CytoDyn Conference Call December 17th Transcript (
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Posted On: 12/20/2019 4:08:51 AM
CytoDyn Conference Call December 17th Transcript (autogenerated)
0:00 Welcome to the CytoDyn investor community
0:01 conference call. At this time all
0:03 participants are in a listen-only mode.
0:05 A brief question-and-answer session will
0:07 follow the formal presentation. If I
0:09 don't want to require operator
0:10 assistance during the conference please
0:11 press star 0 on your telephone keypad. As
0:14 a reminder this conference is being
0:15 recorded.
0:16 It's now my pleasure to introduce Craig
0:18 Eastwood the chief financial officer.
0:20 Thank you. Hello everyone
0:24 and thank you for joining today's
0:25 conference call this is Craig Eastwood
0:27 CytoDyn’s chief financial officer.
0:30 Joining me on today's call is our
0:33 president and CEO Dr. Nader Pourhassan.
0:36 Before we begin it is essential that we
0:39 provide you with important cautionary
0:42 language related to certain federal
0:44 securities laws. Our comments today in
0:48 today's conference call and the Q&A
0:50 session will include forward-looking
0:52 statements. Forward-looking statements
0:55 are not guarantees of future performance
0:56 and involve known and unknown risks
0:59 uncertainties and other factors that are
1:01 difficult to predict actual results may
1:05 materially differ from any future
1:07 results express or implied by such
1:10 forward-looking statements these risks
1:13 and uncertainties include amongst other
1:14 matters statements regarding leronlimab’s
1:17 potential efficacy in certain
1:19 immunology and oncology indications, the
1:23 company's ongoing ability to raise
1:25 additional new capital, clinical trials
1:29 that may not commence or proceed as
1:30 planned,
1:32 products that appear promising in
1:34 early-stage trials may not subsequently
1:37 prove to be viable unsafe to keep safety
1:39 or efficacy grounds, products may not
1:43 receive regulatory approval or market
1:45 acceptance, competition may reduce the
1:49 commercial potential of our products, we
1:52 may experience product recalls,
1:53 manufacturing issues or product
1:55 liability, and our patents may be
1:58 challenged or unenforceable. Although
2:02 forward-looking statements helped to
2:04 provide complete information about the
2:06 company,
2:07 forward looking statements maybe less
2:09 reliable than historical information. The
2:13 company undertakes no obligation to
2:15 update publicly these forward-looking
2:17 statements except as required by law.
2:19 Please refer to our recent quarterly and
2:22 annual reports filed with the Securities
2:24 Exchange Commission for more information
2:27 about the risks and uncertainties that
2:29 could cause actual results to differ
2:31 materially versus our current
2:33 expectations. I will now turn the call
2:37 over to our CEO Dr. Nader Pourhassan.
2:49 Thank You Craig and thank you everyone
2:51 for joining us for our investor update
2:54 call today. My first update is going to
3:01 be about the BLA timeline. As we have said in
3:05 the public domain, we have filed the
3:08 first section of the BLA many months ago,
3:12 which was non-clinical section. The other
3:16 two sections, one is clinical section
3:19 and then the other one is CMC. Clinical
3:27 section, we were ready to submit a 700
3:33 milligrams data to the FDA. We have
3:36 done that in in November and the FDA is
3:43 discussing all of that with us. We are in
3:46 deep discussions with them. They are most
3:49 likely gonna go with 700 milligram dose
3:51 they have told us and we just need a
3:54 green light from them of exactly what
3:57 more data they might need from our
3:58 monotherapy data. So providing we get
4:02 that any day, we should be able to submit
4:05 the clinical trial section this
4:07 month if if it dragged it would have
4:11 accomplished
4:12 will happen in January. In regards to the
4:16 CMC section, the manufacturing section, we
4:20 have all the data that is being created
4:23 from AGC except stability and they are
4:27 providing us that by the end of the
4:29 month. So we should be able to have the
4:32 CMC completed if we get that in the
4:35 next few days. If not, again, there will be
4:38 maybe a week or two delay and the CMC
4:41 will be filed in January. Nonetheless, we
4:44 are very very confident that the January
4:47 deadline would be met if December is
4:51 not met. My next up update
5:12 is in regards to triple
5:17 negative breast cancer, metastatic triple
5:19 negative breast cancer. As we all know,
5:22 there were several blood samples and
5:25 analysis on the first patient in our
5:28 metastasic triple negative breast cancer
5:30 phase 1B/2 trial and the results
5:33 were very promising as dr. Bruce
5:36 Patterson indicated in our last press
5:38 release. In this regard that the fourth
5:42 blood sample from the metastases triple
5:45 negative breast cancer patient drawn
5:47 following eight weeks of treatment
5:49 demonstrates a notably sustained
5:53 response to leronlimab. Now this is
5:56 very strong statement from ex-Stanford
6:00 professor, who is the expert in ccr5 and
6:03 the CEO of a diagnostic laboratory. For
6:05 ccr5, we also heard from others involved
6:09 in this study that the patient
6:11 apparently is responding to leronlimab.
6:13 treatment. So if this is the case, the
6:17 main question here is when can we have
6:20 several more patients hopefully with the
6:23 same results so we could file breakthrough
6:25 designation
6:26 for naive metastasis triple negative
6:29 breast cancer trial. At the same time we
6:33 have a compassionate use agreement so
6:36 patients who have different type of
6:38 cancer and those are melanoma, pancreatic,
6:42 lung, liver, breast, and prognostic
6:45 prostate I'm sorry prostate cancer, can
6:48 also enroll in compassionate use
6:51 protocol. We have many people reaching
6:54 out to us to get involved in those and
6:57 the good news is that the enrollment is
7:01 really picking up. The screening is
7:03 happening right now and we should have
7:05 quite a bit of number of patients in
7:08 expanded access that would be enrolled
7:11 but in our phase one B - - that's our
7:15 main protocol we have four potential
7:18 cancer patients which we believe we
7:21 could be able to enroll in most of them
7:24 this month. Keep in mind, we have one
7:27 patient, two more we will be filing breakthrough
7:30 designation if the results are
7:32 positive as the first one. So, the fourth
7:41 update that, I'm sorry third update that
7:43 I would like to give everyone is in
7:45 regards to licensing agreements for our
7:49 other indication besides HIV, which is
7:52 Nash but after this triple negative
7:54 breast cancer, other cancers and
7:56 perhaps HIV. In regards to Nash, we have
8:01 sent our very strong results to many
8:06 big pharmaceuticals and we are in
8:08 discussion with several of them and we
8:11 will let the shareholders know as soon
8:14 as we have confirmation of
8:16 something substantial. In regards to
8:20 cancer, we also are still talking to
8:22 different pharmaceuticals that are
8:25 interested in our cancer trial from all
8:28 over the world. We have
8:30 our discussions for outside of united
8:32 states and again we will let everyone
8:34 know as we get closer to those
8:36 milestones. Our next update is in regards
8:44 to prevention of HIV. As we discussed in
8:48 the past we have signed a Memorandum of
8:52 Understanding for for prevention study
8:57 in Thailand with Thai Red Cross. The
9:00 protocol involves about 1200 patients
9:03 and there has been a lot of activities
9:06 in that in that size one major finding
9:11 for us was that the HIV in Thailand that
9:15 we're going to be conducting we are
9:17 going to have arm on that has once a
9:19 month prevention not once a week. Current
9:24 treatments for HIV is either Truvada or
9:27 disco B for example there are pills
9:30 every day have toxicity side effects
9:33 patient has to be on them for quite a
9:35 bit of time so that would not that's in
9:46 regards to prevention. We're very hopeful
9:48 that if we have early results that is
9:50 positive we will also be able to file
9:53 breakthrough designation and there are
9:54 multiple organizations looking at this
9:57 prevention trial for funding and dr.
9:59 Jonah Sacha said he will be having the
10:02 funding for us. In regards to our another
10:06 very interesting study that we will be
10:08 now looking at is our ms study multiple
10:11 sclerosis study. There was very nice
10:16 results that dr. Denis Burger had found
10:20 in that study and I have invited him
10:23 here today so he could explain to us
10:26 what was the data in the past and what's
10:28 the potential.
10:30 Please. Thank You and honor. Well first of
10:33 all, MS, multiple sclerosis, is an
10:37 autoimmune disease. Autoimmune diseases
10:40 are those diseases where the patient's
10:45 own immune system attacks some
10:50 structures in the body. In the case of MS,
10:53 the immune system attacks the myelin
10:56 sheath around nerve cells and in the
10:59 spinal cord and brain creating plaques,
11:03 which eventually lead to the symptoms
11:06 that are range from paralysis to quite
11:10 extensive paralysis. It's been known for
11:14 some time and published that ccr5 is
11:20 involved in the pathogenesis of multiple
11:25 sclerosis.
11:28 We believe that part of that pathogenesis
11:31 involves transportation the
11:35 migration of immune cells from the
11:39 peripheral blood across the blood-brain
11:42 barrier into the brain and spinal cord.
11:47 This has already been established as one
11:50 approved drug on the market Tysabri
11:53 from Biogen. it targets its a monoclonal
11:59 antibody that targets integrins and
12:04 integrins are sticky molecules that
12:06 allow immune cells to stick to the
12:09 endothelium to open the blood-brain
12:11 barrier and allow lymphocytes to
12:13 penetrate. So this bodes well for the use
12:17 of leronlimab and to do that we tested
12:21 this hypothesis in a model for MS called
12:27 experimental allergic in several MA
12:29 or ei e and we did this in a particular
12:33 strain of mice called sjl mice and when
12:39 these mice are immunized in an adjuvant
12:43 with their own myelin sheath then they
12:47 develop a paralytic disease and what's
12:51 unique about this model is the paralysis
12:54 then subsides they have a recovery
12:57 period and then they develop paralysis
12:59 again and then they recover and then
13:02 develop paralysis again so this is a
13:05 model that mimics the exacerbating
13:08 remitting type of MS in humans. We tested
13:13 leronlimab in this model at Providence
13:17 Hospital under the direction of an MS
13:20 investigator here locally and we found
13:24 when we gave leronlimab after the
13:28 first symptoms of paralysis in the mice
13:34 we decreased the number the time of the
13:39 paralysis compared to the controls and
13:42 half of the animals didn't develop a
13:45 second round of paralysis. So these are
13:50 strong indications that we have can have
13:53 effective applications in humans.
13:57 Now there's one caveat here that I think
14:01 is worth mentioning and that is that
14:03 Lleronlimab is highly effective and
14:08 recognizing human ccr5 and very poor at
14:13 recognizing mouse ccr5 because of course
14:17 it was developed in mice originally. This
14:22 means that you can't expect stunning
14:27 results in the mouse models. Now this is
14:31 what happened when we first tested our
14:33 drug in nash we found out that
14:38 we didn't inhibit in the mice lipid
14:44 acquisition in the liver but we did
14:49 inhibit fibrosis in the liver later
14:53 stage and this was a surprise to the
14:59 pathologist that ran the study they
15:01 hadn't seen this before. So what we did
15:05 is we followed up and used humanized
15:07 mice that we took as we took
15:13 immunodeficient mice and we transplanted
15:21 them with a human immune system human
15:23 bone marrow stem cells and we previously
15:26 published that we can maintain these
15:29 human humanized mice with leronlimab
15:35 things were Rh BBD studies though when
15:45 we use the humanized mice we got a
15:47 stunning result in NASH and we
15:49 completely in a statistically
15:53 significant manner inhibited lipid
15:55 uptake. So can we use humanized mice for
16:01 our MS study? We don't really know yet
16:05 but because of the implications of ccr5
16:09 in human MS and because of our
16:14 preliminary results we feel we can go
16:17 right to a phase two study of preventing
16:23 exacerbations in human MS and it's I've
16:28 discussed this with the head of
16:30 neurology at the medical school here and
16:33 we've designed a phase 2 protocol very
16:37 similar to the two sabi phase 2 protocol
16:41 in MS.
16:43 So we have high potential here to attack
16:47 this autoimmune disease just as we did
16:50 with Nash. So with that I'll turn it back
16:53 to Nader. Thank you then it's appreciate
16:57 that. So my last update is my most
17:02 exciting update in our company's history.
17:05 It is about the licensing agreement that
17:08 we talk about to the shareholders about
17:10 12 weeks ago. About few minutes ago
17:14 started I announced signing of a
17:17 licensing agreement. Allow me to read the
17:21 title of this press release for those
17:23 who did not have a chance to read the
17:25 press release since it just came out. The
17:29 title says CytoDyn signs definitive
17:33 agreement with Vyera Pharmaceuticals to
17:35 commercialize leronlimab in the US for
17:38 the treatment of HIV in exchange for the
17:41 exclusive right to market and distribute
17:44 tleronlimab in the US for HIV related
17:47 indications. Vyera will pay upfront and
17:50 regulatory and sale based milestone
17:53 payments of about eighty seven point
17:55 five million dollars as well as a
17:57 royalty of 50 percent on net sales. Vyera
18:01 will also make an investment in CytoDyn
18:03 of four million dollars in the
18:06 form of register CytoDyn common stock.
18:10 I am very proud of our team at CytoDyn
18:14 that led to this definitive
18:16 agreement signed today. This deal is
18:20 historical to us at CytoDyn as we have
18:24 now secured our path forward for
18:26 potential revenue in 2020 avoiding to
18:31 raise over 50 million dollars to launch
18:34 leronlimab sales. With almost 90
18:38 million dollar upfront payments I'm
18:41 sorry upfront and regulatory and sales
18:43 base milestone payments for the sale in
18:48 US alone for HIV alone. I would like to
18:53 remind all of our shareholders
18:56 that if we had to raise 50 million
18:59 dollars right now to launch leronlimab
19:02 we would have needed minimum 300 million
19:07 more shares and when we got Samsung's
19:11 deal done to take care of our
19:14 manufacturing needs so we could have a
19:16 launch of a product that saved us
19:19 another 300 million shares of dilution.
19:22 When we had a public warrant and they're
19:24 offering recently we saved about 40
19:27 million shares of dilution as compared
19:30 to a normal fund raising at that time.
19:33 When we change our path of fundraising
19:36 in July 2018, we saved another 60 million
19:40 shares or so by offering 50% were in
19:43 instead of 100% were in our fund raising
19:46 as we were doing prior to July. So with
19:53 that I would like everyone to keep take
19:58 note that the launching of the product
20:01 and the submission of BLA and having
20:05 manufacturing product ready to go next
20:08 year mid next year this company will
20:11 then become a Revenue company and that's
20:13 a major achievement with that let's
20:16 please go to Question and Answer.
20:18 Thank you. You'll now be conducting a
20:21 question and answer session if you would
20:23 like to ask a question please press star
20:25 1 on your telephone keypad
20:27 a confirmation tone will indicate your
20:29 line is in the question queue your press
20:31 star 2 if you will let you move your
20:33 question from the queue for participants
20:35 using speaker equipment it may be
20:36 necessary to pick up your handset before
20:38 pressing the Starkey's 1 millon please
20:40 slowly poll for questions
20:43 thank you our first question comes from
20:46 Chen with HC Wainwright
20:48 please proceed thank you for taking my
20:51 question could you clarify the variety
20:54 of structure and additional milestone
20:56 sales-based milestones from the
20:58 agreements yes so we are going to a
21:01 trade agreement so that milestone
21:03 payments will be defined on that we just
21:06 put the presses out so if you don't mind
21:09 let us
21:09 to have this the details of it you know
21:12 it is going to be out in 8k also okay
21:16 sure in the you are pretty confident at
21:19 this point that all the BLA
21:21 submission should be completed at the
21:23 latest in January right
21:25 that's correct that's correct we have
21:27 been working very carefully with our
21:30 manufacturing folks and they had many
21:35 stability data that we received but the
21:38 last part of it was dragging and we hope
21:41 to even have it by you know by the end
21:43 of December but again if it doesn't
21:45 happen by the end of December January
21:47 would definitely we feel very confident
21:49 on that obviously these are all
21:52 forward-looking statements so I am
21:54 Telling You everyone as we receive
21:57 information good thank you
22:00 yeah sure thank you again if you'd like
22:05 to ask a question please press star 1 on
22:07 your telephone keypad
22:08 a confirmation tone will indicate your
22:10 line is in this question queue Thank You
22:12 our next question comes from line of
22:14 Paul Hideout a private investor please
22:17 proceed good afternoon how are you doing
22:23 great thank you
22:24 great hey when do you anticipate
22:28 enrolling the additional tnbc patients
22:35 so we believe that the four patients
22:37 that we have currently under under
22:40 clinical trial phase 1B - - who are
22:43 naive MT and DC we'll be sending the the
22:48 biopsy couple of them have already sent
22:50 that so hopefully you know we will have
22:53 some kind of enrollment this this month
22:56 and I'm hoping that two of them at least
22:59 will be enrolled which would be
23:00 sufficient for us to have a you know
23:02 breakthrough designation filing once we
23:04 have a couple of results from them right
23:10 have you had any more test results come
23:12 back or the existing patient that was
23:16 injected in August and how is your
23:18 mother-in-law doing
23:20 no thank you so first of all the the
23:24 results that are coming out because this
23:27 is a life-threatening condition and
23:30 because when we announced last time the
23:33 results we saw many patients with very
23:36 very serious condition calling us and
23:38 trying to get involved we will be
23:40 announcing every result that comes out
23:43 that is you know the analyze results
23:46 that are able to be able to be analyzed
23:49 we will put it out so with that with
23:52 that we will wait for the next press
23:53 release to have results for that patient
23:56 and thanks for asking about my
23:57 mother-in-law she has already got an MRI
24:00 and scanned and we will let everyone
24:04 know about the results also as she's one
24:06 of the patients right now so with that
24:08 thanks Paul nextly
24:10 thank you our next question comes from
24:12 line of Shawshank or Patti and a private
24:14 investor please proceed good afternoon
24:18 I have a question you talked about the
24:20 CNC submission for the BLA is that going
24:23 to be of AGC or of Samsung so the BLA
24:31 has to be with AGC because all the
24:34 methods were validated in America an
24:37 agency which is a very good thing with
24:39 Samsung once we get the first clinical
24:41 grade product then we have to get our
24:43 app for which Samsung is very good at
24:46 that also but it will take some times
24:48 but of but if you if you're intending
24:51 the manufacturer you know are you
24:53 intending to manufacture the first
24:54 commercial batches through AGC or
24:56 through Samsung AGC okay and then second
25:01 question is going to be when do you
25:03 expect there to be a move of the stock
25:05 or the company to the capital markets so
25:08 we can start getting some better
25:09 coverage
25:12 yes so as you know we're an OTC B we
25:16 have raised tremendous amount of funding
25:19 to get to this point or these are dreams
25:22 for any biotech company that is in
25:24 Nasdaq or New York Stock Exchange
25:26 let's excited I have done that by
25:28 raising money from retail investors
25:31 therefore pressure we have not have a
25:34 single break from anywhere we constantly
25:36 had to raise enough funds to get to this
25:39 point telling everybody that you know it
25:42 could take 1 billion dollars to get to
25:44 the approval doesn't make anybody feel
25:45 any better but those are the facts that
25:47 we have defied all the odds and we have
25:50 gone against all the people that thought
25:52 we will not be able to make it to this
25:54 point so stock has to take its you know
25:58 react our chief financial officer Craig
26:01 Eastwood has done some analysis of what
26:05 this was you know what when with the
26:07 stock go to whatever levels after after
26:11 we have revenue and those numbers are
26:14 stunning just with the combination
26:16 therapy alone the numbers look very high
26:19 based upon you know the the analysis
26:22 that he has done and was conservative
26:23 analysis so I don't know exactly when
26:26 the stock will react but these are we
26:29 are solving major problems with very
26:32 little you know resources but I find I
26:37 find I find that answer to be inadequate
26:39 because the stock is not going to move
26:41 unless it gets better coverage thank you
26:46 for your opinion I appreciate that next
26:48 question please
26:51 thank you again if you'd like to ask a
26:54 question please press star 1 on your
26:56 telephone keypad
26:56 a confirmation tone will indicate your
26:58 line is in the question queue and one
27:01 moment please loophole for additional
27:02 questions thank you our next question
27:15 comes from the line of Steve Carnac a
27:17 private investor please proceed hi Nader
27:22 congratulations no I'll work thank you I
27:26 had a question about kind of the basket
27:28 case studies that you were talking about
27:30 doing in the past and I'm just kind of
27:33 curious since Network we're going with
27:35 the MS possible phase 2 study are they
27:39 going to include diseases such as lupus
27:42 and Hashem Oto's those kinds of immune
27:45 diseases as well I don't think so we
27:49 will definitely have dr. Burger update
27:51 everyone as soon as does those trial
27:54 gets going for now we will be filing IND
27:57 an and protocol perhaps for phase 2 with
28:01 the data that dr. Burger has for us and
28:03 then we're just going to have to wait
28:05 and see how everything you know turns
28:08 out to be in regards to stock price and
28:10 everything before we start any new trial
28:11 but we are going to have expanded access
28:14 perhaps for the certain patients who
28:17 have serious disease with MS we might
28:19 even let those people get involved okay
28:22 thank you yeah thank you
28:25 next please thank you our next question
28:28 comes from line of Eric's lender a
28:29 private investor please proceed
28:31 hi congratulations on the licensing
28:35 agreement we've been looking on the
28:37 internet for the press release and can't
28:39 see it wondering could you repeat who
28:42 you signed the licensing agreement and
28:44 it was 87 million upfront plus 50%
28:47 royalties what I heard just wondering if
28:50 you could go over that again as I can't
28:52 find it anywhere
28:54 yeah so he probably takes a while to
28:57 please hit the wire but there
29:00 title that I read to everybody I will
29:02 read it again CytoDyn signs
29:04 definitive agreement with Vyera Pharmaceuticals
29:07 to commercialize leronlimab
29:10 in the US for the treatment of
29:12 HIV in exchange for the exclusive right
29:16 to market and distribute leronlimab
29:19 in the US for HIV related indications
29:22 Vyera will pay upfront and
29:24 regulatory and sale based milestones
29:28 payments of up to eighty seven point
29:31 five million dollars as well as a
29:33 royalty of 50 percent on net sales the
29:37 Vyera will also make an investment
29:39 inside a line of four million dollars in
29:42 the form of registered CytoDyn common
29:45 stock the the contract will be 8k so
29:50 people will be able to read all the
29:52 details great thank you very much yeah
29:57 thank you
29:58 thank you our next question comes from
30:01 the line of Matt eldering with a private
30:03 investor please proceed hane honored hey
30:07 congratulations on the licensing
30:09 agreement that's that's great news I
30:10 wanna I want to just ask kind of a more
30:14 kind of dumb down question you know for
30:16 myself as well as the other investors
30:18 who have gotten into this company for
30:21 the sole purpose of it appears to be a
30:23 tremendous financial opportunity beyond
30:25 that I got to be honest there's about
30:27 you know maybe 10 to 15% of these
30:29 acronyms that I understand that you guys
30:30 are throwing around but I just want to
30:32 if you could speak to the
30:34 differentiation between the HIV piece
30:36 that you guys just signed with this
30:38 licensing and by the way is it Vyera
30:40 pharmaceuticals to you spelled of the
30:41 air or whatever that name is sure Matt
30:45 Pharmaceuticals okay so
30:53 that that was specifically about HIV but
30:58 but but again and I and I apologize for
31:00 the rather you know simplistic question
31:03 here but the real the real opportunity
31:06 the homerun ball if you will is is
31:08 cancer right and how far out if you were
31:12 able to speculate
31:14 you know are we from you know making a
31:16 you know some significant headway in in
31:19 that regard and does this this licensing
31:22 agreement with the era diminished that
31:23 opportunity for the cancer piece no
31:27 actually that's a great question Matt
31:29 actually either helps us to get to the
31:33 some major you know milestones now that
31:37 we have this in our bag you know telling
31:41 a world that now we have manufacturing
31:44 all set with the third payment during
31:47 the work that we have a company like
31:49 Vyera who have tremendous business the
31:53 tremendous sales force ready to go to
31:56 launch the product and having the BLA
31:58 submission in the brink of being
32:00 finalized this tells everybody that we
32:03 will have revenue if all goes well right
32:06 now with the whatever we have left over
32:07 to do in and next year I mean that's
32:10 that's incredible and when Craig is
32:14 without CFO did their numbers of what
32:17 the stock could word post revenue with
32:21 just like 50,000 or 60,000 patients
32:23 taking care of the stock could be
32:26 undable digits that that's now is
32:28 getting very close to reality and we are
32:31 going to make sure that we work as
32:33 expedited as we always have now in
32:36 regards to chances we we have a whole
32:39 different ballgame here people that want
32:41 to do commercialization license they
32:43 don't want to talk about cancer because
32:45 cancer takes about five to ten years
32:47 sometimes if you have breakthrough
32:49 designation for something like what we
32:52 have T NB C which is triple negative
32:54 breast cancer then that changes
32:57 everything and if people who are failing
33:00 in NASH like Gilead we just failed again
33:02 for second time in NASH C a result that
33:05 we have and they see the opportunity
33:08 they might want to come in and license
33:10 that portion buys for themselves but
33:12 this agreement is for United States only
33:14 for HIV treatment combination therapy
33:18 and potentially when we get approval for
33:20 mono therapy and when you have a sales
33:23 force set to sell your combination
33:26 therapy and
33:26 let's say a year later you have
33:28 monotherapy you have a great great grip
33:31 on the market to go and take care of the
33:34 monitory piece so this does not by any
33:36 way shape or form stop us from cancer or
33:40 any potential that we have and this
33:42 company has potential that is unheard of
33:44 in my opinion I don't think anybody can
33:47 find anything like this in the whole
33:49 world that the product and monoclonal
33:52 antibody comes into the market and the
33:54 story is just incredible also but anyway
33:56 he comes and now you see animal studies
33:59 are stunning as it was for cancer we
34:03 took it to human it's duplicated that
34:05 results for one patient almost
34:08 duplication something almost the
34:10 duplication of the animal study and if
34:13 we have few more then we were off and
34:15 running and everybody who trusted in us
34:18 and trusted in the fundamental and
34:20 trusted in the fact that we put out and
34:22 trusted that we are saying it truth to
34:24 them they're gonna benefit now that's
34:26 just the financial part when you when I
34:29 hear patients calling me and crying
34:31 saying please please let me have this
34:33 product and we immediately try to open
34:36 that door if there is potential research
34:38 potential in cancer I will never be able
34:40 to forget these days the days that we
34:43 were able to maneuver with our great
34:45 team or path from HIV to chance eV and
34:49 the funding was so low when the fires
34:51 were everywhere we not only went with
34:54 HIV but we didn't stop we try to get it
34:58 to everything else that we can get and I
35:00 am so proud to see at least one patient
35:02 coming back and saying that I can I have
35:05 a better life now thank you and probably
35:07 this is gonna work great for me it's two
35:09 months of treatment right now for the
35:11 first patient but it is really
35:13 breathtaking what we have right now in
35:15 front of us and thank God for that
35:20 thank you for your vision next oh yeah
35:23 next question please thank you our next
35:27 question comes from line of nicosia
35:28 within a telescope Capitol please
35:30 proceed oh yeah congratulations not as
35:34 fantastic news and also congratulations
35:37 to Brendan I know he's been working
35:39 really hard on this
35:40 i quick a couple questions one is what
35:43 is the plan and amount of funding to
35:45 bridge the gap between now and the
35:47 milestone payments going forward so Nick
35:51 the question is great question and I
35:53 hope everybody pay attention that I'm
35:55 not giving out our fundraising final
35:59 strategy because I'm not I don't we make
36:02 up things as we go out since six years I
36:04 mean we we just don't know what we have
36:07 and when things happen and we have to
36:09 change it for the better everybody why
36:11 you did that so I'm going to tell you
36:12 that my my intention right now is not to
36:16 raise any more money til end of February
36:18 or if we raise money would be from just
36:21 certain shareholders perhaps you know
36:23 the coverage of their no I mean
36:26 exercising their you know ten and I have
36:28 to be able to convert the rewards we are
36:31 we have all these options and we're
36:33 going to be very careful as I read the
36:35 number of shares with saved for the
36:37 company that tender offer we did saved
36:39 us about fourteen million shares we also
36:42 had one hundred million shares and we
36:44 still have shared lives and that is that
36:46 was months and months ago that we
36:47 authorized that so I hope everybody
36:50 appreciate that we're not just jumping
36:52 and getting any money at these thrown at
36:54 us we are very careful but the
36:56 fundraising to bridge this gap right now
36:58 what we have coming up is good enough
37:00 for us to get to February for us in my
37:02 opinion maybe few million here all
37:04 deltas very small amount that we might
37:07 raise in a different setting but no more
37:09 our default in my opinion and no more
37:11 preferred shares but I need to run all
37:14 of these by our CFO and Mike Mulholland
37:16 who has stayed with us to watch over me
37:19 because he has done that for the last 8
37:21 years he's very capable and I have asked
37:24 him to please stay at the executive
37:25 advisor to see one guide me and he is
37:29 staying here he trained he trained Craig
37:31 for all of these but he's going to be
37:33 here because three of us going to make
37:35 sure that we take the right path the
37:37 correct path and raise money at the
37:39 right time only okay and the next
37:43 question it sounded like sebacean or the
37:45 previous caller's question that Vyera
37:47 doesn't have rights to prep is that
37:49 correct
37:51 yeah let's let's talk about that when we
37:54 have our business development personal
37:56 doctor the Brandon Rae you who's also a
38:00 JD and attorney I would rather he talk
38:03 about that because the deal is just came
38:05 out and I don't want to elaborate on
38:07 that to the next time we all talk okay
38:11 that's all I started about that Thank
38:13 You Nick appreciate it next question
38:15 please thank you our next question comes
38:17 from line a Francisco Tuscola with tusk
38:19 oh please proceed Enid our it's Michael
38:23 Holly oh great great
38:26 yeah I had a question about the the
38:28 relationship going forward with insult X
38:31 and if we had soap any medication to
38:34 them yet I'm sorry I missed the question
38:38 yeah do we have we sold any medication
38:42 to himself yes yeah we uh we had some
38:45 stock that we might be selling to them
38:47 and how was our relationship with them
38:50 going forward how about going what dr.
38:53 Bruce Patterson has been nothing but a
38:54 spectacular for this company he's the
38:57 one that allowed the enrollments of the
38:59 patients happen because based upon all
39:01 criteria we couldn't have and he came in
39:03 and said the mechanism of action is
39:05 absolutely there much much better than
39:08 what you guys thought so I cannot thank
39:11 him enough but the agreement we made
39:12 with his company who his CEO up he has
39:15 already given us orders and purchase
39:18 orders but this is a small number there
39:21 needs to be work to be done that
39:25 commercialization of I'm sorry the
39:27 selling of the product that we talked
39:29 about was for non-commercial product it
39:32 was clinical grade product for a
39:34 diagnostic so they could only use that
39:37 to locate the ccr5 so that's it as I
39:39 said before it's a small amount but we
39:41 just didn't want to throw away our
39:42 clinical grade product and one of the to
39:46 make sure that goes to use also so once
39:48 we get the substantial sales obviously
39:50 it'll being on our earnings thanks doc
39:54 yeah absolutely
39:55 next question please thank you our next
39:58 question comes from line of Paul Whalen
39:59 a private investor please proceed yes
40:03 good afternoon everyone
40:04 I I'm very excited by what I'm hearing
40:10 and it's for a selfish reason because my
40:14 wife has been suffering from triple
40:18 negative breast cancer now for two years
40:20 and so when I got involved in your
40:25 company it was because I had done some
40:27 research to try to find out if there was
40:29 anything coming up that would be helpful
40:32 so I am very excited by what I hear and
40:35 I'm looking forward to hearing more
40:39 positive information on the treatment of
40:42 the triple negative breast cancer No
40:46 thank you very much and I'm sorry thank
40:48 you and I'm sorry to hear about your
40:50 wife and I'm glad that we are out there
40:53 and trying to see if we can help anybody
40:55 with this product
40:56 thank you so last question please thank
40:59 you our final question will come from
41:01 the line of elusive social or private
41:03 investor please proceed yes how I would
41:06 like to say hello to everyone in C why
41:09 do I and congratulation congratulation
41:13 and with the licensing and all of the
41:16 medical results dr. parris on just a
41:19 short question IRB was approved for all
41:23 metastatic triple negative breast cancer
41:26 November 12 actually this is a very very
41:29 is a protocol in my opinion I was
41:35 expecting that we will have by now maybe
41:37 20 patients and will have on the floor
41:39 there was happy enough of centers open
41:41 or do you plan to open any more centers
41:44 and thank you very much thank you dr.
41:47 zosh I appreciate it so in regards to
41:51 opening new centers we are going to be
41:54 very careful with our funding situation
41:57 that's one of the problems but expanded
42:01 access I believe maybe we have close to
42:04 20 people that have reached out to us
42:05 and they are trying to get biopsy to us
42:07 so we can check their qualification so
42:10 we are getting quite a bit of
42:12 number of patients coming to us and in
42:14 regards to the phase 1 2 & 2 we are we
42:18 have enroll another Center but we just
42:21 you know taking our time now because it
42:23 seems like there's a lot of patients
42:25 coming in and last press rates we put
42:27 out it was really a great turnaround the
42:30 first 10 months of this protocol which
42:32 we enjoyed zero patients then we
42:34 enrolled one and the result was good now
42:37 beginning all these patients so that's
42:39 where we are so with that we are going
42:43 to end the call today so I want to thank
42:48 everybody for being here today and I
42:50 want to thank everyone to be so patient
42:52 with us the stock price is a big problem
42:55 for everybody and I understand that but
42:58 I hope that everyone concentrate on the
43:00 fundamentals and realized that we are
43:02 going forward no matter how difficult
43:05 things gets and as we just announced the
43:08 licensing agreement deal I hope people
43:10 will now get confidence that when we say
43:13 we signed non-binding term sheet and we
43:16 just need some time to negotiate for the
43:19 best of shareholders I hope that
43:21 everybody is paying attention about that
43:23 we are having more licensing agreements
43:26 right now that we are talking to and we
43:28 are going to report to all of you when
43:30 the non-binding term sheet is assigned
43:32 for that and that way everybody will see
43:35 that there your company is going forward
43:38 in it in my opinion a great way except
43:41 the stock price is lagging that's the
43:44 story of our life so far but it I
43:46 believe it will change big time so with
43:48 that thank you very much everybody and
43:49 have a great day thank you
43:52 this concludes today's conference so you
43:54 may disconnect your lines at this time
43:55 and have a wonderful day
0:00 Welcome to the CytoDyn investor community
0:01 conference call. At this time all
0:03 participants are in a listen-only mode.
0:05 A brief question-and-answer session will
0:07 follow the formal presentation. If I
0:09 don't want to require operator
0:10 assistance during the conference please
0:11 press star 0 on your telephone keypad. As
0:14 a reminder this conference is being
0:15 recorded.
0:16 It's now my pleasure to introduce Craig
0:18 Eastwood the chief financial officer.
0:20 Thank you. Hello everyone
0:24 and thank you for joining today's
0:25 conference call this is Craig Eastwood
0:27 CytoDyn’s chief financial officer.
0:30 Joining me on today's call is our
0:33 president and CEO Dr. Nader Pourhassan.
0:36 Before we begin it is essential that we
0:39 provide you with important cautionary
0:42 language related to certain federal
0:44 securities laws. Our comments today in
0:48 today's conference call and the Q&A
0:50 session will include forward-looking
0:52 statements. Forward-looking statements
0:55 are not guarantees of future performance
0:56 and involve known and unknown risks
0:59 uncertainties and other factors that are
1:01 difficult to predict actual results may
1:05 materially differ from any future
1:07 results express or implied by such
1:10 forward-looking statements these risks
1:13 and uncertainties include amongst other
1:14 matters statements regarding leronlimab’s
1:17 potential efficacy in certain
1:19 immunology and oncology indications, the
1:23 company's ongoing ability to raise
1:25 additional new capital, clinical trials
1:29 that may not commence or proceed as
1:30 planned,
1:32 products that appear promising in
1:34 early-stage trials may not subsequently
1:37 prove to be viable unsafe to keep safety
1:39 or efficacy grounds, products may not
1:43 receive regulatory approval or market
1:45 acceptance, competition may reduce the
1:49 commercial potential of our products, we
1:52 may experience product recalls,
1:53 manufacturing issues or product
1:55 liability, and our patents may be
1:58 challenged or unenforceable. Although
2:02 forward-looking statements helped to
2:04 provide complete information about the
2:06 company,
2:07 forward looking statements maybe less
2:09 reliable than historical information. The
2:13 company undertakes no obligation to
2:15 update publicly these forward-looking
2:17 statements except as required by law.
2:19 Please refer to our recent quarterly and
2:22 annual reports filed with the Securities
2:24 Exchange Commission for more information
2:27 about the risks and uncertainties that
2:29 could cause actual results to differ
2:31 materially versus our current
2:33 expectations. I will now turn the call
2:37 over to our CEO Dr. Nader Pourhassan.
2:49 Thank You Craig and thank you everyone
2:51 for joining us for our investor update
2:54 call today. My first update is going to
3:01 be about the BLA timeline. As we have said in
3:05 the public domain, we have filed the
3:08 first section of the BLA many months ago,
3:12 which was non-clinical section. The other
3:16 two sections, one is clinical section
3:19 and then the other one is CMC. Clinical
3:27 section, we were ready to submit a 700
3:33 milligrams data to the FDA. We have
3:36 done that in in November and the FDA is
3:43 discussing all of that with us. We are in
3:46 deep discussions with them. They are most
3:49 likely gonna go with 700 milligram dose
3:51 they have told us and we just need a
3:54 green light from them of exactly what
3:57 more data they might need from our
3:58 monotherapy data. So providing we get
4:02 that any day, we should be able to submit
4:05 the clinical trial section this
4:07 month if if it dragged it would have
4:11 accomplished
4:12 will happen in January. In regards to the
4:16 CMC section, the manufacturing section, we
4:20 have all the data that is being created
4:23 from AGC except stability and they are
4:27 providing us that by the end of the
4:29 month. So we should be able to have the
4:32 CMC completed if we get that in the
4:35 next few days. If not, again, there will be
4:38 maybe a week or two delay and the CMC
4:41 will be filed in January. Nonetheless, we
4:44 are very very confident that the January
4:47 deadline would be met if December is
4:51 not met. My next up update
5:12 is in regards to triple
5:17 negative breast cancer, metastatic triple
5:19 negative breast cancer. As we all know,
5:22 there were several blood samples and
5:25 analysis on the first patient in our
5:28 metastasic triple negative breast cancer
5:30 phase 1B/2 trial and the results
5:33 were very promising as dr. Bruce
5:36 Patterson indicated in our last press
5:38 release. In this regard that the fourth
5:42 blood sample from the metastases triple
5:45 negative breast cancer patient drawn
5:47 following eight weeks of treatment
5:49 demonstrates a notably sustained
5:53 response to leronlimab. Now this is
5:56 very strong statement from ex-Stanford
6:00 professor, who is the expert in ccr5 and
6:03 the CEO of a diagnostic laboratory. For
6:05 ccr5, we also heard from others involved
6:09 in this study that the patient
6:11 apparently is responding to leronlimab.
6:13 treatment. So if this is the case, the
6:17 main question here is when can we have
6:20 several more patients hopefully with the
6:23 same results so we could file breakthrough
6:25 designation
6:26 for naive metastasis triple negative
6:29 breast cancer trial. At the same time we
6:33 have a compassionate use agreement so
6:36 patients who have different type of
6:38 cancer and those are melanoma, pancreatic,
6:42 lung, liver, breast, and prognostic
6:45 prostate I'm sorry prostate cancer, can
6:48 also enroll in compassionate use
6:51 protocol. We have many people reaching
6:54 out to us to get involved in those and
6:57 the good news is that the enrollment is
7:01 really picking up. The screening is
7:03 happening right now and we should have
7:05 quite a bit of number of patients in
7:08 expanded access that would be enrolled
7:11 but in our phase one B - - that's our
7:15 main protocol we have four potential
7:18 cancer patients which we believe we
7:21 could be able to enroll in most of them
7:24 this month. Keep in mind, we have one
7:27 patient, two more we will be filing breakthrough
7:30 designation if the results are
7:32 positive as the first one. So, the fourth
7:41 update that, I'm sorry third update that
7:43 I would like to give everyone is in
7:45 regards to licensing agreements for our
7:49 other indication besides HIV, which is
7:52 Nash but after this triple negative
7:54 breast cancer, other cancers and
7:56 perhaps HIV. In regards to Nash, we have
8:01 sent our very strong results to many
8:06 big pharmaceuticals and we are in
8:08 discussion with several of them and we
8:11 will let the shareholders know as soon
8:14 as we have confirmation of
8:16 something substantial. In regards to
8:20 cancer, we also are still talking to
8:22 different pharmaceuticals that are
8:25 interested in our cancer trial from all
8:28 over the world. We have
8:30 our discussions for outside of united
8:32 states and again we will let everyone
8:34 know as we get closer to those
8:36 milestones. Our next update is in regards
8:44 to prevention of HIV. As we discussed in
8:48 the past we have signed a Memorandum of
8:52 Understanding for for prevention study
8:57 in Thailand with Thai Red Cross. The
9:00 protocol involves about 1200 patients
9:03 and there has been a lot of activities
9:06 in that in that size one major finding
9:11 for us was that the HIV in Thailand that
9:15 we're going to be conducting we are
9:17 going to have arm on that has once a
9:19 month prevention not once a week. Current
9:24 treatments for HIV is either Truvada or
9:27 disco B for example there are pills
9:30 every day have toxicity side effects
9:33 patient has to be on them for quite a
9:35 bit of time so that would not that's in
9:46 regards to prevention. We're very hopeful
9:48 that if we have early results that is
9:50 positive we will also be able to file
9:53 breakthrough designation and there are
9:54 multiple organizations looking at this
9:57 prevention trial for funding and dr.
9:59 Jonah Sacha said he will be having the
10:02 funding for us. In regards to our another
10:06 very interesting study that we will be
10:08 now looking at is our ms study multiple
10:11 sclerosis study. There was very nice
10:16 results that dr. Denis Burger had found
10:20 in that study and I have invited him
10:23 here today so he could explain to us
10:26 what was the data in the past and what's
10:28 the potential.
10:30 Please. Thank You and honor. Well first of
10:33 all, MS, multiple sclerosis, is an
10:37 autoimmune disease. Autoimmune diseases
10:40 are those diseases where the patient's
10:45 own immune system attacks some
10:50 structures in the body. In the case of MS,
10:53 the immune system attacks the myelin
10:56 sheath around nerve cells and in the
10:59 spinal cord and brain creating plaques,
11:03 which eventually lead to the symptoms
11:06 that are range from paralysis to quite
11:10 extensive paralysis. It's been known for
11:14 some time and published that ccr5 is
11:20 involved in the pathogenesis of multiple
11:25 sclerosis.
11:28 We believe that part of that pathogenesis
11:31 involves transportation the
11:35 migration of immune cells from the
11:39 peripheral blood across the blood-brain
11:42 barrier into the brain and spinal cord.
11:47 This has already been established as one
11:50 approved drug on the market Tysabri
11:53 from Biogen. it targets its a monoclonal
11:59 antibody that targets integrins and
12:04 integrins are sticky molecules that
12:06 allow immune cells to stick to the
12:09 endothelium to open the blood-brain
12:11 barrier and allow lymphocytes to
12:13 penetrate. So this bodes well for the use
12:17 of leronlimab and to do that we tested
12:21 this hypothesis in a model for MS called
12:27 experimental allergic in several MA
12:29 or ei e and we did this in a particular
12:33 strain of mice called sjl mice and when
12:39 these mice are immunized in an adjuvant
12:43 with their own myelin sheath then they
12:47 develop a paralytic disease and what's
12:51 unique about this model is the paralysis
12:54 then subsides they have a recovery
12:57 period and then they develop paralysis
12:59 again and then they recover and then
13:02 develop paralysis again so this is a
13:05 model that mimics the exacerbating
13:08 remitting type of MS in humans. We tested
13:13 leronlimab in this model at Providence
13:17 Hospital under the direction of an MS
13:20 investigator here locally and we found
13:24 when we gave leronlimab after the
13:28 first symptoms of paralysis in the mice
13:34 we decreased the number the time of the
13:39 paralysis compared to the controls and
13:42 half of the animals didn't develop a
13:45 second round of paralysis. So these are
13:50 strong indications that we have can have
13:53 effective applications in humans.
13:57 Now there's one caveat here that I think
14:01 is worth mentioning and that is that
14:03 Lleronlimab is highly effective and
14:08 recognizing human ccr5 and very poor at
14:13 recognizing mouse ccr5 because of course
14:17 it was developed in mice originally. This
14:22 means that you can't expect stunning
14:27 results in the mouse models. Now this is
14:31 what happened when we first tested our
14:33 drug in nash we found out that
14:38 we didn't inhibit in the mice lipid
14:44 acquisition in the liver but we did
14:49 inhibit fibrosis in the liver later
14:53 stage and this was a surprise to the
14:59 pathologist that ran the study they
15:01 hadn't seen this before. So what we did
15:05 is we followed up and used humanized
15:07 mice that we took as we took
15:13 immunodeficient mice and we transplanted
15:21 them with a human immune system human
15:23 bone marrow stem cells and we previously
15:26 published that we can maintain these
15:29 human humanized mice with leronlimab
15:35 things were Rh BBD studies though when
15:45 we use the humanized mice we got a
15:47 stunning result in NASH and we
15:49 completely in a statistically
15:53 significant manner inhibited lipid
15:55 uptake. So can we use humanized mice for
16:01 our MS study? We don't really know yet
16:05 but because of the implications of ccr5
16:09 in human MS and because of our
16:14 preliminary results we feel we can go
16:17 right to a phase two study of preventing
16:23 exacerbations in human MS and it's I've
16:28 discussed this with the head of
16:30 neurology at the medical school here and
16:33 we've designed a phase 2 protocol very
16:37 similar to the two sabi phase 2 protocol
16:41 in MS.
16:43 So we have high potential here to attack
16:47 this autoimmune disease just as we did
16:50 with Nash. So with that I'll turn it back
16:53 to Nader. Thank you then it's appreciate
16:57 that. So my last update is my most
17:02 exciting update in our company's history.
17:05 It is about the licensing agreement that
17:08 we talk about to the shareholders about
17:10 12 weeks ago. About few minutes ago
17:14 started I announced signing of a
17:17 licensing agreement. Allow me to read the
17:21 title of this press release for those
17:23 who did not have a chance to read the
17:25 press release since it just came out. The
17:29 title says CytoDyn signs definitive
17:33 agreement with Vyera Pharmaceuticals to
17:35 commercialize leronlimab in the US for
17:38 the treatment of HIV in exchange for the
17:41 exclusive right to market and distribute
17:44 tleronlimab in the US for HIV related
17:47 indications. Vyera will pay upfront and
17:50 regulatory and sale based milestone
17:53 payments of about eighty seven point
17:55 five million dollars as well as a
17:57 royalty of 50 percent on net sales. Vyera
18:01 will also make an investment in CytoDyn
18:03 of four million dollars in the
18:06 form of register CytoDyn common stock.
18:10 I am very proud of our team at CytoDyn
18:14 that led to this definitive
18:16 agreement signed today. This deal is
18:20 historical to us at CytoDyn as we have
18:24 now secured our path forward for
18:26 potential revenue in 2020 avoiding to
18:31 raise over 50 million dollars to launch
18:34 leronlimab sales. With almost 90
18:38 million dollar upfront payments I'm
18:41 sorry upfront and regulatory and sales
18:43 base milestone payments for the sale in
18:48 US alone for HIV alone. I would like to
18:53 remind all of our shareholders
18:56 that if we had to raise 50 million
18:59 dollars right now to launch leronlimab
19:02 we would have needed minimum 300 million
19:07 more shares and when we got Samsung's
19:11 deal done to take care of our
19:14 manufacturing needs so we could have a
19:16 launch of a product that saved us
19:19 another 300 million shares of dilution.
19:22 When we had a public warrant and they're
19:24 offering recently we saved about 40
19:27 million shares of dilution as compared
19:30 to a normal fund raising at that time.
19:33 When we change our path of fundraising
19:36 in July 2018, we saved another 60 million
19:40 shares or so by offering 50% were in
19:43 instead of 100% were in our fund raising
19:46 as we were doing prior to July. So with
19:53 that I would like everyone to keep take
19:58 note that the launching of the product
20:01 and the submission of BLA and having
20:05 manufacturing product ready to go next
20:08 year mid next year this company will
20:11 then become a Revenue company and that's
20:13 a major achievement with that let's
20:16 please go to Question and Answer.
20:18 Thank you. You'll now be conducting a
20:21 question and answer session if you would
20:23 like to ask a question please press star
20:25 1 on your telephone keypad
20:27 a confirmation tone will indicate your
20:29 line is in the question queue your press
20:31 star 2 if you will let you move your
20:33 question from the queue for participants
20:35 using speaker equipment it may be
20:36 necessary to pick up your handset before
20:38 pressing the Starkey's 1 millon please
20:40 slowly poll for questions
20:43 thank you our first question comes from
20:46 Chen with HC Wainwright
20:48 please proceed thank you for taking my
20:51 question could you clarify the variety
20:54 of structure and additional milestone
20:56 sales-based milestones from the
20:58 agreements yes so we are going to a
21:01 trade agreement so that milestone
21:03 payments will be defined on that we just
21:06 put the presses out so if you don't mind
21:09 let us
21:09 to have this the details of it you know
21:12 it is going to be out in 8k also okay
21:16 sure in the you are pretty confident at
21:19 this point that all the BLA
21:21 submission should be completed at the
21:23 latest in January right
21:25 that's correct that's correct we have
21:27 been working very carefully with our
21:30 manufacturing folks and they had many
21:35 stability data that we received but the
21:38 last part of it was dragging and we hope
21:41 to even have it by you know by the end
21:43 of December but again if it doesn't
21:45 happen by the end of December January
21:47 would definitely we feel very confident
21:49 on that obviously these are all
21:52 forward-looking statements so I am
21:54 Telling You everyone as we receive
21:57 information good thank you
22:00 yeah sure thank you again if you'd like
22:05 to ask a question please press star 1 on
22:07 your telephone keypad
22:08 a confirmation tone will indicate your
22:10 line is in this question queue Thank You
22:12 our next question comes from line of
22:14 Paul Hideout a private investor please
22:17 proceed good afternoon how are you doing
22:23 great thank you
22:24 great hey when do you anticipate
22:28 enrolling the additional tnbc patients
22:35 so we believe that the four patients
22:37 that we have currently under under
22:40 clinical trial phase 1B - - who are
22:43 naive MT and DC we'll be sending the the
22:48 biopsy couple of them have already sent
22:50 that so hopefully you know we will have
22:53 some kind of enrollment this this month
22:56 and I'm hoping that two of them at least
22:59 will be enrolled which would be
23:00 sufficient for us to have a you know
23:02 breakthrough designation filing once we
23:04 have a couple of results from them right
23:10 have you had any more test results come
23:12 back or the existing patient that was
23:16 injected in August and how is your
23:18 mother-in-law doing
23:20 no thank you so first of all the the
23:24 results that are coming out because this
23:27 is a life-threatening condition and
23:30 because when we announced last time the
23:33 results we saw many patients with very
23:36 very serious condition calling us and
23:38 trying to get involved we will be
23:40 announcing every result that comes out
23:43 that is you know the analyze results
23:46 that are able to be able to be analyzed
23:49 we will put it out so with that with
23:52 that we will wait for the next press
23:53 release to have results for that patient
23:56 and thanks for asking about my
23:57 mother-in-law she has already got an MRI
24:00 and scanned and we will let everyone
24:04 know about the results also as she's one
24:06 of the patients right now so with that
24:08 thanks Paul nextly
24:10 thank you our next question comes from
24:12 line of Shawshank or Patti and a private
24:14 investor please proceed good afternoon
24:18 I have a question you talked about the
24:20 CNC submission for the BLA is that going
24:23 to be of AGC or of Samsung so the BLA
24:31 has to be with AGC because all the
24:34 methods were validated in America an
24:37 agency which is a very good thing with
24:39 Samsung once we get the first clinical
24:41 grade product then we have to get our
24:43 app for which Samsung is very good at
24:46 that also but it will take some times
24:48 but of but if you if you're intending
24:51 the manufacturer you know are you
24:53 intending to manufacture the first
24:54 commercial batches through AGC or
24:56 through Samsung AGC okay and then second
25:01 question is going to be when do you
25:03 expect there to be a move of the stock
25:05 or the company to the capital markets so
25:08 we can start getting some better
25:09 coverage
25:12 yes so as you know we're an OTC B we
25:16 have raised tremendous amount of funding
25:19 to get to this point or these are dreams
25:22 for any biotech company that is in
25:24 Nasdaq or New York Stock Exchange
25:26 let's excited I have done that by
25:28 raising money from retail investors
25:31 therefore pressure we have not have a
25:34 single break from anywhere we constantly
25:36 had to raise enough funds to get to this
25:39 point telling everybody that you know it
25:42 could take 1 billion dollars to get to
25:44 the approval doesn't make anybody feel
25:45 any better but those are the facts that
25:47 we have defied all the odds and we have
25:50 gone against all the people that thought
25:52 we will not be able to make it to this
25:54 point so stock has to take its you know
25:58 react our chief financial officer Craig
26:01 Eastwood has done some analysis of what
26:05 this was you know what when with the
26:07 stock go to whatever levels after after
26:11 we have revenue and those numbers are
26:14 stunning just with the combination
26:16 therapy alone the numbers look very high
26:19 based upon you know the the analysis
26:22 that he has done and was conservative
26:23 analysis so I don't know exactly when
26:26 the stock will react but these are we
26:29 are solving major problems with very
26:32 little you know resources but I find I
26:37 find I find that answer to be inadequate
26:39 because the stock is not going to move
26:41 unless it gets better coverage thank you
26:46 for your opinion I appreciate that next
26:48 question please
26:51 thank you again if you'd like to ask a
26:54 question please press star 1 on your
26:56 telephone keypad
26:56 a confirmation tone will indicate your
26:58 line is in the question queue and one
27:01 moment please loophole for additional
27:02 questions thank you our next question
27:15 comes from the line of Steve Carnac a
27:17 private investor please proceed hi Nader
27:22 congratulations no I'll work thank you I
27:26 had a question about kind of the basket
27:28 case studies that you were talking about
27:30 doing in the past and I'm just kind of
27:33 curious since Network we're going with
27:35 the MS possible phase 2 study are they
27:39 going to include diseases such as lupus
27:42 and Hashem Oto's those kinds of immune
27:45 diseases as well I don't think so we
27:49 will definitely have dr. Burger update
27:51 everyone as soon as does those trial
27:54 gets going for now we will be filing IND
27:57 an and protocol perhaps for phase 2 with
28:01 the data that dr. Burger has for us and
28:03 then we're just going to have to wait
28:05 and see how everything you know turns
28:08 out to be in regards to stock price and
28:10 everything before we start any new trial
28:11 but we are going to have expanded access
28:14 perhaps for the certain patients who
28:17 have serious disease with MS we might
28:19 even let those people get involved okay
28:22 thank you yeah thank you
28:25 next please thank you our next question
28:28 comes from line of Eric's lender a
28:29 private investor please proceed
28:31 hi congratulations on the licensing
28:35 agreement we've been looking on the
28:37 internet for the press release and can't
28:39 see it wondering could you repeat who
28:42 you signed the licensing agreement and
28:44 it was 87 million upfront plus 50%
28:47 royalties what I heard just wondering if
28:50 you could go over that again as I can't
28:52 find it anywhere
28:54 yeah so he probably takes a while to
28:57 please hit the wire but there
29:00 title that I read to everybody I will
29:02 read it again CytoDyn signs
29:04 definitive agreement with Vyera Pharmaceuticals
29:07 to commercialize leronlimab
29:10 in the US for the treatment of
29:12 HIV in exchange for the exclusive right
29:16 to market and distribute leronlimab
29:19 in the US for HIV related indications
29:22 Vyera will pay upfront and
29:24 regulatory and sale based milestones
29:28 payments of up to eighty seven point
29:31 five million dollars as well as a
29:33 royalty of 50 percent on net sales the
29:37 Vyera will also make an investment
29:39 inside a line of four million dollars in
29:42 the form of registered CytoDyn common
29:45 stock the the contract will be 8k so
29:50 people will be able to read all the
29:52 details great thank you very much yeah
29:57 thank you
29:58 thank you our next question comes from
30:01 the line of Matt eldering with a private
30:03 investor please proceed hane honored hey
30:07 congratulations on the licensing
30:09 agreement that's that's great news I
30:10 wanna I want to just ask kind of a more
30:14 kind of dumb down question you know for
30:16 myself as well as the other investors
30:18 who have gotten into this company for
30:21 the sole purpose of it appears to be a
30:23 tremendous financial opportunity beyond
30:25 that I got to be honest there's about
30:27 you know maybe 10 to 15% of these
30:29 acronyms that I understand that you guys
30:30 are throwing around but I just want to
30:32 if you could speak to the
30:34 differentiation between the HIV piece
30:36 that you guys just signed with this
30:38 licensing and by the way is it Vyera
30:40 pharmaceuticals to you spelled of the
30:41 air or whatever that name is sure Matt
30:45 Pharmaceuticals okay so
30:53 that that was specifically about HIV but
30:58 but but again and I and I apologize for
31:00 the rather you know simplistic question
31:03 here but the real the real opportunity
31:06 the homerun ball if you will is is
31:08 cancer right and how far out if you were
31:12 able to speculate
31:14 you know are we from you know making a
31:16 you know some significant headway in in
31:19 that regard and does this this licensing
31:22 agreement with the era diminished that
31:23 opportunity for the cancer piece no
31:27 actually that's a great question Matt
31:29 actually either helps us to get to the
31:33 some major you know milestones now that
31:37 we have this in our bag you know telling
31:41 a world that now we have manufacturing
31:44 all set with the third payment during
31:47 the work that we have a company like
31:49 Vyera who have tremendous business the
31:53 tremendous sales force ready to go to
31:56 launch the product and having the BLA
31:58 submission in the brink of being
32:00 finalized this tells everybody that we
32:03 will have revenue if all goes well right
32:06 now with the whatever we have left over
32:07 to do in and next year I mean that's
32:10 that's incredible and when Craig is
32:14 without CFO did their numbers of what
32:17 the stock could word post revenue with
32:21 just like 50,000 or 60,000 patients
32:23 taking care of the stock could be
32:26 undable digits that that's now is
32:28 getting very close to reality and we are
32:31 going to make sure that we work as
32:33 expedited as we always have now in
32:36 regards to chances we we have a whole
32:39 different ballgame here people that want
32:41 to do commercialization license they
32:43 don't want to talk about cancer because
32:45 cancer takes about five to ten years
32:47 sometimes if you have breakthrough
32:49 designation for something like what we
32:52 have T NB C which is triple negative
32:54 breast cancer then that changes
32:57 everything and if people who are failing
33:00 in NASH like Gilead we just failed again
33:02 for second time in NASH C a result that
33:05 we have and they see the opportunity
33:08 they might want to come in and license
33:10 that portion buys for themselves but
33:12 this agreement is for United States only
33:14 for HIV treatment combination therapy
33:18 and potentially when we get approval for
33:20 mono therapy and when you have a sales
33:23 force set to sell your combination
33:26 therapy and
33:26 let's say a year later you have
33:28 monotherapy you have a great great grip
33:31 on the market to go and take care of the
33:34 monitory piece so this does not by any
33:36 way shape or form stop us from cancer or
33:40 any potential that we have and this
33:42 company has potential that is unheard of
33:44 in my opinion I don't think anybody can
33:47 find anything like this in the whole
33:49 world that the product and monoclonal
33:52 antibody comes into the market and the
33:54 story is just incredible also but anyway
33:56 he comes and now you see animal studies
33:59 are stunning as it was for cancer we
34:03 took it to human it's duplicated that
34:05 results for one patient almost
34:08 duplication something almost the
34:10 duplication of the animal study and if
34:13 we have few more then we were off and
34:15 running and everybody who trusted in us
34:18 and trusted in the fundamental and
34:20 trusted in the fact that we put out and
34:22 trusted that we are saying it truth to
34:24 them they're gonna benefit now that's
34:26 just the financial part when you when I
34:29 hear patients calling me and crying
34:31 saying please please let me have this
34:33 product and we immediately try to open
34:36 that door if there is potential research
34:38 potential in cancer I will never be able
34:40 to forget these days the days that we
34:43 were able to maneuver with our great
34:45 team or path from HIV to chance eV and
34:49 the funding was so low when the fires
34:51 were everywhere we not only went with
34:54 HIV but we didn't stop we try to get it
34:58 to everything else that we can get and I
35:00 am so proud to see at least one patient
35:02 coming back and saying that I can I have
35:05 a better life now thank you and probably
35:07 this is gonna work great for me it's two
35:09 months of treatment right now for the
35:11 first patient but it is really
35:13 breathtaking what we have right now in
35:15 front of us and thank God for that
35:20 thank you for your vision next oh yeah
35:23 next question please thank you our next
35:27 question comes from line of nicosia
35:28 within a telescope Capitol please
35:30 proceed oh yeah congratulations not as
35:34 fantastic news and also congratulations
35:37 to Brendan I know he's been working
35:39 really hard on this
35:40 i quick a couple questions one is what
35:43 is the plan and amount of funding to
35:45 bridge the gap between now and the
35:47 milestone payments going forward so Nick
35:51 the question is great question and I
35:53 hope everybody pay attention that I'm
35:55 not giving out our fundraising final
35:59 strategy because I'm not I don't we make
36:02 up things as we go out since six years I
36:04 mean we we just don't know what we have
36:07 and when things happen and we have to
36:09 change it for the better everybody why
36:11 you did that so I'm going to tell you
36:12 that my my intention right now is not to
36:16 raise any more money til end of February
36:18 or if we raise money would be from just
36:21 certain shareholders perhaps you know
36:23 the coverage of their no I mean
36:26 exercising their you know ten and I have
36:28 to be able to convert the rewards we are
36:31 we have all these options and we're
36:33 going to be very careful as I read the
36:35 number of shares with saved for the
36:37 company that tender offer we did saved
36:39 us about fourteen million shares we also
36:42 had one hundred million shares and we
36:44 still have shared lives and that is that
36:46 was months and months ago that we
36:47 authorized that so I hope everybody
36:50 appreciate that we're not just jumping
36:52 and getting any money at these thrown at
36:54 us we are very careful but the
36:56 fundraising to bridge this gap right now
36:58 what we have coming up is good enough
37:00 for us to get to February for us in my
37:02 opinion maybe few million here all
37:04 deltas very small amount that we might
37:07 raise in a different setting but no more
37:09 our default in my opinion and no more
37:11 preferred shares but I need to run all
37:14 of these by our CFO and Mike Mulholland
37:16 who has stayed with us to watch over me
37:19 because he has done that for the last 8
37:21 years he's very capable and I have asked
37:24 him to please stay at the executive
37:25 advisor to see one guide me and he is
37:29 staying here he trained he trained Craig
37:31 for all of these but he's going to be
37:33 here because three of us going to make
37:35 sure that we take the right path the
37:37 correct path and raise money at the
37:39 right time only okay and the next
37:43 question it sounded like sebacean or the
37:45 previous caller's question that Vyera
37:47 doesn't have rights to prep is that
37:49 correct
37:51 yeah let's let's talk about that when we
37:54 have our business development personal
37:56 doctor the Brandon Rae you who's also a
38:00 JD and attorney I would rather he talk
38:03 about that because the deal is just came
38:05 out and I don't want to elaborate on
38:07 that to the next time we all talk okay
38:11 that's all I started about that Thank
38:13 You Nick appreciate it next question
38:15 please thank you our next question comes
38:17 from line a Francisco Tuscola with tusk
38:19 oh please proceed Enid our it's Michael
38:23 Holly oh great great
38:26 yeah I had a question about the the
38:28 relationship going forward with insult X
38:31 and if we had soap any medication to
38:34 them yet I'm sorry I missed the question
38:38 yeah do we have we sold any medication
38:42 to himself yes yeah we uh we had some
38:45 stock that we might be selling to them
38:47 and how was our relationship with them
38:50 going forward how about going what dr.
38:53 Bruce Patterson has been nothing but a
38:54 spectacular for this company he's the
38:57 one that allowed the enrollments of the
38:59 patients happen because based upon all
39:01 criteria we couldn't have and he came in
39:03 and said the mechanism of action is
39:05 absolutely there much much better than
39:08 what you guys thought so I cannot thank
39:11 him enough but the agreement we made
39:12 with his company who his CEO up he has
39:15 already given us orders and purchase
39:18 orders but this is a small number there
39:21 needs to be work to be done that
39:25 commercialization of I'm sorry the
39:27 selling of the product that we talked
39:29 about was for non-commercial product it
39:32 was clinical grade product for a
39:34 diagnostic so they could only use that
39:37 to locate the ccr5 so that's it as I
39:39 said before it's a small amount but we
39:41 just didn't want to throw away our
39:42 clinical grade product and one of the to
39:46 make sure that goes to use also so once
39:48 we get the substantial sales obviously
39:50 it'll being on our earnings thanks doc
39:54 yeah absolutely
39:55 next question please thank you our next
39:58 question comes from line of Paul Whalen
39:59 a private investor please proceed yes
40:03 good afternoon everyone
40:04 I I'm very excited by what I'm hearing
40:10 and it's for a selfish reason because my
40:14 wife has been suffering from triple
40:18 negative breast cancer now for two years
40:20 and so when I got involved in your
40:25 company it was because I had done some
40:27 research to try to find out if there was
40:29 anything coming up that would be helpful
40:32 so I am very excited by what I hear and
40:35 I'm looking forward to hearing more
40:39 positive information on the treatment of
40:42 the triple negative breast cancer No
40:46 thank you very much and I'm sorry thank
40:48 you and I'm sorry to hear about your
40:50 wife and I'm glad that we are out there
40:53 and trying to see if we can help anybody
40:55 with this product
40:56 thank you so last question please thank
40:59 you our final question will come from
41:01 the line of elusive social or private
41:03 investor please proceed yes how I would
41:06 like to say hello to everyone in C why
41:09 do I and congratulation congratulation
41:13 and with the licensing and all of the
41:16 medical results dr. parris on just a
41:19 short question IRB was approved for all
41:23 metastatic triple negative breast cancer
41:26 November 12 actually this is a very very
41:29 is a protocol in my opinion I was
41:35 expecting that we will have by now maybe
41:37 20 patients and will have on the floor
41:39 there was happy enough of centers open
41:41 or do you plan to open any more centers
41:44 and thank you very much thank you dr.
41:47 zosh I appreciate it so in regards to
41:51 opening new centers we are going to be
41:54 very careful with our funding situation
41:57 that's one of the problems but expanded
42:01 access I believe maybe we have close to
42:04 20 people that have reached out to us
42:05 and they are trying to get biopsy to us
42:07 so we can check their qualification so
42:10 we are getting quite a bit of
42:12 number of patients coming to us and in
42:14 regards to the phase 1 2 & 2 we are we
42:18 have enroll another Center but we just
42:21 you know taking our time now because it
42:23 seems like there's a lot of patients
42:25 coming in and last press rates we put
42:27 out it was really a great turnaround the
42:30 first 10 months of this protocol which
42:32 we enjoyed zero patients then we
42:34 enrolled one and the result was good now
42:37 beginning all these patients so that's
42:39 where we are so with that we are going
42:43 to end the call today so I want to thank
42:48 everybody for being here today and I
42:50 want to thank everyone to be so patient
42:52 with us the stock price is a big problem
42:55 for everybody and I understand that but
42:58 I hope that everyone concentrate on the
43:00 fundamentals and realized that we are
43:02 going forward no matter how difficult
43:05 things gets and as we just announced the
43:08 licensing agreement deal I hope people
43:10 will now get confidence that when we say
43:13 we signed non-binding term sheet and we
43:16 just need some time to negotiate for the
43:19 best of shareholders I hope that
43:21 everybody is paying attention about that
43:23 we are having more licensing agreements
43:26 right now that we are talking to and we
43:28 are going to report to all of you when
43:30 the non-binding term sheet is assigned
43:32 for that and that way everybody will see
43:35 that there your company is going forward
43:38 in it in my opinion a great way except
43:41 the stock price is lagging that's the
43:44 story of our life so far but it I
43:46 believe it will change big time so with
43:48 that thank you very much everybody and
43:49 have a great day thank you
43:52 this concludes today's conference so you
43:54 may disconnect your lines at this time
43:55 and have a wonderful day
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