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 A.M. Pacific Time on November 24th, 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 and 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 14th, 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. Questions or comments may be submitted by typing in the field under the Ask a Question header on the left side of your screen and clicking send.
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 assigned an oath of 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. The first item of business is the election of directors. As indicated in the company's proxy statement, at today's meeting, six directors will be elected to serve on the board of directors for a one-year term until their respective 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 Missuras, Rosenbaum, and Patterson purported to nominate five 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 31st, 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 Four 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 these polls. I will now pause briefly to allow for voting.
The polls for each matter to be voted on at this meeting will close shortly. It is 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. Number 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.
Number four, the proposal to approve an amendment to our charter to increase the total number of shares of common stock has been approved. These are the preliminary results of voting. The 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 24th, 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 wanna 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 have been very difficult and trying. A lot of you folks are happy with CytoDyn. Today, we wanna update you on a 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 flying everywhere, and we wanna make sure to our supporters and those who don't agree with us to please look at the first eight minutes of this presentation. We will talk about how we got here. Then decide if this management that you chose today to lead the company for the next year is the right person. We will be covering quite a bit of forward-looking statement in this presentation. Just a quick overview.
We're gonna go over this in five, six minutes of the last 13 years of where we came from. In 2008, I was hired to raise funds for this company, but it was on the brink of bankruptcy. Allen D. Allen was the CEO for the next three years. The result of what he accomplished was Cytolin, the product that we had at that time, not PRO 140 or leron, but what we call leronlimab. Cytolin was put on clinical hold when we went to FDA. During that three years, no trials. 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. It was handed to us and our team. In the next nine years, as you can see, quite a bit of things was happening. However, the strength of a company, especially OTCBB, is, in my opinion, how much trading volume dollar amount you do per day. That's the strength of a public company. If you look in 2008 when we first got involved with this company, $500,000 was the trading volume, the whole year. What we've done is we went 10,000 times higher to a level of $5 billion trading in 2020. How did we do that?
This management team did quite a bit of trials, and you can see on the right side of this slide. Quite a bit of trials and quite a bit of indication. We've been very busy. 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 four clinical trial, and the only thing they produced for FDA was three weeks of efficacy. That was their management team. 12 years, 168 patients, three weeks of efficacy. Here's ours. 1,445 patients have been exposed to leronlimab as high as seven years. You don't have clinical trials for seven years. Usually, it's a year, right?
Seven years of efficacy has been produced. In seven years of efficacy, 1,445 patients. We had to raise money to do that, right? We raised $400 million, but we also manufactured $400 million worth of products priced at the low price potential revenue. This could be $1 billion potential revenue, but let's just leave it at that. 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 their development, they went to FDA on April 21st, 2008. Here's a cut and paste of the minutes of the FDA minutes for 2008 minutes. FDA says. Well, the FDA was told by Progenics that we would like to go to phase III.
Here's our results of three 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 one month of efficacy." That's what was handed to us. That's why Progenics let it go and sold the product. That's one of the reasons. Now, what do we do? Put yourself in our shoes. You're there, you got a product, and top people in the world in biotech are giving up. What are you gonna do? We came up with the articulated strategy of two-prong 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, an answer to FDA question, which was, "You don't have enough efficacy." We produced six months of efficacy, immediately went back to the FDA, said, "Here it is." They gave us a phase III. We overcome that problem. The phase III injected the first patient in October 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. We had a primary endpoint in 2018, February 2018. We solved the problem, right? Shouldn't we say total victory was amazing? What they couldn't do, we did it in four years, starting from 2014.
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. Here specifically, you can read it yourself. It said, "If you're successful to find that, we'll give you permission to file a second BLA, another BLA for label expansion." 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 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? Progenics had done that.
Cannot inject a patient with four shots back to back. That was the problem. We solved it by injecting double the amount with two injections. That was the trick without having any extra injection site reaction than what we had already. We met with FDA, and FDA said, "Well, if you are higher, if you discover 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. It took a year. It delayed a year. In that one year, our CRO, Amarex, was supposed to put everything together, so we can file the BLA right after we get the 700 milligram results. 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, two months. Then they come up with lame excuse. Recently, they released an email from me saying that, "Submit the BLA, the darn thing, no matter what." They're taking it out of context, obviously. They had told us we were gonna submit it, and they submitted, and they submitted it incomplete. Now, they're claiming that I told them to submit incomplete. Well, FDA doesn't accept incomplete BLA. The proof is right there. April 27th, 2020, they submitted, and so incapable they were. They didn't even give the charts that they were telling us they had it ready. They took another two weeks because FDA rejected it. Said, "Submit the whole thing.
You can't submit an incomplete BLA." They submitted again on May 13th. This one 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 four 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. We stopped them. With that, the refuse to file, which was very painful, we went to other regulatory top agency, and they said they'd never seen a BLA this poorly done. We changed that. Thanks to Dr. Chris Recknor and now Dr. Nitya Ray being in charge.
Demonstrating how we solved the problem is why you should feel comfortable that we're gonna solve the problem of not having our first approval yet. We will have our first approval yet. That's what I believe. 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 response 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 one year. We overcame Amarex's poor performance in most crucial time, even though they lied and bashed us about what we had done with them.
Now I must tell you, we are going to overcome the refusal to file that FDA has worked with us so carefully, so we will 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. The FDA had given us a gift. They said, "We will evaluate it 30 days, tell you to make sure it's good, so you can get it done right." We submitted it, 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 commercial product was tremendous difficult task. He and his team done a fantastic job. Now they will do a fantastic job with this. Dr. Recknor was 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 gonna tell you about it in a minute. Then our HIV BLA review, rolling review was granted again.
We are back on track finally with all the chaos that was 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. In the next two weeks, we will be submitting the CMC portion, which is already done by Dr. Nitya Ray and his fantastic team, and it's put in a publication. He will talk about it in a minute.
We are gonna also maybe ask for a phase, I mean, type B meeting with FDA to see if we can submit the clinical section sooner. Maybe we won't, but we are thinking about it. Just to give one more point before we go to updates. In 2019, April 2, we didn't have any product. We didn't have any manufacturing product for commercial. We had for clinical. We had to go sign an agreement with Samsung, which would have cost us $20 million-$30 million that we had to give just to transfer the technology.
But the board members said, "Nader, you're crazy. $20 million or $30 million, we're gonna let you sign an agreement like that just to transfer technology? You don't even have a million dollar right now." The stock was at $0.52. I said, "You have to trust us." Among my supporter that 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 with manufacturing.
Our stock price from that point to eight 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 us reckless in 2019, but today, maybe they call us genius. They should call our CMC team genius, not us, not me, but my team did a fantastic job.
We also were involved with the scientific community. We presented our data at ASM Microbe at CROI, got team discussion selection, which was five out of many hundreds of presentations. Five were selected. We were one of them. Many publications came out. Here's 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. It's not fake. It's real. Here's another abstract. Eight publications in the last 13 months was submitted by doctors that some of them are independent of us.
Meanwhile, we've been saving lives, thanks to God. 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 seven years. When you look at the interview of those patients when they were gone two and a half years, they keep saying that their lives are changed. They feel so much better, not knowing that this product might have other effects, as we are finding out hopefully soon. Combination therapy, we had patients whose doctor has sent me an email saying, "My patient never had suppressed viral load, a dangerous situation for HIV patient. Please let him go to extension."
24 of those patients currently are still in extension for four years, enjoying leronlimab, keeping their viral load suppressed, so they cannot even pass the virus risk to somebody else. CD01 and CD03, five patients and 37 patients going almost four years. We also know about the testimonies of cancer, 40 patients, COVID-19, critical impact published, about 290 patients, a lot of them in Philippines, and long COVID and NASH, we will see about that. Now that's the past, what we did till now. You tell us if this is good enough or not 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. 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 to put Dr. Recknor to talk about that. Dr. Ray, where are we with the BLA submission currently for clinical section?
Yes. Our target is to submit the CMC module of the BLA by next Tuesday. That is November thirtieth. That's what we communicated before. All the sections are complete. They are now in the hands of the publisher. We are working with the downstream regulators who will do the publishing, and so they're doing the final work related to publishing like hyperlinking or some formatting work. We expect that will be submitted on Tuesday, but it may take one or two extra days, but definitely it will be submitted next week. The clinical, we are working very judiciously with our partners, and we are getting ready to get all the documents that we need to submit with the clinical module. We are still targeting by the end of First quarter 2022.
Excellent. Thank you. Dr. Recknor, you have been so amazing on exposing Amarex's lack of work and charging us up to our neck. 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 the 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 multi-drug-resistant patients. Frankly, the doctors have communicated with us that without leronlimab, they really are concerned for the patients' 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 seven years now for some of these patients who have been on leronlimab.
Thank you so much. 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 multi-drug-resistant patient in HIV. There are great need in that population for a new class of drug because of the situation of high resistance, and we are going to be giving that application to the FDA. We're also gonna 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. We're gonna 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 six 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 your submission of the application for breakthrough designation. We want to remind you that if we do give you breakthrough designation for your cancer, mTNBC second-line therapy, you will need to file expanded access within 15 days to make your product available to the public." We will be filing that expanded access as soon as possible, maybe even in a week or two. We're hopeful on that. 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. Dr. Scott Kelly and Dr. Brendan Rae will take over that discussion very soon. If it goes to the next level, we don't know if it will. We are in discussion. 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. With that, I'm gonna ask Dr. Kelly to talk about our cancer program. Dr. Kelly, could you please?
Yeah, no, absolutely. I think what's so exciting with our cancer program is that, you know, we're really targeting the tumor microenvironment. Nobody's been able to successfully do that. You know, as Nader was saying, we're going after all these indications. We've been fortunate enough through Right to Try to have patients that have had lung cancer, breast cancer, pancreatic cancer, ovarian cancer, colon cancer, leiomyosarcoma, prostate, bladder cancer, and, you know, we also have the TNBC.
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. 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 seeing these emails where they say, "God bless your team and yourself for being able to produce this product for my cancer family member." They think some of these patients and their doctors that we save their life, give them a different kind of life. For one person is my own family member. She's alive today still, thank God. She's not doing as great and being able to walk and all that, but being alive when she first had 18 lesions in her head and now her liver is clear of the tumors apparently. It's amazing to see that for two years now. I'm very thankful for leronlimab and the shareholders who gave us opportunity to serve and be able to bring the leronlimab at least to some people.
Now, in regards to COVID-19, we have Brazil trials that have come to halt almost. We don't get any more enrollment that much. There's only four patients in CD16 critically ill population and 23 patients in severe population. We are continuing those two trials. Why? Because we believe there will be a spike as we have seen all over the world with other countries. The team at Einstein folks, they believe that. 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 two. If they do, if this happens, we will have an interim analysis, and if we hit our primary endpoint, we're done. If not, we continue.
In regards to Philippines, people don't know who's working behind the scenes in Philippines for us. There are very, very good people who I'm honored to call them my brothers. They are working very hard. In Philippines, we have seen what we have done. Everybody knows. The orders have been accelerated, but again, right now we're having some hard time getting the shipment to 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 it and got us the result that he did. He's in communication with FDA. We hope to have our trial begin injecting patients in January, but he's working on that. Dr. Recknor, tell us please, what is your excitement about what you saw in the long haulers trial?
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. 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. We are hopeful that the next trial of long hauler will produce enough results and enough mechanism of action 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 it, fantastic anyway. We don't only have NASH, we believe now.
We believe we also have NAFLD, non-alcoholic fatty liver disease and non-alcoholic steatohepatitis, both. 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 the phase III. 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? Second, please explain to our shareholders, what does millisecond mean? Some people have a problem with that. Go ahead, please.
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. We're looking at something very sensitive, specific to reduce fat and also fibrosis. In the liver, there's iron deposition that needs to be removed so that you can see fibrosis. We're working with a company that specializes in that. The cT1 changes-
Yeah, go ahead.
Well, the cT1 changes that are
Sorry, Chris, go ahead.
The cT1 changes that we're seeing are significant, as a 40-millisecond change is significant. 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 one where we looked at 700 milligrams instead of 350. 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.
Chris, first of all, did Amarex cooperate with you with the data and did that not cooperating if they didn't let us know. Did that cause not to be able to unblind the data quickly? When are you gonna unblind the data?
Our issues with Amarex are solved because we're working with another CRO. 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 a MRI vendor that had all of our data. We had a contract directly with the lab company.
We've got all that data. We figured out a workaround for the patient data at the clinics. They've Its data's been reentered by the sites. We're moving forward. Our last patient, December sixth. We're expecting something, even though a little bit of a delay from not having the Numerix database, we reconstructed it, and we're hoping for something, later on in December. We're really excited about it.
Thank you so much.
Hey, 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?
Please.
I think people realize that, you know, 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 this from numerous physicians, that it might even be more pronounced on biopsy, which is exciting because, for the next step, we do biopsy that these changes in fibrosis might even be more pronounced, and I think that's very exciting as well. 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're 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 a-
Well, we think. Yeah.
Go ahead.
We think that, you know, first of all, there's many opportunities with NASH and NAFLD. As I've always said, I think, you know, CytoDyn will ultimately be a, you know, an oncology company. 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, 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. You know, 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 gonna explore.
I think it will definitely open up multiple partnership opportunities. 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, you know, he's an expert at licensing opportunities and drug development. Our problem before was we only had animal data, right? 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. In regards to autoimmune disease, or maybe other trials that we might do, Dr. Recknor, you were excited about few things. Could you share that with us?
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.
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 a unmet medical need. It's exploring some of those autoimmune and/or neurologic associated conditions that will be in our design for doing trials.
When you say, stroke patient improve, which is anecdotal data, which I'm involved, and I understood that. 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. We had a statistically significant p-value. Am I right?
You are correct. We did.
Okay.
Even patients though.
I'm glad that you-
Even patients in the NASH trial who had joint pain are feeling better. You know, 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, yeah, I would encourage everybody to see the interview that we did of two and a half years of monotherapy for HIV patients, where some of them said that, "I feel like I'm gonna live longer." The other one said, "I think my life was just handed back to me after all the toxic drugs." The drugs were toxic at that time, which was about four years ago. Now, the drugs in HIV, I must say, they're not toxic. Biktarvy 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? Is this what Dr. Sherman
Yeah, it's interesting. I think that, you know, that CCR5 has the potential to be the backbone of an HIV regimen for that very reason. That's what we're exploring in our biomarker lab and everything else to see, you know, a lot of patients that are on HAART. They do have an increase in fatty liver disease as well as NASH. If we show the ability to reverse that process, obviously that would be very advantageous to have it in the HIV population.
Beautiful. Just for everyone's information, HIV BLA will not be only filed with FDA in United States, but with Health Canada and other countries. U.K. we're very much thinking about those, and we will be filing with those most likely. You know, this is a forward-looking statement, so we say God willing. Let's go to the next slide there. Now let's look at the first line of this slide says leronlimab from one indication to 31. I'm gonna correct that. 32 indications. NAFLD was just added as per my last slide that I showed. The market size is pretty strong according to all the links that you see there. People can go and read it for themselves. Dr. Scott Kelly, what is our partnership potential looks like now, and what are you doing about that?
Yeah. I mean, we're currently in discussions with pharma companies for HIV internationally and oncology domestically as well as internationally. I think if we get good data in NASH, I think that really opens a whole new world to us. We'll see how that data pans out, but it's very exciting.
Beautiful. Okay, just the last thing is, I wanna remind those naysayers about our companies. 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 300 times more, so maybe we are the right person for the job. Now we got 32 indications potential. This is just the beginning, in our opinion. 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. This is our forward-looking statement for what we're gonna do in the near future. In December, we will also file for expanded access for metastatic triple-negative breast cancer.
We hope to get results by the 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 wanna have one arm, and they wanna have a comparator. If that's the case, we will just proceed with the phase III filing. 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, Mr. Antonio Migliarese. Mr. Antonio Migliarese is working on that last section, and this is very crucial.
We send that to them, then we can allow patients on Right to Try perhaps or whatever the guidelines are. We wanna 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. 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 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. In first quarter of next year, our BLA will be resubmitted, the full package. That's what we have told everybody we are shooting for. In 2022, our potential approval of leronlimab for HIV is there, for multi-drug resistance with a limited treatment option. We are done with the presentation, but I'd like for Antonio Migliarese to talk about finances in a minute. Before that, I'd like to tell you about these four members that you see the pictures of them. This is our team, the head of our 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 had, 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's 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 gets done appropriately, and we don't get no more refuse 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 realize 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. 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 lawsuits that everybody keep bringing against us, he had to be there at the very crucial time, especially when Michael Mulholland said, "Nader, this man is genius.
You never find anybody better than him as CFO." With the blessing of Michael Mulholland, Antonio Migliarese took over tremendous amount of work, and in the last many months now, he has done tremendous job. Last but not least is the man who was able to do the long hauler and NASH in a very record time, figure out Amylyx's problems, and took us away from the way they hold our data hostage.
That's Dr. Christopher Recknor, who was first given liraglutide when he had problems with COVID-19 himself, and then came to the company. 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 future and be appreciative about that. With that, dog, 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. 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 31st, 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 1st, we have raised gross proceeds of approximately $28.7 million, as disclosed in our subsequent events in our latest 10-Q, 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 three 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 one-time 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. 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 funding 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 two 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, we've been focused on HR and 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, comprised of attorneys, accounting, and finance staff.
Additionally, as the business continues to grow, as we reported for the first time last quarter, we now have revenue. With that comes 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. Lastly, we began working with a new IR/PR firm, PR firm, excuse me, out of New York, Sloane, we've been very happy with to date.
Excellent. Antonio, is it safe for me to say we know how to raise money?
I think so.
Okay, great. Thank you. With that, let's go to Q&A please.
Okay. What are our current enrollment numbers in Brazil?
We addressed that already. Next, please. Let me just say it again. four 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 E.U. and U.K. are seeing an increase in COVID-19 cases with multiple lockdowns. What is CytoDyn doing to pursue leronlimab usage for COVID-19 in the U.K. and/or E.U.?
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?
Yep.
Didn't you say it would follow the first application by a week?
Whenever we talk in any of these conference calls, we always say forward-looking statements. This is what we wanna do. We will be filing that, but it's gonna be delayed because we like to see what the agency says about the first one, which is just around the corner and now going through Thanksgiving and Christmas. With all the work that we have, we are just overloaded. We will definitely go with that. That's for the patients with brain metastasis. We had six in MTNBC, one in MBC, which is metastatic breast cancer, and that result is, in fact, really strong. We will definitely look at that, but please don't think that every time we say something, that's gonna happen right away. We tell you what we think, and you make your decision.
Right. 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. The BLA is about 100,000 pages. They are working on that. The number of files that we do right now, Dr. Bernie Cunningham has done a fantastic job. Dr. Nitya Ray told me that his team is doing really strong work.
Yeah. 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. As soon as FDA is comfortable, this is a very difficult trial because there is not a lot of trials to look back and say, "Okay, this is the way you do it." If the FDA sets a primary endpoint, that becomes a very major point. Dr. Recknor, amongst everything else he's doing, he's working very diligently to make sure that happens.
Do we have a patent to treat COVID-19 and long COVID path with leronlimab? CytoDyn was just granted one from Maraviroc.
Yeah, maraviroc, I don't believe anything I hear from anybody just till I see the documentation of things. 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 who we have as our IP legal team.
Great. 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 with Dr. Nitya Ray had told me that FDA probably wants to have a placebo control trial, so the data might not be good enough for a breakthrough designation. We don't know that. We will investigate that. The phase III for NASH will definitely be provided right now. Fast Track Designation is gonna be filed hopefully by the end of December. I'm just giving you a guess.
When will results from the NASH trial be released to the public?
Hopefully by the end of December, I believe. Dr. Reckner, am I right about that, end of December?
That's what we're trying to do.
Great.
End of December.
There are biomarkers associated with NASH or COVID long haulers, so you can check biomarkers and know leronlimab will work.
Dr. Recknor, you wanna answer that, or do we get in trouble with our patent stuff?
I think we're taken care of there. Yeah, 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. It is according to the mechanism of action that 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. I think we're onto it.
Yeah. I just wanna 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 it out what's going on. Dr. Chris Recknor has shown us, and perhaps Dr. Kelly can weigh in on 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 monotherapy HIV and some people didn't, and then we had to give them higher dose. Dr. Kelly, do you wanna 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 a huge undertaking to figure out the mechanism of action, why it works in certain indications, but it's very important for the trajectory of the company. If we can do that successfully, then obviously all these multiple indications will come together, and hopefully we'll know exactly what dose works in each specific patient and the populations it'll work.
So the work he's doing has just been amazing, in my opinion. 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, Prasad Yang and Jonah Sacha, thank them too as well. Jonah, looking at the receptor occupancy, we're very supported and feel very fortunate.
Beautiful. Go ahead.
Couple questions with regards to executive compensation. Is CEO compensation on par with other biopharma companies? Why are the CEO and the other executives of CYDY are 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. Having said that, we don't get $10 million. My salary, I believe, is $650,000. Antonio, you know better at what my salary is right now. The cash salary is, I believe $650,000 a year. Am I right?
That's correct.
With that said, I don't know who spread these lies, but a CEO of a company, according to Mercer and other companies that we checked with, the board member checked with, supposed to own 10% equity. Now, I've been here for 12 years and been the CEO for 9 years. I don't know why I'm the lowest-paid equity person in the world, probably. And the 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.
Yeah. 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. It's in line with independent with other independent third party companies. 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. There were some stock options issued in the past that were issued when the stock was at a very high level. Those options now are probably underwater if you were trading at $1 today, and some of those options were issued at $3 and $6.
I see. That's where the confusion to people comes up. Okay, great. Next, please.
It looks like we've covered a lot of these other questions with regards to Brazil. Our question section is over for the day.
I'll just give a finishing comment. 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 have the right team to get our first approval. I think after the first approval, God willing, 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. With all that said, I wanna thank all the shareholders again for the vote of confidence that you gave us. We will make sure that we work very hard and make everybody proud. Thank you for everything.
Thank you, ladies and gentlemen. This concludes today's presentation. You may now disconnect.