CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Good day and welcome to the CytoDyn Inc. Annual Meeting of the Stockholders. Today's conference is being recorded. At this time, I'd like to turn the conference over to Dr. Scott Kelly. Please go ahead.

Thank you. Good morning, ladies and gentlemen. I am Dr. Scott Kelly, the Chairman of the Board of Directors of CytoDyn. It is my pleasure to welcome you to CytoDyn's 2021 Annual Meeting of Stockholders. We are holding today's meeting as a live virtual webcast. Please note that following the adjournment of the Annual Meeting of Stockholders, our management team will be providing a business update. Pursuant to the company's bylaws, I will act as the presiding officer of this meeting. The time is now 8:00 Pacific Time on November 24, 2021. I hereby call this meeting to order and declare the polls open for each matter to be voted upon today. You may vote your shares by ballot by clicking the link labeled Shareholder Ballot on the left side of your screen. Antonio Migliarese, our Chief Financial Officer, will act as secretary of this meeting and record the minutes. We also have members of our Board of Directors and executive team attending our meeting today as well as Mike Barbera of First Coast Results, our inspector of election; representatives from Warren Averett, our independent public accounting firm; and representatives from Sidley Austin and Miller Nash, our outside Corporate Counsel. In order to ensure that the business of the meeting proceeds in an orderly fashion, we ask that you please observe the rules of procedures for the meeting, which may be accessed on the left side of the virtual meeting console. We do not expect any technical difficulties today. However, in the event we lose our webcast connection or otherwise experience technical difficulties, please allow for some time for these difficulties to be resolved. Our operator may also provide updates through the phone bridge. This annual meeting is being held in accordance with the company's organizational documents and Delaware law. During the meeting, we will address the matters described in the company's proxy statement dated October 14, 2021. Following the adjournment of the formal annual meeting, the management team will provide a brief business review and update. We will hold a Q&A session after this business update. So if you have any questions or comments, about the company or business, please save them until this time. Questions or comments must comply with the rules and procedures for the meeting. [Operator Instructions] I have proof by affidavit that the notice of meeting, the proxy statement for the meeting, and our annual report on Form 10-K as amended, were mailed in on or about October 14, 2021 to all stockholders of record at the close of business on September 1, 2021, which was the record date for the meeting. Copies of the proxy statement, which includes the notice of meeting and the affidavit of mailing, will be filed with the minutes of the meeting. We have appointed Mike Barbera of First Coast Results to act as inspector of election for this annual meeting. The inspector of election has signed an oath to office, which we filed with the minutes of this meeting. The inspector of election has in his possession a list of the company's stockholders of record as of the record date. A list of the company's stockholders of record as of the record date is available for inspection during this meeting on the virtual meeting website. Our proxy solicitor, Morrow Sodali, has advised me that we have present virtually or by proxy a majority of the voting power of all issued and outstanding shares of our voting stock entitled to vote at the annual meeting. Accordingly, we will proceed with the business of the meeting on the presumption that a quorum is present, pending final confirmation by the inspector of election. Let me briefly describe the voting procedures. Stockholders attending the meeting may vote their shares by ballot until we announce that the polls are closed. If you have already submitted a proxy to vote your shares, you do not need to vote by ballot unless you want to change your vote. If you wish to vote by ballot, please accept the ballot available on the left-hand side of the console and follow the instructions provided. Voting by ballot at this meeting revokes any prior proxy you may have submitted. Remember, you must submit your ballot before the polls close in order for it to be counted. So the first item of business is the election of directors. As indicated in the company's proxy statement, at today's meeting, 6 directors will be elected to serve on the Board of Directors for a 1-year term until their retrospective successors are duly elected and qualified or until his or her earlier death, resignation or removal. All of the company's nominees have been duly nominated. Our Nominating and Corporate Governance Committee has recommended and our Board of Directors has approved Dr. Scott Kelly, Dr. Nader Pourhassan, Jordan Naydenov, Dr. Lishomwa Ndhlovu, Dr. Harish Seethamraju and Tanya Durkee-Urbach as nominees for election to the Board of Directors at this meeting. As you may know, an activist group led by Messrs. Rosenbaum and Patterson purported to nominate 5 director candidates for election to the Board of Directors at this meeting. The Board informed the activist group that its nomination notice was invalid due to its failure to comply with the company's bylaws. The Delaware Court of Chancery has affirmed the Board's decision to invalidate the nomination notice. Therefore, any proxies and votes in favor of the activist group nominees will be disregarded. The second item of business is to ratify the selection of Warren Averett as the company's independent registered public accounting firm for our fiscal year ending May 31, 2022. The third item of business is the approval, on an advisory basis, of the compensation of our named executive officers. The last item of business is the approval of an amendment to our amended and restated certificate of incorporation to increase the total number of authorized shares of common stock from 800 million to 1 billion. If this proposal is approved by the requisite stockholder vote, the proposed amendment to Article 4 of our Certificate of Incorporation will be adopted. Our Board of Directors has unanimously recommended that you vote for each of the Board's director nominees and for all of the other proposals. Our proxy statement for this meeting contains information about each proposal. If you are voting today, you must submit your votes at this time in order for them to be counted by the inspector of election. The inspector of election will not accept ballots, proxies or votes or any changes or revocations submitted after the closing of the polls. I will now pause briefly to -- for voting. [Voting]

Thank you. The polls for each matter to be voted on at this meeting will close shortly. It's now 8:09 p.m. Pacific Time, and the polls for each matter to be voted on at this meeting are now closed. Based on the preliminary tabulation by our proxy solicitor, we believe that each of the company's director nominees has been selected to serve on the Board until the company's 2022 Annual Meeting of Stockholders. For two, the proposal to ratify the appointment of Warren Averett as the company's independent auditor has been approved. Number three, the proposal to approve, on an advisory basis, the compensation of our named executive officers has been approved. And number four, the proposal to approve an amendment to our charter to increase the total number of shares of common stock has been approved. Again, these are the preliminary results of voting. A final vote count may vary following the final examination of the votes by the inspector of election. The final results of voting will be set forth in the report of the inspector of election and will be included in the minutes of the meeting. The final results will also be reported in a current report on Form 8-K that the company will file with the Securities and Exchange Commission in due course. This concludes the formal business of today's annual meeting of stockholders. I declare that the 2021 Annual Meeting of Stockholders is hereby adjourned at 8:10 Pacific Time on November 24, 2021. Now that we have concluded our 2021 Annual Meeting, I would like to turn it over to Antonio Migliarese, our CFO, who will lead off to our business update presentation. We will hold a Q&A session after this business update. So if you have any questions or comments about the company and our business, please save them until this time. Antonio?

Thanks, Scott. Good morning, everyone, and thank you for joining us today. This is Antonio Migliarese, CFO of CytoDyn. Joining us for today's business update presentation is our President and CEO, Dr. Nader Pourhassan; our Chairman, Chief Medical Officer and Head of Business Development, Dr. Scott Kelly; our Chief Operating Officer and Chief Technology Officer, Dr. Nitya Ray; and our Senior Executive Vice President of Clinical Operations, Dr. Chris Recknor. Before we begin today's presentation, it is essential that we provide you with important cautionary language related to certain federal securities laws. Our remarks during today's presentation 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, among other matters, statements regarding leronlimab's potential efficacy in certain immunology and oncology indications; the company's ongoing ability to raise additional new capital that clinical trials may not commence or proceed as planned; products that appear promising in early trials may not subsequently prove to be viable on safety or efficacy grounds; products may not receive regulatory approval or market acceptance; competition may reduce the commercial potential of our products; we may experience product recalls, manufacturing issues or product liability; and our patents may be challenged or unenforceable. Although forward-looking statements help to provide complete information about the company, forward-looking statements may be less reliable than historical information. The company undertakes no obligation to update publicly these forward-looking statements, except as required by law. Please refer to our recent quarterly and annual reports filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to differ materially versus our current expectations. I will now turn the presentation over to Dr. Nader Pourhassan.

Thank you, Antonio. I want to thank all of our shareholders who believe in us and our vision for leronlimab. It's been a long ride, and it's been a very long year. The last 18 months especially has been very difficult and trying. A lot of you folks are happy with CytoDyn, and today we want to update you on the year that's to come, a year that we would like to call it a year of approval for leronlimab. We believe we have worked hard enough to deserve to be at the point that we are to have our first approval. However, there are many people talking about certain issues that are not correct. There's a lot of lies -- lying everywhere. And we want to make sure who are supportive and those who don't agree with us. So please look at the first 8 minutes of this presentation, we will talk about how we got here, and then decide if this management that you chose today, to lead the company for the next year, is the right person. So we will be covering quite a bit of forward-looking statements in this presentation. Just a quick overview. We're going to go over this 5, 6 minutes. Of the last 13 years of where we came from, in 2008 I was hired to raise funds for this company as it was in the brink of bankruptcy. Allen D. Allen was the CEO for the next 3 years. The result of what he accomplished was Cytolin, the product that we had at that time, not PRO 140 early on but what we call leronlimab. Cytolin was put on clinical hold when given to FDA. So during that 3 years, no trial. Next CEO was Mr. Kenneth Van Ness. He started working on an antibody called CytoFeline, for cats. No trials of cats was done in that year either. Then it was handed to us and our team. And in the next 9 years, as you can see, quite a bit of things will happen. However, the strength of a company, especially OTCB, is in my opinion, how much trading volume dollar amount you do per day? That's the strength of a public company. And if you look in 2008 when we first got involved with this company, $0.5 million was the trading volume, the whole year. And what we've done is we went 10,000x higher to a level of $5 billion trading in 2020. How did we do that? This management team did quite a bit of trial. And you can see on the right side of the slide, quite a bit trials and quite a bit of indication. We've been very busy. But this leronlimab wasn't handed to us because it was already working beautifully and everything was fine. It wasn't. Progenics, here's the record. 12 years, top biotech people in the world, developed it, did a fantastic job with it. 168 patients were involved in the 4 clinical trials. And the only thing they produced for FDA was 3 weeks of efficacy. And that was their management team: 12 years, 168 patients, 3 weeks of efficacy. Here's ours. 1,445 patients have been exposed to leronlimab as high as 7 years. You don't have clinical trials for 7 years. Usually, it's a year, right? 7 years of efficacy has been produced. In 7 years, 7 years, 7 years of efficacy, 1,445 patients. And we have to raise money to do that, right? So we raised $400 million but we also manufactured $400 million worth of product priced at the low price, potential revenue. This could be $1 billion potential revenue but let's just leave it at that. And what was the problem that Progenics came up? And what problem did we solve? Did we just luckily go there and start something? No. Progenics after all the development, they went to FDA on April 21, 2008. Here, the cut and paste of the minutes of the FDA minutes -- for 2008 minutes. FDA said -- FDA was told by Progenics that, "We would like to go to Phase III. Here is our results of 3 weeks of efficacy." FDA answered, again cut and paste from the FDA minutes, exactly what they said, is, "No, you cannot go to Phase III because you only have 1 month of efficacy." That's what was handed to us. That's why the Progenics let it go and sold the product. That's one of the reasons. Now what did we do? Put yourself in our shoes. You're there. You got a product. And top people in the world in a biotech are giving up. What are you going to do? We came up with an articulated strategy of two-pronged approach. We went to monotherapy trial to get to a Phase III in combination trial. In monotherapy, we conducted the study started immediately in February 2014. As soon as the trial was done, we had created it and answered to FDA question, which was, "You don't have enough efficacy." We produced 6 months of efficacy. Immediately went back to the FDA, said, "Here it is." They gave us a Phase III. We overcome that problem. And the Phase III injected the first patient in October of 2015. Meanwhile, monotherapy as you can see, we also got a Phase III but not a pivotal Phase III. But investigational Phase III, which is like a Phase II perhaps to investigate that. And we had a primary end point, in 2018, February 2018. We solved the problem, right? Shouldn't we say total history was amazing? What they couldn't do, we did it in 4 years, starting from 2014. And then monotherapy, we wanted that because it was a higher market size, but we had a problem. FDA said very clearly, this is again minutes from FDA saying that, "You cannot do monotherapy Phase III unless you show higher responders rate." And here specifically, you can read it yourself, they said, "If you're successful to find that, we'll give you permission to file a second BLA," another BLA for label expansion. So that was another problem. How do you solve that? All of our key opinion leaders were not able to solve it. Finally, we were able to solve it, which was we go to a higher dose. Really, just higher dose, just inject more, is that -- I mean that's -- they should have figured that out already when they did a dose justification, right? But Progenics has done that. Cannot inject a patient with 4 shot back to back to back to back. That was the problem. We solved it by injecting double the amount between injections. That was the trick, without having any extra site injection reaction than what we had already. So we met with FDA. And FDA said, "Well, if you have higher, if you discovered that, that's great. But your combination therapy has to also be for higher trials. So you have to give us some data from the monotherapy." Very reasonable, but it took -- it delayed a year. In that one year, our CRO, Amarex, was supposed to put everything put together, so we can file the BLA right after we get the 700-milligram results. But they didn't do that. Not only they didn't do that, after we got enough data from 700 milligrams, they delayed it a month, 2 months, 3 months. Then they came up with lame excuse. Recently, they released an e-mail from me saying that, "Submit the BLA the darn thing no matter what." And they're taking it out of context obviously. They had told us, "We were going to submit it." And they submitted, and they submitted it incomplete. But they were claiming that I told them to submit incomplete. Well, FDA doesn't accept incomplete BLA. The proof is right there. April 27, 2020, they submitted. And so incapable they were, they didn't even give the chart that they were telling us they had it ready. So they took another 2 weeks because the FDA rejected it. Just submit the whole thing. You can't submit an incomplete BLA. So they submitted again on May 13. This finally was submitted, and it was all the sections were there. But when the sections are opened, Amarex had not done their job. FDA had told them 4 times, "We need the dose justification to be done in this way." And they refused to do what FDA said. And we got refused to file because Amarex was charging us without doing their job. And we stopped them. And with that, they refused to file, which was very painful. We went to other regulatory top agency, and they said they've never seen a BLA this poorly done. And we changed that, thanks to Dr. Chris Recknor and now Dr. Nitya Ray being in charge. But demonstrating how we solve the problem is why you should feel comfortable that we're going to solve the problem of not having our first approval yet. We will have our first approval yet. That's what I believe. So what did we do? We overcame what we inherited from Progenics, which was lack of efficacy, long-term efficacy. We overcame the problem of needing higher responder rate for monotherapy. We found out how to do that right. We overcame the problem of manufacturing new vials for the new higher dose, which delayed us 1 year. We overcame Amarex's poor performance in most crucial time, even though they lied and bashed us about what we have done with them. And now I must tell you, we are going to overcome the refused to file that FDA has worked with us so carefully, so we will become -- we would get to the point where we get approval. In July 2021, dose justification was given to the FDA by with our new team, Dr. Chris Recknor, Dr. Nitya Ray and their people. And the FDA has given us a gift. They said, "We will evaluate it in 30 days and tell you -- to make sure it's good, so you can get it done right." We submitted it and got guidance, and we are getting it ready to submit. In August 2021, just recently, FDA gave us exact guidelines about that dose justification of what to do so you can get it done the right way. Dr. Nitya Ray is heading that. Dr. Nitya Ray submitted the CMC portion before without any problem. The manufacturing of promotional product was tremendously difficult to have. He and his team has done a fantastic job. Now they will do a fantastic job with this. But Dr. Recknor was a huge part of this process. And now he's focusing on something very crucial, which I can't wait to tell you about it, and he is going to tell you about it in a minute. And then our HIV BLA review, rolling review was granted again. We are back on track finally, with all the chaos levels created by Amarex and other elements. November 16, we also submitted our first module of BLA. Yes, we are back. We are back on track, and we are solving this problem also. And in the next 2 weeks, we will be submitting the CMC portion, which is already done by Dr. Nitya Ray and his fantastic team and put in a publication. He will talk about it in a minute. And then we are going to also maybe ask for a phase -- I mean type B meeting with the FDA to see if we can submit the clinical sections sooner. Maybe we won't but we are thinking about it. So just to give one more point before we go to updates. In 2019 April 2, we did not have any product. We didn't have any manufacturing product for commercial. We had for clinical. So we had to go sign an agreement with Samsung, which would have cost us $20 million to $30 million that we had to give just to transfer the technology. Well, the Board members said, "Nader, you're crazy. $20 million or $30 million, we're going to let you sign an agreement like that just to transfer technology? We don't even have $1 million right now." The stock was at $0.52. I said, "You have to trust us." And among my supporters who always trusted me, which I'm grateful. Mr. Jordan Naydenov, Dr. Scott Kelly, they stepped up big and they got that approved to go forward in manufacturing. Our stock price from that point to 8 months later went down from $0.52 to $0.28. How did we handle that? Does anybody think about that? Because when the people say nothing is being done, do they think about how we did it, how we paid that? Well, at that time, they'd call it reckless in 2019. But today maybe they'd call us genius. They should call our CMC team genius. Not us -- not me, but my team did a fantastic job. Okay. So we also were involved in the scientific community. We presented our data at ASM Microbe at [indiscernible] (27:18) team discussion selection, which was 5 out of many thousand -- many hundreds of presentation, 5 were selected. We were one of them. And many publications came up. Here is one of the examples of the abstract that we submitted to ASM. All the data is out there. We don't hide any data. All our data is in front of the whole world to see. This is what we generated. Please look at it. That's not fake. It's real. There's another abstract. A publication in the last 13 months was submitted by doctors that some of them are independent of us. And meanwhile we've been saving lives, thanks to -- thank God. And that saving life is according to the doctors. Not according to us, we don't make those claims. We let them say whatever they want. In monotherapy, we have now patients who have gone 7 years. And when you look at the interview of those patients when they were gone 2.5 years, they keep saying that their lives have changed. They feel so much better, not knowing that this product might have other effects as we are finding out pretty soon. Combination therapy, we had patients who had -- their doctor have sent me e-mail saying, "My patient never had suppressed viral load. It's a dangerous situation for HIV patients. Please let them go to extension." 24 of those patients currently are still an extension for 4 years, enjoying leronlimab, keeping their viral load suppressed, so they cannot even pass the virus -- the risk to somebody else. And CD01 and CD03, 5 patients and 37 patients going almost 4 years. And we also know about the testimonies of chance of 40-patient COVID-19 critical ill published about 290 patients, a lot of them in the Philippines. And long-hauler and NASH, we would see about that. So now that's the past, what we did till now. You tell us if this is good enough for us. And if you think we can solve the next problem of getting approval. In regards to HIV, we believe approval is in 2022. And I'd like to ask Dr. Nitya Ray right now to give us an update on the clinical section of our BLA. And then after that, I'd like Dr. Recknor to talk about that. Dr. Ray, where are we with the BLA submission currently for clinical?

Yes. Yes. Our target is to submit the CMC module of the BLA by next 2 days. That is November 30. That's what we communicated before. All the sections are complete now are the hand of the publisher. We are working with the drug regulatory who will do the publishing. And so that the final work related to publishing, like hyperlinking or some formatting work. So we expect that will be submitted on Tuesday, but it may take 1 or 2 extra day. But definitely it will be submitted next week. And the clinical, we are working with the – very judiciously with our partners. And we are getting ready to get all the documents that we need to submit with the clinical module. And so we are still targeting by the end of first quarter 2022.

Excellent. Thank you. And Dr. Recknor, you have been so amazing on exposing Amarex's lack of work and charging us to our head -- up to our head. Could you tell us where we are with the extension patients where Amarex stopped the data and stopped us from going forward, shamelessly? Where are we with the extension patients who are right now taking leronlimab? Dr. Recknor, go ahead.

Thanks, Nader. Well, the most important thing is the patient safety and making sure that these patients continue to get medication. As you mentioned in the CD02, they were multidrug-resistant patients. And frankly the doctors have communicated with us that without leronlimab, they really -- they were concerned for the patient's lives and well-being. We've been able to continue the extension studies. We're working with another CRO. And we're actually looking at rolling those extension studies over into a new study. We're really excited about looking at biomarkers and other variables on these patients. Because what we're coming up on 7 years now for some of these patients who have been on leronlimab.

Thank you so much. So we are going to file. This is what we are hoping to do very quickly, expanded access to allow our drug to be available for multidrug-resistant patients in HIV. There is great need in that population for a new class of drug because of the situation of highly resistant. And we are going to be giving that application to the FDA. We're also going to ask the agency to allow us to charge these patients because we just can't provide this product anymore the way we have been doing in the past, freely. So we're going to be asking for that. We already are in discussion with FDA about that. And hopefully we get the last section that they ask for submitted, so we can charge the patients. Now in regards to our cancer, we filed a Breakthrough Designation. Another 6 weeks, we will know what the agency will tell us, whether we have it or we don't. However, we did receive a letter from the agency saying that, "We acknowledge we submit the application for breakthrough designation. We want to remind you that if we do give you a Breakthrough Designation for your cancer and TNBC second-line therapy, you will need to file expanded access within 15 days to make it -- make your product available to the public." We will be filing that expanded access as soon as possible, maybe even in a week or 2. We are hopeful on that. And in regards to the other countries, Canada, we received our first approval for first patient to have access under emergency treatment. We are now in discussion with pharmaceutical doctors. Scott Kelly and Dr. Nitya Ray will take over that discussion very soon if it goes to the next level. We don't know if it will. We are in discussions. So again if that doesn't go through, we will tell you it didn't go through. But that's what we're doing right now. So with that, I'm going to ask Dr. Kelly to talk about our cancer program. Dr. Kelly, could you please?

Yes. No, absolutely. I think what's so exciting with our cancer program is that we're really targeting the tumor microenvironment. Nobody has been able to successfully do that. And it's not that we're saying we're going after all these indications. And we've been fortunate enough to right to try to have patients that had lung cancer, breast cancer, pancreatic cancer, ovarian cancer, colon cancer, leiomyosarcoma, prostate, bladder cancer. And we also have the TNBC. And we've been very -- we've just been very encouraged. And we know this is anecdotal. We're very well aware of that, but we've been very encouraged by the responses of both patients and their physicians to leronlimab in oncology. And we will be exploring this relentlessly, and we will find out the exact mechanism of action in the tumor microenvironment and press forward to help these patients. Nader?

I must say when I keep saying -- seeing these e-mails where they say, "God bless your team and yourself for being able to produce this product for my cancer family member." Taking some of these patients think and their doctors that we saved their lives, give them a decent kind of life. But one person is my own family member. She's alive today still, thank God. She's not doing as great and being able to work and all that, but being alive when she first had 18 lesions in her head, and now her liver is clear of the tumor. Definitely, it's amazing to see that for 2 years now. So I'm very thankful for leronlimab and the shareholders who gave us opportunity to serve and be able to bring leronlimab, at least to some people. Now in regards to COVID-19, we have Brazil trials that had come to halt, almost. We don't get any more enrollment that much. There's only 4 patients in CD16 critically ill population, and 23 patients in severe population. But we are continuing those 2 trials. Why? Because we believe there will be a spike, as we have seen all over the world with other countries. And the team at Einstein folks, they believe that. So getting 40 hospitals together by the middle of or end of December would allow us that if there is a spike, which they believe there would be, then they could enroll 50, 60 patients within a week or 2. And if they do, if this happens, we will have an interim analysis. And if we had our primary end point, we've done. If not, we continue. In regards to Philippines, people don't know who's working behind the scene in Philippines for us. They are very, very good people who I'm honored to call my brothers. They are working very hard. And in Philippines, we have seen what we have done. Everybody knows. The orders are -- have been accelerated. But again right now, we're having some hard time getting the shipment there quickly. We're working on all of those avenues. But Philippine news, I believe everybody knows what's going on. U.S. FDA, a protocol for critically ill population is being prepared, and we are hoping to file that in the United States also. Because we are hearing that the ICUs in some states are pretty full, and we should have a trial going forward. We have communicated to the FDA about this critically ill population, and our protocol should go to them, hopefully soon. In regards to long haulers, this is a trial that Dr. Chris Recknor single-handedly started and got us the results that he did. He's in communication with the FDA. We hope to have our trials begin injecting patients in January, but he's working on that. But Dr. Recknor tell us please, what is your excitement about what you saw in the long-haulers trial?

So this was the first trial that we were able to implement our biomarker lab, and we gained a lot of knowledge during that trial. We then used that knowledge base for NASH, which we'll talk about. The other thing is that we're just getting a lot of support from the FDA. In fact, multiple divisions within the FDA are helping us to refine the protocol to increase the chance of getting an approval. And it's a global problem. Long-hauler indication is just so new, we're learning about it. But what we're seeing is that the same trends for fibrosis may likely extend over to the long-hauler patient population. That's helped us refine our mechanism of action, who we pick for the trials and how long we give the med?

Thank you so much. And we are hopeful that the next trial of long hauler would produce enough results and enough mechanism of actions that we are working to figure out. And that would happen hopefully early part of next year. Now in regards to NASH, we just announced some fantastic results. That's what I call fantastic anyway. But we don't only have NASH, we believe now. We believe we also have NAFLD, nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, both. And we believe we will file Fast Track designation right away. Our animal data already showed us what we have. We already have Fast Track designation for HIV and cancer. We will file for NASH and NAFLD FTD. And we're also working on a Phase III. But Dr. Recknor, we announced this morning that some patients had 93-millisecond drop on the fibrosis. First of all, is there any other drug approved that showed fibrosis going down? And second, please explain to our shareholders what does millisecond mean? Some people have a problem with that. Go ahead, please.

So Nader, there are no approved FDA drugs for NASH. The problem is that in trying to reduce the fibrosis, the millisecond amount that we're seeing is obtained from an MRI scan that we're looking at. And so we're looking at something very sensitive, specific to record fat and also fibrosis. In the liver, there is iron deposition that needs to be removed so that you can see fibrosis. And we're working with a company that specializes in that. The CT1 changes...

Yes, go ahead.

Well, the CT1 changes that are...

Sorry, Chris. Go ahead.

The CT1 changes that we're seeing are significant as to a 40-millisecond change is significant. And what's really exciting is we're not just stabilizing fibrosis, we're reducing it. Now it's only in this open-label extension. I can't wait to look at the part 1 where we looked at 700 milligrams instead of 350. But we're actually seeing reductions. And the surprising thing is that we're seeing reductions in patients with advanced fibrosis, not just mild/moderate. This has implications beyond NASH even for fibrosis of other organs and may even tie back into long haulers.

So Chris, first of all, did Amarex cooperate with you with the data? And did that -- not cooperating, if they didn't, let us know. And then did that cause not to be able to unblind the data quickly? And when are you going to unblind the data?

So our issues with Amarex are solved because we're working with another CRO. And I think that, as a key to the company, is going to increase our success with all the clinical trials. We're not just relying on one CRO to do everything. We're dividing it up for what that CRO can help us with. If they're small and agile, larger, with experience with NASH, et cetera, that's the route that we're picking. I think that our prospects going forward are amplified because of that. The data, we had a contract, as I said, with the MRI vending -- vendor that had all of our data. We had a contract directly with the lab -- company. So we've got all that data. We figured out a workaround for the patient data at the clinics. This data has been reentered by the sites, and we're moving forward. Last patient is December 6. And so we're expecting something even though a little bit of a delay from not having the Amarex database. We've reconstructed it, and we're hoping for something later on in December. We're really excited about it.

Thank you so much.

Chris, this is Scott. Do you mind if I make a few points about NASH real quick that I think it's important for people, if that's okay? So to sort of realize that this has only been 14 weeks. I mean a lot of the recommendations of people would be to continue a drug for well over a year to show results that we believe we're seeing so far, even though it's just an open-label arm. The other thing is that with the changes that you're seeing on MRI, we believe and we've been -- Chris and I have both been told us from numerous physicians, that it might even be more pronounced on biopsy, which is exciting because for the next step, we do a biopsy that these changes in fibrosis might even be more pronounced. And I think that's very exciting as well. And a lot of the other medications have been limited by toxicity, as we know. And we think that leronlimab might potentially have an advantage in that. Okay, thanks, Nader.

Yes. Dr. Kelly, while you are talking about this, can you tell me what you are doing in regards to business development, in regards to NASH and NAFLD? We get to the other things, but for NASH and NAFLD, what are you doing? Because this is...

Well, we think -- yes, we think that, first of all, there's many opportunities with NASH and NAFLD. We think that this, as I've always said, I think, CytoDyn will ultimately be an oncology company, but -- and I think Dr. Recknor would agree with this, but the results we're seeing so far are very impressive. Now we hope those results continue. But what I will say is it can open up a lot of different partnership opportunities, both domestically and internationally, not only as a monotherapy, but as a potential partnership to do it as a dual therapy. A lot of people are looking for a reduction in either. Our animal models were strong. And now that we're seeing this reduction in fibrosis, I think we have something very unique. And that's what we're going to explore. But I think it will definitely open up multiple partnerships opportunities. And that's why we've brought back Brendan Rae as well. Brendan used to work with us. He's an attorney and a virologist, and he's an expert of licensing opportunities in drug development. And our problem before was we only had animal data, right? And that's a big difference in having human data now. We believe we'll have the human data to approach these companies, and we think good things will have the potential to happen. Nader?

Excellent. Thank you. And in regards to autoimmune disease or maybe other trial that we might do, Dr. Recknor, you were excited about a few things. Could you share that with us?

So on the long-hauler trial, we saw a dramatic improvement in osteoarthritis in patients. Whether that was related to actual post-COVID joint syndrome or OA itself, we don't know. Any opportunity to study patients though gives us more biomarkers to be able to look at patients' response rates and also genetic tendencies for those patients. We are seeing very similar signals from long haulers to NASH. And more biomarkers will only help us with the mechanism of action. So other things that we're looking at are neurologic. There's a CCR5 signal with Alzheimer's and dementia. We've seen improvements with stroke patients. Our design for trials are going to be quicker trials that we can get done, that have an unmet medical need. And exploring some of those autoimmune and/or neurologic associated conditions will be in our design for doing trials.

So when you say a stroke patient improved, which is anecdotal data which I'm involved and I understood that. But in regards to what you're talking about, we saw 350% improvement in the joint pain on your long haulers with only 26, 27 patients. And we had a statistically significant p-value. Am I right?

You are correct. We did.

Okay. I'm glad that you...

Even patients though in the NASH -- even patients in the NASH trial though, that had joint pain, are feeling better. And Nader, you've talked about this multiple times as well, but the HIV patients who are on the med feel better. It's not just because of not having a lot of other toxic HIV meds. I think leronlimab in some of these patients really helps them to feel better.

Well, yes, I would encourage everybody to see that interview that we did of 2.5 years of monotherapy for HIV patients where some of them said that, "I feel like I'm going to live longer." The other one said, "I think my life was just handed back to me after all the toxic drug." The drugs are toxic at that time, which was about 4 years ago. Now that drugs in HIV, I must say, they're not toxic. [ Bictegravir ] from Gilead is fantastic. They're doing a great job. But still having a drug, according to Dr. Sherman, having a CCR5 antagonist drug as part of the regimen for HIV patients is very crucial, according to his publication. Because that would allow the liver to be managed in a better way. Am I right, Dr. Scott Kelly? This is what Dr. Sherman...

Yes, I mean -- yes, it's interesting. I think that CCR5 has the potential to be the backbone of an HIV regimen for that very reason. And that's what we're exploring in our biomarker lab and everything else, to see if we do have -- a lot of patients that are on [ PARP ], they do have an increase in fatty liver disease as well as NASH. And if we show the ability to reverse that process, obviously that would be very advantageous to have it in the HIV population.

Beautiful. And just for everyone's information, HIV BLA will not be only filed with FDA in the United States, but with Health Canada and other countries, U.K. are very much we're thinking about those. And we will be filing with those most likely. This is forward-looking statements, so we say God willing. Okay. So let's go to the next slide here. Now let's look at the first line of this slide say leronlimab, from one indication to 31. I'm going to correct that. 32 indications. NAFLD was just added as per my last slide that I showed. So the market size is pretty strong, according to all the links that you see there. People can go and read it for themselves. But Dr. Scott Kelly, what is our partnership potential looks like now? And what are you doing about that?

Yes, so I mean we're currently in discussions with pharma companies for HIV internationally, and oncology domestically as well as internationally. But I think if we get good data in NASH, I think that really opens a whole new world to us. So we'll see how that data pans out, but it's very exciting.

Beautiful. Okay, so just the last thing is I wanted to remind those naysayers about our company. We purchased the product with a $3.5 million down payment. And now our market size is around $1 billion. I believe that's like 300x more. So maybe we are the right person for the job. And now we've got 32 indications potential. And this is just the beginning, in our opinion. And in regards to the goals, long term and short term. In December, this coming month, we will file for expanded access for HIV MDR patients in U.S. So this is our forward-looking statements for what we're going to do in the near future. In December, we will also file for expanded access for metastatic triple-negative breast cancer. And we hope to get resolved in this end of December or beginning of January about our Breakthrough Designation, a very crucial item. In December, we will also file for Fast Track designation for NASH and perhaps for NAFLD. In December, we also will file for Breakthrough Designation for both NASH and NAFLD if our experts agree. What we are hearing is they might not want to have one arm, and they want to have a comparator. If that's the case, we will just proceed with the Phase III filing. So we might not do the Breakthrough Designation if that's the case. In December also, we will file with the FDA to allow us to charge for leronlimab. We are at the very last portion of that of that. Doctor -- not doctor, but Mr. Antonio Migliarese is working on that last section. And this is very crucial. We send that to them. Then we can allow patients their right to trial perhaps or whatever the guidelines are. We want to charge the patients in U.S. and abroad. In December also, we will have long-haul trial. Hopefully, we will start the process. Not injecting the first patient because we don't have the clearance from FDA yet. We are working with their guidelines. And as -- once we address all the guidelines that they gave us, then we can inject the first patient. But until the FDA says you're ready to go, we will not be injecting any patient, but the process is going forward. In December also, Health Canada had authorized us for one patient to be sold -- to sell leronlimab to. So we are working with companies over there to allow that for other patients, perhaps under the guidelines of Health Canada. In January, we are hoping to have the Breakthrough Designation for mTNBC, whatever that result is. And in first quarter of next year, our BLA will be -- we submitted the full package. That's what we have told everybody we are shooting for. And in 2022, our potential approval of leronlimab for HIV is there, for multidrug resistance with a limited treatment options. So we are done with the presentation, but I'd like for Antonio Migliarese to talk about finances in a minute. But before that, I'd like to tell you about these 4 members that you see the pictures of them. This is our team, the head of other teams that they have. Dr. Scott Kelly, who single-handedly, with Mr. Jordan Naydenov, stopped some of the madness of other Board members who wanted to sell the company for $0.20 a share. They came in. Dr. Scott Kelly believed in all the indications that this product has, and the amount of work he did to turn things around. I think in future when all the stories come out, people will be tremendously thankful to him and to Mr. Jordan Naydenov. Dr. Nitya Ray, he is not only our Chief Operating Officer, but Chief Technology Officer. He agreed to be Chief Operating Officer because I told him I need his expertise to look over all the BLA and make sure that it gets done appropriately, and we don't get no more refused to file. Dr. Nitya Ray has produced commercial product. You need about 100 people usually to get a Phase III commercial product manufactured. He has an excellent team and his record, I don't think people realized what he has done. He's the first person who started the manufacturing of PRO 140, it was called, back in Progenics. We're lucky to have him. And Mr. Antonio Migliarese. I get up early in the morning every day, and I never get up early enough to beat him. He always is up before me. And he's in the office very early and leaves very late. With all the lawsuit that everybody keeps bringing against us, he had to be there at a very crucial time, especially when Mike Mulholland said, "Nader, this man is genius. You'll never find anybody better than him as CFO." With the blessing of Mike Mulholland, Antonio Migliarese took over a tremendous amount of work. And in the last many months now, he has done a tremendous job. And last but not least is the man who was able to do the long hauler and NASH in a very record time, figured out Amarex's problems, and took us away from the way they hold our data hostage. That's Dr. Christopher Recknor, who was first given leronlimab when he had problems with COVID-19 himself and then came to the company. And the amount of work that he has done, I am tremendously indebted to him. And I know the shareholders will hear all the detail of what he has done in the future and be appreciative about that. With that, Antonio, could you please talk about our cash situation as much as we are allowed to tell them?

Sure. Thank you, Nader. I wanted to provide a brief financial update and some other areas of focus that we're currently working on. So just as a general update, we do not report cash balances during interim months. However, our last reported cash balance was in our 10-Q for the quarter ended August 31, 2021, which we had a balance of approximately $6.5 million. Prior to that for the fiscal year ending May 31, 2021, we had approximately $33.9 million of cash on hand, which was the result of a very successful year of fundraising in which the company raised capital in excess of $137 million. We have continued to raise the necessary capital to continue to advance the business. Since September 1, we have raised gross proceeds of approximately $28.7 million, as disclosed in our subsequent events in our latest 10-Q and in our most recent 10-Q filings. This has been primarily through private placement offerings and through private warrant inducements. For the year ended May 31, 2021, we reported an approximate use of cash of $117.6 million or a monthly usage of $9.8 million, of which approximately $53 million in total or $4.4 million per month was related to our investment in inventory manufacturing with Samsung Biologics. In our latest 10-Q for the 3 months ended August 31, 2021, we reported an approximate use of cash of $31.7 million or $10.6 million per month, of which approximately $11 million or $3.6 million per month was related to onetime legal settlement payments. Further, during our last 10-Q, the company retired approximately $15 million of debt and fully retired the November 2020 convertible note, which had an original balance of $28.5 million. And also as disclosed in the 10-Q, this was settled via debt exchanges. We will have additional information to report in our upcoming 10-Q filing for the quarter ended November 30, 2021, which is due to be filed no later than Monday, January 10. With regards to financing activities, we cannot comment on the specifics of any future capital-raising activities. However, as noted in recent 8-K filings, the company is focused on continuing to align the availability of capital to meet the needs of the business. Further, as we continue to evaluate and advance multiple indications, we will continue to evaluate potential partnership opportunities, which could provide a source of dilution-free capital to the company. In addition to financing activities, some of the other main areas of focus have been to continue to build the back-office infrastructure to be able to continue to support the advancement of the business on all fronts. We have been focused on building a team of the right people in which we can build scalable systems and processes to support the business as it continues to mature. To put things into perspective for our investors, as of today, the company has 2.5 more employees than it did just over 2 years ago. And we were doing a lot of things for the first time. With that being said, a lot of the areas that we have been focused on building internally, to support the R&D team and the clinical operations team and the CMC team, is we've been focused on HR and in recruiting new employees. We've been focused on building IT systems, infrastructure and security. We've continued to build out our public company compliance team composing of attorneys, accounting and finance staff. And additionally as the business continues to grow, as we reported for the first time last quarter, we now have revenue. So with that comes from new processes, order processing, supply chain and also managing all the inventory. Also with the high volume of warrants that we have, we've put an equity administration team into place. And last week, we began working with a new IRP firm -- PR firm, excuse me, out of New York Sloane, we've been very happy with to date.

Excellent. So Antonio, it's safe for me to say we know how to raise money?

I think so.

Okay. Great. Thank you. So with that, let's go to Q&A, please.

Okay. "What are our current enrollment numbers in Brazil?"

We addressed that already. Next, please. Just let me just say it again. 4 for critically ill population, 23 for severe. We want the hospitals to be established by December. So when there is a spike, we should be able to enroll 50 or 60, enough to do interim analysis. Go ahead.

"The EU and U.K. are seeing an increase in COVID cases with multiple lockdowns. What is CytoDyn doing to pursue leronlimab usage for COVID in the U.K. and/or EU?"

We are looking at everything very carefully. But we have limited resources, and we just can't go to the whole world without having income coming in. So we are looking at everything, and we will do our best to address those if we can. Go ahead.

"What happened to the second application for breakthrough therapy for mTNBC? Didn't you say it would follow the first application by a week?"

So whenever we talk in any of these conference calls, we always say forward-looking statements. This is what we want to do. We will be filing that but it's going to be delayed. Because we like to see what the agency says about the first one, which is just around the corner and now going to Thanksgiving and Christmas. But with all the work that we have, we are just overloaded. So we would definitely go with that, that's for the patients with brain metastases. We had 6 in mTNBC, 1 in MB, which is metastasis breast cancer. And that result is really strong, so we will definitely look at that. But please don't think that every time we say something, that's going to happen right away. We tell you what we think, and you make your decision.

"Is there another portion of the BLA for HIV being filed this month?"

Yes. CMC as Dr. Nitya Ray said, that's quite an extensive package. Some of these packages are 100,000 pages, just so everybody should know that the BLA is about 100,000 pages. So they are working on that. There's a number of files that we do right now. Dr. Bernie Cunningham has done a fantastic job. Dr. Nitya Ray told me his team is doing really strong work.

Yes. Just a couple of questions here with regards to the long-haulers trials. "What is the status of the next long-haulers trial? What is the update on the long-hauler clinical trial? Has the FDA approved the protocol?"

No. As we said, we are working with FDA. Dr. Chris Recknor is providing whatever he needs to provide for the FDA. And as soon as the FDA is comfortable -- this is a very difficult trial because there is not a lot of trial to look back and say, okay this is the way you do it. And if the FDA sets the primary end point, that becomes a very major point. So Dr. Recknor, amongst everything else he's doing, is working very diligently to make sure that happens.

"Do we have a patent to treat COVID-19 and long haul -- excuse me, in long COVID path with leronlimab? We saw CLDX was just granted one for maraviroc?

Yes. Maraviroc, I don't believe anything I hear from anybody just until I see the documentations of things. But we are always having our long-term IP attorneys, and they are always looking at everything very carefully. And we are feeling very strong about what we have, as our IP legal team.

Great. A few questions with NASH. "When will the Breakthrough Designation application for NASH be filed?"

We will not file Breakthrough Designation most likely. If we are hearing what Dr. Nitya Ray told me, that FDA probably wants to have a placebo-controlled trial, so the data might not be good enough for a Breakthrough Designation. We don't know that, and we will investigate that. But the Phase III for NASH, we're definitely seeing provided right now. Fast Track designation is going to be filed hopefully by the end of December. I'm just giving you a guess.

"When will results from NASH from the natural be released to the public?"

Hopefully, by the end of December, I believe. Dr. Recknor, am I right about that end of December?

That's what we're trying to do, end of December.

"Are there biomarkers associated with NASH or COVID long-haulers, so you can check biomarkers and know leronlimab will work?"

Dr. Recknor, do you want to answer that? Or do we get in trouble with our other patents stuff?

I think we're taken care of there. Yes, we're really excited about this. Because just recently here, we're seeing biomarker changes that we can see in patients that are having symptoms. And then those that, when they get leronlimab, are not having the symptoms. And it is according to the mechanism of action that we've seen and have looked at through long haulers and with NASH. Also just getting some lab results back even today, that I'm looking at some of the NASH patients in the open label and seeing some of the similar trends, too. So I think we're on to it.

Yes, I just want to add one thing that when we were stuck with monotherapy low responders rate, and wanted to go to higher responders rate, all the key opinion leaders could not figure out what's going on. Dr. Chris Recknor has shown us, and perhaps Dr. Kelly can weigh in, and that if you don't agree or agree with me. Dr. Recknor has looked at so many different things, for example, the haplotype, different type of CCR5, how does people react to that. There has to be a reason why some people really respond so well in a monotherapy HIV, and some people didn't. And then we had to give them higher doses. So Dr. Kelly, do you want to elaborate on that?

No, I agree. This is like putting together a big piece of a puzzle, and Chris has done a fantastic job in doing that. I mean it's really -- it's a huge undertaking to figure out the mechanism of action, why it works in certain indications. But it's very important for trajectory of the company. If we can do that successfully, and then obviously all these multiple indications will come together. And hopefully we'll know exactly what dose works in each specific patient and in the populations that will work. So the work he's doing has just been amazing, in my opinion.

And really, Nader, just to chime in here, the biomarker lab with Dr. Scott Hansen has been crucial in being able to make this happen. Also Otto Yang and Jonah Sacha, thanking them, too, as well. Jonah, looking at the receptor occupancy. And so we're very supported and feel very fortunate.

Beautiful. Go ahead.

A couple of questions with regards to executive compensation. "Is CEO compensation at par with other biopharma companies? Why are the CEO and the other executives of CYDY receiving yearly salaries of up to $10 million? A full explanation would be warranted."

Absolutely. If I was getting $10 million, I wouldn't be here. I would have been in Bahamas right now. But having said that, we don't get $10 million. My salary, I believe, is $650,000. Antonio, you know better what my salary is right now. My cash salary is, I believe, $650,000 a year. Am I right?

That's correct.

Okay. So with that said, I don't know who spread these lies. But as CEO of a company, according to Mercer and other companies that we check with, the Board members checked with, I'm supposed to own 10% equity. Now I've been here for 12 years. I've been the CEO for 9 years. I don't know why I'm the lowest-paid equity person in the world probably. And people keep saying, "He is getting too much." How much should I get? Should I pay the company to be the CEO, perhaps? There is 70 million shares supposed to be by equity, according to what they're saying, 10%. I don't know if I even have 5 million or 6 million. Perhaps, Antonio, you can explain a little bit more.

Yes, I'll just provide a little insight. We have an independent Compensation committee, which hires an outside advisory firm, which benchmarks the executive compensations against other biotech companies. And that is how compensation is derived. So it's in line with independent -- with other independent third-party companies. And with regards to the $10 million in compensation, I'm not exactly sure where that number is being derived. However, when we do report compensation in our proxy statement, it does include the grant date fair value of equity compensation and stock options. And there were some stock options issued in the past that were issued when the stock was at a very high level. And those options now are probably underwater if you -- we're trading at $1 today, and some of those options were issued at $3 to $6.

I see. So that's where the confusion to the people comes from. Okay, great. Next.

It looks like we've covered a lot of these other questions with regards to Brazil. So our questions section is over for today.

So I'll just give a finishing comments. Please note that in the next month alone, we are loaded with the milestones that we hope to achieve. In regards to 2022, we believe we are the right team to get our first approval. And I think after the first approval, God willing, comes, all other approvals will be following. Without having approval right now, we're having revenue, which is by itself an amazing thing, thanks to the Philippines order. But with all that said, I want to thank all the shareholders again for the vote of confidence that you give us. We will make sure that we work very hard and make everybody proud. Thank you, everyone.

Thank you, ladies and gentlemen. This concludes today's presentation. You may now disconnect.