CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Okay. We're on. Okay. Good afternoon, everybody, and welcome to Wall Street Reporter's NEXT SUPER STOCK livestream to for today, April 17, 2020. We're very proud to bring you a very special presentation from CytoDyn. CytoDyn, as many of you have been following since August, the stock has done tremendously. The company has reported incredible progress. And obviously, there's a very topical presentation for today. As you know, the stock is up significantly. And with CytoDyn's impressive pipeline, this could be just the beginning. So today, we have a lot of people on the call. So I'm going to skip my usual remarks, we'll get right to it. The format for today is simple. Nader Pourhassan, CEO of CytoDyn, is going to speak. Then we're going to engage in a panel discussion with Dr. Bruce and Jay. And then we'll open up for Q&A. Hopefully, we'll have time to answer the questions. We've got about 70 questions. I don't know if we'll have time but -- with that being said, everybody, please welcome Dr. Pourhassan. Nader, take it away.

Thank you, Jack, and thanks, everyone, for being on this call. I'm not going to do the usual presentation of talking about what is leronlimab. I'm hoping everybody on the call knows about the leronlimab. It's a humanized monoclonal antibody. And it has been used in many different indications to be -- I mean, I'm sorry, it has been on clinical trials for many indications. Today's presentation will have many forward-looking statements. And as most people are aware of this slide, we are about to file BLA, biologic license application, for final approval for combination therapy. We've been saying that a lot, but people are getting very tired of hearing that. However, with coronavirus coming into the play, and we put a lot of resources and the time of all of our team members that delayed it, but we are very close to that time. A monotherapy trial, again, that's something that always is going on, and we will get to that. In regards to the cancer trial, they're going forward. But again, as I explained in the cancer trial, we can't get blood sample from some of these patients. They do get products at home to inject themselves and continue with the trial. But it is [ Janssen ] coming to the lab to get the results of the blood samples for us. But the results that we have so far, whoever we were able to get, has gone very well. My own family member is doing very well. Graft versus host disease, one patient was indicated. The other patients that are coming in, we will get an update on that. In regards to the most important indication, coronavirus. Why did we get involved in this coronavirus trial? I want to make sure everybody understands that Dr. Bruce Patterson on the call right now and Dr. Jacob Lalezari already with me. I'm honored to have them on this call. Dr. Bruce Patterson is a former Standard University Professor, and he was the Head of Virology; and the CEO of IncellDx. Now IncellDx is a diagnostic company. All of these tests that we have been doing is the work of Bruce Patterson. Without that results and without his guidance at beginning that coronavirus should be something we move on, we wouldn't be doing anything with coronavirus. As he guided us that we need to go that path, we listened to it as we listened to him when he talked about the cancer indications that you've got to go in that direction. In a different way, your enrollment is taking a year. You're not getting anybody because of this and that. And we listened. Again, the shareholders saw what happened immediately, the results of enrollment. But in coronavirus, I want to make sure that we explain this very carefully. And you, all the shareholders, whoever is on the call, can ask questions when it comes to Q&A from the 2 doctors that are on the call. But we have 3 things going on in coronavirus. One is Phase II. That Phase II is a randomized placebo controlled trial for 75 patients. We get the primary endpoint results after 2 weeks. We have about 15 patients enrolled, as we said that in the last time we talked to one of the press release. And we are enrolling sites. We have about 4 sites ready to go right now. It takes a lot of time. It takes a month or 2 to get a site ready, they're ready to go. And we should have a few more sites even in road. Our Clinical Operation Vice President, Head of all of our trial at Amarex, Dr. Kush Dhody, has told me this morning that I don't see how you cannot enroll everybody within 2 weeks or maximum 3 weeks. He is very optimistic about the enrollment process, the way it's going to go forward. He is the person who enrolled all of them for monotherapy combination therapy, so he has a lot of experience with this product. As soon as we get these 25 patients enrolled, 2 weeks later, we will submit the final results to the FDA. In regards to another clinical trial, Phase III, which is called Phase II2b/III. Again, double blinded. Everybody is making a lot of issue about why is it double blinded. People aren't going to get heard or -- and a lot of different issues they're bringing to us. This double blinding, the patients is still going to get oxygen, the patients still get to go to ICU. The patient is going to get whatever they were getting if they were not double blinded. And if they get on any kind of drug, then that's different. And a lot of people that come in, they don't need to get on the drug. They just need oxygen, they need ventilators. That's what's going to happen for the placebo as well as the controlled. So this is not something different than what has been doing. Patients, if they need to get off of the trial for some reason, they can and take other drugs also. That trial, we have 3 cases involved. Again, all the process we have, they -- both of them -- of all the sites, they get involved in [ both ] the trials. And then we have emergency IND. And you saw the videos of the patients who are doing as they were doing very well taken to the interviews, and we saw what happened with what they're saying is happening. We do have some patients right now that were severe. They've got off the oxygen, they got discharged. There's a lot of things happening here, but there are papers that needs to be published, and we need to be careful about the data. So please don't make assumption that because we're not giving you all the results very clearly it's because we need to have the papers to be published with certain people and they have the right to those things. But with all of that, I want to ask Dr. Bruce Patterson first about -- to explain to us what has he seen, and then we'll go to Dr. Jacob Lalezari, on the emergency IND, that what the data has to come up. Please, Dr. Patterson, explain, what have you been seeing? What is the process that's going on right now? What is your take of all these data that you're seeing? Go ahead, please.

Yes. Thank you, Nader, and it's a pleasure to be here. What really strikes me about COVID disease is the spectrum of disease. There's patients with mild to no symptoms. And then there's critically ill patients with significant comorbidities, like renal failure, and liver abnormalities. And that's what we're dealing with. And I think the most important thing about leronlimab is we're seeing a multitude of effects. COVID is not an IL-6 disease. It's not an IL-8 disease. It's not a GM-CSF disease. It's a composite of a lot of these factors going on at one time. And what's been so impressive about leronlimab is it's been quieting this so-called cytokine storm that consists of IL-6, IL-8, TNF alpha and a lot of other chemicals that are causing damage to the lungs. But what's most relevant is we're seeing profound immunodeficiencies in these patients with significantly low cytotoxic T cells, which are responsible for fighting off virally infected cells in cancer for that matter. And leronlimab is doing 2 things. It's restoring these immune cells and immune homeostasis while also quieting the cytokine storm, which is really remarkable, I think, for a single drug.

Thank you very much, Bruce. So in regards to Dr. Jacob Lalezari's experience, Jay, would you like to say a few words on what you have seen and what is your take?

Sure. I'd like to be clear that I'm your Chief Science Officer, but I have no stock in CytoDyn. So I'm going to be free to offer my opinion. Obviously, I have a bias and the same bias as everybody else that we're living under this hard. But my potentially biased opinion is that both the world and CytoDyn got incredibly lucky here. That when there's a full disclosure of all of the data that we have, the world will understand that CytoDyn picked absolutely the right target. And that the results that Bruce just described where you see day 3 recovery of immune homeostasis or movement toward recovery, day 3 reductions in IL-6 and other cytokines following a single subcutaneous dose of drug, a drug that we've given to 800 patients and know to be safe, is an incredible story. And my biased view is, I don't think antivirals are going to significantly impact the outcome in this illness unless they're taken very early or to prevent infection in the first place. And I think all of the other immunomodulators are barking up the wrong tree. So I think that this is going to be a fantastic story, biased though opinion might be.

Thank you so much, Jay. I appreciate it. So with that, I would like to go to some of the questions that everybody have been asking, and I'm going to read the questions and either ask Dr. Patterson, Dr Jay Lalezari or myself.

First question said that of all the COVID-19 patients who have received leronlimab, how many, if any, have not improved their condition after 7 days? So again, when we talk about results, we have double blind study, both of them, so we don't have any results. The only results that we gave is anecdotal, emergency IND patients, and I cannot go through the results of each hospital. But I can tell you, at one of the hospitals from 11 patients, 3 were critically severe patients, the other 8 were moderate, well, we call it severe according to FDA's definition. From those 8, we have seen 6 improve greatly. Some of them got discharge as we talked in the press release, 2 we haven't seen improvement yet. And the other 3 that was critically severe, 2 of them extubated, and 1 of them as of yesterday was only on the ventilator for 30%. So that's the kind of result we're seeing from the site. Now we have to wait a little bit to have the published data come out so the shareholders can get the maximum benefit of the publicity and the credibility in the scientific community when it's published by Dr. Patterson and other folks. The next question says why is leronlimab not listed as a fast track on the FDA website? I have no idea, but we do have fast track designation for HIV. Every time we communicate with FDA for our HIV, we say fast track normally at the top of the letters. And we also have fast track designation for our cancer. We -- when we say these things in press release, these are monitored by our legal team, by our -- by FDA, by SEC. So everything we say in the public is 100% gone through the right procedures to get there. Could you provide an update on the existing cancer patients on our trials with the clear [indiscernible]? Welll, cancer patients, again, we had -- everybody, we got the resource of the biomarker CTC, circulating tumor cells. We saw great results with all the dose that we need to see for progression free perhaps after 6 months, a year, and we are working on those. But Bruce, would you like to add anything about the cancer?

Well, again, I think we haven't been able to get the patients in to draw the particular labs. But all of these patients are improving. We see shrinkage of both the tumor, reduction of CTCs to 0, reduction of metastases size and number. So I think everything is as we've published previously in press releases, and we're still enrolling patients in the various trials for cancer. So that hasn't slowed down. In fact, I just got 2 more additional samples today. So it's ongoing, and we're very encouraged. And of course, we'll report the results when we can get the data.

And Dr. Lalezari has been enrolling the first patient in the basket trial just recently. Jay, would you like to say anything about your cancer patients?

Sure. And then I want to go back to the last question for a second. The -- it's difficult in the middle of a COVID crisis with all the travel restrictions. And we've had patients and women with breast cancer reaching out to us from all over the world. We've been -- several women enrolled from Europe and Canada. And there's a lot of enthusiasm in part because our first patient did so exceptionally well, and she broadcast that on Facebook. The -- but these are -- we are also attracting people with very end-stage disease. So it's difficult. And -- but the bottom line is that in the patients that we've been able to get results, both in terms of measuring tumor size and certainly measuring the CTCs, it seems like everybody is going to 0. So we're very encouraged by that, even though the data in the end is going to be confounded by what COVID-19 did to us. So in the meantime, we're continuing to enroll. We enrolled our first patient in CD09. There's tremendous interest out there. And as Bruce and Nader have said, there are signals, early signals of positive benefit, which is super exciting.

Well, thank you.

And I just want to address, to the last question, Nader. It's a source of frustration to us as well. JAMA published a paper 2 or 3 days ago listing all of these potential COVID-19 treatments and leronlimab wasn't even listed. I think the world has missed this. I think from the get-go, FDA did not understand why Bruce's idea of using leronlimab in this setting was brilliant. And it's taken us many weeks and a couple of months to get FDA caught up as to why this makes sense. And when the data -- full data set of Bruce's work is published, the entire world will understand why this makes sense. But in the meantime, our job at CytoDyn has been to try to raise awareness of not only leronlimab and why it makes sense. But the early clinical results, which I think have been pretty spectacular. And it is a bizarre thing at this moment that leronlimab isn't higher on the list of the conversation. I think basically, Gilead and remdesivir has dominated the conversation. And I think as some of these other experimental therapies begin to fall off because an antiviral drug isn't going to do it here. There will be more room, more oxygen in the room. And I think CytoDyn is going to get a lot more exposure, but you're going to have to be patient.

Thank you, Jay, for that. So the next question is, CytoDyn on February 12 announced testing in China of leronlimab of COVID-19 patients. What happened? We never announced that we tested anybody in China. We were in talk with a company called Longen, and as we got other companies involved, we moved to the different companies. And there are 2 companies in China right now that are very close to making some temp sheets, some nonbinding temp sheet presentation to us. We are very happy with those 2. We're going forward. We also talk about Taiwan, we didn't move forward on that either. We need to have everything set the right way for us to benefit our shareholders before we do. But I do have something to add to that. And that is, as of this morning, our [ CRO ], all of our data for United Kingdom is ready to move forward, and they have been told that there is a special program that we can get in front of the Chief Medical Officer, United Kingdom with our data and protocol, and we will be doing that starting today. So hopefully, by Monday, they will have everything. And by next week, it will be in front of the Chief Medical Officer of United Kingdom and they are giving approval, some limited approval for the product. And Amarex indicated to me that we have a very good chance of that because our data is very nice. So we could have some very nice pleasantly surprised next week from United Kingdom. We don't know, but that's where we are so far. As always, we will let everybody know where we are. Some things may pan out to become perfect, some may not come through at all. So please make sure you realize that. Next question, is there any interest from the big pharmaceutical companies? I don't have the names to give anybody at this time because the names are always confidential, but we were told that there was interest from certain folks. They wanted to do a study of leronlimab and remdesivir. But we're not going to be moving on that yet until we get our own trial finished, which is 75 patients that we are having right now. That's our filing. Next question is what is the difference in mechanism of action between leronlimab and IL-6 inhibitor ACTEMRA? Any federal brands -- so let have that question go to Dr. Patterson. Bruce, would you please.

Yes, that's a common question. And like I said, this is not an IL-6 disease or solely an IL-6 disease. So that's attacking this disease piecemeal. Why don't we just add a monoclonal antibody to IL-8, in IL-1 beta and GM-CSF. I mean you can't quiet a storm with one target. And that's what so impressive about leronlimab, is not only does it bring levels of IL-6 back down to normal by 14 to 21 days from sky high levels in some patients. But like I said, it also restores immune homeostasis. It also brings down TNF alpha. It brings down GM-CSF when it's present. So it's got a much broader treatment and much broader effect on the cytokine storm than just one of the many cytokines that are part of the storm.

So then one question also, Bruce is, can you compare leronlimab to Gilead remdesivir? Can you please do that? And then perhaps Jay will also elaborate enough. Go ahead, Bruce, first.

Yes. As Jay said, remdesivir is an antiviral. And it's a relatively nonspecific antiviral, meaning it wasn't designed specifically for COVID. But this is not a viral disease at a certain point. It's a very fascinating disease from a pathology standpoint because it may start as a viral disease and may remain a viral disease and very mild in some patients. But in many of the patients, you start getting the immunologic abnormalities and it's the immunologic abnormalities that are causing the morbidity and mortality. So this -- you cannot compare the 2, an immunologic modulated that both enhances the immune system and quiets the cytokine storm and compare that to something that if it did work, would only decrease replication of the virus. It's apples and oranges. And the fact is this is an orange disease or an immunologic disease causing all the morbidity and mortality.

Jay, do you have anything to add to that or...

Well, as Bruce said, it's the virus that makes you sick but it's your immune system that's killing people. When you look at the virologic curves of the illness, the virus replication happens early. That's why people are most infectious before they're symptomatic. But their symptoms correspond with an immune system that's kicking in to bring down viral levels in all but a few patients. There are some patients who clearly have prolonged viral replication, who probably would benefit from an antiviral drug. And certainly, one could imagine a combination of an immunomodulator and an antiviral. But if you were to just pick one, the virus is done doing its thing pretty early in the disease. It leaves behind a lung -- an injury to the lung and it's the immune response to that injury that is driving clinical illness and mortality. So you can't really compare remdesivir and leronlimab because as Bruce said, they're completely different concepts.

Okay. So the next question is they want to know if we have gone to Dr. Fauci or not, if they -- if we have data from Novant Health and if big pharmas are coming. So let me just sum up a couple of things. First of all, these rules and regulation in the United States of America, thank God for that. Those rules and regulations means we go through regulatory agency. And as soon as you go there, people can't just jump up and down, say: "Oh my God, they got a couple of patients, okay," they cannot do that. They won't do that. Thank God, they won't do that. In regards to getting it to somebody like Dr. Fauci, he's already very, very busy with a lot of things going on. We already know what we need to do. We need to finish our 75 patients. And we need to continuously allow those patients who want emergency IND to be able to be involved. We're going to do our thing, and we're going to remember that there's 160 companies think they have something that's going to work. We believe our data is strong. We believe the science is solid behind it. But again, we also have to go through the right path and nobody is stopping us. FDA has opened the door for us. They said, "Here's your Phase II. You want to do a Phase II, here it is. You want to do a Phase III in severe population, here it is." You want to do emergency IND, have anybody call and we'll let them have leronlimab." So nothing is closed here because of some kind of conspiracy. Those are all wrong. So I want to make sure we put it into that for everybody. Let's go to the next question is why not -- they're asking why can't we just do the testimony of the patients? Well, we did one -- we are about to do one, but I'm going to ask Dr. Patterson to talk about one patient that's close to him. And Bruce, do you feel comfortable talking about that?

Yes. I mean we've heard from the one patient coming out of UCLA. I think there's another patient, which is a truly remarkable story, who is on ECMO, which is essentially a cardiac lung bypass, which they use in life or death situations. Within 24 hours, she came off of ECMO and she's now down to about 20% on the ventilator and breathing normally at times in the absence of a ventilator, so-called weaning off of the ventilator. But we couldn't be happier that this patient has gone off heart-lung bypass and is now breathing on her own for a majority of the time. And soon, we'll probably be hearing from her.

Great. Thank you. The next question says, have you tried to get funding via BARDA or CARES Act? What is the status of any? Okay. So we will talk about any of the collaboration that's going on once we have something similar to what Dr. Bruce Patterson is working, helping us. And everybody in Amarex is working to do what we have to do to talk to other government agencies. But again, we are at the very beginning. We got 30 patients injected perhaps in emergency IND, about 27, 28. I guess that's the final number. We have 30-some EIND approval from [ FDA ]. Let's give it a few weeks. I know everybody would like to see things happen in 24 hours. But right now, we are really doing things that has never been happening in this speed. So once we get the result of the 75 patients, I think that would change everything. And also, next week with the United Kingdom, I'm really excited to see what happens with that because we'll see what they want to do with our data, I think they'll give us a special approval on that. What delay effect will the COVID-19 crises have on clinical trials? Is CYDY asking for transit? Okay. So the delays on clinical trials, we won't be able to get blood samples, as Dr. Lalezari has already explained. Other than that, the trials are going forward. There are delays, obviously, when they have to come to the hospital, but our product is set to inject that home. We can get new patients perhaps, but we are working on that also. Next question, do we know yet if coronavirus is causing self-acute chronical immunodeficiency in some cases? Bruce, would you like?

Yes, absolutely, it is. And I think we were the first to report that several months ago, that it was astounding how low these special lymphocytes where the CD8 T cells in these patients. It was -- they were at levels that demonstrated enormous immunosuppression. So that is definitely a part of COVID as we're looking at more and more patients across the spectrum. And the fact that leronlimab reverses that over 3 days and almost fully by 7 days is one of the most remarkable things about the drug.

Thank you for that. There's question I think a lot of people asked us. Have any of the 840 patients we have got coronavirus? And if they haven't, perhaps leronlimab is working. So I have to make sure everybody understands. Some of these patients were injected 15 years ago. They're no longer in the trial. When you say 840 patients, 70 patients were enrolled in 2000. So -- we don't have whatever patients are left on our trial, we do not -- it's roughly about 100. They have not recorded coronavirus. If they do, we get serious adverse event and then we'd know, but so far we don't. But we can conclude anything from that. That's just not possible. Okay. Then perhaps part of our FDA approval time line moves compared to other companies treating coronavirus. Well. We have 75 patients. As we said, if we're able to do what Amarex thinks we can do, which is 3 weeks of enrollment, 2 weeks of last-patient results, then another week to get the results. So we're talking about a couple of months is the best case scenario that we have, and we believe we might be able to meet that. So the next question is, how does leronlimab compare to remdesivir? I think we answered that question. Let's talk about another -- discuss the stage of drug manufacturing broken down by whom, how much by each. Dr. Patterson, based on your knowledge, what differentiates leronlimab versus other market approach. For market approach to Dr. Patterson talked about that. Bruce, do you want to say anything else about [ testing ] and everybody else?

Yes. I mean I'm just going to reiterate the fact that all these other approaches are piecemeal. They're targeting one part of the cytokine storm or they're targeting the virus or they're targeting some of the growth factors that may or may not be upregulated. And the fact is it's piecemeal. It's just part of a very complicated disease. And again, I'll go back and say that the most remarkable thing about leronlimab is it's correcting a lot of the deficiencies across the spectrum of disease and we're not attacking this piecemeal. So for instance, interleukin 6 is going down dramatically with leronlimab, at the same time has increased in the CD8 T cells. I mean that's -- it's truly unbelievable, but it's a testament to the mechanism of action that we defined a couple of months ago now. And it's now being played out and supported by clinical evidence.

Jay, do you like to add anything to that?

Well, I think a lot of this will become more clear when data is in the public domain. But yes, the rest of it is going after one part of the puzzle or another. But the -- God and the universe, mild on CytoDyn, and everyone will understand that in a couple of weeks.

So thank you. So let's talk about the next -- a couple of more questions and then we go to the live questions. Aside from leronlimab ability to successfully treat COVID-19, what is your biggest challenge with bringing it to the market? The biggest challenge is we always have to be careful about being able to hit our primary endpoint. We already hit our primary endpoint with HIV. So the biggest question for everybody is are we really going to file BLA. Just for everybody's information, I have made it very clear to all of our departments that the BLA needs to be filed next week. We have all the information that we needed. They are all being put together. And next week, I'm hoping to be filing the BLA. If there is something goes wrong in the last minute, again, we will let everybody know. But this is a very, very difficult time with coronavirus and then being able to get everything we need to get. Next question, aside from leronlimab -- by the time the FDA approved the leronlimab, will there still be a need for patients to receive therapeutics? Well, first, let's pray to God that there will not be any coronavirus very soon no matter who fixes that. But the way it's going right now, unfortunately, there are reports that this problem will not be resolved until perhaps 2022. That's the -- Bruce, would you like to add to that, or Jay? Bruce, go ahead first.

Yes. Absolutely. There's other viral infections, most notably influenza, that happens every single year that also has a cytokine storm in its severe cases. So it's absolutely possible. And probable, I would say, that we would be looking at leronlimab for influenza as well. And we do have a good antiviral there. So the combination of an antiviral and leronlimab in severe cases of influenza is very, very exciting. So what we've learned through COVID is going to be incredibly beneficial for CytoDyn going forward in terms of additional indications and -- because of the broad effects that we see on the immune system.

Jay, would you like to add anything?

Yes. Unfortunately, I don't think we have to worry about COVID-19 going anywhere. There's no chance that this pandemic is ending within 12 to 18 months until there's a vaccine. And if societies want to open between now and then, they are going to need a way to treat people so that the mortality rates are not 5% or 10%. And until we have that treatment, I don't see any way to come out of lockdown. But as I've said, I do think CytoDyn has that treatment and that it will be a key piece to societies opening around the world. So if we could just hold on for 2 or 3 months, I think that process is going to start playing out.

Okay. So the last question I'm going to read from here is about manufacturing. For Dr. Jay Lalezari, it's very adamant for our manufacturing to go forward much faster than it has. So thanks to helping us some of those. We now have got discussions with Samsung and Samsung agreed to deliver to us this year 1.2 million vials. We have 40,000 vials, 30,000 ready to go, 10,000 is being worked on with FUJIFILM Diosynth. We do have AGC agreeing to do 4 runs of this product, which will be available a few months from now. But if we are able to go forward treatment, the is 2 weeks. So we need 2 doses per patient, perhaps for more than a month. And that is going long way to get 1.2 million. And Samsung, its CEO, Dr. Rim, also said if you need a lot more product, we can make as much as you want without any limit, almost. I know there is a limit, but because they have 180,000 liter run, and they could produce 1 million to 2 million to 3 million vials a month if we want to. So that's the kind of setup Dr. Nitya Ray, which I cannot thank him enough, set this up 1.5 years ago, and despite the fight that we had to do, Dr. Ray and I, and Dr. Scott Kelly, our Chairman of the Board, backed us up big time. And that process started at that time, which was very difficult with the mentality of other people at this time. So thank God we are there. We have our manufacturing in a good shape. So with that, Jack, would you like to see if anybody wants to ask any live question?

Yes, Nader, can you hear me?

Yes, go ahead.

Okay. Yes. So you -- okay, so you pretty much answered -- we have 300 questions that came in. Okay. So we have Gray that's asking...

Let's do 4 to 5 more minutes of questioning and let Dr. Bruce Patterson and Jay Lalezari go back to work and I do, too.

I guess we have hundreds of questions. Okay. So Gray is asking, what's the full game plan schedule for next week as you still observe these trials?

What is the game plan for next week as we observe the trial? What does that mean? Jack, can you explain?

Yes, I don't know. Okay. Let's go to the next one.

Yes, please.

Steve is asking regarding the EIND compassionate usage in New York and other locations, has there been 100% recovery so far of the patients that were on ventilators?

Absolutely not. You're asking for the severeness of the severest patients, especially at the beginning, to -- for us to do merit. Dr. Patterson, could you explain a little bit about those 10 patients at the first when we got the severest of severe patients?

Yes, it did. Now categorized as critical patients. I mean every single one of these patients had some degree of renal failure, many required dialysis for their renal failure. I mean, these were the worst of the worst cases, and we had success treating them. So we'll leave it at that. But I was amazed that we were able to pull some of these patients out from a very bad situation with a multi-organ system failure.

And to credit the FDA big time on this, because a lot of people are saying FDA is not giving you approval, why don't you go forward right now. It's not right to say that because FDA allowed those emergency INDs and when they saw that there is something there, they expedited our Phase II immediately. Thanks to Dr. Jacob Lalezari, also, who was very much adamant that we need to move quickly on this trial. We were able to expedite. Jay, would you like to say anything about that? Or...

When patients are in the critical phase, we've seen reports from around the world of 90% mortality. We can't share, I guess, yet the results in New York other than to say we did a lot better than that. But as Bruce said, that's a very difficult situation. The drug is not meant to be given to patients in critical condition. When this drug is launched, and it will be launched, it needs to be given in patients with anything more than mild shortness of breath. So when they're on the cusp of cytokine storm, when they're on the cusp of severe immune suppression. But before those things start. And in my view, it's even possible that some patients might be able to get away with a single dose in that setting. But right now, it's 2 doses. And there are some patients also who may end up needing 3 doses. So there's a lot to be learned here.

Thank you. Jack, a couple of more questions and then go ahead and conclude.

Okay. So we got -- this is a question for Dr. Patterson. So Philip is asking viral disease typically results in thrombocytopenia, did I pronounced that correctly?

Thrombocytopenia.

Okay. That's it. Without measuring viral load, a reversal in thrombocytopenia would provide indirect evidence that the viral load has decreased. Can Dr. Patterson comment on platelet counts following treatment.

It's a thought. We aren't looking at platelet counts per se. We have some platelet markers in our cytokine panel. But most importantly, right now, we're actually working on a plasma viral load assay. And I'm not as convinced that leronlimab isn't capable of also bringing down viral load because of its ability to inhibit T regulatory cells, which turn off the immune response. So I think by enhancing the immune response, we may also see viral load decreases in these patients just with one drug. So I think the best answer is we're actually working on a plasma-based viral load assay so that we don't have to do the nasopharyngeal swabs, which have a lot of variability.

Okay. Next question is from Jeff. He's asking Gilead does set to be acquiring a stake in Arcus Biosciences, which is an HIV, cancer therapeutics company. Why would Gilead not engage in CytoDyn since the drug is superior over the Arcus HIV drug. And has Gilead approached CytoDyn regarding the above?

So as I said before, we don't talk about any discussions that might be going on. But if you have any question from Gilead, you guys have to ask Gilead because I don't make any rules for Gilead. I barely make its own rules for CytoDyn. So in regards to Gilead, I'm sorry but I cannot answer. So with that, let's -- Jack, let's have the last question, please.

Okay. Yes. We get a lot of same questions. Okay. So Elaine is asking, when will Bruce's paper be published?

It's -- I think we're very excited that by the end of next week, we'll have all the data accumulated. We're actively writing right now. And I'll probably be writing a lot over the weekend with Jay and others. And we're very excited. But I think it's going to be probably 2 weeks until it gets submitted. And as we've seen with COVID papers, I think the turnaround time in the papers ending up in print is relatively short compared to the normal cycle of manuscripts where they don't come out for 6 to 12 months. So I'm hopeful that we can get this out in print within 4 to 6 weeks.

Excellent. All right. So Jack, with that, would you like me to finish it off with a comment about everything, summarize?

Absolutely. Yes. Go ahead. Okay.

So first of all, I want to thank Dr. Patterson, Dr. Lalezari being kind enough to be on this call. And for all the shareholders and the people on the call, thank you. We do have, again, our cancer program going forward, our basket trial had the first patient injected for 22 different type of tumor cancer. Our breakthrough designation, preliminary hearing, preliminary meeting, we are waiting for a date. In regards to BLA, as I said, I'm hoping to get this done by next week. In regards to our coronavirus, we hope to finish the trial for Phase II randomized in 2 to 3 weeks. And the emergency IND, as the results comes out, whatever it is, we can -- whatever we can talk about from the participant hospitals, we will do that. And in regards to our severe population, we have 3 patients enrolled and we will continue to update the everybody about the progress. Thank you for being here. Have a good day.

Okay. Thank you, everybody, for joining us, and we'll see you again next time.

Thank you.

Thank you.