Transcript of The Amazing April 7th CYDY CONference Call

Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity

Date: 2021-04-07
Investment Community Webcast

INITIAL DRAFT
Company Participants
Christopher Recknor, MD., Chief Operating Officer
Michael D Mulholland, Chief Financial Officer
Nader Z Pourhassan, Director, President and Chief Executive Officer
Nitya G Ray, Chief Technology Officer, Head of Process Sciences, Manufacturing &
Supply Chain
Scott A Kelly, Chief Medical Officer, Head of Business Development and Chairman of
the Board
Unidentified Speaker
Other Participants
Analyst
Presentation
Operator
Greetings and welcome to the CytoDyn Investment Community Webcast. At this time, all
participants are in a listen-only mode. A question-and-answer session will follow the
Bloomberg Transcript
presentation. (Operator Instructions) Please note that this conference is being recorded.
I will now turn the conference over to your host Michael Mulholland, Chief Financial
Officer. Thank you. You may begin.
Michael D Mulholland {BIO 1465414 <GO>}
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 Z Pourhassan, our Chairman Chief Medical
Officer and Head of Business Development, Dr.Scott Kelly; and our Chief Operating
Officer, Dr.Chris Recknor. Before we begin, it is essential that we provide you with
important cautionary language related to certain Federal Securities Laws. Our remarks
during today's webcast include forward-looking statements, forward-looking statements
and 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
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matters, statements regarding leronlimab 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 proved to be viable on safety or efficacy grounds.
INITIAL DRAFT
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, maybe 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 as compared
to our current expectations. I will now turn the webcast over to Dr.Nader Pourhassan.
Nader Z Pourhassan {BIO 16568801 <GO>}
Thank you, Mike, and thank you to all our shareholders.
Before I start talking about our updates, I would like to ask Dr.Scott Kelly to explain the
current situation with COVID-19 in US and abroad and also in regards to long others.
Dr.Kelly, could you please.
Scott A Kelly {BIO 20132670 <GO>}
Yes, absolutely. Thank you, Nader.
So, I will begin by giving an update in the United States and then update on the rest of the
world for Global COVID-19 cases have risen for the sixth consecutive week. We are acutely
aware that although vaccination efforts are improving in the United States. The rest of the
world is in dire need of assistance. We will pursue these opportunities relentlessly to help
those in need of run the map.
A number of global COVID-19 hotspots in South America and Europe recently reported
new daily records, including Brazil, Chile, Turkey and Bulgaria. And the United States,
New York, Michigan, Florida, Pennsylvania and New Jersey accounted for 44% of all new
infections. New York, the original epicenter for COVID-19 in the United States accounted
for 12% of all new cases in the United States, and Michigan is not far behind. There have
been 150 million vaccine doses administered.
40% of US adults have now received, at least one COVID-19 shot. The most common
strain in the United States is the UK variant, B-117, which is now present in all 50 states.
although the three vaccinations and the US appear effective against this variance. There
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are several other strains in circulation that can diminish the fighting capability of the
vaccine.
INITIAL DRAFT
The duration of the vaccine remains to be seen. And Canada the B 117 variant has now
likely replaced the original COVID-19 virus and many parts of the country. New variants
are making younger people sicker and seem more to the hospital. Canada is now in the
third wave of the pandemic hospitalizations are surging ICUs are filling up of concerning
Canada, P1 variant is spreading rapidly in British Columbia.
And causing what is thought to be the largest known outbreak of the virus outside Brazil.
In South America are friends in Brazil just recorded the deadliest day of the pandemic so
far by reporting more than 4,000 deaths in a single day. In Brazil, the situation is dire and
it is worsening on a daily basis. The more transmissible P1 variant is circulating
uncontrollably, hospitals are overwhelmed and 90% of ICU beds are full.
Brazil now accounts for 25% of the daily COVID-19 worldwide deaths. 6,000 COVID-19
patients are waiting for ICU beds. The more transmissible P1 variant is predominant in 13
Brazil's 26 States and the rise and ICU occupancy involves all age groups, which is a
significant concern. And India there in the midst of the second wave of COVID-19 that is
spreading throughout the country with more than 90,000 new cases reported daily over
the last three days.
India has reported 12.6 million cases since the pandemic began, the highest after the
United States and Brazil. And the Middle-East, Iraq yesterday reported a record 6664 new
cases, and Jordan reported a new daily record for deaths with 111 new fatalities. And
Europe we are seeing sharp rises and infection in several European countries including
France, Poland, Germany, and Turkey. And France Paris has entered a new lock down
together with several other regions in the North and the South some 21 million people are
affected.
Vaccine roll out across the European Union has been problematic with delays to deliveries
as well as concerns of the safety of vaccines. Bulgaria and Turkey, are among the countries
in Europe reporting new daily highs for cases , while others including Ukraine and
Hungary reported new daily highs for deaths. Poland is struggling to cope with its highest
number of new infections since the pandemic began, 60 times higher than at the start of
the pandemic in the spring of last year. This is because of the rapid spread of the UK
variant of the virus.
Hungary now has one of the highest COVID mortality rates in the world with more than
21,000 coronavirus related deaths and a third wave claiming hundreds of lives every day.
I'll move on to the Philippines, the Philippines our friends in the Philippines reported a
daily record on April 2. They've reported more than 795,000 COVID-19 cases with 13,425
deaths, the highest totals in Southeast Asia after Indonesia. 80% of intensive care capacity
in Metro Manila is filled.
60% of ventilators are already in use and 70% of isolation beds are occupied and
increasing the list goes on and on throughout the world. Let's discuss Long Haulers. What
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about the aftermath of all of those patients infected with COVID-19? Unfortunately COVID-
19 Long Haulers are packs is rapidly evolving into a global health emergency at the
current rate of COVID-19 infections. Global cases will exceed 200 million by the end of
2021.
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Estimates conclude that 10% to 30% of those infected will have persistent symptoms
leading 20 million to 60 million patients without effective treatment options. PACs is
devastating to the quality of life of patients and the economic reality is problematic.
Please keep in mind that PAC shares many features of chronic fatigue syndrome and
approximately 50% to 75% of patients with chronic fatigue syndrome are unable to work
and they are unable to attend school. At cited on we are very excited to be in a position to
potentially help these patients.
Nader
Nader Z Pourhassan {BIO 16568801 <GO>}
Thank you, Dr.Kelly. Wow. This is very sudden news that you gave us Dr.Kelly. Without
explanation from Dr.Kelly, I believe I feel very safe on making this statement.
In my humble opinion, there is no doubt that the leronlimab will be part of the future of
COVID-19 therapy. opinion of mine is justified for me from the fact that with one trial in
severe to critical population receive data that indicated 82% 14-day survival benefit.
Survival benefit was 82% with statistically significant p-value of 0.0233[ph] change in
clinical status for 14 days in the basis of ordinal scale 400% better with a statistically
significant p-value of 0.021[ph] 7% of these critically ill patients on the only map arm who
were on invasive mechanical ventilator or ECMO walk out of the hospital within 14 days,
where it says zero in placebo. We could not evaluate the p-value for this scenario,
because since in leronlimab and in a placebo or zero patience walk out.
Hospital stay also shortened, we again, statistically significant p-values. So these four
strong items make me feel justified in my statement of saying in my humble opinion.
There is no doubt that we're on the map. We'll be part of the future of COVID-19
therapies.
So this is 14 day results, I am talking about. So what happened to the patients in critically
ill population in day 28. 21 days, after the second injection of leronlimab for 28 28 days
result of predefined primary endpoint or secondary endpoint. However, you look at the
data leronlimab [ph] on was better than placebo for all three different primary endpoint
and secondary endpoints.
This is the basis of my excitement for future of leronlimab just in COVID-19 other
indications I get to it. Now, there is an urgency that all our shareholders have and that is
why they want us to get EUA today. They want to talk to you right now. However, no one is
looking at how much product do we have? If we get EUA today, do we have enough
product for one country? Just one country, any country? The answer is not if we are
looking at a large country.
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We only have 1. 1.2 million buyers good for 300,000 treatment per patient. 600,000
doses which would treat 300,000 patients as we have said in the past. We would like to
dedicate more than half of these to Brazil if we are able to ensure EUA and we already are
talking about a 100,000 miles[ph] perhaps dedicated to Philippine.
INITIAL DRAFT
We just announced that right after the market, so I'm sure everybody can see the press
release. This is a 100,000 volts[ph] for potential compassionate special permits sales.
Meanwhile, we don't have EUA anywhere in the world yet, even though we are very
optimistic about getting EUA with an additional small trial or maybe with our CD12 extra
data that is coming in. So let's talk about additional data, and how we are thinking about
this We are currently exploring three paths to get the next study for COVID-19 completed
and perhaps hit our primary endpoint, like we did three years ago with a small HIV trial.
The three options are these -- first one. We can simply add more patients to their open-
label of CD-12 that we have, and we calculate the p-value, until it is less than 0.05. Is this
acceptable by Regulatory Agencies? I'm not sure. But we will be informing everyone
about how this is shaping up.
As so far, let me give you an update, so how it's shaping up right now. A very good news
today is, we have 28 day mortality amounts are for new 55 patients and open arms data.
That is better in the whole mITT mITT population and in the mITT population less than 65
or over 65 for our primary endpoint 28-day mortality. And also the results of foreign debt
is better in the 28-day mortality for critical the ill population.
And some of the results are much better. For example, the mortality rate in the extension
of CD12 right now in critically ill population is about 16.7% about 17%. CD12, we had results
of 28% Leronlimab, 37% placebo. So the data is actually coming strong.
That's one option get more data recalculate and see who likes to look at it. Second
option, study we can have for under 65 year old patience CD12 value for this age group in
a critically ill population indicated we could had a primary endpoint is less than 75
patients. So we definitely will pursue if different regulatory agency or cavities. We will
have a 200 patients study and perhaps your interim analysis at 75 and see how things are.
MHRA has told us they will accept interim data and so forth. That's the second option.
Third option is we want to do four doses. We do three arms.
Placebo two does, three does -- I'm sorry two does and four dose and then look at the
data, we might do this. But whatever we do, it will be heavily recruiting in overseas,
especially in countries that are having problems. So in regards to our other times I'm sorry
emergency use timeline. Health Canada are April 15 eight more days, we will be
submitting interim order packages, all the packages that we need to send to them CMC
and so forth.
We believe once we finish giving that interim or their package when it's completed and if
we commit ourselves to do a trial over there, we can start selling this [ph] of the product
that's what we have seen through our people who are checking into the guidelines, but
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we'll find out. MHRA is coming up with new relax criterias. We're working with them. With
US.
INITIAL DRAFT
, we are definitely going to do it the trial, we are working with them in regards to the trial.
With Brazil and Philippine we're very, very hopeful if they have to do whatever we have to
do we will and we will update everybody. Now, let's talk about our cancer trial. We
haven't talked about that for a while.
Nine patients, I've been saying that, 9 patients to 10 patients. We have 9 patients in Basket
Trial, to all together about 14 patients, but nine patients in Basket Trial. They didn't go on
for about a year, these are stage four. The laboratory that we've worked with days, they
don't think that there is no response.
I think that the response here. We're going to get this data and we are asking for pre-
breakthrough designation meeting with FDA, and we really think cancer is very, very
strong. That's what Dr.Kelly Larson said, we like to be oncology company, because a --
and our HIV BLA If I give you that update, I would like to tell you that, so I advise you to
everyone that Dr.Rahman, on Saturday night ex Chief Science Officer is no longer with
CytoDyn. Dr.Ramos[ph] last day of employment with CytoDyn was Monday April 15.
We wish him well in his future pursuits. We already have in place resources to advance
and accelerate the remaining work on our BLA resubmission. We have many good
organization ready to go and as always RexRay is working with us, but we have brought
extra resources and we will be working on that very carefully and update everybody exact
time line. The time line does not going to be very long in my opinion, but I like to talk
about that in the next call.
In regards to NASH and long-hauler trial. We are officially finished the long-hauler trial, we
would put a press release out either tomorrow or day after and let everyone know, this is
getting very exciting and we are getting to good -- very good places. Now, we do have a
lot of other activities are happening which we which we will be updating you on the next
two weeks in regards to all that organizations that are reaching out to us to do study of the
leronlimab. People are realizing leronlimab is a real deal, that's what I feel.
The published data that has come out. The doctors are talked about us. These are very
solid people and solid places to publish data, we have done that. We will not drop the
ball and we will not stop pursuing approval and what's our first approval comes in any
indication any country, we believe back-to-back-to-back we will have many-many others
approval.
So with that please let's go ahead go to Q&A [ph]
Questions And Answers
Operator
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Question And Answer
Q - Analyst
INITIAL DRAFT
Thank you, Nader. How difficult is it to get a refusal to file on a BLA backed by a successful
trial as was the case with our HIV trial, where we met our primary endpoints? How likely is
it to have that. Is that the question?
Yes. How common is it to get a refusal to file?
A - Unidentified Speaker
I looked at that and I saw this some big pharmaceuticals getting refused to find.
I didn't do any analysis, it's going to be -- I was more focused and what we're going to do
to go forward, and I was very happy to see refused to file has nothing to do with clinical
data to add, I mean to add more clinical trial -- I'm sorry not data, but trial. I saw it refused
to file from big pharmaceuticals that came and they had asked for more clinical trials. So
the big news for me was there was no additional clinical trial just get the data in the right
format, and we're doing that the heart part of our ELA was that we were doing a small
clinical trial in combination therapy. There wasn't enough safety patients for safety so the
FDA was kind enough to allow us to pull data from another trial.
Now, you got to try not as complication, and those things may force us to go and get
more vials with higher volume and everybody knows investment. Next, please.
Q - Analyst
And I think, Dr.Richard, -- will be able to add one little additional point on this. Dr.Wagner,
do you have a additional point on the refusal to file in the common, whether they're
common?
Sure.
There was a recent gemma article out in February, just took this year looking at it. And
basically, the median time period for getting the BLA back on track with these reviews that
were refused, was about a 189 days.
Q - Analyst
Thank you. Next question.
It has been many months since the refused to file a letter for HIV What is the missing
component in order for the filing T-fixed? Do receptor occupancy tests need to be done
and most important our samples from the trial still available for testing??
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So eventually we couldn't get the receptor occupancy happening in other places and I --
we stepped in Dr.Chris Recknor and Dr.Jonas Sasha[ph] and they started to looking at it in
INITIAL DRAFT
a different way and the we believe we're going to get it done on time.
Q - Analyst
Dr.Recknor, do you have anything to add?
A - Christopher Recknor
Yea. The -- actually the dose justification of the issue with the BLA and in particular the
receptor occupancy and Nader I think it's important to note that the prior assay was the
thing that was in question, which was the same thing that we saw on the CD10 Trials. The
receptor occupancy, I say just had the FDA had a lot of questions with it.
So we're repeating that with the solid FDA, we have two different companies working with
us on that. But the does justification alone from the standpoint of the viral load of is very
impressive. At the 700 dose it's p-value statistically significant .006 at the 700 do, so we
feel very confident just with the data that we have is exclusive of the receptor occupancy
that we can make the argument.
We are also doing receptor occupancy though in the extension patients that we have
ongoing.
Let me just add one thing, also everyone should know that we have also simultaneously
done a lot of work on the dose justification. Here's the thing that FDA has said they have
said that send us that dose justification and receptor occupancy. And will take 30 days to
tell you if you are good to go without getting any more refuse to file.
So we're going to be very-very happy to send that to the FDA Hopefully, next month
perhaps and be able to see what they say. And then we believe it's going to be fine. So
we have a lot of hopes, but I would like to give very detailed update and Dr.Recknor
probably would do that on the next time we talk. -- go ahead.
Q - Analyst
Institutional investors understand the background regarding the increasing dosing in CD2
and CD3. What we don't understand what specifically CytoDyn is doing between now and
may that will address the FDA's concerned. I think you've probably already answered that
question Is the timeline with respect to the filing of the BLA as reported still on target?
We're on target right now, and we will update you again on the next two weeks. Dr.Chris
Recknor is our new Chief Operating Officer.
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He's done doing fantastic job. He and Dr.Scott Kelly along with myself; and Dr.Nitya Ray
on meeting in New York next week to finalize all these, that's why not giving the update
exactly till we finalized everything, and we don't have solid people helping us right now.
INITIAL DRAFT
Q - Analyst
Is the company still meeting with the FDA today, regarding inserting Samsung, as the
manufacturer for the CMC portion of the BLA?
The meeting was completed by. Dr.Nitya Ray.
He called me right after award and gave me the good news that the FDA said that if we
submit our BLA, thetywill not require six months of stability from Samsung's batch, three
months would be so fast aAnd we have that now, so that was a very good news I got from
Dr.Nitya Ray. He has done a fantastic job in many front. People should know that without
Dr.Ray we wouldn't have 1.2 million wise right now. We wouldn't be able to do anything
till we get that was.
The last company who did a great job with our primary end point, they're not going to
have any doses, may be 100,000 they report by the end of the year. So it's very hard to
manufacture these and I don't think he's being appreciated enough by us Dr, Nitya Ray.
Go ahead please.
Q - Analyst
Can we say definitively that we will not need another trial for HIV in order to refile the HIV
BLA or is this dependent on the outcome of the work that's being done right now?
No more trial needed.
Next please. are the UK and Canada HIV filings dependent on the work being done by
the labs doing the receptor occupancy?
Yeah, we have to have receptor occupancy with England, but Canada has a request that,
but we are meeting with them. Once we have that meeting if we do have that meeting,
because we believe USA we might be able to give the BLA soon. So we'll update
everybody in two weeks about them.
Q - Analyst
Okay.
Next please.
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Q - Analyst
When can we expect this is somewhat related. When can we expect a UK and Canada HIV
filings for 350 milligram dose?
INITIAL DRAFT
No filing in that regards.
We're doing 700 milligram. Next please.
Q - Analyst
Given the news of Brazil's distribution relationship. How long from now till a decision from
the regulators does a trial need to be completed completed in Brazil first? We will be
updating everyone when we conclude our discussions with an visa and know exactly what
we have to do.
What kind of trial if we have to do trial and how many things and you tried on. We are very
happy to do the trial that the US FDA asked us and perhaps do the whole trial in Brazil, if
you have. So enrolling Brazilians would be for sure part of this equation either way. Next
please.
Can biomass a in Brazil sale leronlimab to patients on a compassionate use basis before it
is approved by their FDA?
A - Nader Z Pourhassan {BIO 16568801 <GO>}

They will explore all of those avenues and let us know. And we will let everyone know in
our every two week updates. Next please.
Q - Analyst
Again, these are related.
But where are you in the process for regulatory clearance with Brazil and it sounds like the
filings filings have not been made yet and we'll be updating the shareholders when we
have further information. Is that correct?
That's correct.
Q - Analyst
When you say regulatory clearance in Brazil, do you mean Brazil's regulatory clearance or
US FDA clearance?
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We're talking about Brazilian, their own regulatory clearance, which is called NVISA.[ph]
Q - Analyst
INITIAL DRAFT
Will Biam producer on the map, if you get regulatory clearance?
Will Biam produce leronlimab? They cannot reproduce, they have from us.
Nobody can produce the only leronlimab, but us.
Q - Analyst
Can you disclose the terms of the deal with Biam?
Know that this time, we will put AKN, and everybody will know everything at the time. Am
I right, Arian? We do put a case.
Q - Analyst
That's correct.
How do you intend to book deploy recent rates of 25 million for drug manufacturing for
possible EUA and Brazil.
I'm sorry, how do we do what?
Q - Analyst
How do you intend to -- the question, I think relates back to the press release of the raise
of 25 million that funds of from that raised will be used with respect to pursuing the
distribution in Brazil. Do you have any intend within those funds at this time?
To the major reason that we wanted to raise that much is manufacturing. We immediately
wanted to make sure Samsung is current with us and we want make sure you have
Samsung see that we are moving very strong and we need more product in our opinion.
We don't think 1.2 million while is going to cut it. We're going to be successful. The results
don't lie. This is very strong results.
We feel very strong and we the respect every regulatory agency that they might need
more result will be happy to bring those new results, but we have to get more product
right now. Next please.
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Q - Analyst
Do you expect result to require approval from some other country before they will
approve an EUA in Brazil?
INITIAL DRAFT
Maybe yes. Next please.
Q - Analyst
Now the questions concern the C12 trial. What went wrong with CD12. Why were the ratios
so wrong? Why were there so many people over 65 and why didn't we control this to
begin with? Is there any way we could have control the outcome of CD12?
And US stratified, there are so many criterias you stratify and there's so many stratification
you can put in place. When in February we were designing the trial.
Rex[ph] did a fantastic job Our scientists looked at it and they are very happy with it.
Please keep in mind, when we talk about big pharmaceutical doing seven clinical trial to
get to the point where they actually didn't see any result that speaks volume epidemic
trial. Don't focus on the negative. Please shed some light on the very-very positive stuff
that came out of this.
Nobody that I know have 24% mortality in the critical in population after 28 days, when
they gave their product only on day-o and day-7 and 82% mortality better in day-14 for
critically population. We do statistically significant population -- statistical significant p-

value. So I will change the question to how do we do such a great job and that's that is
credit to our scientists. And that's what I would say.
Next please. could the DSMC have done something to alert us when they did their review.
So, I want to say something to defense of the DSMC When they look at this result? The
pandemic was going through the roof. It was like perhaps Brazil right now.
At that time, perhaps, they wanted to they were look at critical in population and perhaps
at that time, if we had those results at final results at that time, maybe the FDA would feel
like that was that would be something that they want to in parallel of doing clinical trial
whatever else. So I can't speak for DSMC but I can assure you that the results were
positive. That's why they saw that they got to go forward and to achieve the primary
endpoint even at 75 percentage it if you remember if everybody remembers. Next please.
Q - Analyst
What is the support for the representation that lever on the map administration was
associated with a 400% improvement in clinical outcome based on ordinal scale with
discharge rate much better in leronlimab with the p-value statistically significant?
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What is the significance of that is that? --
INITIAL DRAFT
Q - Analyst
No. What is the support? What's that state all based on?

Based upon the data we have data that we have to give out. We're calculate everybody's
ordinal scale at the beginning and at 28-days. And when we look at that or where in this
case was 14-days we were talking about.
And we look at the numbers and the numbers will for time better for 14-days and 2.5
times better in 28-days. And p-value was significant at 14-days and we believe this is a very
strong results in the critical in populations. Next please.
Q - Analyst
What is the support for the statement the half-life of life of leronlimab is 10 days.
This has been done during the time that we were working with the inventor of the
Dr.Format[ph], and he was always helping us. And we were asked to go to QPS to look at
the half right now in the progenics old slides that somebody looked at it and they say, oh
they have life is three and a half days and these guys made a mistake. They don't realize
that, that study was based upon a very short trial and it wasn't -- it didn't have enough
time to look at the blood concentration of leronlimab at a later time perhaps. But that QPS
document was reduced by Dr.Paul Martin himself, and he said is valid and he verified it 10
days is the half life based upon that study.
And QPS is very distinguished laboratory. So we have send that report to the the FDA was
a study that was a study on patients and their half life is 10 days.
Q - Analyst
Can paradigm [ph] published the day 14 results in an analogous manner to that 28 day 8-
K at filed?
We could and we might do that. We are working on too many things.
As everyone see we have a requirement at CytoDyn. And that is very, very fast. Everybody
have to move, but they have to move very efficient without sacrificing any quality and
we're doing that with the number of patients -- the number of people that we have here
with the amount of resources that we have. So we will do that to hopefully soon, if we can.
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Next please.
Q - Analyst
INITIAL DRAFT
We can't change it. But what was the FDA's reasoning for limiting CD12 to just two doses?
I don't recall the process that happened at that time, the perhaps the emergency IMB's
ever happening with two doses only, that just told everybody, go ahead and go with two
doses. But, I just don't recall exactly.
Yeah, in the clinical trial, they caught something, it's called the research. That means, you
already searched. You didn't find it. So you do research.
You research again. This is clinical trial. This is not an easy thing. This is not something
everybody after the Monday morning, quarterback is easy, but we shouldn't be doing that
too much.
Next.
Q - Analyst
Let me see here. On Saturday night's latest report, on the CD-12 trial that showed a 82%
reduction in the mortality rate, compared to the placebo at 14 days. I have not seen any TV
news or interviews about this amazing result.
Do we send out these reports to news outlets and the critical care and infectious
infectious disease doctors with some follow-up?

Everyone has to pay attention that we have regulatory agency in the United States called
FDA and they are very-very good, and they are solid. They want to see primary end point
0.05. That's the requirement. Everybody has to match it.
So when you don't have that for the whole population now, you're looking at
subpopulation justifiably FDA says repeated, repeated on doing a longer trial. And the
number of patients in America are getting a lot less. So that's the stands and we're going
forward with that night, the news media want to talk to us, we never say no, we always
want to. And when we reach out sometimes they say no, it is -- what is the FDA says? We
say FDA's do another trial.
They said come back when the other trial is done. So we have to be very open about that.
Next please.
Q - Analyst
Page 14 of 33
Date: 2021-04-07
Why wasn't our severe our severe to critical trial not designed as REM disappear and
leronlimab with adaptive design studies where the company is allowed to see the results
without a penalty.
INITIAL DRAFT
So I want to give you a comfort that during this study, they did thousands of patients
before they got to that. They had the resources to do that. We have a way to do with the
small resources that we have. We have a result that's better than anybody out there in
critically population in my opinion.
Hopefully that to tell that to the best of my knowledge. So, why didn't we do this or that I
just won't be able to answer you in a way that I can perhaps convinced you but we did
everything we could. Next please?
Q - Analyst
Was the agent balance in City 12 much more evident at some centers than others?
We don't know I have to ask Dr.Kush Duty. Next please? and Hammer[ph] both said on
past calls that we asked for three to four doses for the CD12 trial,, but the FDA declined to
request and they only -- that only two doses would be approved.
I think we asked this question before and you doesn't know -- you don't -- I think you
don't know the reason for why the FDA said to use to I think you surmised it (inaudible).
Arian. Hold on. I am not saying FDA say do two doses.
Please do not quote me saying FDA I did not say. I am saying and I'm like getting after
your, I'm just saying to the person who's saying that.
Q - Analyst
Right.
Please don't say that the CEO of the company says that.
I didn't. And if FDA is listening, I'm sorry for that whatever they say. [ph]
Q - Analyst
Why is the FDA ignoring the results from this trial?
Page 15 of 33
Date: 2021-04-07
They haven't. They looked They look at it very carefully, very carefully.
The p-value for the whole trial was not .05. When it's not and then you looking at
INITIAL DRAFT
subpopulation, they were kind enough to say do another trial show what you got
increasing our it's population, everybody should take the comfort that the new patients
that are coming in critically ill population right now and the open arm is having 17% that
versus what we had in leronlimab 27%, which was 37% placebo. So that's a good thing.
I think it should be happy everybody about that's.
Q - Analyst
The next point a questions are concerning the long hauler trial. First question, can clinical
trial participants through had successful clinical changes weekly shots of PRO 140 at 700
milligram receive expanded access with EUA through their local infectious disease or post
COVID Care Center I'm a COVID-19 long hauler, and believe, I was given the wrong
leronlimab in one of the trials, and have experienced substantial improvement since my
first injection. After being overwhelmingly disabled for a year.
My smoothing chest pains are gone, diseases is gone, muscle weakness has improved,
and I have the energy and stamina that I had to be able to resume work. So the question
from this particular person is, can they continue to receive leronlimab?
So they have to send us an email and Dr.Scott Kelly will follow-up with the regulatory team
immediately as he does with all the patients that were requesting. So, please, do send us
an email -- And Dr.Kelly, you want to add anything to that?
A - Scott A Kelly {BIO 20132670 <GO>}

I'd be happy to, but it wouldn't be easy way. I mean, when we have a clinical trials, they're
not going to want eIND's or EUA When he says, EUA the that's not correct.
I mean it wouldn't want the INDs for that. It would -- they would rather some that is maybe
in a clinical trial.
I'd like to comment as well to.

Yeah, please.
The CD15 trial is completing enrollment this week. And just reiterating again that the
patients that are in this trial are either on placebo or leronlimab. I'm just ecstatic that the
Page 16 of 33
Date: 2021-04-07
patient's doing well and especially the chest pain and business[ph] and some of these
very chronic plating symptoms or doing better for this person. But at this time there's --
there is not an EUA available for long haulers.
INITIAL DRAFT
We're hopeful that the data will show us that it's helping in these patients. And then can
and then can get the patient's access they need.

Yes. It's a reiterate the best way to do it is through a clinical trial for the around -- and long
haulers.
Q - Analyst
With Dr.Ray, -- be willing to discuss his personal experience with the healing effects over
on the map during his struggle with COVID-19. And are there any plans for Dr.Rector to
discuss his experience via a television media interview.
Dr.-- ?
Well, I yeah sure. I mean Wall Street Journal did an article on it and this was early on in the
disease when COVID-19 over from China.
So I had caught it early on and I had three visits to the hospital. Fortunately, I was able to
get an emergency IND the last visit to the hospital and I guess I can go into really the
symptoms that I had were similar to this patient that you mentioned before with the chest
pain, the dizziness, muscle weakness and fatigue. And I probably was developing long-
hauler symptoms. I had it for many weeks already, but still kept having bad symptoms
where my -- I was having very bad palpitations brain fog, fatigue and really bad headache
and within hours of getting leronlimab, I started feeling better.
In fact, I noticed the first thing was I could breathe in deeply and I could get oxygen much
better. And I was discharged in two days. And so I think this phenomenon that we're
seeing as -- and I was actually feeling and I've seen with patients in CD12 and CD10 is real.
And ad part of this experience is what is helpful and recognizing that it will treat this long
hauls or patient population.
Q - Analyst
Hauler will CD12 Trial leronlimab patients be assessed and analyze regarding possible
development of long hauler syndrome. If so, when might we anticipate getting those
results.
So we are focusing on getting EUA and going forward, so there is a lot of work. But
Dr.Richard [ph], would you like to chat the answer, if you like to do extra work?
Page 17 of 33
Date: 2021-04-07
Sure.
Well, I think that's a good question looking at those patients with potential long hauler.
INITIAL DRAFT
But I'll pivot back to CD10 and the unique thing about this trial was that there wasn't a
particular time from when you had a diagnosis of COVID where you could enter the trial,
every trial that looks at moderate COVID usually used a less than five days from a PCR
COVID test. This one did not. And so there were patients that were like myself developing
long-hauler or symptoms.
What's really interesting about it though. Is that the adverse events in placebo group were
30% higher than leronlimab treated group. And when you look at those symptoms, a lot
of those -- are those long-hauler symptoms and especially in the fatigue. And so, this was
-== there was a follow-up period in the CD10 trial that looked at safety and that's what we
saw.
As far as looking beyond that, we have not with CD12 or CD10, but that's a good question.
And I would just add. That's that's really lets everybody know that with long haulers that
we really believe obviously this is a multi-system inflammatory disorder and the fact that
we had less SAEs is really very interesting to us we've spoken about this internally and is
attributed to with the fact that it is a multi-system inflammatory disorder. So, go ahead
here in.
Q - Analyst
Have you received any verbal responses from patients or treating physicians with
information about these participants in the long haul or trials. That have been treated with
leronlimab and can you share in the immediate effects, identified or testimonials that
might reaffirm its viability and treating long haulers.
CD 15 long-hauler data is blinded to the treating physicians and patients and the staff and
to the sponsor. So, I can only give my personal experience and then what I've observed in
in the CytoDyn's CD12 trials.
So, I don't know (Inaudible)
CytoDyn to CytoDyn's, whether to take an interim look and do a readout of the Long
Hauler data after 28 days of treatment or is the plan to wait until after 56.
So the trial is for eight weeks in patients, end up with a four week safety period after that.
We will be able to get the data rapidly at the end of eight weeks, but we need to look
completely until the safety data finishes. I think that four week period of time will be
opportunity to assess through a batch analysis of all the cytokines and chemokines, and to
look at some other very interesting things that we're seeing in these patients that point to
how long that's working.
Page 18 of 33
Date: 2021-04-07
So it doesn't know current plan to look at an interim look and this is it's a biomarker study
the small group of patients but --
INITIAL DRAFT
A - Nitya G Ray {BIO 6292171 <GO>}

It has been reported that vaccines are relieving some patients have long hauler
symptoms. The CytoDyn been following this closely and how may affect or impact the trial
that's going on right now.
Q - Analyst
So yeah. So I'm glad that this may be helping patients.
And this may be representative that there is active virus in patients, but it's about a 13, 13,
13. So some 13 get better 13 to do worse and as in being a long hauler and actually getting
worse is really not a good because they're invisible shapes sometimes so and I remember
the most are stay the same.
Yeah. And I'll add one thing that.
There is nothing literature about CCR5 antagonism in and actually helping that problem
in conjunction with vaccine. So there might be a synergistic effect with leronlimab and
vaccination in this population. So something we're looking into.
Q - Analyst
The next questions are concerning the CD16 and new COVID-19 trial that you're in the
process of finalizing.
Have you received any communication from the FDA with respect to the conditional EUA
request that company submitted to the FDA?
The FDA does not have a conditional EUA in their guidelines. We were asking them if they
would give us EUA during the time we do the trial, which would be conditional and they
have responded that they like for us to do the trial.
Q - Analyst
Has the protocol been finalized with the FDA for this trial?
It's in the process. We have several different scenarios.
Page 19 of 33
Date: 2021-04-07
One of them is doing for those that we have asked them. One of them is to do under 65
and over 65. Over 65 using IV We are in the process of doing that.
INITIAL DRAFT
Q - Analyst
You have a timing as to when it might be finalized.
I'm hoping within next week. We might be able to get there, but I'm just guessing. You
asking me for guess. So I hope everybody doesn't start saying that they said one week
and taking more.
Q - Analyst
Will you have the DSMC review this trial like you did with the other?
Absolutely yes.
Q - Analyst
And do know what the primary and secondary endpoints will be for it at this time?
Yes, we do still -- I don't see any EUA news about it. But, we should investigate the EUA,
but the product that they don't have, it's going to be in the position where we can enroll
whatever we want, and we are going to heavily enroll overseas also.
Q - Analyst
Did you ask the FDA specifically? I think, we've asked a question.
This is about the four dose. So let me move on to the next one. Explain the cost-benefit
analysis of a CD16 trial. When will it begin? How long will it realistically take to enroll? And
most important, what happens in the event that another drug is approved prior to trials
completion?
So, I don't know if everybody -- whoever asked that question heard, Dr.Scott Kelly.
The situation in the world is not where one drug is going to come and take everything
away, and everything was going to be fine. I'll pray for that, and we We all should pray for
that, but that's not the situation. The situation unfortunately is very bad. And as I said in
my statement is that, very humbly think that we definitely going to be part of treatment for
COVID-19.
Page 20 of 33
Date: 2021-04-07
But Scott Dr.Kelly, would you like to add anything with or recommend.

INITIAL DRAFT
No. I mean, I agree with everything you said Nader. I think that's very accurate.
I mean the problem is not going away and in fact, it's getting worse in large part of the
world and the vaccinations are not there and they won't be for a significant amount out of
time. We don't know how long the vaccinations will last the variance may be a problem
and this is not going anywhere anytime soon. And my opinion and one drug that comes
in is not going to take out the whole market. They'll be plenty of opportunity.
Yeah, and I just got to add one thing here. I won't -- I'm hoping that all the shareholders
keep in mind that leronlimab binds to CCR5. We believe it's an effective immune
modulator you later. It affects we believe NASH cancer many other indication.
We are here to stay, we're here to get approval and we're here to make sure that we
impact patients quality of life and mortality rate. So that is something we set up and we
have only been here for a few years. These are big pharmaceuticals, if anybody ask them
they will tell you it takes long time to get approval. We are in a fantastic position.
Everybody can throw him at all the negative they want as much as they want everywhere.
This is a product that is unique and it will be doing fantastic work for the future. That's my
opinion forward-looking.
Yeah, and now you make an excellent point that I'd like to clear up that is reminding me.
I get a lot of questions from shareholders about the variance and what I would like to clear
up is, we do not believe leronlimab. Is dependent upon the variance at all. A lot of the
other monoclonal antibodies that are directed towards the virus in the spike protein. And
if the virus mutates then a lot of times they're not effective anymore or it has nothing to do
with the CCR5 receptor.
So I think that's an important point because as this virus continues to mutate new get
variance, we still believe leronlimab will be incredible -- incredibly effective as an
immunomodulator.
Q - Analyst
Well for dose regimen will likely be optimal based on the consensus expert opinion. It will
increase revenue because of the amount of files needed, but the company will be able to
treat fewer patients. Has the company engaged another pharma to assist with this
dilemma or is awkward operation work speed a possibility and we have Samsung be able
to handle this increase?
Page 21 of 33
Date: 2021-04-07
I think people who are looking at this company right now and they're saying how come
nobody's jumping and buying the company right away with this or that.
INITIAL DRAFT
. They're not looking at everything in this company company the right way. The company
has about 700 million shares, and we are very happy that we have not increased that the
way it used to be increased. To buy a you have to pay a certain amount of dollar per
share.
So our company is claiming, we have all these Phase tools. The standard is, if your Phase 2
is successful, they're going to give you 15% of your total value, and those numbers go
through the roof. And I don't want to talk about stock price, because everybody will get,
maybe very happy in this short, will not be happy. But having said that, I want to make
sure everybody knows that, we have tremendous opportunity with this product and we
will be looking at all the avenues that are out there and we will be getting approval, and
that's in our horizon.
That doesn't take a lot of brain work in my opinion to figure it out. We're going to get
approved, in my opinion. Next?
Q - Analyst
How will we recruit and fund these trials? Conceivably given the volume of critically ill
patients in Brazil, this could enroll very quickly. Will there be any interim analysis and have
we found the Brazilian partner for recruiting and marketing?
We have work on all avenues in everywhere, and we will do that with Brazil if we need to
and I'm telling everyone that in the press release, we stated it few press release before
20,000 patients where in ICU in that press release that was out few days ago in Brazil
20,000.
If we're going to get 200 of them, it's not going to be that hard. The hard part would be
to get this study started over there that could take four weeks, six weeks something like
that. But, if we just enroll another center in Brazil for the open-label that could happen
happened very quickly and we are thinking about all of these things, we're strategizing.
And as I said, Dr.Scott Kelly, Dr.Chris Recknor, myself Dr.Nader we're going to meet in
New York and along with Amrex [ph] folks, which is Dr.Carson for the SR President.
We are going to find the shortest path to get this done. But again, look at the data, look at
what leronlimab does, look at all the history and tell yourself. Do you really think this is a
great situation or not. Next please.
Q - Analyst
Will there be a follow-up for the trial patients that may that we're discharged before 28
days. This is for the new trial. So they will be included in trial reporting and continue to
Page 22 of 33
Date: 2021-04-07
receive weekly shots for the full 28 days.
INITIAL DRAFT
Let's focus on the work at hand.
I mean there might be a lot of things, but let's not go there please. Next.
Q - Analyst
Okay. Pleasing every country in which CytoDyn has filed a formal application for an
emergency use authorization.
We have already said what we have done in the past in the press release, please refer to
those. Next please.
Q - Analyst
I've heard conflicting information regarding an EUA approval in the Philippines. On a
video.
Dr.Nicholas said that in order for leronlimab to get an EUA there. We need any EUA from
the country of origin being the US or like the nation first before the Philippines can apply
their EUA Is this statement true?
So there was a presidential order. I hope everybody remember that, we said that,
emergency INDs in another country will suffice and then the order was taken back, not the
number of debt is going through the roof and we are exploring all of that and we believe
we're getting closer to some kind of resolution, and we might be able to get EUA before
we get EUA anywhere else. We don't know, but we feel very strong about what's
happening right now, what we're doing with them right now.
Next, please.
Q - Analyst
This is a question concerning the cancer Basket Trial. Is the cancer Basket Trial still
accepting patients, that clinical trial site says, it's still accepting patients? But I can't find
information about the trial or contact information on CytoDyn's website. The trial is still
open, and we will look into that to make sure it's on our website soon as we can.
Next, please.
When should we expect -- this is a finance question for you,Mike. When can we expect a
dividend payout? Last year you stated, we would be receiving dividends.
Page 23 of 33
Date: 2021-04-07
Okay.
INITIAL DRAFT
Did you ever say that, Mike?
A - Michael D Mulholland {BIO 1465414 <GO>}

I did not sir.
Okay. I I said that. So, let me explain what I said.
I said, if we sell product leave leronlimab, and all the product that we have. And we are
able to generate a billion or $2 billion from our product. That's what we were hoping at
that time to generate the might be less than that now. Then we definitely will look at
giving dividends and buying back stock.
These are all forward-looking statements and they can change as we go forward and
things change. And as of right now, with $25 million that we did financing was for
manufacturing, not to pay dividends. We really got that to be able to buy more products.
Go ahead.
Yeah, not really just add a follow-on comment there with respect to dividend payouts.
More specifically, for everyone's interest, the only dividend we are required to pay is on
on our outstanding convertible preferred stock, which by Delaware corporate law can
only be paid when the company has a surplus in equity. Thanks.
Q - Analyst
Now the next line of questions there are probably from me, because they're related to
lawsuit questions.
And I'm going to try and combine them, because they're all fairly related. I think again,
there's continued confusion as to how many lawsuits have been filed against the
company. There is only one lawsuit a class action suit that has been filed, it was filed in
Washington and now there are other class action law firms trying to seek shareholders
who experienced losses during a certain period that stated in the complaint. The
company is won't know the definitive nature of those claims until likely maybe July,
because that's the process of the class action lawsuit.
It will likely not even resemble the complaint that was originally filed. And so at that time
the company will respond as it should to those complaints and defend it vigorously, which
we intend to do. So there's only been one lawsuit, not several even though the news that
comes out seems to suggest there's more than one. And with regard to all of our other
litigation that arises in the ordinary course of a business that will be reported in our 10-Q
when it gets filed likely next week.
Page 24 of 33
Date: 2021-04-07
So that's -- what that's all I have to say about lawsuits. It does it takes a tremendous
amount of money and resources, but we are pursuing.
INITIAL DRAFT
But let me give add, that we are thinking about bringing about bringing a lawsuit against
Adam, Tristan and his organization for saying a lie during the market trading time, which
was -- they said that Dr.Scott Kelly sold shares -- his wife's sold shares, I'm sorry. And that
was opposite.
For doing that during the market time, we will definitely are looking right now to bring the
lawsuit against him personally and his organization, and we will update you on that
lawsuit also very soon. Please go ahead.
Q - Analyst
The next questions are more general. And the first question is, as a shareholder, what can
we do to at leronlimab approved? Should we contact our senators or news media, or
contribute to a Go-Fund-Me to raise money for larger trials?
No.
We appreciate always great thoughtful process that everybody going through. But,
please, do not send emails to the FDA, an overload them. They have been nothing but
good to us. I'm not saying that to get in the good side of FDA I'm saying that because it's
the right thing.
They need p-value of 0.05 from everybody. Big farmers, small farmers, literally work
everybody. Now, we are very close to that. We just saw what we saw, that was a strong.
But, let's take our time and do the rest of this stuff and maybe we get lucky and get you a
in other countries much faster. We working on that too. Look at what this can click on
company has accomplished way our trading when I first got involved in this company was
1 million share a year. Now we are trading $5 billion per year.
1 million shares a day versus $5 billion a year. So, we are doing good. Thanks to you
shareholders supporting us and whoever in the company is not going to do good, they
got to go if it whether it's me and the the Dr.Kelly has to do that, if he doesn't he
cargo[ph]. Everybody has to be responsible.
With this we were dealing with a product that impacts the life of people and no regulatory
agency has done wrong by us. Nobody. Please, I'm sorry, I got emotional. Go ahead.
Sorry.
Page 25 of 33
Date: 2021-04-07
Q - Analyst
I recall that in one of design[ph] presentations last year. Mention was made of an
opportunity to evaluate leronlimab efficacy with combinations of COVID and various
INITIAL DRAFT
comorbidities. Will you be analyzing data of that sort to suggest further indications or
research opportunities?
We -- Dr.Kelly you want to answer that?

Yeah.
I will say that, one of the things about COVID is that. As I said earlier that it's a multi-
system inflammatory disorder, it can affect the liver, the kidneys, the pancreas central
nervous system. So we are aware of all this and we are monitoring some of that some of
that the clinical symptoms, we're looking at biomarkers, we're considering imaging
studies to further evaluate the manifestations of COVID
Q - Analyst
Can you provide an update on licensing and any partnering deals?
I'll be happy to take.
Well, go ahead.
We're saying -- I just ask.
Not we can't comment on active discussions and we have to let everybody know at the
same time so.
Sure. Yeah, perfect.
Q - Analyst
I think they have found this earlier, but when do you expect to file the breakthrough
designation for cancer given our current cohort of cancer patients?
We will be doing that next two weeks and we meet. We are hoping to submit that break to
pre breakthrough designation meeting. I feel so strong about the data, Dr.Scott Kelly
does and we can't wait to send that to the FDA along with the package. I mean the
application.
Page 26 of 33
Date: 2021-04-07
And, I just want to also clarify one thing. Last time people ask us about big formal deals,
when we answer like the way Dr.Scott Kelly did, I actually liked that. Everybody said, well,
they don't have any discussions with anybody. We did not say that.
INITIAL DRAFT
We did not say. We do not have discussion with DPharma. Please make sure you note
that. We said, we cannot comment.
Next, please.
Q - Analyst
You've touched on this, but I'll ask it, because it was an investor question. How would you
characterize the relationship between CytoDyn and the FDA? Do you believe, we are
getting a fair review by the FDA, and what actions prompt you to believe this?
Sure. When the FDA saw the data from combination therapy from HIV, and then we
announced we had a better results with the higher dose.
The FDA could have said, do another trial. That would have took us five years. Because it
took us five years to enroll 50 patients. So five years to enroll 50 patients same amount in
500 those.
They had to go and get advisory committee to allow them to give them permission to
give us the idea of give us just your safety from another try. They don't do that for other
companies. You can check on that. And they were very nice to us to be allow us to have
that.
So, we don't get crushed at that time and we pass those very tough milestone that people
don't know about dating. Oh my god, they got the BLH this or that not happen. No,
everything was happening with the small amount of money, with a small amount of
delusion that we did, and we had to deal with our own problems and demons in the
inside the company. So we had to clean air a lot of those and be able to go forward.
Now, with all that said, here comes a COVID-19. FDA didn't want to us to to do IND or
protocol that's why I'm very thankful to them. They said you need to submit pre-IND like
the other 500 companies who want to submit IND for COVID-19. Right then Dr.[ph] got
emergency IND They said, okay, we'll accept it.
They expedited us 90 days. Then they ask us to shut down IND, so we can enroll faster in
each of that. They guiding us. What else do you want to them to do and they hope, and I
think we're getting there now.
I mean, I don't know if people see this 82% better rate. They need to check a box that says
p-value 0.005 in the primary endpoint and we're going to do that now, because we
learned a lot. Another company, big pharma did seven clinical trials to get there, we did
Page 27 of 33
Date: 2021-04-07
one. And we're going to do one more and that's it and maybe we're getting EUA before
we do this one.
INITIAL DRAFT
Who knows we got 55 patients already in our open arm label. We are thinking of
expediting that perhaps perhaps and get more data and we will work with all the
countries. Next?
Q - Analyst
Congratulations betadine on saving lives. How many lives in total have been saved for
leronlimab use for COVID-19, including trials and all compassionate uses?
So when I say we save lives is nothing to me.
When our doctors, Auto dr. Otto Yang. Dr.Stidham Raju. Dr.Nick accuracy.
Dr.Nick a Christian indicated to the regulatory agency. The four patients that he had there
was a lot of patients like that in the past two years in that institute and they all died. He
said these are the only four that survived. Those things brings me to my tears.
I Cry. Because that never happened. I don't know my life never expected to have this
amount of honor to be here to be able to do to do that. So whatever pounding all the
negatives would do and found us.
I love it. Because I deserve to stand strong with my team and my team is fantastic and we
are saving lives, even one life is a lot of life to save and we setting quite a bit of it. So
thank God for that. I'm very, very happy.
And yes, we are very happy, but we don't know the exact numbers, but the numbers are
well into double digits and we may be looking to that. That's a good thing to look. And
you guys saw the case study that we just published. Okay.
Next please.
Q - Analyst
Do you want to elaborate on that matter? That's pretty important.
Where the patient was on the -- yeah, of course the on ECMO for 82 days or so and the
patient had to go to MHRA to get us to send leronlimab that took some time. And once
they got that, they couldn't believe that the patient was coming out of ECMO, and in our
study also -- six patients where is in -- leronlimab, five of them walk out.
Page 28 of 33
Date: 2021-04-07
These are very strong, but these are anecdotal, and anecdotal data are dangerous.
Because, if FDA or any regulatory agency give you approval with anecdotal data, they're
putting a lot of patients live at risk. Keep that in mind, also. I know everybody knows the
leronlimab is safe and everything, but we got to be respectful to the regulation that has
INITIAL DRAFT
worked and saved bit millions of lives in America perhaps, because of that.
Maybe we can save a few hundred if we, but we got to go through the right path and we
are going through the right path, and I'm very thankful to FDA and other regulatory
agencies. Next, please.
Q - Analyst
Do we have any data on the HIV patients who are receiving leronlimab, and whether
they've had any incidents of COVID-19?
We add one-time, long-time ago. I said, there wasn't any, but maybe there is that I heard
about, I don't know if there's any, I haven't checked but that fun time.
I think we got one patient that has but I'm not sure about that. But it's got Dr.Kelly can you
tell us anything about HIV patients getting COVID-19, if they are leronlimab, what's the
chances of it? Let me know [ph].

Yeah, I'm hearing numbers. We discuss launch with AmRex[ph], but I haven't heard any
numbers, but I think that it's very minor.
It's at all.
Okay.
Q - Analyst
Has big pharma reached out to CytoDyn. I think you answered this before so we can.
I'll answer it answer. The answere is, they have -- yes, they have reached out to us, but we
can't comment on active discussions.
Q - Analyst
Given the success of the Philippines' patient.
Page 29 of 33
Date: 2021-04-07
Why are they more -- why aren't more people using it in the Philippines?
INITIAL DRAFT
We have to go through the process process please go ahead the press release that
Mr.Michael Mulholland work very hard and the last minute to put it together. This man
works more than anybody I've seen in my life as I said before and I'm honored to have
him in our team. So, that presley's was put by him at one o'clock today. So, please read
the press release.
Next please?
Q - Analyst
Do you want to highlight what's in the press release not -- .
Yeah. So, the thank you everyone for that. So the first patient in Philippines -- yeah go
ahead -- .
Q - Analyst
No, I was going to say and I was going to say next to your attorney works as hard as its
first.
Yeah. You doing a fantastic. -- absolutely, I am greatfull to that.
People going to realize what complicated things gets when you have so many x board
members wanting to sue you getting this getting that's so. She has done fantastic. So, the
press release on the Philippines The first patient was able to get off in 35-hour got better
and then got off the hospital within two days after that, and prior to that for 10 days, they
gave the patience to of the product that they thought it might help, it didn't. And that was
the last resource like Samantha Moti, which was one of the first patient who had no other
option and was giving up and leronlimab saved her life according to her and Dr.Otto
Yang.
And then the well happened is this patient was really so, the other hospitals is started --
realizing that they might want to give this product to their patients. So 28 patient
compassion special permit was requested from one hospitals. We got that today and
where the product went out. We also have non-binding term sheet for 100,000 wiles of
our inventory.
And that's for compassionate passionate special permit sales. So we're going to be able
to sell we don't know how fast this contract is going to be sine. I will always stay sign it.
We don't know how many while there we want to send over time.
Page 30 of 33
Date: 2021-04-07
There's a lot of different things in here. So don't get surprised if it's not all hundred
thousands at one time or things may slow down just be conscious. I'm learning too
cautious everybody when I give this kind of good news, but it's a very good news for us.
INITIAL DRAFT
Q - Analyst
Rarely, do you speak about competitive threats such as other nab-treatments from other
companies like Humanigen assuming therapeutics like a very logic have been have a big
market potential.
What do you consider to be your biggest competitive threat?
The biggest competitive threat we have is not from other products from getting financing
and making sure our shareholders are happy with us, but Dr.Kelly wants to say something
go ahead.
No, that's fine. we're really not focused on the competition, like leronlimab, and we, as an
owner said before, I think, there's a limited drug supply, and we also -- there's plenty of
patients throughout the world, working in the Philippines, Brazil, all over the world, there's
plenty of patients. There were, I think, you know, as not always saying, our biggest threat
is really not from an external competitor, just getting the job done and moving forward.
So the next question I will answer, and the question came in, as an international patent
was found online on the patent scope website related to CytoDyn, and cancer with the
publication date, February 11, 2021. It seems to indicate that CytoDyn was granted the
patent. Can you discuss the patent, and what it means for the future of the company? The
answer to that question is, yes. The application is CytoDyn.
Our examination is in the early stages and the application is part of CytoDyn on ongoing
efforts to develop patent protection for continuing innovations, and that's all the company
can say with regard to these patent applications. The next question. The CRO and
NATO[ph] chose mortality as the primary endpoint for CD12. But other companies did not
use that endpoint, because it takes more participants to reach significance.
For example, the Rocks and gene[ph] specifically chose not to use a mortality primary
endpoint due to the difficulties in the mortality endpoint. And this last fall blas[ph] failed
while using mortality endpoint due problems with the mortality endpoint. Yet, none of the
misguided your CD12 trial. How do you respond to that?
We have done the best as we can do.
We do get information from other scientists. We do look at the data and we look at the
DSMC what they had said to us. We do everything we can and at the end, we'll proud that
we did one trial only and we have tremendous amount of hope now to go forward with
one trial only. And other form that you just mentioned.
Page 31 of 33
Date: 2021-04-07
Look at how many trials they had to do to get to the point a guard. Next, please?
Q - Analyst
INITIAL DRAFT
Advise why cited -- and leronlimab is not listed in the Philippines as being submitted for
EUA I have searched and cannot find a link on the website.
In what country?
Q - Analyst
The Philippines.
As soon as we have anything substantial and we are in discussions to see where we can
get.
We don't have anything substantial to report on. But, we are hopeful and as the press
release today showed in Philippine is very strong. So, I think this is the last question area.
Q - Analyst
And company has gone through and what we have done with leronlimab.
And to look at the leronlimab success and not to be able to extrapolate that this is really
getting to the very very beautiful places to me is very unwise. So I believe the whole world
would know about us as soon as we have won approval we working on that and I want
everybody to know that when we raise money we think about shareholder dilution, please
look at when we ask for 100 million shares to be authorized and how money of that we
have used? In the past, we used to add 400 and it would have been gone within a year
and now it's not that and our trading is going much better. Trust me, believe in facts
believe in the leronlimab by need to CCR5 and all the testimonies that you get and the
result of we put out. Everything else is noise.
With that, I want to thank everybody for being on this call. Have a great day. bye.
Operator
Thank you.
This concludes today's call. All parties may disconnect. Have a good day. The Event has
Ended
Page 32 of 33
Date: 2021-04-07
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INITIAL DRAFT
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incidental, consequential, special or punitive damages in connection with the furnishing,
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Company Name: CytoDyn Inc

Company Ticker: CYDY US Equity

Investment Community Webcast

Michael D Mulholland {BIO 1465414 <GO>}

Hello everyone, and thank you for joining us today.

This is Michael Mulholland, Chief Financial Oﬃcer of CytoDyn. Joining us on today's

matters, statements regarding leronlimab potential eﬃcacy in certain immunology and

Products may not receive regulatory approval or market acceptance.

The company undertakes no obligation to update publicly these forward-looking

Nader Z Pourhassan {BIO 16568801 <GO>}

Thank you, Mike, and thank you to all our shareholders.

Scott A Kelly {BIO 20132670 <GO>}

Yes, absolutely. Thank you, Nader.

Nader Z Pourhassan {BIO 16568801 <GO>}

of 28% Leronlimab, 37% placebo. So the data is actually coming strong.

So with that please let's go ahead go to Q&A [ph]

Questions And Answers

Question And Answer

Yes. How common is it to get a refusal to ﬁle?

We're doing 700 milligram. Next please.

A - Nader Z Pourhassan {BIO 16568801 <GO>}

Will Biam producer on the map, if you get regulatory clearance?

Nobody can produce the only leronlimab, but us.

critically population. We do statistically signiﬁcant population -- statistical signiﬁcant p-

A - Nader Z Pourhassan {BIO 16568801 <GO>}

A - Nader Z Pourhassan {BIO 16568801 <GO>}

A - Nader Z Pourhassan {BIO 16568801 <GO>}

Arian. Hold on. I am not saying FDA say do two doses.

I think it should be happy everybody about that's.

an email -- And Dr.Kelly, you want to add anything to that?

A - Scott A Kelly {BIO 20132670 <GO>}

A - Nader Z Pourhassan {BIO 16568801 <GO>}

A - Nader Z Pourhassan {BIO 16568801 <GO>}

So, I don't know (Inaudible)

A - Nitya G Ray {BIO 6292171 <GO>}

whatever we want, and we are going to heavily enroll overseas also.

A - Scott A Kelly {BIO 20132670 <GO>}

receive weekly shots for the full 28 days.

Let's focus on the work at hand.

Did you ever say that, Mike?

A - Michael D Mulholland {BIO 1465414 <GO>}

only be paid when the company has a surplus in equity. Thanks.

the right thing.

A - Scott A Kelly {BIO 20132670 <GO>}

We're saying -- I just ask.

Sure. Yeah, perfect.

A - Scott A Kelly {BIO 20132670 <GO>}

numbers, but I think that it's very minor.

Yeah. You doing a fantastic. -- absolutely, I am greatfull to that.

What do you consider to be your biggest competitive threat?

We have done the best as we can do.

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