CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, and welcome to the CytoDyn Investment Community Webcast. [Operator Instructions] As a reminder, this webcast is being recorded. It is now my pleasure to introduce your host, Mr. Michael Mulholland. Thank you, sir. You may begin.

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

Thank you, Mike. And thank you, everyone, for participating in today's conference call. The purpose of today's call is to provide an update regarding our progress on all the potential indications for Vyrologix, leronlimab, and the number of indications are just getting larger and larger. We are so close to some major events and excited about our near future goals. The first update will be in regards to our CD12, the Phase III trial for COVID-19, then the status of our Phase II for long-haulers for COVID-19. In that regard, in regards to long-hauler trial, we have some very exciting news for this indication, and I'm very excited for Dr. Kelly to explain that to you. Then we will talk about the filing of EUA in Philippines and the status of that. Then we will update you on NASH Phase II followed by update on cancer and then HIV BLA for U.S., U.K., Canada. And then we will talk about HIV Cure project that we signed some agreements with amfAR and we'll talk about PrEP for HIV. And then a quick update on the leronlimab-Vyrologix potential as a once a month rather than once a week, very exciting project. Dr. Jonah Sacha is working on that with Dr. Scott Kelly, and we will update you on that. And the last update will be NASDAQ, which Mike Mulholland will talk about. So first, in regards to CD12. Enrollment is now at 371 patients. We need 390 and we are averaging 5 to 6 patients a day enrollment. We should be done with the enrollment of 19 more needed by this weekend, hopefully, give or take a day or 2, very exciting indeed. In regards to our DSMC, we had finished the enrollment several days ago, a couple of weeks ago. And we have to wait 42 days for the last patient before we can do the DSMC. We were talking about many different plans, but we finally decided that because the enrollment has picked up so much that we actually had a 15-patient enrollment record in 1 day. So with that said, we're going to go ahead and finish the trial, which we believe, if we finish in the next 5 days or so, it will be December 15, 28 days later would be sooner than when we could have DSMC data ready and the 42 days done. So it doesn't make sense to do the interim analysis, but we just go ahead and unblind the data. In regards to our long-hauler trial, we have some exciting news about recent advancements in the potential mechanism of action of COVID long-haulers. This MOA, mechanism of action, is going to be very important to us. And we believe we are going to have incredible data to share with the FDA. As soon as we get to our 60 patients enrolled in the long-hauler Phase II trial, we will do an interim analysis. Dr. Scott Kelly has some exciting information that Dr. Mahboob Rahman, our Chief Science Officer; and Dr. Chris Recknor, our own doctor, and along with Dr. Scott Kelly have come up with about how leronlimab is using long-hauler and Dr. Kelly will be explaining that. Dr. Kelly, could you please?

Sure, absolutely, Nader. So as you all know, the collateral damage with COVID-19 is worsening on a daily basis as the virus is currently uncontainable. There's really not a time frame for the aftermath of this virus. We are moving forward with our COVID-19 long-hauler study and close to submitting our final comments to the FDA for approval to proceed this week. As of this morning, we have over 70 million diagnosed cases of COVID-19. If 10% of the COVID-19 population develops long-hauler syndrome, that means 7 million patients will be affected. What is perplexing in that long-hauler syndrome is not just in the elderly and it's not just in the most severe cases, but young, healthy patients are getting long-hauler syndrome as well. So the opportunity to help a lot of patients in other post-viral syndromes is tremendous. For example, to put this in perspective, there are 2.5 million people in the U.S. alone that have chronic fatigue syndrome, excluding other post-viral syndromes. Our team has been working very hard in trying to help these patients. We believe a plausible mechanism of action for COVID long-haulers is the following. This will be posted to our website with a reference today after the call. I am quoting from the article. Postmortem SARS research indicated that the virus had crossed the blood-brain barrier into the hypothalamus via the olfactory pathway. The pathway of the virus seemed to follow that previously suggested in chronic fatigue syndrome in myalgic encephalopathy patients involving disturbance of lymphatic drainage from the microglia in the brain. One of the main pathways of the lymphatic drainage of the brain is via the perivascular spaces along the olfactory nerves through the cribriform plate and to the nasal mucosa. If the pathogenesis of coronavirus affects a similar pathway, it could explain the anosmia or lack of smell observed in proportion of COVID-19 patients. The buildup of cytokines in the central nervous system may lead to post-viral syndromes due to pro-inflammatory cytokines passing through the blood-brain barrier and circumventricular organs such as the hypothalamus, leading to autonomic dysfunction, manifesting acutely as a high fever and in the longer term to dysregulation of the sleep-wake cycle, cognitive dysfunction and profound unremitting inertia, all characteristics of chronic fatigue syndrome and myalgic encephalopathy. COVID-19 patients may go on to develop a severe post-viral syndrome we term post-COVID-19 syndrome, a long-term state of chronic fatigue characterized by post-exertional neuroimmune exhaustion. This is one of the many reasons we believe leronlimab has an excellent opportunity to help these patients. Remember, in our CD10 trial, we did not exclude patients beyond 7 days from symptom presentation. Some of these patients had symptoms ongoing for many weeks. During the trial, we noticed patients improving with peripheral symptoms, but also noted improvements in brain fog, balance and fatigue. Nader?

Thank you, Scott. Third update is about the status of our application, EUA that we are filing. We have not filed yet. We are filing that. And when we finished or completed our CD10 study, we told the world that 3-day recovery is what happens between these patients, 3 to 7 days, but 3-day recovery was 90% versus 70% in favor of leronlimab. That was the outcome of CD10. And there was also a much better results with the NEWS2, which is an indication of if the patient is going to get in trouble or not. We also had great safety record. But the number of the patients were small. So when we applied for EUA with CD10, the Philippines pharmaceutical that we talked to and are representing us, Chiral Pharmaceuticals, indicated that the Philippines gave one EUA to lenzilumab and that's all they would give. So they won't even consider it. Now there has been a presidential order to consider other products as soon as possible as long as they're safe and they show some kind of efficacy. We have got on the phone with all the Chiral Pharmaceuticals team and our own team who is putting this together and Amarex folks and Dr. Rahman's team in our own internal team. And we feel very strongly that the application will be ready as soon as the FDA in Philippines is ready for this new order, presidential order to go in effect, which we hope to be in a couple of weeks. So we're very excited to see if we could actually get EUA without the data from CD12. We will give CD12 data as blinded data, what we have from DSMC, and we will update everybody in regards to this very, very exciting situation. Our fourth update is Dr. Kelly will give his update about our NASH trial, NASH indication with Vyrologix. Dr. Kelly, could you please?

Sure, absolutely. So in regards to NASH, earlier this month, we announced that our first patient first visit metric was met in our Phase II NASH trial. This is a tremendous opportunity for both the general patient population as well as the HIV population. I'm excited to announce we have a new partnership with Perspectum Diagnostics in Oxford, England to use MRI-derived biomarkers, including PDFF and corrected-T1 imaging, to best visualize inflammation, fatty liver and fibrosis within this population. We will leverage this technology with Perspectum to minimize screen failures in preparation for Phase III. So we know that there have been many drug failures in NASH space. And so people ask us why we're pursuing NASH. And the reasons we are pursuing NASH are the following. First and foremost, we believe we have a tremendous opportunity to help a lot of patients. We know that stellate cells, which produce scar tissue in the liver, and hepatocytes contain CCR5. We believe we have identified a valid target for fatty liver disease as well as NASH. We know that patients with liver disease have higher levels of both CCR5 and CCL5. Many of the current drugs being developed in the NASH space have been limited by toxicity. Other CCR5 antagonist have safety concerns in this population, including maraviroc, which has a black box warning for hepatotoxicity. We have prior animal studies, which showed a threefold reduction in fatty liver disease and an earlier study which showed a reduction in fibrosis. NASH is fast approaching the milestone of being the #1 cause of liver transplant. It's affecting 30% to 40% of adults in the United States have fatty liver disease and 3% to 12% have NASH, and it's even higher in the HIV population. And I want investors to understand that we will be pursuing using leronlimab in the HIV population as the cornerstone of their HIV regimen to promote liver health. We have spoken to many of the leading physicians in NASH and all have agreed with exploring this $27.2 billion market opportunity for CytoDyn. Nader?

Thank you, Scott. So now let's talk about cancer program in a specific stage IV metastasis cancer in our basket trial. Everyone should know that Keytruda had approval when they were able to show that they can extend the life expectancy by 3 months. We now have in our basket trial 5 colon cancer patients. One has passed away. We have 2 prostate cancer and 5 breast cancer. And our colon cancer patients, they are approaching 6 months. Dr. Massimo Cristofanilli, who is an expert in triple-negative breast cancer had told me that if you're able to show that leronlimab can carry the patients with whatever chemotherapy they are on for 6 months, that's significant. We now have about 8 patients in this trial that are anywhere from 3 to 4 and mostly more than 4 months along. We are very excited about that. Our emergency IND cancer patient who had metastases, breast cancer metastases to lung, liver and brain, is now reaching 12 months and 1 week. That's amazing. This patient originally for the first 6 months didn't have any treatment for their brain but leronlimab. Dr. Rahman is also assuming responsibility for the development plan for our cancer trial. And he will update us on that. Dr. Rahman is a PhD, MD, with extensive background in approval and regulatory path for drug development. Dr. Rahman, could you tell us about the cancer program development with Vyrologix?

Absolutely. Thanks, Nader. Yes, we are taking the cancer program with a renewed zeal now with some data that we have. We are analyzing all the data we have with all the patients we have in these 3 different studies. We are building a team with very experienced professionals. We have already in place a clinical operations lead and the project management lead and also we have hired a very experienced oncologist, Dr. David Loesch. And with his medical leadership for the oncology program, we are really encouraged that we will be able to enroll and finish the 2 Phase II trials that we have currently, the basket trial as well as the TNBC trial. And then we are going to have Advisory Board to put together our strategy for oncology, and we will go forward from there. We think we will have, as Nader mentioned, we can focus on certain cancers based on our results from the basket trial, but I think we will have a very good program in oncology very soon. We will be able to provide you more details with that. Thanks, Nader.

Thank you, Mahboob. So in regards to our HIV BLA, now we have 3 countries that we are working and perhaps we will file also with EU, which is a European regulatory besides U.K. because U.K. and European are separating by the end of this month. So U.S., U.K., Canada and EU. Dr. Rahman has been involved in more BLA submission and NDA submission than I have seen anybody. And I've seen a lot of top experts in this field. So what I'm going to have Dr. Rahman do is to explain to everybody what he thinks about our chances of getting approval and the fact that the BLA had a problem, we refused to file. Was that a major thing in his opinion and what is he thinking? Dr. Rahman, could you please?

Sure. So yes, even though we had this refusal to file, but FDA has been very gracious in giving us extensive and very detailed advice and guidelines, what we need to do when we go back to them. So it also indicates that they are very eager to approve this drug once they have an appropriate package. So we have had multiple interactions with FDA. And based on their advice, we are moving forward. The team is working very diligently and following all the FDA requests in a meticulous fashion. We will try to submit as soon as possible, but we will maintain the highest quality of the data and the documents and fulfilling all the FDA requests. And I think we have excellent data in a patient population with very high unmet need. And as we said, FDA is very engaged and has provided us advice indicating their eagerness to get this drug in the market and help patients as quickly as possible. And we are very confident. And based on my knowledge and experience with BLAs, this seems like a very high probability of success for this BLA, the way we are proceeding. And I'll make sure that we submit the highest quality BLA in terms of the documents and data and fulfill every single request that FDA has. So we have a very good chance for this BLA to be successful. Thanks, Nader.

Thank you so much, Mahboob. So in regards to our HIV Cure project and amfAR agreement that we signed, I'm going to have Dr. Scott Kelly give us an update on that. Dr. Kelly, go ahead.

Yes. This is something, Nader, thank you. This is something that we are very excited about with our recent collaboration with amfAR. As you all know, amfAR is very highly respected for its international efforts in AIDS research, HIV prevention and HIV cure. There have only been 2 documented cases of HIV cure. Both cases have revolved around the CCR5 receptor. The Berlin and London patients were both cured via allogeneic stem cell transplant from CCR5-deficient donors. In preclinical studies, leronlimab has demonstrated the ability to mimic CCR5 deficiency by binding to CCR5 receptors, thereby preventing HIV from interacting with its primary co-receptor. We are in the process of developing the protocol to begin the study for HIV cure in collaboration with amfAR. Nader?

Thank you so much. And we are also working on looking at leronlimab to be a once-a-month treatment, not once a week. Without touching this molecule, we believe that leronlimab is once a month when it comes to prevention, and we will be testing that. But the number of very exciting events for leronlimab to impact the world is just mind-boggling to me. But with that said, let's have Mike Mulholland give us the update on NASDAQ listing. Mike, please?

Yes. Thank you, Nader. To provide everyone with an update, I'd first like to confirm that our application has not been rejected. We are on hold. Why? Very simple, we've referenced several times certain quantitative listing criteria in NASDAQ's publicly available booklet called Initial Listing Guide. There is no mystery here. The items for initial listing are outlined on Page 10. Until we have net income, there are 2 standards potentially applicable to CytoDyn. First, the equity standard or the market value of listed securities standard. Of the 9 requirements described for each standard, our focus is on 3 requirements under the equity standard. Those 3 are as follows, and I'll compare them to our most current public filing for the 10-Q for the August 31 quarter. Number one, stockholders' equity. Under the equity standard, an applicant must have positive stockholders' equity of $5 million. Where was CytoDyn on its last filing? 8/31, we were a positive $2.7 million. The second requirement, the primary requirement is the stock price. A bid price of $4 a share or a closing price of $3 a share. So we're not at $4, but we are over $3. So if an applicant is seeking qualification under a $3 closing price requirement rather than the bid of $4 and meets all other requirements, then Page 10 states a third requirement. Then the applicant must have net tangible assets of more than $2 million. As reported in our 10-Q for the August 31 quarter, our net tangible assets was a negative $10.2 million. So very simply, this calculation is equity of a positive $2.7 million, subtracting out our intangibles of a positive $12.9 million results in a negative $10.2 million. So as we stated before and many times, these shortfalls are curable. But let's not forget the final decision still rests with the exchange at the end of the day. Nader?

Thank you, Mike. So with that, let's go to Q&A. Arian, could you please?

Yes, Nader. When do you anticipate the BLAs will be filed in the U.S., U.K. and Canada? And how are the filings different in the U.K. and Canada versus the U.S.?

So the difference is just technical differences. The package is going to be very similar. But in regards to timing, as everyone knows, we have a new sheriff in town. The name of that sheriff is Dr. Mahboob Rahman. It's not me anymore. So he won't give me time line that cannot be met 100%. And he will be giving us that time line soon. And as soon as I get it from him, we will be sharing it with everyone. Next, please.

When making a scientific assessment to study further indications like NASH, how do you triage the data to determine study potential success and time frame?

Every potential indication that everyone see right now that we are assessing comes from a published data, in vitro study or just some kind of animal study or sometimes maraviroc had done that study. Once we saw that, we immediately tried to do an animal study of our own. With NASH, we did it and it was fantastic. Dr. Denis Burger showed that the fibrosis actually was reduced. And then we saw the next thing, the fatty deposit was really reduced. So Dr. Denis Burger's test wasn't as strong because it was in mice. Leronlimab doesn't bind to mice as well. But having said that, the data was very compelling. Then what we do is we immediately write a protocol and then we look at the number of patients we can enroll and let everybody know. So it's just simply getting the ball rolling and writing the protocol once we see that we can convince the FDA to give us a Phase II. Getting a Phase II is a very, very big milestone. It usually costs $100 million and 5, 10 years to get there. but we are so fortunate with the safety of this product that we immediately are getting Phase II after Phase I. I don't know if everybody really appreciate this as much as you would if you were in drug development business. Next.

Is there any practical way to do a rolling CD12 review by having an independent expert panel review the blinded data on a rolling basis to alert the DSMC or FDA when there is data that bears consideration given the accelerating COVID death rate and their EUA authority?

So I want to make sure everybody's 100% confident of what we're telling you is the truth. We look at everything very detailed, in a very detailed manner. And not just me, I'm not the expert. The experts are Amarex folks, Dr. Rahman, Dr. Scott Kelly, Dr. Chris Recknor, all the doctors that we have. And we make very educated estimate of what is the best path. Right now, what we just said is we are going to finish the trial because that will give us the best chance of approval and not just in Philippines, but in U.S., EU and Canada. Next, please.

Please explain broadly the differences between the FDA, the U.K. and Canada's HIV BLA requirement as it affects the ability to quickly file? Is the CCR5 occupancy test required by any or all?

So this is very important. A receptor occupancy test, which we did not get it done right, and FDA is making us do it again the right way, actually takes a long time, and that's really burdening us, but we're getting it done. But that receptor occupancy, if it's done right, it could, in my opinion, it could replace tropism test because receptor occupancy test will show if the patient has enough CCR5 that could be a responder. Now that's just a combination therapy. Imagine what happens to monotherapy. We own the whole HIV franchise for CCR5 patient if we're able to have a receptor occupancy that says, hey, this patient can get a monotherapy. They can put away all their drugs, all their problems are gone. They just take this subcu self-injectable injection once a week. We are very close to some very really, really exciting task, but we will update everybody on that. In regards to U.K. being different, Dr. Mahboob Rahman is on the call. Mahboob, is there any difference between BLA here and U.K. and Canada?

There isn't much of a difference. There are some differences, as you said before, Nader, technicalities and the way the documents are structured. Although responding to the question, FDA is requiring the receptor occupancy, but MHRA, the U.K. authority, has not asked for it yet. So long as we can give a good dose justification, it may not be required. Of course, if we have, they will like it. But as it is a requirement for FDA, it's not for MHRA, that much I can tell you.

Perfect. Thank you. Next.

Could you discuss the considerations and obstacles in designing the long-hauler trial parameters and explain the rationale for the parameters selected?

Dr. Kelly, can you?

Yes. I mean, I think when you look at the main, this is going to be more based on symptoms, and we're looking at fatigue as one of the major indicators. And for all the reasons I described before, we think that there's a component of autonomic dysfunction and fatigue and brain fog, and we believe a lot of that is due to neuroinflammation. And now that we know that leronlimab crosses the blood-brain barrier in macaques in our HIV studies, we are very, very excited about the fact that we can help these patients with the neuroinflammatory component.

Dr. Rahman, do you have any comment on that?

No. I think Scott has pretty nicely explained. I don't have anything more to add.

Perfect. Thank you. Next question.

When do you anticipate any approval for any application of leronlimab that can generate revenue?

So as everyone knows, COVID-19 is coming very, very close to some major result that we want to announce. We hope that Philippines takes advantage of what we are going to give them because we're only going to have 1.5 million vials, which is going to be about $2.5 billion or so worth of revenue to us. So whoever comes in first, we're going to give it to them first if the result is positive enough for them. So the first approval could be sometime in January.

Why spend valuable resources on other indications besides HIV and COVID?

So when you say why, this really hits a nerve with me. Two weeks ago, a dear friend of mine, [ Rich Arano ], who allowed me to talk about this, called me and said, my dad is in hospital for COVID-19. And I immediately tried to get everything together for them and Right to Try Act, use. And we were able to prove, give the drug to the patient with that, the day before Thanksgiving. And he took the first drug and 3 days later, the next day, he was better the next couple of days. Then he turned for the worse and became really sick, got on mechanical ventilator. Second injection, the condition didn't really get better, but he was stabilized. And then he turned around a lot. And now he's off the ventilation and got his third injection also. That just means everything to anyone with a little bit of humanity. Now I have a little bit of that so. When it comes to cancer, I saw my own mother-in-law at home. The doctor said you got 3 months left. She's been alive, thank god, for a year. And then I see other cancer patients, I see some of the data are just fabulous. It's not perfect for everybody. Some people didn't do very well. They were too far to the finish line, unfortunately. So why not check everything. I'm not slowing down the HIV program. We file everything. And whatever obstacles we had, we overcame those, thank god. And we are where we are. You mean somebody thinks that we shouldn't have cancer and NASH. NASH with the 60 patients, we can have an interim analysis that is $27 billion market. Should I say, I wish I never started NASH? And had that animal data that was so fantastic. I mean, anyway, that's all I got to say.

I'll add one thing. Nader, I'll add one thing. I think to answer the question, we are doing a disservice to patients if we don't explore these opportunities that are based on sound science. That's all I'll say.

If I may also add here?

Yes, yes, please.

So this idea that if we are focusing on some other diseases where leronlimab may have a really good chance is not taking away from what we are doing for HIV. We are doing it separately. It is going at its own speed. It is not affected by trying in other diseases. And humanity is something that's why we are here. So let's not forget that.

Yes. No, that's great. Thank you. Next, please.

When will CD10 M2M trial participants learn whether they received leronlimab versus placebo?

They already have. Next question.

Can you clarify, one second, why not open the data and force the FDA to make a decision on EUA and full approval for COVID-19?

We want to do things that our experts are telling us to do and what FDA guidelines are. We would never go 1 inch away from that. And when they suggest something, that means everything to us. And we will follow those and reach the finish line proud, god willing, very soon. Next.

Does the BLA application have to be filed with respect to COVID CD12?

Sorry, what was the question?

Does a BLA have to be filed with respect to approval for COVID CD12 trial?

There will be a BLA, but it would be much simpler and perhaps Dr. Rahman can answer that question.

Yes. It will depend on how the efficacy is. And we will probably get an EUA immediately. And then we will have negotiations with FDA in terms of if the results are really good. And that's why it's very important that we don't fiddle with it and complete the study and do it appropriately so that whatever data we get is of highest quality and the highest level evidence. So if we have that, it is quite possible that with just this one study, we can file the BLA and get a full approval.

Yes. Thanks, Mahboob. Next.

Have there been any HIV trial patients also diagnosed with NASH?

So we have talked to Dr. Dhody at Amarex, and he has not reported to me anything in that regard, but perhaps we will look at it as we go forward. But as of now, I haven't seen any SAEs regarding to NASH with anybody. Next.

If approved by the FDA, how much will leronlimab be sold for?

So for COVID-19, we will match remdesivir price of $6,000 to $10,000, I believe, per treatment. That would be about $1,500 per vial because 2 vials for each treatment, 2 treatments, which would be equivalent to $2.5 billion with the vials that we have right now, which is why I said that we would definitely look into giving dividend to the shareholders if possible and so forth. Next.

As an investor in CytoDyn, I want to believe the scientific community and positive outlook that leronlimab appears to be presenting. However, for months now, there have been very strong statements about the future events to come, but no results. So many forward statements about Mexico, Philippines, U.K., NASDAQ. These have all been not -- we're all waiting for them. What can you tell the investor community to solidify confidence of real events that had happened?

So every time we give an update, we told everybody back in few years ago when I became the CEO, the path that we took is different than other CEOs. We want to tell everybody everything at all times as much as legally possible. So when we update you and we say we want to deal with Mexico, we had a meeting with them with doctor, I forgot the name, but one of the top guys and their team. And when they don't get back with us, we tell the investors. Now we could go quiet like other companies do. And when they do Phase I, they can go quiet and they come back 10 years later and say, here it is. That's what Gilead can afford to do because they're a big pharmaceutical. Smaller companies, we don't. What I just said to everybody, it's fantastic to me. And I'm wondering if anybody agrees with this. We are about to read data on a phase III COVID-19. This is less than several months trial from beginning to the end and now trying to get approval. So if that's not good enough, in the world of biotech, it takes 20 years, 15 years, best case scenario of 10, 12 years. So that's what we have. Next, please.

In light of the Philippines recent revision of EUA review time lines being reduced to 30 days, has there been any movement from the health agency regarding our submission?

Yes. Well, we have 3 people that are working on this with Chiral Pharmaceutical. And these 3 persons, which we will name at a later time, have done a fantastic job getting us situated with Chiral Pharmaceuticals. You have to have a deal with the pharmaceutical over there. And we made that deal and announced it several months ago when everybody thought, what are they announcing this for? These are all planned ahead of time, and we are right now in a position for them to file the EUA. And they've been getting everything they need to form that application. So as soon as the presidential order is in place with their FDA, they are submitting it immediately. Next.

Has the company made the monthly payment to Iliad affiliate as required on the most recent debt financing?

Mike, please?

Yes. The answer to the question is yes, of course, we've fulfilled our obligation under the new note. It's important to note that if we had not, we would be in default. And if we were in default, we would have to report such an event on an 8-K. So we're good.

Mike, thank you so much. But I'm going to add just one quick thing. I know you might not like it. But everybody was saying that we have to give $7.5 million back to these people who we got the loan, the note from. And if we had that, the money that we had in our account that will be reported by the January, sometime early January, will show that we did not pay those cash, but we took care of our obligations. So I want to make sure everybody knows that Mike Mulholland is a fantastic CFO and he's doing a great job. So you're going to like what you're going to see in our Q of what is our cash balance. Go ahead. Next, please.

And this is a three-part question and perhaps directed towards Dr. Kelly. Is there any indication and/or theoretical promise on the part of CytoDyn that Vyrologix may be used as a prophylactic for a multitude of post-viral syndromes or as a regular part of an annual vaccine protocol for influenza or coronavirus or even as a pre-operation medication regimen for generalized immunological inflammation?

Dr. Kelly?

Yes. No, that's a great question. So I'll take the first part first. And so when we look at these post-viral syndromes, as I read today, I think we have really, really compelling evidence to pursue this. And I think we have the clear mechanism of action across a spectrum of post-viral syndromes that, just not only chronic fatigue syndrome but Lyme disease, COVID long-haulers, et cetera. So I think that's incredible in terms of the opportunity. And in regards to vaccines, there was a recent article that was just published and talking about the reason for failed vaccines, including like malaria and AIDS and tuberculosis. And one of the problems with these vaccines is that they were never able to get a sustained amount of antigen-specific CD8 T cells. And one of the theories behind that is that there's a prolonged exposure to inflammatory signals and they think it's really pro-inflammatory cytokine. So they looked at maraviroc in combination with vaccines in the HIV population and they showed an increased memory T cell and decreased CD8 T cell activation. So is there a role for leronlimab in enhancing vaccines? I think it's becoming more clear that there is a tremendous potential role for leronlimab in vaccinations. Nader?

So one thing I want to add to this is, please keep in mind the way HIV works is it needs to bind to a CCR5 of a T cell, enter to the T cell and copy a billion copies a day. If you have leronlimab as prevention and take a shot of this. The leronlimab has been shown by Dr. Paul Madden at Progenics time that it stays on that CCR5 for 60 days. Now there are more CD T cells that are produced by the body, so that's a different subject. But if you cover the CCR5, which we do 100% in most cases, then patients can't get HIV. So that's prevention. So there is no way we're going to drop the ball on pursuing this for prevention for HIV in addition to all the stuff that Dr. Kelly just mentioned. Next, please.

And Nader, let me say one thing. I want people to understand this because it's something, one of the main reasons I got involved in this company very early is I want everybody just to think about how much sense what Nader was just saying. The current standard of care in HIV is to wait until the virus goes through the CCR5 receptor, enters the cell and starts making billions of copies of itself. Now why in the world wouldn't you block CCR5 to protect healthy cells from viral entry. I mean, that's exactly what leronlimab does. Why would you wait until the virus enters the cell and starts making billions of copies? Why wouldn't you protect healthy cells from viral entry? Go ahead, Nader.

Absolutely. Next, please.

Were you aware leronlimab was given a billing code for Medicare. What do you think this does for chances of approval?

So we don't comment on the FDA's doing and whatever they're doing, so we don't comment on that. Sorry, go ahead, next.

When the FDA gives EUA approval for Vyrologix, what are the remaining steps to actually provide Vyrologix to hospitals and doctors? Is CytoDyn ready to go?

Ready to go, as we announced that we had a pharmaceutical, I mean, we had commercialization contract signed with American Regent, which is part of Daiichi, a very big pharmaceutical in Japan. And we need to thank our Board member, Dr. Samir Patel, for getting us that hospital. He also is the person who introduced Dr. Mahboob Rahman, which is incredible. So we have a Board member that does things that people don't see, but it's incredible. So yes, because of his introduction, we were fortunate to sign that already, and we're ready to go as soon as we get the EUA. Next, please.

Have you begun to plan for building your own marketing, sales and managed care reimbursement teams or will this be outsourced at least initially? If the plan is to stay in-house, can you talk about specifics, such as goals, objectives and time lines with respect to those things?

To launch a product for commercialization, you need a year and $50 million. That's what we saved the company when we signed agreement with Vyera Pharmaceuticals for HIV in U.S. only. Then we signed with American Regent for COVID-19 in U.S. and then we signed with Chiral Pharmaceuticals in Philippines. So no, we will not be doing that in-house. We don't have the expertise, and we don't have that kind of money right now or the time to launch it. So next, please. Arian, next, please.

Sorry, sorry about that. We know that remdesivir doesn't work as advertised. It was hastily approved in an EUA. And then on the same day that the WHO criticized the remdesivir data showing it doesn't work, the U.S. FDA fully approved it. Does CytoDyn intend to petition the FDA that they should revoke their approval?

So at CytoDyn, we're not hateful people. We are loving people. At least I'm trying to be loving, god help me to be a good person. Remdesivir did something fantastic, it reduced the number of days to be in hospital. Some of our doctors, who are very, very helpful to us, did the trial of remdesivir and they told us, and I won't mention their names that remdesivir does work. Now if World Health Organization said that they are not agreeing with the data, those doctors that we talked to, they agree with the data. They were part of that study. And they think that WHO's study was really, really bad. It was then randomized and so forth. So we don't build our company on trashing other companies. We build our company, and that's all we focus on. Next, please.

Can you provide an update on enrollment for CD12 at U.K. hospitals?

So the U.K., unfortunately, we had delays and delays, but they're all ready to roll, and we are hoping to have the first patient injected. But we do have, I believe, the first patient in the U.K. is going to be getting then the compassionate use very soon. And once that happens, that they've been working with us with Arian and the team, we will announce that in a press release. Next, please.

Please tell us the performance conditions attached to the 4.3 million performance stock units granted to executives on June 15, 2020 and approved at the Annual Shareholder Meeting?

Mike, could you please?

Sure. Each award is tailored to the executive's specific goals and objectives for the upcoming fiscal year. The Compensation Committee will evaluate each executive's performance against his or her goals at the conclusion of the fiscal year. And at that time, the vesting in the PSUs will be determined by the Compensation Committee.

Thank you, Mike. Next, please.

Have any of those performance stock units vested?

No. And they will not be until the end of the fiscal year based upon the specific evaluation for each executive by the Compensation Committee of the Board.

For example, getting the EUA, right?

Well, that could be one of them, could be an uplist. It could be a number of any other strategic business initiatives for the company.

Which is very beneficial to the shareholders.

Absolutely.

Okay. Next please.

Do you have any thoughts on the CBS report stating that 75% of 50 ICU patients on ECMO being weaned from the same and recovering from the virus?

I don't. Dr. Kelly, do you have anything to say about that?

No. I have to look at that data. But typically, ECMO patients don't come off ECMO. We've had some success with leronlimab in that, we believe. But those patients are very sick and are on full life support. So I'd have to look at that data, but I'm not familiar with it. I have to look into it further.

All right. Thank you. Next, please. Arian, I think you might be muting yourself.

Sorry, yes, you're right. Is there a likelihood that leronlimab was a player in that CBS report?

No, I don't. I have no idea. Next.

Given the variety of human serious illnesses that may respond to leronlimab, would you consider leading a combined task force consisting of appropriate personnel and resources from other drug companies devoted to reducing the time for determining leronlimab's effectiveness in curing or minimizing the terminal effects of these conditions?

No. I mean, if you know the drug development path, which I'm now fortunate to be in it for 12 years. By the way, my PhD took much less time than that. And I know it's not pretty good, I think. And now that we bring the top expert, I believe, in the world, Dr. Mahboob Rahman, we don't need to do those things. We'll do what needs to be done to get the job done. Next, please.

Can you update us on the collaboration business venture with Dr. Kush Dhody and Amarex referred to 1 or 2 conference calls ago as for building a COVID scientific panel and strengthening the relationship with Amarex and who are those scientists and medical-related professionals to join that team?

So please keep in mind that Amarex is a CRO. Dr. Kazem Kazempour is the President and CEO. Dr. Kush Dhody is the Director of our clinical trial at Amarex. So we outsource to Amarex to do this work, and they do fantastic work. And Dr. Mahboob Rahman, since he joined us, has made a very solid team between us and Amarex. And he's doing fantastic work, and I can't wait for everybody to see the result, but we are doing all the things that we need, the right things to get the next step. Next, please.

What are fiscal year 2021 revenues forecasted to be?

I'm hoping to be around $5 billion to $10 billion if we have approval from COVID-19. And in regards to other indications, I don't know. But if COVID-19 is approved, I believe $10 billion would be right, $5 billion to $10 billion would be the right number. Next, please.

Have you looked into testing leronlimab with patients with Crohn's disease?

No. And I hope Scott doesn't say we're looking.

So you want me to comment on that, Nader? So there is some very compelling literature regarding that, that we've been looking into. We don't have a trial as of yet, but we certainly would like to help the Crohn's and ulcerative colitis patients. And we do think that it is an inflammatory component due to immune trafficking to those areas. And it's an inflammatory response that we think that we have the potential to help, but we have not investigated it yet.

And it's amazing because we see more and more indication. As I told everybody, when we saw my own family member have a stroke and recover, unlike what the doctor told them would happen and she recovered, we said that in one of the conference calls and one patient came with the right to try and took it. And they said that it's really helping the recovery from stroke for them. So it's amazing what this product has, the number of potentials that it has. Next, please.

Yes. And I will say one thing about stroke, we are having some, Nader, if it's okay. We are having some really excellent dialogue with some of the top specialists in stroke and traumatic brain injury that are very excited about our potential to cross the blood-brain barrier and the ease of administration of leronlimab as a subcutaneous injection.

Yes. I think, Arian, we might have time for only maybe 2 or 3 more questions. So go ahead.

Okay. Is there a way to make a spreadsheet or link on the homepage that shows ongoing enrollments for all the trials we have going so that we can see how many are being enrolled and how many we need?

It's going to be too late for CD12. By the time we do that, we are going to complete the enrollment this weekend, hopefully. So with the other ones, with cancer, perhaps we could do something like that. We will look into it. Next, please.

I'm looking through. Why is the Philippines news link to the news section on CytoDyn's website?

Because we believe this is going to have a big impact on us, and we will be able to hopefully get an EUA from Philippines. We're very, very positive about that. Chiral Pharmaceuticals is very positive, and the team that's working on that is very positive. Next, please.

With regards to the long-hauler study, will there be pre-post treatment measurement of patient biometrics, CCL5 and other cytokine levels?

Dr. Kelly will answer that.

Yes. We'll be looking at inflammatory markers, both pre, during the study and after.

Next, please.

With the overflow of patients that are severe and critical, do you think the clinical data is strong enough to request EUA?

Yes, I think so. That's based upon the emergency IND that we saw. So with that, what we saw and testimonies, I believe so. Next.

Looking through the questions that have been submitted online and many of them you have already answered.

Yes.

Do you consider the CytoDyn measures against a hostile takeover robust enough?

Yes. Next, please.

One second. Does President Trump's new executive order limit CytoDyn's ability to do business overseas prior to an EUA being issued by the FDA in the U.S.?

I don't think so. Next, please.

Is there any way to find out if any previously treated patients who received leronlimab are suffering from long-hauler effects?

Dr. Kelly?

No. I can tell you that what we saw in CD10 was patients that were technically falling into the long-hauler classification improve in terms of cognitive dysfunction and everything from impairments and balance, et cetera. So we are very encouraged by what we've discovered in terms of the mechanism of action and our future, not only long-hauler but all post-viral syndromes.

So with that, I'm just going to give you closing comments. First of all, thank you, everyone, for being on the call. Second of all, please keep in mind that we have raised funds with minimum dilution as we always promised everybody, and that put us in a good financial position where we're now exploring all of these avenues that we have. COVID-19, CD12 is one study that we are very excited, but the long-hauler and all other post-viral syndrome that we believe we'll be able to hopefully impact if long-hauler has a great result is just tremendous by itself. And then we will have the EUA to file with Philippines, with the BLA for HIV and multiple avenues with HIV prevention, cure and treatment for combination and treatment for monotherapy, which we will file immediately after the first approval of combination. With cancer, results are being analyzed. And all the other indications like NASH, I think we have put this company, thank god, in a very, very good position to be able to harvest quite a bit for our shareholders. So with all of that, thank you again for being on the call. Have a great day. Bye-bye.

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