CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, ladies and gentlemen, and welcome to the CytoDyn Investment Community webcast. [Operator Instructions] It is now my pleasure to introduce Mike Mulholland, Chief Financial Officer. Thank you. 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 being on this call, and Happy New Year, everyone. On February 20, 2018, CytoDyn proved its case that with no doubt leronlimab is a fantastic product. We did this by hitting our primary endpoint in a well-controlled gold standard, double-blinded pivotal Phase III trial. FDA acknowledged that and awarded the company rolling review BLA submission. For the next 22 months following February 2018, CytoDyn presented leronlimab's potential indication and accomplishments in many different conferences, LD Micro, Singular conference, Biotech Showcase, et cetera. In all these presentations, one of our main messages was CytoDyn has hit its primary endpoint, and therefore, CytoDyn is no longer a high-risk, high-reward company, but a very low risk with high rewards. But the shorts did not believe us and the results were financially catastrophic for those who shorted CytoDyn in that period. I pray that they learned from their mistake as we entered a new chapter for CytoDyn with more powerful opportunities, more explosiveness and a future that is about to be fine-tuned by -- and realized in 2021. Potential of giving higher quality of life to patients and potential of saving lives should never be shorted. This is just my humble opinion. CytoDyn's stock has now traded over $5 billion in just last 12 months. Every investor who trusted us, when the stock was around $0.30, has been handsomely rewarded. As we said, high reward and very little risk. Past 12 months proved our case and completely shattered the shorts. CytoDyn now is in the top of the chart amongst all 11,700 OTCP companies. And hopefully, we will be uplifting CytoDyn to NASDAQ soon. And hopefully, we can shine amongst NASDAQ companies that we will be among. For our recent announcement, the FDA has given CytoDyn clear and concise instruction of what to do to get to the finish line for the HIV indication and potentially COVID-19 indication emergency use authorization. In HIV indication, there is hardly any doubt that we will be successful. In my opinion, our chances of success is outstanding as long as we just follow the FDA guidelines and instructions for which we are 100% confident, we have the most capable CSO, Chief Science Officer, to advance the collective efforts of our BLA team for our BLA projects in HIV and/or BLA for COVID-19. Dr. Mahboob Rahman is the medical doctor with a PhD, who has a proven track record of many successful BLA submissions. He's a brilliant man, who is in charge of CytoDyn's BLA for HIV and COVID-19, and all of our other clinical development. But before I get to all what we could accomplish in 2021, let me just briefly address the human side of what leronlimab has provided for many patients. Dr. Kelly will read several testimonies, one from an ECMO patient in Europe, which we just received for COVID-19 patient, one from Stage I colon cancer patient and another from stage 4 bladder cancer. Dr. Kelly, could you please?

Yes. Thank you, Nader. So out of respect for patient and doctor confidentiality, I will keep these anonymous. The first is a testimony from a family member of a patient with COVID-19 on ECMO. "Dear Nader, just wanted to thank you once again for the amazing support and kindness shown to me and my husband in providing leronlimab for its compassionate use in Europe. We are not out of the woods as yet, but I know we will get there. Thus, I hope this rather generic record of what has happened to date can be of use to you and your team. My husband is in his late 50s and other well-controlled hypertension and a prior history of smoking with some smoking-related lung changes. He was a fit and strong individual. In October 2020, he became unwell with COVID-19. Initially, he was managed at home, but eventually, he was admitted to the hospital in ICU for oxygen support therapy, remdesivir, plasma exchange and dexamethasone. This worked well for 10 days, but he then deteriorated, necessitating the need for mechanical ventilation and eventually ECMO. He remained on ECMO in excess of 45 days, and we were told he would not be suitable for further treatment as he had end-stage pulmonary fibrosis. Fortunately, further opinion suggested that this may not be the case when his chest imaging was compared to his pre-COVID images. This gave me the huge push to seek alternative therapies and through a network of personal contacts, physicians and scientists, I was led to your door. I started to read up about leronlimab, and to me, it appeared to be the drug of choice given my husband's very difficult clinical state. Having undergone scrutiny by the hospital team and the regulatory authority, we were fortunate enough to be able to give him leronlimab just before Christmas. Within 5 days, he was off ECMO. And by day 8, the ECMO cannulas were out. Since then, he has been predominantly weaned off sedation and is starting to wake up. He can follow a conversation with his eyes, which has been so heartening to see. His oxygen needs are being reduced gradually and all of his parameters of ventilation, infection, renal, liver function are normalizing. He is slowly getting better and stronger. The impact of leronlimab on him has been nothing short of a miracle, and I'm eternally grateful to you and the CytoDyn team for your phenomenal help in saving his life. I feel strongly that this drug must be made available for every patient that can get a hold of it to save their life in ICU. It works even the most dire of circumstances and to date, I have not seen any side effects. Whatever I can do to help you and the CytoDyn team and your partners to get this drug to the people who need it, I will do. I am waiting for my husband to make that final move off ICU to the ward and then home. When this is done, you will have my undivided attention. Best wishes." The second testimony I'll read is from a patient with colon cancer. "Dear Dr. Pourhassan. This is a heartfelt thank you from me and my family. I was diagnosed with Stage IV colon cancer in May of this year. My wife immediately contacted Quest Clinical, because we know what a miracle drug leronlimab is. I was lucky enough to get an exception and be enrolled in your trial. This past August, which made us super excited and gave us a lot of hope, I received a Christmas miracle about 2 weeks ago, when I got the results of my PET scan and my oncologist informed me that there was no sign of cancer anywhere. I believe that leronlimab had a lot to do with this, and I am so grateful to you and your team. It is my hope that this drug gets approved fast, so that it may help millions of people. You guys should be very proud of yourselves for being such -- part of such a wonderful drug. Thank you so much once again from the bottom of our hearts. Please keep up the wonderful work you're doing. Wishing you and your families a wonderful holiday season." The third testimony is from a physician regarding a patient with bladder cancer that I just received on January 4. "Dear Dr. Kelly, I hope my note finds you well. I wanted to update you on my patient. As you know, he suffers with bladder cancer and is not a candidate for chemotherapy due to other health issues. CytoDyn was kind enough to supply us with leronlimab as a right to try drug. After reading on the drug and its limited side effects and with permission of the family, we started the injections 9 weeks ago. A recent procedure indicated no metastatic lesions or spread of the cancer beyond its borders. To put things into perspective, he was told by the urologist that this could potentially take his life within 6 months. It is now 9 months. Without metastatic lesions visible on direct visualization or CT scan, I believe that the leronlimab has curtailed the spread of this potentially lethal cancer, which is what it is intended to do. I understand that it's still too early to come to any final conclusions, but leronlimab has given my patient hope for survival and possible cure. It has given me hope in humanity in a very difficult year medically, and I remain truly grateful for the kindness that CytoDyn continues to demonstrate to my patient. May god bless you for your support and for trying to make the world a better place. Thank you again." We also just received an e-mail from a stroke patient's family member that the patient continues to improve as well. Nader?

Great. Thank you, Scott. So does leronlimab have some rock solid data in regards to its efficacy in any application? The answer is yes. Not only did we answer this question by crushing the primary endpoint in our HIV pivotal trial with a p-value of 0.0032, but HIV monotherapy also had many human elements that I hope our investors don't forget, allowing HIV patients stop taking any HIV pills and just have a simple once-a-week subcutaneous dose of leronlimab has been met with tremendous results according to HIV patients. And I just don't want our investors to lose the sight of that accomplishment. We have gone -- come a long way with COVID-19 and constantly talk about that. That's our primary focus now. But as an update, I have to get into this HIV great situation that we have. Since we are reading testimonies, I would also like to let our shareholders hear from HIV patients directly for the first time by listening to the audio of 9 patients, who spoke about their experience with 2.5 years of monotherapy. Some of these patients are now gone 6 years with HIV monotherapy with our drug -- with our leronlimab. But I want to just have everybody hear 10, 15 seconds of what they thought after taking leronlimab for over 2.5 years, and for the first time in their lives put away pills. [Presentation]

So because of the lack of time, I won't get into detail of this, there's a lot to be said, but just very quickly, Gilead and ViiV have taken 30 to 35 years and come up with some fantastic pills that have very low side effects and toxicity now. However, they have not been able to give the patient a subcu injectable that's once a week, so they can take a rest for 6 days. You heard these patients saying they love that, that if they miss their regimen, they have 3 days, plus or minus 3 days is okay with leronlimab. You heard that they said that taking this pill makes them feel alive. Obviously, leronlimab, we believe that has something else to do with the body, because the role of CCR5 in many indications has been published in peer review with many different doctors, not just 1 or 2, many. So this brings us to the point that, okay, we get approval for HIV. What do we do for manufacturing? Because obviously, we believe we're going to have a tremendous amount of revenue. So we are working very closely with our manufacturers to make sure that they're ready to advance, expedite our manufacturing process. But our BLA, how is our BLA right now? Our BLA for FDA, I am 100% confident that we have it in the hand of the right person. And that right person is our Chief Science Officer, Dr. Rahman, and I'm going to have him give you a little bit of explanation as an update of where we are with our BLA. Dr. Rahman, could you please?

Sure. Thank you, Nader. Yes. Happy New Year, everybody. Yes. Regarding the BLA, the team is working very diligently point by point everything that FDA has asked us to do. And we are thinking of doing a rolling submission that FDA had initially approved, and we are discussing with FDA regarding the time line for that. The nonclinical part of the BLA -- so we're dividing it with 3 segments, the nonclinical part, our modules, then we have the CMC modules and then the clinical modules. So the nonclinical part is essentially ready to be submitted. And then we will submit the CMC or the clinical module, whichever becomes completed. And we should be able to do this by the second quarter of this year. In addition to that, we're also working in parallel to submit to MHRA, which is the U.K. health authorities and then EMA, the European health authorities, and Health Canada soon after all around -- depending on how much we can do around the BLA submission, we will submit these also. So basically, we will have 4 jurisdiction applications for marketing authorizations submitted. Thank you.

Thank you, Dr. Rahman. So I want to make sure everybody is clear that CytoDyn team is working very hard on this BLA even though we have a lot of work with COVID-19. Amarex folks have been fantastic, Dr. Rahman and Dr. Kelly and myself talk every day about this. We are meeting every week. We have several team meetings that Dr. Rahman is leading, and we are very, very optimistic. But I want to make sure everybody knows in regards to prevention and monotherapy. Our monotherapy trial has right now as of 11/16, November 16, the update that we have is almost 300 patients have gone almost 1 year without any HIV pills. We shattered the world record. Ask anyone. In 1990s, when David Ho became TIME's Magazine Man of the Year, it was claimed that no one product can suppress the viral load. You need 3 products from 2 different classes. We shattered that idea. We are about to change HIV paradigm if monotherapy is approved, and we're working very hard to get that approved. And as of right now, the latest data shows that with 700 milligrams, HIV patients have 90% get suppressed viral load for many months to come, and they are continuing in extension some of them. But our rate of efficacy is at 90% post the first 10 weeks, which we call induction period. In regards to prevention, I hope everybody pays attention, because prevention is not going to be once a week, but once a month. An individual, who is in risk of HIV, could take HIV -- like leronlimab subcu injection, if we're approved for that indication, and they can go for a whole month and be covered. Now that we're going to address in 2021 with a very quick proof-of-concept study. That's what we're thinking right now. We hope to follow through by that. We will update everybody, but we might wait to get our approval first when then prevention becomes much easier to get. But just for the record, 180,000 individual use prevention for HIV and the selling price was $20,000 per year. That's $3.6 billion. We believe we're going to capture all of that once we get going and get approval. So potential revenue from HIV alone, we believe could be, with all the different population that could be added to our label post approval, about $5 billion to $10 billion. Now these are not the things that I'm just throwing in there. FDA in 2017 rejected our request for orphan drug designation. The letter indicates that leronlimab most likely will be selling to over 200,000 patients. Therefore, you don't qualify for orphan drug designation. 200,000 x any price that you want to pick from the price of the market -- HIV field, $30,000. If you multiple 200,000 with $30,000, that's $6 billion. I show that letter of FDA to Samsung, Dr. Kim, the CEO of Samsung, and he was very impressed. So -- we are talking to Samsung very closely, because if emergency use authorization for COVID-19 comes, Dr. Nitya Ray and myself will be flying to South Korea to negotiate expediting manufacturing. Operation Warp Speed has already talked to us before. We hope that they will get involved. And in regards to HIV alone, we're going to need quite a bit of product. So we are signing new agreements for more production for 2021 and 2022. In regards to HIV cure. I want to make sure everybody understands that we've signed an agreement with amfAR, because Dr. Jonah Sacha has indicated that there are reasons that he saw in his animal study that when a patient needs bone marrow transplant, in animal study, he was able to duplicate what happened to Timothy Brown, who had a bone marrow transplant because of cancer. Almost 10% of HIV patients when they have HIV for a long time, they develop AML, MDS or some kind of cancer that requires bone marrow transplant. If they have bone marrow transplant and leronlimab covers the CCR5, then the new immune system might become delta 32, like Timothy Brown. If that happens, we have a cure for that population, 10% of 30 million is like 3 million, 10% up 1.4 million, that's number of the HIV patients in the U.S. is 140,000. So again, big market. The next update I want to talk about emergency use submission time line to the same 4 countries that we talked about, Europe, Canada, U.K. and United States. Now as of recently, we have been approached by some countries that they're telling us they could get us perhaps marketed without CD12 data. Now this is new development that's really exciting. I don't know how far we're going to go in this direction, but we are following through. And countries like Indonesia, Brazil don't require you to have complete approval, but you can market the product, and we are working -- we have been reached -- contacted by pharmaceuticals in Turkey and Pakistan. We are working with them. But all of this is not to distract our investors from our main thing, which is Philippines, because Philippines can give us emergency use authorization, hopefully. That's what they have indicated to us without finishing our CD12 data, which is this month. CD12 data is this month. But if that happens, we will start selling right now. We have put our manufacturing people on alert that if we need to send vials immediately to Philippines or any other country, because marketing is allowed, we will proceed. And we have 0.5 million vials ready to go and another 700,000 vials can be made from the bulk drug that we already have made at Samsung. So we believe emergency use authorization application for Philippines should be submitted mid-January. This is just 10 more days or so. This is very exciting for us. But CD12 data, that's what I'm very excited about. How did we do all these great things with leronlimab in emergency INDs in critical patients? Those -- we talk volume, speaks volume. And we have published papers, 3 of them, and there's 2 more coming up. So we'll see how that goes, but we will be updating the shareholders as everything happens. Now the next update is about long-hauler trial. I'm going to have Dr. Kelly talk about it. Dr. Kelly, could you please?

Yes. Sure, Nader. So in regards to the COVID long-haulers, as the pandemic continues to grow exponentially, we know this to be true. The result is going to be more COVID long-haulers. As of this morning, there have been over 87 million worldwide documented cases of COVID-19. If you take a conservative estimate of 10% to 30% of those infected with COVID-19 that become long-haulers, you can begin to see how the collateral damage of COVID-19 will play out. Even with the most conservative of estimates between 8 million to 24 million people will seek medical care and answers from their physicians. Their physicians have limited, if any, treatment options to provide these patients. COVID-19 is unchartered territory and CytoDyn is one of the first to attempt to address this critical issue for long-haulers. The questions we have been trying to identify are how you define long-haulers syndrome? What symptoms best define long-haulers? Who is most likely to be affected? How do you effectively measure the response to a therapeutic? What is the mechanism of action and how does it apply to other postviral syndromes? These questions we are working on in real time and reevaluating as the situation evolves. For these very important questions, we are working with the FDA and targeting our first patient randomization this month. Our goal is to help patients and gather data. Demand for this trial is overwhelming and will fill rapidly. The time invested on the front end, we believe, is time well invested in the long run for both patients and shareholders.

And could you also update us on NASH? Scott please.

Sure. So I'd like to begin talking about NASH to congratulate Dr. Chris Recknor, our VP of Clinical Development, on a job well done during the COVID-19 pandemic and moving our NASH trial forward. I'm pleased to announce that our first patient was randomized on December 29, and we are ahead of schedule. This patient has already received their second injection. We have 25 patients currently in screening, 20 patients scheduled for MRIs and multiple sites being activated. Our progress in the midst of a pandemic speaks for itself. We are using advanced MRI technology to monitor fatty deposition via proton density fat fraction and fibrosis by CT1 analysis without invasive biopsy. We believe this technology will give us excellent data regarding the therapeutic benefits of CCR5 antagonism in NASH and NAFLD. And I also want shareholders to understand when Nader was speaking about HIV, that we are acutely aware that the HIV population has a 6x higher rate of fibrosis than the general HIV-negative population. We are also aware that liver-related disease has been estimated to account for 13% to 18% of all-cause mortality in HIV-infected patients. Liver disease is one of the leading causes of nonage-related deaths. We will be pursuing leronlimab as the anchor of the HIV treatment paradigm to help address HIV-related liver disease.

Thank you, Scott. So the next update is about cancer. Now I'm very excited as everyone heard a couple of testimonies. There is more testimonies in cancer, but we read 2 of them to you. Cancer trial, we talked about breakthrough designation in the past. In our basket trial, we have prostate cancer patients, breast cancer, colon cancer and the data is for Stage IV patients, with some of them have been diagnosed 2, 3 years ago. That means the life expectancy for Stage IV is not very long. And these patients that we have, if you have 5 patients that have gone 6 months with your product, that's very strong. We now have 9 patients, and we have most of them going 6 months or more. Now we are going to FDA, and we're going to have breakthrough designation talk immediately. We're going to request that this month most likely and that's our plan. These patients that we have gone with leronlimab have CTC of almost 0. These 9 patients -- not all the patients who were enrolled, there were several patients, 3, 4 of them that passed away very quickly that leronlimab perhaps didn't have any effect on them or it was too late when we gave it to them. So we want to make sure that everybody is clear that we didn't give 9 patients out of 9, this was 9 out of 16. 2 or 3 got kicked out of the trial or they couldn't come in because of the COVID-19. But overall, 9 is what I'm reporting to you right now. So the breakthrough designation, we're very excited to see what happens with that. These patients mostly have CTC, circulating tumor cells of 0. Their CAML size is reduced. This is a marker for -- this is a marker for cancer that we have measured. And we are waiting for the CT scan and MRI of these patients, but we are going to ask FDA for breakthrough designation talk this month. In regards to GvHD trial, Dr. Rahman will explain. Dr. Rahman, could you please?

Sure, Nader. Thanks. So as you probably know that we had some very good results in an animal model of GvHD. However, we had difficulty enrolling our human trial. It's not just we had difficulty enrolling trials, there are other companies also who had to stop their trials because they could not enroll. And the reason for that is Jakafi, as you know, has been approved and a couple of other drugs are pretty close to approval. And FDA requires a placebo-controlled trial -- randomized placebo-controlled trial. Now Jakafi was the first one, so they were able to get it through with a single-arm study. But now that you need placebo-controlled trial, it is very difficult to enroll. Their own trial, the REACH2 -- Jakafi's REACH2 trials, it took them 3 years to enroll their 300 patients. And you can imagine if now it is difficult to enroll, how long will it take. So that doesn't mean that we will -- we are completely abandoning GvHD, we just have many other more important and we feel where the return on investment will be bigger, that's where we are focusing. But we will return to GvHD at an opportune time and see if there are after all these drugs that are approved, there may be still opportunity there for patients who do not respond to any of these or even preventing the GvHD and that's another area we can focus on. So that's why for now, we will put our GvHD program on hold until we come back after we are working on the current programs and reevaluate it. Thank you.

Thank you, Mahboob. So in regards to the next update, stroke, MS and Alzheimer, all 3 trials, we are hoping to start doing these 3 trials this year. And we will let everyone know. And the last item is NASDAQ uplisting, which I'm going to have Mike give you the latest. Mike, please?

Yes. Thanks, Nader. Good afternoon. Based upon our recent discussion with the exchange, I believe we have a very clear path forward. We simply need to execute our plan. All of this must be supported by a stock price of greater than $4. As we've stated several times before, there are multiple quantitative initial listing criteria. To be clear, there are 7 specific criteria. All itemized in what's called the Initial Listing Guide. So please recognize, stock price is only 1 of 7. To be more specific, our biggest challenge as a company thus far on the uplist has been to achieve stockholders' equity of a positive $5 million. For those of you, who follow our published financial statements, you will note that at May 31, 2020, our fiscal year-end, stockholders' equity was a deficit of $2.5 million. Then at the end of August, our August 31 10-Q, stockholders' equity had bounced back up to a positive $2.7 million. Our stockholders' equity for the quarter ended November 30 will be reported soon as the filing deadline is next week. So in summary, we have a plan to cure the shortfall in equity. Let's remember that there are many other subjective issues considered by the exchange. And at the end of the day, it is ultimately their decision based upon a mix of quantitative and qualitative issues. Nader?

Thanks, Mike. So Mike Mulholland spoke to NASDAQ just a couple of days ago. I just want to make sure everyone know that we are in touch with them. They have given us some optimism that we can go forward and hope that we will be uplisted. Any amount of money that would need to be raised to get the shareholder equity has been positive, we can do very quickly. Any items that they will request from us, we will work on it immediately. And I'm very optimistic that we could get to uplist as soon as we hear the next step from NASDAQ. So with that, let's go to Q&A. Arian, please?

[Audio Gap] selling CytoDyn stock. Most recently, one of our senior executives made a preplanned sale of stock pursuant to what's called a 10b5-1 plan. A rule 10b5-1 plan is a written plan for trading securities that is designed in accordance with SEC rules. The amount, price and date for the sales of stocks under a 10b5-1 plan are specified in advance. Once the plan is put in place, the executive cannot exercise any subsequent influence over how, when or whether to make stock trades. In accordance with the SEC rules, our executive 10b5-1 plan was entered into when our executive was not in possession of material nonpublic information about the company. We were in a window period and the plan was preapproved as required by our insider trading policy. The media have reported on this trend across the biopharmaceutical industry in 2020, as other biopharmaceutical executives with 10b5-1 plans have also made stock sales that were automatically triggered by changing market conditions, such as increase in stock price. CytoDyn's insider trading policy permits 10b5-1 plans and is available on our website, and we invite investors with questions to review it. Trades under the 10b5-1 plan are disclosed on Form 4s and the Form 4s indicate that the trades were made pursuant to the 10b5-1 plan. And that is all the company or its executives or directors have to say about the company's stock sales. Nader, the first question is how many deaths have been reported to date in CD12?

So the CD12 number of deaths so far -- and we don't know which on these deaths are. Last time we talked about that, there was a lot of confusion amongst our shareholders. There have been 87 deaths so far, and the 28 days had not been reached for the last patient. So we could see more, unfortunately, but there is 87 as of right now. Next, please.

The CD12 protocol states that participants in the control group will receive placebo. However, the note to the exclusion criteria states that subjects who were prescribed hydrochloroquine or chloroquine without acetaminophen, remdesivir, convalescent plasma therapy or immunomodulatory treatment for COVID-19 prior to study enrollment may be included and may continue to receive the agents as part of the standard of care. Please clarify whether CD12 participants and particularly the control group were able to receive the standard of care without restrictions or were limited to treatments that we're receiving at the time of the trial enrollment?

So the trial protocol was approved by FDA. The patients get what they need to get according to their physician, and they will add placebo to some of them and to some of them will add leronlimab. So it's very clear protocol. People can access that. Next, please.

Nader, can I just add to that?

Yes, yes. Sure. Sure. Go ahead. Go ahead, please Mahboob. Go ahead.

Yes, I just wanted to clarify that when the patients are randomized, it's blinded. Nobody knows which patients is getting into the treatment arm, leronlimab arm and which patients are getting into the placebo arm. So everybody is treated the same way because the treating physician doesn't know which group they are in. So I just want to make that clear.

Yes, absolutely. Thank you, Mahboob.

Will there be a statistical analysis of the CD12 data that distinguishes between severe patients and critical patients?

Absolutely. Next, please.

Do you know whether there were any trends in terms of the number of severe versus critical patients that enrolled?

We will disclose those information very shortly as everyone knows. Next, please.

When does the company plan to make the top line mortality figures from CD12 available to the public?

As soon as we can get to the data, we have to lock the data and unblind it, then write the report. So we will let everyone know very soon. Next.

Assuming positive results from 100% enrolled trial, an open-label extension and EINDs resuming, hasn't CytoDyn got enough to warrant full approval instead of EUA for leronlimab?

Absolutely not. If we had, FDA would have given us approval. Trust me. FDA is very good about recognizing opportunities for the patients, and we trust them. Next, please.

Why did the FDA restrict EIND criteria compared to open-label extension when no other good therapeutic alternatives to Vyrologix exists?

We need to continue CD12 the way it was to help agency have more data. And if we're going for this population and the potential, they want to make sure that we just mimic that exact same condition. Next, please.

Since the December 22, 2020, press release on EINDs and open-label extension, how many have been requested, issued, turnaround time? And will the data from either both be useful to CytoDyn And if so, how?

We've been getting crushed by number of EIND as requested, but to get them approved by the FDA is not as easy, because the doctors have to get involved and call FDA themselves, get the number, get a letter of authorization from us and so forth. So we'll get to all of those details at the right time. Next, please.

In prior calls discussing CD10 trial, it was said that the FDA wanted to see CD12 trial results first. Is there a chance of approval to use leronlimab as -- for all or part of CD10 mild to moderate population based on the CD12 trial confirmation?

No. The CD10 is being reviewed by other countries also. And the data that we had was too little. 84 patients per protocol, I think we had 26 or 27 patients in leronlimab, intended-to-treat population was 2/3 of 84. So the numbers were very small, and the primary endpoint was missed. The secondary endpoint that was positive for us to go forward with Phase II was great for us. We could go to the Phase III with moderate perhaps or others, but we decided instead of going and trying to meet with the FDA and do a Phase III on the information that we have learned, which was very valuable to us, we will concentrate all of our efforts on CD12. Next, please.

Do you believe Vyrologix will be effective against the new strains that emerged in the U.K. and South Africa?

Scott, please.

Yes, sure. So yes, I'll address that. So there's 2 new strains. The one in South Africa, which is known as 501b2 and the U.K., which is B117. It appears that the South African strain is entering into Brazil as well, and it appears to be more dangerous. And I know that we've had a number of questions about will leronlimab work on this stream. And I can tell you that, because they had said that monoclonal antibodies might not work. Now people need to realize that our target is CCR5. It is not the spike protein. So we have no reason to believe that leronlimab will be less effective in this population. Some of the other drugs might have difficulty, but our target is CCR5 and not the spike protein.

Great. Thank you. Next please.

Can you provide any clarity as to how long patient protection will last for Vyrologix once approved for COVID, HIV and any other indication?

So the patents that we have, we have over 100 patents. But as biologics, you have 12 years of protection once your first approval gets there. So after 12 years, we can also look at other applications -- other patents that we have that goes further than that. Next, please.

What happened to the Philippines EUA application that was supposed to be filed within 2 weeks?

So when you ask the Chiral Pharmaceuticals that what all we need, they told us at the beginning that perhaps we could get it done within 2 weeks. Once they send us a requested list of items that has been tremendous, and Amarex and Dr. Mahboob have done a fantastic job getting a lot of information to them, we now have one more item that it needs detailed information of all the patients that they have requested. That will be done, hopefully, within the next 9 to 10 days. That's what we're hoping. And I want to make sure all the shareholders know. When I said this is what we're hoping for, I'm updating you on where we are. If anything changes, I will let you know, but we hope to have EUA submitted within 10 to 15 days and that's our best guess right now. Next, please.

Regarding the capacity for manufacturing with Samsung, what has been secured for 2021?

2.5 million vials and 2.5 million has been secured for 2022. I'm sorry, yes, 2022.

Can that number be bumped?

Yes, we believe so. Dr. Nitya Ray, our Chief Technology Officer, has told me that if we need to, we need to go to South Korea, sit with the CEO of Samsung, and discuss those possibilities. We hope we can, but we have to see. Next.

Nader keeps stating that he has done everything in his power not to dilute shareholder value by issuing stock, but isn't doing that by giving Streeterville Capital, LLC shares every month that's equal to repayment of $7.5 million?

So if you like for us to raise money, we have few options, registered direct or a PIPE. When you do those kind of raise, you have to give warrants. For example, we were approached many times by people to, "Hey, let's do a registered direct $50 million at the price $0.3 below the market price, plus 50% to 100% warrant." That's very dilutive. Right before we started showing the public why we thought we were low-risk, high reward, and before those things happened, we were offered $25 million raise from a very well-known banker -- $25 million for 300 million shares, 300 million shares. We avoided that disaster. We never got a call from anybody on tanking us, because probably they don't even know that. Recently, we announced -- we have $25 million, another $25 million, another $25 million, over $10 a shares. Now if we are able to give back $7.5 million at the current price of, let's say, $4, $5, that's 2.5 million shares. We were trusted with 100 million shares more authorized. Some people in the past Board members were wanting us to get 300 million shares outright. I fought against that. And Dr. Scott Kelly backed me up and Jordan Naydenov, we were able to stop that madness. So we got 100 million authorized. Do you -- does people know how many of that we have right now available still, after all these things that we've been doing that's burning sometime $5 million, $10 million a month? Please do the math. Do the math, just do the math and tell us what you think. Next, please.

Are you able to charge money for leronlimab right now with the current EUA arm of the Phase III trial? If not, when will you be able to charge money?

We can charge money, what I have heard from our regulatory right now. We haven't done that. But the more interesting it had brought to my attention is we can actually sell leronlimab right now. I hate to sell our shares that we have. I like to reserve it for United States. That's the country I believe myself, I owe to this country for everything that I have ever received, and I'm fighting for that. But if we were going to go to other countries, we could sell right now. Next, please.

How does one access the trial for long-haulers?

By just getting enrolled through their doctors, and we have just way too many people. We can't even take any more volunteers right now for potentially getting in those trials. Next, please.

How do see CytoDyn growing in 2021 as an organization? And what do you dream for the future of CytoDyn?

So when I said very little risk, very high reward, that people laugh at us and showed us at $0.3. I think we have a little bit of room to be a little bit proud, if you don't mind and not to be arrogant, but thank god, we got what we got. And my estimate is about 10x better than what you guys just saw. Because if we're successful, if we have a bump on the road, it's going to delay it. But if we are successful, the path that we're going forward, we're taking every opportunity and moving it forward. One step at a time. We're not taking a break, just raise $30 million, sit back, do one indication, relax and let our team relax. Our team does not sleep very well. We sleep maybe 5, 6 hours, I don't know, but not that much. Now this is the way we have worked in the past. Mike Mulholland, I don't think he goes home. I really don't know. I mean I'm going to ask his wife very soon. How many hours does he spend at home? You -- people might think, Mike Mulholland sold shares, my god, $1.8 million and that's 0.00001%. Please, let's be real and let's be fair to each other. We are going to do fantastic in 2021, in my opinion, and we want to prove that with facts, with approval and with hopefully some licensing deals. Next, please.

Is your monotherapy possible with once-monthly injection?

Absolutely, we believe so. And we are going to prove that also. We will -- we are thinking about doing some proof-of-concept study in prevention. I would love to do that. Scott is 100% aligned with me on that. So we will let everyone know when we're ready for that. Next, please.

This is a 2-part question. When will the CD12 secondary endpoint 14-day mortality data be released? And can an EUA be issued upon positive secondary endpoint data rather than waiting for CD12 primary endpoint data?

So I do not speak for FDA. I will not dare do that. But what I will tell you is mortality is very crucial item in the FDA's list for approval. I can't promise anybody anything, but I know for a fact, the agency will look at everything very carefully, and they will do the best thing for us. Next, please.

The primary endpoint for COVID-19 long-hauler study is changed from baseline and fatigue severity score at day 28. The fatigue severity score seems to be rather subjective. Does this pose a challenge with achieving statistical significance, especially considering the heterogeneity of long-haulers? Can the CytoDyn team comment on why a more objective measure such as Dr. Patterson's long-haulers index was not selected?

So Dr. Mahboob Rahman is on call. Mahboob, would you like to say something about this before I say anything?

Could you please repeat the question? I didn't quite get the question.

Sure. The primary endpoint for COVID-19 long-haulers is changed from baseline and fatigue severity score at day 28. The fatigue severity score seems to be rather subjective. Does this pose a challenge with achieving statistical significance, especially considering the heterogeneity of long-haulers? Can the CytoDyn team comment on why a more objective measure, such as Dr. Patterson's long-haulers index was not selected?

Yes, very good question, and we are at present discussing with FDA, and we will have a different primary endpoint for that, but it will be something that FDA accepts. And that's probably the criteria of what we will select. So we are in discussions with the FDA currently.

Thank you, Mahboob. So let me just add one thing. I hope the shareholders have a little bit of confidence that I, Nader Pourhassan, do not make these decisions. We go to the top people in the world, and we ask them how to go forward. We don't just listen to the heights or somebody, who thinks somebody is great or let's go this, we go to the agency, FDA. We ask them, would you feel good about us doing this or that, and the FDA gives us excellent guidance. And the top of the world scientists give us advice. We use them as consultant. We use them as adviser and so forth. But we are going to have a perfect protocol, as we have shown in our record what we have done with HIV hitting primary endpoint and so forth. Dr. Kelly, do you want to add?

Yes. I just will add that I think that we are really on the cutting-edge of this and determining the best measures for both long-haulers and for the postviral syndromes. And I want people to understand that we are trying to do this in the right way to propel us forward to evaluate all the postviral syndromes. And we feel that if we get it right on the first trial, it will lead to more opportunity for patients and for shareholders.

Thank you so much. Next, please.

Are there any clinical or anecdotal results from the open-label extension or EIND usage that can be shared?

No. Next.

Will there be data from CD12 study related to cause of death?

I'm not sure. Next.

Explain in layman's terms what the COVID mutation means for the current vaccine and for leronlimab?

Yes. So we really don't know -- this is Scott. We really don't know in regards to the vaccines. I mean I know there is some concern about the South African variation. We don't know for sure whether the vaccines are going to be maybe a little bit decreased in terms of effectiveness. We certainly hope not for the world's sake, but there is that possibility. As of now, we think that the vaccine should work for the current strain as well as the U.K. strain. But yes, there is a growing suspicion regarding the South African variant.

Next, please.

Does the recent Humanigen patent filing infringe of CytoDyn patent since there was a mention of cytokine storm in the patent?

Cytokine storm is mentioned in every study that has been done with COVID-19. We have a team, very solid team of patent attorneys. And they always watch for anybody violating our patents and they jump on it. The composition of material patent that we will have for 12 years does not allow anybody to use this product for anything. It doesn't matter if you have a patent for cancer, HIV or anything, we were patented for every indication, but we're safe. Next.

Will you explain the storage requirement and shelf life again for leronlimab?

Bulk product at negative 80 degree Celsius, we have a stability of almost 7, 8 years, and we think it can go even more. The stability test for vial product in refrigerator temperature, they -- the stability we have data for more than 2 years. We are hoping that FDA will give us a 2-year shelf life when we get approved. So we do have -- so I want to make sure everybody knows there's 2 types of stability that we are testing as we speak, bulk and in vial. Next.

Could nondetectable HIV plus patients use Vyrologix once approved? And when do you expect approval in the U.K.?

Not HIV. I didn't get the first part, Arian, I'm sorry.

The nondetectable HIV patients. I don't know what it means here.

So if a patient doesn't have HIV, can they use leronlimab? Well, this is the right to try or emergency IND and different countries have different rules. Next, please.

Could Vyrologix be ordered for patients in other countries in case the country does not allow specific medication approval guidance?

Every country have their own rules and regulation. Next, please.

I think you may have answered this one. On the last call, you talked about 3 or so cancer patients who were at the 3- or 4-month point. Any update on these patients? I think the...

As I said -- absolutely. We have patients that have gone 6-month, I believe, 4, 5 of those 9 that I mentioned have gone that long, and we're excited about that. But let's have one last question, because we already passed 2 o'clock time. Go ahead.

Why did the FDA exclude our critical patients of the trial from EIND authorization process, defined by CytoDyn as mechanically ventilated with peak greater than 15 cm H2O, et cetera, and those critical patients on vasopressors for greater than 48 hours?

So there was a typo in the letter that was going back and forth between FDA and us, and we corrected that typo. So, you will see that that's not the case. So with that, I want to end the call today, and thank everyone for being on this call, and I want to end it by summarizing that 2021 would be a year, in my opinion, that everybody will talk about it. If we are able to get emergency use authorization, this would be great, great assistance to humanity. We're really hopeful, and we want to see what happens. Selling leronlimab without EUA is also possible in other countries. That's what we've been hearing. And Philippines team has told us that we have a strong chance of getting EUA without CD12, because of the latest presidential order that came out. With all of that, we also have our HIV, and we have not taken our eye off of the ball, and we are constantly going forward with Dr. Mahboob Rahman, Dr. Kelly, Dr. Chris Recknor. We also have Mr. Brian Brothen, who did an amazing work. He expedited our enrollment and now he's looking at helping us to look for pharmaceuticals, who -- in the countries like Indonesia where EUA is not needed, so we can potentially sell the product if we choose to do so. And with our cancer product, I'm so excited to go for breakthrough designation discussion with FDA. This could be huge for our company. This will all come to some kind of conclusion in this year. And that's why I think this year would be amazing and NASH through our interim analysis, long-hauler interim analysis, they're all going to come out this year. And if long-hauler is successful, we're going to do a trial in postviral syndrome, which is a tremendous population. So with all that, I want to thank everybody, again, and have a great day. Bye-bye.

Thank you. This concludes today's webcast. All parties may disconnect.