CytoDyn Conference Call September 30th Transcript
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Posted On: 10/01/2019 4:44:56 PM
CytoDyn Conference Call September 30th Transcript (autogenerated)
00:03 greetings welcome to CytoDyn
00:05 investment community call at this time
00:07 all participants are in a listen-only
00:09 mode a question-and-answer session will
00:11 follow the formal presentation if
00:12 anyone's require operator assistance
00:14 during the conference please press star
00:16 0 on your telephone keypad please note
00:18 this conference is being recorded I
00:20 would now like to turn the conference
00:21 over to your host Michael Holland thank
00:24 you you may begin hello everyone and
00:27 thank you for joining us today this is
00:29 Michael Mulholland chief financial
00:31 officer of cider diamond joining us on
00:34 today's call is our president and CEO
00:36 dr. Nader
00:37 Pourhassan as well as dr. Bruce
00:40 Patterson before we begin it is
00:44 essential that we provide you with
00:46 important cautionary language related to
00:48 certain federal securities laws our
00:51 remarks during today's conference call
00:54 will include forward-looking statements
00:56 forward-looking statements are not
00:58 guarantees of future performance and
00:59 involved known and unknown risks
01:02 uncertainties and other factors that are
01:05 difficult to predict actual results may
01:09 be materially different from any future
01:12 results expressed or implied by such
01:15 forward-looking statements these risks
01:18 and uncertainties include among other
01:22 matters statements regarding leronlimab
01:25 abs potential efficacy in certain
01:27 immunology and oncology indications the
01:31 company's ongoing ability to raise
01:33 additional new capital that clinical
01:36 trials may not commence or proceed as
01:38 planned
01:39 products that appear promising in early
01:42 trials may not subsequently prove to be
01:45 viable on safety or efficacy grounds
01:48 products may not receive regulatory
01:51 approval or market acceptance
01:53 competition may reduce the commercial
01:56 potential of our products we may
01:58 experience product recalls manufacturing
02:01 issues or product liability and our
02:04 patents may be challenged or
02:06 unenforceable while the forward-looking
02:10 statements helped to provide complete
02:11 information about the company
02:13 for looking statements maybe less
02:15 reliable than historical information the
02:18 company undertakes no obligation to
02:20 update publicly these forward-looking
02:22 statements except as required by law
02:25 please refer to our recent quarterly and
02:28 annual reports filed with the Securities
02:30 and Exchange Commission for more
02:32 information about the risks and
02:34 uncertainties that could cause actual
02:37 results to differ materially versus
02:41 outcome our current expectations I will
02:44 now turn the call over to dr. Nader
02:47 Pourhassat thank you Mike I appreciate
02:51 everyone taking time to participate in
02:54 today's call before any update I would
02:57 like to say a few words about cytodyn
02:59 share price so in regards to our share
03:03 price I can tell you that I believe that
03:06 fundamentals and science have never been
03:09 stronger but I am sure you have heard
03:12 that before we have a molecule that we
03:17 know it hits the target in humans with
03:20 no serious adverse events related to the
03:23 earldom up in greater than 830 HIV
03:27 patients in nine clinical trial as our
03:31 story unfolds we continue to discover
03:34 new potential opportunities for the only
03:37 map if we are right about any of these
03:40 indications for example cancer we will
03:44 make history if you are right about Nash
03:47 we will make history and the list goes
03:50 on and on and this list is getting
03:53 larger yet I believe the stock price is
03:56 still not showing anything close to our
03:59 true value but as a reminder we started
04:04 with combination therapy for HIV with
04:06 fast track designation from the FDA
04:08 since then we have developed significant
04:11 advancements in the following HIV mono
04:14 therapy GVHD with orphan drug
04:17 designation metastatic triple negative
04:20 breast cancer with fast track
04:21 designation colon cancer with green
04:24 light too
04:24 phase two we have also recently filed
04:27 for Phase two Nash trial with FDA we
04:30 have uncovered new potential
04:32 opportunities in prep which is
04:34 prevention and prophylaxis and cure in
04:38 HIV under the leadership of dr. Jonas
04:41 OSHA according to doctors Sasha
04:44 Cytodyn in regards to HIV alone had
04:48 planted many seeds and there will be a
04:51 coming harvest these are Ward's of a
04:54 professor at OHS the Oregon Health
04:56 Science University and many other top
04:58 brilliant minds are saying the same kind
05:01 of thing I will be discussing more
05:04 regarding the work of dr. Jonas Sasha
05:06 momentarily in addition we are exploring
05:11 new potential pathways in the treatment
05:13 of cancer including prevention of tumor
05:16 metastasis tumor angiogenesis synergy
05:21 with current oncology treatment and
05:23 positioning leronlimab as a true
05:26 immuno oncology molecule in regards to
05:29 tumor and angiogenesis we have a
05:33 stunning results from death dr. Daniel
05:35 Linder from Cleveland Clinic and dr.
05:37 Bruce Patterson ex Stanford professor
05:40 will speak about that to you today we
05:45 will also be pursuing opportunity based
05:47 upon our safety data in humans and the
05:49 mechanism of action of leronlimab in
05:52 melanoma pancreatic prostate lung liver
05:55 and stomach cancer the bottom line is
05:58 this if just one of these opportunities
06:01 proves to be true and we believe many
06:04 well we believe the share price will
06:07 react accordingly and appropriately many
06:11 powerful stories came too close to
06:13 failure and the only thing that investor
06:16 had to do was to recognize that amazing
06:20 triumphs success and glory or just
06:23 inches away we believe cytodyn fits
06:26 this model today I'm not here to give
06:29 anyone the speech I'm here to state
06:33 facts and facts only in my humble
06:36 opinion cited on is
06:38 in the brink of failure in any way shape
06:40 or form however the stock price might
06:42 mislead many investors who have very
06:45 little knowledge of this space everyone
06:48 who knows the space knows that if any
06:51 biotech company without revenue received
06:54 FDA approval for their product they will
06:57 see appreciation that they deserve so
07:00 allow me now to give you comprehensive
07:04 update by stating facts and a stay
07:07 crystal clear and transparent to you the
07:10 shareholders as I have always tried to
07:13 do so in regards to combination therapy
07:16 or be a late submission timeline the FDA
07:19 had requested that we give 50 patients
07:22 from our mono therapy that had past 24
07:25 weeks of mono therapy with 700
07:28 milligrams and 524 525 milligram this
07:33 delayed our timeline from September on
07:36 by October 31st we will have 51 patient
07:40 with 700 milligram and our timelines for
07:43 BLA for clinical section becomes
07:46 November to December timeline important
07:49 note is please note if we did not have
07:52 success with higher dose 525 and 700
07:56 milligrams in our mono therapy we would
07:58 have submitted or BLA to the FDA before
08:01 September now the next section the last
08:05 section is CMC again because of our
08:08 success the FDA needs to have a
08:10 disability from vials with 2.4
08:13 milliliter instead of 1.4 million liter
08:16 with 1.4 milliliter
08:18 we have a year worth of stability and
08:20 again note if we did not have success
08:24 with higher dose 525 700 milligram we
08:27 would have been submitting the BLA by
08:29 September or before regards to our mono
08:33 therapy pivot our protocol will be
08:36 submitted to the FDA again because of
08:40 our success with these higher doses the
08:43 FDA has asked for our pivotal trials to
08:46 be modified by the FDA so in regards to
08:50 mono therapy
08:51 the statement changes because of our
08:53 substance with this higher 522 five and
08:56 seven hundred milligrams we are allowed
08:58 to give pivotal mono therapy if we
09:00 didn't have that success we would have
09:03 had no mono therapy monitor they would
09:05 have been dead
09:06 so because we investigated the higher
09:09 dose we found a way to make it work and
09:12 hopefully change the HIV paradigm so we
09:16 get to have a little bit delay in our
09:19 ble which I believe is not that much
09:22 price to pay for such structures but
09:26 we're not done with HIV I mean I got a
09:28 lot to go through with known HIV
09:30 indication but I'm not done with HIV HIV
09:33 in regard to prep which is very hot
09:36 topic in the world of HIV prevention and
09:40 cure so there Jonas Sasha wanted to come
09:44 to the this call and address the
09:46 shareholder however he couldn't do to
09:48 his travel schedule but he brought me an
09:51 email to read to everybody on the call
09:55 he said I would like to update you on
09:58 some of the new development that I am
10:01 working on this is that his after he
10:03 said in regard to HIV cure program he
10:06 has had discussions with both and for
10:09 American Foundation for AIDS research
10:11 and with the Bill and Melinda Gates
10:14 Foundation and funding research into the
10:18 world him up to for HIV cure dr. Sasha
10:22 indicated that these discussions have
10:24 been very productive and continue to
10:27 move forward in regards to prevention
10:30 potential for little on Reba recently he
10:33 also had very preliminary conversation
10:36 with MH RP the United State of America
10:39 military HIV research program but the
10:43 social in foremost that this is
10:44 preliminary but we will keep you posted
10:46 at this story unfold but the social is
10:50 also working on enhancing the half-life
10:52 of Leon Deema
10:54 he is in the process of making this
10:56 compound
10:56 and plans to complete the initial PK
10:59 pharmacokinetic studies by early next
11:02 year he anticipates a four-fold increase
11:06 in the half-life and if successful would
11:09 translate into a once monthly injection
11:12 of lire on the map versus the current
11:14 once weekly approach this would lower
11:18 production costs but more importantly
11:21 with encourage compliance and
11:23 potentially improve efficacy and current
11:26 and convenience for patients the only
11:29 map is a self injectable subcutaneous
11:31 injection not an intramuscular injection
11:34 and in our opinion there is a world
11:36 world of difference between the two and
12:12 see when all of our shareholders hear
12:14 about all dr. Kelley has done for them
12:17 to ensure many solid developments four
12:19 sided nine they will be very pleased so
12:24 in regards to HIV we also have something
12:26 else to tell everyone the Croi is
12:29 conference of retroviruses and
12:31 opportunistic the infection is the most
12:33 powerful conference for HIV we
12:37 participated in that in the past but
12:39 this time for CROI we did not submit
12:43 abstract directly but other people are
12:45 now noticing the potential of literally
12:48 map and they have the first abstract was
12:51 for prep prevention that was submitted
12:55 dr. Jonas saw some very strong result
12:57 and the abstract has been submitted to
13:00 CROI as of the deadline of September 26
13:03 November 15 the results of access
13:05 we'll be announced we expect major media
13:08 to cover this presentation as prepped in
13:11 HIV space is a very important and hot
13:14 topic the second abstract is from dr.
13:17 Stefano Ross Connie from university of
13:20 milan italy very exciting results we
13:24 have given permission to them to publish
13:26 the results of our molecule in akroy as
13:30 we agreed the results are stunning we
13:33 can't talk about this result but I can
13:35 tell you we are so impressed by them
13:38 that we are including them in our BLA
13:41 submission to the FDA and in regards to
13:44 Thai Red Cross previously we announced
13:48 that we signed Memorandum of
13:49 Understanding for prevention study of 50
13:52 patients perhaps and that is going
13:54 forward and we will be announcing any
13:58 major development as soon as we get it
14:01 so this concludes the HIV portion but
14:05 before I go to the knowledge IV the
14:09 manufacturing of this product was taught
14:11 to us that we had to raise 50 million
14:13 dollars just we had to do that at least
14:16 early as a year ago that means we have
14:19 to dilute the company and raise 15
14:21 million to support manufacturing or we
14:23 would have have product to sell and we
14:25 can approve samsung has agreed and we
14:28 will have product clinical grade by mid
14:32 of next year and we will have it
14:35 commercialized grade by very beginning
14:38 of 2021
14:39 this is substantial and we have talked
14:41 about that before but the last thing
14:43 about HIV that we said in our annual
14:45 shareholder meeting with potential
14:47 licensing to launch leronlimab
14:50 licensing out the cells of the only map
14:52 for us exclusively at our natural
14:56 holders meaning i discussed the
14:57 potential for commercialization part
14:59 partners and discussions regarding
15:02 strategy strategic partners i can say
15:05 now that we are far enough along in
15:09 these discussions that i can no longer
15:11 comment today i will not give an inch of
15:15 free ride to anyone in regards to
15:17 potential
15:18 partnership due to cited as current
15:20 share price we believe we are very close
15:23 to major success and our shareholders
15:25 deserve full value and in my humble
15:28 opinion we are set to potentially
15:31 realize these values that is all we have
15:34 to say about this at this time the next
15:37 thing I would like to update you is
15:38 graft-versus-host is described as of
15:41 today dr. Daniel Porter Porter or
15:44 principal investigator for
15:45 graft-versus-host disease has told me
15:48 that all tasks are completed and they
15:52 are ready to inject the first patient
15:54 any time and we hope to have that in
15:56 October in regard to metastasis triple
15:59 negative breast cancer long waiting
16:01 journey for us to get the first patient
16:04 and you got the presentation on Friday
16:06 thanks to dr. J Lalezari and in regard
16:10 to is this gonna work or not are we
16:13 gonna get the first human data that
16:15 shows the only map potential I'm going
16:18 to turn the call to dr. Bruce Patterson
16:21 who knows Lee only map very well and his
16:24 expert of CC alpha
16:25 Bruce please yes thank you another it's
16:30 it's it's a very exciting time for cydy
16:33 both on the HIV front and on the cancer
16:37 front it's interesting that all the
16:39 disease states that you mention in terms
16:42 of efficacy of leronlimab are ones
16:45 that have a very strong immune component
16:48 to them ccr5 expressing cells really
16:54 control the the immune response and the
16:57 fact is by blocking ccr5 you promote the
17:02 anti-tumor activity of a cell type
17:04 called macrophages which are like
17:06 pac-man and scavenge tumor cells in
17:10 addition ccr5 inhibits the migration of
17:14 T regulatory cells that turn off the
17:17 immune system that's brought back by
17:20 some of the other common immuno oncology
17:23 drugs what we've seen in the screening
17:26 samples from the T MVC trial is patients
17:30 with large number
17:32 of immune cells expressing ccr5
17:34 around these tumors that can be
17:37 inhibited by leronlimab and promote
17:40 the anti-tumor activity within the tumor
17:44 and also for metastasis so that's the
17:47 stage we're at right now and like I said
17:50 we haven't found a tumor yet that
17:52 doesn't have this very strong ccr5
17:56 positive immune infiltrates that can be
17:59 targeted using ccr5 so is truly truly an
18:05 immuno oncology drugs thank you so much
18:10 Bruce I appreciate it
18:12 so continuing with that with our update
18:14 the next item is metastasis colon rectal
18:18 cancer where FDA gave us green light to
18:21 to have our face to initiate it dr.
18:25 daniel linda from cleveland clinic had
18:28 studied this product for us and his
18:31 results led to phase two I want to read
18:33 a paragraph of what he wrote for him for
18:36 us to share with a share of the
18:39 shareholders to determine if literally
18:43 map could affect the host slash tumor
18:46 interface we perform a dermal
18:49 angiogenesis assay in order for a tumor
18:53 to grow larger than two millimeter
18:55 diameter new host blood vessels must be
18:58 induced SW 480 tumor cells were
19:03 inoculated in the dermis of humanized
19:07 NSG mice the only map tree that might
19:10 had over 2 fold reduction in neo vessel
19:14 for male information compared to IgG
19:17 treated might evidence by decrease in
19:20 total pixel count vessel intensity and
19:23 overall number of vessels most dramatic
19:27 was reduction of a smaller vessel as
19:30 compared to larger vessels the mechanism
19:34 of angiogenesis inhibition by the Ronda
19:36 map suggests that suggests that this
19:39 agent may inhibit the growth of several
19:41 solid tumors that
19:43 dependent upon this process especially
19:46 during the establishment of metastasis
19:49 lis lesions this is a sadness from dr.
19:54 Daniel Linda after he's the very largest
19:56 animal study the next item to update
19:59 everyone is Nash animal study with dr.
20:02 Daniel Linda the results of that large
20:05 animal study will come out hopefully in
20:07 mid or end of October and the last thing
20:11 that I will update you on is Nash phase
20:15 two trials that we have sent the
20:17 protocol to FDA I have been told by many
20:21 experts of Nash that a company with a
20:25 face to green-light
20:26 with Nash should have a market cap of
20:30 significantly higher than ours market
20:33 cap as of today I would like to announce
20:36 that FDA has given us green light to
20:39 initiate our face to Nash study and we
20:43 will be talking about that in our in the
20:44 press this coming up in a day or two
20:47 so with that let's let us go to a
20:49 question and answer please thank you at
20:53 this time we conducted a
20:54 question-and-answer session if you would
20:56 like to ask a question please press star
20:58 1 on your telephone keypad
20:59 a confirmation someone indicate your
21:01 lines in the question queue you may
21:03 press star 2 if you would like to remove
21:04 your question from the queue for
21:06 participants using speaker equipment it
21:08 may be necessary to pick up your handset
21:09 before pressing the star key one moment
21:12 please while we pull for questions our
21:17 first question
21:18 comes online of Mustafa listing which
21:20 farmers capital please see what the
21:22 question hi dr. nadir how are you very
21:26 good thanks
21:28 my question is that if the science is as
21:32 strong as the company is claiming and
21:34 has been claiming for each investigative
21:36 strategy and cited ein has also been
21:40 given fast-track FB approval in several
21:43 areas then in your opinion why is the
21:46 stock continuously moving in the
21:48 opposite direction and where is the
21:51 disconnect between the medicine and what
21:54 Wall Street is interpreting yeah thank
21:58 you for your question so in an OTC B
22:01 space everyone knows in order for us to
22:05 have people buy our share we have to
22:07 have retail investors individual
22:10 investors purchase our product purchased
22:13 I'm sorry ours are shared and to bring
22:16 people to the table to buy that you have
22:18 to do Roadshow of the roadshow you don't
22:20 have institutions we have taken a
22:24 product bought at for three and a half
22:26 million dollars and raised 210 million
22:29 dollars after we bought it because of
22:31 the success that we have shown this
22:32 product has and could have all these
22:34 opportunities are getting to the point
22:36 where revenue is very close to us
22:38 perhaps second third quarter of next
22:41 year and if it is then when you raise
22:43 when you have revenue coming in your
22:46 stock has no choice but to show the
22:48 value in regards to why Wall Street
22:50 doesn't look at it this we are not the
22:52 only one that this happened there are
22:53 many companies in the past biotech
22:55 that's why they have inflection points
22:57 people don't stay with the solid
22:59 fundamentals they get very nervous about
23:01 the stock going up ten percent or lower
23:03 10% we saw two hundred million dollars
23:06 that's adaptable equivalence of maybe
23:08 three hundred million shares or so when
23:10 these shares on Excel and there you are
23:12 tired of waiting
23:13 we don't have sellers sometimes and that
23:15 but that's what happens but we made sure
23:17 we stay focused on the science and
23:18 fundamental next question please
23:24 our next
23:25 constant line of Mike Walker with M
23:28 contract please see what your question
23:31 yeah good morning Nadar
23:33 good afternoon honor I had a question on
23:36 the combination therapy our last meeting
23:39 said we were going to have our file for
23:41 the BLA for the combination therapy and
23:43 was going to be completed by September
23:45 and this time we didn't even mention
23:47 that you talked about the mono therapy
23:48 so what changed
23:51 thank you Mike for the question I did
23:54 have this the monitor combination VLAN
23:57 ID three times said because of our
23:59 success we were severe now have been
24:02 told by FDA to get data from 700
24:05 milligram from mono therapy for
24:08 combination therapy which we are very
24:10 very lucky and very very grateful and
24:12 thankful to FDA for allowing us to use
24:15 another trial to give data for the BLA
24:19 so BLA submission as I said would have
24:21 been done and in September if we did not
24:24 have the success with the higher dose if
24:26 we didn't have the success with higher
24:28 dose we wouldn't have mono therapy and
24:30 the potential of changing HIV paradigm
24:32 wouldn't be there so thank you next
24:34 question please
24:36 our next question comes online of Ralph
24:38 warden a private investor please shoot
24:40 your question yes my question is about
24:44 the competition with car T which over
24:50 time although it looks very good at the
24:52 start the relapse rate is about 40% if
24:57 do you know what the half-life is of the
25:01 drug of this formula and what the
25:05 likelihood is of resistance to it over
25:07 time let's say compared to party
25:11 great question or appreciated so the
25:14 half-life of leave only map is 10 days
25:16 and the half-life we would like to make
25:20 it longer but in order to do that it
25:23 would take us a year and a half to have
25:24 GMP product ready
25:27 if the hapless can be extended and then
25:30 is also successful but the half-life is
25:33 10 days in regards to resistance every
25:35 HIV product that is
25:37 administered by itself usually have
25:41 resisted within six months or product
25:43 whenever yeah so there is no resistance
25:47 with our product we haven't seen any
25:49 resistance for five years now with some
25:53 of the patients well that's a good go
25:58 ahead I'm sorry I just wondering you
26:02 know about the car key work I'm sure
26:05 where they take out the white cells and
26:08 educate them to eat the tumor cells and
26:10 put them back you you you are familiar
26:12 with it what they call CA r - t therapy
26:16 RT Carson not a listen I can put up in
26:21 my yeah yeah since I've worked with both
26:26 basically infusing effector cells
26:29 against the tumor what is very
26:32 interesting about leronlimab and it can
26:34 be complementary to car see is that it
26:37 inhibits the cells that inhibit the
26:39 infector cells
26:40 okay so cd8 t-cells are targeting the
26:45 tumor and they're brought back to life
26:47 by PDL one and pd1 antagonists and
26:52 agonist right so RT strategy is to
26:56 infuse cells that target the tumor now
26:59 they would also be susceptible to T
27:02 regulatory cells coming in and
27:05 inhibiting from doing their job and not
27:07 squares leronlimab functions in
27:11 preventing the T regulatory cells from
27:14 from migrating into the tumor and
27:17 shutting off the immune response that's
27:19 already been brought back by these
27:20 blockbuster drugs or blockbuster
27:23 approaches as you suggest so it goes
27:26 very very complementary well that's a
27:29 guy he was asking so you could take car
27:31 key failures they have about employers
27:34 and failure Lee yeah well we also get
27:37 brilliant results yeah yeah way back in
27:40 the day that you know there also
27:41 recognizes for in cell sometimes and so
27:45 the immune system targets the actual
27:48 cells that are doing good so you know
27:50 there's
27:51 this is the intricacy of the immune
27:54 system is fascinating and and ccr5
27:57 pathway is the quarterback of that
28:00 immune system by making cells moves to
28:03 areas where they're needed and and and
28:05 to even promote metastasis at times in
28:09 tumor cells so that is why there's such
28:13 a diverse array of applications for
28:16 leronlimab and it's not because in you
28:19 know we're looking for all these
28:20 different things it's because everything
28:23 involves this same pathway so it's not
28:26 cited I've done an amazing job of
28:28 focusing on the indications that are
28:31 closest to approval despite the fact
28:34 that the pipeline of applications is
28:37 extensive it's so exciting about this
28:40 drug yep okay thank you thank you for
28:44 your question crazy I said appreciate it
28:46 next please our next question comes from
28:49 one of Peter Gibbons professor please
28:51 shoot your question oh thanks for taking
28:56 my call today I only have one question
28:58 on the September 12th shareholder
29:01 meeting you referenced that you had
29:03 secured funding through the end of the
29:05 year from people who would be funding us
29:06 could you speak on that further please
29:08 form so unfortunately because of legal
29:12 advice I'm not allowed to talk about
29:15 that but we will address that for sure
29:17 you know at the appropriate time and you
29:19 will and you will be able to understand
29:22 why I said that but thanks for the
29:25 question next week our next question
29:28 comes from line I'm James MacIntyre
29:30 primary investor please see what your
29:31 question yeah hi dr. porous Juan um I'm
29:36 concerned with sales and marketing of
29:39 the drug after approval and in order to
29:42 help the patients and generate revenue
29:44 doctors have to know about the leronlimab
29:46 and so a couple months ago you'd
29:50 mention seniors health partnering with
29:52 CEOs health for outsourcing the sales
29:56 and marketing and that there was going
29:58 to be a plan opposed to the website
30:00 within a few weeks I'm just wondering
30:03 you know where you are with that I
30:04 understand
30:05 a very fluid situation and what is the
30:07 plan for for sales and marketing after
30:11 the drug is approved No thank you very
30:14 much for the question very good question
30:16 launching a product costs quite a bit of
30:19 funding about 50 million or so to just
30:22 soft launch the product and we have got
30:26 the plan from seniors health but because
30:29 of our discussions in potential
30:31 licensing out and having a company who
30:34 has a sales force already established
30:36 ready to go which would save us a lot of
30:39 time and funding we did not post that
30:42 because we are negotiating our right now
30:44 in the mix of negotiation with a couple
30:48 of different companies so thanks for the
30:50 question but we definitely would address
30:51 that
30:52 next question our next question comes
30:55 from line of each end with HC wine right
30:57 please see what the question thank you
31:01 for taking my question
31:02 my first question is yes you previously
31:04 announced that the FDA has allowed a
31:08 phase 2 study for the combination
31:10 therapy in colorectal cancer to proceed
31:13 and now you also mentioned that you FDA
31:16 has allowed the nash trial to proceed so
31:20 when do you plan to initiate these two
31:23 phase 2 trials No thank you for the
31:26 great question so as the Bruce dr.
31:29 Patterson said we have to be focused on
31:32 our first approval to generate revenue
31:35 we are trying to do all kind of
31:38 articulate fundraising to have the
31:40 smallest dilution as possible
31:42 manufacturing we were very lucky with
31:45 the launching of the product we are
31:46 working to avoid having to spend a lot
31:49 of money and therefore in regard to
31:51 metastases colorectal cancer and Nash
31:54 we're going to think very carefully
31:56 because the funding that we bring we
31:58 bring very small amount because we want
32:01 to make sure we just meet the need as
32:03 needed for the fund so we don't dilute
32:06 the company the shareholders get to do
32:08 that if we raise funding for right now
32:10 for colon cancer we're going to give it
32:11 a little bit
32:12 this is the next three months is just in
32:16 my opinion the most crucial three months
32:18 of this company we are entering to some
32:21 very very new areas and we do not want
32:25 to start another trial that would be
32:27 costly in any way shape or form but take
32:30 you know major said to have a strategy
32:34 that would be fit for us
32:37 Carter thank you and my follow-up
32:39 question is you just mentioned on the
32:41 call that the manufacturing of leronlimab
32:43 for commercial-grade could be ready
32:46 in 2021 can we understand that if the
32:50 Ronnie map is approved in 2020 let's say
32:53 the revenue generated from by the draw
32:56 from the drug could start in 2021
32:59 is that correct and that's a very good
33:02 thing he pick up he I don't know if
33:04 everybody picked that up so we said
33:07 before that 2021 early part the product
33:10 on Samsung will be ready but the product
33:13 as I said in a called clinical grade
33:15 would be ready by mid 2021 so all these
33:19 studies providing we have funding a
33:21 revenue how to started we will have
33:23 product we don't have to wait a year to
33:25 make more product for clinical grade but
33:27 the commercial grade that same product
33:30 becomes commercial grade six months
33:31 later but in regards to commercial
33:34 product we have currently 62 million
33:37 dollars worth of commercial product
33:39 about if you evaluate it as at $120,000
33:44 per year per patient and we have started
33:46 three other batches which is going to
33:49 give us another 35 million dollars at
33:51 the same price so we will have about 100
33:53 million or so domestically are
33:56 definitely other and this is the as
33:58 Mikey suggests the time reminding me
34:00 the on right Union United States nothing
34:02 movie yeah so we have to CMOS one
34:05 Samsung and one AGC and that's the kind
34:08 of product we will have got it thank you
34:11 thank you
34:12 next question please our next question
34:15 comes from lineup Daniel Nolan primal
34:17 investor
34:17 please shoot the question
34:21 well muttered hey how are you good are
34:25 you doing great movie results on triple
34:29 negative breast cancers section is good
34:32 question Daniel so the well what we are
34:34 doing right now is especially when we
34:37 have potential the situation where
34:40 people wanna you know look at these non
34:43 HIV indication we like to get some human
34:45 data but the human data that we're gonna
34:48 get is actually for us to be able to see
34:50 that yes this is exactly panning out the
34:52 way our animal study was showing them
34:56 98% suppression of metastasis the first
34:59 patient about the injected will have a
35:01 city series every three weeks but we
35:04 might not announce everything because
35:06 you want patients one three weeks time
35:08 is not anything we can get too excited
35:11 about we need to have few patients but
35:13 we will be analyzing it through the eyes
35:15 of our scientist the expert and as we go
35:19 forward I believe first quarter of next
35:21 year having some kind of interim results
35:23 that meaningful is possible next
35:27 question
35:28 thank you yep our next question comes to
35:32 line of Robertson with century
35:34 securities CC with Russian yeah hi
35:37 daughter how are you today doing great I
35:41 just wanted to clarify that the in your
35:46 talk just a little while ago the
35:49 licensing is not a dead issue
35:52 it sounds like you're probably under
35:54 specific NDA where you can't really get
35:57 into it and pop there's probably more
36:00 people maybe more interest involved in
36:03 the licensing them I'm reading that
36:04 correctly you're absolutely right but we
36:07 as I said we are far along enough where
36:10 now if I keep talking about every step
36:13 then we are not doing justice to the
36:15 shareholders in regards to you know
36:17 negotiating terms that we like to get
36:20 for the shareholders I just think that
36:22 it would help it maybe you clarified a
36:24 little bit more that it it's not a dead
36:27 issue issue absolutely 100% it's not
36:32 dead
36:33 thank you very much yeah Thank You beau
36:36 I appreciate it next two coffees once
36:39 again if you like to ask question please
36:41 press star 1 on your telephone keypad
36:43 once again if you would like to ask a
36:45 question please press star 1 on your
36:47 telephone keypad
36:49 one moment please while we pull for
36:51 questions our next question comes the
36:58 line of Timothy sink forms private
37:00 investor please - it's a question I
37:03 matter thanks for the information in for
37:06 the update sure as a CEO and then
37:09 someone who is so familiar with the
37:11 company and everything that's going on
37:12 behind the scenes as far as you can get
37:15 into detail what what's the thing the
37:18 first thing you think of in the morning
37:19 and the last thing you think of before
37:21 you go to bed about sited I'm well
37:24 started i'm b la submission time that is
37:27 the most important thing to my mind
37:29 because i want to make sure shareholders
37:30 realize that we are not going to drop
37:33 the ball in any way shape or form so any
37:35 even one day sooner versus one day later
37:38 people who know me decided and they know
37:40 i push everybody to the maximum RC are
37:44 always being fantastic they always
37:47 laughed because whatever timeline they
37:48 gave me i was saying i wanted you know a
37:50 month earlier so first thing is saturday
37:52 and the last thing inside of that and
37:54 it's about pla all about the LA right
37:56 now but the non HIV indication has been
37:59 so fantastic and stunning to me that
38:01 it's just amazing and i just know there
38:04 are a lot of naysayers not believing the
38:05 data or the fda communication we have
38:08 but i hope that we are able to show
38:10 results even stronger but thanks for
38:13 your question maybe a follow-up uncle if
38:17 you have a second yeah i'm but regarding
38:20 someone's question regarding commercial
38:22 inventory for the year 2020 just yet
38:25 just going off of your answer and his
38:27 question is is that to say that we have
38:31 we have a limited amount of potential
38:33 revenue for next year the limited amount
38:37 of potential is also quick so let me
38:42 explain that a little bit
38:43 so they're manufacturing when you want
38:46 to put an order of manufacturing you
38:48 have to have all the technology process
38:50 characterization process validation
38:52 all has to be set because the Lord said
38:56 we can order the F suite to be reserved
39:00 for us and have much more product
39:03 manufactured at the time that we need it
39:05 for example let's just say we sell the
39:08 first 100 million in the three months
39:10 per year
39:11 best-case scenario I'm just making up
39:13 numbers then we need more well as soon
39:16 as we get to the approval letter that
39:18 comes to us the patients who are on
39:20 extension they're gonna have to pay us
39:22 for the product and we are going to be
39:24 able to have revenue but we will also be
39:26 able to secure funding based upon the
39:29 product being approved that would be our
39:31 asset we can borrow money from the banks
39:33 perhaps and immediately order more
39:35 product to be made very quickly because
39:38 of all the processes and technologies
39:40 said which Samsung is taking very long
39:42 for the first batch because all these
39:44 technology is being transferred right
39:46 now but don't think I'm perfect answers
39:49 my question thank you yep you're welcome
39:52 so one more last one last question
39:55 please our final question comes from
39:57 line of Michael Seaver with mjo
39:59 properties please see what equipment
40:06 Michael your line is live oh sorry can
40:13 you hear me now
40:13 yes but okay Oh before do you guys get
40:18 along in this process is there other
40:21 companies that are going to start
40:22 looking to want to buy your company or
40:25 our company or is there any hospital
40:29 take or problems or anything like that
40:30 what the juries have to be concerned
40:32 about
40:33 I appreciate the question in regards to
40:37 people wanting us in regards to non HIV
40:39 we have discussions with major
40:42 institutions and people and they want to
40:44 see human data and that is very close to
40:47 us so I believe once we have human data
40:50 nobody if it's positive as we think it
40:52 is because and it's comparable to the
40:54 animal data we will be wanted by I
40:56 believe everybody who's in this space of
40:58 cancer and Nash and all that in regards
41:01 to HIV because the market is very
41:04 limited to make couple of or two or
41:07 three major players that would be
41:10 different but as the Gilead the top
41:12 panel one of the analysts said two years
41:15 ago if this little company successfully
41:17 throw 140 there will be major pushback
41:20 in regard to monitor so so that you know
41:24 that's where they always everything good
41:26 but thank you for the question next
41:32 please our next question comes from one
41:34 of ELISA shorts prime investor is
41:36 Twitter question yes please excuse me
41:39 yes hello first I would like to thank
41:43 say hello to everyone and see why do I
41:45 and to thank everyone for the hard work
41:48 and taking my call dr. Morris on special
41:52 congratulation to you for your recent
41:54 award thank you I am I am there are so
42:00 many medical accomplishment here that
42:02 sometimes it is really difficult to
42:05 follow but I just want to make clear I
42:08 mean one thing I think you said that for
42:11 FDA will have stability for 1.2
42:15 milliliter of blood only map which i
42:18 think is about hand 875 milligram and
42:23 we're looking right now for stability of
42:26 2.4
42:27 milliliter which will be a little bit
42:29 more than 350 that I understand well
42:31 that's correct
42:33 so 1.4 million later the patient will
42:36 take out one milliliter point four would
42:39 be wasted because of the safety for the
42:42 first batches that we have this will be
42:44 resolved when we have previous range but
42:47 one point for your correct one
42:48 milliliter of that is a hundred and
42:50 seventy five milligrams outside that's
42:54 right thank you very much thank you and
42:57 just one quick when do you expect a
43:01 decision from FDA about our breakthrough
43:04 designation for combo doctor / - so we
43:08 are thinking about having you know
43:10 submitting a breakthrough designation
43:12 for HIV in hopes of getting their
43:16 stability result turned in during their
43:20 review however our CRO that works with
43:24 us is advising us to not to do that and
43:27 just perhaps just go to FDA and ask them
43:30 for is you know to defer the disability
43:33 data to be submitted during the review
43:35 which is a task that you can do if you
43:37 have right to the job so we probably
43:40 just gonna ask FDA for that we are too
43:42 close to be a late submissions they say
43:45 it doesn't make sense to ask for
43:46 breakthrough thank you very much and
43:50 again dr. Ferguson special
43:52 congratulation to you of your recent
43:54 awards we are very proud of you and
43:56 thank to everyone thank you thank you so
43:59 much for having there is a question and
44:02 being supported of citation to all the
44:03 shareholders so I will wrap it up with
44:06 this and just summarize that today we
44:07 talked about the updates with our HIV
44:10 the BL a timeline the mono therapy
44:12 pivotal trial prep prevention study
44:15 which is now being is looked at by major
44:18 people major institutions to fund this
44:22 program
44:23 pure project Troy applications that have
44:26 been submitted are very strong with very
44:28 strong result Samsung is going forward
44:31 for manufacturing the great way
44:32 licensing agreement
44:34 is absolutely not there is alive and
44:36 kicking very well and I am very excited
44:39 to report to the shareholders as soon as
44:42 I can and in regards to knowledge heavy
44:44 we talked about Nash today was a great
44:46 day for us to get green light to
44:48 initiate our phase 2 Nash we already
44:51 have green light to start metastatic
44:52 colorectal cancer and again we on Friday
44:55 we had a good news of injecting the
44:57 first patient after long waiting
44:59 metastatic triple negative breast cancer
45:02 so with all that I want to thank all the
45:03 shareholder one more time for all the
45:05 great support that you have given us
45:07 thank you and goodbye this concludes
45:10 today's teleconference you may now
45:11 disconnect your lines at this time thank
45:13 you for your participation and have a
45:15 wonderful day
00:03 greetings welcome to CytoDyn
00:05 investment community call at this time
00:07 all participants are in a listen-only
00:09 mode a question-and-answer session will
00:11 follow the formal presentation if
00:12 anyone's require operator assistance
00:14 during the conference please press star
00:16 0 on your telephone keypad please note
00:18 this conference is being recorded I
00:20 would now like to turn the conference
00:21 over to your host Michael Holland thank
00:24 you you may begin hello everyone and
00:27 thank you for joining us today this is
00:29 Michael Mulholland chief financial
00:31 officer of cider diamond joining us on
00:34 today's call is our president and CEO
00:36 dr. Nader
00:37 Pourhassan as well as dr. Bruce
00:40 Patterson before we begin it is
00:44 essential that we provide you with
00:46 important cautionary language related to
00:48 certain federal securities laws our
00:51 remarks during today's conference call
00:54 will include forward-looking statements
00:56 forward-looking statements are not
00:58 guarantees of future performance and
00:59 involved known and unknown risks
01:02 uncertainties and other factors that are
01:05 difficult to predict actual results may
01:09 be materially different from any future
01:12 results expressed or implied by such
01:15 forward-looking statements these risks
01:18 and uncertainties include among other
01:22 matters statements regarding leronlimab
01:25 abs potential efficacy in certain
01:27 immunology and oncology indications the
01:31 company's ongoing ability to raise
01:33 additional new capital that clinical
01:36 trials may not commence or proceed as
01:38 planned
01:39 products that appear promising in early
01:42 trials may not subsequently prove to be
01:45 viable on safety or efficacy grounds
01:48 products may not receive regulatory
01:51 approval or market acceptance
01:53 competition may reduce the commercial
01:56 potential of our products we may
01:58 experience product recalls manufacturing
02:01 issues or product liability and our
02:04 patents may be challenged or
02:06 unenforceable while the forward-looking
02:10 statements helped to provide complete
02:11 information about the company
02:13 for looking statements maybe less
02:15 reliable than historical information the
02:18 company undertakes no obligation to
02:20 update publicly these forward-looking
02:22 statements except as required by law
02:25 please refer to our recent quarterly and
02:28 annual reports filed with the Securities
02:30 and Exchange Commission for more
02:32 information about the risks and
02:34 uncertainties that could cause actual
02:37 results to differ materially versus
02:41 outcome our current expectations I will
02:44 now turn the call over to dr. Nader
02:47 Pourhassat thank you Mike I appreciate
02:51 everyone taking time to participate in
02:54 today's call before any update I would
02:57 like to say a few words about cytodyn
02:59 share price so in regards to our share
03:03 price I can tell you that I believe that
03:06 fundamentals and science have never been
03:09 stronger but I am sure you have heard
03:12 that before we have a molecule that we
03:17 know it hits the target in humans with
03:20 no serious adverse events related to the
03:23 earldom up in greater than 830 HIV
03:27 patients in nine clinical trial as our
03:31 story unfolds we continue to discover
03:34 new potential opportunities for the only
03:37 map if we are right about any of these
03:40 indications for example cancer we will
03:44 make history if you are right about Nash
03:47 we will make history and the list goes
03:50 on and on and this list is getting
03:53 larger yet I believe the stock price is
03:56 still not showing anything close to our
03:59 true value but as a reminder we started
04:04 with combination therapy for HIV with
04:06 fast track designation from the FDA
04:08 since then we have developed significant
04:11 advancements in the following HIV mono
04:14 therapy GVHD with orphan drug
04:17 designation metastatic triple negative
04:20 breast cancer with fast track
04:21 designation colon cancer with green
04:24 light too
04:24 phase two we have also recently filed
04:27 for Phase two Nash trial with FDA we
04:30 have uncovered new potential
04:32 opportunities in prep which is
04:34 prevention and prophylaxis and cure in
04:38 HIV under the leadership of dr. Jonas
04:41 OSHA according to doctors Sasha
04:44 Cytodyn in regards to HIV alone had
04:48 planted many seeds and there will be a
04:51 coming harvest these are Ward's of a
04:54 professor at OHS the Oregon Health
04:56 Science University and many other top
04:58 brilliant minds are saying the same kind
05:01 of thing I will be discussing more
05:04 regarding the work of dr. Jonas Sasha
05:06 momentarily in addition we are exploring
05:11 new potential pathways in the treatment
05:13 of cancer including prevention of tumor
05:16 metastasis tumor angiogenesis synergy
05:21 with current oncology treatment and
05:23 positioning leronlimab as a true
05:26 immuno oncology molecule in regards to
05:29 tumor and angiogenesis we have a
05:33 stunning results from death dr. Daniel
05:35 Linder from Cleveland Clinic and dr.
05:37 Bruce Patterson ex Stanford professor
05:40 will speak about that to you today we
05:45 will also be pursuing opportunity based
05:47 upon our safety data in humans and the
05:49 mechanism of action of leronlimab in
05:52 melanoma pancreatic prostate lung liver
05:55 and stomach cancer the bottom line is
05:58 this if just one of these opportunities
06:01 proves to be true and we believe many
06:04 well we believe the share price will
06:07 react accordingly and appropriately many
06:11 powerful stories came too close to
06:13 failure and the only thing that investor
06:16 had to do was to recognize that amazing
06:20 triumphs success and glory or just
06:23 inches away we believe cytodyn fits
06:26 this model today I'm not here to give
06:29 anyone the speech I'm here to state
06:33 facts and facts only in my humble
06:36 opinion cited on is
06:38 in the brink of failure in any way shape
06:40 or form however the stock price might
06:42 mislead many investors who have very
06:45 little knowledge of this space everyone
06:48 who knows the space knows that if any
06:51 biotech company without revenue received
06:54 FDA approval for their product they will
06:57 see appreciation that they deserve so
07:00 allow me now to give you comprehensive
07:04 update by stating facts and a stay
07:07 crystal clear and transparent to you the
07:10 shareholders as I have always tried to
07:13 do so in regards to combination therapy
07:16 or be a late submission timeline the FDA
07:19 had requested that we give 50 patients
07:22 from our mono therapy that had past 24
07:25 weeks of mono therapy with 700
07:28 milligrams and 524 525 milligram this
07:33 delayed our timeline from September on
07:36 by October 31st we will have 51 patient
07:40 with 700 milligram and our timelines for
07:43 BLA for clinical section becomes
07:46 November to December timeline important
07:49 note is please note if we did not have
07:52 success with higher dose 525 and 700
07:56 milligrams in our mono therapy we would
07:58 have submitted or BLA to the FDA before
08:01 September now the next section the last
08:05 section is CMC again because of our
08:08 success the FDA needs to have a
08:10 disability from vials with 2.4
08:13 milliliter instead of 1.4 million liter
08:16 with 1.4 milliliter
08:18 we have a year worth of stability and
08:20 again note if we did not have success
08:24 with higher dose 525 700 milligram we
08:27 would have been submitting the BLA by
08:29 September or before regards to our mono
08:33 therapy pivot our protocol will be
08:36 submitted to the FDA again because of
08:40 our success with these higher doses the
08:43 FDA has asked for our pivotal trials to
08:46 be modified by the FDA so in regards to
08:50 mono therapy
08:51 the statement changes because of our
08:53 substance with this higher 522 five and
08:56 seven hundred milligrams we are allowed
08:58 to give pivotal mono therapy if we
09:00 didn't have that success we would have
09:03 had no mono therapy monitor they would
09:05 have been dead
09:06 so because we investigated the higher
09:09 dose we found a way to make it work and
09:12 hopefully change the HIV paradigm so we
09:16 get to have a little bit delay in our
09:19 ble which I believe is not that much
09:22 price to pay for such structures but
09:26 we're not done with HIV I mean I got a
09:28 lot to go through with known HIV
09:30 indication but I'm not done with HIV HIV
09:33 in regard to prep which is very hot
09:36 topic in the world of HIV prevention and
09:40 cure so there Jonas Sasha wanted to come
09:44 to the this call and address the
09:46 shareholder however he couldn't do to
09:48 his travel schedule but he brought me an
09:51 email to read to everybody on the call
09:55 he said I would like to update you on
09:58 some of the new development that I am
10:01 working on this is that his after he
10:03 said in regard to HIV cure program he
10:06 has had discussions with both and for
10:09 American Foundation for AIDS research
10:11 and with the Bill and Melinda Gates
10:14 Foundation and funding research into the
10:18 world him up to for HIV cure dr. Sasha
10:22 indicated that these discussions have
10:24 been very productive and continue to
10:27 move forward in regards to prevention
10:30 potential for little on Reba recently he
10:33 also had very preliminary conversation
10:36 with MH RP the United State of America
10:39 military HIV research program but the
10:43 social in foremost that this is
10:44 preliminary but we will keep you posted
10:46 at this story unfold but the social is
10:50 also working on enhancing the half-life
10:52 of Leon Deema
10:54 he is in the process of making this
10:56 compound
10:56 and plans to complete the initial PK
10:59 pharmacokinetic studies by early next
11:02 year he anticipates a four-fold increase
11:06 in the half-life and if successful would
11:09 translate into a once monthly injection
11:12 of lire on the map versus the current
11:14 once weekly approach this would lower
11:18 production costs but more importantly
11:21 with encourage compliance and
11:23 potentially improve efficacy and current
11:26 and convenience for patients the only
11:29 map is a self injectable subcutaneous
11:31 injection not an intramuscular injection
11:34 and in our opinion there is a world
11:36 world of difference between the two and
12:12 see when all of our shareholders hear
12:14 about all dr. Kelley has done for them
12:17 to ensure many solid developments four
12:19 sided nine they will be very pleased so
12:24 in regards to HIV we also have something
12:26 else to tell everyone the Croi is
12:29 conference of retroviruses and
12:31 opportunistic the infection is the most
12:33 powerful conference for HIV we
12:37 participated in that in the past but
12:39 this time for CROI we did not submit
12:43 abstract directly but other people are
12:45 now noticing the potential of literally
12:48 map and they have the first abstract was
12:51 for prep prevention that was submitted
12:55 dr. Jonas saw some very strong result
12:57 and the abstract has been submitted to
13:00 CROI as of the deadline of September 26
13:03 November 15 the results of access
13:05 we'll be announced we expect major media
13:08 to cover this presentation as prepped in
13:11 HIV space is a very important and hot
13:14 topic the second abstract is from dr.
13:17 Stefano Ross Connie from university of
13:20 milan italy very exciting results we
13:24 have given permission to them to publish
13:26 the results of our molecule in akroy as
13:30 we agreed the results are stunning we
13:33 can't talk about this result but I can
13:35 tell you we are so impressed by them
13:38 that we are including them in our BLA
13:41 submission to the FDA and in regards to
13:44 Thai Red Cross previously we announced
13:48 that we signed Memorandum of
13:49 Understanding for prevention study of 50
13:52 patients perhaps and that is going
13:54 forward and we will be announcing any
13:58 major development as soon as we get it
14:01 so this concludes the HIV portion but
14:05 before I go to the knowledge IV the
14:09 manufacturing of this product was taught
14:11 to us that we had to raise 50 million
14:13 dollars just we had to do that at least
14:16 early as a year ago that means we have
14:19 to dilute the company and raise 15
14:21 million to support manufacturing or we
14:23 would have have product to sell and we
14:25 can approve samsung has agreed and we
14:28 will have product clinical grade by mid
14:32 of next year and we will have it
14:35 commercialized grade by very beginning
14:38 of 2021
14:39 this is substantial and we have talked
14:41 about that before but the last thing
14:43 about HIV that we said in our annual
14:45 shareholder meeting with potential
14:47 licensing to launch leronlimab
14:50 licensing out the cells of the only map
14:52 for us exclusively at our natural
14:56 holders meaning i discussed the
14:57 potential for commercialization part
14:59 partners and discussions regarding
15:02 strategy strategic partners i can say
15:05 now that we are far enough along in
15:09 these discussions that i can no longer
15:11 comment today i will not give an inch of
15:15 free ride to anyone in regards to
15:17 potential
15:18 partnership due to cited as current
15:20 share price we believe we are very close
15:23 to major success and our shareholders
15:25 deserve full value and in my humble
15:28 opinion we are set to potentially
15:31 realize these values that is all we have
15:34 to say about this at this time the next
15:37 thing I would like to update you is
15:38 graft-versus-host is described as of
15:41 today dr. Daniel Porter Porter or
15:44 principal investigator for
15:45 graft-versus-host disease has told me
15:48 that all tasks are completed and they
15:52 are ready to inject the first patient
15:54 any time and we hope to have that in
15:56 October in regard to metastasis triple
15:59 negative breast cancer long waiting
16:01 journey for us to get the first patient
16:04 and you got the presentation on Friday
16:06 thanks to dr. J Lalezari and in regard
16:10 to is this gonna work or not are we
16:13 gonna get the first human data that
16:15 shows the only map potential I'm going
16:18 to turn the call to dr. Bruce Patterson
16:21 who knows Lee only map very well and his
16:24 expert of CC alpha
16:25 Bruce please yes thank you another it's
16:30 it's it's a very exciting time for cydy
16:33 both on the HIV front and on the cancer
16:37 front it's interesting that all the
16:39 disease states that you mention in terms
16:42 of efficacy of leronlimab are ones
16:45 that have a very strong immune component
16:48 to them ccr5 expressing cells really
16:54 control the the immune response and the
16:57 fact is by blocking ccr5 you promote the
17:02 anti-tumor activity of a cell type
17:04 called macrophages which are like
17:06 pac-man and scavenge tumor cells in
17:10 addition ccr5 inhibits the migration of
17:14 T regulatory cells that turn off the
17:17 immune system that's brought back by
17:20 some of the other common immuno oncology
17:23 drugs what we've seen in the screening
17:26 samples from the T MVC trial is patients
17:30 with large number
17:32 of immune cells expressing ccr5
17:34 around these tumors that can be
17:37 inhibited by leronlimab and promote
17:40 the anti-tumor activity within the tumor
17:44 and also for metastasis so that's the
17:47 stage we're at right now and like I said
17:50 we haven't found a tumor yet that
17:52 doesn't have this very strong ccr5
17:56 positive immune infiltrates that can be
17:59 targeted using ccr5 so is truly truly an
18:05 immuno oncology drugs thank you so much
18:10 Bruce I appreciate it
18:12 so continuing with that with our update
18:14 the next item is metastasis colon rectal
18:18 cancer where FDA gave us green light to
18:21 to have our face to initiate it dr.
18:25 daniel linda from cleveland clinic had
18:28 studied this product for us and his
18:31 results led to phase two I want to read
18:33 a paragraph of what he wrote for him for
18:36 us to share with a share of the
18:39 shareholders to determine if literally
18:43 map could affect the host slash tumor
18:46 interface we perform a dermal
18:49 angiogenesis assay in order for a tumor
18:53 to grow larger than two millimeter
18:55 diameter new host blood vessels must be
18:58 induced SW 480 tumor cells were
19:03 inoculated in the dermis of humanized
19:07 NSG mice the only map tree that might
19:10 had over 2 fold reduction in neo vessel
19:14 for male information compared to IgG
19:17 treated might evidence by decrease in
19:20 total pixel count vessel intensity and
19:23 overall number of vessels most dramatic
19:27 was reduction of a smaller vessel as
19:30 compared to larger vessels the mechanism
19:34 of angiogenesis inhibition by the Ronda
19:36 map suggests that suggests that this
19:39 agent may inhibit the growth of several
19:41 solid tumors that
19:43 dependent upon this process especially
19:46 during the establishment of metastasis
19:49 lis lesions this is a sadness from dr.
19:54 Daniel Linda after he's the very largest
19:56 animal study the next item to update
19:59 everyone is Nash animal study with dr.
20:02 Daniel Linda the results of that large
20:05 animal study will come out hopefully in
20:07 mid or end of October and the last thing
20:11 that I will update you on is Nash phase
20:15 two trials that we have sent the
20:17 protocol to FDA I have been told by many
20:21 experts of Nash that a company with a
20:25 face to green-light
20:26 with Nash should have a market cap of
20:30 significantly higher than ours market
20:33 cap as of today I would like to announce
20:36 that FDA has given us green light to
20:39 initiate our face to Nash study and we
20:43 will be talking about that in our in the
20:44 press this coming up in a day or two
20:47 so with that let's let us go to a
20:49 question and answer please thank you at
20:53 this time we conducted a
20:54 question-and-answer session if you would
20:56 like to ask a question please press star
20:58 1 on your telephone keypad
20:59 a confirmation someone indicate your
21:01 lines in the question queue you may
21:03 press star 2 if you would like to remove
21:04 your question from the queue for
21:06 participants using speaker equipment it
21:08 may be necessary to pick up your handset
21:09 before pressing the star key one moment
21:12 please while we pull for questions our
21:17 first question
21:18 comes online of Mustafa listing which
21:20 farmers capital please see what the
21:22 question hi dr. nadir how are you very
21:26 good thanks
21:28 my question is that if the science is as
21:32 strong as the company is claiming and
21:34 has been claiming for each investigative
21:36 strategy and cited ein has also been
21:40 given fast-track FB approval in several
21:43 areas then in your opinion why is the
21:46 stock continuously moving in the
21:48 opposite direction and where is the
21:51 disconnect between the medicine and what
21:54 Wall Street is interpreting yeah thank
21:58 you for your question so in an OTC B
22:01 space everyone knows in order for us to
22:05 have people buy our share we have to
22:07 have retail investors individual
22:10 investors purchase our product purchased
22:13 I'm sorry ours are shared and to bring
22:16 people to the table to buy that you have
22:18 to do Roadshow of the roadshow you don't
22:20 have institutions we have taken a
22:24 product bought at for three and a half
22:26 million dollars and raised 210 million
22:29 dollars after we bought it because of
22:31 the success that we have shown this
22:32 product has and could have all these
22:34 opportunities are getting to the point
22:36 where revenue is very close to us
22:38 perhaps second third quarter of next
22:41 year and if it is then when you raise
22:43 when you have revenue coming in your
22:46 stock has no choice but to show the
22:48 value in regards to why Wall Street
22:50 doesn't look at it this we are not the
22:52 only one that this happened there are
22:53 many companies in the past biotech
22:55 that's why they have inflection points
22:57 people don't stay with the solid
22:59 fundamentals they get very nervous about
23:01 the stock going up ten percent or lower
23:03 10% we saw two hundred million dollars
23:06 that's adaptable equivalence of maybe
23:08 three hundred million shares or so when
23:10 these shares on Excel and there you are
23:12 tired of waiting
23:13 we don't have sellers sometimes and that
23:15 but that's what happens but we made sure
23:17 we stay focused on the science and
23:18 fundamental next question please
23:24 our next
23:25 constant line of Mike Walker with M
23:28 contract please see what your question
23:31 yeah good morning Nadar
23:33 good afternoon honor I had a question on
23:36 the combination therapy our last meeting
23:39 said we were going to have our file for
23:41 the BLA for the combination therapy and
23:43 was going to be completed by September
23:45 and this time we didn't even mention
23:47 that you talked about the mono therapy
23:48 so what changed
23:51 thank you Mike for the question I did
23:54 have this the monitor combination VLAN
23:57 ID three times said because of our
23:59 success we were severe now have been
24:02 told by FDA to get data from 700
24:05 milligram from mono therapy for
24:08 combination therapy which we are very
24:10 very lucky and very very grateful and
24:12 thankful to FDA for allowing us to use
24:15 another trial to give data for the BLA
24:19 so BLA submission as I said would have
24:21 been done and in September if we did not
24:24 have the success with the higher dose if
24:26 we didn't have the success with higher
24:28 dose we wouldn't have mono therapy and
24:30 the potential of changing HIV paradigm
24:32 wouldn't be there so thank you next
24:34 question please
24:36 our next question comes online of Ralph
24:38 warden a private investor please shoot
24:40 your question yes my question is about
24:44 the competition with car T which over
24:50 time although it looks very good at the
24:52 start the relapse rate is about 40% if
24:57 do you know what the half-life is of the
25:01 drug of this formula and what the
25:05 likelihood is of resistance to it over
25:07 time let's say compared to party
25:11 great question or appreciated so the
25:14 half-life of leave only map is 10 days
25:16 and the half-life we would like to make
25:20 it longer but in order to do that it
25:23 would take us a year and a half to have
25:24 GMP product ready
25:27 if the hapless can be extended and then
25:30 is also successful but the half-life is
25:33 10 days in regards to resistance every
25:35 HIV product that is
25:37 administered by itself usually have
25:41 resisted within six months or product
25:43 whenever yeah so there is no resistance
25:47 with our product we haven't seen any
25:49 resistance for five years now with some
25:53 of the patients well that's a good go
25:58 ahead I'm sorry I just wondering you
26:02 know about the car key work I'm sure
26:05 where they take out the white cells and
26:08 educate them to eat the tumor cells and
26:10 put them back you you you are familiar
26:12 with it what they call CA r - t therapy
26:16 RT Carson not a listen I can put up in
26:21 my yeah yeah since I've worked with both
26:26 basically infusing effector cells
26:29 against the tumor what is very
26:32 interesting about leronlimab and it can
26:34 be complementary to car see is that it
26:37 inhibits the cells that inhibit the
26:39 infector cells
26:40 okay so cd8 t-cells are targeting the
26:45 tumor and they're brought back to life
26:47 by PDL one and pd1 antagonists and
26:52 agonist right so RT strategy is to
26:56 infuse cells that target the tumor now
26:59 they would also be susceptible to T
27:02 regulatory cells coming in and
27:05 inhibiting from doing their job and not
27:07 squares leronlimab functions in
27:11 preventing the T regulatory cells from
27:14 from migrating into the tumor and
27:17 shutting off the immune response that's
27:19 already been brought back by these
27:20 blockbuster drugs or blockbuster
27:23 approaches as you suggest so it goes
27:26 very very complementary well that's a
27:29 guy he was asking so you could take car
27:31 key failures they have about employers
27:34 and failure Lee yeah well we also get
27:37 brilliant results yeah yeah way back in
27:40 the day that you know there also
27:41 recognizes for in cell sometimes and so
27:45 the immune system targets the actual
27:48 cells that are doing good so you know
27:50 there's
27:51 this is the intricacy of the immune
27:54 system is fascinating and and ccr5
27:57 pathway is the quarterback of that
28:00 immune system by making cells moves to
28:03 areas where they're needed and and and
28:05 to even promote metastasis at times in
28:09 tumor cells so that is why there's such
28:13 a diverse array of applications for
28:16 leronlimab and it's not because in you
28:19 know we're looking for all these
28:20 different things it's because everything
28:23 involves this same pathway so it's not
28:26 cited I've done an amazing job of
28:28 focusing on the indications that are
28:31 closest to approval despite the fact
28:34 that the pipeline of applications is
28:37 extensive it's so exciting about this
28:40 drug yep okay thank you thank you for
28:44 your question crazy I said appreciate it
28:46 next please our next question comes from
28:49 one of Peter Gibbons professor please
28:51 shoot your question oh thanks for taking
28:56 my call today I only have one question
28:58 on the September 12th shareholder
29:01 meeting you referenced that you had
29:03 secured funding through the end of the
29:05 year from people who would be funding us
29:06 could you speak on that further please
29:08 form so unfortunately because of legal
29:12 advice I'm not allowed to talk about
29:15 that but we will address that for sure
29:17 you know at the appropriate time and you
29:19 will and you will be able to understand
29:22 why I said that but thanks for the
29:25 question next week our next question
29:28 comes from line I'm James MacIntyre
29:30 primary investor please see what your
29:31 question yeah hi dr. porous Juan um I'm
29:36 concerned with sales and marketing of
29:39 the drug after approval and in order to
29:42 help the patients and generate revenue
29:44 doctors have to know about the leronlimab
29:46 and so a couple months ago you'd
29:50 mention seniors health partnering with
29:52 CEOs health for outsourcing the sales
29:56 and marketing and that there was going
29:58 to be a plan opposed to the website
30:00 within a few weeks I'm just wondering
30:03 you know where you are with that I
30:04 understand
30:05 a very fluid situation and what is the
30:07 plan for for sales and marketing after
30:11 the drug is approved No thank you very
30:14 much for the question very good question
30:16 launching a product costs quite a bit of
30:19 funding about 50 million or so to just
30:22 soft launch the product and we have got
30:26 the plan from seniors health but because
30:29 of our discussions in potential
30:31 licensing out and having a company who
30:34 has a sales force already established
30:36 ready to go which would save us a lot of
30:39 time and funding we did not post that
30:42 because we are negotiating our right now
30:44 in the mix of negotiation with a couple
30:48 of different companies so thanks for the
30:50 question but we definitely would address
30:51 that
30:52 next question our next question comes
30:55 from line of each end with HC wine right
30:57 please see what the question thank you
31:01 for taking my question
31:02 my first question is yes you previously
31:04 announced that the FDA has allowed a
31:08 phase 2 study for the combination
31:10 therapy in colorectal cancer to proceed
31:13 and now you also mentioned that you FDA
31:16 has allowed the nash trial to proceed so
31:20 when do you plan to initiate these two
31:23 phase 2 trials No thank you for the
31:26 great question so as the Bruce dr.
31:29 Patterson said we have to be focused on
31:32 our first approval to generate revenue
31:35 we are trying to do all kind of
31:38 articulate fundraising to have the
31:40 smallest dilution as possible
31:42 manufacturing we were very lucky with
31:45 the launching of the product we are
31:46 working to avoid having to spend a lot
31:49 of money and therefore in regard to
31:51 metastases colorectal cancer and Nash
31:54 we're going to think very carefully
31:56 because the funding that we bring we
31:58 bring very small amount because we want
32:01 to make sure we just meet the need as
32:03 needed for the fund so we don't dilute
32:06 the company the shareholders get to do
32:08 that if we raise funding for right now
32:10 for colon cancer we're going to give it
32:11 a little bit
32:12 this is the next three months is just in
32:16 my opinion the most crucial three months
32:18 of this company we are entering to some
32:21 very very new areas and we do not want
32:25 to start another trial that would be
32:27 costly in any way shape or form but take
32:30 you know major said to have a strategy
32:34 that would be fit for us
32:37 Carter thank you and my follow-up
32:39 question is you just mentioned on the
32:41 call that the manufacturing of leronlimab
32:43 for commercial-grade could be ready
32:46 in 2021 can we understand that if the
32:50 Ronnie map is approved in 2020 let's say
32:53 the revenue generated from by the draw
32:56 from the drug could start in 2021
32:59 is that correct and that's a very good
33:02 thing he pick up he I don't know if
33:04 everybody picked that up so we said
33:07 before that 2021 early part the product
33:10 on Samsung will be ready but the product
33:13 as I said in a called clinical grade
33:15 would be ready by mid 2021 so all these
33:19 studies providing we have funding a
33:21 revenue how to started we will have
33:23 product we don't have to wait a year to
33:25 make more product for clinical grade but
33:27 the commercial grade that same product
33:30 becomes commercial grade six months
33:31 later but in regards to commercial
33:34 product we have currently 62 million
33:37 dollars worth of commercial product
33:39 about if you evaluate it as at $120,000
33:44 per year per patient and we have started
33:46 three other batches which is going to
33:49 give us another 35 million dollars at
33:51 the same price so we will have about 100
33:53 million or so domestically are
33:56 definitely other and this is the as
33:58 Mikey suggests the time reminding me
34:00 the on right Union United States nothing
34:02 movie yeah so we have to CMOS one
34:05 Samsung and one AGC and that's the kind
34:08 of product we will have got it thank you
34:11 thank you
34:12 next question please our next question
34:15 comes from lineup Daniel Nolan primal
34:17 investor
34:17 please shoot the question
34:21 well muttered hey how are you good are
34:25 you doing great movie results on triple
34:29 negative breast cancers section is good
34:32 question Daniel so the well what we are
34:34 doing right now is especially when we
34:37 have potential the situation where
34:40 people wanna you know look at these non
34:43 HIV indication we like to get some human
34:45 data but the human data that we're gonna
34:48 get is actually for us to be able to see
34:50 that yes this is exactly panning out the
34:52 way our animal study was showing them
34:56 98% suppression of metastasis the first
34:59 patient about the injected will have a
35:01 city series every three weeks but we
35:04 might not announce everything because
35:06 you want patients one three weeks time
35:08 is not anything we can get too excited
35:11 about we need to have few patients but
35:13 we will be analyzing it through the eyes
35:15 of our scientist the expert and as we go
35:19 forward I believe first quarter of next
35:21 year having some kind of interim results
35:23 that meaningful is possible next
35:27 question
35:28 thank you yep our next question comes to
35:32 line of Robertson with century
35:34 securities CC with Russian yeah hi
35:37 daughter how are you today doing great I
35:41 just wanted to clarify that the in your
35:46 talk just a little while ago the
35:49 licensing is not a dead issue
35:52 it sounds like you're probably under
35:54 specific NDA where you can't really get
35:57 into it and pop there's probably more
36:00 people maybe more interest involved in
36:03 the licensing them I'm reading that
36:04 correctly you're absolutely right but we
36:07 as I said we are far along enough where
36:10 now if I keep talking about every step
36:13 then we are not doing justice to the
36:15 shareholders in regards to you know
36:17 negotiating terms that we like to get
36:20 for the shareholders I just think that
36:22 it would help it maybe you clarified a
36:24 little bit more that it it's not a dead
36:27 issue issue absolutely 100% it's not
36:32 dead
36:33 thank you very much yeah Thank You beau
36:36 I appreciate it next two coffees once
36:39 again if you like to ask question please
36:41 press star 1 on your telephone keypad
36:43 once again if you would like to ask a
36:45 question please press star 1 on your
36:47 telephone keypad
36:49 one moment please while we pull for
36:51 questions our next question comes the
36:58 line of Timothy sink forms private
37:00 investor please - it's a question I
37:03 matter thanks for the information in for
37:06 the update sure as a CEO and then
37:09 someone who is so familiar with the
37:11 company and everything that's going on
37:12 behind the scenes as far as you can get
37:15 into detail what what's the thing the
37:18 first thing you think of in the morning
37:19 and the last thing you think of before
37:21 you go to bed about sited I'm well
37:24 started i'm b la submission time that is
37:27 the most important thing to my mind
37:29 because i want to make sure shareholders
37:30 realize that we are not going to drop
37:33 the ball in any way shape or form so any
37:35 even one day sooner versus one day later
37:38 people who know me decided and they know
37:40 i push everybody to the maximum RC are
37:44 always being fantastic they always
37:47 laughed because whatever timeline they
37:48 gave me i was saying i wanted you know a
37:50 month earlier so first thing is saturday
37:52 and the last thing inside of that and
37:54 it's about pla all about the LA right
37:56 now but the non HIV indication has been
37:59 so fantastic and stunning to me that
38:01 it's just amazing and i just know there
38:04 are a lot of naysayers not believing the
38:05 data or the fda communication we have
38:08 but i hope that we are able to show
38:10 results even stronger but thanks for
38:13 your question maybe a follow-up uncle if
38:17 you have a second yeah i'm but regarding
38:20 someone's question regarding commercial
38:22 inventory for the year 2020 just yet
38:25 just going off of your answer and his
38:27 question is is that to say that we have
38:31 we have a limited amount of potential
38:33 revenue for next year the limited amount
38:37 of potential is also quick so let me
38:42 explain that a little bit
38:43 so they're manufacturing when you want
38:46 to put an order of manufacturing you
38:48 have to have all the technology process
38:50 characterization process validation
38:52 all has to be set because the Lord said
38:56 we can order the F suite to be reserved
39:00 for us and have much more product
39:03 manufactured at the time that we need it
39:05 for example let's just say we sell the
39:08 first 100 million in the three months
39:10 per year
39:11 best-case scenario I'm just making up
39:13 numbers then we need more well as soon
39:16 as we get to the approval letter that
39:18 comes to us the patients who are on
39:20 extension they're gonna have to pay us
39:22 for the product and we are going to be
39:24 able to have revenue but we will also be
39:26 able to secure funding based upon the
39:29 product being approved that would be our
39:31 asset we can borrow money from the banks
39:33 perhaps and immediately order more
39:35 product to be made very quickly because
39:38 of all the processes and technologies
39:40 said which Samsung is taking very long
39:42 for the first batch because all these
39:44 technology is being transferred right
39:46 now but don't think I'm perfect answers
39:49 my question thank you yep you're welcome
39:52 so one more last one last question
39:55 please our final question comes from
39:57 line of Michael Seaver with mjo
39:59 properties please see what equipment
40:06 Michael your line is live oh sorry can
40:13 you hear me now
40:13 yes but okay Oh before do you guys get
40:18 along in this process is there other
40:21 companies that are going to start
40:22 looking to want to buy your company or
40:25 our company or is there any hospital
40:29 take or problems or anything like that
40:30 what the juries have to be concerned
40:32 about
40:33 I appreciate the question in regards to
40:37 people wanting us in regards to non HIV
40:39 we have discussions with major
40:42 institutions and people and they want to
40:44 see human data and that is very close to
40:47 us so I believe once we have human data
40:50 nobody if it's positive as we think it
40:52 is because and it's comparable to the
40:54 animal data we will be wanted by I
40:56 believe everybody who's in this space of
40:58 cancer and Nash and all that in regards
41:01 to HIV because the market is very
41:04 limited to make couple of or two or
41:07 three major players that would be
41:10 different but as the Gilead the top
41:12 panel one of the analysts said two years
41:15 ago if this little company successfully
41:17 throw 140 there will be major pushback
41:20 in regard to monitor so so that you know
41:24 that's where they always everything good
41:26 but thank you for the question next
41:32 please our next question comes from one
41:34 of ELISA shorts prime investor is
41:36 Twitter question yes please excuse me
41:39 yes hello first I would like to thank
41:43 say hello to everyone and see why do I
41:45 and to thank everyone for the hard work
41:48 and taking my call dr. Morris on special
41:52 congratulation to you for your recent
41:54 award thank you I am I am there are so
42:00 many medical accomplishment here that
42:02 sometimes it is really difficult to
42:05 follow but I just want to make clear I
42:08 mean one thing I think you said that for
42:11 FDA will have stability for 1.2
42:15 milliliter of blood only map which i
42:18 think is about hand 875 milligram and
42:23 we're looking right now for stability of
42:26 2.4
42:27 milliliter which will be a little bit
42:29 more than 350 that I understand well
42:31 that's correct
42:33 so 1.4 million later the patient will
42:36 take out one milliliter point four would
42:39 be wasted because of the safety for the
42:42 first batches that we have this will be
42:44 resolved when we have previous range but
42:47 one point for your correct one
42:48 milliliter of that is a hundred and
42:50 seventy five milligrams outside that's
42:54 right thank you very much thank you and
42:57 just one quick when do you expect a
43:01 decision from FDA about our breakthrough
43:04 designation for combo doctor / - so we
43:08 are thinking about having you know
43:10 submitting a breakthrough designation
43:12 for HIV in hopes of getting their
43:16 stability result turned in during their
43:20 review however our CRO that works with
43:24 us is advising us to not to do that and
43:27 just perhaps just go to FDA and ask them
43:30 for is you know to defer the disability
43:33 data to be submitted during the review
43:35 which is a task that you can do if you
43:37 have right to the job so we probably
43:40 just gonna ask FDA for that we are too
43:42 close to be a late submissions they say
43:45 it doesn't make sense to ask for
43:46 breakthrough thank you very much and
43:50 again dr. Ferguson special
43:52 congratulation to you of your recent
43:54 awards we are very proud of you and
43:56 thank to everyone thank you thank you so
43:59 much for having there is a question and
44:02 being supported of citation to all the
44:03 shareholders so I will wrap it up with
44:06 this and just summarize that today we
44:07 talked about the updates with our HIV
44:10 the BL a timeline the mono therapy
44:12 pivotal trial prep prevention study
44:15 which is now being is looked at by major
44:18 people major institutions to fund this
44:22 program
44:23 pure project Troy applications that have
44:26 been submitted are very strong with very
44:28 strong result Samsung is going forward
44:31 for manufacturing the great way
44:32 licensing agreement
44:34 is absolutely not there is alive and
44:36 kicking very well and I am very excited
44:39 to report to the shareholders as soon as
44:42 I can and in regards to knowledge heavy
44:44 we talked about Nash today was a great
44:46 day for us to get green light to
44:48 initiate our phase 2 Nash we already
44:51 have green light to start metastatic
44:52 colorectal cancer and again we on Friday
44:55 we had a good news of injecting the
44:57 first patient after long waiting
44:59 metastatic triple negative breast cancer
45:02 so with all that I want to thank all the
45:03 shareholder one more time for all the
45:05 great support that you have given us
45:07 thank you and goodbye this concludes
45:10 today's teleconference you may now
45:11 disconnect your lines at this time thank
45:13 you for your participation and have a
45:15 wonderful day
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