CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, ladies and gentlemen, and welcome to the CytoDyn Investment Community Webcast. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Antonio Migliarese, Chief Financial Officer. Thank you. You may begin.

Hello, everyone, and thank you for joining us today. This is Antonio Migliarese, CFO of CytoDyn. 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; and our Chief Operating Officer and Head of Clinical Development, Dr. Chris Recknor. 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, amongst 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. Please note that we will not be addressing any questions on matters related to the Annual Meeting or [ 13D Group ] on today's call. I will now turn the webcast over to Dr. Nader Pourhassan.

Thank you, Antonio, and thank you, everyone, for being on this call today. In today's call, we're going to talk about very important results regarding cancer long hauler, COVID long haulers. We will update you on Brazil trials. We will talk about Philippines and India, what we are doing with them. The BLA submission for HIV, a very important task. We will talk about that. And NASH trial. But finally, we will talk about forming a diagnostic laboratory under Dr. Chris Recknor because of very important findings that we are coming up with in regards to the mechanism of action of leronlimab. Now the first [ test is our case ]. I want to -- Before I turn it over to Dr. Scott today, I want to make sure everyone understands. We put out some results just recently. They were from 30 patients who were majority on compassionate use and some the Phase Ib-II trial. You don't mix these 2 populations. What we have done is we just looked at them and compare them to the historical data. What is historical data? It's the data that means how does this patient with mTNBC usually do? And what was the survival rate. Based upon those preliminary finding, which is now being finalized, we put out some results that we have been analyzing. We will be updating everybody with final results. And meanwhile, we will be talking to FDA in regard to these results and how we're going to go forward. This was not an interim analysis. This was closing the trial for mTNBC and then going to talk to FDA and see what we have to do to hopefully to do a Phase III or whether we can get a breakthrough designation or not. We are feeling that we need to have a cancer CRO that would focus on cancer for us, and we are closing that trial. The same thing we're going to do for Basket trial results, which we are also excited about. And we will follow with that in the same path. But because we have not talked to FDA yet, we will not take any questions about the results. The results are in this press release. You welcome to read it. It's comprehensive and everything is there. And it's 8-K -- the slide will be 8-K, and it will be available on our website. But with that said, I would like now to go to Dr. Scott Kelly, who is in charge of our cancer program and has done a fantastic job with this program. Dr. Kelly, would you please?

Yes. Thank you, Nader. So I would like to begin by reading you a few testimonies regarding patients that I've received within the past week being treated with leronlimab for cancers other than metastatic triple-negative breast cancer. The first testimony is from a patient with Stage IV prostate cancer. The miracle cancer drug has arrived. Last March 15, I was diagnosed with terminal advanced metastatic Stage IV prostate cancer. Of course, no treatment was available for me due to all hospitals being closed due to coronavirus until the first week of May. But the only treatment with my condition was hormonal. I was beyond chemotherapy or radiation treatment. I was given 6 months to 1 year by 3 different hospitals and oncologists in each. I was very fortunate that one of my customers shared with me about a study with leronlimab in San Francisco with Dr. J. Lalezari. After testing and an evaluation, they concluded that this study may benefit me. So September 1 was my first injection with 2 given per week. I was and still am faithful taking them every Monday around the same time taking my blood test every 3 -- still I'm faithful taking them every 3 weeks and complete CAT scans with nuclear medicine every 3 months. So I've had a catheter inserted suprapubic in the stomach for over a year, so I can urinate. As you may imagine, that comes with plenty of bladder infections and once early September massive sepsis due from a bladder infection. The first time I thought I was dying was the 6-month mark. My palliative care doctors said, "I need to prepare for hospice." My CAT scan in October showed many areas of concern with many spots noted on my pancreas, liver, kidneys, bladder and lung. But consistently taking leronlimab and my faith in God, I can truly say I am a miracle. This is the end of July. I have beat the deadline of depth in my last 2 CAT scans, 1 in February and 1 in May, I have no new growth and no new movements. The cancer cells in my pelvis only show a hole and no active cancer. All those spots in organs, no movement or growth. Unfortunately, the study is ending at the end of the month, but thankfully, I live in a right to Tri-state, and I will be continuing treatment. I am able to inject myself. Oh, I forgot the best thing, no side effects. Everyone that sees me now also comment about my health and how great I look. The second testimony is from a physician who is treating a patient with Stage 4 bladder cancer. I hope my note finds you well. Please forgive me for the tardiness of this update for my patient. As you know, my patient has Stage 4 bladder cancer in the posterior wall of the bladder. Due to other health issues, he was not able to take the chemotherapy, and we found leronlimab through Ohio's right-to-try legislation. He has had a series of 37 injections of leronlimab. And thank the good lord he has no metastatic lesions from the bladder wall. His urologist stated that he would not live past December of 2020. He is doing well, is active and still works 60-plus hours a week. It is also important to note that he has not received any other treatment with the exception of natural vitamins and over-the-counter medications, diet and exercise. He will be having a surgical procedure to evaluate the ureteral stents in the near future, which will supply us with the visual of the bladder wall. I will keep you informed as to the results. I again remain truly grateful and blessed for the kindness that you and CytoDyn have granted in my patients. To me, it is still unbelievable that in spite of your incredible work schedules, you would drop everything to help my patient overcome this cancer. May God continue to bless you for your kindness and expertise. I remain truly grateful. Now although these testimonies are anecdotal, I wanted to discuss the reasons we are excited about our opportunities in oncology, and I'll begin with the mechanism of action. So leronlimab has multiple potential mechanisms of action, including suppression of T regulatory cells. And remember, Tregs turn off the immune system and research has shown the Treg migration to the tumor microenvironment is mediated by CCR5, and these cells are promoting tumor growth via inhibition of anti-tumor cells, such as cytotoxic CD8+ T cells and blocking of macrophages, including TAMs, and TAMs are simply tumor-associated macrophages. It is also widely accepted that macrophages have plasticity and is believed that repolarization of M2 to M1 macrophages or anti-tumor macrophages can occur through CCR5 antagonism. In addition, CCR5 antagonist can prevent tumor cells with CCR5 expression from metastasizing and prevention of neoangiogenesis. In other words, without a blood supply, tumors can't grow. Cancer cells also secrete CCL5 which can act on CCR5 positive tumor cells to sustain their proliferation to recruit immunosuppressive cells such as Treg cells and monocytes to induce osteoclast activation and bone metastasis and to induce neoangiogenesis and to guide tumor cells to disseminate the distant organs. CCL5 is a ligand to CCR5 and leronlimab can block the CCR5 activation by CCL5. We are making great progress in terms of our mechanism of action of leronlimab in various conditions with the ability to see how leronlimab affects subsets of immune cells and ability to restore immune function under the care of Dr. Recknor. This is applicable to our mechanism of action in the tumor microenvironment. So regarding triple-negative breast cancer, we are very excited about our recently released results in metastatic triple-negative breast cancer. Triple negative breast cancer has been proven to be a very difficult cancer to treat because it tends to be more aggressive with a higher proliferative rate and a higher propensity to metastasize. Once these patients metastasize, they tend to have a much shorter survival. Unlike HER2-positive cancers where you could use HER2-targeted therapies is a challenge to find true target therapies in metastatic triple-negative breast cancer. And the effect of chemotherapy is often transient. When cells are rapidly dividing, they tend to be more vulnerable to chemotherapy. The problem is resistance and it develops rapidly and then the tumor starts to grow again and again, and response starts to grow very rapidly. And let's not forget the quality of life issues with most oncology drugs, including chemotherapy. As patients have told me, "I would rather die of cancer and go through chemotherapy again." The side effects of the current immunotherapies as well as antibody drug conjugates have a variety of side effects ranging from mild to life-threatening but all can have a significant impact on the quality of life of patients. So why is cancer so hard to treat? Cancer cells not only make themselves invisible to the immune system, but also favor the formation of an immunosuppressive microenvironment unable to eliminate cancer cells. This is what makes it so difficult to treat cancer. And what does this mean for the rest of our oncology program, where is the opportunity for leronlimab? So some of the top CCR5 expression tumors include urothelial cancer, breast cancer, lung cancer, colorectal cancer, pancreatic cancer, head and neck cancers, TNBC, sarcoma. But also don't forget, CCR5 is overexpressed in gastric adenocarcinoma, prostate cancer, melanoma, Hodgkin's lymphoma, esophageal cancer and acute lymphocytic leukemia among many others. So in summary, why are we so excited about our potential opportunities for leronlimab oncology? First, we believe our animal studies support our findings in human subjects. In an animal model, we showed a 97% reduction in human breast cancer metastasis in a murine xenograft model. We then have Dr. Dan Linder of the Cleveland Clinic do an animal study in colon cancer with leronlimab. He saw a 62.8% reduction in tumor volume by day 42 and a significant reduction in angiogenesis. Remember, without a blood supply, tumors cannot grow. We were also recently given clearance to advance to Phase II in our TNBC trial with a 700-milligram dose due to a lack of a strong safety signal. We have been granted fast track status in metastatic triple-negative breast cancer, which is an unmet medical need. We have the potential to have opportunities in at least 23 cancers. In immuno-oncology, the bar is low. If we can prove efficacy, we have an excellent chance of approval. Now we've received many questions regarding breakthrough designation and what this could possibly mean. In summary, if we were to apply for a breakthrough designation to receive it, the average approval time could be reduced by 2.5 to 3.5 years. Most people typically define a blockbuster drug is a drug that generates over $1 billion in annual sales. In general, this threshold, according to analysis, seems to lead to a value for a Breakthrough Designation drug of $10 billion. So receiving a Breakthrough Designation adds significant value to a company. Based on historical averages, a pure-play company with a Breakthrough Designation for a significant population could be worth $8.3 billion. So for 1 particular cancer, the value of a breakthrough designation could be worth $8.3 billion. We have the opportunity to pursue 23 different cancers. Obviously, 1 Breakthrough Designation puts you on the map to be acquired by Big Pharma. It is rare for a company with 2 Breakthrough Designations to not be acquired. We will be meeting with the FDA to set up a clear path forward for discussion of Breakthrough Therapy. I also think it's important to note that many of the patients that we have treated so far receiving leronlimab are receiving this late in their disease course. We see no reason that earlier administration might help these patients even more. Some of the patients that are metastatic triple-negative breast cancel trial and compassionate use were on their fifth or sixth line of therapy. If you look at the market potential, the global cancer immunotherapy market is expected to grow at a compound annual growth rate of 10.25% from 2021 to 2027 to reach $174 billion by 2027. Global cancer immunotherapy market is experiencing significant growth, owing to increasing patient pool and a higher mortality rate worldwide. And last, but most important, we do it for the patients to improve the quality of their lives and to give them more time to spend with those they love. Nader?

Thank you so much, Dr. Kelly. I want to remind everybody that the compassionate use data is anecdotal data. We want to hear from FDA guidance and instruction. And as soon as we do, we will explain all that to our shareholders. We always said that this data that we put out was being put together. And I want to thank Quest Clinical Dr. J. Lalezari for gathering all this data when it was so difficult and there was a lot of data missing. His wonderful team and himself did a fantastic job getting this data together and they're still getting the rest of it together. We're also going to do the same thing with Basket trial with Dr. J. Lalezari and Quest did a fantastic job for us. Now all the patients who we stopped the metastasis triple-negative breast cancer trial and Basket trial will be given right to try. So we will not leave any patients behind. We are committed and Dr. J. Lalezari has already done a really good job filling out most of those paperwork for the Basket trial patients, and we look forward to -- for the rest of them. So the testimony that you heard right now showed that there is a very, very important patient side to all of these. The longest patient in our cancer trial, emergency IND had metastases to lung, brain and liver. 18 months later, that patient is now doesn't seem to have any lesion in liver and no new metastases to the organs that was checked all the way in the last 18 months. It's amazing, 3 different metastases, especially to brain. So that's our longest patient, but that patient was in emergency IND, so it was not included in this analysis event. So the testimonies always impressive from our product. HIV, we had impressive testimony from 10 patients who had gone 2.5 years without any HIV drug, but only with leronlimab. 2.5 years, which was about 4 years ago. Some of these patients are closing to 7-year monotherapy. When they testify, they said, "I feel like I can sleep better. I think I can have -- I now have more energy. It sounds like a long-hauler trial we just did and some of the patients are saying that. Does that mean the leronlimab can do that? That's why we are so excited and so blessed to have Dr. Chris Recknor figuring out what is going on. Why are these patients feeling so much better when they take it for any indication. HIV patients saying that I can now exercise normally like I used to, and I wasn't able to do that for 30 years. So next slide, please. And then let's...

From what slide number we should be on here?

Yes. So let's go all the way to Slide number, I believe, 12, please. So with all that said, now I'm going to ask Dr. Chris Recknor who has done a fantastic job on long-hauler as Dr. Scott Kelly has done in cancer I'm indebted to both of you. Dr. Recknor, could you please start with Slide #12 and explain to what you're finding on long hauler?

Sure. Thank you, Nader, and thank you for the listeners and the support. And basically, what I wanted to do is talk about the data from long haulers. And we've looked at the responses to COVID in terms of what is different about the long-hauler patient population.

Chris, your voice is going away. Could you get closer to the microphone, please.

It's not better, sir. Are you on speaker phone?

Is that better?

Much better.

Okay. Sorry. Okay. So -- In looking at responses to COVID, we're all familiar with the first response, and that is normal response. A lot of patients get COVID, they don't have any problem. They have an appropriate inflammatory response and an appropriate balanced healing response. And cytokines help, they allow the blood vessel walls to become leakier to promote healing of damaged tissue via inflammation. We've heard of the cytokine storm, that's the worst case where patients are in the hospital and oftentimes don't make it through the viral infection. You think it may be related to increased viral load, but in any event, there's an excess of cytokine production. But what about the long haulers, oftentimes, these patients can have had hardly any symptoms at all or it can be that they were severe. And so this has been the pursuit of this trial to try to help these patients. And what we found is that there's a very inappropriately low inflammatory response with an inappropriately high healing response. So the immune system is very dysfunctional. It's not regulated properly, and there are imbalance of cytokines. Now it's been noted through different research that about 60% of these patients may have a reactivation of Epstein-Barr. Other studies have looked at HSV infections. What we are going to be showing you is the data at baseline and then after leronlimab comparing the treatment group to controls. And that's important in terms of the reactivation. We studied 24 symptoms in the CD15 trial.

You go to the next slide. I'm sorry, Chris, we got to continue to this slide. This is the next slide with [indiscernible]. Sorry about that. Go ahead.

So we looked at 24 symptoms in CD15, along with cytokine and cellular biomarkers. And if you look at the data, and this is clinical improvements, we're looking at shift tables. I'm not looking at p-values. I'm looking at this in terms of the clinical response. Out of these, this slide and the next one will show 17 of the symptoms improved and 18 of these symptoms lessened worse in leronlimab-treated patients. So for a total, they were -- clinically 21 out of the 24 symptoms were better. And if you look at the differences, improved headache, improved sleep disturbance, tingling or numbness, sense of taste and smell. And these numbers are small such that it's an exploratory study. And so I'm just looking at this from a clinical trend. Anxiety, we didn't do as well with. That may be related to the 700-milligram dose. Difficulty in concentration improved. Joint pain was substantially different along with muscle aches, cramps and muscle weakness, feeling fast heart rate. And if you look at the next slide, a lot of the long-hauler patients have feelings of tightness in the chest, cough, shortness of breath and fatigue and exertional malaise. Our hope is to look with this information and do another study that's powered sufficiently so that we can show a statistical change to get an indication for long haulers and work with the FDA on it. If you can go to the next slide.

Slide #15.

Yes, Slide 15. Here's where it gets interesting because remember, what we were saying is that a lot of these patients may have reactivation of viruses, and their immune system is confused. The T cells aren't coordinating things properly. Immune systems really down regulated. And when you look at other viruses, it's not too different. For example, CMV infections generate their own IL-10 and IL-10 down regulates our immune system and shift it more into a healing state. In this case here, what we're seeing is that very interesting in those patients that were responding p-value 0.01, we are increasing the NK cytolytic cells to go after virus versus those that did not get leronlimab. These patients feel better, and this may be similar to what we're seeing when people get vaccines. Where they have a wake up or a reboot of the immune system. If you go to the next slide. And this is further support for restoration of immune function. We're bringing the CD4 counts back online, 0.008 p-value. You see we're actually activating B cell proliferation, B cell memory. The natural killer cells in this, you're looking at leronlimab versus placebo, not just only the other one feeling better versus not.

And Chris, let me interrupt for 1 second. Chris, let me interrupt for 1 second. I want people to understand this is that one of the things about leronlimab, when you think about CCR5 antagonism, we want to be sure that people understand that and this, it appears that what we are doing is restoring the immune function rather than it being immunosuppressive. And I think that's a very important point for people to understand because that is applicable in oncology as well. Go ahead.

Yes. Thanks, Scott. And even with the CD8 cells, activated effector memory are coming back online, 0.01, very significant at week 8. Go to the next slide. We're still working on the cytokines, but it's interesting that these same increases in the cell lines are significant for what you're seeing then in terms of the actual cytokine levels. So naive progenitor cells use CD40L and it allows the differentiation of T cells and B cell antigen-presenting cells. If you look at 2, IL-27, same thing, naive CD4 differentiating into T helper. And we see this in the populations that we look at with an increase in NKG2A. They're basically going now and being able to look for a virus, whereas before they weren't. We're seeing B cell proliferation as well consistent with this. You go to the next slide. And so what's very interesting, too, is that Scott was talking about the CD163 or the M2 monocytes and how they are changing in these patients. And what's very interesting is that in some of these patients, they had huge amounts of M2 polarization as much as 66% of the monocyte population was M2. leronlimab takes the M2 polarization and changes it into M1. But it's very interesting as well, too, is that 163 or these M2 macrophages are producing CCL2. So the situation here, CCL2 is neurotoxic and it does cause a lot of problems. We're decreasing this along with IL-10 in these patients, which we think is correlating with the symptoms and actually helping the patients feel better at the same time that their immune system is coming online. If you go to the next slide. So we had an improvement in symptoms at baseline, there was dysregulated immune function in the control and treated groups with downregulated T cells we're talking about this immune system that's shifted really into a hyper healing mode along with M2 polarization. After long therapy, the immune system is basically rebooted. It shifted more to a normal and patients felt better. Scott, what are your thoughts on the M2 and M1 with cancers?

Yes. This is very, very exciting for a number of different reasons. And as Chris' work has shown, I think we've made more progress in terms of the mechanism of action over the past 3 or 4 months, as I've stated previously, the number of the past years combined. What this is showing is exactly what we anticipated. We're seeing M2 to M1 shifts and macrophage polarization with leronlimab. It goes right in line with all the other mechanism of actions in cancer. And now we believe we're seeing this clinically, although it's anecdotal in some of these patients with tumors that are a reduction in tumor size that patients are stating. We're also seeing a decrease in metastasis for CCR5 on the tumor. And also, like the reduction in tumor size, we believe that now you're allowing the immune system to fight the cancer rather than evade the immune system. So I think this is incredibly important.

And Scott, to the difference with leronlimab binding external to the loop versus internal loop is related to cyclic AMP that's not increased along with tyrosine kinase. And the significance of that, I think, is the same with these long-hauler patients as what we're seeing with the cancer patients as well, and that is that it's preventing the leaky vessels in these cases.

Yes, absolutely. Agreed.

Further interesting data that we are looking at is that these biomarkers will greatly help us with other studies. And just recently, we are now discovering after sequencing CCR5, different genetic types that may respond better with leronlimab than others. Now heading clinical development, I'm very excited about that because now what I can do is carve out after we're sure about this, carve out patients and use this as a biomarker to actually show who's responding and who's not. And if we can tag biomarkers with those with our nonresponders, it's the same way probably with long haulers. That's what it is with NASH as what it is with all other indications we're looking at. And so we're really excited about that as well.

Thank you so much, Dr. Recknor. So I just want to make sure that everybody knows. When you see these results on the screen. These are blood samples for so many different testing that has to be done, 56 patients, multiple tests, and we have a laboratory that we assigned, Dr. Recknor has assigned, with many people working very hard to make sure all these data come out. So it's not a simple task. At the same time, Dr. Recknor is working on BLA transition team from our CRO to other places. So there's a tremendous amount of work being here. And I just also want to say that slide -- all the way to Slide 12 that we just skipped through, those were the detailed results of press release that we put out about cancer trials. Those are all details that you guys have not seen. So I encourage everybody to go and look at those slides detailed results of the 30 patients in mTNBC, which was compassionate use and in Phase Ib-II. Now the next thing we want to talk about is COVID-19 trial in Brazil. Just for everybody's information, twice a week, Mondays and Thursdays, we meet with the whole team of Albert Einstein Research Group and Biome, the company that we have a licensing agreement with from Brazil. And we work on every aspect of this regulatory submission that we will be working, which is CD16 for severe population and CD17 for -- I'm sorry, CD16 for critical and the 1 for severe, which is they call it -- they have a different definition for that. But after going through 2 months almost, of back and forth and giving all the data to whatever they were asking us, we now have a solid CRO in Brazil that can take our data and do any study. As a matter of fact, in Brazil, we will be starting, hopefully, very soon HIV PrEP study because now they have all of our data. We have a new CRO that is in Brazil much more cost-effective and their reputation, they just published in New England Journal of Medicine. They have a lot of credibility in Brazil and in the United States. Now they also have got all of our trial sites, the hospitals ready to go, they are ready to inject or they're in process of getting to that point. So there is fantastic things happening. There are 316 patients in critical population of this trial, 612 patients is severe. We will do interim analysis at 40 patients. We also built in bonus for the company to make sure that we can do this enrollment from first to last patient in a very expedited way, and we're going to talk about time line as soon as we get green light. So far, we have given ANVISA final comments. And every comment is done and we are waiting any day to get green light, God willing. So now I want to also ask Dr. Scott Kelly and Chris Recknor to weigh in. You both have been on all these massive calls that we have with about 20 people or so from all 3 of our companies. What is your take? Are they a solid company? Dr. Kelly?

Yes. This has been -- this has really truly been an exceptional opportunity for us. I mean Biome and I'd say have been absolutely fabulous. They are a world-class organization, and we feel we have tremendous partners moving forward that we can get studies done quicker and more cost effective. So we're very, very happy with the progress.

Dr. Recknor, are you happy with the situation in Brazil?

They're outstanding and another to point out to the investors, they've done 7 prior COVID trials. COVID is still a big issue in Brazil, and we expect the study to fill quickly. We actually have readjusted the patient population such that the interim analysis is achievable with the number of patients that we have anticipated. So we're hoping to get the results on this.

Excellent. And I want to thank Dr. Nitya Ray and his wonderful team, Bernie and everybody else in the team have done a fantastic job getting so much documentation to the people. Bernie is now ready to ship products because we are getting very close to that point out. We're very excited about that.

I want other people -- I want people to realize that a lot of the work we've done through this whole process in Brazil in terms of CMC and nonclinical has really put us in a fantastic position for submitting all throughout the world as well as all other indications. It's really now we need to show efficacy in these certain indications, and we have the ability to move forward very, very quickly, which most people do not have.

Yes. And then I said, Bernie, I should say, Dr. Bernie Cunningham. I have to correct myself. Okay. So in regards to Philippines and India, we don't stop any process when somebody approaches us say, "Can you please try to help patients lives. No, I'm not saying leronlimab saving patient lives right now. I'm saying the doctors who use the drug they come back and say, "My patients life was saved like Samantha Mottet. That was very big during that time. Now Philippines approached us. We made an agreement with a pharmaceutical over there, and they want to sell the product. CSP, compassionate special permit, was granted. And then everybody asked us, why are we going quiet. We're not going quiet. There is no more news to put out about that. We haven't got new PO yet because there are a lot of other complications. We know that the COVID-19 is getting worse in most of the country, and we're ready to go forward with anybody who wants to go forward. India, they are -- the cases have gone down, but they want to now look at the long-hauler protocol and they're asking us, can we do a long hauler with it? So as we get new information, we'll let you guys know exactly where we are. What I'm excited about is Brazil critical and severe population. Interim analysis and hopefully all the data that we're going to be getting in the next few months, I believe. And long hauler has been a very fantastic thing and the cancer. So let's go to the next slide, please. Slide #21, please. Now that brings us to a very important tap BLA submission process. We're trying so hard to get the right trial designed with the right parameters to make sure we had the primary end point. Well, with HIV, we had the primary end point. But why did we stop with 350? Why didn't we just go with 350? Because this product, as Dr. Recknor is showing, could have indication in multiple areas and 350 versus 525 versus 700 is very important dosage analysis that we have done. Now I heard some people say that there is no difference between 350, 525, 700. And I just laugh because FDA sees the data. In our HIV patients who failed with 350, we gave them 525 and start kicking them out in big trial, and they were able to suppress their viral load. There were patients that we didn't give 525. 350. And we let them stay on 350. Their viral load did not go back down because those patients are not responding. Whatever the percentage is, Dr. Recknor is working on finding out how we can predict they responded for every indication, and it's different. It's a very complex product because it's doing, in my opinion, fantastic thing in many multiple indications. So you got to figure it out. And we can't just say, let's do a sloppy job and get the first approval. We're going to do a fantastic job, God willing, and we're going to get approval in all of these, God willing. That's forward-looking statement by the way when say God willing. So BLA submission process. Dr. Recknor, could you please tell us all the hard work you have done with your team. And I want to thank your team because there's a lot of people I see in the background that are coming from you and they're doing such a fantastic job. I'm blown away, but please tell us where we are with this.

Well, just to talk about the team, Nader, that we've really got a lot of consultants and help on this. So we've got done regulatory. We've got different statistical groups, virologic reporting. And so we're really -- we're well supported. Our internal team is fantastic. What we did is we took the biggest problem, I guess, with the BLA. And just wanted to turn things around and submit that and take care of that first with the FDA. And so in talking with the FDA in the past, there were issues with receptor occupancy assay. And so we submitted on this draft to them about our plan for receptor occupancy, and they agreed, and we're proceeding. And we're thrilled. This is 1 huge obstacle that we now have overcome. We've always had the CMC portion dialed down. The issue has been the dose justification and it's complicated with the 2 different studies. Like you said, the p-value is significant. If you go to works, 0.032 significance. So really needed to get the dose justification, and we corresponded with the FDA. They wanted us to submit a draft dose justification, and that's what we've done. And we're waiting for word back from them. This doesn't change our October deadline. We have everything still in play for that. But I think getting the first hardest part that's always been the stumbling block out of the way first, is the best thing and we're able to go forward. So we're expecting to hear back from the FDA and when we get a green light on that or if we have to modify things, we'll do so, but we'll have the hardest part taken care of and behind us.

Thank you, Dr. Recknor. Could you please go, operator, to Slide #22. So before I pass it along to the person who has done a fantastic job in NASH to Dr. Chris Recknor, I'd like to say a few words about this. NASH trials take a long time to enroll. Am I right, Dr. Kelly?

Yes, absolutely.

You want to say something about that?

Yes. I mean a lot of NASH trials, as people know, will take years. And Dr. Recknor has done a fantastic job. This is actually, we believe, the fastest NASH trial that's ever occurred in America.

Thank you. That's what I wanted to hear. And I want to thank Dr. Recknor to there -- for doing such a great job. Now 60 patients was completed. We added 30 patients because Dr. Recknor wanted to do more work. But because we are going to a different CRO perhaps in Brazil or something we might -- I'm tempted to stop the trial right now and read the data. We saw the animal study. We saw what was that, that was reducing fat. We really stopped the trial right now, read the data perhaps for Phase III in NASH. That will be something may be beneficial. But I'm going to ask my boss, Dr. Scott Kelly; and my colleague, Dr. Recknor to make sure they both allow me to do such things. But before that, Dr. Recknor, please tell us about NASH.

So the mechanism of what we're talking about a polarization of macrophages and also leaky vessels applies to NASH as well and lipid deposits also that we've noticed in the animal models that then improved with leronlimab. So we're in the 60 patients. This was at a 700-milligram dose and different things that we were seeing in the biomarker lab, we wanted to see what the 350-milligram dose would do as well, and it gives us more of an opportunity to follow biomarkers to where we can better understand NASH, we're developing now a central repository for all of our biomarkers of which we can then learn from 1 indication to the next. I'm in favor of just continuing 30 patients getting the results. And this is in CT1 and a PDFF, which is buying MRI. It's a very precise way and accurate way of following these patients. This should be recruited. In fact, there's 44 in screening right now. The sites have been fantastic. We've put into play recruitment strategies to help them. And of those, we should be getting a feel of the study of those 30 within the next 30 to 45 days. And with that, we will have more results of what 350 looks like, but also in combination with all these biomarkers that are immensely helping us.

Thank you so much, Dr. Recknor. Could we, operator, go to Slide #23. Biomarker diagnostic test lab for Dr. Chris Recknor. He has done a fantastic job with receptor occupancy tests. We are going to put in a public domain what FDA said about the previous receptor occupancy test that we submitted to them and Dr. Recknor receptor occupancy that he will talk about in a minute, but I want to let everybody know, QPS, LabCorp, other very fantastic diagnostic laboratory that work with us when we give them a big project, $2 million, $3 million, they do a fantastic work, and they love us. So any diagnostic lab would love to have something like leronlimab. Why? Because when we get to the approval, that will be needing a diagnostic companion test. And Dr. Recknor is making those diagnostic companion test who could respond to leronlimab? What dose do we use? Do we use loading dose and then reduce it to 350 or do we go 350 and so forth. So with that, Dr. Recknor, could you tell us a little bit about this exciting project?

Sure. The one that we had just mentioned, most apparent for clinical development is that we can sharpen who respond and who doesn't respond by learning this. And so then as that applies to clinicians, as a clinician, I might be seeing a lot of patients with leaky vessel issues that have cytokine imbalances either through long haulers or they may have fibrosis issues like NASH or dementia or other things, the immune systems throughout the whole entire body. And each of these indications may have a different nuance to it. So we want to be able to look at those. But as a clinician, and Scott, maybe you can weigh in on this, too, wouldn't it be great to have a report you could order on your patient, those complex ones. You don't really know what's going on with them and you [ order ] this report and it's got an immune profile on your patient. And it looks at certain things that I can't go into, but that the lab is not showing right now that physicians don't have the ability to do. But if they did see this, it could affect how they prescribe medications. What are your thoughts, Scott?

No, absolutely. And I want to reassure people that our patent protection is growing rapidly at this point. We are really discovering some things about this molecule that weren't discovered previously, and I want to reassure our investors that we are being very active in that for patent protection.

And we are aware of patents being put on our products sometime that should have not been and we are aggressively pursuing those things. And we will be reporting to the shareholders about all of those but we are immediately patenting quite a bit of stuff and Dr. Recknor and Dr. Kelly has done a fantastic job on that. So...

One thing that's interesting is that in a patent, there are a number of names that are on patent. Those names are people that have participated in the work, but the assignment of the patent goes to the company itself. And there's also NDAs in place where people that are working for the company obligate that, any right to a patent because they're working for the company and getting paid.

And contracts as well. Yes, excellent point. Thank you, Chris.

Yes. And we -- exactly. And when we patent things for the shareholder, this product belongs to the shareholders. When somebody patents our stuff which is shareholder product, we aggressively pursue that. Among the other fights that we have to take because we are in a position of, in my opinion, a fantastic product, and we are working on all those fronts. With that said, Operator, can we go to Q&A, please. Mike, could you please?

Certainly. Thank you, Nader. First question, when will data from the Phase Ib/II metastatic triple-negative breast cancer be presented at a scientific conference this year or any time in the near future.

Yes. So we plan for that to be done by the end of this year.

Next question. When will data from the COVID studies be presented at a scientific conference?

So we do have a manuscript that we worked on. The only problem is we have to get the data from our CRO. We are trying very hard to get those data. Sometimes that process takes too much time, and we don't like that, but we just have to get it. But definitely, we are going forward with that.

On a somewhat related question, when will data from the CD12 study be published in a peer-reviewed journal?

We are going to also submit that to the peer-reviewed journal when the data is completed and the tables are made and the analysis is done. The problem is we now have long haulers. This data needs to be published. So our focus is on long haulers, maybe a letter to a publisher whichever that is and then a full paper. This is some fantastic results in our opinion, and it needs immediate publication in major publications.

So one thing, too. While everything is now becoming clearer with the BLA. This is the opportune time to be publishing the HIV information, and we're working on that. So we're working with the CD12 and 10, what we learned from that long haulers and also HIV. And we have draft, and we're hopeful to be submitting those. The order of which, though, may be first long haulers and then working with either HIV or CD10 and 12. And that may have some to do with also the Brazil trials as well.

Okay. Switching topics. What is happening with the multiple loans CytoDyn has taken out? According to the terms of the loan repayments were to have started by now.

And we have Antonio Migliarese. Antonio, could you, please?

Yes. So we have a monthly $7.5 million obligation that's due in cash. And as we reported in our June 4 8-K, the note holder agreed to settle the May obligation and negotiated exchanges for common stock. So on a monthly basis, we'll continue to evaluate how to settle each monthly obligation.

Thank you, Antonio. Next, please.

I want desperately to believe you, but every time we discuss a new place like Mexico, U.K., Canada, Philippines, India and now Brazil after while you just drop all discussion and move on to the next. Please in this webcast give clarity on real facts and not wishes or desires.

Okay. Well, I'll take that as a compliment, if you guys don't mind. The fact that we started in Mexico, that means when I heard about Mexico, our team heard about Mexico, we immediately move forward. we don't drop the ball. Why? Because people are dying from COVID-19, we didn't slow down. Now should I tell the shareholder or should I keep that secret. No. I tell the shareholders because the path that we said we're going to go forward is to update you guys so you don't stay in the dark. So you know exactly what we're doing. And then when the Mexican government perhaps or the regulatory agency stop talking to us. We don't wait. We have multiple things to do. We are -- we believe we have a powerful product, and we're going to go forward with all of that. And when we tell you guys forward-looking statement of what we are doing, please don't expect an approval next week. Expect that the FDA guideline saying 10 to 15 years for approval is what it is. We got 7 years under us and these are the multiple indications that we have. Please next.

What was your cash position as of June 30, 2021? Antonio?

So we don't report financial results on an interim basis. However, in our last filed 10-Q for February 28, 2021, we reported a cash balance of $14.3 million. We'll be filing our annual Form 10-K shortly, which is due July 30. And at that time, we'll report our May 31 cash balance.

Next, likely for Antonio. How many fully diluted shares were outstanding as of June 30, 2021?

Yes. So same note, as previously we don't report interim financial information. However, as of February 28, we had 800 million shares authorized, 609 million shares outstanding and 62 million shares available for issuance.

Next. Please shed a little light on the intellectual property that CytoDyn acquired from Dr. Patel's company. Is there any value? Was there any fraud involved regarding the prostate test?

We cannot talk about any of this at this moment, especially this prostate test that we're talking about. We just cannot talk about it. We will talk about it at the right time.

With respect to the long-hauler results, you previously discussed where you talked about statistically significant findings. Can you elaborate on the methodology you used to determine such significance and opine on whether the FDA would agree with that methodology, if presented with the same results with a much larger patient population.

So Dr. Recknor will talk about that, but I just want to say that the results that we presented last time that we said there was 8 had statistically significant 8 symptoms improving. There we put all the information of where that came from, what method was used. So I encourage everybody to go out and look at that. But Dr. Recknor, do you want to add anything to that?

Sure. I prefer to look at it from a shift table standpoint. The FDA -- in regard to the FDA, it's an exploratory study. We're looking at clinical trends. Now you're seeing p-values in the labs. And you can get trends and p-values, but smaller numbers need to be taken into consideration and the larger study needs to be done.

It seems as though 350 milligrams, 525 and 700 milligrams are all safe for patients based on no severe adverse effects. Since the half-life of leronlimab is about 10 days, would it make sense to have 350 milligrams and 525 milligrams obsolete in future trials.

Absolutely not. The half life is not 10 days for IV. It's 10 days for subcu injection. And for the IV, it's 4 days. In the HIV setting, when you go 1 week, that means the 700 milligram, you have about 400-some milligram left when you get your second injection, now you just jumped to 1,100. We want to look at every indication very carefully, as Dr. Recknor is doing, to see should we give loading dose and then drop the dose or should we give loading dose, for example, in cytokine storm, you're getting 4 shots. Do you want to give a low dose? No, that one is a no-brainer for us. We get 700 milligram. In Brazil, we're going to do this with IV because it's essential for the patients to get the product absorbed to their body immediately. With IV, it takes 1 hour to get there. With subcu, it takes 2 days or so. So we will look at every aspect of this. This is a complex situation. And Dr. Recknor, would you like to add something to that?

I think the indications may be different maybe with a different dose is the issue. So with cancer, for example, you may need 7 -- it looks like we need 700. And so just checking the biomarkers and your indications for your end points of what you're looking at, would be pertinent to the specific dose. But I think between the 350 and the 700-milligram dose would be my preference rotating between those depending. So for example, long-hauler patients seem to have more anxiety or there were a few that did and it may be genetically related based on their receptors. But they may not respond as well to a 700-milligram dose as what they would to a 350 dose. But that's why we need a biomarker lab and to test that further.

Yes. And I'd like to say something, Chris, as well. So as Nader was saying about the IV every minute counts in these critical patients. So we think we could potentially have even better results with IV formulation. And so we're very excited about giving these patients via IV. The other thing is I think people need to understand that it's actually a good thing to have some versatility in this and have 350 milligrams, 525 and 700. So we know that based on our studies, which is the appropriate dose to give to each patient and for what indication. So I actually see that as an advantage.

And another dose-related question -- go ahead...

Well, I was going to say, Mike, and for that matter, too, post marketing as well, too, in Brazil, we're using 700 IV for the critical patients that gets the drug in them very quickly. As Nader said, it has a reduced half-life versus the subcu of 4 days versus 10. But -- and then -- but for an outpatient setting of subcu would be better. It just allows versatility in terms of commercialization as well.

Dr. Jonah Sacha was said to be working on a concentrated version of leronlimab, where it can be taken potentially every 3 months instead of weekly. Is there any update to the status or time frame?

Go ahead, Scott.

Yes. No, this is a very, very timely question as I was just updated on this yesterday. So first of all, in terms of the concentrated version, we've had excellent news on that and as well as the longer acting half-life of leronlimab. We've had some very excellent news on that. So this puts us in a unique position as you can imagine, from going from a once-a-week to a once-a-month oncology drug or once every 2 months or once every 3 months. So we're doing those studies right now, but it is, I would say, incredibly encouraging on both fronts.

Is there any potential partnership available by the end of the year? Is there any word on what indication it could be.

Yes, I'll take that one as well. Well, we have done 3 partnerships, 1 in Brazil, 1 in the Philippines and 1 in India, and we are looking at potential partnerships in the United States. And I can say that's getting even more interesting.

Next question, have we considered moving to the New York Stock Exchange as opposed to current NASDAQ application? This would help with the short selling and nefarious tactics as there would be daily margin calls. I believe the requirements to list to a national exchange, even AMEX would be 1,000x better than current OTCQB. Please provide some guidance to this question.

So we provided guidance about 4 years ago for a period of 2 years, telling everybody that we will not do reverse split when we were sitting at $0.25, $0.30, $0.40, $0.50 level, that was a range. And we said we would stick to the fundamental with Dr. Scott Kelly being so strong about multiple indication as I was myself. We had a synergistic effect, I believe. We move forward. Dr. Scott Kelly brought Dr. Chris Recknor and now we really have synergy effect between 3 of us. and Dr. Nitya Ray helping us with the manufacturing. What does that mean? That means we've got a solid position in our opinion. What we have to do is continue with this and go forward to get to the stock price that we need for the New York Stock or NASDAQ. Do we think we have a chance at that? What's the chance of Gilead being 10x its price a year from now? What's the chance of CytoDyn? So I bet -- I will bet and time is on our side because we are getting closer and closer to major things. So no, I'm not suggesting to the Board, obviously, the Board has to decide. I'm not suggesting to them to do a reverse split or look at New York Stock or anything. I'm confident on the fundamentals, get the price of the stock at the right price, then we -- all the doors are open.

First, I would like to congratulate CYDY for the outstanding preliminary results from the mTNBC trial. We all understand CYDY can always use more cash as a pre-revenue company. With these results, what plans, if any, does CYDY have to pursue available grants to ensure future trials are completed properly.

Yes. So I'll take that one. So listen, we are looking at all potential options, including grants. We're looking at partnerships, we're looking at everything currently for all the different potential trials going forward.

Next question, finance related. Beginning in the month of May 2021 and for each of the following 5 calendar months thereafter, the company was obligated to reduce the outstanding balance of the April 2021 note by $7.5 million per month, the debt reduction amount. How are we paying this obligation -- is it from cash on hand or in available shares.

I think we already answered that question. Yes, we did.

Let me say one quick thing. I know -- have we got a default on any of the payment, Antonio?

No.

We diluted the company $33 million in the $190 million that we raised versus before it was like we diluted 425 million shares to get $120 million. So I think that's a pretty good record. Wouldn't you say that?

I agree.

Okay. So I hope the shareholders take that confidence that we are doing everything with the articulated way of raising money, whether it's [ deregistered rack or pipe or note ], the dilution is main consent to us, always it has been. So with that, I hope everybody has the confidence that we would do the right thing. And I don't think, God willing, we're not going to run to any problem financially because our record has been very good. But we always have to raise money that's in our forward-looking statements.

Two remaining questions. Is the HIV data being submitted to other countries?

So we will give to the other countries. But because the volume of work has just gone through the roof and we have limited staff. And we want to make sure that we get the BLA done over here for United States. If we do get that then we will talk to other countries also. We have already been in talk with Canada, U.K. and everything. But if we get approval for COVID-19 faster than BLA, HIV, then we will pursue that and the path would change a little bit.

Yes. And I hope that people realize that by going through this process, as I said earlier, this is a very turnkey solution for us. When we get this and we get the BLA submitted to the United States. Obviously, it's going to be tremendously easier to go throughout the rest of the world and submit to other countries. So it will be very turnkey.

Okay. Last question...

I was going to say, Scott, that's an excellent point. Our focus is on getting this BLA across the finish line, and we're very, very close.

Absolutely.

Last question. Has the company made distribution arrangements with distributors in the U.S. and elsewhere for when and if an EUA for any indication is approved by any country's drug agency or will we partner with a larger pharmaceutical company?

So we are going to look at the situation as it comes in regards to Brazil, which we are very hopeful to get approval over there for COVID-19. We have a distributor volume. We have an extensive contract with them. So we said -- but with the United States, if we do get approval for COVID-19, perhaps long-hauler, we like to partner with other pharmaceutical, would you agree?

I would agree.

All right. So with all that -- I think this was the last question, and I just want to close it up by saying that in regards to our company currently. We have cancer results that we just talked about. We have long hauler data that we are very excited about. We have CD16, CD17 two indication for COVID-19 in Brazil, which we hope to start the study any day, and we have done a lot of work on that. HIV BLA is back on track. Dr. Recknor has done a fantastic job. NASH, we might stop the trial. We don't know. We will work on that and see what's the best path for us. And then our diagnostic laboratory that we are building. We're going to be doing all of this simultaneously. And as our progress is shown, we will be able to see where we go -- what we're going to do after that. Any comment, Dr. Kelly or Dr. Recknor before we close it off. Thank you, everyone, for the great call. Take care.

That concludes today's conference. All parties may disconnect. Have a good day.