CytoDyn Inc. (CYDY) Earnings Call Transcript & Summary

Greetings, and welcome to the CytoDyn investment community webcast. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Michael Mulholland, Chief Financial Officer. Please go ahead, sir.

Hello, everyone, and thank you for joining us today. This is Michael Mulholland, Chief Financial Officer of CytoDyn. Joining us on today's webcast is our President and CEO, Dr. Nader Pourhassan; our Chairman, Chief Medical Officer and Head of Business Development, Dr. Scott Kelly; our Chief Scientific Officer, Dr. Mahboob Rahman; and Dr. Harish Seethamraju, Medical Director for the Mount Sinai Lung Transportation -- Transplantation Program in New York. Before we begin, it is essential that we provide you with important cautionary language related to certain federal securities laws. Our remarks during today's webcast will include forward-looking statements. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are difficult to predict. Actual results may be materially different from any future results expressed or implied by such forward-looking statements. These risks and uncertainties include, 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. [Operator Instructions] I will now turn the webcast over to Dr. Nader Pourhassan.

Thank you, Mike, and thank you for all shareholders for participating in today's very important call. On April 15, 2020, less than a year ago, just 1 year ago, we injected the first patient in CD12. On Friday, we announced not only very strong results of 394-patient trial but the fact that 3 regulatory agency, including U.S. FDA, are working with us and have suggested the final path to approval of leronlimab for COVID-19 in multiple countries, including U.S.A. Less than 1 year to get an approval for an indication we had not been involved with or know anything about. That time line is so short. In the world of biotech, that is mind-boggling for me. However, in my opinion, the most important message for all of our shareholders in today's call is that we believe CD12 demonstrated that leronlimab works as an immunomodulator, which means we believe leronlimab helps regulate one's own immune system to fight disease. In our opinion, this was proven in CD12, which showed a statistically significant secondary endpoint, and it showed superiority to many of the other drugs in use to fight an especially difficult disease like COVID-19. But leronlimab's mechanism of action is not specific to COVID. COVID, we believe, is just one of many diseases that would benefit from the immune regulation that the leronlimab provided. So in our opinion, leronlimab works in HIV. We had primary endpoint Phase III based upon that and that leronlimab works as an immunomodulator. CYDY will have revenue from HIV hopefully by the end of the year -- this year, if we get approval by the end of the year. And we will have revenue from COVID as soon as an EUA is given or maybe sold in a different setting, which I will explain what I mean by that shortly. We are very grateful to the U.S. FDA allowing us to extend CD12 trial to generate more data to demonstrate we can achieve a statistically significant p-value and not only get EUA but also file a BLA for full approval. As the world knows very well, unfortunately, COVID-19 will not go away completely. We expect to sell leronlimab for COVID-19 for many years to come in U.S. and abroad. And we believe this will be a revenue-generating path for us on top of all other indications that we are pursuing. So before I give a quick summary of our fantastic results, CD12, I first would like to ask Dr. Scott Kelly to give us a quick update on what results are out there from big pharma in regards to COVID-19 severe and critical population. Dr. Kelly, could you please?

Sure. Thank you, Nader. So I want to begin by addressing a few questions regarding the competitive landscape in COVID-19. More precisely, what is the role of leronlimab in the severe and critical COVID-19 population moving forward? Let's go through some of the commonly used medications in COVID-19 and their role in the severe and critical COVID-19 population. I'll begin with remdesivir. Although approved, the benefits in the critical population remain uncertain. It may lessen time to recovery but mortality benefit has not been clearly demonstrated in this population. Convalescent plasma. The Emergency Use Authorization is being scaled back by the FDA to limit use of plasma to hospitalize patients early in the course of disease. Now when we look at hospitalized patients, recall that hydroxychloroquine failed lopinavir and ritonavir failed, azithromycin failed. Now colchicine was stopped as part of the RECOVERY trial on March 5 due to the lack of efficacy by the DSMC. If you recall, both our safety and efficacy DSMC evaluations recommended continuation of our trial with leronlimab. And Merck's molecule, we're just waiting for further clarity until they enroll more patients. Now let's talk about the standard of care in this population, and I'll begin with dexamethasone. I will now read from the New England Journal of Medicine article published on February 25, 2021. "So there was a total of 2,104 patients who were assigned to receive dexamethasone and 4,321 to receive usual care. Overall, 482 patients or 22.9% died in the dexamethasone group and 1,110 patients or 25.7% died in the usual care group within 28 days after randomization." In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation, 29.3% versus 41.4%; and among those receiving oxygen without invasive mechanical ventilation, 23.3% versus 26.2%, but not among those who are receiving no respiratory support at randomization, 17.8% versus 14%. In summary, the effect of dexamethasone is shown in the severe and critical population with tremendous power of thousands of patients but not recommended in the mild to moderate population as symptoms may worsen. Now let's move on to IL-6 inhibitors. The role of IL-6 inhibitors is more difficult to interpret. There were 7 previous randomized, controlled trials on the use of IL-6 inhibitors for the treatment of COVID-19. Taken together, the trials did not show a significant mortality benefit until the RECOVERY trial. This was a randomized but open-label trial. It was not blinded. The RECOVERY trial had 3x as many deaths as all previous trials combined. There were over 4,000 patients involved in the trial. 82% of patients in the RECOVERY trial received steroid. Since this study was largely performed following the publication of positive results regarding dexamethasone, the results showed that 596 of the patients or 29% in the tocilizumab group died within 28 days compared with 694 or 33% of patients in the usual care group. This is a 14% reduction in relative mortality. Tocilizumab caused a reduction in mortality when combined with dexamethasone but had no impact on mortality when given alone. In other words, the mortality benefit was not seen in tocilizumab monotherapy. What does all this mean? And is there room for improvement in the severe and critical population for leronlimab? If dexamethasone is approximately 30% effective, what about the other 70% of patients that are lying in the ICU beds on mechanical ventilation? What about the other patients with co-morbidities including diabetes, that are status post-organ transplant have a hepatic impairment or renal insufficiency? Leronlimab has been used in these patient populations without safety signals. We believe there is a tremendous opportunity to help these patients. Nader?

Thank you, Dr. Scott Kelly. So next, I would like to ask a physician who treated many COVID-19 critically ill patients. And there could be nobody better for us to elaborate on the results of CD12 than Dr. Harish Seethamraju, who is a pulmonary and lung transplant specialist at Mount Sinai Hospital and is the first doctor to ask for leronlimab in emergency IND in U.S., and he enrolled many patients in CD10 and CD12 clinical trial. So Dr. Seethamraju, please give us your understanding of CD12 results. Go ahead, please.

Thank you, Nader. My name is Harish Seethamraju. I'm a pulmonary critical care physician. I practice in New York, and I have seen the worst cases of COVID-19 in the pandemic. My interpretation of the study, CD12 data, is simply that in critically ill population in a well-balanced age group, the outcome and the absolute risk reduction is phenomenally better than any other medication that we have actively used either as an EIND or EUA in our institution. The benefit that we saw in the critically ill population translates into absolute risk reduction, much more than what dexamethasone has shown, which has been used liberally all over the world. I believe it's primarily because of availability of medication and physician's affability as an "you know the medication for a long time." And that are the 2 main reasons driving the use of these medications. But with the data that we see with leronlimab in critically ill population, if given the proper delivery mechanism as many physicians could use it, this will definitely show remarkable improvement in survival. And the benefit is not only acute but also prevent, in my view, the long-haulers, too. It will help with mitigating inflammation, promoting immunity, so we don't have patients ending up with organ damage after their critical illness. Thank you for this opportunity, Nader.

Thank you so much, Dr. Seethamraju. Next, I would like to ask our own Chief Science Officer and Director of our Clinical Operations, Ph.D. and Medical Doctor, Dr. Mahboob Rahman, who knows our data very well. He has been part of approval of many drugs and has about 25 years of experience in the field of regulatory and getting approval for drugs through FDA. Dr. Rahman, please tell us your take of CD12 data.

Thanks, Nader. Yes. So even though we did not hit the primary endpoint p-value, as they say, but if you look at the data, the -- even in the overall population, you will see consistently in essentially all the endpoints, you see a benefit, maybe numerical, but you see a benefit consistently. And then you remember that these trials were -- this trial was designed in March, April of last year with very little knowledge of the disease, very little knowledge of the natural history of the disease. And usually, the common things that we need to design a trial like the -- any effect of age or those kinds of things, we did not know. Despite that, we had prespecified the critically ill patients as one of the subpopulations that we will test our primary and secondary endpoint. And if you look at those prespecified analysis, you will see that this -- the mortality was reduced by 24% in this critically ill patient population, which was defined as ordinal scale 2, which means intubated -- either just intubated or on ECMO. These patients, 24% mortality was reduced. Then if you look at the time to recovery or discharge from hospitals, our hospital stay in this patient population, you actually see a statistically significant difference, 6 days less in this patient population. And another secondary endpoint, which is called discharge alive through day 28, and in here, we see a pretty wide difference between the patient who received leronlimab, 28%, versus patients who only received standard of care, 11%, a 166% better rate than placebo. So with these results in this critically ill patient population, we think that regulatory authorities will take a very close look and see if there is a potential for saving lives under the conditions that we are in right now, with essentially no medication having an impact in the mortality and benefit in the critically ill population. Nader?

Thank you so much, Dr. Rahman. So similar to Dr. Rahman and Dr. Seethamraju, Dr. Nicholas Agresti, Dr. Chris Recknor, Dr. Kush Dhody, Dr. Kazem who was an ex-reviewer and biostatistician at FDA, they all believe the results are very strong to warrant conditional EUA while we generate more data. So we are working on all avenues for this immediate conditional EUA while we conduct a small 140-patient trial to support our data. That protocol for 140 patients has been submitted to FDA. As soon as we get the agency's comments, we will immediately start with the same site. We have everything ready to go, so we believe that could go very quickly. So we have explained the results in some detail already in 2 press releases, so we will not take more than 5 to 10 minutes on it, but want to let everyone know that we decided to put out the whole executive summary of the company for all to see as we are very proud of these results, and we like everyone to be able to read the data as it was generated. Before I get to these results, allow me to give you 1 new developing news in regards to Philippines FDA. I was told last night that Chiral Pharmaceuticals, which we are working with in Philippines, is ready to file CSP as of last night. Perhaps they have done a deal. I haven't got the confirmation, but they are doing it because they have received from hospitals indication of wanting to get leronlimab for certain patients. As soon as this is filed, if it hasn't been already filed, it would take 48 hours for us to get clearance. Chiral Pharmaceutical has told us that their FDA has said that the CSP will be given when they file but we still don't have it yet. But once they get it, we will send them vials of leronlimab immediately for immediate sales to their patient. This will start with a very small number of patients. But if we get some good results, they have told us that Emergency Use Authorization, along with CD12 data that we have, could be very possible. We will not know until we hear from them, and we will update everyone in that very important new development. Furthermore, Brazil is having terrible situation with COVID-19, and we are reaching out to their regulatory agency and we'll keep everyone updated on that situation as we go forward. As I said on Saturday interview, we will try to have 1 -- few updates as much as we can, as much as the regulatory and our legal team allows us when we have something to report on to the whole shareholders. Now let's talk about the results very briefly. Critically ill population, we've shown relative reduction in mortality of 24%. In regard to the whole population, we talk about 309 patients severe and critical. What happened when they took were commonly used drugs and leronlimab versus placebo, and we talk about 233 patients that took dexamethasone with leronlimab versus dexamethasone and placebo. The results will be out there and everyone will be able to see what we have out there. This will be an 8-K with the exact executive summary and all the details. In regards to U.S. FDA, again, we are very, very thankful that we are able to go forward with another protocol of 140 patients perhaps, and we hope to generate that result very quickly. It will not take us very long because the sites are already set. We will give time lines to everybody as soon as we can get our hands wrapped around the exact time line. MHRA gave us accelerated approval. We met with them, and they said that they will accept data from CD12 extension. We don't know if the current data will be accepted. The current data, I believe we have 5 critically ill patients. One has died, that's 20% so far. And the results that we've shown was 28% almost. So we don't want to make a big deal out of this until we get more data together. In regards to Health Canada, the interim order, we will be filing that. And whether we can sell drugs or not, we are questioning that from them, and we're going to find out if we can sell products while interim order is going on. We don't know that answer and we will let everyone know as soon as we know. We will also file with Europe, Brazil and Philippines, as we said, as soon as possible. So before we go to Q&A, I will update you briefly on other indications also. The indication for cancer, the recent results that we're getting, 10 patients are surviving in stage 4 that we talked about before, and they're reaching 11 months. That does not include our other patient who's in emergency IND that is going to 16 months. So seeing a stage 4 patients going there. And some of the patients, their chemo and CTCs are really fantastic. And without saying too much more, I'm going to ask Dr. Scott Kelly, what do you think about the cancer...

Yes. After seeing this recent data and discussing with the treating physicians as well as the patients on their progress, I feel very comfortable in saying that, ultimately, I think that CytoDyn will be an oncology company.

Dr. Rahman, do you agree with that?

Absolutely, Nader. And we are seeing more and more results in various patients, some in our currently running trials that really surprises us -- impresses us, the results that we see. And we -- I also believe and completely with Dr. Kelly that we will eventually become more of an oncology company because the fact that many of these solid tumors expressed CCR5 and the mechanism of action of our molecule, it could be a tumor-agnostic treatment, which could be huge, which means that it may be able to help many different cancers. So yes, I totally agree. Thank you.

Thank you, Dr. Rahman. Now in regards to NASH and long-haulers, Dr. Chris Recknor and Dr. Scott Kelly and Dr. Rahman have worked on that. And Dr. Kelly, would you like to elaborate on that?

Yes, absolutely. And I have some very exciting news for the shareholders in regards to both of these projects. And I know that we're working very hard on CD12 and people were not thinking about long-haulers or NASH as much. But I tell you, I think you're going to be very pleased with our progress. I'll go through each trial and give you a little brief update. So as you know, NASH is a Phase II trial. It's a 60-patient study for 14 weeks. There's 4 weeks of screening, 14 weeks of treatment and 4-week follow-up. So patients will get 14 doses of leronlimab on a weekly basis. And we're looking at, as the primary endpoint, PDFF, we're looking at fatty deposition in the liver. We're also looking at fibrosis and that will be done at baseline in week 14. And I'm really, really pleased to announce that thanks to Dr. Chris Recknor and his group, that we are already 30% filled with multiple sites being activated and on target for results in early Q4. And I think that one of the benefits of being involved in COVID is really being involved in long-haulers or post-acute sequelae of COVID-19 early. This has been a lot of work to get this right, but I've got some fantastic news in regards to that. And I'll begin by just giving an overview about what the opportunity is there. So if you look at -- there's roughly 117,500,000 people who have been diagnosed with COVID-19. And you're going to see different numbers. Some people say 10%, some people say 30% or more are going to be affected by long-haulers. And that leaves between 11,750,000 or 35,250,000 people who will need treatment options. Our study at CytoDyn with leronlimab is a 50-patient study. I'm very pleased to announce that the trial started on March 1, 2021. We are 50% filled after only 1 week and expect results in early Q3, June or early July. So again, I want to thank Dr. Chris Recknor and his team for doing a tremendous job in this trial. This is not easy, okay? And the point of this trial to do an investigative trial with 50 patients is to look at subjective complaints and correlate these subjective complaints with biomarkers, and then use these biomarkers and subjective complaints to really extrapolate that to other post-viral syndromes. So in this trial, patients will receive a total of 8 doses of leronlimab weekly. We're going to look at the primary endpoint of symptoms through day 56. The secondary endpoints include fatigue, brain fog and sleep based on the PROMIS scale. And then we'll be looking at exploratory biomarkers to correlate the 2. Nader?

Thank you so much. So I want to make sure everybody notices that we are not getting away from HIV. The BLA submission for HIV has had tough time because of the receptor occupancy that did not work for us, and we had to generate another one and that was one of the big setbacks. But we're working on that and that's one of the main delays that we have. But having worked on 2 clinical trials, CD10 and CD12, in the last 1 year as hard as we did and getting all these patients and getting the data to where we have, meanwhile doing all of these other trials, it's a big task. And we will have some firm time lines for HIV, but we are hoping to have approval by the end of the year. But this is again not firm until I have more verification of exactly what time lines we have. With that, please let's go to Q&A. Arian?

The first question. Provide clarity on the long-hauler trial protocol, and I think Dr. Kelly spoke a little bit about this. Do you have anything further you'd like to add?

Yes. I would just say again, reiterate, what we're doing is really looking at the clinical symptom scale and exploratory biomarkers to correlate the 2, so we can have a successful trial in the future and help these patients.

Why did the company file an additional protocol to enroll more patients in the critically ill population? Is it because the difference in the percentage of critically ill patients receiving leronlimab who died and those who received standard of care who died is not yet statistically significant but could be made more so with further trials?

So we have to show much better clear numbers according to what U.S. FDA has told us. The MHRA told us that they will accept CD12 extension. So we said, well, if we're doing a trial of 140 patients to generate more data to clearly have a p-value statistically significant and then we can also perhaps do interim analysis, if we decide to do that with MHRA, we hope to enroll so quickly that we don't have to do that. But we will work with everybody. Dr. Rahman, do you have anything to add to that?

Sure. Yes. I mean, so if you -- I mentioned 3 endpoints, right? There's the survival benefit, we got 24% reduction. We got in the discharge alive, there was actually 166% better results. And in one of the endpoints, the hospital stay, we actually got statistically significant results. So now the other 2, the delta is so big that we are pretty sure, we are confident that if we had a few more patients, we could have achieved the statistical significance. And that's why we feel very comfortable, very confident that if we do a trial, a very quick trial in a patient population which is critically ill, we will be able to show these results to be statistically significant. So that's why we are -- while we are discussing with the health authorities for a path forward, we felt that we will start this protocol. And thanks to FDA, they were very supportive of this and they are willing to work with us in designing the trial. So we have submitted the protocol with FDA. FDA is looking at it. We are expecting their comments any moment. And as soon as we have resolved those and we have an agreement on the protocol, we'll start enrolling these patients, especially in the patient -- in the sites that are already -- 25 or so sites which have enrolled the CD12, we believe that we will start with them, and we can enroll these 140 patients very quickly and we'll be able to show the statistic significance.

Why did we not go for the 28-day interim evaluation as suggested by DSMC and complete the trial with 42-day mortality as the primary endpoint? By rushing the 28-day trial, it is costing us more delay.

So when we did get to the point where we had 75% of the patients enrolled, Dr. Scott Kelly worked with Brian Brothen, Mr. Brian Brothen, very aggressively with Dr. Kush Dhody, who did a fantastic job to enroll all of our patients before the 42 days or very close to that 42 days. So it didn't make sense for us to only use 75% of the data and go to the agency rather than the whole 100%. Now if you go back and say, "Okay, at 75%, we couldn't look at the data," and they would have said enroll more patients, then that will be one of the options that people are maybe thinking about it. We thought this was the cleanest path to go and all of us made that decision and we went for it.

Could you please provide a NASDAQ uplist status?

Mike?

Sure, thanks. We currently have 3 primary issues to address, none of which are insurmountable. Number one is the elimination of what's called the going concern exception to the audit opinion on our financial statements. This issue can be resolved in 1 of 2 ways: raise a lot of capital now, which we choose not to do so; or obtain some form of approval, resulting in product revenues or product orders and, therefore, revenues. We believe an approval is near. Therefore, this is management's preference to resolve the going concern exception. The second issue is a shortfall in stockholders' equity requirement of $5 million at the time of the uplist. As we've stated before, we have a plan to cure this shortfall. The last criteria is the seasoning of our stock price above $4. And lastly, we remind everyone again, the exchange also considers various subjective issues. And ultimately, it is their decision alone as to approving an uplist for any company.

The next is a set of 3 questions from 1 person. ClinicalTrials.gov named all-cause mortality as the primary endpoint. Why report the 24% reduction in all-cause mortality without a p-value?

We discussed that. We put the p-value for primary endpoint. Critical yield was another primary endpoint.

The press release does not support a p-value for shortened time to recovery but nowhere is shortened time to recovery listed as an endpoint at ClinicalTrials.gov. Do you want a future trial protocol to include this as an endpoint?

Dr. Rahman, would you like to address that?

Yes, yes. Maybe in the ClinicalTrials.gov, it is listed as hospital stay -- length of hospital stay, which is the same as essentially shortened time to recovery. We just made it more understandable in terms of lingo but it's the same. And that is one of the secondary endpoint, and that is the one that was statistically significant in the critically ill population.

And the last question from this caller. Why does ClinicalTrials.gov state planned number of subjects or 50 subjects for the long-hauler protocol and then has an estimated enrollment as 102 participants?

Yes. That's what I was addressing before, which is we're going to do a quick investigative trial to further establish the clinical symptoms and correlating with biomarkers. And that's the reason to do that.

How many additional severe, critical and critical severe patients need to be enrolled to potentially reach statistically significance for mortality?

So we did the power for critically ill population. And as we said, 140, believe -- we believe that the number that we need to get to.

Do you have a time frame for the BLA filing in the U.S., Canada and the U.K.?

We're not prepared to talk about that because of uncertainty about the receptor occupancy. We will talk about that very shortly and have a specific time line. We hope for approval by the end of the year. But again, we don't want to commit to that yet until we have more clarity.

What is the status of the triple-negative breast cancer trials?

Yes. The triple-negative breast cancer trial, due to all of the uncertainty with COVID, we're not having a lot of people travel right now. We will be restarting the TNBC trial shortly.

And maybe I can add that the basket trial would be our focus mainly because that would include all of this cancer indication. But go ahead.

Do you expect to fund any additional trials, if needed, by having a secondary offering, assuming after uplist to NASDAQ is completed?

We have not decided to do that yet. We are planning, as we said before, to have a couple of trials this year, but we want to get this COVID-19 situation to the point where we have revenue. We believe we're very close to that. And we get that done, mission accomplished hopefully soon. And then, yes, we will talk about that.

Do you believe that by pushing to become the approved medication for critical patients, we'll eventually see doctors using it for severe simply because there are not many choices? In other words, just by getting it over the regulatory bar for critical, does it open us up to be able to use it for the severe population?

We do not talk about anything about off-label. We're not allowed to sell off-label, and that's not something we will talk about. We only will go for critical populations, sell for that. And then if we want to do severe, we have to do a trial for that also as an expanded label. So we'll talk about that at that time.

Are there any ongoing discussions with the EMA for admission into the European market? If not, why not? And if so, how are these discussions going? And do they offer prospects of a speedy admission of Vyrologix in the European market?

So we are submitting our application next to the European agency. And as soon as we do that, we'll let everybody know.

In the course of the CD12 trial, have you seen any patterns that suggest leronlimab is particularly effective in patients with certain co-morbidities?

So we had primary endpoints, secondary endpoints, prespecified secondary endpoints. And those things, we analyzed it for the sake of getting approval. Many other things, we just did not look at. And they're exploratory endpoints. We also have an executive summary where everybody can see that.

What is the all-cause mortality for the trial 28, 42 and 60 days?

What is all-cause mortality? Is that 28 days for primary endpoint, 42 days was not primary endpoint. It was another -- a point that we wanted to look at, but it was not -- it was not secondary endpoint, I don't believe so. Dr. Rahman was 42 days the secondary endpoint?

Yes, it was a secondary endpoint or exploratory on [indiscernible]. And it was very similar because there were very few people died after day 28. Most of the patients died before day 28, which was like 80 patients and another 8 patients died after day 28. So you will expect the results will be similar.

How will the FDA view the open-label data since it's not trial standard double-blinded placebo?

That's why we're doing a double-blinded placebo control of 140 patients.

I think the question was in relation to the open -- the open-label that you're allowed for the additional CD12 patients. Are they going to be viewing that data that's not double-blinded?

We have not talked to them or MHRA as we said in the talk, so those are open label. But the FDA needs to have double-blinded study in that 140 patients, 50% leronlimab, 50% placebo.

Since our last communication, how have the manufacturing logistics come along?

Very nicely. As I said, the CEO of Samsung congratulated us about the results and told Dr. Nitya Ray and myself that, "We are ready to support whatever amount that you guys need, we will be willing to put all of our resources for you to have your needs met." And I was very appreciative of that.

You also stated that there was $2 billion worth of tubes ready for distribution. What is an update on this?

So I never said $2 million. I always said...

He stated $2 billion worth of...

$2 billion. Okay. Yes. So if you look at the price of -- that we want to sell it at the time, I said that the price of -- at that time was -- evaluating 1.2 million while -- with that price, which came to $2 billion. If the price goes down and up by the time we get approval, then we have to reevaluate. But the number is very high, so we'll leave it at that.

With the FDA approval or EUA and revenues expected from the sale of an entire first batch of 1.3 million vials to the U.S. and/or to other countries, is a dividend still likely happening later this year?

If we have approval and sell 1.3 million, as we said before, my intention is to definitely give dividend to the shareholders. This is something that we are -- I am very much for it. The Board will vote on it and they will make the final decision. But I don't see why they would vote against it.

Has a stock buyback been considered in conjunction with the dividend or as an alternative to a dividend?

No. In conjunction, that's what my take is. So you can't take that as -- this is the way I think. There has to be a lot of analysis done also at the time and do the best that is good for the shareholder -- all the shareholders.

Is there any expectation for government financial support towards manufacturing leronlimab?

Yes, I'm hopeful for that. But I don't have anything concrete to report on it.

Is there any news on the application for BARDA and/or Operation Warp Speed in getting funding from government from the -- for CYDY or CytoDyn, like other companies, especially like Novavax?

As soon as we have EUA, then we will reach out to them and say if we can have the discussions open up again.

What is the difference between overall mortality and probability of being discharged alive?

So discharged alive was ordinal scale of 2. Everybody was scored between 1 to 7, 1 being dead to being on invasive mechanical ventilator, intubated in ICU. And 7 was released from hospital with no problem. 6 was released from hospital with some minor problems. So those patients who walk out with OS 2 and they received a score of 6 to 7, and that's what we evaluated at the time of discharge because 6 and 7 means discharged. And the other one was -- go ahead. Go ahead, Dr. Rahman.

Sorry, sorry. Once you are done, I wanted to add something.

No, no, please. I'm done. Go ahead, please. That will be good. Please go ahead.

Okay. Yes. So to explain it simply, overall mortality is patients who died. And discharged alive not only takes into account whether you're alive but also takes into account that you are well enough to leave the hospital. So it's a combination of being alive and well enough to leave the hospital. So you may be alive, but you're not in a condition to leave the hospital by day 28 because that's also a benefit. And as I said before, in this endpoint, you see that the patients who received leronlimab, 28% of them were able to leave the hospital by day 28, whereas only 11% of the standard of care. So yes, so it takes into account death as well as how well you are feeling if you're alive. Thank you.

How many additional critically ill patients have been enrolled since CD12 completed?

Five, and we had one dead, which is 20% as compared to our study at 27.9% dead. So we don't want to make a big deal out of it. It's positive. But let's wait until we get more patients.

Recently -- this question is with respect to a quote that you had previously, Dr. Pourhassan, about the recently approved IL-6 blocker used to treat severe to critical hospitalized COVID-19 patients requiring mechanical ventilation, reducing mortality by 2% in comparison to the 24% from our trial. The question is, are you indicating tacitly that the standard of care included tocilizumab after their approval and that, in fact, our results for the critical population are much superior to a standard of care that included tocilizumab?

So we were talking about comparing what our result was versus theirs. Obviously, the results are, in our studies, taking the commonly used product. Their absolute delta was 1%. Their relative delta was 2%. Our absolute data was -- percentage was 9%, our relative was 24%. So we thought that was -- you want to add something?

Yes. I would just say that there's been a number of different trials for the IL-6 inhibitors that we discussed earlier and the 7 previous trials. And the most recent, I think, a lot of people are referring to is the RECOVERY trial, which we discussed already.

Since the press release has referred to their outdated trial, please explain whether we really have any chance going forward given the result of the present trial. Why would other countries want our [ popular ] drug, either given that they have better results for a more comprehensive trial? And even though we have 6 days over their 5, that seems like a small difference.

So I think everybody would agree that when FDA says do another trial to show that critical population is solid, your data, that means they're seeing a signal and they're seeing a need that perhaps they can work with us. MHRA said the same and Health Canada had the same opinion. Do you have anything to add?

Yes. No. And I think it's important to realize that if you're talking about it strictly from a medical economics perspective that -- and each night in the ICU can be $25,000 or more. So if you're talking about it in those terms from a medical economics perspective, that it's actually not that expensive to use a drug for 2 doses as a subcutaneous injection.

Yes. Thank you. Dr. Rahman, do you have anything to add to this?

Yes. In addition to that, in addition to the expense, remember, there were sometimes, in some hospitals, some areas of the country where there were no ICU beds available. So if you could discharge these patients 6 days earlier than the standard of care, that will open up and that itself will save some more lives, too. So look at it that way also. Thank you.

That's an excellent point, Dr. Rahman.

What are the pending requirements to obtain either an EUA or full approval? And what are the anticipated time lines for each?

So we don't have an anticipated time line yet because we want to finish the 140 patients. However, we believe we can finish the enrollment we need to start within 4 to 6 weeks. If you have to wait 28 days after the last patient and if we can start everything quickly because we already have the sites set, keep in mind, we have 10 active sites. We have 25. But if you have 10 active sites alone, that's 14 patients per site. And Dr. Scott Kelly and Mr. Brian Brothen and Dr. Kush Dhody would be working very hard, and Dr. Rahman would be involved with them. So we are very excited to get that done very quickly.

What are the current funding opportunities for ramping up manufacturing at Samsung?

So we -- as always, we would let everybody know that we are going to raise funds in the best conditions. This is not the best condition, so we believe we have some major event that could help us with the appreciation of the stock. When we get those, we will raise funds at a higher level. That's what we hope. That's what we always hope. So let's talk about this once we get this mission accomplished, which is getting EUA or get revenue from other source.

What is the readiness for American Regent distribution in the U.S. if the FDA does approve leronlimab for COVID-19?

Very ready to go. Mike Mulholland and the team has worked with them on all the contract issues, and everything is resolved.

Do they do any production or labeling with regard to the finished product or just distribution?

Distribution. The labeling will be done through Dr. Nitya Ray and the company that he has under his control for this matter.

What is the anticipated price of leronlimab for other countries, specifically Brazil and the Philippines?

With Philippines, they have told me that they charge the same as the United States, which I was surprised. With Brazil, I have not checked into that. But we will look at that very carefully and let everybody know.

How long will the EIND and open label that's continuing to go last, especially with the trial, the next trial you'll be doing?

So we are hoping to close those. So we haven't talked about that to the FDA. But once we open the 140 patients, then there is no need for us to have those 2 available unless the agency says different and want us to continue EIND in the hospitals that are not participating in CD12. We don't know. But we'll let everybody know as soon as we know.

I think you answered this question already, but if full approval is obtained for leronlimab for COVID critical severe, can leronlimab be used routinely for off-label use by physicians?

I do not have any comments about that.

Any plans to use open funding sources leading to stock dilution?

Well, the funding that we did in the past was selling shares at $10. And then we have the options to take care of our debt the way we have done in the past. I hope everybody is very happy that we authorized 100 million shares. How long ago, Mike, we authorized 100 million shares?

Last summer.

Last summer. And we still -- we had to put 25 million for the...

Equity [ plan ].

And the rest of it, I think most of it is available. So I hope everybody is very happy with that.

What is the status of the Scientific Advisory Board?

Yes. The Scientific Advisory Board is moving along beautifully. In fact, I've been going to individually meet with a lot of the Scientific Advisory Board members. I've been to San Francisco, New York, et cetera. Obviously, it's been slowed down a little bit just because of COVID, but I've been vaccinated now so I'm going to meet with them individually.

What percentage of patients were given steroids? And would steroids be contraindicated with leronlimab?

Steroids are not contraindicated with leronlimab. In fact, one of the interesting things we're seeing is the synergistic response with this. And I think that's encouraging. And in regard to the safety with leronlimab is that we're able to use this medication with a lot of different agents and potentially enhance the effectiveness for us to worried about drug interactions.

What are the latest shareholder equity and net tangible asset numbers you can share?

Mike?

Yes, the last numbers we can share are as of November 30 in our 10-Q. And as of November 30, which was filed in early January, we reported stockholders' equity at a deficit of $6.5 million.

What is the plan to meet the Samsung payment that was previously reported as being due in Q1?

We have worked with them several times, and they always have worked with us if we needed to get more time to pay. But we are hoping to make those payments and we will let everybody know our plan very soon.

Is the work that the company is doing with regard to COVID somehow impacting or delaying the BLA submission?

Well, when you have so many different items to take care of, obviously, it's not as easy, but we thought COVID-19 is very important as we saw patients reaching out to us, physicians wanting emergency IND, then we got the protocol going. So now that we see that there are potential efficacy signal that is showing a path to approval, we have to finish that. And then HIV, we will have time lines. Now did it affect the HIV time line? I think perhaps it has but I just can't be sure of that.

Do you feel that the FDA understands the importance of giving leronlimab earlier in the disease process?

You have to decide what you want to do with your protocol and go to the FDA. It's not the FDA's job to come and find out how your product will work.

Why are you extending the trial, which takes time, especially since COVID deaths are declining and there are less patients to enroll in order to get the p-value?

We have to follow the law. If you had a red light and there's no car coming, you can't just pass even though there is no car coming. There is rules and regulation that fits perfectly for all the products that have to be treated the same way. And we are being treated very fairly and we are very happy to go forward. And if it takes a year and 3 months versus a year to get approval, I think that's an amazing achievement. Maybe people think differently, but I just -- I'm very proud of our team getting this done, Amarex, Dr. Rahman, Dr. Scott Kelly, Chris Recknor, all of our people that are doing fantastic jobs. So this is the best we can do. And that's it.

What was the mortality rate in the over 65 age group in the leronlimab arm versus the placebo arm, with the understanding that this population was overrepresented in the leronlimab arm and that the overall mortality rate in this population was 42%?

So -- yes. So the mortality rate for the overall population, when age adjustments happen, was 9% better, less mortality in over 65. And overall in the whole population, less than 65, the relative reduction, the mortality reduction was 32% in the less than 65. Very impressive. That's what I thought.

I've heard your position on buyout potential, but has there been any discussion on partner potential that would be interested and make economic and resource sense?

Yes. So Dr. Scott Kelly wears 1 million hats. He's Chairman of the Board, he's the Chief Medical Officer and he's also Chief Business Development. So Dr. Kelly?

Yes. No, there's been some interesting things happen. We've talked about how we think in terms of business development for these companies. And one of the things that everybody knows now, the data is out there and that's certainly one of the things that I think these companies were waiting on. And now seeing the potential that this is a potential immunomodulator, I think that companies are going to be paying a lot more attention to this. And I will say something that we think is very interesting that I think a lot of people are not aware of and not paying attention to and I think that I feel comfortable at this point talking about. But as we've gained awareness with leronlimab, both from a national and a smaller scale, we've had a lot of people approach us about the potential for doing trials but paying for the trials as long as we supply the drug and -- but not asking for equity in the company. And I think this is a really strong position for the shareholders to have these trials completed to look at multiple different indications but have other people pay for the trials. And that's just to supply the drug and that's happened in numerous indications.

So let me add one thing. One time, I look at the percentage of deals that happened between big pharmas and small biotechs. I think it was 90% of the deals happen when the company finished Phase II. Right now, we just finished the Phase III, and we just put the results out on Friday and today's Monday. I think there is potential here. Whether we get something or not, we would let everybody know as soon as we get those information.

Can you tell me the number and percent given placebo versus leronlimab in those over 65 compared to the percent and number of placebos given to those less than 65?

So in the overall population, 17 deaths out of 171, which was less than 65 years old patient in leronlimab. Placebo was 14 divided by 96 patients. 14.6% versus 9.9%, absolute delta of 4.7%, relative reduction was 31.8% in mortality.

Could CytoDyn keep the same CD12 trial going and just extend the mortality review of 42 days?

We will not do that because we want to get the results very quickly. As Dr. Rahman alluded, the time to discharge is fantastic. The p-value was already there. And when we did age adjustment, the p-value got even better. It was like 0.01. Then we did age adjustment. That was 0.005. So we feel very comfortable with this indication. And Dr. Rahman said it very clearly.

Have any of the patients that have been treated with leronlimab shown signs of long-hauler symptoms?

We have not looked at that. Dr. Rahman, is there anything you want to add about that?

No, we haven't been able to look at it because it's still pretty soon after completing the study. So we will be looking into that. Thanks.

Do you know the proportion of patients who progressed from severe to critical in leronlimab plus standard of care versus standard of care alone?

Well, we talked about the ordinal scale. So 1 was death, 2 was invasive mechanical ventilator, intubated in ICU and so forth. So we did look at those and those results are in executive summary that will be 8-K. So everybody can see every explanatory population, subpopulation, main population, first -- primary endpoint, secondary endpoint. It's all going to be out there for everyone to see.

Can you please explain in lay terms how monoclonal antibodies are effective in the treatment of solid tumors?

So you want us to -- the question is asking for us to explain the mechanism of action of our monoclonal antibody against the tumor, is that right?

I believe so, yes. They're general but I think that it's specific to our molecule.

Yes, yes. So when you look at the tumors, there's a number of different mechanisms of action in oncology arena. One is CCR5 expression on the tumor. You've got M2 to M1 macrophage conversion. You've got blocking of Tregs and then you've got endothelial cell migration. So those are really the main ones. We actually have an excellent summary on our website, if you look at a video that will go through all the different -- the mechanism of action of leronlimab in oncology and immuno-oncology.

Dexamethasone has an EUA and it failed to meet statistical significance. CD12 is the same but we hit statistically significant with hospital stay. Will we apply for an EUA, especially when Janet Woodcock's new pandemic guidelines of p-value not mattering in small trials?

So we don't talk about the agency's decisions besides what they tell us and we tell to you guys. We are very, very happy with what we have. They could just say, "Go away. You don't have anything in COVID-19. Go ahead and do just HIV." They didn't. So let's celebrate on that. Let's build on that and let's get it to the finish line.

You've touched on this a bit but I'll do it all in one question here. Is our current cash position sufficient to fund the new 140-patient CD12 trial, get the BLA for HIV combo, complete the long-hauler study and current NASH study? And if not, how will you fund these items?

So I hope that all of our shareholders are very proud that we raised almost $400 million in the last, I don't know, 10 years or 9 years, if we have done that. So hopefully, you all will feel very comfortable that we will not dilute you guys more than what we have to. For example, the last fundraising at $10, that would be like $20 million comes with 2 million shares. And even if we go lower, then the numbers are completely different than what it was 1.5 years, 2 years ago. So we have come a long way. We're very proud of that. But I want to put everybody's mind at rest that we have a good resume. So fundraising, when we get to it, if we have to do it, we'll do it in a very careful way.

How can you ensure that in the trial that you're about to do, the inequalities that happened in CD12 won't happen again?

So back in February, as Dr. Rahman said, the design of the trial was happening in February. The first patient got injected in March. But when we -- looking at that time, the severity of the patient was the criteria that we were looking at mainly. As time changed, everybody learned about more COVID-19. Some companies did 7 clinical trials before they got to the final trial. We did one trial. And now we learned so much. So we have very positive results that we can build on, and we will do that.

Yes. So a lot of that information wasn't available at the time we designed the previous trial. It is now, so we'll take it all into account.

Why didn't the DSMC say something about the 65-year-old contingent?

So the DSMC only look at certain items that was in the SAP, statistical analysis plan. So we can't just keep -- we don't look at what if that happens, what if this happens. We look at what are we going to do to make this or that happen in the future based upon what we learned in the past and that we are in the present, so we're doing that.

Why should investors believe something will happen with these foreign regulatory bodies when nothing has happened to date?

Please, everybody, go and Google if you feel this way. I respect it and I totally have respect for anybody thinking anyway. Google, how long does it take to get an indication to the finish line? And we have started with a product that was shelved. And we have done what we have done. I don't want to go through all of that because everybody knows what happened. We took 1 year with CD12. We're very excited about the results. Let us enjoy the excitement so we can get energized and do a lot better for you, guys.

Would it be more prudent to focus on HIV than COVID-19 given the results that just happened?

I think we should concentrate on both of them based upon results that happened.

Is it possible to exclude patients administered with dexamethasone? And do you recommend that?

No. We saw good results with that.

It seems like current mortality and hospitalization data are sufficient to pique the interest of one or more governments around the world and could be leveraged for an agreement to purchase supply in advance of the U.S. 140 critical trial results. Are there any plans to do this?

That's what we just talked about, Philippines, and hopefully, we see what happens. And Brazil is coming up next. We'll see what happens. We are working on every avenue. We're just as anxious as everybody else to get -- be able to have revenue.

Is it possible to use the patients from the 46 open label toward the 140 needed for the trial?

I don't think so.

Are the standard of care patients getting just 2 doses 1 week apart since -- and I don't know what this means but maybe you will, M/M, get 2 doses and standard of care are in worse shape? Shouldn't they get more, dependent on the markers? Any thoughts on providing more?

No. We gave 2 dose, day 0 and day 7. And that's it.

If the Phase II long-haulers trial is successful, what would the key elements of a follow-on Phase III trial be in terms of number of patients and completion of time frame, if you know?

Phase II, are they talking about this trial or -- because this trial was Phase III, Phase IIb/III, which could be categorized.

Long-haulers.

Oh, they're talking about long-haulers.

Sorry, the long-haulers.

That, as Dr. Scott Kelly said, is a proof of concept. If we get that, then we can have the data we want to design the trial to go forward.

We don't know that until we have the data. And we're looking at the biomarkers and the clinical symptoms and correlating the 2. And that will help us determine the numbers. And from that -- that's why we're doing an investigator trial.

Can you provide an update on the meeting with the FDA regarding Breakthrough Designation for triple-negative breast cancer?

Triple-negative breast cancer was not enrolled very well because of the COVID-19, as Dr. Kelly said. But basket trial, we do have fantastic results, in my opinion, because the chemo market -- the CTCs are all 0 and chemo markets are lower and lower in most of the patients. Some patients goes up but then it comes right back. That means getting it controlled. My own mother-in-law now has no tumor in the liver. She's not doing very well, but it's been 16 months now. And she has got her liver with no metastasis and her lung is doing very well. So the only problem she had was the one that was metastasized to the brain from long time ago. We see that in other patients. CTC are 0. Chemos are stable. These are really great results, but we need to substantiate these results by seeing the data from the CT scan, MRI and so forth and Dr. Rahman is working to getting all of that together.

Have you considered reaching out to patients or families who've been successfully treated under EIND, open-label, right to try to provide testimonials to Janet Woodcock at the FDA?

So Dr. Janet Woodcock has a perfect way of doing things, in my opinion, and does -- and so does the agency. You might think I'm just saying that, but I really, really am passionate that the FDA in America does a fantastic job, and they don't need me or anybody like me telling them how to do their job. They give us what they give us. It's a fantastic opportunity and we're going to try to make that count.

Can you control the data age skew in this next trial?

We definitely are going to do that.

Are you concerned that the worst of this pandemic will have passed us before we gain FDA approval?

We hope that most of this pandemic gets past us immediately. That's our prayer and we are hoping for that. Given that Philippines told us that it will take them 3 years to get vaccinated. The -- there is 60,000 flu patients still. Flu is the indication that everybody know that is taken care of but still there is a lot of death. After this is over, which is never going to be over, over in the sense of having 0 patients, then there's going to be a lot of patients still that's going to need this product. We anticipate to hopefully get approval and sell this product for the next 10 years. With what amount and what is the dollar amount is going to be pretty high to start with and then perhaps goes down.

In the new trial, will mortality be a secondary endpoint given the 24% mortality reduction in the 62 patients?

Yes, absolutely.

Dr. Patterson made a comment, science strong, trial design blender, not age batching controlled. What do you have to say about this, Dr. Pourhassan?

Thank you for your comment. Appreciate it.

Have you considered selling to China?

We consider selling to anybody who we can get approval from. So we're working with all the agencies that we listed. And other countries will be added to that list soon.

I don't recall hearing any reference to RANTES recently. And I wonder if you have been recording RANTES levels in patients prior to the treatment with leronlimab.

So we did have -- we wanted to measure cytokine storm before we did that. We've shown what we have shown. So in this trial, we have laboratory data also but we haven't talked about that. We will at the right time.

Do you believe there was any problem in the trial design?

I don't think so. I think they did a fantastic job given the data, as Dr. Rahman explained.

What is CytoDyn's larger marketing plan moving forward for accurately informing larger media outlets, hospitals, health professionals, et cetera, about its drug potential and efficacy across multiple indications?

So as soon as this drug gets one approval, then the other approvals could be coming back to back as a label expansion. Always the first approval is going to be a difficult thing. So we are working, as Dr. Kelly said, with individuals and organizations that wanted perhaps to do the trial -- bigger trial without charging us, just provide leronlimab. As a matter of fact, Dr. Scott Kelly and myself are flying to Los Angeles to talk to a potential investor -- a very large investor in this kind of -- in these matters.

Severe to critical patients likely have underlying conditions that are potentially responsive to leronlimab. Has the company been able to track and monitor the progress of these underlying issues and use the data for future studies?

No. We are way overloaded with everything else we have. So we want to just handle what we have.

I think you may have talked about this previously, but do you have the application for the Interim Order already completed for Health Canada? Or is it in the process of being completed?

You have to first give time line of when you're going to give certain modules to them. So we're working on that and that should be given to them hopefully soon. We'll have time line for everybody and update very, very soon.

A lot of these questions now. These are the ones that are coming through. Those were all the pre questions. What are the -- I think you gave this. What are the mortality numbers in the open label? I believe you said there was one death. Is that right?

No. I said one death in the critical patient, not the whole. The whole was 46 patients and more deaths, and I believe it was 8 or 9 or something like that. I just don't have the latest number. Kush sent it to me. I just forgot.

Is leronlimab effective against variants and mutations of COVID-19?

Yes. We don't -- this is Dr. Kelly. We don't think that variants are going to play a role with leronlimab in that we're blocking the CCR5 receptor and not looking -- and not attacking the virus. It's not an antiviral.

Sorry, the system is not working for me to see these questions. Hang on 1 second.

Sure. I think we are past 90 minutes, are we?

No, but getting close.

Okay.

Sorry, there's just technical difficulties we're having here with our systems. Let me ask you this question. Why do you think it will only take 4 to 6 weeks to enroll the additional 140 critical patients?

If you have 25 sites, let's just say 10 gets active, 14 patients per site, so we asked our expert who really made the enrollment go high in the last part of the CD12. We asked him to give us estimation. And he's giving estimation of 4 weeks, best case. And worst case, he thinks 6 weeks or so. So we'll see. We are hoping for that. That's what -- that's the information I got, and I'm hoping that we can push everybody to get it done as soon as possible.

And are we continuing to monitor these patients in the CD12 trial so that we can provide that information to regulatory bodies, either here or abroad?

CD12 is not the one that we are doing. It's a new trial. Perhaps we'll call it CD13. That's 140 patients. As soon as we get that completed, we definitely will give the results to everybody.

It's CD16.

Sure. CD16, right, Dr. Rahman?

Yes. It is CD16.

Perfect thank you. Okay. Arian, I think -- go ahead. Let's get...

Yes, I think probably we could wrap them up just because, unfortunately, the system of being able to review these questions is not -- I don't know if it's because they've been so overloaded with questions or not, but they're not scrolling through, unfortunately.

That's no problem. Let me just give some ending statement and let's call it a day for now. We are very proud that the team that we have assembled worked so hard to get this trial finished, completed. And the results speak for itself. We met with the regulatory agencies and we have a path to go forward to get final approval. We're excited to continue to do this great progression -- progress that we have. And we hope that we have some major news about that. But in regards to cancer and oncology that Dr. Scott Kelly and Dr. Rahman talked about, we will also be updating everybody with the results and hopefully Breakthrough Designation potential path if we have any, which we believe we do. And NASH and long-hauler, we're getting close to getting, hopefully, some interim results in the next few months. And that's exciting to us. Do we -- are we worried about fundraising and all that? We're not because fundraising is something we always have to be -- to do. And I'm hoping that shareholders are feeling comfortable the way we have done things. So we look forward to updating you as soon as we have more things to talk about, and thank you for participating. Take care. Bye-bye.

Thank you.