CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, everyone, and welcome to the CytoDyn Investor Community Conference Call. [Operator Instructions] Please note that this conference is being recorded. I'll now turn the conference over to our host, Michael Mulholland. Please go ahead.

Thank you. Hello, everyone, and thank you for joining us today. This is Michael Mulholland, Chief Financial Officer of CytoDyn. Joining us on today's call is our President and CEO, Dr. Nader Pourhassan; our Chairman, Chief Medical Officer and Head of Business Development, Dr. Scott Kelly; our Chief Technology Officer, Dr. Nitya Ray; and Dr. Kush Dhody, Senior Vice President of Clinical Operations with our CRO, Amarex. Before we begin, it is essential that we provide you with important cautionary language related to certain federal securities laws. Our remarks during today's conference call will include forward-looking statements. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are difficult to predict. Actual results may be materially different from any future results expressed or implied by such forward-looking statements. These risks and uncertainties include, among other matters, statements regarding leronlimab's potential efficacy in certain immunology and oncology indications, the company's ongoing ability to raise additional new capital that clinical trials may not commence or proceed as planned, products that appear promising in early trials may not subsequently prove to be viable on 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. Please refer to our recent quarterly and annual reports filed with the Securities and Exchange Commission for more information about the risks and uncertainties that could cause actual results to differ materially as compared to our current expectations. I will now turn the call over to Dr. Nader Pourhassan.

Thank you, Mike, and thank you, everyone, for being on this call. Today's call is to explain the letter from the FDA requesting information about our BLA filing that has received a refuse to file and did not get the PDUFA date. Here is some explanation of the situation with our BLA for HIV in the last 2 years. In 2018, CytoDyn announced that the company had hit its primary end point in HIV indication for the MDR population, multi-drug-resistant population. In 2019, CytoDyn met with the FDA on a pre-BLA meeting and was able to receive a rolling review for its BLA submission. FDA also requested the BLA submission should be for a higher dose of 700 milligrams since the company had shown success with 700 milligram dose as compared to 350 milligram dose. The FDA requested CytoDyn to enroll at least 50 patients and obtain data at 24 weeks with 700 milligram dose in the CD03, which is our monotherapy trial, to demonstrate safety of 700 milligram dose. CytoDyn achieved this in October 2019, and the BLA included information about the CD03 trial for the safety portion of the BLA. CytoDyn felt the application was completed for the FDA to provide the PDUFA date. The FDA may ask for additional information at any time during the review process. However, the agency felt the information was not complete to start the review process. The takeaway from this FDA refusal to file letter is that this letter provides us with very clear and detailed information about what additional data and analysis the FDA needs for us to cure this problem, and we now have an opportunity to meet with the FDA in a Type A meeting to fully be aligned with the agency in regards to this situation. We have reviewed the FDA letter in detail. I feel confident that all the data requested by the FDA is very clear and obtainable by CytoDyn. Again, the FDA had indicated in great detail and clarity what they need from CytoDyn to grant PDUFA date, and CytoDyn will be working on this as fast as possible. We are thankful that the information needed does not require any more trials, and it is simply getting the information that the agency requested with the detail that they require. So the company will be delayed a little in getting final approval, but we are confident that we are in a position to get the FDA what they need. And in the grand scheme of things, this will hopefully be a minor setback. The information requested by the FDA is mainly for one module, the clinical and a few minor points about manufacturing. In this regard, we are very happy to let you hear about the comments concerning the manufacturing of leronlimab from our CTO, Chief Technology Officer, Dr. Nitya Ray, the person responsible for this significant aspect of the BLA filing and the company's manufacturing of leronlimab. However, before Dr. Ray does, allow me just to take 30 seconds and let you know about Dr. Ray's background. Dr. Nitya Ray is the person who started the manufacturing process of leronlimab back in Progenics from day 1. There is no one in the world more acquainted with PRO 140, which was called at that time, or leronlimab, which we call it now. And we are in a very good hands. So with that, I will now let Dr. Nitya Ray explain his take of the PDUFA date rejection letter that we received about manufacturing section. Dr. Ray, please?

Thank you, Nader. Yes. That one deficiency on CMC that Nader just cited in the refuse-to-file letter, and that is not related to manufacturing, analytical testing, stability or quality of the product. That is related to the devices that is like syringes and needles that we proposed in the commercial packaging co-packaged with leronlimab trials. So FDA had said in that letter that we didn't provide the name of the manufacturers of the needles and syringes as well as the testing that was done was not submitted with the BLA. However, we did provide the name of the manufacturers and the testing that was conducted on the device following 21 Code of Federal Regulation Part 4, and that was provided in 2 different sections. So we will clarify with the agency that whether they had the chance to review those sections and if there's any additional information on that. Just to understand, this is not the devices that we are providing -- we propose to provide with the commercial product. These are co-packaged. These devices are independently manufactured by the manufacturers. They are commercially available. They come in their original packaging, sterile packaging and we'll just insert those devices, needles and syringes with the leronlimab vials in the packaging, the commercial packaging. We don't do anything with the devices. We just purchase. That is already available commercially and installed into the commercial packaging. And we're confident that we'll be able to clarify that with agency whether they had the chance to review that.

No. Thank you so much, Nitya. So I want to make sure everybody is clear. Dr. Ray just indicated there is no problem with the manufacturing. There was no comment on the PDUFA date letter about manufacturing, quality of the product, the way we manufacture, the process that we use, the characterization, validation of all of those. The comment was about the fact that we are providing syringes for self-injectables at home. And that was the problem. Dr. Ray, am I correct?

Yes. You are correct. So this is the one comment that CytoDyn related to the [indiscernible] to find.

Perfect. Thank you so much, Dr. Ray. Let's go to the next section, which is the clinical section. Now Dr. Kush Dhody is under [indiscernible] Before we go to Dr. Dhody, I just want to give one very important point about manufacturing before we go to Dr. Dhody, and that is the only monoclonal antibody that got approved for HIV for the same population is called Trogarzo. After they got their PDUFA date and they passed the 6 months ready to get approval, they had problems with manufacturing of the quantity, and that delayed them about 6 months. So I want to make sure that everybody knows that we are very happy to be in the good hands of Dr. Ray for manufacturing of our products being in the position that we are. With that, Dr. Dhody, could you please tell us in regards to what you believe? Dr. Kush Dhody is the Clinical Operations Director for all of our clinical trials. He is the person provides all the communication with the FDA. So Dr. Dhody, could you please tell us what is your take of the comments that we got on the clinical section?

Thank you, Nader. Hi, everyone. This is Kush. One of the critical components for this recent communication with FDA is related with the fact that we are seeking an approval for a 700 milligram dose that was tested in the monotherapy indication under our ongoing CD03 trial, whereas the heavily treatment experience, the indication for which we are seeking an approval was done on 350 milligram dose. As you mentioned in your previous comments that FDA has recommended us to consider 700 milligram dose for a heavily treatment experience based on the results from an ongoing trial, now, because we are getting an approval for a 700 milligram dose that FDA would want additional analysis to be performed on an ongoing CD03 trial, and that is the majority of the comments that FDA has, that FDA requested some of the information from ongoing trial. The CD03, which has tested 350 milligram dose as well as 500 and 700, and FDA has recommended that we do an integrated assessment of the efficacy as well as safety, all the exposure-related analysis, receptor occupancy and bioanalytical analysis. And those all analysis can be done. We have the data of the label. The reason that trial is ongoing, and at this point of time, we have completed all the treatments for all 500-plus subjects that are enrolled in the study. So at this point of time, while we have completed the treatment, we would be in a much stronger position to address all those comments that agency has for us, which has been difficult while trial is ongoing. So although we have patients currently in a follow-up, but from a treatment aspect, we have -- as of June 2020, we have completed the enrollment in our ongoing CD03 study, and patients are currently in a follow-up stage.

Perfect, perfect. So thank you so much, Dr. Dhody. So I want to summarize that. So in your view, we are capable to get all the items that FDA is requesting and provide them to the FDA.

Absolutely, yes.

Okay. Thank you so much, Dr. Dhody. So I will summarize the whole thing real quick. Nonclinical -- there are 3 section. Nonclinical, no comments. There were no comments from FDA in this letter. Manufacturing, nothing to do with manufacturing. No comments about that except the syringes and how we're going to package that for self-injectable at home. Clinical, Dr. Dhody explained it very well. I appreciate that. So with that, I would like to now talk about a different subject, COVID-19 pandemic and all clinical trials. We are planning to unblind our data in CD10, mild to moderate population this week. When I say this week, it could be Friday, so please bear in mind that it could be as late as Friday and most likely, it will be Thursday or Friday. And we will announce our results shortly after. What does that mean shortly after? That means the week after, once we do the analysis and we feel that there is a biostatistician and Dr. Dhody and his team feels comfortable to announce what the result is, we will do that. In the same time frame or, I should say, the week after that, which is, next week, we also will have a safety review by Data Safety Monitoring Committee, DSMC, for our ongoing Phase III study, which is for severe and critical population. But now before we go to Q&A, which I will allow -- we will allow about 40 minutes or so, I'd like to ask Dr. Scott Kelly, our Chief Medical Officer and Chairman of the Board, to update us quickly about licensing, partnering and Scientific Advisory Board that I'm very excited about. Dr. Kelly, could you please?

Absolutely. Thank you, Nader. So in regards to potential partnerships, we are currently in discussions with 5 worldwide pharmaceutical companies. We're also in discussions with companies in Brazil, China, India, Europe, Middle East and Northern Africa. Nader, the other thing I would like to bring up about the Scientific Advisory Board. Do you want me to go ahead with that? I'll do that.

Yes, yes, please.

In regards to our Scientific Advisory Board, we have commitments from 3 leaders in HIV, including Timothy Brown's position. I was looking for candidates with particular expertise in prep, cure, HIV and aging as well as combination therapy and monotherapy, and I believe we have accomplished our goal in that arena. We also have commitments from key oncologists and are discussions with leaders in NASH, GvHD and pulmonary. Nader?

Thank you so much, Scott. But I want everybody to know that our strategy of staying very clear and transparent with all the investors will continue. We have some major development for ourselves, we believe, in regards to COVID-19. We will address all of these situations. When Dr. Scott clearly said that we have Timothy Brown -- Dr. Timothy Brown was the first HIV patient who got cured. When we talk about cure project in the past, just the last time, I don't think the shareholders perhaps got the magnitude of this. We are hoping to use leronlimab during a bone marrow transplant to a patient that has HIV and cancer and to see if we can cure them, that patient from HIV. That is a very strong project, and PrEP once-a-month leronlimab injection at home could change the HIV paradigm for prevention. Now I just want to make sure that the shareholders understand that we believe these are major items. Now before we go to Q&A, I want to ask Doctor -- Mr. Michael Mulholland to tell us about Nasdaq uplisting and our activity. Just briefly, what do we have with Nasdaq?

Sure. Thanks, Nader. As previously reported, you know that our team has been very focused and working very diligently on the uplisting requirements and that we're very excited to announce that earlier today, we've completed our submission of a multi-part application for Nasdaq.

Awesome. That's great. Thank you, Michael. So I'd like to ask you about the money raising situation in the last 6 months and particularly this month, how much warrant was exercised?

Sure. In the first 6 months of the year, the company has raised $50 million. And of that $50 million, $42 million, thankfully, has come from our stockholders in exercising their warrants. And even more significantly, in the month of June, we realized $12 million in proceeds from warrant exercises.

I want to take the time right now and thank all the shareholders who have trusted us and believed in us and hang in there with us and exercised their warrants to support us. This helps us to not dilute the company more than what we have. I am thankful to all of you. Michael, the last question for me is the requirement for Nasdaq is between $3 and $4. That is both our approval both to go to Nasdaq. What's the difference?

Correct. First of all, I'd say that we meet -- we have no issues on the other standards. And if we look at the stock price, if at the time of uplist, the stock is at $4, we're fine. If by chance the stock should soften a bit to less than $4 down to, say, $3 or above, we're still okay. We're still fine because we meet the net tangible asset standard. So we're in good shape.

Beautiful. Thank you so much. And let's have the operator please go to Q&A.

[Operator Instructions] Our first question comes from Yi Chen with H.C. Wainwright.

First question, on the clinical section, that is the additional analysis requested by the FDA, just want a little more granularity. So the FDA wanted an integrated analysis of the efficacy and safety data of leronlimab at 350 milligram, 500 milligram and 700 milligram from the monotherapy CD03 trial that's currently still ongoing. Is that correct?

So the CD03 is completed. But Dr. Dhody, can you answer this question, please, for us so that way you can hear it from the person himself?

Yes. Absolutely. I will be happy to answer. So that is correct. As we said, one of the biggest, this has been a groundbreaking approach that FDA has not used it before in which they are considering to approve a product on a higher dose that has been tested for an indication. So as you know, the approval that we are asking for is heavily treatment experience population, which was tested with 350 milligram dose. However, FDA is willing to give an approval for leronlimab for a 700 milligram dose that has not been tested in the heavily treatment experience population. But to do that, for FDA to give us an approval for 700 dose, they would want us to provide an analysis of dose exposure at 350, 525 and 700. And that is -- can be done. It is not that it is not doable. It's -- the challenge is always about the trial that is ongoing. Now that we have completed the treatment with 3 dose levels in our monotherapy study, we can use the data from monotherapy to provide that additional information that agency is requesting for at this time.

And let me just add one thing in the -- Yi, to your question. The reason we filed the BLA without the issue between 700 and 300 and 525 comparison, if there's any more questions, we'll be on the review section of the whole thing, which is usually 6 months or 10 months standard. We thought that would be there. The fact that FDA wants to feel comfortable with that is very reasonable, and the fact that they are trying so hard to help us to get approval without having us do 700 milligrams heavily treatment experience population is a very, very good situation. I'm very thankful to the agency. But go ahead, if you have other questions.

So as you said, this would be the first time that the FDA would approve a drug at 300 milligrams for heavily treated patients without actually having heavily treated patients exposed to 700 milligrams as long as you're providing that data from a monotherapy treatment group.

So it's 350 milligram. And Kush, could you elaborate on that, please?

Yes. That is correct. So -- and -- but that bring us that -- although you can say that the trial for the CD02 was completed, and it's just because of this additional higher dose level data that is still being ongoing at this point of time, that leads us to the situation where we have to do more in-depth analysis for an ongoing clinical trial. But we are definitely equipped, and we are planning to get this information back to FDA as quickly as we can.

And let me just add to this, Yi, that a lot of our investors say, "Oh, my god. You have already all these 900 patient safety data. Why is the FDA doing that?" I'm going to have to explain that the guideline say when you do a trial from the same trial, you need 300 to 500 patient safety. FDA did a great job allowing us not to be failing and said that get just some patients from your monotherapy and only 50, not 300 to 500, which would have been very difficult for us. So go ahead.

Could you remind us again that in the CD03 trial, how many patients in total have been enrolled? And within that, how many have been exposed to 700 milligram?

So 595 patients was enrolled, and I'll let Dr. Dhody go through the breakdown. Kush, can you please let us now? Okay.

So we have close to more than 550 patients enrolled in overall CD03 trial, of which close to 130 patients have been exposed to -- have been enrolled with the 700 milligram dose. And most of these patients are recent patients because, as you know, the study has gone through changes in which the study was originally started with 350. Then we introduced the 525 option. And then later on, at the later part, we introduced 700 milligram dose. So most of these patients have -- were enrolled in 2019. So last patient was enrolled in the study back in June of 2019. And because this is a one-year treatment, the patients have completed their last treatment in June 2020.

Got it. And then I was just to add one -- sorry, just to confirm. You said 170 patients were exposed.

130.

130, okay.

So let me answer that question exactly. The number is over 225 was in 350 milligram. Over 180 were in 525, and over 125 was in 700. I have the numbers in front of me, but go ahead.

So what is your current estimate time frame to complete the additional analysis requested by the FDA and refile the BLA?

So we will not comment on that, Yi. And let me please explain, we're not trying to be difficult, but we are having a Type A meeting with the FDA. We'd like to elaborate on the time line. The Type A is usually given very quickly according to the people that I talked to that used to have Type A meeting before. Celgene had a PDUFA date missed and refuse to file, and they got their Type A meeting very quickly. So we believe that as soon as we finish with that, we're going to be coming out and talk about the exact time line. But for now, the time line that I want everybody to be focused is COVID-19, very crucial time line, very crucial data for the whole world. We don't know if it's positive or negative. We can't elaborate because we don't know. It's double blinded. But once it's unblinded, we will be happy to share that. And then after the Type A meeting, we'll share the time line for that. As I said, we believe it's not going to be a very lengthy process.

Got it. My last question is, could you let us know the current shares outstanding and the current warrants outstanding?

Yes. Mike, would you, please?

Yes. Sure. About 519 million shares outstanding, 519 million, 520 million. Changes every day due to the warrants. And as of about a month ago, fiscal year-end, we're about 116 million in warrants, but that has come down significantly, particularly in the month of June. So we'll true those numbers up when we file the K in a few weeks.

Our next question comes from [ Jeff Pfeifer ].

I know it's been a wild couple of weeks, and this is not the PR we expected to wake up to. But you've already answered a lot of my questions. One of my questions involves uplifting. I just want to make sure, last time, Mr. Mulholland, you talked more about the New York Stock Exchange, and you had started that application process. It was a 6-week process. And now we're talking about the NASDAQ and starting that process. I'm still confused on how all the cash requirements for these. If you could just elaborate on why the switch of exchanges and then still solving the problem for cash and balance sheet.

Yes, sure. Thank you, Jeff, for your question. In regards to cash requirement, we really like to raise just maybe a little bit of fund before [ uplifting ] majority after we [ uplift ]. We have talked to the agency, I mean, to the national exchange right now. So we will wait to elaborate on that more as soon as we can. Mike is all over that with his whole team. They have provided quite a bit of document to them. In regards to which exchange, NASDAQ is the exchange that it is -- everybody is wanting to be NASDAQ instead of New York. All of our shareholders who call me was always expressing if you can get on NASDAQ, it's the best exchange for us, and we are going to be that for now. So with that, let's go to next question, please.

Your next question comes from Jeff Smith.

Can you please provide an update and some status on the collaboration announcement with Mexico and the trial there. Has it either started or going to start?

Yes. I'm getting a massive -- operator that's not a static noise. So if everybody could mute the presenter, please do mute. I guess there is static being heard from the other side. In regards to the Mexico trial that we want to have, our attorney has the -- have a attorney, colleagues within Mexico, and we just have asked them to help us and guide us with this process, and we are in touch with them. The ball is in their court, and they are working on that. Please keep in mind that we can't force anybody to go faster than what they can. They have to translate the protocol. They have to translate the memorandum of understanding. The MOU was signed, and the protocol, I'm hoping any day we get a call from them saying that this study can start, and enrolling 25 critical patients would be very quick. But I'm anxious as everybody else. So let's see what happens. Next, please.

Next questions comes from [ Mark Ramstead ].

First of all, thank you guys for all your work and efforts. Just the first question, really just 2 questions, one you kind of started to answer. But do you have a specific date that you will be announcing the COVID results on? I know you said you'll unblind them this week and announce them next week, but do you have a specific date and then also a specific data on the uplift completion?

Sure. The uplift, I'll let Mike answer that. But in regards to COVID-19, next week is not that far away. It's Monday to Friday. So the last time I guessed within a week, I was wrong every time. So I'm just as anxious as all of you. Please know that we are working very hard to get that. As soon as we get it, we give it to you, and the time frame is next week. Mike, go ahead.

Sure. In connection with the uplift, right now, as I look to the future, I would estimate that this could be about a 4- to 6-week process. Some of the key variables that are still in front of us would be the results of a July 22 special shareholder meeting. Number two, I'm quite certain that the exchange is going to want to see our audited financial statements and our 10-K for the fiscal year ended May 31. Some of you may know, we have 75 days to file that, which is -- makes it due on August 14, and we're pushing our team very hard to get that wrapped up sooner. But we still have an audit firm that needs to conduct their work. And once we've done everything we can, then it's up to the exchange to push it forward.

Our next question comes from [ Richard Andrews ] with [ RA Securities ].

My question is for Nader. Nader, in the coming weeks and months, CytoDyn will be submitting documents to the FDA for both of the COVID-19 trials and for all of the cancer trials that have either started or about to start. So my question to you as a shareholder is how could I have confidence that the company will submit these documents effectively when you have failed to do so with regards to the HIV trials, which, of course, you have years of experience in dealing with the HIV issue.

No. I appreciate your question, and thank you for that. So let me explain. The way I look at the resume of somebody, I'm going to see if they did the Phase I correctly, then Phase II, then Phase III, then BLA, then primary endpoint and PDUFA date and then final approval for each indication. We have successfully started many Phase II indications, and we have successfully got this HIV program to this point. What we have chosen to do in the past, and it will be continuously that, is to be very clear and very transparent and very honest about exactly what's happening. When FDA needs certain things, we will immediately say yes, for sure, we would do it, and we will do our best to do it. Now in regards to the credibility, I don't mind you saying that I don't have any credibility in that, but I want you to know that Celgene got refused to file just like the way we did. Now I don't know if all the scientists that are over there and all the top biotechs will be discredited because they have a lot of other products that they did get through. And in regards to filing the application like the last monoclonal antibody, as I said, they got 6 months delay after the review was over because of manufacturing. Didn't they know that they're going to have about 80 or 90 issues in their manufacturing? Perhaps there is some reason for them that they can explain. I cannot -- I do not wish to defend myself. If this is something that should be against me, please, I understand. And I apologize if that's what everybody feels. But I'm going to do my best, as I have always done in the last 11 years, and I will report to everybody as soon as I can, anything that we get.

Fair enough. As a follow-up, I would just ask was there anything that surprised you with regards to the FDA's response?

So I was hoping to get the PDUFA date. But when you look at the grand scheme of things, FDA has worked very, very good with us. I mean what am I going to say? I'm going to say why they are asking for 700-milligram dose from another trial when we are -- we had 350 all wrapped up 2 years ago, we could get approval? No, because the FDA worries about patients, safety and efficacy. In this case, they wanted to have the 700 milligram that we said is better than 350 milligram. How can I point the finger at them? It's point the finger at me for being successful with 700 milligrams. And Dr. Kush Dhody clearly said when that came about, FDA did something spectacular for us. They didn't make us to the trial over. They have to go and have a meeting, and they voted on that. And they came back and said, congratulations. We will allow this for a one time. So these are the things I'm learning. But at the same time, we don't have a situation where somebody dropped the ball or, in my team, maybe I dropped the ball. But if it is, then, I -- again, like I said, I apologize. But we have the situation with -- FDA has said exactly what they want, and we will hopefully be successful and be able to get past this.

Our next question comes from [ Robert Smith ].

Yes. Nader, just 3 things. In the interest of being clear and transparent, why not just share the FDA letter with us, with the shareholders? That would be one question. The other question I have has to do with the interim work at 51 patients. You seem to be sure that they would be 1, and then you kind of backed off saying you need FDA sign-off. And now you're back quite positive that it would happen sometime this month. Have you actually gotten the FDA sign-off to do the Data Safety Monitoring Board? That's second question. Third question has to do with the Phase II moderate trial. It seems to me the secondary endpoints line up with Gilead's remdesivir having to do with death and intubation and hospitalization status and stuff like that. Whereas your primary endpoints are not something that I would think a Phase III trial would ever have as a primary endpoint. So I'm confused why you've chosen secondary endpoints, which really seem to be primary endpoints. And Gilead was the one that had that.

So we never reported that our Phase II COVID-19 primary endpoint is mortality and morbidity. It's a different primary endpoint, and I will have Dr. Kush Dhody explain that in a second. But let me answer the first question. Sharing FDA letter with the whole public, now no company that I know give the shareholder the FDA communication to the public. Now we have, as I said before, people who sign NDA, and they wanted to look at the company, we open it, and we give everything to them. And that's why we had licensing agreements, a very strong licensing agreement and another distribution agreement because they see everything. Now in order to open the share drive to the whole world, again, everybody would have to sign a NDA. And that's just not feasible. In regards to the interim look, interim look, I wanted to do 51-patient look, Amarex, which is Dr. Kush Dhody, told me, let's not do that. Then when we talk about 51, FDA also told us that's not what they were looking for. So we went to a different number. And I'm going to have Dr. Dhody explain the safety look. Kush, are you on the call, Dr. Dhody?

Yes. Yes.

Go ahead. Please explain the difference.

I can explain that. So for the -- so we have 2 trials, CD10, which is for mild to moderate population. The sample size was planned for 75 subjects. We end up actually enrolling 86 of those patients. At one point of time, and just so that you know at liberty, we have completed the enrollment in close to 2 months. In 2 months, we got this case study from start to an end. At one point, there was a discussion that can we do an early interim analysis for CD10, which was not planned in the protocol. So our approach was discussed that can we go back to FDA and request for an early interim analysis for PD10 study, plan for 75, can we do it early. What was discussed that in the interest of time, if we wanted to do an early interim analysis, this will require amendment to the protocol. It would have to go through an approval with the FDA. And realized that by the time we do all these starts, we will be actually able to complete the enrollment of the study and do a final analysis when the study gets complete. And that is exactly what we were able to do. So our last patient was actually enrolled on 17th of June. The study overall has a follow-up of day 42, but the primary and secondary efficacy end points are all linked with day 14. So our last patient day 14 occurred in the first week of July. And what we are hoping that by later this week towards the end of the week, we can do a final lock of the data and hopefully soon after, we can come up with the results. And these are the best possible time lines that we could have done instead of going with the decision to do an early interim analysis. So I think this decision has actually turned out to be the best way to complete the study and do the final look, which we are going to do. Now in terms of the other questions about the primary end point, so the primary end point for the CD10 study is based on the patient improvement of their clinical symptoms. In the CD12 study, which is a severe and a critical population, the primary endpoint is mortality, whether a patient is being alive or dead. And that is considered as the most objective endpoint for FDA. Everything else in terms of how much percentage patient has improved, whether they are in the hospital, not in the hospital, these are all subjective based on the resource available at the hospital. Whether hospital end up being discharging a patient or trying to keep it, it depends on the overall load in the hospital. So these are all subjective endpoints. But when you talk about the endpoint, which is as objective as being dead or alive, that is what always FDA believe that is the best way to analyze the efficacy of the product. And that is what we have done, use that as a primary endpoint based on discussion with the FDA. So there is no question about whether FDA -- this is a Phase III trial FDA has agreed upon, and they have recommended us to use mortality as our primary endpoint.

I wasn't talking about that trial. I was talking about the Phase II trial for moderate population. And for that one, you're using symptoms like fever, which has never been used as far as I know in a COVID trial and muscle ache and things like that, whereas Gilead's remdesivir did use mortality and intubation. And those are secondary endpoints in your Phase II moderate trial. I just don't understand why they're not primary endpoints because if you do a Phase III, that's what your endpoints are likely to be.

So this is a Phase II. It is a proof-of-concept study, in which you are going to evaluate all of those endpoints. So it is -- like when the results will be presented to FDA, the results will include all that information. So for a proof-of-concept trial, it's based on what we discussed with the agency at that time. If you remember, like that is the presenting symptoms back -- if we are talking about back in February, there are all these new symptoms that we talk about now. Back in February, shortness of breath, cough and fever were the presenting symptoms in majority of the patients with the data that is coming out from China. So those endpoints, again, has been presented based on the discussion with the agency. FDA has reviewed that protocol. We have discussed with the FDA for those endpoints. So that was made -- decision was made based on at that time. And when you end up in a situation where you have an ever-changing situation, you don't go and change your endpoint just to support the way some of the other companies that we know they have done that just before the results come out, you change the endpoint. That is not the right way of doing it.

Thank you, Dr. Dhody. Thank you for your question. Before we go to the next question, I want to add one thing, and that is that in regards to Phase II, as Dr. Dhody explained, there are multiple exploratory endpoints that we are going to report: how many serious adverse events, for example, was in placebo versus leronlimab. What were those scores in regards to fever and all of that? What was the time perhaps that somebody got -- how many of the patients got intubated and so forth than when were in the hospital? And then what was the mortality, perhaps? Was there any death in leronlimab or placebo? Those are all going to be explored reported publicly. And we are very excited because of our emergency IND patients who are publicly have been talking about all of these things, have been reporting very fantastic results, which means nothing for our approval. These are anecdotal data. But having 60 patients that was enrolled give us comfort. Does that mean approval? No. That means comfort. We just have comfort, and we're going to hopefully see the results and announce it to the world.

Our next question comes from [ Michelle Starke. ]

My question to you is this. With regards to the COVID side of the business, have you been in touch with the coronavirus task team for discussions, God willing, that everything goes ahead as you plan to become part of Operation Warp Speed?

No. I appreciate your question. We have not because we have been moving as fast as we can for the BLA in HIV in on one side with all the other trials and then with the COVID-19. We did talk to several different people at the beginning, and we realized that there was not a lot of confidence in the leronlimab. As soon as we injected emergency IND patients, the confidence went to the roof amongst a lot of people. But the time line has not allowed us. We want to get the primary endpoint hit on both of these trials, hopefully, God willing. And if it does happen, then I believe we will be involved with many different organizations. We do have -- we have been reached out by big pharmaceutical. They want to see the data immediately and big media who want to do a story immediately. So we are ready to go -- as soon as this is positive, I think things will turn out to be very nice for us.

Perfect. And that kind of leads on to my second question, really. You talked about media. Have you thought about going on Jim Cramer's Money Show on CNBC because you guys need the exposure, I think, because your short -- the shorts are really not doing you guys any favors right now.

No. I appreciate that. No, the shorts have their own agenda, regardless of the lights they have. They then, God bless everybody for whatever they want to do. But having said that, we believe that all the medias will come to us as soon as we have this primary endpoint hit, if we do hit it. And other than that, we'd be happy to go to anywhere. I'm sure what we haven't talked about. We have been very -- trying to be as visible as we can. But the major media, I believe, a national coverage will come to us as soon as we have primary endpoint hit.

Next question comes from [ Alan Kayne. ]

You've answered all of my questions. So I'll defer to the next question.

[Operator Instructions]

Operator. I'm sorry, operator, could you please make this the last question or so because I think we only got 3, 4 minutes left.

Last question comes from [ Nick Sorloth ].

I have a question whether you guys noticed any correlation in HIV test population on leronlimab and the cancer risk or a COVID-19 risk. Is there any data to see if it does any effect on that?

So I'm confused with your question. Are you asking if we have seen correlation for the patients who have both HIV and cancer and perhaps HIV?

The HIV population that is currently on leronlimab and whether or not the risk of cancer goes higher or lower.

Yes. We haven't had any HIV in monotherapy reporting COVID-19. I don't believe. So maybe I'm not right, but let me ask Dr. Dhody, who has better knowledge Dr. Dhody, do we have any reports of COVID-19 amongst the leronlimab monotherapy patients that was concluded recently?

Yes. So we had this discussion some time back, and we reviewed the data. And at that point of time, we know that there is no HIV for patients that were currently on the CD03 and a couple of our extension trials have, in fact, reported COVID. So that has been really a positive sign for us to know that none of these patients have, in fact, reported. And that is based on the last review that we did.

Yes. No, I appreciate that. And I just want to make sure everybody knows that on our monotherapy, we had over 200 patients going 1 year almost without any drugs. And in the 525 and 700-milligram responders rate with our criteria tend to be 90 -- over 90% to 95% post 10 weeks. And in regards to COVID-19 that we haven't seen, there are patients also in CD02 close to 25% or more that Dr. Dhody is talking about. That population and about 50 patients and extension in CD03. So quite a bit of number of patients. So with that, please allow me to conclude the call and just summarize that we are very focused to get -- to have a Type A meeting and answer all these questions. As you -- everybody heard, 3 sections of the module, mainly clinical. Mainly CD03 was not completed. So now we can get a lot better access to the data and analysis that FDA is requesting. And in regard to manufacturing, you heard Dr. Ray, how we are very well set. And in regards to nonclinical, there was no comment. So I believe, personally, that this is a very small delay for us and, hopefully, we can assure that. In regards to COVID-19, the world is waiting, and they're waiting for something that worked very, very fantastic. And I don't know if we are one or not, but we are about to find out. So with that, thank you very much for all of your support and all this time. Bye-bye.

Thank you. This concludes today's conference. All parties may disconnect. Have a great day.