CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

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

Joining us on today's call is our President and CEO, Dr. Nader Pourhassan; our Chairman, Chief Medical Officer and Head of Business Development, Dr. Scott Kelly; our Senior Science Adviser, Dr. Jacob Lalezari; and a representative from Creatv MicroTech. 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 conference call 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 efficacy or safety 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 must 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 as compared to our current expectations. I will now turn the call over to Dr. Nader Pourhassan.

Thank you, Mike, and thank you, everyone, for being on the call today. Before I start this call, I want to thank so many of you, shareholders, for really supporting leronlimab and going out of your way trying to bring awareness about our product to politicians and other health professionals. CytoDyn just announced a few minutes ago that the company has been granted a meeting with MHRA to discuss Fast Track approval in a teleconference on September 9, which is just 7 days from today. We have been having a very positive dialogue with MHRA, and I will explain this right now in great detail. On August 14, CytoDyn asked MHRA U.K. regulatory agency to consider granting Fast Track approval for leronlimab based on CD10 results, and our top line report was sent to them along with emergency IND patients and other data. On August 24, just 10 days later, MHRA responded to us by indicating that, "We have reviewed your request and are sending your request to senior management team in licensing division for further input. We aim to have a response to you within 5 working days." That's what MHRA said. This was on August 24. On August 27, 3 days later, MHRA responded to our request. Amarex Director of Regulatory, Dr. Ahmad Bayat, indicated to CytoDyn, and I'm going to read you his e-mail after receiving a response from MHRA. He said, "Dear all, please see below e-mail from MHRA. This is great news that MHRA is offering a teleconference with us to discuss the regulatory pathway for Fast Track approval for leronlimab based on CD10 results." MHRA e-mail in regards to this meeting indicated, MHRA is granting a 1-hour teleconference to discuss their route to the market for leronlimab in U.K. Amarex indicated to CytoDyn that prior to this meeting, the MHRA needs a summary of our BLA and that this meeting is equivalent to a pre-BLA meeting in U.S. MHRA is requiring 5 business days to expeditely review the package, specifically manufacturing, clinical and nonclinical. Amarex has put all their workforce, which is led by Dr. Kush Dhody, on this project and have finalized this package earlier today. And CytoDyn team, Dr. Nitya Ray, Dr. Thomas Boyd, Dr. Scott Kelly, Dr. Jay Lalezari, myself and a few more advisers and consultants, will review the package and get back to Amarex by no later than tomorrow close of business as we have put a 24-hour limit in turning this document back to Amarex. Meanwhile, we have communicated to MHRA that the package will be delivered on 9/4, September 4, and therefore, asking for a teleconference on September 9. MHRA got back to us quickly, which was yesterday, and granted the meeting for September 9, as we requested it. In short, we believe we have a very good chance to get Fast Track approval from MHRA, and our September 9 meeting was told to us by Amarex that is equivalent to a pre-BLA meeting, and we believe we have a strong case for Fast Track approval. Having said that, please keep in mind that I am not saying we will get Fast Track approval. All I am saying is we are very hopeful, and we are very appreciative of MHRA making this a very top priority and granting us what we call a pre-BLA meeting on September 9. These are extremely expedited process, and it is mind-blowing how quick everyone is moving forward. Okay. So that takes us now to U.S. FDA and our status of Emergency Use Authorization. We sent an e-mail to the FDA and requested the status of CytoDyn's potential EUA request, which was filed with them on August 12. The FDA has indicated to us that a decision is forthcoming. So for everyone to think this that this is just a simple thing, please think again. We are asking the FDA to do something in 2 to 3 weeks that usually takes months or sometimes years. So please be patient with this process. They are doing everything they can, I believe, and same thing with other regulatory departments. That takes us to CD12 trial. First, let me explain CD4 -- I'm sorry, CD12 enrollment in U.K. So I am ready now -- I'm going to read to you the e-mails that the regulatory Director at Amarex, Dr. Ahmad Bayat sent me in regards to that. This is what he said. "We received great news today. The U.K. Ethical Committee approved CD12 studies to be conducted in the U.K. Now the study can officially be initiated there. Please also see our MHRA's comments below." They have recommended CytoDyn to resubmit the CytoDyn CD12 COVID study to the Urgent Public Health, UPH, scheme. If UPH scheme badges CD12 study as urgent health issue, CytoDyn would receive extra support from the sites and from the U.K. government. This is a very good news that we hear that U.K. is urging us to ask for government assistance, providing that we are -- we show that we have urgent public -- we have a product that can meet the urgent public health needs. In regards to CD12 in U.S., our interim analysis will be conducted early part of October, and the results will also be shared with MHRA for approval for that population of CD12 in U.K. as well as in U.S. So now let's talk about the BLA submission with HIV program. We do have some very encouraging news about our Type A meeting that I would like to update you now. As of 1:01 p.m. today, just a few minutes ago, we announced that the FDA is now granting us something more than what they granted before. Before, they wanted to just give us the written answers to our questions. And our press release in the past about this said, and I'm reading the title of the press release, "To avoid delay, the FDA recommends CytoDyn conduct its Type A meeting in writing with FDA response goal date of September 4." The FDA just got back with us yesterday with all their answers to our questions, 3 days earlier than September 4. We appreciate that very much. FDA also offered -- and I'm going to read this part from the letter that they send us. They said, "To ensure that your revised BLA includes the pertinent information needed for FDA reviewers to perform a substantive review of the dose you have selected, the agency is willing to perform a multidisciplinary review of your revised dose rationale and integrated assessment of supportive safety, efficacy, PK and PD data prior to the submission of your revised BLA. If you choose to take advantage of this offer, please provide us at least 30 days to review the submission and allow you sufficient time to revise the BLA in response to our recommendation, if needed." But that's a very beautiful thing we're getting. That means the problem that we had was with the dose escalation of 700-milligram and the safety needed to come from 700-milligram. There was a lot of problems with that because we had to match that study with the CD02. They're saying in order to make sure that we don't decide and doesn't have any problems, give that to us, and we're offering you to review it for you and say, "Hey, you're good enough. Go for it." And that means we are now feeling very strong that we are going to bring the people that we have brought, and this is like additional few people that are going to really help us with BLA. And Dr. Scott Kelly will talk about that to make sure that we get this BLA submission in great shape as soon as possible. Now the next thing is very exciting, and that is why are we filing BLA for HIV only in U.S. Well, we should file the BLA for 350-milligram to U.K., and that 350-milligram BLA was ready 2 years ago. Two years ago, we had a BLA package ready for 350-milligram. As we explained, 700-milligram made us go and do a lot more work. So when we had submitted that, we also have an exciting situation where we're going to ask U.K. to consider monotherapy as an approval also. Europe is very, very positive on monotherapy. If everybody recall, many years ago, they did a study called SMART study, strategically managing antiretroviral therapy. And European countries, some of them continue with that even though that study failed. So we believe we have a great chance at 2 approval for HIV in U.K., combination therapy for 350-milligram, monotherapy with 700-milligram. So that takes us now to cancer program. So I have asked a representative from Creatv MicroTechnology to be on this call. Creatv MicroTechnology, just a quick introduction, is the lab CytoDyn has used to analyze all of our ongoing cancer trials. We didn't use any other lab for that. There's another lab for screening, which was Dr. Hallgeir Rui in Wisconsin. Creatv MicroTechnology's CEO is Dr. Cha-Mei Tang, doctoral degree from MIT, who concentrated her work in early detection of cancer. Joining us today from Creatv MicroTechnology is Daniel Adams, who is currently the Director of Clinical Research and Development at Creatv MicroTechnology and manages their clinical laboratory in Monmouth Junction, New Jersey. He has worked in the clinical diagnostic field for over 16 years and is credited with the discovery of circulating cancer-associated macrophages-like cells, CAMLs, and their clinical application in cancer detection and treatment. He has extensive expertise in liquid biopsy. Example given is circulating tumor cell, CTC, and circulating tumor DNA. He currently supervises the sample processing and analysis of cancer patient specimens in 12 actively clinical trials for research and FDA approvals of new therapies and combination therapies. I want to thank Dan for joining us today. Dan, could you please explain the cancer market that CytoDyn is looking at currently for all of our cancer patients at your lab? Namely, could you explain CAML and CTC market? Dan, go ahead, please.

Of course. Hello, and thank you, Nader, for that introduction. So yes, my name is Daniel Adams, and I am the Director of Clinical Research and Development at Creatv MicroTech. As Nader said, my company studies and specializes all aspects of blood-based biopsy. And for the past 10 years, we have focused specifically on the communication access of tumor cells and their pro-tumorigenic immune cells and their ability to migrate through the bloodstream during invasion. Specifically, we study how these cells and immune macrophages work in coordination to allow tumor invasion, tumor spread. For -- so I'm hoping to discuss a little bit about the background because it is a novel field and also the context of the CCR5 work. Many years ago, we actually discovered during our large-scale proteomic metadata analysis encompassing a few hundred different cancer patient subtypes that CCR5 was actually one of the most commonly expressed protein biomarker receptors in both circulating tumor cells and the pro-tumorigenic macrophages invading through the bloodstream to metastatic sites. Now CCR5 has always been well known as a migratory cell receptor that has for well over 20 years of published work described it as the receptor responsible for cell motility from one part of the tissue into invading space. It has numerous ligand activators: MIP-1, RANTES also known as CCL5 and MCP-2 and eotaxin as well as many others. But in general, the activation of CCR5 is usually in the context of brands, which allows pro-tumorigenic cells, both macrophages and tumor cells, as I said early, to migrate and invade. And that's really where our interest is kind of live. Interestingly, that what we discovered, and again, this is very many years coming, is that CCR5 expression has historically been very difficult to quantify specifically as cells tend to down-regulate when they're in their stagnant state within primary tumors per se and when they're growing. But when they're invading, they upregulate CCR5 as their motility marker. And this is where our work really found a clear parallel with CytoDyn's when we started working with them. Now while CCR5 can -- often being low in primary and in metastatic biopsies in the circulation, we've actually seen extremely high expression of CCR5 in both circulating tumor cells and in circulating pro-tumorigenic macrophages. To that end, we partnered with CytoDyn to evaluate these invasive migratory tumor cells during and after treatment with leronlimab. Now based on our previous preclinical models before we started working with patients specifically with leronlimab, we expect that most of the migratory cells and pro-tumorigenic macrophages should see a precipitous drop in both number and expression of CCR5 when leronlimab should be added. Now our models to date have largely been -- and again, we're talking about hundreds, if not thousands, of cancer patients across a broad range of cancer subtypes. Now most of our studies have been without the context of leronlimab, but one thing we have constantly seen is our models have found that patients with diminished CCR5 expression is always associated with fewer migratory tumor cells and better clinical outcomes and that our models clearly have shown that we -- a prediction that treatment with leronlimab will further diminish any existing migratory tumor cells and result in less patient progression. Now if anyone was curious about this work with CCR5, we actually have presented this for many years, ongoing in posters and in conference form and expect to have a publication on the topic of CCR5 in the migratory tumor cells in different patient populations coming out probably within the next few months and definitely within the year. And we're always open to questions, and hopefully, that covers the context of where we come in. Nader?

Thank you, Dan. I appreciate that explanation. So I want to make sure everybody is very clear that lab data, whatever marker that we use for HIV, cancer, for anything, will not give the company approval, and FDA will not consider it as approval. What we need is clinical outcome. The reason we get this lab markers, viral load for HIV or CAML and CTC for cancer or anything is just that we can understand what's happening. And animal data also won't give you approval. So I want to make sure everybody understands that it's very important to do clinical trial and have clinical outcome. But the bar for clinical outcomes are very low in cancer because there aren't that many effective drugs that are coming to the market. So with that, I'm going to ask Dr. Scott Kelly to explain that. Scott, please?

Sure. Thank you, Nader, and thank you, Dan, for your insight. So we believe the opportunities for cancer immunotherapies will grow exponentially, but there are limitations. Some immunotherapies have great potential against some cancers. Still, it doesn't work on all tumor types, and many patients who initially respond to currently approved immunotherapies later relapse or develop resistance. You will see different statistics such as only about 1/5 of cancer patients respond to immunotherapies like KEYTRUDA or 90% of patients will not respond to immunotherapies. This is the challenge we all face when trying to fight cancer. That said, we believe the bar is very low for leronlimab to make a difference in a $100 billion immunotherapy market. In 2011, the first checkpoint inhibitor received approval. So we are very early in the exploration of immunotherapies in the treatment of cancer. It is not an easy task, and it will require us to persist despite many obstacles. I will be exploring with our Scientific Board of Advisers the role of the CCR5 receptor in the control of the tumor microenvironment. We refer to this as the second wave of immunotherapy. The questions we need to answer include: how can we further enhance and leverage the natural ability of the immune system to fight cancer; how can we limit metastasis; how can we turn off Tregs to allow the current standard of care treatments to work more effectively; how can we effectively use leronlimab to help turn macrophages that promote tumor growth into those that fight cancer; how do we further enhance the natural ability of the T cells to kill tumors while limiting the migration and invasiveness of cancer itself; what are the best complementary treatments due to our strong safety profile of leronlimab and known drug-drug interactions? These are difficult questions but the questions we will be exploring further to define the role of leronlimab in the tumor microenvironment. As we move forward, we will continue to look for biomarkers to show the effectiveness of leronlimab. We will continue to look at cutting-edge diagnostics like cancer-associated macrophage-like cells, or CAMLs, and circulating tumor cells, or CTCs. This will all happen with our collaboration with Creatv MicroTech. We believe that CAMLs and CTCs have the potential to provide a minimally invasive alternative to tissue biopsy to determine cancer therapy and monitor treatment response and recurrence. Cancer is a challenge to treat. We don't want to provide false hope. But independent research outside of CytoDyn confirms the potential importance of the CCR5 receptor in various aspects of cancer progression, and we owe it to cancer patients to explore the potential benefits. The results of our animal studies have been outstanding, but we all know that animal studies do not always translate into successful trials in humans. We are very fortunate to be at the stage where we can explore the effects of leronlimab in human subjects and hopefully help a lot of cancer patients. Our goals in our oncology program are to be honest and transparent. We don't want to create confusion between doctors and patients. We want to manage expectations and limit misunderstandings. Cancer patients are often in a very vulnerable state and facing the challenge of a lifetime. We owe it to cancer patients to try and help them with a molecule that has been safe in over 1,000 HIV patients, COVID-19 patients and cancer patients and a world full of treatments that are known for their toxicity. Nader?

Thank you, Scott. And now let's talk about the business development. We are working with a lot of different companies, and we are in discussions with them. I want everybody to realize, when we did the viral licensing, it took us several months. Then we did American Regent licensing, and that took several weeks. These things don't happen right away. And in order for us to get tremendous credibility, it is important to get approval in one of these indications, either COVID-19 or HIV. But with that, let me ask Dr. Scott Kelly to give us update on this business development relationship. Scott?

Yes. Sure, Nader. So in regards to business development, we are moving forward and are now in contact with many international pharmaceutical companies at various stages of engagement. We are also in contact and in active discussions with pharmaceutical companies in Asia, Brazil, India, China, Europe, the Middle East and North Africa.

Thank you, Scott. So before I talk about -- again, back to COVID-19 for long-haulers, which is a potential state that we might want to talk about. But before that, I want to say that the person who knows more about HIV in clinical trial than anybody is Dr. Jacob Lalezari. He injected many patients in monotherapy. He is aware of those 5 patients that have gone 6 years. That was his patients. There are 200 and some patients going 1 year with monotherapy. A lot of them were his patients. There is about 40-some patients in extension of that CD03, which some of them have gone 4 years. Those are mostly his patients. And he has seen the COVID-19 CD10, how it came about. So I'm going to ask Dr. Lalezari to give us his assessment of leronlimab potential in HIV and COVID-19. Dr. Lalezari, please?

Thank you, Nader. I wasn't expecting that question. So for HIV, yes, we have patients who've been on leronlimab now for years, as you said, some out to 6 years. I think the challenge there is to identify upfront which patients are going to be able to remain suppressed, although we observed that the majority of patients who breakthrough, breakthrough in the first 12 weeks. So that's one advantage. I'm excited about leronlimab in combination. I think that if there were a second drug that we could administer to our HIV patients that were also once a week that the leronlimab weekly therapy would be a very big deal. In terms of CD10, I would say that -- what I said on the last call was we're in a world that's upside down and backwards. I don't understand quite what the FDA did with convalescent plasma. I'm encouraged that the United Kingdom is taking such interest in leronlimab. I think you look at CD10, and it is impossible to conclude anything other than the drug works. In terms of the primary endpoint, having 90% versus 70% of patients improved their total clinical score at day 3. In a study where about half the patients were at home with no symptoms at all is a remarkable result. And when you add in the statistically significant impact on NEWS2 outcomes and the reduction of SAEs unheard of by over 50%, I think it's impossible to conclude that anything other than the drug is working and that there are folks who are promoting the idea that it's not working, but they're working off a different agenda. I know it's disheartening to see other drugs being given EUA status that have a marginal, if any, benefit and have clear toxicity. And here we have leronlimab which is, I think, showing clear benefit and remains to be proven whether it's a little benefit or a huge amount of benefit, and I think we'll know more at the end of CD12 or at the interim analysis of CD12, and also a drug in leronlimab that, as Scott said, been given to 1,000 patients without significant safety signal. So it's -- I'm mystified as to why we don't even have an EUA right now for this drug in the U.S., but I'm very encouraged to see the actions being taken abroad. And back to you, Nader.

Thank you, Jay. That was a great explanation. So in regards to long-haulers, CytoDyn took on a Phase II COVID-19 trial in such an expedited fashion that I don't think you can find it in any other company has ever been done. We started it. We submitted IND. We finished and completed it, got the top line report. Now our second trial has reached interim analysis. But then what are we talking about? What kind of -- how many population is this? Well, it's mild to moderate, that's one, and then moderate -- I mean, severe and critical, another one. So that's only 2. So we cover the whole theme. But now we are hearing that there are patients that are having -- they call them long-haulers. They're having symptoms after they finish the trial. I've heard that Chris Cuomo from CNN apparently has those kind of problems. Now with that said, we do have a Phase III ready to go for this. But if we get approval, our Phase III changes. That would be label expansion. That might not even need a study. So with that, let me add Dr. Scott Kelly to elaborate on this long-hauler, please.

Yes. Sure, Nader. So I want to personally thank many of you who have reached out to us to express your interest in trying leronlimab for yourself or for your loved ones. Long-haulers are people that were infected with COVID-19 and never fully recovered. They have lingering symptoms similar to the acute phase such as coughing, tightness in the chest, shortness of breath. Fatigue is prevalent. They also describe a condition known as brain fog, which can affect their ability to think clearly and impair their cognition. There have been some recent concerns regarding the COVID-19 virus crossing the blood-brain barrier. If we receive Emergency Use Authorization, we believe we may have the ability to help these patients in an expedited manner. If we need to do a Phase III, and we are prepared to submit another protocol under our current IND for COVID long-haulers, the bottom line is we hear you, and we will do whatever we can to help you. The now 26 million patients that have been affected as of today with COVID-19 worldwide are the long-haulers of tomorrow. Nader?

Thank you. So the next thing before we get to NASDAQ uplisting is status of the publication of our manuscript. Many of you are thinking that we -- when we talk about manuscript submission, perhaps we're not fast enough. But the reality is there are a lot of problems with manuscript, and sometimes they do not get accepted. And if they don't, we can't do anything about it. But in regards to our completed trial CD10, manuscript is ready for review for internal team by Thursday, and our review will be done within a couple of days. Dr. Seethamraju from Montefiore is going to be the lead author -- lead person on that manuscript, and other principal investigators will be under -- Amarex folks and CytoDyn folks will be on it. Dr. Nicholas Agresti have submitted manuscript for 5 emergency IND critical patients who survived by using leronlimab. Dr. Otto Yang had about 30 patients. He has submitted manuscript for those emergency IND patients, about 30 of them. We also have prepared abstract for our CD10 results, which will be submitted for acceptance. There are animal study done in prevention -- HIV prevention. That publication will be ready, hopefully, in the next several weeks. CD01 extension manuscript for those 5 patients who have gone 6 years should be ready in the next couple of weeks. And CD02 for HIV and CD03 are also going to be worked on. This is quite a bit of manuscript and publication that we believe we're going to get a lot of attention from scientific community. So with that, we're going to ask Mike Mulholland to tell us about NASDAQ uplisting. Mike, please.

Yes. Good afternoon. Brief update on where we are with our NASDAQ uplisting. Directly, we are still in an evaluation mode with the exchange. As I said a few weeks ago, we expected a comment letter based upon our initial submission in week 3, where we received a comment letter at the end of week 4, just as we were wrapping up our -- the completion of our filing of our 10-K. And so we are now preparing our responses to a number of expected questions that the exchange has asked. And the exchange is assessing a number of variables as the landscape of the company has changed. So Nader, in conclusion, really, more variables simply adds a little bit more time. Any other questions or issues that may arise, we firmly believe we have a solution.

Beautiful. Mike, appreciate all the hard work you're doing on this. Before we go to Q&A, I'd like for Dr. Scott Kelly to take just a couple of minutes and talk about the additional expertise that we're bringing on our Scientific Board of Advisers. Scott, please.

Right. So as we announced yesterday, we are very proud of the initial members of our Scientific Advisory Board. These are true leaders in the chosen fields of HIV, NASH, rheumatology, autoimmune diseases and oncology. We have had further commitments now in the fields of urology and pulmonary and critical care. We are currently defining a few key areas to add value to our Scientific Advisory Board, including neurology to explore diseases within the central nervous system and further subdisciplines of oncology. We feel we have a firm foundation with our initial members. We will continue to add new members of national and international recognition.

Thank you, Scott. So now we're going to go to Q&A. Please note that before we go to Q&A that if there is any question that's not appropriate or not related to leronlimab, we will immediately go to next question and no disrespect is meant from our side. Operator, please open the call for Q&A.

[Operator Instructions] Our first question comes from the line of [ Donald Kerr ], a private investor.

Yes. I have 2 questions. One, with the increased number of trials and activity, do you foresee any new financing required? And approximately when that might be? Or do we have enough financing to cover 6, 8 months' worth of activity? Second question on the Phase II trial. The performance with the drug versus the placebo was 250% on the NEWS2 on day 3. What was the performance on day 7, 9 and 10? Was there a decrease in performance? Or did it maintain that 250%?

Thank you, [ Don ], for your question. So in regards to increasing the trials, we are monitoring this very carefully because we believe that our stock should be in double digit or higher. That's what we believe. And because of that, we want to wait and see where the chips fall and then raise funding. We did that when the stock was at $0.30. We always keep saying to everybody, we have a better day ahead of us. People got tired of hearing that, but it happened and it happened very quickly. So we will raise funding. But Mike, could you...

Yes, let me just add to that, Nader. And thanks for that question. First, let me just add that we're unable to comment on future financing plans based upon SEC rules. However, let me add that just within the last 3 months, the company has raised over $24 million from warrant exercises. So as the regulatory path continues to move forward and we get some positive response in the stock price, we could have a substantial continuation and increase in warrant exercises. So that's a key variable as to whether or not we would have to raise any additional money externally. Nader?

Thank you, Mike. So the second question is a good question. Was Phase II performance 250% for -- better for NEWS2? It was 150% by the way. It's 2.5-fold better. Dr. Jay Lalezari corrected me last and saying, do your math. It's 1.5x -- about 2.5x is 150%. So with that said, we were -- we reported on our top line report only data that was gathered was day 0, day 3, day 7 and day 14. So 8, 7 -- 8, 9, 10 and those, we don't have any data of any sort. 0, 3, 7 and 14. When you look at the population for analysis, you either look at all the patients without excluding anyone or you're allowed to exclude some per protocol. This is something you give to FDA before the trial saying, if a patient falls into those categories, we want to exclude them and do the analysis per protocol. Per protocol or intended to treat, which is all the patients, we hit the endpoint for both of them with a p-value less than 0.04, whatever it was, 0.02, whatever, 0.03, about. Now day 3, we also hit the primary -- I mean, that endpoint for intent to treat, I believe. But I don't know exactly what was it per protocol. So we can perhaps send you an e-mail, if you send us an e-mail, and we'll give you the result. But the most important was day 3, we headed very strongly, and day 14.

Nader, if I could just jump in. I just wanted to point out that before you and I saw the results, I had challenged CytoDyn that in order for these results to be credible, I believe we needed to see an impact at day 3. I wasn't going to necessarily stand by day 14 endpoint without seeing a replication of the early activity we saw in the emergency IND patients. And so the fact that we did see the decrease at day 3 in the total clinical score as well as the NEWS2 in the per protocol population, I think, was very important. And I just want to note to your investors that I challenged the company to make -- to meet that endpoint before we ever saw the result.

Yes. No, thank you for that, Jay. And I want to just add one quick thing. There was some question that was sent to us about somebody was analyzing NEWS2 and they're coming up with a very weird negative assessment. So if you add 2 numbers together, like A plus B equal to C, it doesn't matter if A is very high or B is very high. C is a combination of those 2. So they were saying that if there is 7 parameters that come up and assess NEWS2 and if one of them can be taken care of by aspirin and the other one can be taken care of perhaps in massaging the patients, so what the heck are we talking about? And that's so funny because the published data that has been peer reviewed are so strong, and there are so many professional people in this field that are so high on this NEWS2 that when somebody comes and says this, I see a lot of investors just panic and say, "Oh, my God, maybe they're right." No, they're not right. There is 7 parameters that integrated and gave a number that Royal College of Physicians in England declared that this is a very crucial number that predicts the -- if that patient is going to become critical -- in a critical situation or not. Now we reduced that. That means, in my opinion, leronlimab actually working in a lot of other things. As we know, leronlimab corrects the immune system. Perhaps we did so many good over there that is not measurable with other parameters.

Our next question comes from Peter Levine with Ameriprise Financial.

Great news update. I was hoping you could tell me something a little more precise on the time line of the uplisting, the estimated time? And on the last conference call, you had 12 patients in the cancer trial that had very good CTC results. So I was wondering if there's any update as far as the increased number of patients now? And any other data that came out of that, that you can tell us?

Yes. Thank you for your question. So cancer trial, we don't have clear signal that we want to see yet. We need more data. And the patient who has done wonderful, in our opinion, is my own family member. I'm the CEO of this company. So whatever I say. Everybody's going to take it with the skepticism, and they should. So she is on 700-milligram. And Dr. Jay Lalezari has requested that we need to have 700-milligram. We have asked FDA last week. And as soon as we get that, we will see how the basket trial patients react to that. But there is a lot of information that needs to be gathered before we can come up with a powerful statement, and we're not there yet.

Our next question comes from [ Nick Kova ] from [ Tintoku Capital ] -- sorry, please go ahead.

So Mike, go ahead, please.

Yes. The first question by the last caller was, can you give us some sort of insight as to what the uplist time line looks like going forward? Well, we embarked on this process, we knew it was going to be about a 6- to 8-week process. The financial landscape of the company, stock price, et cetera, has moved around in sort of a rather variable fashion, which creates some more evaluation by the exchange. They sent us their comment letter a week later than we had expected, and that arrived the day before we filed our 10-K. We received the comment letter, which was some operational as expected questions unrelated to the 10-K. So we're going to be responding within the next couple of days very comfortably. And I can't say whether or not there'll be another follow-on round of inquiry. But it's a process. Nader and our clinical and regulatory team have been dealing with the FDA. I wouldn't characterize the NASDAQ as the FDA, but it is a process. It's an ebb and flow, and we think we're all on our game to continue to move forward.

Yes. Next question. Go ahead, [ Nick ], please.

Our next question comes from [ Nick Kova ] with [ Tintoku Capital ].

I'm just trying to get some more color on a couple of things. That's 3 questions, I guess. One is related to NEWS2 and in the leronlimab arm, which has the 2.5x greater incidence of a "beneficial" improvement versus the placebo. And I was wondering if you could add some color as to what that beneficial improvement was? Is it something like a point on the NEWS2 scale? Or was there an average improvement on the NEWS2 scale? Anything you could add in terms of color on that beneficial improvement?

Yes. So let's go one at a time. Let's answer that. So NEWS2 consists of 7 parameters: systolic blood pressure, oxygen need and so forth, body temperature. So these are measurable parameters, not something you ask the patient how are you feeling, do you have aches, which was our primary endpoint. Those are subjective. In that regard, the patients' numbers came 2.5x lower. So imagine if the body temperature was from 0 to 3. They get 3 or whatever the scale is. They take those numbers and articulate it in a formula. It's not just adding these numbers like we did with the primary symptom -- primary endpoint symptom score. This is articulated by top professionals in the world that came up with this, and they were able to put this in a way that they were weighting different mechanism of action of each one of these parameters in a very articulated way. And they call it NEWS2 because NEWS that they came, they upgraded that. And in that regard, the numbers were much different, which was, as our Amarex folks called me, they said, "You just had a jackpot. This is incredible." That's what they saw. So the numbers are objective analysis of these parameters. It's a most crucial parameter for, I mean, for COVID-19 patients. I mean I think this should be the primary input for every study as a matter of fact. But that's all we can say for now. Go ahead, [ Nick ], for your second question.

Okay. And then the second question was the leronlimab showed 64% fewer SAEs versus placebo. And I was curious if you had a p-value on that delta.

No. We -- they don't do p-value on SAEs. But just knowing that you just got your -- there was like double -- more than twice more SAE events or AE events in the placebo arm, that tells me, Nader, myself, just me thinking and the other doctors who I talk to, that the leronlimab is correcting the immune system as we always thought it will. And therefore, we don't see that. Scott, do you want to elaborate on that?

Yes. I mean I think that when you think about COVID-19 as a multisystem inflammatory disorder, we think that the reason that you're having less serious adverse events and adverse events is due to the effects of leronlimab in this population and the fact that COVID is actually causing this problem and that leronlimab, we believe, is helping to correct the problem.

Okay. Jay, please do.

Yes. One thing I don't believe we've emphasized enough is how healthy this population was of CD10 that, yes, we saw that 90% versus 70% at day 3, but that was only in the half of the patients that had symptoms that half of these 85 patients basically had a symptom score of less than 4. None of them are on oxygen, and they were mostly at home or a good part of them were home. So the fact that we have moved the needle on total clinical symptom score or NEWS2 or SAEs in a population that started the study as well as they are is, I think, the thing that's so stunning about this. And the thing that bodes well, I guess, we set the study to look at clinical symptom score because we thought that would be an appropriate primary endpoint. But if we had known that we were going to move NEWS2 or SAEs, that obviously is a far more relevant and important, meaningful endpoint than just improving your muscle aches. The fact that they did all of them in a patient population that started as healthy as they were is, I think, incredible.

Thank you so much, Jay. That's excellent explanation. Let me just add one quick thing to that before we go to your third question. CytoDyn takes a gold standard trial, double-blinded placebo. But we didn't just take that gold standard trial. We've gone ahead and did something for the benefit of the patients and made it 2:1. It's so much tougher to hit a primary endpoint. When big pharma like Gilead does a trial at 1,400 patients, if you see a small benefit anywhere, you're going to have a much better chance of hitting your primary endpoint in a small amount of improvement. Now those big pharmas, they go and analyze every patient, which one would give a better chance of having a better outcome for themselves. We didn't have any of that. Little CytoDyn takes anybody who can come in. There are -- a lot of people were 0 and -- had 0 symptom score at the beginning, and we're just throwing everybody in there because we believe in leronlimab. And boy, we hit a jackpot with NEWS and have our safety talk for itself. So we're very proud of these results, and we will be talking about it, hopefully, more very soon. But go ahead, [ Nick ], with your third question, please.

Okay. Yes. My last question is just, does the company currently meet the shareholder equity or tangible asset requirement for uplisting?

Mike?

Yes. [ Nick ], I can't comment on currentness as down to date. As we reported on August 14, we reported negative equity of $2.5 million. We all know that the NASDAQ standard is either a positive $4 million or $5 million, depending on the path. If you carefully read Note 18 subsequent events, you will also be able to discern that from June 1 through late July, we added -- we enumerated transactions that would increase equity of approximately $33.8 million in a positive fashion. On the other hand, for you accountants out there, you would know that, that $33.8 million would be offset by operating losses. So the negative or positive equity issue can be cured, in my view, at any time with a small offering of some sort. Or if the stock kicks up, warrants are going to be exercised. So it's a fluid issue, and positive equity is the test at the time of uplisting. May 31 was not at uplist.

And to add to that, if NASDAQ comes back and says you need to raise another $5 million to $10 million to have the required positive equity shareholder value, we will do that within 24 hours, maximum 48 hours. That's what I believe we will do. So with that, thank you, [ Nick ], for all your questions.

The next question comes from the line of [ Ali Cusi ] with LPL Financial.

My question basically goes into the -- in regards to the uplist, and I think Mike has answered most of it. But I think as we sat back and this process has gone on, Mike, can you give us any more insight on this? I mean I think most of us are really looking forward for this uplist to happen. But again, I don't think we're getting a clear definite version from you guys.

Yes. Before Mike talks about it, let me just say this. When you go to regulatory agencies and you ask them, what do I need to do, they give you -- they hand you an application. When you file that application, they're going to have questions for you. And if the question is like go to your auditor and have them do this and that and have 18 different questions, then we're moving as fast as we can. And we didn't tell anybody we're going to have it done next week or 2 weeks later. We said what we're going to do, and we're updating everybody. And we're going to do that with everything that we have been doing always. But with that, Mike, do you have anything to add?

Really, again, it's simply a process. On the Internet, it's readily available, the NASDAQ initial uplisting guide dated June 2020. And for those of you that are becoming students of the uplisting process, you can see that there are 3 paths where we are running concurrently on 2 paths. And of the quantitative financial metrics, you can read those quite carefully. You understand our financial statements, and it's fluid.

Thank you, Mike. Thank you for your question.

Our next question comes from [ Mark Lancey ] with [ Centaurus Financial ].

Thanks for all your hard work. Just a quick question about the current test that started about a week ago. I noted that Pfizer, J&J, Moderna and Novavax all have studies in Phase III with approximately 20,000, 30,000 people enrolled. And just wondering how the current test, which I think is 195 enrollees, is going to stack up to that, if there has to be another 20,000 behind that. Or could that be sufficient to go for some kind of approval?

So that's a great question. The reason FDA gave us one trial for CD12 and indicated to us that this is a registrational trial that could be approved if the results are positive is because the safety of leronlimab is unheard of. Other trials, they need 20,000, 30,000. Gilead needed 1,400, and they increased that number when they did interim analysis because the safety is not established. We have safety of leronlimab that is great and -- in the 1,000 patients that we have given leronlimab. And those data are with FDA, so they felt comfortable with this size. Thanks for your question.

Our next question comes from the line of [ Michael Camareno ], a private investor.

Burning the midnight oil, as a private investor, I speak on behalf of most to say that we appreciate all the work you're doing to help those with cancer, HIV and COVID. And I have 2 questions. Number one, can you get into -- and this is perhaps for Michael Mulholland, can you get into the issues concerning uplisting a little bit more? Is it just the stock price? Is it equity position because of the form that was filed on August 14? And two, once you hear back from the U.K., what is your expected turnaround time? Given that we're already into September, are we thinking October? Are we thinking late September? Any information would be helpful.

Mike?

Yes. Just briefly on the variables related to the NASDAQ uplist, as you've seen in the 10-K, again, equity is a variable which can be solved. The stock price is a variable that could be up or down. Equity can be solved by warrants being exercised. If the stock price goes up, if the stock price remains where it is, there are other avenues to address. There are also the going concern issue with respect to our audit opinion. Some people were shocked by the going concern exception. But those who read financial statements would know it's a nonevent. For 17th consecutive year, we've been -- we've received such a qualification to our audit opinion. Notwithstanding that, our outside audit firm is well versed in this, and we initiated discussions with them about how to resolve that several weeks ago. So as I said initially, there are many variables on the landscape, and we believe we have a solution for all of them. Now is that a guarantee of an uplist? No. But again, we are on our game with respect to the variables.

Thank you for your questions. So this concludes the question-and-answer session because we already passed 2:00. But let me just give a small summary of where we are. We have COVID-19 CD10 completed trial with great results. Don't let anybody tell you anything about that. Anything besides that is not fact. It's fiction. We don't make fictions here. We tell facts here. These facts indicate we did a superb job in this trial. Now do we need a Phase III to get approval in U.S.? Do we need a Phase III to get approval in U.K.? We hope not. We're very upbeat about U.K., and we're going forward full blast. Our CD12 already completed enough patients for interim analysis. We hope to report that first half of October, and that will be also turned into U.K. In regard to our HIV, all the naysayers who talk about refuse to file, they're going to have to now think again because we went to FDA. The FDA answered all of our questions in a beautiful way. They give us more things to help us as they have always done that because their intention, in our opinion, is to get us approved and get us through all these regulatory that sometimes is very difficult. We have great explanation from them, and now we're going to have a call with them on September 8. That's a beautiful situation for us. And with U.K., we're going to submit our application for approval for 350-milligram combination, 700-milligram monotherapy. Great results again we hope to have from those discussions. We are also very excited that very soon we will be injecting the first patient for HIV cure. You heard me right, HIV cure in the subpopulation that has HIV and need bone marrow transplant. Those results could be very stunning if it appears to be as what we think it's going to be based upon some animal study that we have seen. And with all other activities that we're doing, we are feeling very comfortable with the expansion of our team that Dr. Scott Kelly is doing a fantastic job attracting all the top professionals in the world for our Scientific Advisory Board. And I'm hoping to report some major, major world-stage results to everybody very soon. So with that, have a very beautiful day, and thank you for being on the call. Bye-bye.

Ladies and gentlemen, this does conclude today's teleconference and webcast. Once again, we thank you for your participation, and you may disconnect at this time.