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Cytodyn Pay-for-Play Conference Transcript Sept 29 2021
Cytodyn Pay-for-Play Conference Transcript Sept 29 2021
Company Participants
Nader Z. Pourhassan, Director, President and Chief Executive Officer
Scott A. Kelly, Chief Medical Officer, Head of Business Development and Chairman of
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the Board
Unidentified Speaker
Other Participants
Anna Barry
Presentation
Unidentified Speaker
(Call Starts Abruptly) CytoDyn Inc It trades on the OTCQB, under the symbol CYDY and is
a late-stage biotechnology company developing innovative treatments for multiple
therapeutic indications using leronlimab a novel humanized monoclonal antibody
targeting the CCR5 receptor. Please welcome its President and CEO, Dr.Nader
Pourhassan; and Chief Medical Officer, Dr.Scott Kelly. And remember you can submit all
your questions for CytoDyn right here through the webinar module. Thank you gentlemen
Bloomberg Transcript
Thank you for the introduction and it's great to be back at Emerging Growth Presentation
and thanks for everyone being on this call. We will be covering quite a bit of slides that
are under forward-looking information statement, please review this slide that you see
I'm not going to go over this one slide, the first slide as we have done in the past. But just
the highlight of this slide is this company took one product with one indication potential
to 31 indication potential in seven years. FDA guidelines show that it takes about 12 to 15
years to get approved. People should keep that in mind, please.
Again, the trials that were done in the past biotech company Progenics over 12 years'
time. They got to the point where they had four trials and their business plan was not able
to allow them to go forward. They had to sell this product to us. We were lucky enough to
look for opportunities and locate them. And we were able to take that, and in seven years
the number of trials are listed here for your review.
Now, in HIV it's very important for shareholders to examine our mentality as a
management of CytoDyn. What do we think when we talk about business plan, is business
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
plan something we just say yes, let's go get it and just get it to the finish line and get
approval or do we really have something and we are real, or is it just fake? Well for your
comfort when we took this product, the business plan for Progenics stopped, integrand to
the dead end. We took it, we examine it, we went to key opinion leaders, top people, we
gathered the right team, and after doing so, we stopped that trial that was going to take
10 years to do Phase 2 alone, get the money, NIH money of 6 million back and we came
up with a business plan that did monotherapy that we claim, if we're successful, we will
change HIV paradigm. Did we do that? That was our bread and butter. That's why we
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lasted. That's what we went through fire and we still walk out without scratch, and raise all
the money with it. And thanks to god, we were able to do what we did because
leronlimab is showing that it potentially can save people's life. That was our business plan
that we went and executed.
Now, let's talk about the business plan going forward, because there is no more one
indication, but 31 potential indications. So let's talk about the first one. Let's go to the very
first indication that I would like to talk about is cancer. This indication makes me not to be
able to sleep at night because there are patients, who reach out to us, that tell us that
leronlimab has done so much, that gives me enough comfort of whatever trials and
tribulations and hardship that we go through me and my family are grateful to be able to
do what we are doing and having saved just one patient alone which is a lot more than
that by now, it's gratitude, it's just beautiful for us. The results of our cancer trial we
generated that result. Some people take 10 years to generate results in cancer, but we
generated. We generated enough results to show that if you take patients in cancer, 23
different -- 22 basket and one mTNBC. Then if the patients were stopped right now,
minimum is we are 400% better in our result than patients on a standard of
chemotherapy. But if they last longer because the data is with there right now, that's
660% better progression-free medium, progression-free survival for 12 months. That's
Bloomberg Transcript
Now, as we were talking to the folks that analyze our data, we asked them what do you
guys think our breakthrough designation chances are, they said we don't see how you
don't get it. And then dig into the data with them we realize that the last company that got
approval for the drug. They had to eliminate from 500 patients, which they were doing
that trial while they got approval actually 61 or so patients had to be taken out because
they had metastasis to the brain because the product has to go through blood-brain
barrier in order to work on the brain. And we asked the people, how about our data? If
you have any brain metastases patients, they said actually you had six who has the data.
Good or bad. They said the data was as good as the rest of the 73% of patients who you
see over here. And we were blown away, so we got to definitely include that in top --
breakthrough designation application. But keep in mind, leronlimab passes through
blood-brain barrier. That's huge, that's very important for people to keep in mind.
Now breakthrough designation, two requirements. The mTNBC has to be unmet medical
need, it is. We will document that in our application and then we have to show efficacy. To
show efficacy you need five patients in a clinical trial. In this data, we have 10, that's the
business plan that we had, to go for smallest unmet medical need population, mTNBC,
get approval and breakthrough designation then go and try 22 other cancer and get
those breakthrough designation approval post this one. And then try all kinds of
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
combinations with PDL inhibitor and all that which could take many years if you go for first
approval. But people who understand this approval process unlike the others, they know
that's genius. You go for small indication as unmet medical need and you go there for
other things and I want to thank our key opinion leaders who always right there and
talked to Scott Kelly, who led this.
Yes, if you don't mind. Please tell us any new testimonies that might be --
Yeah I would, and the other thing I'd like to add to Nader's point is in terms of
breakthrough designation, on average that can decrease the approval process by 2.5 to
3.5 years. We already have fast track and triple negative, which is very exciting and the
average is about $8.3 billion market cap on one breakthrough designation. So I want
investors to understand that. The reason I received the testimony from a patient's wife,
who has pancreatic cancer that I'd like to share with you. This is a relatively new indication
for us, but something as you know there's limited treatment options and very exciting.
Hi Dr.Kelly, I have some really great news to share. My husband has responded very well
to leronlimab, she attached CT scan. He had his first dose of leronlimab on 7/27. He then
Bloomberg Transcript
took leronlimab with gemcitabine and braxidin on 8/3, 8/12 and 8/19. Then he took
leronlimab solely on 8/26, 9/2 and 9/9. And between his 8/12 and 9/7 CT with contrast
scan, his tumors shrunk. The largest liver tumors went from 4.8 centimeters to 4.3
centimeters, 4.6 centimeters to 4.3 centimeters and 2.5 centimeters to 2.2 centimeters.
The oncologist called the radiologist to ask about the pancreas and he verbally said it
shrunk from 4.6 centimeters to 1.5 centimeters he's CA was 19, tumor markers dropped
dramatically as well from 183,022 on 8/10 to 56,806 on 8/26. It dropped again to 51,491 on
9/7. There was initial concern of a potential kidney infection, but the blood work and
ultrasound (inaudible) that concern.
Thank you again, for helping him on this compassionate used drug. We are very hopeful
that we will continue to see great results although you have always humbly tried to assist
us and never ask anything in return. I feel compelled to pay it forward. If there is anything
you need from us to champion your efforts, please let us know. And again, this is one of
many we've been receiving lately and very encouraging in other types of cancers well.
Nader?
Thank you so much Scott and just for everyone information. The very first patient that we
enrolled in mTNBC I believe that was the first one their Dr.Call -- send us an email. I have
the email and the documents to share with anybody who likes. They said that the tumor,
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
they send the CTC scanned documents of the patient saying, look, the main primary
tumor shrunk 25%, in three weeks after leronlimab and they never seen that on
carboplatin and that patient was on carboplatin and leronlimab. So we got some --
Yeah there is genesis effect. And I think that when you think about -- when you start
looking at the smaller vessels, you see an 80% reduction in our animal models and these
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are humanized models and a 62% reduction in the total vessel pixel area. We think that
that's really the reason is blocking angiogenesis in order to grow these tumors have to
have a blood supply. So it's a very interesting thing we're evaluating.
I appreciate it. So we believe in our team that we are very close to hopefully get a triple
maybe -- I mean for the triple negative breast cancer, get a breakthrough designation and
let things -- let the chips fall in place.
The next thing that we have got involved. Thanks to Dr.Seethamraju and Dr.Scott Kelly.
Dr.Scott Kelly recognizing the mechanism of action despite other people trying to take
credit for all the things that our team does. He's the one that told us that this should be
tested and, then the heavy-lifting was done by Dr.Seethamraju who actually went to FDA
and said, I want to inject my patients right now. They're on ventilator, they're on renal
failures and also the problems and we were able to have the first patient self-extubated,
which was amazing that paved the roads for us to go forward faster.
Bloomberg Transcript
Now, we did a Phase 3 in critically ill population and severe from that population of 394
which of 384 were in the modified intend to treat mITT, 62 were critically ill population. If
we know that we need to go for critically ill population, and would have changed our
primary endpoint halfway. We believe we would have been at EUA right now, but we were
not able to do that. But there are CRO dropped the bottle, we dropped the bottle,
whoever dropped the bottle, there's no reason to worry about that. It's just that all the
pharmaceuticals do 10 trials or so before they can get at primary end point. So, we
believe we can get the primary end point now, why? Look at the results and just make a
decision for yourself. The first dose on day zero was given to the patients and critical ill
population. And there were 78% better survival than placebo after seven days, at day
seven. Second dose was given at day seven, seven days later, at day 14, even up 4% more
82% survival better. But we didn't give any more leronlimab day 14 and 21, and the
percentages then down 50%, 31% even though 31% probably is the best result anybody
has ever seen in this population that's what I believe, maybe there's somebody else they
can send us.
So let's predict what we believe mathematically could happen. First of all we did a great
job, thanks to our team getting an IV administered to patients. But the fact if we look at
the bottom picture of the table our prediction is, if the first dose dropped drastically by
78% and in the second dose it just got better four more percentage. So let's just assume it
just gets better four more percentage each week, that's 86% and 90%. That means we will
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
hit the primary endpoint by a very small number of patients, but let's look at the next
slide.
Here, I just put it in the graph. The CD12 on the top, look at the graph day zero shoots up
today, seven and then continues to improve and then it drops. It just drops, but the
prediction A versus B, if B is a prediction that the percentages stay the same the next two
weeks. That's what we're going to have. If it gets improved more, it gets like that, but
okay. But we have done something that took a lot of work and I hope our shareholders
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give the management team a lot of credit for that and to Biom Pharmaceuticals and Albert
Einstein in Brazil. We negotiated with the ANVISA folks to get the mortality not to be our
primary endpoint in CD16, why? Because it's CD12, we recognize that the patients on
ventilators who just got out of the ventilation and walk out of the hospital. The percentage
was 166% better than placebo. I mean the primary endpoint, if it's that we can look at the
P-value in CD12, the CD12 P-value for 62 patients along was 0.1119. But this stratification of
the age group was against us. So when you adjust for that which you're allowed to do, we
get 0.0824. Like, that was a primary endpoint and this 62 became 70. We would have had
the primary endpoint met probably.
So, if you look at the number of patients that we have in CD16. You will see that the interim
analysis will be happening at 127 patients. That's double of what we actually, almost
double of what we need to have the primary endpoint with that indication, with that
primary endpoint. So 127 how fast can we get there? We believe this year is definitely our
year that we're going to get there that's what we believe, we might get there much
sooner even, but 127 patients and the world has seen anecdotal data perhaps we'll be
ready to get leronlimab to be used.
Bloomberg Transcript
So the next indication that our business plan allowed us to have, is we keep thinking on
how to make this company better and bigger and more prosperous for patients and for
our shareholders. So, our business plan was let's try long-hauler, thanks to Dr.Scott Kelly
and very much to Dr.Chris Recknor, who says I will enroll and initiate long-hauler for you
this year and finish. I told him, I don't want it. I was against it because I thought he would
take two years. As soon as he said, I'll get it done this year, I said, let's do it right now, let's
move. And lot of people talk about enrolling right away, we have heard that before, but
Dr.Chris Recknor is different. He said what he's going to do and he did it and the result is
out.
For all 24 symptoms of long-hauler, if you combine that the primary endpoint was not met
at 0.05, which we were not trying to hit primary endpoint. We were trying to understand
what we can do with this symptom -- 24 symptoms, there's too many of them. We were
100% better in leronlimab arm than placebo in regards to dropping the severity of all
these 24 symptoms lumped up together. That means our business plan was fulfilled in a
record time to get leronlimab closer and closer to approval in less than one year for a
whole new indication that opens the door to all post viral syndrome. Scott, can you talk
about the post viral syndrome, is that a small market that we just opened up the door for
ourselves?
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
I mean, this long-hauler alone is a tremendous market. I mean, I think of as of this morning
that's been over 233 million people infected with COVID. And if you look somewhere
between 20 million to 60 million people might have this for long-haulers. It could be up
to 100 million for all we know. But then post-viral, we're looking at lot of different things in
these patients in exploratory endpoints, including CCR5 expression, immune cell
phenotypes and plasma cytokines. And we think it's the perfect way to pivot into post-
viral syndromes because we see a lot of similarities Nader. So by pivoting into that space,
it's millions and millions and millions of patients with myalgic encephalopathy and the list
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goes on and on. So we're really trying to crack the code in that arena.
So, when we are approached by somebody like Dr.Recknor, and Dr.Scott Kelly himself
believing in that. Saying that hey, we got to really check this out and we say look what we
got our all our people are working hard, adding this is just tremendous pressure, more
fundraising. We don't drop the ball. Thank god, we don't. We continuously go forward,
we saw some patients on wheelchair in this trial up on leronlimab. They got out of our
wheelchair and they're asking us right now when they can get back on leronlimab. That's
something we are proud of no matter what.
Yeah, Nader to your point 45% of these patients. They have to reduce their work hours
and 22% don't work at all. So you can imagine the economic impact and currently there's
just not effective treatment options and that's why we're working really hard to get this
done for the patients.
Bloomberg Transcript
And we have a protocol to the FDA. We are discussing with FDA the next trial, they are
giving us guidelines on how to do it and what to do and we should have hopefully all
really had resolved in the next few weeks. So, yes there will be another trial which could
get us approval whether it's Phase 2 or 3. If we hit the primary endpoint, we would make
the case for approval. So, we're very proud of this achievement. And thanks again to
Dr.Chris Recknor for excellent job.
Now, let's talk about Philippine. Again, these are the number of things that we do. Record
time, we signed a licensing agreement with Cairo Pharmaceutical. These are not small
things. This is very difficult task. And we don't sleep enough; the whole team constantly is
working on this. And the people who brought Philippine to us, they know who they are.
And I want to thank them right now again, you guys did a fantastic job, and I cannot thank
you enough. And right now, Philippine is back on track again, and their orders are flowing
in. We have received close to $300,000 worth of orders. And that's -- 85% of that is just
happened in the last few weeks, so the rate is going, the media coverage of the
physicians saying claiming that leronlimab save a person's life whether that patient was a
person who everybody knows them or not, it doesn't matter. We're saving patients' lives,
according to these physicians and they are talking about it and the orders are really
picking up. And we really think we're going to get to $2 million to $3 million if not more
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
worth of sales to Philippine without approval. And hopefully by then we'll have
emergency use authorization.
And Brazil. Again, the last four, five months we've been taking a lot of beatings, but we
don't let it bother us. We have a job to do. We have patients who need this and we
recognize that. So we put our head down and all of us focused on Brazil. And signing a
contract with a pharmaceutical is a necessary thing to do. If you're going to sell product in
any country, you cannot do that without it. We were able to do that with Biom. Thanks to
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them for signing a contract within a week or two. And we were able to go to ANVISA, and
we believe we're going to hit the primary endpoint in record time. The business plan was
created, a new business plan for this. And it was executed in a record time. And it will get
to a very good place in our opinion. CD17 is 612 patients; first patient was injected and
announced. CD16 critical ill population, we will get update tomorrow. But we hope to get
to 127 patients very quickly. The hospitals who are in the hot spots. They are all enrolling in
those hospitals. This CRO is not, this CRO that we had before. This is a world-class CRO;
they enroll COVID-19 patients for Pfizer trial. They published in New England Journal of
Medicine. They know where to go, they're giving us excellent detailed report every week
and we're enjoying very much working with them.
The next thing is NASH, again I got to thank Dr.Chris Recknor, he comes to us to Scott and
I. And said that I can start the NASH trial and enroll this year and I laugh, I said last time I
thought you're not going to do it, you did it so I'm not doubting you. Scott says do it,
don't wait. We went full blast with a good business plan 60 patients enrolled; we believe
this is the best enrollment ever from anybody in the world that's what we believe. Please
send us any data, if you have that this is, you have something better. And then open-label
almost 350 milligrams was added. What is open labor arm mean? That means we see the
data. We see the data, we see if the fat deposit is lower or not, 6 patients is completed.
Bloomberg Transcript
We can't wait to announce whatever results we can as soon as possible. We're working on
a Phase 3 right now to in anticipation that the results are positive in Phase 2 and starting a
Phase 3 NASH. Scott is -- NASH is small indication.
Yeah. It's over a $21 billion market Nader and it's 30% to 40% of the population and 3% to
12% of the population NASH and like I said, 30% to 40% have NAFLD and HIV population
is even higher. So it's a tremendous market opportunity.
So that brings us to a question of, do we have enough product. Well, Dr.Nitya Ray done
the job that everybody should look at it. Two years of transfer of technology is a long time.
We started a long time ago, $20 million had to be spent. Without getting any problem,
just transfer of technology. We have done that with Samsung. And because of that
transfer, we were able to manufacture, with Dr.Nitya Ray leading the way for 1.2 million
vials, but we still continuously have to raise money to not lose our spot next year February,
which we would like to perhaps manufacture 3 million vials. And, that's going to cost us a
lot of money. So that's cost dilution. So, what do you do when you have a company who
has this kind of potential, needs product, can't drop the ball in any way shape or form in
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
any of the tasks, but you need money to make sure that this happens the right way. So in
order to get that done, I would like to go over the fundraising that we have done in the
past and tell you all how we are going to do this, we are planning to do this, what is our
business plan.
So 2017, '18, '19, when a group of people thought that they can do a lot better job than us,
they put us aside and they become the leader. We got diluted in two years, 400 million
shares to raise $100 million. Do not let yourself forget that as a shareholder. I'm pleading
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to you to remember all of these carefully, run it by experts and see if we are really telling
you the correct things or not. 400 million shares that diluted, we don't want that to
happen again. So when we were put back on the leadership, we immediately cleaned up
the mess and raised $200 million, almost 50 million shares. And then we get these
questions that -- we do a good job or not. Well, somebody criticize us said that, tell us
what's your plan on raising funds right now, don't tell us about the past. Okay, I'm telling
the past to make you feel comfortable, but let me tell everybody the plan. We usually
raise money with private investment in private equity, or the register direct note or loan.
Loan happens when you have collateral, when you're in NASDAQ, we're not. You don't
have approval, you don't have collateral. Note is the only way we found out that we can
raise funds without diluting completely perhaps, we pay cash back or we may be repay
shares back but then little bit at a time, so you have given yourself a chance as a success.
This is what we did always hoping for a better day tomorrow so to pay back next day to
make sure that their shares perhaps go higher value.
Now with that there's a lot of talk, let's just look at the results only. What we see right here
in the screen is 50 million dilution for $200 million. Now, we're asking the shareholders to
authorize 200 million more shares, not that we're going to go crazy and sell all of those.
We are going to have strength when we have 200 million shares in our authorized shares.
Bloomberg Transcript
The big pharma will see that if the stock is on $10, $20, $30 if it is, they know that those
shares can be turned into billions of dollars. That way we will be in position of strength.
That's what we're asking for. CytoDyn, our history of dilution, everybody can see.
Now, there is a group of shareholders that doubt us, and we respect that. Anybody should
doubt us, and they do what they have to do that they think is appropriate for the
company. So the man named Paul Rosenbaum which I know him very well. We met
several time, pleasant person. He's been saying that we did a terrible job on the raise that
we have done with CVP the company that we getting know that we are very-very happy
with. Because the results show right here, but then I talked to Dr.Scott Kelly and I said,
didn't Paul Rosenbaum tell you that he was very happy with this, no. He goes well, let me
send you the text. So I took a picture of that text for everyone to read it to see the
motivations of what anybody does anything. I don't know what is but Mr.Paul Rosenbaum
after we raise money with CVP told Scott Kelly undertakes. I'm reading it from the screen.
Congratulations on loan in 30 years of doing this. I have never seen a better deal. Smiley
face, Paul Rosenbaum.
So, please keep in mind, we have to be realistic and of the motivation of everybody. But
let's just look at our report card real quick. And we'll then -- the report card in the last
seven years because CytoDyn management team get at A in anything. Number one,
developing two powerful clinical trials that put us on the map of huge indication, like
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
NASH and long-hauler which lot of thanks goes to Dr.Chris Recknor. Do we get A on that.
Business plan to launch breakthrough designation for mTNBC, that could lead to 22 other
cancer breakthrough designation and perhaps approval and then we can do expanded
label expansion. Number three, HIV trials after running two roadblock with our CRO we
switch a very difficult task to avoid many delays is a lot of fires in a biotech companies
always, and they need to manage that we believe it. Number four, Brazil trials two Phase 3
trials initiated in less than a few months, some companies go few years to get one Phase
3, and they're proud of what they achieved. And number six is the fundraising with
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minimal dilution. If the above six accomplishments are fact, then why is a group of
CytoDyn shareholders so intent on replacing our Board.
I'd like to share another text from Mr.Paul Rosenbaum who's leading this group. What he
told me in a text. This is his text to me. Plain and simple, this is March 20th, 21st as you can
see in the screen. Paul Rosenbaum said plain and simple. I am very proud of you and the
job you're doing in this very trying times, Paul Rosenbaum. I said thank you, Paul. I
appreciate that. He said, I have faith in you and the product, double smiley face. So at that
time, if you look at the chart for CytoDyn stock, the stock was at $0.95, look at that
numbers. The next 384 days what changed, well, the average stock price was 3 -- more
than 3 times $3.19. I don't get it, but anyway, maybe I can state loss for now, but we have a
new state of the Board that we are so proud of and we like for Dr.Scott Kelly to talk about
he is the Chairman of the Board. He's instrumental in selecting these people. Go ahead.
Yes. This is something we're very proud of. We think we have the perfect slate of directors.
I'll begin with Lish Ndhlovu. Lish was on our company's Scientific Advisory Board since
July of 2020 and he has been extremely impressive. And we've always been looking for
Bloomberg Transcript
The second one is Dr.Harish Seethamraju, who Nader knows well and I know very well. He
is one of the leading experts in the world at lung transplant and advanced lung failure. As
Nader said, he was the one that went to the FDA to get our first two ANDAs for leronlimab
in COVID-19. Right now, he's the Medical Director of Mount Sinai Lung Transplant
Program. Before that, he started the program at Montefiore at New York. But he's really
focused on advanced lung disease and lung transplantation. He has conducted numerous
clinical research trials. He has co-authored some of the most respected journal articles in
the field. He also completed a fellowship in pulmonary and critical care at Baylor College
of Medicine. So again, he's well published. He knows clinical trials and his knowledge in
this field is just unparalleled. So we're very-very pleased with having Harish join us.
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
And the last is Tanya -- Durkee Urbach. She is attorney, she has extensive corporate
governance, corporate finance, business growth experience, investment banking
experience, security regulatory compliance. And has a deep foundational knowledge, she
is an expert in corporate issues and legal issues. And obviously, this is very important as
well to CytoDyn. So we think we have three world-class people that are joining the Board,
and we're very excited about that. Nader?
Nader Z. Pourhassan
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A - Unidentified Speaker
(Question And Answer)
A - Nader Z. Pourhassan
Bloomberg Transcript
But what we did is, -- what he did is, he changed, and now I asked him to please take over
the business development role and he said, why, I mean, I'm Chief Medical Officer
Chairman of the Board. I said because you can't stand the calling people that you know
very well known people some of them and you know the deals that are happening.
The reason Dr.Scott Kelly got involved with us is because he was following Gilead when
Gilead had acquisition of a small company. He can tell himself. He's wanted to find the
next deal that could happen that would be huge and he thought sided I would be one of
those companies that would be acquire. And he doesn't drop the ball. He reads
constantly about what deals are happening and that's what we need. And immediately he
jumps on a people who are reaching out to us and when they asking for leronlimab in
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
right to try or emergency I indeed, they can verify that when they send me an email, they
will get a call or email from Dr.Scott Kelly usually within five minutes. That's what how
aggressive we wanted to be. But Scott would you like to add but anything?
think it's in the best interest of the company, but will be bringing in more people for
business development, as we move along, and get bigger and bigger.
And I want people to understand that one of the things that people always ask about is
about partnerships. We're certainly exploring international partnerships right now to also
retain our rights in the U.S. but I think there's now that we have data and triple-negative
breast cancer. I think we're in a whole new realm of trying to get partnerships, and have
people pay for trial. So, I think we're in a unique situation right now, we were never -- we
didn't have the data to do that.
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Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
As Peyton says, why should the shareholders believe your business strategy is better than
the activist group?
enough funds, everybody claims they can do that. So, business strategy right now, I don't
know if everybody saw the presentation today, but Nash long-hauler to COVID-19 trial in
Brazil in the hands of very powerful CRO. Our HIV back on track for BLA after leaving our
old CRO. And the cancer situation, saving patients lives that physicians claim they did.
This is our business plan, saving people's lives. And I hope people have seen enough of
it. Read the media in Philippine which is getting much bigger now in regards to the
leronlimab. What people think about leronlimab for COVID-19. Talk to some of the cancer
patients, do they have good business plan? And then perhaps we can figure out if we do
or not, but our business plan is very clear.
Page 12 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
I have enough funds in my account and we're sitting in a good situation with my family,
but knowing that I took an oath to Jordan, Nathan of our board members, almost 10 years
ago and telling them I would never drop the bond, knowing that I took it oath, Tom,
Jonah Paulson, said promise me you will never step down, promise me. No matter what. I
shook his hand I said brother I would never do that. Knowing that a lot of shareholders
who are loyal to us and they're sending email saying, please don't step down. I will not do
that, because if I do and our manufacturing gets dropped because Dr.Nitya Ray came
back to company for second time.
Based upon one condition that I'd be there, because I treat him like a brother that he is to
me. And knowing that the whole thing would drop everywhere, there's so many people
are now hooked up to each other through me because of the position, not because I'm
special because the position that the shareholders have graciously given to me to
perform. But if I don't perform, please vote against us. But if I am performing I am willing
to stay and then I also promise Scott, I will never stop, so that.
Yeah. I went through this before, when unfortunately when the stock was at a very low
price, I told Nader that it is my job as a fiduciary, is my fiduciary duty to look for the new
CEO. And we went through that process. And let me tell you be careful what you wish for.
It's a -- it would be a very unpleasant thing for that to happen for the company and for the
shareholders.
Page 13 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
Page 14 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
Most of the sites have critical and severe some say that we don't have lot of critical in
order facilities dice you rooms are very minimal. So but most of them are joined, but yeah,
we are very excited to have 30, 40 sites even the protocol 22 sides. I believe on each one
of these protocol or so we're going to reach 30, 40 sites within three weeks. That's how
many sites we're going to have, or that's what I believe, this is approximation.
Yeah. The (Technical Difficulty) trial, have that 3,500 sites in the critical is going to have 22
minimum. So, I think we're going to be in pretty good shape with that.
Q - Anna Barry
Bloomberg Transcript
Page 15 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
too much till we get updated. But the group that work on this, this is fantastic people and
I'm really blessed to be able to work with them. We work with them for five, six years and
we constantly had this great relationship and they constantly brought opportunities and
quite a bit of funds for us always.
Page 16 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
inhibitors and antibody drug conjugates and chemotherapy. So there's a lot of different
interesting opportunities and that's one of many that we are going to pursue.
So due to the discontinuation with Amarex folks, we are managing to get all of our data in
our own hands which were deeply were denied by them. They were not cooperating on
the data. So therefore, we have found certain issues that we need to resolve those and
that everybody know the timelines. But our goal our business plan is to get approval
emergencies authorization for COVID-19, if that happens this year with the interim
analysis, with a great results, hopefully, God willing, we don't have a lot of vials.
So even if you get approval for HIV by middle of next year, even let's say best case or end
of next year, we need to make vials, and we need to realize that when Dr.Scott Kelly says
we should think about oncology company, we're not avoiding HIV BLA, we love that. This
is our baby that we work so hard to go to monotherapy and combination therapy. But it's
just that the number of indication keep in mind what our work all are and breakthrough
designation for 23 indication and having HIV perhaps BLA submitted some time is fine,
but then COVID-19 is the one that's coming up much sooner, but we will give new
timelines for sure.
Page 17 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
something super positive. Lauren Williams says, how can you get 200 million authorized
shares if the SEC won't authorize S3.
somebody I even heard that say that, Oh my God, I cannot raise money anymore because
they can't use S3. You don't have to use S3 to sell shares. We just did announce some of
the sales that we made, but we can do pipe.
But S3 is on track, our CFO, Mr.Antonio is doing a fantastic job. Mike Mulholland is with us
and he has done a fantastic job before that always getting the S3 is removed. So I don't
see why anybody is not looking the past, see how we got approved constant and why
worry. Let's wait to see what the SEC says. And once we get approval, let everybody
know.
Page 18 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
We have tons of questions left for you all. And there are lots of compliments in here.
Some people are saying, you're doing phenomenal, keep going. We all support you with
our blood, sweat and tears. So, there's a lot of that as well. Would you like to finish with
just a few closing remarks?
is a lot of people that will tell you we raise the money. I had a quote from person that was
on the board - in our board that they said dilution will never kill you. Raise the money, with
whatever dilution. At one point, I had to stop them from raising with 300 million shares for
$30 million, I had to stop. So we very along when somebody says, I'm going to raise the
money don't worry, because you're going to have to have track record. If you don't have a
track record of raising any money, if you don't have track record of having revenue in your
own company perhaps, only $2 million to $3 million with no profit then you don't have a
good track record. Our track record is very clear to everybody. But please note long-
haulers protocols submission to the FDA in the next week or two.
CD16 that we give to Brazil, we are going to submit that in United States also, because we
might enroll patients here also due to the critical population is getting larger here. So
we're going to follow with that also. The Brazil trail, we will update everybody constantly.
NASH tried in the next couple of weeks or so. We would have results for you that if we
have positive results in NASH in the next couple of weeks, imagine the $20 billion dollar
market cap that we are trying to get approval for it. That's a huge event, very soon. And
cancer breakthrough designation, we might do two of them, one from patients to have
metastasis to the brain and one just mTNBC. But with all that, please send us any
questions via email also and we will address in our next presentation.
Bloomberg Transcript
Page 19 of 20
Company Name: CytoDyn Inc
Company Ticker: CYDY US Equity
Date: 2021-09-29
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Bloomberg Transcript
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