of patients. So I think they're an excellent resource.

Absolutely. And they're very positive about being able to get a primary endpoint based upon the analysis of CD12. They're more excited than we are even.

Okay. Last question. Why was the long-hauler study not written as a Phase II/III adaptive design so that the Phase III study could be immediately started once these statistics were hit? Now we have to wait at least 2 to 3 months to get the Phase III protocol started.

So I don't know if anybody has to look at the FDA guidelines. It takes 15 years to get approval. When we did long-hauler, we went to the FDA and they gave us guidance that, look, 24 symptoms is a lot. And this disease is very, very new. They don't have as much information as they would like to have. With all that said, giving us an exploratory trial was very, very great of them to do so. And Chris, you perhaps wanted to talk about -- you got -- you were involved in all of that.

Sure. The reasons were the FDA wanted an exploratory study. And our next study is already queued up and we're adding to it and modifying based upon what we are finding. And so we think that we can recruit those very quickly at the sites that we've already looked at having participate. And so it will be a fast Phase IIb/III or whatever direction the FDA would like to explore this data in, but ultimately, to try to help these patients that don't have an option at this time point.

Okay. Thank you so much, Chris and Scott. And just want to again sum up that in 2021, BLA submission, critical COVID-19 trial completion and results, severe COVID-19 completion in Brazil, long-hauler Phase III result, HIV PrEP initiation and NASH trial results, mechanism of action that is very crucial to us for many indications and hopefully, breakthrough designation talk with the FDA that could lead to breakthrough designation for cancer is all what we are working on right now. And we will be updating the shareholders at the next time that we have development. Thank you so much, everyone, and have a great day. Bye-bye.

Thank you. This concludes today's conference.