CytoDyn CC (Auto) Transcript July 30, 2019 with c
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CytoDyn CC (Auto) Transcript July 30, 2019 with comments from Drs. Sacha, Patterson and Lalezari.
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00:00 greetings and welcome to the CytoDyn
00:01 investment community conference
00:03 call at this time all participants are
00:05 in a listen-only mode a
00:06 question-and-answer session will follow
00:08 the formal presentation as a reminder
00:11 you may submit your questions at any
00:12 time by using the ask a question box on
00:15 the webcast on the left side of your
00:16 screen if anyone should require operator
00:18 assistance during the conference please
00:20 press star 0 on your telephone keypad as
00:22 a reminder this conference is being
00:24 recorded it is now my pleasure to
00:26 introduce your host Michael Mulholland
00:28 chief financial officer thank you sir
00:30 you may begin hello everyone and thank
00:33 you for joining us today this is Michael
00:35 Mulholland chief financial officer of
00:38 sighted I'm joining us on today's call
00:42 is our president and CEO Dr. Nader Pourhassan
00:45 as well as dr. Jonas Sasha dr.
00:48 Bruce Patterson and dr. Jacob Lalezari
00:51 Ari before we begin it is essential that
00:55 we provide you with important cautionary
00:57 language related to certain federal
00:59 securities laws our remarks during
01:03 today's conference call will include
01:05 forward-looking statements
01:07 forward-looking statements are not
01:09 guarantees of future performance and
01:11 involve known and unknown risks
01:13 uncertainties and other factors that are
01:16 difficult to predict actual results may
01:20 be materially different from any future
01:22 results expressed or implied by such
01:25 forward-looking statements these risks
01:28 and uncertainties include among other
01:30 matters statements regarding LaRhonda
01:33 mobs potential efficacy in certain
01:36 immunology and oncology indications the
01:40 company's ongoing ability to raise
01:42 additional new capital that clinical
01:45 trials may not commence or proceed and
01:47 planned products that appear promising
01:50 in early trials may not subsequently
01:52 prove to be viable on safety or efficacy
01:56 Grim's products may not receive
01:59 regulatory approval or market acceptance
02:02 competition may reduce the commercial
02:05 potential of our products we may
02:07 experience product recalls manufacturing
02:09 issues or product liability and our
02:12 patents may be challenged or
02:14 unenforceable
02:16 although forward-looking statements
02:18 helped to provide complete information
02:20 about the company forward-looking
02:22 statements may be less reliable than
02:25 historical information the company
02:27 undertakes no obligation to update
02:29 publicly these forward-looking
02:31 statements except as required by law
02:34 please refer to our recent quarterly and
02:37 annual reports filed with the Securities
02:38 and Exchange Commission for more
02:41 information about the risks and
02:43 uncertainties that could cause actual
02:45 results to differ materially versus our
02:49 current expectations I will now turn the
02:52 call over to dr. Lorenson not thank you
02:56 Mike thank you everyone for
02:59 participating in today's shareholder
03:01 conference called in today's update
03:04 called we have invited three of our
03:06 advisors to speak to you so our
03:09 shareholders could hear directly from
03:11 them their professional opinion about
03:14 Leronlimab and its potential role in
03:16 future of HIV and cancer therapy our
03:20 first invitee is dr. Jonas Sasha
03:23 recently cited I had named dr. Jonas
03:27 OSHA as its senior science advisor to
03:29 explore leronlimab probe on 4e
03:32 potentials in HIV pre exposure
03:35 prophylaxis and cure
03:38 dr. Sascha is an expert in hiv/aids
03:41 research who served on the National
03:44 Institute of Health offices of AIDS
03:48 research Advisory Council and leads a
03:50 research laboratory in the vaccine and
03:53 gene therapy Institute and Oregon
03:55 National Primate Research Center at the
03:57 Oregon Health and Science University
03:59 OHSU the social laboratory aims to
04:03 identify novel therapeutic approaches
04:07 for us for use in prophylactic HIV
04:11 vaccines and HIV remission
04:13 including treatment to this effect dr.
04:17 sasha has been working with leronlimab
04:19 for about a year and his preclinical
04:22 studies produce some very exciting
04:26 results he's the person that lead that
04:29 led the collaboration between citation
04:31 and size Red Cross and those discussion
04:34 led to SATA dine and red tie Red Cross
04:37 signing a Memorandum of Understanding
04:40 for prevention study and we announced
04:42 that currently dr. sasha is a professor
04:45 at the vaccine and gene therapy
04:47 Institute dr. Salk would you please
04:50 explain to our shareholders the Cure and
04:53 prep potential that you see for our
04:56 shareholders dr. Sasha go ahead please
05:00 right thank you for that introduction
05:02 another so I'm excited to officially
05:05 join CytoDyn because I firmly believe
05:08 the future applications of Miranda
05:09 mapped HIV pre exposure prophylaxis or
05:12 prep and HIV cure is both well grounded
05:15 in the basic biology of HIV and it's
05:18 also clinically relevant with the direct
05:19 path into patients these two
05:22 characteristics I believe augur very
05:23 well for the future of leronlimab and
05:25 HIV prep and cure applications I'll
05:28 begin by discussing the application of
05:31 prep pre-exposure prophylaxis so in the
05:34 absence of a prophylactic HIV vaccine
05:36 HIV prep is the best weapon we have for
05:38 slowing the spread of the epidemic
05:40 so adherence the current regimens which
05:42 currently are daily oral antiretroviral
05:45 drugs and the uptake of those regimens
05:47 are the most critical barriers to ruling
05:49 out prep worldwide according to surveys
05:52 of high-risk individuals of men who have
05:54 sex with men approximately 25% of them
05:57 cite the inability to take oral
05:59 antiretroviral drugs daily as a reason
06:01 for their failure to adhere to the
06:02 regimens so the individuals that are at
06:05 high risk of HIV acquisitions are want
06:09 long-acting which we define as once a
06:12 week our greater prep agents and
06:14 currently their dose of leronlimab
06:16 which is once weekly subcutaneous
06:18 administration would fill a major gap in
06:20 prep we also believe that we can extend
06:22 this to further than once once weekly
06:25 the science really
06:27 we're on the map WordPress so mucosa
06:29 Lior look all sexually transmitted HIV
06:31 is always ccr5 tropic that means the HIV
06:35 that is transmitted from when it should
06:37 be infected individual to the other
06:38 always uses the ccr5 co-receptor it's
06:41 well established in the literature that
06:43 individuals are deficient for the ccr5
06:45 molecule the so called ccr5 Delta 32
06:48 mutation are resistant to sexual
06:51 transmission of HIV with no documented
06:53 cases so therefore we in the field of
06:55 HIV research refer to CCR thought as the
06:57 gatekeeper of sexual transmission of HIV
07:00 in my laboratory State we have shown
07:02 that leronlimab effectively converts cd4
07:04 t-cells these are the targets of HIV
07:06 into ccr5 decisions that is they appear
07:09 as if they have come from the individual
07:11 with the ccr5 Delta 32 mutation because
07:14 the basic science of ccr5 and sexual
07:16 transmission and our results to date
07:19 others in the sealed I began to
07:21 recognize the potential for leronlimab
07:22 in prep my lab has received an NIH
07:25 National Institutes of Health grant to
07:27 test the hypothesis of the leronlimab as
07:30 pre exposure prophylaxis in preclinical
07:31 studies in non-human primates and when
07:35 we approached the Thai Red Cross they
07:36 eagerly agreed to initiate a clinical
07:38 trial in Bangkok which has one of the
07:40 highest rates of sexual transmission in
07:42 the world so the seeds that we're sewing
07:44 now I believe will bear service in the
07:46 next year as results of our preclinical
07:48 non-human primate study has become
07:50 published and we commence with the
07:52 clinical work in Bangkok for HIV chor I
07:56 believe leronlimab is also well founded
07:59 in the science fear such a date there
08:01 have been two individuals HIV positive
08:03 individuals who have been functionally
08:04 cured of HIV the so-called Berlin and
08:06 London patients there's also a third
08:09 patient called the essent patient who
08:11 has not yet been published all three of
08:13 these individuals received stem cell
08:14 transplants from ccr5 Delta 32 donors
08:17 so these are donors to lack the ccr5
08:19 molecule
08:20 thus it is currently believed in the HIV
08:22 field that ccr5 deficiency holds the key
08:24 to HIV cure as I mentioned earlier
08:27 Leronlimab administration effectively
08:29 converts cells in a patient's into the
08:30 ccr5 Delta 32 phenotype my laboratory
08:34 has established the only preclinical
08:35 non-human primate model of stem cell
08:37 transplantation we are currently testing
08:39 around the map as an ability to cure
08:41 these animals in stem cell
08:43 transplantation and based upon a results
08:46 in the science funding agencies are
08:48 eager to support both our preclinical
08:50 work and begin initiating human clinical
08:52 trials so specifically as far which is
08:55 the American Foundation for AIDS
08:56 research actually funded the London
08:58 patient work have already verbally
09:00 expressed extremely high interest in
09:02 funding both of these studies both the
09:03 preclinical and the clinical I'm flying
09:05 to New York City on Friday to complete
09:07 these initial conversations the stem
09:09 cells transplant physician that multiple
09:11 Institute's including the University of
09:12 Medicine where the third currently
09:14 unpublished individual is cured wish to
09:16 lead these clinical studies with
09:17 leronlimab so initially the wrong
09:19 level we use in conjunction with stem
09:21 cell transplantation but the future of
09:23 this is the foundation for any therapy
09:25 aimed at HIV cure the biggest example of
09:28 this is Sangamo in their ccr5 editing
09:31 program I believe that ccr5 should lay
09:33 the foundation for all HIV cure
09:35 approaches and based on this I think the
09:37 future is extremely bright from around
09:39 leronlimab in both HIV prep and HIV - thank
09:43 you not her thank you so much dr. Sasha
09:46 just in that regard I want to say one
09:49 word that the prep there which is the
09:53 prevention of people getting HIV when
09:55 they are at high risk of HIV currently
09:58 so is telling there is a product out
10:00 there for prep which is true water is
10:03 currently we have data that says that
10:06 there was one hundred thirty six
10:09 thousand individual uses for $20,000 per
10:12 year that's the cost that's about 2.6
10:15 billion dollars so this is a very
10:17 important aspect of our product that
10:20 we're going to go forward and explore
10:22 our next invitee is dr. Jacob Lalezari
10:27 is doctored dollars are you on the call
10:29 yet yes hi Nana okay so I'm gonna just a
10:33 few words dr. Lalezari is our
10:37 principal investigator for our mono
10:39 therapy and he was involved in our
10:41 combination we started our monotherapy
10:44 five years ago with dr. Lalezari and he
10:47 wrote the very first patients he
10:49 immediately called me and said
10:50 you don't need to enroll anymore
10:53 and I had
10:53 said that to all the shareholders he
10:55 said that the mono therapy is
10:58 well-liked by the patients in that area
11:00 and he will enroll all 40 patients
11:02 himself and he did he's also known at
11:05 the key opinion leaders physicians for
11:09 the world of HIV dr. Lalezari was also
11:11 very excited about the potential use of
11:14 Leronlimab in the world of chance
11:16 and accepted to inject patient in triple
11:19 negative breast cancer study and
11:21 therefore we have allowed triple
11:23 negative breast cancer patients that are
11:25 not naughty patients to enter into tnbc
11:29 therapy with literally map with either
11:31 compassionate protocol or expanded
11:35 access so without any more I'm gonna
11:38 lift off the loaded area name Jay go
11:41 ahead please sure well I'll start with
11:44 the latter scenario because that's I
11:46 think very new and exciting like others
11:49 I've seen the work that Richard had done
11:52 showing that ccr5 was a integral part of
11:56 breast cancer invasion and metastasis
11:58 and we were excited about the triple
12:01 negative breast cancer study but found
12:03 it very difficult to find women who were
12:06 naive in the metastatic setting and so
12:09 we had a referral last week voluminous
12:12 on third line therapy with triple
12:15 negative breast cancer and we've called
12:17 the FDA and applied for an emergency
12:20 treatment IND and we're sending off her
12:23 tissue for confirm her or ccr5
12:26 positivity and then we'll start her on
12:28 treatment and which leads to a broader
12:31 conversation I think was I designed
12:32 about the original protocol being set up
12:35 to both demonstrate perusal concept and
12:39 create a pathway for approval whereas I
12:41 think it might be easier for us if we
12:43 focus on showing proof of concept and
12:47 once we demonstrate that leronlimab is
12:49 is is active in breast or perhaps
12:52 prostate or colon then leading the
12:57 approval protocols for a little bit
12:59 further down the road sorry the first
13:01 order of business is to get the drug
13:03 into patients who need it and show that
13:05 it works and I'm pleased to report
13:07 that the first such patient should be
13:09 starting soon in terms of HIV I guess
13:14 that's all those will neither say that
13:17 we could enroll the full study but it is
13:19 certainly true that in San Francisco we
13:21 it's been an easy sell
13:23 to offer patients once a week cept once
13:26 a week therapy I think that's what
13:27 everyone needs to sort of how to frame
13:30 this it's not sub-q it's it's once a
13:33 week and there are a lot of reasons why
13:34 people want to switch from daily oral
13:37 therapy to once a week therapy some of
13:40 its side effects some of its pill
13:42 fatigue some of its chaotic lifestyles
13:45 but it's not all patients but it is a
13:48 solid ten to fifteen percent of the
13:50 population and I think we'd probably
13:52 enrolled 150 patients now from a tour
13:55 over the years and it you know obviously
13:58 does not work in everybody there are
14:00 some questions as to why it's not
14:02 working in everybody because we're not
14:04 seeing resistance we're not seeing
14:06 co-receptor shifting we're not seeing an
14:09 t drug antibody some of the problems may
14:12 be occurring early because we're not
14:14 overlapping with the ARB long enough to
14:17 go through five half-lives
14:20 of the antibody some of it is that
14:23 patients get six the later on in
14:26 treatment and they have us what appears
14:29 to be an increase or up calculation of
14:31 ccr5 receptor expression that we'll get
14:34 to that with the next speaker but it's
14:37 now working in the great majority of
14:39 patients and I think the data I would
14:41 support over 90%
14:43 once you get past week 12 and I think
14:46 the what I could contribute to this
14:48 conversation is just the observation
14:50 that the patients who do well on leronlimab
14:54 mono therapy love it and
14:57 whatever reason drove them into the
15:00 study obviously they got what they
15:02 wanted and then when it works are quite
15:04 happy but it's been a life changer for
15:08 patients that we have some of them have
15:10 been on this mono therapy now for five
15:12 years or more we don't see any concern
15:17 around injection site reactions I don't
15:20 see any at
15:21 all really safety or toxicity which is
15:24 partly why I'm excited about the breast
15:26 cancer study because if it works there
15:28 it's going to contribute some benefit
15:31 without adding any additional toxicity
15:34 or other issues so the patients do well
15:37 along the mouth is mono therapy for HIV
15:39 love it
15:40 I'm glad to see that the FDA is working
15:44 with high design to try and figure out
15:45 how both to help them cross the finish
15:49 line for their approval in the salvage
15:52 of the treatment experience population
15:55 and obviously they've given a fast track
15:58 designation and they are engaging
16:01 cytodyn in conversation as to what a
16:02 phase 3 mono therapy study would
16:04 look like in the meantime I've been also
16:07 talking with a variety of other
16:10 potential partners for CytoDyn
16:12 because I think if we had a two drug
16:14 regimen that was a two drug once a week
16:17 regimen it would be a killer and it
16:20 would do very well and would be a huge
16:22 benefit to the HIV community and I think
16:25 other sponsors are waking up to that
16:27 idea I think there's a lot of interest
16:30 in monthly intramuscular
16:33 injections but the reality of what's
16:35 involved with patients having to go to
16:38 an office or a pharmacy and painful
16:41 monthly injection is setting in and
16:44 there are a variety of potential
16:46 compounds now that CytoDyn could
16:48 partner with I think there's a model of
16:51 therapy it's good I think there's a
16:53 combination when the second drug it
16:54 could be great um and I'll just stop
16:58 there yep thanks so much
17:00 any questions yeah we were going to go
17:03 okay we're on thank you so much I'm very
17:06 excited to hear a key opinion leader
17:08 telling or shareholder it's really big
17:10 it's huge it's a killer it's always been
17:13 me saying that so I'm appreciative of
17:16 you saying that the next invitee is dr.
17:19 Bruce Patterson dr. Bruce Patterson
17:21 medical doctor former medical director
17:24 of biology at Stanford University
17:26 Hospitals and Clinics
17:27 he's also the CEO and founder of in cell
17:31 BX
17:32 Inc and a top expert
17:34 in ccr5 he has revealed that through
17:37 certain laboratory tests looking at the
17:40 genetics and expression of CCR permanent
17:43 in individual patients sided I'm a more
17:47 closely match the most effective dose
17:50 for each HIV monitored application to
17:53 achieve viral suppression cytodyn also
17:56 signed an agreement to sell pro 140 non
17:59 commercial grade to insert the for
18:02 diagnostic use dr. Patterson will now
18:05 say a few words about this receptor
18:07 occupancy test that he developed for us
18:10 and our definitive agreements that we
18:13 just signed with his lab dr. Patterson
18:15 please go ahead thank you a lot nodded
18:19 in it and again it's my pleasure to be
18:22 talking about this very exciting
18:24 compound having worked with ccr5 since
18:28 the mid 1990s and I'm also excited to
18:33 hear from the other speakers and
18:35 embellish what they both said about the
18:39 clinical utility of leronlimab and
18:43 planned or pro 140 starting in the 1990s
18:48 when we first discovered ccr5 was a
18:51 co-receptor of HIV my laboratory
18:54 published the first work on the
18:56 distribution of ccr5 both on cells and
19:00 tissues and related to what dr. Sasha
19:03 said we were the first to find that ccr5
19:07 was the major co-receptor in the female
19:10 genital tract and responsible for the
19:14 majority of male to female transmission
19:17 coming through the ccr5 receptor the
19:21 same can also be true for mother to baby
19:24 transmission of HIV which it was also
19:28 ccr5 driven but most importantly our
19:33 work from the mid-1990s she really
19:36 showed what are the
19:38 factors have involved the expression of
19:40 ccr5 in the surface of cells because
19:43 that's where the drug is binding and
19:45 blocking the path of the virus into new
19:49 immune cells and we found some very
19:52 interesting things about ccr5 number one
19:55 as Nader mentioned what's the genetics
20:00 ccr5 comes in two different forms a
20:03 wild-type form and a mutated form the
20:06 patients with mutated forms expressed
20:08 less ccr5 and therefore would require
20:11 less drug for an equivalent response
20:17 against against HIV the other important
20:20 factor is that ccr5 is is a highly
20:23 regulated protein many patients have
20:27 different levels on their cells that
20:29 level on immune cells can be affected by
20:33 infections other inflammation other
20:37 illnesses so it's extremely important to
20:41 be able to know how much ccr5 is
20:44 expressed on the surface of the cells
20:47 that get infected by HIV on a patient by
20:50 patient basis and what's really exciting
20:53 is a much like cancer we're bringing
20:56 personalized medicine to infectious
20:58 disease testing and in particular HIV
21:01 therapy and so with this suite of assays
21:05 that we've developed both ccr5
21:07 genotyping we know the genetic type of
21:10 ccr5 at the patients have and they
21:13 receptor occupancy assay which is now up
21:16 and going strong we know exactly how
21:19 much receptor is being made in each
21:22 individual patients and we can tell you
21:25 by the data that we've looked at so far
21:27 that the patients who have spikes in HIV
21:32 viral loads are the ones that have a
21:35 reduction in receptor occupancy it's not
21:38 due to resistance like in other HIV
21:40 drugs but it's solely
21:42 a balance between whether or not you
21:45 have enough drug to block all the routes
21:47 by which HIV can get into cells and that
21:50 can be monitored the patients can be
21:53 boosted to ensure that all of their
21:56 receptors are blocked in addition we've
22:00 taken a lot of the immunology that we
22:02 were working on in regards to ccr5 in
22:06 the mid 90s and we too have looked at
22:09 cancer in the last five years in terms
22:12 of the markers that are being expressed
22:14 on the immune cells that are attacking
22:16 the cancer and we discovered a few years
22:20 ago that ccr5 is expressed on a on a
22:24 population of immune cells called T
22:28 regulatory cells that inhibit the immune
22:32 response against cancer so there's
22:35 actually a second mega mechanism in
22:37 addition to what dr. Pestell has described
22:40 that may also be a target for leronlimab
22:44 in cancer and that is it can
22:47 inhibit the influx in the movement of
22:51 these T regulatory cells which come in
22:54 to shut off the immune response against
22:57 the tumor in addition to the fact that
23:00 ccr5 is actually expressed on the tumor
23:03 itself as dr. Pestell has had published
23:07 so all told in in in my career of over
23:12 20 years of working with this molecule
23:15 we've seen very dramatic effects both in
23:18 terms of an HIV therapy and more
23:21 recently in terms of a potential cancer
23:24 therapy and now it's not just one Mehcad
23:28 cancer mechanism that it's inhibiting
23:30 but potentially a second cancer
23:33 mechanism as well so I can't tell you
23:36 how excited I am to be working with this
23:40 baby on and dr. Sasha's work we're also
23:43 capable of doing receptor occupancy
23:45 actually in tissues and that goes for
23:48 the cancer applications as well so we're
23:52 very
23:53 excited and we now have a suite of
23:57 Diagnostics to personalize treatment
24:00 with Longo map in a patient by patient
24:03 basis to ensure efficacy and to minimize
24:08 side effects so with that you know I'll
24:13 finish and and I'm always happy to
24:15 answer questions thank you Bruce I
24:17 appreciate it so I will only take few
24:19 more minutes since we have taken some
24:21 time for with our invited guests I
24:24 appreciate them very much the update
24:27 that I have for everybody would be very
24:29 quick number one is that dr. Pestell do
24:33 it CytoDyn now that we are he's not
24:36 no longer with sighted that what would
24:38 happen there's a lot of questions about
24:40 that has became my way and I want to
24:42 address that in regards to triple
24:44 negative breast cancer Dr Massimo Cristofanilli
24:47 is going forward just like
24:50 before and he's our principal
24:52 investigator for that trial he was very
24:54 impressed with the speed that cited and
24:56 had taken an IND through the process of
24:59 FDA he indicated he took many months and
25:02 for them to do such thing and we did it
25:05 in three and a half weeks and we have a
25:07 great relationship dr. Scott Kelly our
25:09 chairman of the board and myself have
25:11 been in touch with him and he's excited
25:13 to continue going forward as fast as he
25:15 can and I will talk a little bit of more
25:17 about that in regards to colon cancer
25:19 dr. John Marshall is the person who has
25:22 been our principal investigator for that
25:23 trial and that that trial is going
25:25 forward great in regards to all the
25:28 animal studies which starts with Nash
25:30 and many others cancer indications I
25:32 will update you in a minute and in
25:34 regards to prognostic test we will be
25:37 also continuing to have our first
25:39 meeting with the FDA in the August 28
25:41 and we will have experts to go with us
25:43 and discuss that with FDA so that's all
25:47 the duties that I want to make sure
25:49 everybody knows that we have have right
25:51 we have right people at the right place
25:53 in the second update is about our most
25:56 important task BLA biologic license
25:59 after
26:00 we just hear heard from FDA that we are
26:04 approved for waivers for blacc for small
26:08 businesses which is about a million
26:09 dollars this morning we also are waiting
26:13 for BLA submission to be the time not
26:17 to be nailed down after we hear from FDA
26:21 525 is accepted by them to go forward
26:24 and the CMC question that we have and we
26:27 believe both of those questions will be
26:29 addressed with a positive result as we
26:32 are negotiating and going back and for
26:33 the FDA right now and I think we could
26:35 have something for everybody very soon
26:37 but other than that if those two
26:39 questions or pause have a positive
26:41 answer we're talking end of September
26:43 sided eyes we'll have a final complete
26:47 BLA submitted this will allow us to
26:49 hopefully have approval first quarter of
26:52 next year and revenue on the second year
26:54 very important task for us in regard to
26:56 third update is about monitoring see
26:59 timeline as we said before the latest
27:02 data we just got is the 95 percent
27:05 responders rate with 525 milligram post
27:08 ten weeks and that's called maintenance
27:11 therapy portion as also we said before
27:15 110 patients reach about a year with
27:18 monitor of these six of those patients
27:20 have reached about three years and for
27:21 his for patients that have which five
27:23 years there are elements that was not
27:25 incorporated in our study which was a
27:27 half life which was the incorrect half
27:29 life based upon that the overlap for a
27:32 portion of our trial was different and
27:34 receptor occupancy chance that dr.
27:36 Patterson just talks about those are
27:38 going to make or design for pivotal
27:40 trials much better than what we have and
27:43 we excited to meet with FDA in September
27:45 and that's a day they have given us for
27:47 face to face for mono therapy the fourth
27:50 update is about triple negative breast
27:52 cancer I want to make sure I don't go
27:54 too fast on this I want to make sure
27:56 everybody understands everybody is
27:58 anticipating when is the first patient
28:00 in triple negative breast cancer doctor
28:03 Jay orders or is just indicated that he
28:05 has the patient that they want to inject
28:08 Compassionate Use Agreement or expanded
28:11 use argument why why not inject the
28:14 patient our current protocol that we
28:16 have because the current protocol
28:18 designed by doctors Massimo Cristofanilli
28:21 has been excellent and he has
28:25 indicated that he likes to enroll naive
28:28 patients what is naive patient well
28:30 these are patients who are triple
28:32 negative breast cancer and have no
28:34 option there have had no treatment zero
28:37 treatment so far so dr Cristofanilli
28:40 believes that if we are able to
28:43 enroll five patients at least and we see
28:46 that there they are not needing a second
28:49 line as quickly as most of the patients
28:51 need which is about four to five months
28:53 that means leronlimab has a great
28:56 effect and we will go to FDA he will
28:59 lead a discussion with FDA in in regards
29:02 to having approval so this is a very big
29:06 deal for us to keep it going the same
29:08 way as it is but then we have triple
29:10 negative breast cancer patients who are
29:11 not on you know naive population there
29:14 in first I mean a second or third or
29:16 fourth line we are injecting those
29:19 patients also and we're asking for
29:21 compassionate user agreements from the
29:23 FDA and we are also having a protocol
29:26 for multiple expanded access in triple
29:28 negative breast cancer we believe the
29:30 first patient could be injected very
29:32 soon on that protocol in regards to
29:34 naive population dr. Cristofanilli has
29:37 indicated that he is very hopeful to
29:40 have that first patient injected and
29:41 hopefully have five patients like that
29:43 very soon so we can go to the FDA so the
29:47 next update is graft-versus-host disease
29:48 we are excited to inject the first
29:51 patient in the new modified protocol in
29:53 September dr. Porter is our main
29:55 principal investigator we have discussed
29:57 that with him and he is excited to get
29:59 that moving forward in regards to colon
30:02 cancer we have received new data with
30:06 our animal study from dr. Daniel Linder
30:09 very exciting new positive data that we
30:13 are using and we are going to talk about
30:16 that in the press treat and what that
30:18 means for
30:18 and we're also going to fight face to
30:21 colon cancer protocol most likely by
30:24 this Friday to the FDA in regard so all
30:27 the animal study that we talked in the
30:29 past which was Nash melanoma pancreatic
30:32 breast prostate colon lung liver and
30:34 stomach cancer nash is the most
30:37 important one of those and we have we
30:40 believe that any company with face to
30:42 nash if you look at them they have a
30:43 market cap of one or one and a half
30:45 billion dollars so it's very crucial for
30:47 us to get a face to green-light from FDA
30:50 in NASH those results should be
30:52 available to us within six to eight
30:54 weeks result that trial is being
30:56 conducted the animal study is being
30:59 conducted at of the Daniel Linda's
31:01 laboratory Cleveland Clinic in regards
31:05 to breast cancer we have
31:07 completed those results and discussed
31:10 them already and we are in triple
31:11 negative breast cancer currently with
31:13 Phase two in regards to colon cancer
31:15 that completed and we are filing Phase
31:18 two and regards to other cancers we are
31:20 talking to Daniel dr. Daniel Linder to
31:22 give us timeline and he has indicated he
31:25 could conduct all of those animals in
31:27 the eighth update would be about
31:29 commercial plan a detailed and
31:32 well-planned commercialization strategy
31:34 will be posted to our website most
31:37 likely either next week or a week after
31:39 we have two different group working on
31:42 our TPP target product profile for combo
31:45 and mono seniors health is one of them
31:48 and they have over 50 form of pseudocode
31:50 that have launched their product through
31:52 them so we believe we are in good hands
31:54 and we're going forward in regards to
31:57 number 9 of updates license agreement we
32:01 have told everybody that we had a
32:02 non-binding term sheet for licensing out
32:07 the cells up for 145 but we were too far
32:10 away from each other and what we have
32:12 done is we negotiated and we went back
32:14 and for our business development dr. Rey
32:17 has done that and
32:19 we believe we're very close to
32:21 agreements this agreement for the first
32:23 quarter of billion dollar what the sales
32:25 of the only map could be perhaps funded
32:29 by another Capital Group and we could
32:32 get significant funding upfront these
32:34 are all if statement that I'm putting
32:36 here because all these kind of
32:38 negotiations takes time and there are
32:40 lots of things that we have to consider
32:42 to make sure that we don't short
32:44 ourselves we are at crucial position
32:46 with this company too many people work
32:50 too much too hard and too many
32:51 shareholder have this everything they
32:53 have for us to go forward with their
32:54 funding us and we got to be very careful
32:57 with that number 10 is strengthening the
33:00 management and the board by bringing
33:03 strong well known individuals to join
33:06 our board and perhaps take senior
33:09 management positions so we hope that our
33:12 remarks today allow the shareholders to
33:14 see and understand the business through
33:17 the eyes of studied and management as
33:19 always we will we will be very honest
33:21 very transparent and clear about our
33:25 goal and potential with that let's go
33:28 ahead go to question and answer thank
33:31 you ladies and gentlemen at this time we
33:33 will be conducting any
33:34 question-and-answer session as a
33:35 reminder you may submit a question via
33:37 the webcast at any time by typing it
33:39 into the ask a question field at the
33:41 left side of your screen if you would
33:43 like to verbally ask your question
33:45 please press star 1 on your telephone
33:46 keypad
33:47 the confirmation will indicate that your
33:49 line is in the question queue you may
33:52 press star 2 if you would like to remove
33:53 your question from the queue for
33:55 participants using speaker equipment it
33:57 may be necessary to pick up your handset
33:59 before pressing the star keys please
34:01 hold while we pull for questions
34:11 our first question comes from the line
34:12 of David Callahan a private investor
34:14 please proceed with your question I not
34:19 her hey Dave how are you
34:22 sterling well this is the second Richard
34:25 that's gone
34:26 is this gonna create a vacuum in any way
34:30 No thank you for asking but I can't
34:33 elaborate on the individual person
34:34 working with us or not but I can't tell
34:36 you when the first time we had separated
34:39 dr. Richard trogir five six years ago I
34:41 was having a lot of fire on me because
34:44 everybody says you let go the first
34:46 scientists you have and we also gave
34:48 back six million dollars of NIH money
34:50 back to NIH at that time I told you and
34:53 many people please trust me as I am
34:56 bringing a group of top people to
34:58 conduct and conduct clinical trials and
35:02 take this product forward and I will not
35:05 drop the ball and I think five years
35:07 taking it they pay their pay so I was 20
35:10 years and going five years speaks for
35:13 itself in regards to dr. Richardson
35:15 still I have nothing but good thing to
35:16 say about him but we cannot talk about
35:18 our situation but thanks for the
35:21 question next please thank you once
35:26 again to ask a question please press
35:28 star 1 on your telephone keypad at this
35:30 time our next question comes from the
35:34 line of Jeff Roni with Boston life
35:36 please proceed with your question thank
35:42 you you know we're all of course a
35:45 little disappointed with the triple
35:49 negative breast cancer you know in terms
35:52 of first injection and just to confirm
35:55 Northwestern still going to lead the
35:57 naive trial absolutely and when when was
36:04 that document signed with Northwestern
36:06 to tie that in is that Bennett Bennett
36:09 been in place for several quarters or is
36:11 it just a recent development when the
36:15 company met many months ago we engaged
36:18 in ok so the I assume there's a you know
36:22 contract that need to be signed so that
36:23 was signed on for
36:24 okay great that's great thank you all
36:30 right thank you so I have to say that
36:33 it's been 40 minutes for this call and
36:35 we perhaps have to take our last
36:37 question why do we have question time
36:39 for the last word we have one more one
36:42 more okay this is the last question
36:43 please go ahead thank you our final
36:46 question comes from Randy Hardy a
36:47 private investor pleased to see with
36:49 your question this is Randy and a couple
36:52 of questions real quick seems like
36:54 there's a lot of balls in the air and
36:56 focusing on getting one thing or the
36:59 other completed is there a strategic
37:02 plan anywhere that has the timelines and
37:04 the milestones that could be shared
37:06 maybe in the website for cited dying
37:10 investor section that the investors
37:13 could log into yeah absolutely we will
37:17 have all those timelines that we have in
37:19 the website I think Mike do you want to
37:21 add something yeah I would also direct
37:23 your attention to the number of updates
37:26 that we provide for our clinical
37:29 milestones as we advance the company
37:32 forward
37:33 I'm a no project manager and I like the
37:36 strategic planning aspect of it with you
37:39 know solid dates and then if we miss a
37:41 date and there you know there's a reason
37:42 that a date was missed so we have sort
37:45 of would be great absolutely yes thank
37:49 you and yes thank you so this concludes
37:52 our call operator we're gonna stop the
37:57 Q&A; and I'm just gonna give the final
38:00 remarks I just want everybody to please
38:04 take a look at what we have we have
38:07 biologic license application that is
38:10 hopefully completed by the end of
38:12 September once we hear back from FDA
38:15 that should be finalized we have
38:17 monotherapy that FDA as you heard dr.
38:19 Jay Lalezari said that we are they're
38:21 working with us dr. Jay Lalezari by the
38:24 way had gone to everyone almost every
38:26 one of those FDA meeting in person so
38:29 he's very much aware of the FDA's
38:31 position with us so monotherapy
38:34 September 28 we will meet with FDA
38:37 and the hopefully finalized or pivotal
38:39 trial for first humanized monoclonal
38:42 antibody wants a week's up to you for
38:44 the world of HIV in regards to triple
38:46 negative breast cancer I couldn't be
38:48 more excited to having these two paths
38:50 for naive versus second or higher line
38:53 therapy patients in regards to colon
38:56 cancer we're in great shape
38:58 and we should be finding the stage to
39:00 protocol in regards to our animal
39:02 studies Nash is extremely exciting the
39:06 situation we have for this disease with
39:09 the only map hopefully and if the
39:10 results are positive we would fire phase
39:12 2 immediately
39:13 we also have other animals phase that
39:16 will initiate in the doctor Linda's last
39:19 very soon and in regards to our
39:21 prognostic test that we talked before
39:23 we're going to be going forward with
39:24 that and with that I cannot thank all
39:26 the shareholders who have brought this
39:28 company there for the last five years to
39:30 the point that we are thank you for your
39:32 time have a great day ladies and
39:35 gentlemen this concludes tonight's all
39:36 the conference again we thank you for
39:37 your participation and you may
39:38 disconnect your lines at this time
https://78449.themediaframe.com/dataconf/prod...ndexl.html
00:00 greetings and welcome to the CytoDyn
00:01 investment community conference
00:03 call at this time all participants are
00:05 in a listen-only mode a
00:06 question-and-answer session will follow
00:08 the formal presentation as a reminder
00:11 you may submit your questions at any
00:12 time by using the ask a question box on
00:15 the webcast on the left side of your
00:16 screen if anyone should require operator
00:18 assistance during the conference please
00:20 press star 0 on your telephone keypad as
00:22 a reminder this conference is being
00:24 recorded it is now my pleasure to
00:26 introduce your host Michael Mulholland
00:28 chief financial officer thank you sir
00:30 you may begin hello everyone and thank
00:33 you for joining us today this is Michael
00:35 Mulholland chief financial officer of
00:38 sighted I'm joining us on today's call
00:42 is our president and CEO Dr. Nader Pourhassan
00:45 as well as dr. Jonas Sasha dr.
00:48 Bruce Patterson and dr. Jacob Lalezari
00:51 Ari before we begin it is essential that
00:55 we provide you with important cautionary
00:57 language related to certain federal
00:59 securities laws our remarks during
01:03 today's conference call will include
01:05 forward-looking statements
01:07 forward-looking statements are not
01:09 guarantees of future performance and
01:11 involve known and unknown risks
01:13 uncertainties and other factors that are
01:16 difficult to predict actual results may
01:20 be materially different from any future
01:22 results expressed or implied by such
01:25 forward-looking statements these risks
01:28 and uncertainties include among other
01:30 matters statements regarding LaRhonda
01:33 mobs potential efficacy in certain
01:36 immunology and oncology indications the
01:40 company's ongoing ability to raise
01:42 additional new capital that clinical
01:45 trials may not commence or proceed and
01:47 planned products that appear promising
01:50 in early trials may not subsequently
01:52 prove to be viable on safety or efficacy
01:56 Grim's products may not receive
01:59 regulatory approval or market acceptance
02:02 competition may reduce the commercial
02:05 potential of our products we may
02:07 experience product recalls manufacturing
02:09 issues or product liability and our
02:12 patents may be challenged or
02:14 unenforceable
02:16 although forward-looking statements
02:18 helped to provide complete information
02:20 about the company forward-looking
02:22 statements may be less reliable than
02:25 historical information the company
02:27 undertakes no obligation to update
02:29 publicly these forward-looking
02:31 statements except as required by law
02:34 please refer to our recent quarterly and
02:37 annual reports filed with the Securities
02:38 and Exchange Commission for more
02:41 information about the risks and
02:43 uncertainties that could cause actual
02:45 results to differ materially versus our
02:49 current expectations I will now turn the
02:52 call over to dr. Lorenson not thank you
02:56 Mike thank you everyone for
02:59 participating in today's shareholder
03:01 conference called in today's update
03:04 called we have invited three of our
03:06 advisors to speak to you so our
03:09 shareholders could hear directly from
03:11 them their professional opinion about
03:14 Leronlimab and its potential role in
03:16 future of HIV and cancer therapy our
03:20 first invitee is dr. Jonas Sasha
03:23 recently cited I had named dr. Jonas
03:27 OSHA as its senior science advisor to
03:29 explore leronlimab probe on 4e
03:32 potentials in HIV pre exposure
03:35 prophylaxis and cure
03:38 dr. Sascha is an expert in hiv/aids
03:41 research who served on the National
03:44 Institute of Health offices of AIDS
03:48 research Advisory Council and leads a
03:50 research laboratory in the vaccine and
03:53 gene therapy Institute and Oregon
03:55 National Primate Research Center at the
03:57 Oregon Health and Science University
03:59 OHSU the social laboratory aims to
04:03 identify novel therapeutic approaches
04:07 for us for use in prophylactic HIV
04:11 vaccines and HIV remission
04:13 including treatment to this effect dr.
04:17 sasha has been working with leronlimab
04:19 for about a year and his preclinical
04:22 studies produce some very exciting
04:26 results he's the person that lead that
04:29 led the collaboration between citation
04:31 and size Red Cross and those discussion
04:34 led to SATA dine and red tie Red Cross
04:37 signing a Memorandum of Understanding
04:40 for prevention study and we announced
04:42 that currently dr. sasha is a professor
04:45 at the vaccine and gene therapy
04:47 Institute dr. Salk would you please
04:50 explain to our shareholders the Cure and
04:53 prep potential that you see for our
04:56 shareholders dr. Sasha go ahead please
05:00 right thank you for that introduction
05:02 another so I'm excited to officially
05:05 join CytoDyn because I firmly believe
05:08 the future applications of Miranda
05:09 mapped HIV pre exposure prophylaxis or
05:12 prep and HIV cure is both well grounded
05:15 in the basic biology of HIV and it's
05:18 also clinically relevant with the direct
05:19 path into patients these two
05:22 characteristics I believe augur very
05:23 well for the future of leronlimab and
05:25 HIV prep and cure applications I'll
05:28 begin by discussing the application of
05:31 prep pre-exposure prophylaxis so in the
05:34 absence of a prophylactic HIV vaccine
05:36 HIV prep is the best weapon we have for
05:38 slowing the spread of the epidemic
05:40 so adherence the current regimens which
05:42 currently are daily oral antiretroviral
05:45 drugs and the uptake of those regimens
05:47 are the most critical barriers to ruling
05:49 out prep worldwide according to surveys
05:52 of high-risk individuals of men who have
05:54 sex with men approximately 25% of them
05:57 cite the inability to take oral
05:59 antiretroviral drugs daily as a reason
06:01 for their failure to adhere to the
06:02 regimens so the individuals that are at
06:05 high risk of HIV acquisitions are want
06:09 long-acting which we define as once a
06:12 week our greater prep agents and
06:14 currently their dose of leronlimab
06:16 which is once weekly subcutaneous
06:18 administration would fill a major gap in
06:20 prep we also believe that we can extend
06:22 this to further than once once weekly
06:25 the science really
06:27 we're on the map WordPress so mucosa
06:29 Lior look all sexually transmitted HIV
06:31 is always ccr5 tropic that means the HIV
06:35 that is transmitted from when it should
06:37 be infected individual to the other
06:38 always uses the ccr5 co-receptor it's
06:41 well established in the literature that
06:43 individuals are deficient for the ccr5
06:45 molecule the so called ccr5 Delta 32
06:48 mutation are resistant to sexual
06:51 transmission of HIV with no documented
06:53 cases so therefore we in the field of
06:55 HIV research refer to CCR thought as the
06:57 gatekeeper of sexual transmission of HIV
07:00 in my laboratory State we have shown
07:02 that leronlimab effectively converts cd4
07:04 t-cells these are the targets of HIV
07:06 into ccr5 decisions that is they appear
07:09 as if they have come from the individual
07:11 with the ccr5 Delta 32 mutation because
07:14 the basic science of ccr5 and sexual
07:16 transmission and our results to date
07:19 others in the sealed I began to
07:21 recognize the potential for leronlimab
07:22 in prep my lab has received an NIH
07:25 National Institutes of Health grant to
07:27 test the hypothesis of the leronlimab as
07:30 pre exposure prophylaxis in preclinical
07:31 studies in non-human primates and when
07:35 we approached the Thai Red Cross they
07:36 eagerly agreed to initiate a clinical
07:38 trial in Bangkok which has one of the
07:40 highest rates of sexual transmission in
07:42 the world so the seeds that we're sewing
07:44 now I believe will bear service in the
07:46 next year as results of our preclinical
07:48 non-human primate study has become
07:50 published and we commence with the
07:52 clinical work in Bangkok for HIV chor I
07:56 believe leronlimab is also well founded
07:59 in the science fear such a date there
08:01 have been two individuals HIV positive
08:03 individuals who have been functionally
08:04 cured of HIV the so-called Berlin and
08:06 London patients there's also a third
08:09 patient called the essent patient who
08:11 has not yet been published all three of
08:13 these individuals received stem cell
08:14 transplants from ccr5 Delta 32 donors
08:17 so these are donors to lack the ccr5
08:19 molecule
08:20 thus it is currently believed in the HIV
08:22 field that ccr5 deficiency holds the key
08:24 to HIV cure as I mentioned earlier
08:27 Leronlimab administration effectively
08:29 converts cells in a patient's into the
08:30 ccr5 Delta 32 phenotype my laboratory
08:34 has established the only preclinical
08:35 non-human primate model of stem cell
08:37 transplantation we are currently testing
08:39 around the map as an ability to cure
08:41 these animals in stem cell
08:43 transplantation and based upon a results
08:46 in the science funding agencies are
08:48 eager to support both our preclinical
08:50 work and begin initiating human clinical
08:52 trials so specifically as far which is
08:55 the American Foundation for AIDS
08:56 research actually funded the London
08:58 patient work have already verbally
09:00 expressed extremely high interest in
09:02 funding both of these studies both the
09:03 preclinical and the clinical I'm flying
09:05 to New York City on Friday to complete
09:07 these initial conversations the stem
09:09 cells transplant physician that multiple
09:11 Institute's including the University of
09:12 Medicine where the third currently
09:14 unpublished individual is cured wish to
09:16 lead these clinical studies with
09:17 leronlimab so initially the wrong
09:19 level we use in conjunction with stem
09:21 cell transplantation but the future of
09:23 this is the foundation for any therapy
09:25 aimed at HIV cure the biggest example of
09:28 this is Sangamo in their ccr5 editing
09:31 program I believe that ccr5 should lay
09:33 the foundation for all HIV cure
09:35 approaches and based on this I think the
09:37 future is extremely bright from around
09:39 leronlimab in both HIV prep and HIV - thank
09:43 you not her thank you so much dr. Sasha
09:46 just in that regard I want to say one
09:49 word that the prep there which is the
09:53 prevention of people getting HIV when
09:55 they are at high risk of HIV currently
09:58 so is telling there is a product out
10:00 there for prep which is true water is
10:03 currently we have data that says that
10:06 there was one hundred thirty six
10:09 thousand individual uses for $20,000 per
10:12 year that's the cost that's about 2.6
10:15 billion dollars so this is a very
10:17 important aspect of our product that
10:20 we're going to go forward and explore
10:22 our next invitee is dr. Jacob Lalezari
10:27 is doctored dollars are you on the call
10:29 yet yes hi Nana okay so I'm gonna just a
10:33 few words dr. Lalezari is our
10:37 principal investigator for our mono
10:39 therapy and he was involved in our
10:41 combination we started our monotherapy
10:44 five years ago with dr. Lalezari and he
10:47 wrote the very first patients he
10:49 immediately called me and said
10:50 you don't need to enroll anymore
10:53 and I had
10:53 said that to all the shareholders he
10:55 said that the mono therapy is
10:58 well-liked by the patients in that area
11:00 and he will enroll all 40 patients
11:02 himself and he did he's also known at
11:05 the key opinion leaders physicians for
11:09 the world of HIV dr. Lalezari was also
11:11 very excited about the potential use of
11:14 Leronlimab in the world of chance
11:16 and accepted to inject patient in triple
11:19 negative breast cancer study and
11:21 therefore we have allowed triple
11:23 negative breast cancer patients that are
11:25 not naughty patients to enter into tnbc
11:29 therapy with literally map with either
11:31 compassionate protocol or expanded
11:35 access so without any more I'm gonna
11:38 lift off the loaded area name Jay go
11:41 ahead please sure well I'll start with
11:44 the latter scenario because that's I
11:46 think very new and exciting like others
11:49 I've seen the work that Richard had done
11:52 showing that ccr5 was a integral part of
11:56 breast cancer invasion and metastasis
11:58 and we were excited about the triple
12:01 negative breast cancer study but found
12:03 it very difficult to find women who were
12:06 naive in the metastatic setting and so
12:09 we had a referral last week voluminous
12:12 on third line therapy with triple
12:15 negative breast cancer and we've called
12:17 the FDA and applied for an emergency
12:20 treatment IND and we're sending off her
12:23 tissue for confirm her or ccr5
12:26 positivity and then we'll start her on
12:28 treatment and which leads to a broader
12:31 conversation I think was I designed
12:32 about the original protocol being set up
12:35 to both demonstrate perusal concept and
12:39 create a pathway for approval whereas I
12:41 think it might be easier for us if we
12:43 focus on showing proof of concept and
12:47 once we demonstrate that leronlimab is
12:49 is is active in breast or perhaps
12:52 prostate or colon then leading the
12:57 approval protocols for a little bit
12:59 further down the road sorry the first
13:01 order of business is to get the drug
13:03 into patients who need it and show that
13:05 it works and I'm pleased to report
13:07 that the first such patient should be
13:09 starting soon in terms of HIV I guess
13:14 that's all those will neither say that
13:17 we could enroll the full study but it is
13:19 certainly true that in San Francisco we
13:21 it's been an easy sell
13:23 to offer patients once a week cept once
13:26 a week therapy I think that's what
13:27 everyone needs to sort of how to frame
13:30 this it's not sub-q it's it's once a
13:33 week and there are a lot of reasons why
13:34 people want to switch from daily oral
13:37 therapy to once a week therapy some of
13:40 its side effects some of its pill
13:42 fatigue some of its chaotic lifestyles
13:45 but it's not all patients but it is a
13:48 solid ten to fifteen percent of the
13:50 population and I think we'd probably
13:52 enrolled 150 patients now from a tour
13:55 over the years and it you know obviously
13:58 does not work in everybody there are
14:00 some questions as to why it's not
14:02 working in everybody because we're not
14:04 seeing resistance we're not seeing
14:06 co-receptor shifting we're not seeing an
14:09 t drug antibody some of the problems may
14:12 be occurring early because we're not
14:14 overlapping with the ARB long enough to
14:17 go through five half-lives
14:20 of the antibody some of it is that
14:23 patients get six the later on in
14:26 treatment and they have us what appears
14:29 to be an increase or up calculation of
14:31 ccr5 receptor expression that we'll get
14:34 to that with the next speaker but it's
14:37 now working in the great majority of
14:39 patients and I think the data I would
14:41 support over 90%
14:43 once you get past week 12 and I think
14:46 the what I could contribute to this
14:48 conversation is just the observation
14:50 that the patients who do well on leronlimab
14:54 mono therapy love it and
14:57 whatever reason drove them into the
15:00 study obviously they got what they
15:02 wanted and then when it works are quite
15:04 happy but it's been a life changer for
15:08 patients that we have some of them have
15:10 been on this mono therapy now for five
15:12 years or more we don't see any concern
15:17 around injection site reactions I don't
15:20 see any at
15:21 all really safety or toxicity which is
15:24 partly why I'm excited about the breast
15:26 cancer study because if it works there
15:28 it's going to contribute some benefit
15:31 without adding any additional toxicity
15:34 or other issues so the patients do well
15:37 along the mouth is mono therapy for HIV
15:39 love it
15:40 I'm glad to see that the FDA is working
15:44 with high design to try and figure out
15:45 how both to help them cross the finish
15:49 line for their approval in the salvage
15:52 of the treatment experience population
15:55 and obviously they've given a fast track
15:58 designation and they are engaging
16:01 cytodyn in conversation as to what a
16:02 phase 3 mono therapy study would
16:04 look like in the meantime I've been also
16:07 talking with a variety of other
16:10 potential partners for CytoDyn
16:12 because I think if we had a two drug
16:14 regimen that was a two drug once a week
16:17 regimen it would be a killer and it
16:20 would do very well and would be a huge
16:22 benefit to the HIV community and I think
16:25 other sponsors are waking up to that
16:27 idea I think there's a lot of interest
16:30 in monthly intramuscular
16:33 injections but the reality of what's
16:35 involved with patients having to go to
16:38 an office or a pharmacy and painful
16:41 monthly injection is setting in and
16:44 there are a variety of potential
16:46 compounds now that CytoDyn could
16:48 partner with I think there's a model of
16:51 therapy it's good I think there's a
16:53 combination when the second drug it
16:54 could be great um and I'll just stop
16:58 there yep thanks so much
17:00 any questions yeah we were going to go
17:03 okay we're on thank you so much I'm very
17:06 excited to hear a key opinion leader
17:08 telling or shareholder it's really big
17:10 it's huge it's a killer it's always been
17:13 me saying that so I'm appreciative of
17:16 you saying that the next invitee is dr.
17:19 Bruce Patterson dr. Bruce Patterson
17:21 medical doctor former medical director
17:24 of biology at Stanford University
17:26 Hospitals and Clinics
17:27 he's also the CEO and founder of in cell
17:31 BX
17:32 Inc and a top expert
17:34 in ccr5 he has revealed that through
17:37 certain laboratory tests looking at the
17:40 genetics and expression of CCR permanent
17:43 in individual patients sided I'm a more
17:47 closely match the most effective dose
17:50 for each HIV monitored application to
17:53 achieve viral suppression cytodyn also
17:56 signed an agreement to sell pro 140 non
17:59 commercial grade to insert the for
18:02 diagnostic use dr. Patterson will now
18:05 say a few words about this receptor
18:07 occupancy test that he developed for us
18:10 and our definitive agreements that we
18:13 just signed with his lab dr. Patterson
18:15 please go ahead thank you a lot nodded
18:19 in it and again it's my pleasure to be
18:22 talking about this very exciting
18:24 compound having worked with ccr5 since
18:28 the mid 1990s and I'm also excited to
18:33 hear from the other speakers and
18:35 embellish what they both said about the
18:39 clinical utility of leronlimab and
18:43 planned or pro 140 starting in the 1990s
18:48 when we first discovered ccr5 was a
18:51 co-receptor of HIV my laboratory
18:54 published the first work on the
18:56 distribution of ccr5 both on cells and
19:00 tissues and related to what dr. Sasha
19:03 said we were the first to find that ccr5
19:07 was the major co-receptor in the female
19:10 genital tract and responsible for the
19:14 majority of male to female transmission
19:17 coming through the ccr5 receptor the
19:21 same can also be true for mother to baby
19:24 transmission of HIV which it was also
19:28 ccr5 driven but most importantly our
19:33 work from the mid-1990s she really
19:36 showed what are the
19:38 factors have involved the expression of
19:40 ccr5 in the surface of cells because
19:43 that's where the drug is binding and
19:45 blocking the path of the virus into new
19:49 immune cells and we found some very
19:52 interesting things about ccr5 number one
19:55 as Nader mentioned what's the genetics
20:00 ccr5 comes in two different forms a
20:03 wild-type form and a mutated form the
20:06 patients with mutated forms expressed
20:08 less ccr5 and therefore would require
20:11 less drug for an equivalent response
20:17 against against HIV the other important
20:20 factor is that ccr5 is is a highly
20:23 regulated protein many patients have
20:27 different levels on their cells that
20:29 level on immune cells can be affected by
20:33 infections other inflammation other
20:37 illnesses so it's extremely important to
20:41 be able to know how much ccr5 is
20:44 expressed on the surface of the cells
20:47 that get infected by HIV on a patient by
20:50 patient basis and what's really exciting
20:53 is a much like cancer we're bringing
20:56 personalized medicine to infectious
20:58 disease testing and in particular HIV
21:01 therapy and so with this suite of assays
21:05 that we've developed both ccr5
21:07 genotyping we know the genetic type of
21:10 ccr5 at the patients have and they
21:13 receptor occupancy assay which is now up
21:16 and going strong we know exactly how
21:19 much receptor is being made in each
21:22 individual patients and we can tell you
21:25 by the data that we've looked at so far
21:27 that the patients who have spikes in HIV
21:32 viral loads are the ones that have a
21:35 reduction in receptor occupancy it's not
21:38 due to resistance like in other HIV
21:40 drugs but it's solely
21:42 a balance between whether or not you
21:45 have enough drug to block all the routes
21:47 by which HIV can get into cells and that
21:50 can be monitored the patients can be
21:53 boosted to ensure that all of their
21:56 receptors are blocked in addition we've
22:00 taken a lot of the immunology that we
22:02 were working on in regards to ccr5 in
22:06 the mid 90s and we too have looked at
22:09 cancer in the last five years in terms
22:12 of the markers that are being expressed
22:14 on the immune cells that are attacking
22:16 the cancer and we discovered a few years
22:20 ago that ccr5 is expressed on a on a
22:24 population of immune cells called T
22:28 regulatory cells that inhibit the immune
22:32 response against cancer so there's
22:35 actually a second mega mechanism in
22:37 addition to what dr. Pestell has described
22:40 that may also be a target for leronlimab
22:44 in cancer and that is it can
22:47 inhibit the influx in the movement of
22:51 these T regulatory cells which come in
22:54 to shut off the immune response against
22:57 the tumor in addition to the fact that
23:00 ccr5 is actually expressed on the tumor
23:03 itself as dr. Pestell has had published
23:07 so all told in in in my career of over
23:12 20 years of working with this molecule
23:15 we've seen very dramatic effects both in
23:18 terms of an HIV therapy and more
23:21 recently in terms of a potential cancer
23:24 therapy and now it's not just one Mehcad
23:28 cancer mechanism that it's inhibiting
23:30 but potentially a second cancer
23:33 mechanism as well so I can't tell you
23:36 how excited I am to be working with this
23:40 baby on and dr. Sasha's work we're also
23:43 capable of doing receptor occupancy
23:45 actually in tissues and that goes for
23:48 the cancer applications as well so we're
23:52 very
23:53 excited and we now have a suite of
23:57 Diagnostics to personalize treatment
24:00 with Longo map in a patient by patient
24:03 basis to ensure efficacy and to minimize
24:08 side effects so with that you know I'll
24:13 finish and and I'm always happy to
24:15 answer questions thank you Bruce I
24:17 appreciate it so I will only take few
24:19 more minutes since we have taken some
24:21 time for with our invited guests I
24:24 appreciate them very much the update
24:27 that I have for everybody would be very
24:29 quick number one is that dr. Pestell do
24:33 it CytoDyn now that we are he's not
24:36 no longer with sighted that what would
24:38 happen there's a lot of questions about
24:40 that has became my way and I want to
24:42 address that in regards to triple
24:44 negative breast cancer Dr Massimo Cristofanilli
24:47 is going forward just like
24:50 before and he's our principal
24:52 investigator for that trial he was very
24:54 impressed with the speed that cited and
24:56 had taken an IND through the process of
24:59 FDA he indicated he took many months and
25:02 for them to do such thing and we did it
25:05 in three and a half weeks and we have a
25:07 great relationship dr. Scott Kelly our
25:09 chairman of the board and myself have
25:11 been in touch with him and he's excited
25:13 to continue going forward as fast as he
25:15 can and I will talk a little bit of more
25:17 about that in regards to colon cancer
25:19 dr. John Marshall is the person who has
25:22 been our principal investigator for that
25:23 trial and that that trial is going
25:25 forward great in regards to all the
25:28 animal studies which starts with Nash
25:30 and many others cancer indications I
25:32 will update you in a minute and in
25:34 regards to prognostic test we will be
25:37 also continuing to have our first
25:39 meeting with the FDA in the August 28
25:41 and we will have experts to go with us
25:43 and discuss that with FDA so that's all
25:47 the duties that I want to make sure
25:49 everybody knows that we have have right
25:51 we have right people at the right place
25:53 in the second update is about our most
25:56 important task BLA biologic license
25:59 after
26:00 we just hear heard from FDA that we are
26:04 approved for waivers for blacc for small
26:08 businesses which is about a million
26:09 dollars this morning we also are waiting
26:13 for BLA submission to be the time not
26:17 to be nailed down after we hear from FDA
26:21 525 is accepted by them to go forward
26:24 and the CMC question that we have and we
26:27 believe both of those questions will be
26:29 addressed with a positive result as we
26:32 are negotiating and going back and for
26:33 the FDA right now and I think we could
26:35 have something for everybody very soon
26:37 but other than that if those two
26:39 questions or pause have a positive
26:41 answer we're talking end of September
26:43 sided eyes we'll have a final complete
26:47 BLA submitted this will allow us to
26:49 hopefully have approval first quarter of
26:52 next year and revenue on the second year
26:54 very important task for us in regard to
26:56 third update is about monitoring see
26:59 timeline as we said before the latest
27:02 data we just got is the 95 percent
27:05 responders rate with 525 milligram post
27:08 ten weeks and that's called maintenance
27:11 therapy portion as also we said before
27:15 110 patients reach about a year with
27:18 monitor of these six of those patients
27:20 have reached about three years and for
27:21 his for patients that have which five
27:23 years there are elements that was not
27:25 incorporated in our study which was a
27:27 half life which was the incorrect half
27:29 life based upon that the overlap for a
27:32 portion of our trial was different and
27:34 receptor occupancy chance that dr.
27:36 Patterson just talks about those are
27:38 going to make or design for pivotal
27:40 trials much better than what we have and
27:43 we excited to meet with FDA in September
27:45 and that's a day they have given us for
27:47 face to face for mono therapy the fourth
27:50 update is about triple negative breast
27:52 cancer I want to make sure I don't go
27:54 too fast on this I want to make sure
27:56 everybody understands everybody is
27:58 anticipating when is the first patient
28:00 in triple negative breast cancer doctor
28:03 Jay orders or is just indicated that he
28:05 has the patient that they want to inject
28:08 Compassionate Use Agreement or expanded
28:11 use argument why why not inject the
28:14 patient our current protocol that we
28:16 have because the current protocol
28:18 designed by doctors Massimo Cristofanilli
28:21 has been excellent and he has
28:25 indicated that he likes to enroll naive
28:28 patients what is naive patient well
28:30 these are patients who are triple
28:32 negative breast cancer and have no
28:34 option there have had no treatment zero
28:37 treatment so far so dr Cristofanilli
28:40 believes that if we are able to
28:43 enroll five patients at least and we see
28:46 that there they are not needing a second
28:49 line as quickly as most of the patients
28:51 need which is about four to five months
28:53 that means leronlimab has a great
28:56 effect and we will go to FDA he will
28:59 lead a discussion with FDA in in regards
29:02 to having approval so this is a very big
29:06 deal for us to keep it going the same
29:08 way as it is but then we have triple
29:10 negative breast cancer patients who are
29:11 not on you know naive population there
29:14 in first I mean a second or third or
29:16 fourth line we are injecting those
29:19 patients also and we're asking for
29:21 compassionate user agreements from the
29:23 FDA and we are also having a protocol
29:26 for multiple expanded access in triple
29:28 negative breast cancer we believe the
29:30 first patient could be injected very
29:32 soon on that protocol in regards to
29:34 naive population dr. Cristofanilli has
29:37 indicated that he is very hopeful to
29:40 have that first patient injected and
29:41 hopefully have five patients like that
29:43 very soon so we can go to the FDA so the
29:47 next update is graft-versus-host disease
29:48 we are excited to inject the first
29:51 patient in the new modified protocol in
29:53 September dr. Porter is our main
29:55 principal investigator we have discussed
29:57 that with him and he is excited to get
29:59 that moving forward in regards to colon
30:02 cancer we have received new data with
30:06 our animal study from dr. Daniel Linder
30:09 very exciting new positive data that we
30:13 are using and we are going to talk about
30:16 that in the press treat and what that
30:18 means for
30:18 and we're also going to fight face to
30:21 colon cancer protocol most likely by
30:24 this Friday to the FDA in regard so all
30:27 the animal study that we talked in the
30:29 past which was Nash melanoma pancreatic
30:32 breast prostate colon lung liver and
30:34 stomach cancer nash is the most
30:37 important one of those and we have we
30:40 believe that any company with face to
30:42 nash if you look at them they have a
30:43 market cap of one or one and a half
30:45 billion dollars so it's very crucial for
30:47 us to get a face to green-light from FDA
30:50 in NASH those results should be
30:52 available to us within six to eight
30:54 weeks result that trial is being
30:56 conducted the animal study is being
30:59 conducted at of the Daniel Linda's
31:01 laboratory Cleveland Clinic in regards
31:05 to breast cancer we have
31:07 completed those results and discussed
31:10 them already and we are in triple
31:11 negative breast cancer currently with
31:13 Phase two in regards to colon cancer
31:15 that completed and we are filing Phase
31:18 two and regards to other cancers we are
31:20 talking to Daniel dr. Daniel Linder to
31:22 give us timeline and he has indicated he
31:25 could conduct all of those animals in
31:27 the eighth update would be about
31:29 commercial plan a detailed and
31:32 well-planned commercialization strategy
31:34 will be posted to our website most
31:37 likely either next week or a week after
31:39 we have two different group working on
31:42 our TPP target product profile for combo
31:45 and mono seniors health is one of them
31:48 and they have over 50 form of pseudocode
31:50 that have launched their product through
31:52 them so we believe we are in good hands
31:54 and we're going forward in regards to
31:57 number 9 of updates license agreement we
32:01 have told everybody that we had a
32:02 non-binding term sheet for licensing out
32:07 the cells up for 145 but we were too far
32:10 away from each other and what we have
32:12 done is we negotiated and we went back
32:14 and for our business development dr. Rey
32:17 has done that and
32:19 we believe we're very close to
32:21 agreements this agreement for the first
32:23 quarter of billion dollar what the sales
32:25 of the only map could be perhaps funded
32:29 by another Capital Group and we could
32:32 get significant funding upfront these
32:34 are all if statement that I'm putting
32:36 here because all these kind of
32:38 negotiations takes time and there are
32:40 lots of things that we have to consider
32:42 to make sure that we don't short
32:44 ourselves we are at crucial position
32:46 with this company too many people work
32:50 too much too hard and too many
32:51 shareholder have this everything they
32:53 have for us to go forward with their
32:54 funding us and we got to be very careful
32:57 with that number 10 is strengthening the
33:00 management and the board by bringing
33:03 strong well known individuals to join
33:06 our board and perhaps take senior
33:09 management positions so we hope that our
33:12 remarks today allow the shareholders to
33:14 see and understand the business through
33:17 the eyes of studied and management as
33:19 always we will we will be very honest
33:21 very transparent and clear about our
33:25 goal and potential with that let's go
33:28 ahead go to question and answer thank
33:31 you ladies and gentlemen at this time we
33:33 will be conducting any
33:34 question-and-answer session as a
33:35 reminder you may submit a question via
33:37 the webcast at any time by typing it
33:39 into the ask a question field at the
33:41 left side of your screen if you would
33:43 like to verbally ask your question
33:45 please press star 1 on your telephone
33:46 keypad
33:47 the confirmation will indicate that your
33:49 line is in the question queue you may
33:52 press star 2 if you would like to remove
33:53 your question from the queue for
33:55 participants using speaker equipment it
33:57 may be necessary to pick up your handset
33:59 before pressing the star keys please
34:01 hold while we pull for questions
34:11 our first question comes from the line
34:12 of David Callahan a private investor
34:14 please proceed with your question I not
34:19 her hey Dave how are you
34:22 sterling well this is the second Richard
34:25 that's gone
34:26 is this gonna create a vacuum in any way
34:30 No thank you for asking but I can't
34:33 elaborate on the individual person
34:34 working with us or not but I can't tell
34:36 you when the first time we had separated
34:39 dr. Richard trogir five six years ago I
34:41 was having a lot of fire on me because
34:44 everybody says you let go the first
34:46 scientists you have and we also gave
34:48 back six million dollars of NIH money
34:50 back to NIH at that time I told you and
34:53 many people please trust me as I am
34:56 bringing a group of top people to
34:58 conduct and conduct clinical trials and
35:02 take this product forward and I will not
35:05 drop the ball and I think five years
35:07 taking it they pay their pay so I was 20
35:10 years and going five years speaks for
35:13 itself in regards to dr. Richardson
35:15 still I have nothing but good thing to
35:16 say about him but we cannot talk about
35:18 our situation but thanks for the
35:21 question next please thank you once
35:26 again to ask a question please press
35:28 star 1 on your telephone keypad at this
35:30 time our next question comes from the
35:34 line of Jeff Roni with Boston life
35:36 please proceed with your question thank
35:42 you you know we're all of course a
35:45 little disappointed with the triple
35:49 negative breast cancer you know in terms
35:52 of first injection and just to confirm
35:55 Northwestern still going to lead the
35:57 naive trial absolutely and when when was
36:04 that document signed with Northwestern
36:06 to tie that in is that Bennett Bennett
36:09 been in place for several quarters or is
36:11 it just a recent development when the
36:15 company met many months ago we engaged
36:18 in ok so the I assume there's a you know
36:22 contract that need to be signed so that
36:23 was signed on for
36:24 okay great that's great thank you all
36:30 right thank you so I have to say that
36:33 it's been 40 minutes for this call and
36:35 we perhaps have to take our last
36:37 question why do we have question time
36:39 for the last word we have one more one
36:42 more okay this is the last question
36:43 please go ahead thank you our final
36:46 question comes from Randy Hardy a
36:47 private investor pleased to see with
36:49 your question this is Randy and a couple
36:52 of questions real quick seems like
36:54 there's a lot of balls in the air and
36:56 focusing on getting one thing or the
36:59 other completed is there a strategic
37:02 plan anywhere that has the timelines and
37:04 the milestones that could be shared
37:06 maybe in the website for cited dying
37:10 investor section that the investors
37:13 could log into yeah absolutely we will
37:17 have all those timelines that we have in
37:19 the website I think Mike do you want to
37:21 add something yeah I would also direct
37:23 your attention to the number of updates
37:26 that we provide for our clinical
37:29 milestones as we advance the company
37:32 forward
37:33 I'm a no project manager and I like the
37:36 strategic planning aspect of it with you
37:39 know solid dates and then if we miss a
37:41 date and there you know there's a reason
37:42 that a date was missed so we have sort
37:45 of would be great absolutely yes thank
37:49 you and yes thank you so this concludes
37:52 our call operator we're gonna stop the
37:57 Q&A; and I'm just gonna give the final
38:00 remarks I just want everybody to please
38:04 take a look at what we have we have
38:07 biologic license application that is
38:10 hopefully completed by the end of
38:12 September once we hear back from FDA
38:15 that should be finalized we have
38:17 monotherapy that FDA as you heard dr.
38:19 Jay Lalezari said that we are they're
38:21 working with us dr. Jay Lalezari by the
38:24 way had gone to everyone almost every
38:26 one of those FDA meeting in person so
38:29 he's very much aware of the FDA's
38:31 position with us so monotherapy
38:34 September 28 we will meet with FDA
38:37 and the hopefully finalized or pivotal
38:39 trial for first humanized monoclonal
38:42 antibody wants a week's up to you for
38:44 the world of HIV in regards to triple
38:46 negative breast cancer I couldn't be
38:48 more excited to having these two paths
38:50 for naive versus second or higher line
38:53 therapy patients in regards to colon
38:56 cancer we're in great shape
38:58 and we should be finding the stage to
39:00 protocol in regards to our animal
39:02 studies Nash is extremely exciting the
39:06 situation we have for this disease with
39:09 the only map hopefully and if the
39:10 results are positive we would fire phase
39:12 2 immediately
39:13 we also have other animals phase that
39:16 will initiate in the doctor Linda's last
39:19 very soon and in regards to our
39:21 prognostic test that we talked before
39:23 we're going to be going forward with
39:24 that and with that I cannot thank all
39:26 the shareholders who have brought this
39:28 company there for the last five years to
39:30 the point that we are thank you for your
39:32 time have a great day ladies and
39:35 gentlemen this concludes tonight's all
39:36 the conference again we thank you for
39:37 your participation and you may
39:38 disconnect your lines at this time
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