CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Okay. We are live. Okay. Good afternoon, everybody, and welcome to Wall Street Reporter's NEXT SUPER STOCK livestream for today May 13, 2020, and we're proud to bring you another special presentation, with a special update from CytoDyn's stock symbol, of course, is C-Y-D-Y, which many of you have been following since August since they first presented at our livestream. The company has been making tremendous progress on exciting news now with the coronavirus treatment, and we're going to be hearing more about that today with the latest data. And again, CytoDyn is a [Technical Difficulty] next SUPER STOCK series is all about, which is bringing new stocks with 10x upside potential. So the format for today is simple. Dr. Pourhassan is going to present, then we'll -- I think he'll be joined by Dr. Bruce Patterson and Dr. Jay Lalezari, I always mispronounce. I apologize. And then we'll open up for the questions. We've got a lot of questions. We had over 400 questions that came in. Hopefully, we'll answer some of them. So with that being said, please welcome Dr. Nader Pourhassan.

Thank you, Jack. And thank you, everyone, for being on this presentation. Our company is working on some very critical tasks, namely coronavirus, which is haunting the whole world. In today's presentation, I will be making forward-looking statements. But before I start in my presentation, I want to let everybody know that the lady, we are not going to give her name out, gave us a text to Dr. Bruce Patterson and myself, said that past Sunday, Mother's Day, gift to her mom was leronlimab. That patient's mom was an ECMO or life support and have coronavirus, and she survived. And that person thinks that was leronlimab that helped her. I'm going to read the letter that she sent us to Dr. Patterson for us to read to you not just as a thank letter, but also to bring awareness some of our product. I want to say, again, we're not making claim that leronlimab can 100% help everybody in coronavirus. Those things have to be decided with the FDA Phase II randomized and another Phase III [Technical Difficulty] But I just want to bring [Technical Difficulty] of what's happening or emergency IND patients, and here's a letter that this lady sent us. It was late February 2020 when our mom started feeling flu-like symptoms, cold chills, a fever, dry cough and a sharp pinning headache. As symptoms were not unusual to flu-like symptoms. Day 4 into her fever, she went to the doctors to get checked and doctors ensured her that was nothing concerned and advised her to hydrate and rest. Although we had expressed our concern about the coronavirus spread, no tests were conducted as she did not fit the criteria and had not traveled internationally nor was in close contact with anyone who had traveled internationally. Another 3 days passed and symptoms did not improve and her fever was now at 103. Our mom was admitted immediately into the hospital for -- by lateral pneumonia. Her respiratory continued to decline rapidly and was intubated to preserve a lung function. On March 9, our mom was transferred to regional medical center in San José in hopes to access the ECMO machine as a last measure to try and save my mom's life. Doctors prepared us for the worse. She was also the sickest COVID patient in their hospital. Her health was declining quickly, and they were doing every aggressive life-saving measure. She was on 100% ECMO support, receiving a number of drugs to keep her stable and was also given remdesivir. My mom was on Day 31 in ICU and going on 23 days on the ECMO machine. Nothing was working. My family prayed for a miracle. We were fortunate to have been introduced to Dr. Bruce Patterson from a colleague who shared that they were working on a treatment for COVID-19. Doctor at Regional Medical Center in San José, I agreed to give leronlimab under the FDA's emergency IND program. It was our family's last call. We knew there were no guarantees, but we had heard about the positive results to other patients in New York City. On just 3 days, after giving our mom leronlimab, there were significant improvements to our mom's condition. There were no negative side effects. On Day 6, she was taken off support of the ECMO machine. She was given another dose of leronlimab on Day 7. And again, the drug proved to strengthen her condition and oxygen levels. Day after day, she was getting better and better and was requiring less and less ventilator support. There were small improvements, but she was headed in the right direction. Doctors continuously shared positive news. On April 20, our mom was given a drug as the next step to her recovery. Sedations were turned down, and it was the first time our mom smiled after hearing our voices through face time. We know she was still in there fighting to return to us. It is now May 12, and our mom is alive. She is currently in rehab and rebuilding her strength back. Every day, she has shown progress. Doctors have expressed how miraculous it is and how far she has come along. Doctors are optimistic that with the support of therapies, she will soon come off the ventilator. There are so many unknowns to this virus, but one thing is for sure. Had it not been for this miracle drug, leronlimab, and doctors at Regional Medical, who were open to consider this new drug, my mother would not be here with us today. Thank you for giving my mom life again. So with that, I would like to say the reason CytoDyn has been aggressive with press releases in the past few months is because our press releases reaches people and sometimes it saves peoples' live. And in this regard to this patient, I would like to have Dr. Patterson, who is credited for bringing their attention leronlimab to elaborate anything you'd like. Dr. Patterson, please?

Yes. This is just an inspiring testimonial. And for me, anecdotes don't come off life support, okay? And one could argue that she had her own control group, which was herself on the standard of care, remdesivir and failed. So that's the take-home message here is if you are a patient and you're at the hospital at 10 days instead of 11 days, you could attribute that to being anecdotal. But like I said, anecdotes don't come off life support.

Thank you, Dr. Patterson. So let's now continue with our update. Everyone knows the number of indications for this product that has potential for approval is quite a bit in our opinion. And I'm just going to get right into the coronavirus. Again, the 11 patients we talk about at New York hospital that were very critical with multiple organ failure in some of the patients are listed in this slide. The next slide is the Southern California Hospital that is now at 29 critical and intubated were 9, severely ill was 20. As you can see the numbers, the stable -- there were 3 of them are stable from the critical and intubated, 3 have improved extubated and discharged, 3 have passed away. In the severely ill 20 patients, improved was 12 oxygen and discharged were 10. Stable were 5, not improved is 1 and 2 have passed away. There are other hospitals. We will have more update very soon, but the data is coming in, but the one that we have is 5 critical and intubated, 4 have been extubated. Overall, we can just say that in the 45 patients that we have, the first 11 were very, very critical. The next 14, 11 either extubated, improved or at stable and severely ill 20. 17 out of 20 are either discharged, improved or at stable condition. In regards to our clinical trial Phase II, we have about 45 patients, Phase II-b/III, about 25. We have about 6 sites ready to go, which we believe that is really going to help us pick up the enrollment. In regards to compassionate use, the protocol submission is this week. We have worked on it and I'm going to let perhaps Dr. Jacob Lalezari say few words about that -- Dr. Lalezari, about our compassionate use protocol for COVID-19. I think you are on mute. You might be on mute.

There you go. Hi. I just wanted to make a comment about all the summary of the emergency IND data that you don't quite capture from that chart. And that is -- that it seems to me the great majority of those patients are starting to show improvement within 2 or 3 days of that first dose. And what's notable about that similar to the ECMO patient that Bruce just talked about is that it lines up so nicely with the lab data that Bruce has generated, showing that already by Day 3, we're seeing these changes in CD8 and in the cytokine panels. So yes, the survival is very good in the severe and critical patients, but it's also striking how quickly patients are often getting better. We are -- we've gone to the FDA number of times asking for compassionate use since April 8, and Bruce showed the elevated RANTES levels. This story is all fit together and made sense. And since then, Bruce has also shown antiviral data on top of it. So we think that even as the clinical protocols are enrolling that we should be offering compassionate use drug, particularly to ICU patients around the country and now, of course, these children with COVID-associated hyperinflammatory syndrome where it's now been shown that they, too, have elevated RANTES levels. With -- given that the ICU patients are the most severely critically ill, Bruce has shown that RANTES levels, even though the cytokines are coming down and CD8 and CD4/CD8 ratios are normalizing, viral loads are coming down, these patients can still have elevated RANTES levels out to Day 14. So we thought that for the compassionate use protocol for ICU patients that we would extend it to 3 doses to give them coverage out to Day 14 and also proposed that the first dose be administered intravenously so that we get even more rapid receptor occupancy, which seems to be the key to providing benefit to the patients. Similarly, for the kids, we're going to have a protocol to support emergency IND applications. Again, looking at 3 doses, it will be weight based. And again, that first dose will be administrated by IV infusion. And we are waiting for any of the pediatricians in the New York area or elsewhere who want to treat any of these COVID-associated Kawasaki-like syndromes, we'll get the drug and get them started.

And obviously, that would be going through the FDA, asking FDA for emergency IND. If they agree, give us a number, then we will do that. But what I want to ask Dr. Patterson is the 11 patients that was from Dr. Harish Seethramraju, Montefiore Hospital, Albert Einstein College of Medicine Hospital, only 4 survived. But these are the 11 patients that would look at the data and say, leronlimab perhaps was working on most of them, but I want to make sure you explained it what you think because you're writing a paper maybe you get that papers about this. Could you explain what you found in this presentation that made you come up to a conclusion in your papers that you're writing?

Thank you, Nader. That's the beauty of being able to have a suite of diagnostics that are tailored to the drug. For instance, if you're on antiviral, you should show that the viral load goes down, and we didn't see that in some of the results that have been presented. However, in the case of leronlimab, we have special tests that have been developed here at IncellDX that show that the drug is actually doing what it's supposed to be doing. So despite the fact that these 11 extremely ill patients at Montefiore where 4 of them survived. The fact is all 11 showed immunologic improvement, showed decreases in interleukin-6 showed reconstitution of the immune system, showed receptor occupancy of Tregs and macrophages, which are responsible for the cytokine storm. All of them showed that within even 3 days and certainly by Day 7, the fact that they were -- that some didn't survive is the fact that they all had renal failure. They all had liver failure. These patients were the worst of the worst to quote my colleague, Jay. And we're still able to save 4 of them. The beauty is in the other cases that you've seen in UCLA and other sites, we're seeing that harmony between diagnostic and laboratory marker improvement and patient improvement like we should see because we've been able to treat those patients at the appropriate time. And again, having that suite of diagnostics that says, "No, the drug is actually working is so critical or it's so easy when you have a new drug or a new diagnostic." It's so easy for physicians to say, "Oh, this -- they didn't survive, it must be because of the drug or this must be because of the drug." Similarly, we want to show that the success of the drug is due to the fact that it's actually doing what we suggest it's doing in terms of its mechanism of action. That's a beautiful harmony that we have with leronlimab that you don't see with any other drugs that are out in the market. You're not seeing this coordination of response to drug with overall survival or outcomes with the patients, and that's what gives credibility to the drug. Nobody can make the argument at the end of a day that the drug isn't working or we don't see a decrease in viral load to this decrease in time in hospital must be due to the drug. That's a conundrum that exists with some of the drugs that are out there as they can't link the outcome with a positive result in the laboratory finds. And again, that's what's so wonderful about the package that we have right now. We know exactly how the drug is working, if the drug is given. And if there are nuances or some issues, we can say, it's not the drug, and we've already been able to say that in several patients. So I feel great about these trials. These trials are enrolling very successfully. And we're seeing, in the 2 different trials, they are so completely different from mild to moderate and severe. These patients are very, very heterogeneous. There's huge differences between mild to moderate and severe. But the one thing that's in common is that RANTES is elevated. It's elevated fivefold in the mild to moderate and it's elevated 100x normal levels in the severe. And as Jay said, we have to be able to cover these elevated levels of RANTES with drug in some of the most critical patients so that we ensure there's not a rekindling of the fire, if you will.

Yes. No, thank you so much. Appreciate it. So in regards to the children that have been reported with Kawasaki disease from perhaps COVID-19, we are working on a protocol. Obviously, children have different weight. We have to find the right dose. We do not have any pediatric study nor animal study for children. So that could be a problem with FDA. We don't know. We have to see what happens. But Dr. Patterson would check the RANTES on these patients' blood sample. And then if FDA is okay with it, the emergency IND, we could be helping those kids and see if it works or not. In regards to our potential trial in other countries, there are number of countries that we are working with, but the one that I want to bring to your attention is Mexico. The Department of Health over there and some of the government employees over there, I believe, were talking about this combination of a study with leronlimab. So we got on the phone with some of the folks, and we do have an invitation letter to conduct this study. They want to have a 3-arm study with leronlimab 1 arm, remdesivir another arm, remdesivir plus leronlimab on a third arm. We are good with that, and we are pursuing it. And we don't know if it's going to happen or not, again, when I talk about any of these items, I'm just trying to be transparent with the shareholders. And instead of saying no comments till everything is done, I make sure everybody knows exactly where we are at this time. This is what's happening with the potential trial in Mexico. In regards to our United Kingdom, again, our CRO just send me a statement, which I'm putting it here and read it to you. Our team -- that's what they said. The CRO said, "our team in the U.K. has been making inquiries with the various parties that would need to be involved, and it does look promising. Right now, they are trying to work out the last part of the puzzle, which is getting the drug into Ireland. Hopefully, this will be resolved and confirmed in the next day or 2, then we can work on the regulatory files -- again, filings." So again, these are estimates. We never know if it's going to happen in this time frame or not, but that's what they're telling us. In regards to cancer program, so the data that we have received have been pretty promising, but again, anecdotal mainly. So we need to have patients enroll in the Phase Ib/II of metastasis, triple-negative breast cancer. Most of the patients that we have in the metastasis triple-negative breast cancer, perhaps all of them are having CTC of 0. The latest numbers, I don't recall, but they are going to send that to me. We have talked about it on the phone. The 22 solid tumor basket trial, Dr. Jay Lalezari is enrolling those patients. There is only 1 patient enrolled, but there is quite a bit of patients. Dr. Lalezari, you want to elaborate on how many are potential and what's happening with that?

Well, we finished dosing in the first cohort of CD07 and there was, again, no safety issues. So we're on the verge of increasing the dose to 525 milligrams once a week. And we have about 10 patients who are waiting to start the study as soon as that dose increase is implemented, both in the CD07 compassionate use and the CD09. We're trying to focus on breast and prostate, but we are hearing from people, as you can imagine, all over the world who would like to have their tumors tested for CCR5.

No, thank you for that. And there are patients who are giving results to us, but 1 patient that I wanted to talk about the results of their MRI, was my own family member who was told to everybody by me that the radiologists for her has said that there's nothing given to her but leronlimab for her metastases in the brain. I'm going to show you -- show everybody the last MRI from the doctor and perhaps walk everybody through that so everybody can see what's happening with her. Here is the MRI that we did for her. The date on this 9/13 that's when leronlimab wasn't given. Leronlimab was given at the end of November, November 25. So as you can see, the tumor that is marked here analyzed by her doctor shows 65% shrunk of the volume. From January to end of March, this month shows shrunk the tumor by 50%. Here, it shows that the tumor shrunk first for 25%. And then after leronlimab came in, it shrunk even more -- 70% more. Here, we show that the tumor didn't shrink. The tumor actually increased, but the increase in the tumor, the doc, the radiologist confirmed that, first, it was expanding at the rate of 118% in 3 months. But then if you look at the next 1.5 months or so, it only expand -- I mean, I'm sorry, at the beginning, it expanded 118%, but then it expanded 55%, a little bit less. But then we asked Dr. Patterson why. And Dr. Patterson brought to our attention that this could be because the blood supply in the back of this tumor wasn't there. He will explain that in a minute, but I just want to finish this slide. Here again, we see the tumor shrunk after leronlimab was given in this case. And here, again, the tumor shrunk. Here, they have found a spot, which is less than 0.1 CC. They have put a question mark, and there's 2 of them. So with that, Dr. Patterson, can you explain what you told us about why that 1 tumor perhaps she just got radiation for that one to get that shrink again. But go ahead, Dr. Patterson.

Yes. We're still learning about the availability of leronlimab in the brain. I think it's a very exciting in this patient, who has given 3 months about this time last year. And even to date, even if you accept the fact that the size of the metastases are stable, is a remarkable result, especially given the blood-brain barrier and its exclusion of molecules into the brain. But the fact is leronlimab is capable of blocking T regulatory cells, which inhibit the immune response and those T regulatory cells actually migrate into the brain and can inhibit the immune response as well as macrophages also expressing CCR5. So the fact is leronlimab, whether it's actually getting through the blood-brain barrier or all turning the cells involved in the immune system before they migrate through the blood-brain barrier is effective. And this patient, obviously, is now still stable after given only 3 months and now on at least a year from when they are given that diagnosis.

And the radiologists himself said from OHSU that he told me and my wife that if there was no leronlimab, the brain would have been full of metastases. This patient never been like this. So that's a positive on leronlimab. On a breakthrough designation, preliminary breakthrough designation, meeting the status that we ask FDA, we don't have any update on that as far as FDA give us update we will share that with everybody. So with that, I have a slide about uplisting, but just going to go to the questions and answer. And there is a question about that, and we will explain that at the right time. So Jack, would you like to go to Q&A?

Yes. Nader, can you hear me?

Yes, I can. Go ahead.

Okay. First question is from Andrew. He was asking about can you give an update on the Novant Phase II DB trial, which was started in early April?

Yes. So they have -- in both compositions, you have to understand that there are a lot of regulatory steps that needs to be taken by each hospital. So they're doing great. As we said, that we got about 45 patients in 1 trial, 25 patients in another trial and they are part of those 6 sites that are now enrolling. If we get 2 patients a day, going forward, we will make our end of May completion of the trial. And hopefully, 2 weeks later, we can read the data. Next, please?

Okay. Vladimir is asking, will the company consider issuing additional shares to raise funds necessary to complete COVID-19 trials if no government grant?

We could. Obviously, we are proud of not issuing more than 100 million shares since I came back to the leadership position again after the Executive Chairman had stepped down back in June 2018. We try to make sure that the dilution is very low. And we're proud of the fact that we have kept it in this range. So if we have to issue perhaps or authorize or ask permission to authorize another 100 million, 120 million shares, that will be 10%, 15% dilution to the whole company. Those options are on the table. But as always, we are trying to wait and have the warrants get exercised. There are warrants that are being exercised and they are still quite a bit of help to us. So we'll evaluate everything as always to make sure to the benefit of shareholders. Next, please.

Okay. Michael was asking, any plans to do trials with youth with the COVID-related syndrome recently in the news?

So we have a protocol that we're working on and Dr. Jay Lalezari and Bruce Patterson are involving all of that to give us guidance. And Dr. Lalezari, you want to talk about what has been done so far?

Yes. So because we don't have pediatric studies, we don't feel that we could ask FDA for a compassionate capacity use program, but we certainly want to support any pediatricians or institutions that are caring for these children and help expedite their application for emergency IND access to the drug. So that protocol will be done, I believe, by the end of today. So any physician who's caring for any of these children should be able to get leronlimab much as the doctors did for the adult patients when we first started down this road.

Dr. Patterson, anything about this, you would like to share?

I think because we have the ability to measure receptor occupancy, 2 things come to mind. Number one, we can start at the lowest dose and build as needed, depending on how many CCR5 receptors are being expressed. The one thing we see in COVID because CCR5 is a moving target, but we have the capabilities of measuring that moving target. So I think in the kids, it's perfectly justified to start at a low level or a low dose of drug, monitor their RANTES levels, monitor their -- the amount of CCR5 and whether or not it's blocked and go from there and look at -- and obviously, look at response. So again, I think the ability to tailor what we do to the pediatric population is a huge advantage over other drugs where you may just be guessing based on body weight or other criteria.

Thank you.

And I'll just add Nader that switching to that first dose being IV is an effort to try and deal with the receptor occupancy that Bruce just mentioned. In the current studies for Monofer, I think we see 70% occupancy by Day 3, and that's probably what's driving benefit. So the sooner we get there, the better. So we're going to introduce IV dosing for the most ill patients, be they adults or children.

Right. Thank you. Next, Jack, please.

Okay. James asking there appears to be an effort to undermine your attempts, to get leronlimab to market, who is doing this and why?

They attempt to do what? I'm sorry?

To undermine your efforts to leronlimab to market, who's doing this and why?

I have no idea who is doing that, there is always when it does to stock, there's always short and long and will that alone. In regards to the business of going forward with FDA, we could ask for more cooperation. We have got Phase II, asking us shows what you got, and we do that Phase III, IIb/III is going. So I don't know anything about that. Next, please.

Okay. Michael was asking, Nader, can you explain further the stock option and warranty transaction you participated in April? There's still confusion on this.

Yes. So in May 6, I gave an interview and I explained why I sacrificed that situation. And I have to leave it at that. My day-to-day operation is worried about how many lives we can save and what we can do to go forward and everything else has been explained in the public, and that's all we're going to say about that for now. Next, please.

Okay. Scott was asking when do you expect to have a PDUFA date. And in your opinion, what would be -- what would that date be?

The PDUFA date is what the FDA will give us. The FDA has -- we believe we give all the complete BLA to the FDA. They have to come back and accept that that's completed. We don't have that yet from FDA. We're going to wait and make sure they stay. And when they do, they give us that date, and we will again share that with everybody. One of the problems that I'm getting hammered sometime is I try to give the shareholders the visibility of exactly what's happening in our company as we go forward. So you aren't staying in dark. But then that doesn't mean that when we say we could have this happen on the forward-looking statement that this is going to happen. So I just want to make sure everybody knows, we did work on BLA for 1.5 years. We went through a lot of uptick hold. Our team, about 50 people also work very hard on the CMC and the clinical trials and the clinical data. We have our weekly meetings with everybody. So the work has been a tremendous amount, and we are where we are. We will report to you as soon as we have any more news from FDA. Next, please.

Okay. There are about 20 or 30 questions like this, which is, can you explain why leronlimab has not gotten the national press coverage it deserves?

Well, we have to have results. When we have results, then we will be in national news. Right now, we were sharing what results we have. Everybody has to be patient. Everything is going as expedited as we can. Next, please.

David, asking status of FDA compassionate use request.

So we have, as Dr. Lalezari already explained and Dr. Patterson, we have a protocol ready to go. We will be submitting that to the FDA, if not today or tomorrow, maybe in the next few days. Next, please.

Michael, asking the March meeting with oncologists occur, what was the outcome?

We did not have much meeting. There is coronavirus problem, but Dr. Lalezari can perhaps speak about that. Jay?

Well, we'd still like to have a meeting to go over the clinical data. I think Nader had mentioned that one of the encouraging signs was that all the women that had measurements of circulating tumor cells had gone to 0, and that was one of the things that was a signal for us that the proposed mechanism for leronlimab around Tregs and macrophages was actually being borne out in the clinic. And that gave the incentive to then go looking in COVID-19. But we're continuing to enroll the cancer program and very much look forward to having the bandwidth to focus on that again and to do a sort of data summary of what we're seeing.

Yes. Dr. Bruce Patterson will make a presentation to all the oncologists who participate. And Bruce, would you like to say anything about that?

The unbelievable amount of knowledge that we've claimed from the mechanism in COVID translates perfectly to cancer. And frankly, it's the mechanism of action against cancer by enhancing the immune system by repolarizing macrophages, keeping them from producing interleukin 6. We actually found something very interesting in COVID is that leronlimab brings back a protein called granzyme. Granzyme is made by the CD8 T cells, and it's like a bullet. It's like the CDH of cells that destroy the tumor cells. CD8 T cells are the cells that destroy virally infected cells. And leronlimab increases the bullets in the CD8 cells to destroy these cells. So it's a 2-way street. What we learned in cancer contributed to our hypothesis about COVID. Now that that's playing out, the information that we've gleaned from COVID is going to translate perfectly back to our cancer program. And again, that's the beauty of what we're doing with collectively.

Great. Thank you. Next, Jack.

Jerry is asking, what's the current enrollment status of patients in EU countries, if any?

Are there countries, is that what you said?

In the EU, European Union.

We don't have any enrollment yet. We're working on England, and we're working on a few other countries. But we don't have any enrollment overseas at this time. Next question, please.

Jose is asking, can we access the database submitted for the BLA, conduct or not confirm that he has reinvested in the company cashed out?

So there are -- I have explained that I would like to also purchase my warrants. When it's given to me, that's -- so when it's given to me, which is hopefully in the next 1 day or 2, I am able to do that. The company has been receiving quite a bit of warrant exercise. But as I have said that I'm willing to do, yes, absolutely. Next question, please.

Okay. Joseph is asking, can you comment on paper from famous virologist Dr. Austin in Germany, recommending anti-CCR5 for COVID-19, are you in touch?

Dr. Patterson, I have to -- you know that person.

For 2.5 months, we've been working on that premise. So we're happy to communicate with them. But the beauty is, in science, you want corroborating evidence. And not only is this doctor corroborating all of the data that we've presented and now have out in preprint and are waiting responses, but the beauty is people are talking about RANTES. They're seeing RANTES. We're seeing more reports of RANTES associated with COVID. And that's the kind of scientific validation that we need that validates our findings, that validates our hypothesis. And ultimately, that's what makes this a critical find and also a critical path towards the specter of death and their specter of intubation. I think that's the goal to putting this country back on its feet is having a drug like leronlimab that ultimately will show that if we can minimize deaths and minimize the huge morbidity in this disease that we can all go back to work.

Thank you. Next, Jack.

Warren is asking why has GVHD not been a top priority in the past year? Your drug seems like it may be the solution to this problem.

So again, we have to be careful with all the funding that we have, and we have to be careful with all the challenges that we take on. We jumped into the coronavirus arena and trying to help with that. GVHD program is also looking for the store pace, not only because of our own fundings, but also because of the coronavirus creating more problems. Next, please.

Steve is asking what is CytoDyn doing to expedite or enhance the enrollment process? Is someone at the company in charge of that?

That's Dr. Kush Dhody, who had done a fantastic job in the past doing the very difficult enrollment of combination therapy for HIV, which Dr. Lalezari was very impressed by him. He's in charge. We now have 6 hospitals ready to go. So he is working very, very hard with his whole team. And hopefully, we will have the enrollment pick up very soon. Right now, we're at close to 45. We're 30 away from the finish line. Next, please.

Okay. David is asking that we have about 20 questions similar to this, but he's asking basically, has the company been presented with any buyout offers?

So we do have multiple talks with the companies in China. We do have a talk with Philippines. Obviously, we have been working with them. But as soon as we get it, this is a nonbinding tension or something like that side, we would let everybody know. If we get a nonbinding tension signed, that means nothing in regards to getting the deal done. It takes a long time. As everybody remember, when we talk about Vyara and I announced the nonbinding tension, everybody were not very happy when he dragged for 4, 5 months, where usually, these kind of deals take that much time. But we are being presented by other companies' interest, and we will follow with everybody as soon as we get anything. Next, please.

Monty is asking, what is the strategy to accelerate COVID-19 distribution to hospitals around the country for emergency use?

So we do have offer from a company to do that for us, but we haven't accepted it because we like to see how we do going forward with other offers that we believe perhaps will be presented to us. Next, please.

Greg is asking, what are your thoughts on leronlimab's efficacy in treating COVID-related pediatric system inflammatory syndrome?

I have no idea. Dr. Patterson, do you want to elaborate on what do you think?

Bruce? Sorry, go ahead. I think you were mute before.

Again, we've addressed that question. This Kawasaki's like disease, it's been attributed to inflammation caused by RANTES, MCP-1 and other protease MIP-1 beta. And the fact is that inflammation then brings in immune cells, which caused the inflammation of blood vessels and aneurysms in these kids. So leronlimab is actually the perfect drug to treat these patients. And as Jay mentioned, if -- when we measure -- we have a panel that we're capable of measuring RANTES, MCP-1 and MIP-1 beta altogether. And as soon as we can get some plasma, we'll be able to show that these kids -- in these kids, that's exactly what's going on. And that leronlimab is the perfect choice to be able to relieve that inflammation as well. So we're biting at the bit to get involved and help save those kids' lives, but of course, we have some hurdles to overcome.

Yes. So Jack, just a few more questions. We'll get us to the end. So go ahead, please.

Okay. Thomas was asking, can you -- could you clarify whether a large blocks of ESOP stock set?

No, I can't. But I can tell you, since December '18, we're very proud that in the 100 days, we have traded almost 600 million shares equivalent to $1.23 billion trading in open market. So our best year -- the whole year was about 100-some million shares traded. So we are reaching milestones that was very, very difficult for many years, And when we found PRO 140, we're able to raise money from my own friends, buy this product and be able to now get us to HIV and have all these indications that Dr. Scott Kelly, the Chairman of the Board was so crucial to get us to where we are. When the stories come out or what we had gone through to get the company to this level, everybody would be very proud, I believe. Next, please.

Nicholas is asking, what is the production capacity for leronlimab?

So in Samsung, we have talked about the production for this year is going to be 1.2 million, while it could be given to us a little bit more than 1 million vials. We could see the first batch as soon as end of June, mid-July. And this is a lot of credit again to Dr. Nitya Ray, who assured that we have a technology transfer with Samsung almost 1.5 years, 2 years ago. So having that company ready to go, we could increase that production, perhaps 1 million to 2 million more vials in this year. So 1 million vials would be -- will mean that we can treat about 300,000 patients. So if you double that, there will be 600,000 patients, 2 doses and each -- 2 vials is 1 dose. So we are working very hard on all the aspects of our manufacturing, AGC, other manufacturing in the United States. They are ready to do 2 batches for us for our BLA requirement. So everything is on track in that regard now. Next, please.

Okay. Jennifer was asking, when the FDA gives approval for leronlimab for HIV, will the other indications move more quickly?

Label expansions are always much easier than the first approval. And 1 out of 5,000 has been reported get approval. So for us to be in this situation is we are blessed. And hopefully, if we get the first one out of the way, then everybody will be very happy, and we will work on the rest. Next, please.

Caleb was asking, when will CytoDyn uplist?

So Mike Mulholland, who is our Chief Financial Officer, who's sitting here also he has been working with both New York Stock Exchange and NASDAQ. And Mike, can you go ahead and...

Yes, certainly. I think we're very pleased and encouraged by the opportunity presented by uplisting to a national exchange. Real briefly, we have evaluated the quantitative initial listing standards for the New York Stock Exchange, and we currently satisfy all such standards. So importantly, we now have continuing strong clinical results, coupled with a strengthening stock price, both of which support our priority to effect an uplist. So stay tuned, and we'll provide further updates on these efforts when it's appropriate to do so.

Thank you, Mike. Let me just go over this slide. One of the -- when Mike said, most of it is now ready to go, we do need to have cash, but 12 months' cash or 18 months' cash, depending on New York Stock or NASDAQ, but we are going to hopefully sign with a fairly known bank, investment banking. And when we do that, I think that would hopefully help us to be able to up this. We are working very hard, and Mike is working with both the exchange and has his eyes on both of them in the case, whichever we can get into. I'm hoping in the next 1 week or 2, we will have an update about where we had in that regard. Very, very crucial thing. And if we uplist, it will be a major achievement for us, and we're looking forward to do that. Next, please.

Okay. Ben is asking, is Dr. Patterson's paper being submitted to more than 1 publication?

Dr. Patterson?

You're not allowed to do that. Yes, we're -- again, much like the FDA publications go the same route, where you wait. You submit. You wait for comments, you address the comments. You send it back. You wait some more and then you finally get approval. So it's really hard to put a date on it, but it's been submitted. We're waiting right now. In the meantime, what we're doing is we're actually continuing to do experiments to address any comments that could come up and so that we would be able to turn the paper around in a matter of days or a week at the most and get it back in for final approval. So sometimes when they come back with comments, it takes you 2, 3 months to do the experiments to address the comments. But we're doing that contemporaneously so that there is no delay once we get comments back.

Yes. Thank you. Next, please.

Okay. I got a question here from Taib. Hello, MD from Chicago. A question for Dr. Bruce Patterson. What are your thoughts about or of COVID-19 being an endothelial disease? And if so, how does leronlimab mechanism would actually address that?

Well, I mean, obviously, the endothelial cells bear the brunt of the cytokine storm and become leaky. And indeed, that's why we were the first to identify virus and plasma. Is latent disease the endothelial cells are leaky? We feel that this leakiness of endothelial cells, especially in the lung where there's high viral loads, allows the virus to get into plasma, which is a whole another issue about our blood supply, which I've been talking about extensively and nobody seems to catch on that. There's COVID in the blood, and we have a blood supply that probably needs to be tested. Now I've always added the caveat that we need to show that that's infectious virus, and we're in the process of doing that right now. But yes, there's very much pathology with the endothelial cells and it's due to cytokines and chemokines. And by quieting the cytokine storm, hopefully, we can reverse the effects on the endothelial cells, which lead to both fluid buildup in the lungs and release of various constituents into the blood.

So last question, Jack, please.

Okay. We've got to actually got a couple of these. Steve was asking how can I get leronlimab to treat my patients?

So the doctor for the patient has to e-mail us. And when they do, we'll immediately in turn introduce them to Dr. Kush Dhody. He will then immediately will send them the instruction of where to call the emergency IND. So it's just a simple e-mail from the doctor and things could happen very quickly.

Nader, should he e-mail you directly?

That's correct. [email protected].

Okay. I guess that wraps it up. All right. Nader, thank you. Thank you, Dr. Lalezari and Dr. Patterson. Thank you for everybody in our audience for joining us once again, and we will see update in a few weeks, hopefully with more news.

Thank you, everybody. Thank you, Jack.

Look forward to it.

Appreciate it.