CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Okay. All right. Nader, I think we started a little bit earlier. Let me just make sure everything is working. Okay. So Nader, if you can just go to the full screen. Just -- looks okay. So we're showing the full screen. Okay. All right. We've started a little bit early here early here or late. Okay. So good afternoon, everybody. Thank you for your patience. Thank you for standing by. We've had a little bit of technical difficulties, which hopefully are solved now. So again, welcome everybody to Wall Street Reporter's NEXT SUPER STOCK Live Stream for today, June 2, 2020. And we have another exclusive presentation today from CytoDyn which many of you have been following since almost a year now, since they first presented on our live stream and the company has done a tremendous progress and we're going to find out more about the latest news to date. Again, [indiscernible] people. Nader is going to present for about 20 minutes and then we're going to open up for Q&A and he's going to be joined by Dr. Jay. Lalezari. So Nader, let me turn it over to you. Thank you.

Thank you, Jack. Appreciate it, and thanks for everyone being on the call. Sorry about the technical difficulties that we had. Today presentation, like always, we will be making forward-looking statements. Before I start our presentation, I'd like to talk about FDA approval process, real quick. Many people have called us, e-mailed us that why are we not getting approval yet. I want to make sure everybody understands that there is three very important elements in getting approval from FDA. Before anything, it's safety. That requires a long trial. Remdesivir did 1,050 patients. So it wasn't just a quick study. Why are we doing only 75 patients with 1 trial and 3 - 90 with another one is because we have a product that we've been fortunate enough to already test it for HIV for almost 900 individuals, mostly HIV indication. So -- with that, we are blessed to have that part. But people have to realize, if that's not there, like when you do a trial for a vaccine, they're going to need a lot of safety data to make sure that it doesn't become like, something like hydroxychloroquine, where you think you have efficacy based upon anecdotal data. And then later on, you see that actually the product could kill certain people. Then it comes to the efficacy. Efficacy can be very quick, like our first combination therapy for HIV was 50 patients, 5 0, but the safety portion of our final application for approval, the guideline says you need 300 to 500 patients for safety and at least 100 patients have used the product for a year. So it's -- the safety is much bigger, but efficacy was 1-week efficacy. In this trial that we're doing, one of them is 2-week efficacy, the other one, 4 week. Then it comes down to manufacturing. Can you manufacture this product without compromising the safety. So there has to be perfect procedure checked by FDA during the runs that we would do to produce the product. That's for everybody. And that's a lengthy process. But again we are blessed to have our manufacturing all completed for approval process and submitted to the FDA. So we got a lot of potentials here with the situation that we have that I want to make sure everybody knows. These are getting ahead of a lot of obstacles that, otherwise, would take many months. Now we have been involved in COVID-19. Everybody knows the reason for that, was because we did 11 patients emergency IND. Dr. Harish Seethamraju is a hero doctor to us from Mount Sinai. He's the one that called FDA and said, I want to do emergency IND at the time that no hospital had ever wanted to touch leronlimab for COVID-19. And he believed in the science and when he did this emergency INDs and saw positive results, we were fortunate to also use our other adviser, Dr. Bruce Patterson at that time, and he did some analysis of the blood sample that we required, we wanted it to be done, which is at day 0, day 3, day 7, 14 and 21 and 28, if the patient lasted that long. Now these patients, we realized when we got their sample that their CD4 count was very low. They were very, very sick, and we were able to save some of these patients, and the results were impressive enough that Dr. Seethamraju and Dr. Bruce Patterson wanted to author a paper. So Dr. Seethamraju had a paper authored by his colleagues for 31 patients with renal failure, kidney transplant, six of those patients were the patients who received leronlimab, and they talk about those in that New England Journal of Medicine publication. But then it came to the next paper, where Dr. Bruce Patterson was the lead author and Dr. Seethamraju as the co-author and other people like Dr. Jay Lalezari have contributed and they were in the paper. That paper is in preprint and people can read about it, but it's still being reviewed. We have 2 other papers that's going to be submitted to New England Journal of Medicine most likely next week for these results and we will be updating everybody in that regard. So the first step was getting the FDA to recognize that there is something here that we want to get going and ask FDA for a randomized trial. The FDA gave us randomized trial. We got one, Phase II 75 patients, mild and moderate and one Phase III critical patient we had 90 patients. So as we were going forward, the first 11 patients was the results were strong enough that Montefiore not CytoDyn, Montefiore put a press release out on May 21. Here's a quote from Dr. Seethamraju about this" "by calming the overactive immune system of these patients, leronlimab, halted the inflammation and blood clotting that are so damaging to the lungs, liver and kidneys of severe ill COVID-19 patients." That's a strong statement. Now again, what do we need to do to get this product approved, randomized clinical trial, but these are very strong results from the immunological benefit. Another quote was, all 10 patients had extremely high blood levels of CCL5, which are inflammatory molecules known as cytokines. Leronlimab interfered with those CCL5 molecules, preventing them from directing immune cells to swarm into and inflame the lungs and other organs. Now let's look at other emergency INDs results that we have anecdotal but nonetheless, these were the results, 31 patients. Those 31 patients, 4 patients out of the 11 critical patients is in a stable condition. Those critical patients have a small chance of survival. 4 other of those 11 patients have either been extubated or -- I'm sorry, they have been extubated and discharged. And 3 of them have disease. Now the 20 patients who are severely ill, you see the results, again very impressive, 15 discharged and so forth. So we thought that these 31 patients are very strong. There will be paper, perhaps being written about this data of 31 patients, but the two paper that I talked about earlier is not one of them. The 18 other patients from other hospitals, again, the results stable from 18 patient, 7 improved, which means extubated off oxygen or discharged 5, 1 deceased and recently treated, no inflammation is filed. Again, these are anecdotal data that means a lot to us as a company, but for approval, we have to do the trial. So here's the trial. 2 FDA double-blinded placebo-controlled clinical trial. The Phase II mild to moderate, we have 58 patients out of 75 enrolled. Phase IIb/III, we have 51 out of 309 enrolled. The Phase III, again, is for severe and critical with -- for us, and then we are doing a phase -- we want to do a Phase III that will be in conjunction with remdesivir. That trial might never happen. We are thinking about putting a protocol together, but we are working on that. But -- the other trial that -- it is going to happen, and it won't be probably Phase II. It will be probably Phase III, we stated in the slide, Phase II is in Mexico. As of recent, yesterday, I have been in communication with Dr. Gustavo Terán, the Head of NIH in Mexico. We have indicated that we want to expedite everything they agreed. They have seen the anecdotal data. And they believe also like we do, that if we do a critical patient test of 25 patients, so 25 patients, NIH conducting in Mexico probably will take very quick 2 weeks or 3 weeks after the sites are set to enroll. And then we're going to -- they're going to take that data with the anecdotal data that we have, all of it and present it to FDA Mexico, and we hope to get approval over there. Other trials, we are thinking about is the COVID-19 for children that is going forward and other trial that you can see here. Now If you go to, clinicaltrials.gov and search the emergency INDs that have been presented to other companies, I don't think you're going to find any company that has even 20 emergency IND approved. I've made a check, and I had some other people check it for me, and we couldn't find even 20 -- any company with 20. We've got almost 75 approvals. That means people are wanting the emergency IND or immediately are asking because of what we are saying in the public about the current emergency IND data that we have been receiving. But as of last night or yesterday afternoon, FDA sent us an urgent letter that we are not going to give CytoDyn any more emergency IND to do in the hospitals. And their reasoning was absolutely right on. They're saying that we need you to finish the trial, just like the shareholder that we have, can't wait for us to complete, FDA also want us to focus on finishing and completing the trials. The trial is sometimes very difficult to enroll. But what we have heard from FDA in the letter is, if you are able to see that patients need emergency IND. And if you took this much time to enroll perhaps, 60 patients in the emergency IND, so therefore, you must focus on finishing your trial. And if you believe you have something that works, let's give it to thousands and thousands and thousands, not just 70 patients emergency and very reasonable, very reasonable. And I'm very happy to see that FDA is also looking at our manufacturing, the production capability and all of those things, which means very, very positive for us. But I wanted to also invite on this call, Dr. Kush Dhody from Amarex. Just for those who don't know Dr. Dhody, he's the Amarex Director of all clinical trial for CytoDyn. He enrolled 50 patients in the toughest enrollment of HIV combination that Dr. Jay Lalezari under call -- will tell us he is -- Dr. Jay Lalezari is key opinion leader, physician for clinical trial. He indicated that he was very, very pleased with the way Dr. Dhody was able to get those 50 patients. He's the one that enrolled 43 and then 595 patients in monotherapy. So there is nobody better than him in my work that I have done with other people, how fast this person can do things for us. And Amarex has been very, very solid. But with all that said, let me allow Dr. Kush Dhody himself who's on the call right now. Dr. Dhody, can you hear me?

Yes. Thanks. Being online.

Thank you for joining us. Could you please explain to our shareholders the difficulties on enrolling on CD10 and perhaps, where we are right now? And when do you think we're going to complete the enrollment? Go ahead, please.

Sure. So the CD10 study is targeting the mild-to-moderate population. We have an enrollment target of 75 subjects. We have currently enrolled 58 subjects. So we need 17 more subjects enrolled to complete the enrollment in this study. We currently have 8 active sites, and we are targeting to finish the enrollment for these 75 subjects by mid of June.

And -- go ahead.

One of the challenges, as you mentioned, these -- the study itself was started early April. So in 2 months, we were able to enroll these 58 patients in the trial. We are expecting another 17 to be enrolled. But the study was originally ambitioned to be conducted in an outpatient basis. Unfortunately, the way the pandemic has panned out, none of these primary care physicians are actually seeing the COVID patients in an outpatient setting. So we are completely relying on hospitals to enroll the mild-to-moderate population, which itself is a challenge because none of these hospitals are admitting these mild-to-moderate population. The way definition of mild to moderate is, patients have symptoms, but they do not require any oxygen support. So the hospitals have no reasons to admit these patients to begin with, when these patients have the symptoms of COVID, but they do not require any oxygen support. So that itself is a big hurdle that we are able to overcome in that these 58 patients. And I'm confident that we can enroll the remaining patients in the next few weeks.

So Dr. Dhody, can you also talk about -- you have drafted 2 manuscripts for 2 different doctors for -- with our results about study. One of them, I believe it was 3 patients. They were all intubated and got extubated. And the other one, you are working for Dr. Harish Seethamraju's next paper, Am I correct?

Yes. That is correct. So we 11 patients treated at multiple medical centers. And those are the very first patients that were treated under the emergency use IND. So we have day 48 results for those 11 patients. And we have compiled those lab results as well as the clinical outcomes, and we are planning to have this presented or submitted to New England Journal of Medicine. And there is another 3 patients from Georgia that was treated. These are -- as you mentioned, all 3 patients were intubated. They have a positive response. And we are also planning to submit those 3 results as a case study in a New England Journal of Medicine. And we can boast those can go out next week.

Thanks for that, very much, and thank you for your time today, Dr. Dhody. Have a great day.

Thank you.

Bye-bye. So continuing with the results, I want to talk about the cancer trial. And Dr. Jay Lalezari is on the call, Dr. Jay Lalezari is the CEO of Quest Clinical. He's also our Chief Science Officer. He's also a key opinion leader physician that is quoted in global data that comes out on HIV, and he has been involved in many clinical trials. So I couldn't have anybody better to have in our team as a principal investigator than Dr. Lalezari. Dr. Lalezari, can you please speak about the cancer trial?

Sure. I guess I just wanted to circle back and highlight a couple of things you just said that are unique in this situation. Number one, obviously, this pandemic is unique. Number two, it is unique to have so many patients treated under emergency IND such that, we knew the drug was working, before we knew how and we knew the drug was working before we've been able to even enroll our clinical studies. There's no precedent for this in the history of drug development with FDA. And then you add on top of that, the completely new mechanism that leronlimab is bringing into play. This is a unique situation, but it remains true that since April 9, the day that Dr. Patterson showed the high levels of RANTES in these patients, but all the rest of our data has made absolute sense. And it really is just a question of Dr. Dhody figuring out how to crack the nut, get CD10 enrolled and then on to the Phase III. In terms of cancer, I think the leronlimab being in the news has caught people's attention because Quest is being inundated with 2 to 3 calls a day now of folks with cancer. A lot of breast cancer also prostate and colon which, of course, are the big 3 that are CCR5 positive. And we are screening a lot of individuals for eligibility in CD07, the compassionate use as well as the basket trial. I think we have about 10 patients now that have been eligible, that we'll be enrolling in the coming weeks. So we want the COVID situation settled so we can all get busy and focused on cancer because there's a signal or something happening there that we need to immediately jump on.

Thank you so much, Jay. I appreciate it. And I want to let everyone know that we already have decided, and we talked to Dr. Jay, Dr. Dhody, Dr. Kazempour and we are going to unblind most likely CD10 on June 15. So today is June 2. In 13 days, we believe as a [ Phase II ] that CD10 is. We will have enough patients, whether it's 60 or 65 or 70 or 75, we believe there is no difference between those numbers. So we are most likely -- this is a big, big possibility that we would unblind the data. Stop the trial, completely stopped the trial. On June 15, the last patient will have to go 2 weeks. So by the end of the month, we will read -- we will have the results unblinded and would be turned to FDA. Now in regard to our critical patients, we already have passed 50 patients, 5 0. So we will also simultaneously start on the 50th patient, which was already enrolled a couple of days ago, a few days ago. That patient would be gone 1 month by the time we get the 2-week data from CD10. So by the time we get the data for CD10, we will also conduct an interim analysis on the first 50 patients of critical -- indicating critical patients. And that -- those 2 data, even if you have 58 as we have now, and 51, that's like more than 100 patients for 2 different populations. We hope that, that would have the basis for approval. We don't know, I'm not saying we are. But I'm just saying that's what we are going to do, and we have decided that, that will be a best path for us, and we will update everybody as we go forward in that regard. So the last thing I want to talk about before we go to Q&A is the business portion of the company. We have received a lot of complaints some time and a lot of encouragement about what is happening. But what has happened to this company that we believe that our team has a lot of credibility is because -- when you take a product for $3.5 million down payment in 2012 and today are fully diluted, market cap is over $2,000 million, [ $3.5 billion ] $2,000 million. So that's a pretty good impressive record. And we believe the job that has been done is already historical. Now in the last 6 years before 2020, the dollar amount that got traded in 6 years was $300 million. In the last 6 months alone is $1,300 million $1.3 billion, $1,300 million versus 6 years of $300 million. Again, we believe we are very proud that have consistent 6 months of trading the way it has been. And in 2012, the last thing but not least, is we had 1 product, leronlimab PRO 140 that top scientists and biotech wizards had given up on it and had one small indication, which we actually abandoned that indication, went to a whole different indication. Today, that same product is the talk of many, many people and is able to save certain patients' lives according to the patients and their family members and is doing very well in many different trials. That again, to us is very much historical. The last thing that we want to talk about also is, when we get approval, if we do get approval with COVID-19, we need to have distribution in place. And we need to talk about that right now, not when we get the approval. That's too late. So as of today, later on this afternoon or tomorrow, I will be signing a Non-binding Term Sheet for distribution of COVID-19 with a pretty well-known company. And I will make those announcements at the right time, but the Non-binding Term Sheet is most likely being signed tonight or tomorrow. So that would take care of the distribution capacity that we need to have in place immediately. So with all that, let's go ahead and go to question and answer. Jack, would you like to go to questions.

Yes. Nader, you can hear me?

Yes. Go ahead, please.

Okay. Perfect. Okay. So first question that came in last night is, we got a lot of these. How soon can we expect to be uplifted. This is coming from Ed.

We have -- well, when I say we are -- I'm going to say Michael Mulholland has done a fantastic job with our other people, his team. And we have talked to the exchange. We have sent in certain applications, pre-applications are already sent. There was questions. The questions have been answered. So we believe the process is well on its way. As we said, as soon as we get the reply from the exchange, we would be able to address anything else that they want us to address and hopefully have the letter of approval and be able to up this. We have everything -- arranged everything to the satisfaction of the exchange. There will be a fund-raising needing, but we are trying to avoid that by explaining to the exchange, why we should not do a huge uplift fundraising and most likely they are going to agree with us, we believe. But we are in very good shape. And I'm very excited to get us up listed very soon without reverse split, without huge fund raise. And we will give you everybody more information very soon. Next question, please.

Okay. Jose is asking, can you give us an update on the company's financials? And is the U.S. government helping with financing for the COVID-19 trials?

We have had a tremendously large file of application for the government that we have filed. We have almost finished that filing and I mean, finish that process of filing and we should have the final filing perhaps, very soon. And that will be for large funding from government agents. Next, please.

Okay. Next question is, how is CytoDyn results compare to other medication being studied?

Well, if you look at the remdesivir's very small efficacy that they had, our emergency IND is anecdotal, but saving lives, anecdotal or under trial is a fantastic thing for our shareholders to be proud of. So I'll let everybody else do that comparison, but I don't see anybody having more than almost 70 emergency INDs. Obviously, there is a tremendous need and the FDA is focusing us saying, don't waste too much time on this. You need to look at the bigger picture and immediately finish your trial and show us that you can hit your primary endpoint, and we'll focus on that. Next.

Okay, Wendy is asking. What's the time frame for the New England Journal of Medicine Paper to be published?

So the 2 that we will be submitted most likely next week. I don't have any time frame of when that would be accepted or anything, but we will let everybody know, hopefully, by the end of next week.

Okay. Patrick is asking, is the trial in Mexico useful as a proof-of-concept to the FDA.

The FDA in United States, absolutely not. But today -- when you look at Dr. Anthony Fauci leading remdesivir. I mean he's -- NIH was leading the study with remdesivir. Now we have Dr. Anthony Fauci of Mexico, which is the Dr. Gustavo Terán. He's going to be leading that trial. And he said 25 patients, but they are also going to look at all these anecdotal data as just as to have it as a part of the application. We believe it will be a quick approval in Mexico, but not in United States with that trial. In the United States, we hit our primary endpoints, then we let FDA tell us what they like to do. Next?

Okay. Mitch is asking, how are trials going with the remdesivir?

We are not focusing on that as we are really trying to focus on getting the trial that we have right now completed. And as I said, June 15 is our date that we have set. In regards to Remdesivir, we would love to do that trial. So we will be thinking about that, but we like to hear from FDA first, about our results that we will be hopefully turning into them by the end of the month from both trials and then see how that discussion goes. Next, please.

Okay. Next question is investment banking -- investment banker status and any talks with Eli Lilly?

Eli Lilly. I don't know where that name comes from, but the investment bank, we have told everybody, we have very solid investment banks that is going to talk to us and work with us. So we have to select and see if they agree. So we all -- we would announce those at the right time. We cannot talk about anything yet, until it's -- till we have a go-ahead from our attorneys. Next, please.

Okay. Barry is asking. What does you -- what can shareholders expect this June and the future?

As we said, the unblinding that would happen for CD10, very much likely on June 15, end of the June, the primary endpoint will be read out to the world. And we hope to shock the world with a very beautiful results.

Steve is asking. Any specific comments about the piece of enrollments? And what are you doing specifically to get to 75 for mild to medium?

We don't need to get to 75, in my opinion. When you have 75, 25 on placebo 50 on the active arm, that means, if the placebo has one bad result, that's going to count twice because it's 2:1. So -- but the other side of the equation is, do you have 2 in active, but we believe that active is going to be very well because we saw the immunological benefit from Dr. Patterson analysis and Dr. Seethamraju's paper that's coming up. So -- With that said, I think we'll see how things go as the things progress. Next.

Robert's asking, is Dr. Fauci aware of a leronlimab.

I have no idea. The Dr. Fauci, FDA and so forth, they want to see results, I'm sure, if they get the results that we think we're going to get, they will be very happy for us. So everybody have to focus that. We don't have what the FDA has asked us, which is randomized results, and we need to focus on that. And we want to hopefully get that this month, no matter what. Next, please.

Simon is asking how many of the eIND leronlimab patients have been having blood work done by Dr. Patterson and at what intervals?

So they were having the first 11, as I said, the 0, 3, 7, 14, 21, and I have stopped all of that. Dr. Patterson is doing a fantastic job giving us the blood samples data for the trial that we have, 2 trials. Imagine there is 75 and 390. We do not want to do any other work at this time. We want to be only focused to get those data. And Dr. Patterson is doing a fantastic job getting those data put together now. Next, please.

John is asking, can you compare CytoDyn's COVID treatment to other competitors? Where do we stand in the top 5, top 10?

What I would say, there was a news that came out that put us in the forefront ahead of everybody. And I would like to see emergency IND data from other companies. 60 patient's data to compare. But I feel very good from where we are. We wish luck with everybody. I mean everybody, we hope they are successful. We all need to be successful. So -- but I think we are at the very top. Next.

Okay. James is asking, what is Dr. Patterson doing as he was neither on the last call or this call?

So Dr. Patterson is working on the data, as we said, CD10/CD12, and he has done fantastic job. There is nothing more we can say about that. And just thank you. Thank you. Thank you, Dr. Patterson. Next.

Okay. Next question is from Mark, asking, how do you expect to finance this large number of clinical trials?

Well, if you have looked at our past, when we put down $3.5 million to buy PRO 140 leronlimab, we raised almost $300 million, $280 million. About $100 million was raised by us without any investment banking involved. So our capacity of raising money has just went through the roof with the situation that we see now. So raising funds, I hope everybody has complete confidence that we can, but -- what I am not willing to do is to raise money with a dilutive fashion. So as I've proved in the past when the stock was at $0.30 and I hold it as much as I could together to get it to the next level, now we have to go to the ultimate level, which to meet is double-digit, triple-digit. But we need data, the stock can't go to the next level and raise fund cannot happen in those levels, unless we have great data. Data is so far very strong for me to feel good at least and hopefully, everybody else is feeling good about it. And we will raise funds as is needed. Next.

Okay. Nick is asking, is Dr. Patterson continue to see results from the eIND and other trials that are consistent with the results in his paper?

Dr. Patterson's paper is very clear that the results were great. So we don't need to do like 100 more patients to repeat those data. Repeating is something we have to avoid at this time. That's why I stopped every emergency IND data blood sample. I know that FDA gave us to stop emergency IND altogether, what are you doing? Let's finish the trial. And we totally agree and appreciate that, that the FDA also wants us to complete the trial and see the data urgently. Next.

Okay. Bill is asking, thank you for your hard work Two questions. Have we gotten a PDUFA date for BLA submission yet?

No. We don't. There's a 60-business day waiting when you give your BLA till you get that. So once we get it, we will definitely have a press release.

Okay. Marilyn is asking, is there any insider buying going on ? Cluster and sort of borrowings send a strong signal to the investment community?

So we focus on getting the data, and we're not focused to see if we are insiders buying or selling, will tell people what the data is. That's just to me, not very wise. Next.

Okay. If eventually approved, what are the total royalties CytoDyn will have to pay Progenics on leronlimab net sales?

So Michael Mulholland can weigh that he's not here in this room with me, but the Progenics current agreement that we had allows them to get about 5% or 5.5%, but there is another 5% or so that might not be applicable anymore. We are hearing that the patents on those are gone. So we might have our 10% or 11% cut to half royalty. Next.

Any safety study for children?

Not at this time. We have -- let everybody know that we could, Dr. Patterson, could analyze the blood sample of the children, but nobody has sent us anything yet. Next.

Okay. Tony is asking, does Gilead have to agree to the use of remdesivir in the Mexican trial you're proposing?

We are not doing remdesivir in COVID-19 in Mexico. We are doing critical patient, exactly duplicate our protocol was already modified by just changing the number from 390 to 25 and was already sent to Dr. Gustavo Terán of Mexico and they are expediting everything as fast as they can, so we can get that under [ readout ] trial underway. Next.

Okay. Gary is asking, is it possible to get in contact with you for someone with stage IV lung cancer or other cancers that have metastasized.

So Dr. Lalezari perhaps can talk. But.Jay, would you like to talk about, if somebody has cancer?

Yes. Investors have been referring friends and family, and they can either get to me directly at D-R-J-A-Y. Dr. Jay, Quest Clinical or they can e-mail you, Nader and then you'll forward their e-mail to me. And what we do is request 5 unstained slides of the primary tumor or the metastasis and we look for the presence of CCR5. And anyone who has CCR5 will bring them on to the BASKET study.

Next, please.

Marcus is asking how much lead time does Samsung BioLogics need to produce 5 million vials.

So we've been in touch with them, and they have been fantastic. I have never worked with any CMO as fantastic. But me, I'm not a manufacturing, Dr. Nitya Ray is and he told me is -- Samsung is absolutely fabulous. And they can ramp up the 1.2 million vials or so for this year to perhaps, double or triple if we want to. And we are -- we have told them that that's the possibility of what we might want. Next, please.

He's -- Marcus is also asking, are you intending to go at NASDAQ or the NYSE.

Can't talk about that at this time. It's one of the exchanges, but because of what our CFO has told me not to identify that yet.

Okay. Gary is asking, where do we stand with debt financing?

We explore any debt financing that might come on our way. But again, at this time, we are sitting at a very fantastic situation. And we just want to make sure we get some data and then we follow up, but we don't have any debt financing potential right now that has been offered to us. 0 at this time. And we're not following that right now because we're too busy with everything else. Next, please.

Okay. Last question, and then we're going to go to the live questions. Okay. So last question from last night is, have insiders bought or sold any company's stock recently.

So there is another question about my stock that I sold, and they -- a lot of people said, oh, my God, so CEO -- perhaps doesn't have any confidence in the share price, which is absolutely to me, ridiculous to think that way, but obviously God bless everybody to think whatever they want. But last time I said that, I read a statement from our attorney and everybody's -- and then I got e-mail, have you lawyered up. No. this is our attorney, our auditor man. I made up a statement, and I ran it by our attorney to make sure she's okay. And this is the statement I wrote, another attorney, so I'm going to read it to you. " I continue to receive questions about my recent option existed in stock sales. I would like to address this topic one last time, focusing instead on our product and the progress we are making. I have spoken in the past upon our need for funding to pay vendors who are so important to the company's continued success. A month ago May 1, I explained we need funding to pay our manufacturing partner to ensure manufacturing continues. The exercise of my options and the exercise of our Chairman option helped pay for almost 1/3 of what we then owed our manufacturer. I saw the maximum amount could sell in a 3-month period as my intent was to retain a profit I had earned from those brands in the last 10 years or so and have chance available to exercise warrants upon investing if the company was still in need of funds. At that time, I continue to encourage others to exercise their options and warrants to fund the company's operation, which on my urging many investors have done resulting in an increase in funding to the company. I am pleased to report the company made an additional payment to our manufacturing yesterday, making us currently, current with this vendor. That means there will be no delay on the timeline. This is consistent with the trend that I discussed in our investor call last week. The company's ability to timely pay our vendors and partners has improved significantly since 2 years ago in mid-2018. For example, almost 50% of our accounts payable had been due more than 30 days, and we had disclosed that our U.S. CMO had suspended certain preparations for future commercialization activities, which were integral for the timely completion of our BLA filing. Since then, we have been very open about our need to raise additional capital to fund operations and keep our vendors untapped. Today, although our accounts payable have increased substantially as we move toward commercialization. Currently, only 16% of our accounts payable have been outstanding more than 30 days. This progress is crucial given the important work we are doing in the current pandemic and as a result of our increased liquidity and Samsung's important manufacturing work has not been delayed in any way, shape or form. The fundraising we accomplished through my option exercise or the tallied exercise and our investors warrant exercise in the past several weeks has ensured we can continue our important work uninterruptedly and also have our manufacturing 100% not be delayed. I remain heavily invested in CytoDyn and want to thank all the CytoDyn shareholders for their investment and support as well. Going forward, I want to focus my additional comments on the progress we are making with our product. And I want to make sure that everyone understands that the last 11 years, I received certain options, and those options at the time that I selected to exercise and sell the shares was because, again, we thought it was the most appropriate time. Did I profit? Yes, I did. Did I, for 11 years of options? Yes. Did I pay the Samsung very crucial payments? Yes, we did. And as of now, we have completely paid Samsung, and we are very happy that everything is on track. And my focus on the company, 100%. I think I would like to put 110% as my wife knows that every day, what I have to go through. But with that, any other question. Go ahead, please.

Yes. Okay. So now then we're going to go to the live questions right now. So anybody in the audience with a question or you can put in the questions. Okay. So first question we have is from Jason, and this is for Dr. Jay. He is asking, where do you envision leronlimab will rank in comparison to all-time successful drugs?

I'm not sure I want to speculate, too much on the future, but I will say that, if we look at the rest of the COVID-19 landscape, there's no other drug that is showing this kind of antiviral effect and leronlimab isn't even an antiviral. That antiviral effect is the result of immune system restoring balance, CD8 coming up and IL-6 coming down, and it's all happening over 48- to 72-hour period. So yes, it is utterly amazing how well, and that effect is being seen in 100% of patients. So I don't -- I'm weary of the future. Obviously, our country is going through some tough times. As I said, there's no precedent for this that a drug -- you would know a drug would work from emergency IND data before you even understood how it was working or even before you had randomized clinical studies. So I think Nader is doing a great job of trying to match reality with leronlimab with what is happening. But certainly, the potential is that, this is groundbreaking, and the world has never seen anything like it. And in my heart of hearts, I think this drug is a home run. And in my heart of hearts, I wish we had it approved 6 weeks ago and maybe could have saved the first 100,000 lives. But yes, this drug is going to have a huge impact. And my biggest concern would be making sure there's enough drug to treat everybody in the world is going to need it. That's -- at the end of the day, that's going to be the biggest challenge.

And I want to add one thing that Dr. Jay has also helped us with bringing some certain people that's connected to him. And one of them has just recently told me that they're willing to lend us $5 million. They're not trying to even make profit. So there's a lot of people are now trying to come in and help because they see how important it is. And Dr. Jay Lalezari's name carries a lot of weight for us to -- he tells it like it is, trust me. He will not be telling anybody that this drug is wonderful. He will tell it to my face before anybody -- because he worries about the patients more than anybody else, and I've seen that firsthand. So...

I'd just like to also add again, I don't own any stock. I have no position here. And so it frees me to speak what I think is the truth. And the truth is, I think this drug is a home run and the world is going to know it soon.

Okay. Bernie is asking what's the status on our scientific team?

So the Scientific Advisory Board is very crucial to us. And Dr. Scott Kelly had been contacted, 5 very major people, and he's going to let everybody know at the time that those signing are happening with them and when the advisory board is officially hired?

Okay. Jesse is asking, is it possible to give leronlimab intravenous for faster bioavailability in acute disease such as ARDS?

Jay, go ahead, please, if you don't mind.

Yes. So Dr. Dhody and I had talked about that. And indeed, for the pediatric protocol we put together, that's available for emergency IND. We are giving the first dose intravenously because if you look at Bruce's data, the CD8 response, the IL-6 response correlates with the time to at least 70% receptor occupancy. So it only makes sense if you give the drug IV faster receptor occupancy with the antibody, you'd have an even faster effect potentially on restoring immune balance. So I actually -- so we don't want to revise the protocol as we're so close to doing analyses that Nader describes. But if we had to do it over again, certainly, the CD12 protocol severe and critical patients, that first dose would be IV.

Okay. Mitchell is asking, aren't there other hospitals using leronlimab? Why aren't you showing their results?

Other hospitals? We just did 18 patients that was in the last slide for COVID-19, where results from many different hospitals. Next, please.

Okay. Andrew was asking, what do you anticipate to be the full scope of leronlimab, if we're an FDA-approved drug, would you be able to distribute across the country?

Yes. As I said, we are about to sign a distribution agreement either -- I'm sorry, the Non-binding Term Sheet is going to be signed later this afternoon by me or tomorrow -- and we are very -- we feel very strong about this relationship with the company. And we hope to put a joint press release out very soon. Next.

Ken is asking, what data exists that shows that these points improve -- that these patients improved as a result of leronlimab and not just as a spontaneous resolution of the virus.

Jay, would you like to respond?

That is really one of the sticking points on all of this. When people look at the Montefiore data and they say, well, too bad it didn't correlate with clinical outcome, it's not like we took snapshot of patients who are all getting better. The mortality in the Montefiore patients, I think, was 6 or 7 out of the 11. These were patients who mostly were renal transplant on dialysis, intubated, very sick and very terminal. So we got stunning 100% response rates in terms of the immune system and cytokine, but these weren't patients about to get better. The results are even more astonishing because as the group, these patients were so ill and so terminal. So then you have to look to the emergency IND data that Nader's been sharing. And I think one of the telling points for me is that, in Bruce's data set You see that IL-6, CD8, these responses are occurring again over 48 to 72 hours. If you look at the eIND data set like from UCLA, you see that there's a clear trend that patients who are dosed whether they're mild to severe or they're critical, that they start improving over the same 2- to 3-day time frame. So obviously, we need randomized placebo-controlled studies to demonstrate clinical proof-of-concept. But it doesn't seem to me to be there'd be a huge stretch to take the data in patients who are terminal and then see in the eIND results evidence of the same clinical benefit.

Okay. Catherine [ Esther ]. First off, I'd like to thank you for your hard work and passion. If the hospitals are not admitting mild to moderate, how are you recruiting patients?

They are having mild to moderate, but it's just sometimes what Dr. Kush -- Dr. Dhody was saying, it's just very difficult. Jay, do you want to elaborate on that?

No. No. It's a huge challenge. When we started -- I was trying to figure out how I could help enroll the study. And kudos to Dr. Dhody for doing as well as he has.

Okay. Josh is asking, are the 75 emergency eIND additional to the 58 in trial. So does that mean leronlimab has treated over 150 patients.

Over 100 patients and almost 80 patients. That's correct. That's in addition.

Okay. And okay, we have 2 final questions. Again, update on investment banking deal. We've got a bunch of those questions.

No. We cannot talk about the investment banker. Our attorneys have forbidden us to say anything. And we will say at the right time.

Okay. Jan is asking, after the COVID FDA approval, where is Europe with PRO 140, any possible timelines regarding approval distribution?

In Europe, is that what you said?

Yes. He's asking, what's the timelines regarding any kind of approval and distribution in Europe?

Don't have any timelines, focus and right now, United States and Mexico, and we'll -- as soon as we hopefully get approval in the U.S., everything will expedite. And I'm sure there's going to be a lot of big pharmas that might want to come in and partner with us for those purposes. But we'll get to that. Next, please.

Okay. Karen is asking, since you've now recruited 50 patients in the P2 mild-to-moderate clinical trial, is the FDA already reviewing this data?

No. The mild and moderate or the other trial, they are double-blinded. Nobody knows who's who. So, no. Absolutely not. The data has to be locked and unblinded according to FDA rules and regulations, and Dr. Dhody is very much capable of doing that. So let's have one more question perhaps. And call it the last question, perhaps.

Okay. So we've got a bunch of questions. Where is Dr. Patterson?

Probably in his lab working on CD10 and CD12 trial for us. He is a hard-working man. We'll take a few more questions, I guess, it's 10:30.

Yes, let me -- yes, I'm just going through, we got a bunch of questions. Okay. So a question here. In a nutshell, please describe your involvement in PRO 140 exclusivity in different parts of the world.

No. Only United States for HIV only. Next, please.

Okay. Brett is asking was the hire made of the X big pharma commercial executive.

I didn't get that question. Jay, did you get that?

I don't know if we hired anybody new.

No. So next question, please.

Okay. So Mike is asking can Nader provide a bit more color on the distribution partner for COVID as the partner for U.S. only? Will the partner have global coverage capability.

Can't talk about that till we get permission from them. So give us a few more days, and hopefully, we will have an announcement. Next.

Okay, Dee is asking, if you stopped eINDs, how do doctors or patients who want leronlimab get now?

Well, think about it, how many eIND did we saved. Let's just say we saved all those patients where we didn't. Some of them didn't make it but it's 70 perhaps, in the last 2 months or so. FDA wants us to give it to thousands of patients as soon as we are able to show what we have claimed. We were claiming that we're going to hit the primary endpoint. They're saying you're getting distracted. That's a valid point. But unfortunately, unfortunately, it's very sad to see that patients are not making it and this product could do something. But Dr. Jay has helped us, guide us to do whatever we can do to get it to the next level. And we're doing that. Jay, do you want to add anything to that?

Well, I have the same concern as the person asked the question because until yesterday, I thought, well, if I got COVID-19, I can file it as per an emergency IND but that's been taken off the table. So the quicker we get the randomized results, the better. And until then, we should all stay safe.

Absolutely. And that's why we decided that June 15, only 13 more days is our day. We're going to stop the trial. June 15 give the results to FDA by the end of the month and the first 50 patients in critical will have an interim result by the end of the month. So that's the one of the major reasons that we're doing that. Next, please.

Okay. Steve is asking, have you considered offering a discount to the warrant holders in order to raise funds? This would immediately deliver tens of millions of dollars to the company.

Offer what to the work is -- I'm sorry?

Would you consider offering a discount to the warrant holders?

Oh, I see. No, not at this time, right? We had some talk about that, but we haven't done that. We just -- we've been blessed with wonderful shareholder base, and they've been exercising the warrants and keeping us away from fundraising. So, next, please.

Okay. One second -- what's the status of other sites like Yale, Harvard coming online?

Jay could you...

Yale is online.

Yes. Yale is online.

Yale is growing.

So with that question because I didn't realize it's been already an hour and 5 minutes. I thought it was 30 minutes, but this is the last question, please.

Okay. This is for Dr. Jay. So Dr. Lalezari, regarding the cancer trials, if someone is Stage IV breast cancer, are they eligible for the trial? And what are the eligibility criteria?

The main criteria is that, we look at the staining on the slides of the tumor or the metastasis and we find at least 10% of the tumor cells are CCR5 positive or the surrounding cellular infiltrate is got a high degree of CCR5 positive cells. If either of those criteria are met, we can enroll that individual.

Okay. So thank you, everyone, for being on the call. With that, hope to see you guys, everybody next. Thank you, Jack.

Thank you everybody for joining us.

Thank you.

Bye-bye.