CytoDyn Inc. (OTC: CYDY) NEXT SUPER STOCK investor
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Posted On: 08/21/2019 4:57:35 PM
CytoDyn Inc. (OTC: CYDY) NEXT SUPER STOCK investor conference presentation 8/15/2019
with auto transcript
https://www.youtube.com/watch?time_continue=2...v1mzWC80TI
00:01 you
00:10 Saito Donegan is our final presenter
00:12 today a stock symbol is C y dy and the
00:16 CEO is dr. not there poor Hassan you
00:19 know many of you who are subscribers to
00:21 Wall Street or have been you know
00:23 following Saito dynast since you know we
00:25 first interviewed that there back in
00:28 January and you know what I find most
00:31 compelling about this biotech story is
00:33 that the company you know has a
00:35 game-changing therapy for HIV which
00:39 finished you know its phase three and is
00:42 now expecting to receive FDA approval
00:44 which is imminent so potentially they
00:49 can hit the market next year start
00:50 generating significant revenues and
00:53 they're targeting really a multi-billion
00:55 dollar opportunity so the the revenues
00:58 are you know looks like they're around
01:01 the corner so this is not one of these
01:02 you know biotech stories which you know
01:05 is revenues are you know decades away on
01:08 top of you know the near-term revenue
01:10 potential you know cited on also the
01:12 pipeline of drugs targeting cancers and
01:16 you know not there we'll get into more
01:18 of that in the presentation so enough
01:21 about you know you know what I have to
01:23 say let's let's go directly to the
01:25 source and hear about this exciting
01:27 story so yeah please welcome dr. not
01:31 dare poor Hassan
01:33 thank you jack I appreciate it and great
01:35 to be here
01:37 the product that we have is called Lear
01:39 on the map for 140 the last present
01:43 presented presented a very beautiful
01:46 technology that I'm also excited about
01:49 that but in the world of health space
01:52 drug development FDA recognizes that one
01:56 out of 5,000 drugs make it to approval
01:59 now just keep in mind that if you make
02:01 it to that football you raise money to
02:04 get this drug whatever drug you're
02:06 working on together to the approval if
02:07 it gets approval all the shareholder is
02:10 going to rip the harvest big time
02:12 because the your stock will go to
02:15 multiple and that's the way it was in a
02:17 world of biotech the stock will not do
02:19 anything till you do substantial have to
02:23 show substantial
02:24 progress in your drug development so
02:26 with that our product is pro 140 in the
02:29 literature but recently the name is now
02:31 only Ronda map it's in the it's a hat
02:34 indication in the world of HIV cancer
02:37 nash GVHD and i will be talking about
02:40 that as we go forward now my next slide
02:44 talks about that this everything we say
02:46 here is forward-looking statement and
02:48 the third slide that I'm on is our cited
02:51 an overview it's amazing when I present
02:54 this story I get excited more than
02:56 anybody myself because the fact that in
02:59 the biotech world when you're a public
03:02 company you have FDA communication so
03:06 whatever you put out if the FDA did
03:09 something little bit off they
03:12 immediately shut you down they call you
03:14 they put you on hold so whatever I'm
03:16 presenting here it's the stuff that we
03:18 didn't make up it's FDA has the
03:21 communication and it's all backed up by
03:23 that and we talk in our press releases
03:25 about all of these the reason I'm saying
03:27 all this is because the story just seems
03:29 to be very too good to be true and
03:31 seeking off I actually talked about that
03:34 and we had to talk to with the reporter
03:36 and they are everybody gets it made when
03:38 they look underneath the hood with this
03:40 company so in regard to HIV or
03:43 combination therapies our first approval
03:45 going forward and as the Jack indicated
03:48 we are going to have our hopefully final
03:52 application submitted to FDA for final
03:54 approval which is a PLA biologic license
03:57 application by the end of September now
03:59 what that means is you have have all the
04:02 hurdles phase 1 a 1 B 2 a 2 B and 3 and
04:06 pivotal trial we passed that and our
04:09 responders it was great now in this
04:11 world of HIV patients already have good
04:15 drugs out there so you're going to have
04:16 to have something that helps patients
04:18 who cannot take drugs as easily or they
04:21 don't have those options their
04:22 resistance and combination therapy or
04:24 product saved some lives in order to try
04:27 perhaps because they were resistant to
04:29 most of the drugs out there but the news
04:32 that we made big time news is about mono
04:35 therapy when dr. oz actually asked me
04:37 you go to the short celebrity started
04:39 getting involved fish the celebrities
04:42 that have HIV the mono therapy showed
04:45 that patient can for the first time in
04:47 their life put away all their drugs so
04:49 they don't have to worry about taking
04:50 drug that exact time every day for the
04:52 rest of their life and just enjoy subcu
04:54 injection once one time once a week that
04:58 means they will be finished with once a
04:59 week treatment and the patients who come
05:02 we're able to use that some of them have
05:04 gone off five years without any standard
05:08 of care so that's why when I present
05:10 this story I'd say this is no longer a
05:13 high-risk high-reward company this is
05:15 very low risk as we have the risk
05:18 most of the stuff as we have Heather
05:19 primary endpoint and finish the trial
05:22 met with FDA and going for our DLA
05:25 submission for combination therapy and
05:27 mono therapy is in parallel being
05:29 developed as we went forward with this
05:32 company we realized that Pfizer ccr5
05:35 antagonist which is what we are ccr5
05:38 antagonists or product is CCO who binds
05:41 to ccr5 they had the success with graph
05:44 versus host disease that they
05:46 accidentally found out about their HIV
05:48 product so we did a small in vitro study
05:52 and since we had a lot of data out there
05:54 for safety FDA gave us Phase two for
05:56 another indication graft-versus-host
05:58 disease we did the same thing with the
06:01 triple negative breast cancer because we
06:03 realized that there is published
06:05 document out there saying that ccr5
06:08 antagonists are the way of new futures
06:10 the future of new therapies in the world
06:14 of cancer or again animal study was
06:16 spectacular FDA granted us phase one B -
06:19 - we did the same thing with colon
06:21 cancer we just submitted the protocol
06:24 and we also have a prognostic test that
06:28 we will talk about but the list of
06:30 things that's going on is really amazing
06:32 there in regards to cancer because we
06:34 believe our product could stop the
06:36 metastasis of cancer the key opinion
06:40 leaders urges to check this for melanoma
06:42 melanoma pancreatic prostate lung liver
06:46 and stomach cancer and those animal
06:48 studies are going forward also
06:51 so the next slide I just want to show
06:52 you when we started with this product
06:54 and we compare our product with a
06:57 standard of care see how much better RV
06:59 what benefits are there for this product
07:01 at the earliest age in about 2006 FDA
07:06 had look at the data at that time and
07:08 gave this product fast track designation
07:10 with rolling the fast track designation
07:12 with accelerated approval possible NIH
07:17 has given a twenty eight million dollars
07:19 of the grant the reason for those
07:21 excitement was with this product leer
07:25 only map there was advantages in the
07:28 area of side effect toxicity resistance
07:31 and compliance side effect as of now we
07:33 have over 800 patient use this product
07:36 and zero serious adverse event related
07:38 to the Rhondda map has been found this
07:41 is incredible results by the way if
07:43 you're familiar with this space you
07:45 don't find product like that toxicity
07:48 negligible resistance we have patients
07:51 who have gone five years with zero
07:52 resistance if you give them if you give
07:55 a patient in HIV world any product by
07:58 itself without combining it
08:00 they build resistance very quickly about
08:02 six months or so compliance
08:04 taking pills three four pills in exact
08:07 time every day it's very difficult and
08:09 taking an injection sub-q underneath the
08:12 skin like diabetes do many times in a
08:15 week they can just do this once a week
08:18 probably two minutes a week and they're
08:20 done so what happens with our Phase
08:23 three
08:24 why are we so excited that this phase
08:26 three was such a great result we had a
08:29 great result our p-value was point zero
08:31 zero three two and our trial end up
08:34 having eighty one percent of these
08:36 patients who have very limited options
08:38 left with their current standard of care
08:40 eighty-one percent end up having
08:42 suppressed viral load some of them first
08:44 time in twenty years they had suppressed
08:46 viral load the last product approved for
08:49 that population had 43% suppressed viral
08:53 load so we all practically doubled them
08:55 again no report of series at this event
08:57 which is very important to patients and
09:00 FDA going forward
09:01 VLA biologic license after
09:04 and final application for final approval
09:06 1/3 was already submitted because FDA
09:09 gave us rolling vbu
09:10 submission that means the FDA is
09:12 reviewing that and the other 2/3 will be
09:14 hopefully by the end of September now
09:18 what's the value of this card well if
09:20 you look at the columns that are that I
09:22 have put on this slide - claps
09:24 resistance is with the limited treatment
09:27 option or three claps resistant can take
09:30 this product once it's actual if the
09:32 patient is or five there's a test for
09:35 that to check that the strain is our
09:36 file usually 70% of all HIV patients or
09:40 have our five resist or five a strain of
09:43 HIV so the next slide shows that in the
09:46 first 18 months that we get to the
09:48 market we're going to sell the product
09:50 for the same price that they're selling
09:51 another antibody in that mark in that
09:54 space that antibody patients have to go
09:56 to hospital for IV one our IB are this
10:00 self injectable at home and they're
10:03 selling for one hundred eighteen
10:04 thousand for the first 18 months or so
10:07 we will sell at 120 thousand dollars per
10:10 year per patient but going forward post
10:13 18 months we could drop the price
10:15 substantially as we will be
10:17 manufacturing it as one of the largest
10:19 biologic manufacturing who have just
10:21 granted us an agreement that I would be
10:23 talking about that so as you can see in
10:25 this slide the revenue will be
10:28 significant going forward they agree
10:32 mother I'm talking about it in this
10:34 slide I did go to South Korea to sign
10:37 this agreement with a CEO of Samsung
10:39 biologics they are going to produce
10:43 quite a bit of product in the overall
10:46 agreement allow us to have seven billion
10:48 dollars worth of product that 7 billion
10:50 is evaluated at $120,000 per year per
10:53 patient but the first 1 billion will not
10:56 be charged to us till later which is
10:58 very important to a small company like
11:00 us we do not want to raise funds for
11:02 that at this time so we were very happy
11:04 to be able to get granted you know
11:07 deferred payment which is something
11:09 Samsung has not given it to other
11:11 customers according to them so the last
11:14 slide in HIV is
11:17 respondents rate to FDA they wanted our
11:19 mono therapy where you patient can put
11:22 away all the standards of care they
11:24 wanted us to have a higher responders
11:26 rate than what we had before when we
11:28 went to FDA and in this slide we show
11:31 that it is five hundred twenty five
11:33 milligram after 31 weeks duration
11:35 average the patient's ninety-five
11:38 percent had suppressed viral load post
11:40 ten weeks we have to evaluate them in
11:42 the first ten weeks of mono therapy to
11:45 find out the responders so I said at the
11:49 very beginning that this product had
11:50 multiple indication potentially one of
11:55 them was GVHD and we said that Pfizer
11:57 accidentally found out that their
11:59 product had indications in this slide
12:02 you can see that when we did our in
12:04 vitro study for graft-versus-host
12:07 disease to see if leer on the map has
12:09 any indication in that space we
12:13 immediately gave the in-vitro result
12:15 that was positive to FDA and they give
12:17 us a Phase two we are very happy about
12:19 that because phase two cost about one
12:21 hundred million dollars from scratch to
12:23 you know to get to that phone from
12:25 discovery to the Phase two and we did it
12:29 with fifteen or twenty thousand dollars
12:31 now we asked a fee for orphan drug
12:33 designation they said you don't have any
12:35 animal study why don't you take 32 mice
12:38 group I mean a and B as you see in this
12:40 slide and they said if you give if this
12:45 mice are injected with human bone marrow
12:48 they're all going to die but if you give
12:50 it probe on 40 Lear on the map and some
12:53 of them stay alive then we will give you
12:55 orphan drug designation a hundred
12:58 percent of the mice who Godley round the
13:00 map stayed alive after receiving human
13:03 bone marrow transplant marrow injections
13:06 and the left slide you can see clearly
13:08 the red line the weight of the mice was
13:10 going up but then the blue line they
13:12 were going down and the right side is a
13:15 shocking result the red line no my side
13:18 for the blue line all the mice who did
13:20 not receive litter on the map died we
13:22 published this dis findings in a
13:25 peer-reviewed journal and have many
13:28 interests parties wanting to have a
13:30 presenting dinner conferences but the
13:33 next slide is even more exciting the
13:35 next slide shows that the animal study
13:37 indicated the middle row that if you
13:40 inject the mice with a lot of metastases
13:42 cells there are nothing they literally
13:46 map stops metastases the very first row
13:49 shows that mice will die but the second
13:52 line second row show that the might went
13:55 seven weeks which is equivalent to 70 70
13:59 years of human life and I'm sorry 70
14:03 months of human life so this was very
14:06 interesting finding and when when we
14:09 went to ten weeks which is equivalent to
14:12 ten years of human life with the middle
14:15 ear only map no metastases we submitted
14:19 those data to the FDA again we got
14:21 triple negative breast cancer phase two
14:23 and the result of mice was strong enough
14:25 and we received fast track designation
14:27 for this indication so what that means
14:31 that we did with the all the cancer
14:36 indication perhaps we can go ahead and
14:38 explore them because if metastasis is
14:40 the stop that means that tumor cell that
14:43 has chanted only the one that have ccr5
14:47 on it can have a signal that would allow
14:49 them get out of this cancer tumor and go
14:51 somewhere else and metastasize and home
14:54 in their liver lung or wherever so if we
14:57 stop that that means we stop metastases
14:59 which means we can have indication many
15:02 of the cancers that's why we now have
15:05 triple negative breast cancer and colon
15:07 cancer
15:08 phase two submitted to the FDA the first
15:11 one we granted to go forward with it but
15:13 colon cancer the protocol was just
15:15 submitted and we're waiting for FDA to
15:17 give us green light for that so there
15:20 are quite a bit of milestone ahead of us
15:22 triple negative breast cancer we should
15:24 be injecting the first patient in a
15:27 naive setting we already injected the
15:29 first patient who was in a third line
15:31 therapy and the expanded access FDA
15:34 requires us to allow terminal patients
15:37 have this product so we are giving it to
15:39 those who
15:47 request through the website we have a
15:50 report a mutation PLA supposed to be the
15:52 intercept band initiating of pivot touch
15:55 miles monitor be the first monetary
15:57 pivot turtles the world of HIV could
15:59 happen here as a meeting with the FDA to
16:02 finalize our protocol graft-versus-host
16:04 disease we hope to inject the
16:06 prostitution intercept compare and have
16:08 some insurances of this year and
16:10 prognostic test for prostate which is
16:12 completely different thing with a
16:14 diagnostic that we are going forward to
16:16 meet with FDA and see if we can get
16:18 approval for using that triple negative
16:22 breast cancers interim results will be
16:24 very exciting because if we do stop the
16:26 metastases and demonstrate that in a six
16:29 month period we could get up forward
16:31 with as little as five to ten patients
16:33 data because this population is a deadly
16:36 population and we also are we have
16:40 already submitted as I said the protocol
16:42 for cancer and IND for that and large
16:46 pharma discussion is going on right now
16:48 we are we do have as we have said to the
16:50 public non-binding term sheet from
16:53 commercialization companies who want to
16:55 commercialize the first quarter billion
16:57 dollars of the product by themselves so
16:59 we hope to have that happen this year so
17:02 we believe we are very very close to the
17:05 inflection point that all the biotech
17:08 companies live for that day and heading
17:10 our primary endpoint and being able to
17:12 go in front of FDA for the final
17:14 application to be approved is a unique
17:17 opportunity and we have that so with
17:19 that I will go to any questions that you
17:22 might have not there thank you that was
17:26 that was great looks like we have a
17:30 bunch of questions so hopefully you'll
17:33 have it you'll have an opportunity to
17:34 ask to answer them
17:36 okay so we'll first start off with a
17:38 question that came in last night from
17:42 Seth he asks saito Dynes
17:45 commercialization plan for ali ron lee
17:47 map question mark i guess what's your
17:50 commercialization plan and also
17:52 financing it in financing plan until
17:55 revenues begin
17:57 mark yeah absolutely so you're in
18:01 regards harsh realization that's a whole
18:03 different set of that you'll have to
18:05 have but there are very large
18:08 organization like seniors help that help
18:11 the big form was to launch their product
18:14 into the market when they get approved
18:16 we already have engage with seniors and
18:19 we got our go alone commercialization
18:22 plan where we can actually take it to
18:24 the market ourselves because we're so
18:26 close to that point and we are going to
18:30 put that plan actually tour in our
18:32 website so everybody can see how we are
18:36 planning to accomplish that as we said
18:39 we do have non-binding term sheet where
18:41 the you know the other commercialization
18:43 companies want to sell the product and
18:46 they will take care of all the you know
18:49 all the cost associated with
18:52 commercialization to launching a product
18:54 so we we are working with many others
18:57 avenues but we are able to put together
19:00 infrastructure ourself and do this start
19:03 the cells ourselves if we have to again
19:05 it will cost quite a bit of funding but
19:07 we believe our stock would be at a whole
19:09 different level at that time in regards
19:11 to financing in the last five years we
19:15 took this product from phase 2 all the
19:17 way to the point that we are with many
19:19 of potential indications now and usually
19:23 FDA has indicated it takes about a
19:25 billion to a billion and a half to get a
19:28 product to the market we have done that
19:31 with two hundred million dollars and we
19:34 are able to raise that much money
19:37 starting from Phase two so raising more
19:40 funds right now maybe another 15 20
19:42 million to just get to the finish line
19:44 of revenue hopefully is not the going is
19:48 any big concern of us we have a very
19:50 strong banking investment banking that
19:54 have done a tremendous job for us so if
19:56 you have to raise a little bit more
19:58 money and deluded a little bit more all
20:00 of our shareholders for that in order to
20:02 get to the finish line okay so next
20:06 questioner it looks like we have a few
20:08 questions from
20:09 so kurtsyn asks are you prepared for
20:13 potential rapid rollout of sales if FDA
20:16 approval comes yes absolutely so the
20:20 seniors plan that we have received is
20:24 very strong I mean details that it did
20:28 it has a detailed steps of how to go
20:31 forward and what to do however as we
20:34 said we believe we will be using the
20:37 infrastructure of other
20:38 commercialization companies who are well
20:40 suited and ready to go forward we have
20:43 two of them that we are engaging right
20:45 now they have come to us and asked us
20:47 you know to sign it term sheet for
20:51 exclusive cells with them so we will be
20:54 evaluating all of those and I'm sure as
20:56 soon as we announce one of those it
20:58 would be very beneficial to our
20:59 shareholders coming to shareholder value
21:02 okay a few more questions from courts in
21:06 here so other than asks other than the
21:09 US FDA are there any other countries
21:12 where approval is in process so that's a
21:16 very good question we will be able to
21:19 get EU approval very quickly right
21:22 afterward but we already announced that
21:24 one of the huge findings that came out
21:27 just a few months ago from dr. Jonas
21:29 Salk after a year of investigating later
21:31 on the map is that this product probably
21:34 have tremendous potential for cure for
21:38 certain patients in HIV and for
21:40 prevention of HIV so he sent his the his
21:44 the result to in a confidential manner
21:48 to Thai Red Cross where they have a
21:50 connection with the largest prevention
21:53 center and they immediately wanted to do
21:56 a study with us and Jonas Sascha dr.
21:59 Sasha got fundings for this study 50
22:02 patient prevention in Thailand and we
22:05 signed a Memorandum of Understanding so
22:08 obviously we would be getting approval
22:10 in Thailand also if that goes forward
22:12 and dr. Jonas Sasha hopefully will be
22:15 announcing his findings in a published
22:18 paper by the end of the year which we
22:20 believe will bring major media attention
22:22 to our company
22:24 okay next question comes in from our
22:27 Ronald so Ronald asks okay I don't know
22:32 if I can use this name here okay so as
22:33 far as I know it's a celebrity name has
22:37 been on leer on limiter 140 as amount of
22:40 therapy against HIV from multiple years
22:43 now he seems to be doing great have you
22:45 contacted him recently asked him to
22:49 testify about how great he's doing
22:52 because of Lee Ron Lee mAb for 140 so
22:56 the question is have I contacted this
22:58 gentleman or the lady I don't know I
23:01 said it's a you know I think you all was
23:03 on the dr. Oz Show oh I see so yeah so
23:09 we we do not talk about any patient
23:12 unless they sign a consent form and
23:15 allow us to talk about their conditioner
23:17 if they don't which me no patient does
23:19 then we can only repeat what the
23:22 celebrities themselves that use this
23:24 product talk about in a public for
23:27 example when Charlie Sheen has spoke
23:29 about that interview and he talked about
23:32 how great he felt we repeated that when
23:36 he stopped talking about it then we
23:37 stopped talking about you know patients
23:39 we cannot talk about any of the patients
23:41 unless they first go public and say
23:43 something and we can only repeat those
23:46 because anybody okay so next question
23:50 again all from Ronald asks recently a
23:53 lady with a test at triple negative
23:55 breast cancer did get liver on the map
23:58 as a treatment will the market be
24:00 informed about how she's were reacting
24:03 to Iran we map the status of her CT see
24:06 if so when do you expect the market to
24:09 inform so that's a very good question
24:13 this CT see that this person is talking
24:15 about obviously that this person is
24:17 educated about that
24:19 it's called circulating tumor cells so
24:22 if you have a tumor cancer cell and the
24:24 cells are going to go travel through
24:27 your bloodstream to go to your long go
24:29 to the liver to metastasize there which
24:32 would then kill the patient
24:33 it has to go through the bloodstream so
24:36 if you are able to
24:37 measure those tumors that are in the
24:39 bloodstream that's just a blood test
24:40 which does their Massimo crystal finale
24:43 I'll talk to FDA and they use this as a
24:46 secondary endpoint now the mass
24:48 democracy finale is our principal
24:50 investigator for this trial but we are
24:53 enrolling only naive population who just
24:56 got triple negative breast cancer or
24:58 were taking care of and it's the cancer
25:02 came back otherwise we cannot enroll
25:04 second or third or fourth line therapy
25:06 because they are terminal patients
25:08 however FDA has asked us to allow
25:12 terminal patients to be enrolled so we
25:15 filed an IND for emergency IND for this
25:18 one patient and we enrolled them into
25:21 the triple negative breast cancer
25:22 expanded access now we are measuring CTC
25:26 but it would take a month or two before
25:27 we are able to compare these two
25:30 different CDC points time or three four
25:33 of them at least and be able to then
25:34 talk about it okay we have a we've about
25:38 five more questions another hope you
25:40 have time okay so Ronald Ronald the asks
25:45 again are you still in talks regarding
25:47 out licensing partnering regarding the
25:50 prognostic a cancer test absolutely as a
25:54 matter of fact after this column
25:56 supposed to Vienna on another call
25:57 because on August 28th we do have a
26:00 meeting with FDA that there are
26:04 interested parties to develop this
26:06 together if we are able to you know have
26:10 the negotiation done with them where we
26:12 are able to partner with them then we go
26:14 forward with them otherwise we will have
26:16 to figure out a plan for ourselves to go
26:18 forward so we are still working with
26:21 them nothing has slowed down on that in
26:23 that regard so that's going forward and
26:25 I'm hoping to talk about that hopefully
26:28 after August 28th FDA MIDI okay another
26:32 question from Kirsten what is your
26:34 current runway with financing on hand
26:36 any expectations to raise equity
26:39 financing so we do need maybe another
26:42 ten million dollars or so to get past be
26:46 a late submission and perhaps get to the
26:49 end of the year you know maybe 50
26:51 million or so would get us to the end of
26:52 the year so we want to be very cautious
26:54 here though our stock has been taken
26:57 beating I mean when you raise two
26:59 hundred million dollars in four or five
27:00 years in the OTC D market
27:03 it's amazing that you could sell almost
27:05 a hundred million shares a year on OTC
27:07 be our volume has been very high so we
27:10 want to be very careful because this
27:11 talk has taken a lot of beating and
27:13 because we're very very close to some
27:15 major inflection point in my opinion and
27:18 now when that happens in a month or two
27:21 months or by the end of the year we
27:23 don't know so will it be fair all the
27:24 fund raising as much as possible we will
27:27 do small fund raising here and there and
27:29 we are engaged always you know trying to
27:32 look at opportunities for a small amount
27:33 just to take us to the next level and
27:35 hopefully see that big jump on the stock
27:38 and then we can bring more funding okay
27:42 next question comes in from Paul Paul
27:49 asks are there any concerns about your
27:51 non dilute of cash requirements to get
27:54 through the PLA so when you say are
27:59 there any really content of a non
28:01 diluted the non dilute evil we just did
28:05 a tender offer which we offer our
28:07 warrant holders to exercise their
28:09 warrant and give him a little bit more
28:11 shares we raised fifteen million dollars
28:14 and we were given out maybe about 17 18
28:18 million new shares so it was a lowest
28:22 dilution we ever had any any of our race
28:25 so that fifty million really got us to
28:28 the point where we are very very close
28:30 now today being able to finish the year
28:33 perhaps with a little bit more raise we
28:36 were hoping to raise 30 at that time
28:38 with tender offer but we did get 15 that
28:40 30 we are working with non derivatives
28:43 fundraising right now and we are hoping
28:46 to be able to announce some of those
28:47 very soon but we want to get the best
28:49 deal we don't wanna you know be hasty
28:52 and rush to anything I mean we do have a
28:55 time on our side because the approval is
28:58 coming and end of you know submitting
29:01 the VLA is coming either
29:03 major milestone that any biotech company
29:05 will spend 10 20 years and billions of
29:08 dollars just to get to this point and
29:10 we're almost there so we want to be very
29:12 cautious and evaluate every Avenue very
29:14 carefully okay uh let's say I think that
29:18 was it the last question we will see and
29:20 if anybody has any questions uh last
29:24 chance to get it in okay I'm not there I
29:28 think that would that was it for the
29:29 questions there's a lot of questions
29:30 tonight again thank you and I want to
29:35 thank everybody who's on the call today
29:39 and the conference today for joining us
29:41 we had some really great companies and
29:45 you know we look forward to having you
29:48 on board for our next event thank you
29:52 again for everybody
with auto transcript
https://www.youtube.com/watch?time_continue=2...v1mzWC80TI
00:01 you
00:10 Saito Donegan is our final presenter
00:12 today a stock symbol is C y dy and the
00:16 CEO is dr. not there poor Hassan you
00:19 know many of you who are subscribers to
00:21 Wall Street or have been you know
00:23 following Saito dynast since you know we
00:25 first interviewed that there back in
00:28 January and you know what I find most
00:31 compelling about this biotech story is
00:33 that the company you know has a
00:35 game-changing therapy for HIV which
00:39 finished you know its phase three and is
00:42 now expecting to receive FDA approval
00:44 which is imminent so potentially they
00:49 can hit the market next year start
00:50 generating significant revenues and
00:53 they're targeting really a multi-billion
00:55 dollar opportunity so the the revenues
00:58 are you know looks like they're around
01:01 the corner so this is not one of these
01:02 you know biotech stories which you know
01:05 is revenues are you know decades away on
01:08 top of you know the near-term revenue
01:10 potential you know cited on also the
01:12 pipeline of drugs targeting cancers and
01:16 you know not there we'll get into more
01:18 of that in the presentation so enough
01:21 about you know you know what I have to
01:23 say let's let's go directly to the
01:25 source and hear about this exciting
01:27 story so yeah please welcome dr. not
01:31 dare poor Hassan
01:33 thank you jack I appreciate it and great
01:35 to be here
01:37 the product that we have is called Lear
01:39 on the map for 140 the last present
01:43 presented presented a very beautiful
01:46 technology that I'm also excited about
01:49 that but in the world of health space
01:52 drug development FDA recognizes that one
01:56 out of 5,000 drugs make it to approval
01:59 now just keep in mind that if you make
02:01 it to that football you raise money to
02:04 get this drug whatever drug you're
02:06 working on together to the approval if
02:07 it gets approval all the shareholder is
02:10 going to rip the harvest big time
02:12 because the your stock will go to
02:15 multiple and that's the way it was in a
02:17 world of biotech the stock will not do
02:19 anything till you do substantial have to
02:23 show substantial
02:24 progress in your drug development so
02:26 with that our product is pro 140 in the
02:29 literature but recently the name is now
02:31 only Ronda map it's in the it's a hat
02:34 indication in the world of HIV cancer
02:37 nash GVHD and i will be talking about
02:40 that as we go forward now my next slide
02:44 talks about that this everything we say
02:46 here is forward-looking statement and
02:48 the third slide that I'm on is our cited
02:51 an overview it's amazing when I present
02:54 this story I get excited more than
02:56 anybody myself because the fact that in
02:59 the biotech world when you're a public
03:02 company you have FDA communication so
03:06 whatever you put out if the FDA did
03:09 something little bit off they
03:12 immediately shut you down they call you
03:14 they put you on hold so whatever I'm
03:16 presenting here it's the stuff that we
03:18 didn't make up it's FDA has the
03:21 communication and it's all backed up by
03:23 that and we talk in our press releases
03:25 about all of these the reason I'm saying
03:27 all this is because the story just seems
03:29 to be very too good to be true and
03:31 seeking off I actually talked about that
03:34 and we had to talk to with the reporter
03:36 and they are everybody gets it made when
03:38 they look underneath the hood with this
03:40 company so in regard to HIV or
03:43 combination therapies our first approval
03:45 going forward and as the Jack indicated
03:48 we are going to have our hopefully final
03:52 application submitted to FDA for final
03:54 approval which is a PLA biologic license
03:57 application by the end of September now
03:59 what that means is you have have all the
04:02 hurdles phase 1 a 1 B 2 a 2 B and 3 and
04:06 pivotal trial we passed that and our
04:09 responders it was great now in this
04:11 world of HIV patients already have good
04:15 drugs out there so you're going to have
04:16 to have something that helps patients
04:18 who cannot take drugs as easily or they
04:21 don't have those options their
04:22 resistance and combination therapy or
04:24 product saved some lives in order to try
04:27 perhaps because they were resistant to
04:29 most of the drugs out there but the news
04:32 that we made big time news is about mono
04:35 therapy when dr. oz actually asked me
04:37 you go to the short celebrity started
04:39 getting involved fish the celebrities
04:42 that have HIV the mono therapy showed
04:45 that patient can for the first time in
04:47 their life put away all their drugs so
04:49 they don't have to worry about taking
04:50 drug that exact time every day for the
04:52 rest of their life and just enjoy subcu
04:54 injection once one time once a week that
04:58 means they will be finished with once a
04:59 week treatment and the patients who come
05:02 we're able to use that some of them have
05:04 gone off five years without any standard
05:08 of care so that's why when I present
05:10 this story I'd say this is no longer a
05:13 high-risk high-reward company this is
05:15 very low risk as we have the risk
05:18 most of the stuff as we have Heather
05:19 primary endpoint and finish the trial
05:22 met with FDA and going for our DLA
05:25 submission for combination therapy and
05:27 mono therapy is in parallel being
05:29 developed as we went forward with this
05:32 company we realized that Pfizer ccr5
05:35 antagonist which is what we are ccr5
05:38 antagonists or product is CCO who binds
05:41 to ccr5 they had the success with graph
05:44 versus host disease that they
05:46 accidentally found out about their HIV
05:48 product so we did a small in vitro study
05:52 and since we had a lot of data out there
05:54 for safety FDA gave us Phase two for
05:56 another indication graft-versus-host
05:58 disease we did the same thing with the
06:01 triple negative breast cancer because we
06:03 realized that there is published
06:05 document out there saying that ccr5
06:08 antagonists are the way of new futures
06:10 the future of new therapies in the world
06:14 of cancer or again animal study was
06:16 spectacular FDA granted us phase one B -
06:19 - we did the same thing with colon
06:21 cancer we just submitted the protocol
06:24 and we also have a prognostic test that
06:28 we will talk about but the list of
06:30 things that's going on is really amazing
06:32 there in regards to cancer because we
06:34 believe our product could stop the
06:36 metastasis of cancer the key opinion
06:40 leaders urges to check this for melanoma
06:42 melanoma pancreatic prostate lung liver
06:46 and stomach cancer and those animal
06:48 studies are going forward also
06:51 so the next slide I just want to show
06:52 you when we started with this product
06:54 and we compare our product with a
06:57 standard of care see how much better RV
06:59 what benefits are there for this product
07:01 at the earliest age in about 2006 FDA
07:06 had look at the data at that time and
07:08 gave this product fast track designation
07:10 with rolling the fast track designation
07:12 with accelerated approval possible NIH
07:17 has given a twenty eight million dollars
07:19 of the grant the reason for those
07:21 excitement was with this product leer
07:25 only map there was advantages in the
07:28 area of side effect toxicity resistance
07:31 and compliance side effect as of now we
07:33 have over 800 patient use this product
07:36 and zero serious adverse event related
07:38 to the Rhondda map has been found this
07:41 is incredible results by the way if
07:43 you're familiar with this space you
07:45 don't find product like that toxicity
07:48 negligible resistance we have patients
07:51 who have gone five years with zero
07:52 resistance if you give them if you give
07:55 a patient in HIV world any product by
07:58 itself without combining it
08:00 they build resistance very quickly about
08:02 six months or so compliance
08:04 taking pills three four pills in exact
08:07 time every day it's very difficult and
08:09 taking an injection sub-q underneath the
08:12 skin like diabetes do many times in a
08:15 week they can just do this once a week
08:18 probably two minutes a week and they're
08:20 done so what happens with our Phase
08:23 three
08:24 why are we so excited that this phase
08:26 three was such a great result we had a
08:29 great result our p-value was point zero
08:31 zero three two and our trial end up
08:34 having eighty one percent of these
08:36 patients who have very limited options
08:38 left with their current standard of care
08:40 eighty-one percent end up having
08:42 suppressed viral load some of them first
08:44 time in twenty years they had suppressed
08:46 viral load the last product approved for
08:49 that population had 43% suppressed viral
08:53 load so we all practically doubled them
08:55 again no report of series at this event
08:57 which is very important to patients and
09:00 FDA going forward
09:01 VLA biologic license after
09:04 and final application for final approval
09:06 1/3 was already submitted because FDA
09:09 gave us rolling vbu
09:10 submission that means the FDA is
09:12 reviewing that and the other 2/3 will be
09:14 hopefully by the end of September now
09:18 what's the value of this card well if
09:20 you look at the columns that are that I
09:22 have put on this slide - claps
09:24 resistance is with the limited treatment
09:27 option or three claps resistant can take
09:30 this product once it's actual if the
09:32 patient is or five there's a test for
09:35 that to check that the strain is our
09:36 file usually 70% of all HIV patients or
09:40 have our five resist or five a strain of
09:43 HIV so the next slide shows that in the
09:46 first 18 months that we get to the
09:48 market we're going to sell the product
09:50 for the same price that they're selling
09:51 another antibody in that mark in that
09:54 space that antibody patients have to go
09:56 to hospital for IV one our IB are this
10:00 self injectable at home and they're
10:03 selling for one hundred eighteen
10:04 thousand for the first 18 months or so
10:07 we will sell at 120 thousand dollars per
10:10 year per patient but going forward post
10:13 18 months we could drop the price
10:15 substantially as we will be
10:17 manufacturing it as one of the largest
10:19 biologic manufacturing who have just
10:21 granted us an agreement that I would be
10:23 talking about that so as you can see in
10:25 this slide the revenue will be
10:28 significant going forward they agree
10:32 mother I'm talking about it in this
10:34 slide I did go to South Korea to sign
10:37 this agreement with a CEO of Samsung
10:39 biologics they are going to produce
10:43 quite a bit of product in the overall
10:46 agreement allow us to have seven billion
10:48 dollars worth of product that 7 billion
10:50 is evaluated at $120,000 per year per
10:53 patient but the first 1 billion will not
10:56 be charged to us till later which is
10:58 very important to a small company like
11:00 us we do not want to raise funds for
11:02 that at this time so we were very happy
11:04 to be able to get granted you know
11:07 deferred payment which is something
11:09 Samsung has not given it to other
11:11 customers according to them so the last
11:14 slide in HIV is
11:17 respondents rate to FDA they wanted our
11:19 mono therapy where you patient can put
11:22 away all the standards of care they
11:24 wanted us to have a higher responders
11:26 rate than what we had before when we
11:28 went to FDA and in this slide we show
11:31 that it is five hundred twenty five
11:33 milligram after 31 weeks duration
11:35 average the patient's ninety-five
11:38 percent had suppressed viral load post
11:40 ten weeks we have to evaluate them in
11:42 the first ten weeks of mono therapy to
11:45 find out the responders so I said at the
11:49 very beginning that this product had
11:50 multiple indication potentially one of
11:55 them was GVHD and we said that Pfizer
11:57 accidentally found out that their
11:59 product had indications in this slide
12:02 you can see that when we did our in
12:04 vitro study for graft-versus-host
12:07 disease to see if leer on the map has
12:09 any indication in that space we
12:13 immediately gave the in-vitro result
12:15 that was positive to FDA and they give
12:17 us a Phase two we are very happy about
12:19 that because phase two cost about one
12:21 hundred million dollars from scratch to
12:23 you know to get to that phone from
12:25 discovery to the Phase two and we did it
12:29 with fifteen or twenty thousand dollars
12:31 now we asked a fee for orphan drug
12:33 designation they said you don't have any
12:35 animal study why don't you take 32 mice
12:38 group I mean a and B as you see in this
12:40 slide and they said if you give if this
12:45 mice are injected with human bone marrow
12:48 they're all going to die but if you give
12:50 it probe on 40 Lear on the map and some
12:53 of them stay alive then we will give you
12:55 orphan drug designation a hundred
12:58 percent of the mice who Godley round the
13:00 map stayed alive after receiving human
13:03 bone marrow transplant marrow injections
13:06 and the left slide you can see clearly
13:08 the red line the weight of the mice was
13:10 going up but then the blue line they
13:12 were going down and the right side is a
13:15 shocking result the red line no my side
13:18 for the blue line all the mice who did
13:20 not receive litter on the map died we
13:22 published this dis findings in a
13:25 peer-reviewed journal and have many
13:28 interests parties wanting to have a
13:30 presenting dinner conferences but the
13:33 next slide is even more exciting the
13:35 next slide shows that the animal study
13:37 indicated the middle row that if you
13:40 inject the mice with a lot of metastases
13:42 cells there are nothing they literally
13:46 map stops metastases the very first row
13:49 shows that mice will die but the second
13:52 line second row show that the might went
13:55 seven weeks which is equivalent to 70 70
13:59 years of human life and I'm sorry 70
14:03 months of human life so this was very
14:06 interesting finding and when when we
14:09 went to ten weeks which is equivalent to
14:12 ten years of human life with the middle
14:15 ear only map no metastases we submitted
14:19 those data to the FDA again we got
14:21 triple negative breast cancer phase two
14:23 and the result of mice was strong enough
14:25 and we received fast track designation
14:27 for this indication so what that means
14:31 that we did with the all the cancer
14:36 indication perhaps we can go ahead and
14:38 explore them because if metastasis is
14:40 the stop that means that tumor cell that
14:43 has chanted only the one that have ccr5
14:47 on it can have a signal that would allow
14:49 them get out of this cancer tumor and go
14:51 somewhere else and metastasize and home
14:54 in their liver lung or wherever so if we
14:57 stop that that means we stop metastases
14:59 which means we can have indication many
15:02 of the cancers that's why we now have
15:05 triple negative breast cancer and colon
15:07 cancer
15:08 phase two submitted to the FDA the first
15:11 one we granted to go forward with it but
15:13 colon cancer the protocol was just
15:15 submitted and we're waiting for FDA to
15:17 give us green light for that so there
15:20 are quite a bit of milestone ahead of us
15:22 triple negative breast cancer we should
15:24 be injecting the first patient in a
15:27 naive setting we already injected the
15:29 first patient who was in a third line
15:31 therapy and the expanded access FDA
15:34 requires us to allow terminal patients
15:37 have this product so we are giving it to
15:39 those who
15:47 request through the website we have a
15:50 report a mutation PLA supposed to be the
15:52 intercept band initiating of pivot touch
15:55 miles monitor be the first monetary
15:57 pivot turtles the world of HIV could
15:59 happen here as a meeting with the FDA to
16:02 finalize our protocol graft-versus-host
16:04 disease we hope to inject the
16:06 prostitution intercept compare and have
16:08 some insurances of this year and
16:10 prognostic test for prostate which is
16:12 completely different thing with a
16:14 diagnostic that we are going forward to
16:16 meet with FDA and see if we can get
16:18 approval for using that triple negative
16:22 breast cancers interim results will be
16:24 very exciting because if we do stop the
16:26 metastases and demonstrate that in a six
16:29 month period we could get up forward
16:31 with as little as five to ten patients
16:33 data because this population is a deadly
16:36 population and we also are we have
16:40 already submitted as I said the protocol
16:42 for cancer and IND for that and large
16:46 pharma discussion is going on right now
16:48 we are we do have as we have said to the
16:50 public non-binding term sheet from
16:53 commercialization companies who want to
16:55 commercialize the first quarter billion
16:57 dollars of the product by themselves so
16:59 we hope to have that happen this year so
17:02 we believe we are very very close to the
17:05 inflection point that all the biotech
17:08 companies live for that day and heading
17:10 our primary endpoint and being able to
17:12 go in front of FDA for the final
17:14 application to be approved is a unique
17:17 opportunity and we have that so with
17:19 that I will go to any questions that you
17:22 might have not there thank you that was
17:26 that was great looks like we have a
17:30 bunch of questions so hopefully you'll
17:33 have it you'll have an opportunity to
17:34 ask to answer them
17:36 okay so we'll first start off with a
17:38 question that came in last night from
17:42 Seth he asks saito Dynes
17:45 commercialization plan for ali ron lee
17:47 map question mark i guess what's your
17:50 commercialization plan and also
17:52 financing it in financing plan until
17:55 revenues begin
17:57 mark yeah absolutely so you're in
18:01 regards harsh realization that's a whole
18:03 different set of that you'll have to
18:05 have but there are very large
18:08 organization like seniors help that help
18:11 the big form was to launch their product
18:14 into the market when they get approved
18:16 we already have engage with seniors and
18:19 we got our go alone commercialization
18:22 plan where we can actually take it to
18:24 the market ourselves because we're so
18:26 close to that point and we are going to
18:30 put that plan actually tour in our
18:32 website so everybody can see how we are
18:36 planning to accomplish that as we said
18:39 we do have non-binding term sheet where
18:41 the you know the other commercialization
18:43 companies want to sell the product and
18:46 they will take care of all the you know
18:49 all the cost associated with
18:52 commercialization to launching a product
18:54 so we we are working with many others
18:57 avenues but we are able to put together
19:00 infrastructure ourself and do this start
19:03 the cells ourselves if we have to again
19:05 it will cost quite a bit of funding but
19:07 we believe our stock would be at a whole
19:09 different level at that time in regards
19:11 to financing in the last five years we
19:15 took this product from phase 2 all the
19:17 way to the point that we are with many
19:19 of potential indications now and usually
19:23 FDA has indicated it takes about a
19:25 billion to a billion and a half to get a
19:28 product to the market we have done that
19:31 with two hundred million dollars and we
19:34 are able to raise that much money
19:37 starting from Phase two so raising more
19:40 funds right now maybe another 15 20
19:42 million to just get to the finish line
19:44 of revenue hopefully is not the going is
19:48 any big concern of us we have a very
19:50 strong banking investment banking that
19:54 have done a tremendous job for us so if
19:56 you have to raise a little bit more
19:58 money and deluded a little bit more all
20:00 of our shareholders for that in order to
20:02 get to the finish line okay so next
20:06 questioner it looks like we have a few
20:08 questions from
20:09 so kurtsyn asks are you prepared for
20:13 potential rapid rollout of sales if FDA
20:16 approval comes yes absolutely so the
20:20 seniors plan that we have received is
20:24 very strong I mean details that it did
20:28 it has a detailed steps of how to go
20:31 forward and what to do however as we
20:34 said we believe we will be using the
20:37 infrastructure of other
20:38 commercialization companies who are well
20:40 suited and ready to go forward we have
20:43 two of them that we are engaging right
20:45 now they have come to us and asked us
20:47 you know to sign it term sheet for
20:51 exclusive cells with them so we will be
20:54 evaluating all of those and I'm sure as
20:56 soon as we announce one of those it
20:58 would be very beneficial to our
20:59 shareholders coming to shareholder value
21:02 okay a few more questions from courts in
21:06 here so other than asks other than the
21:09 US FDA are there any other countries
21:12 where approval is in process so that's a
21:16 very good question we will be able to
21:19 get EU approval very quickly right
21:22 afterward but we already announced that
21:24 one of the huge findings that came out
21:27 just a few months ago from dr. Jonas
21:29 Salk after a year of investigating later
21:31 on the map is that this product probably
21:34 have tremendous potential for cure for
21:38 certain patients in HIV and for
21:40 prevention of HIV so he sent his the his
21:44 the result to in a confidential manner
21:48 to Thai Red Cross where they have a
21:50 connection with the largest prevention
21:53 center and they immediately wanted to do
21:56 a study with us and Jonas Sascha dr.
21:59 Sasha got fundings for this study 50
22:02 patient prevention in Thailand and we
22:05 signed a Memorandum of Understanding so
22:08 obviously we would be getting approval
22:10 in Thailand also if that goes forward
22:12 and dr. Jonas Sasha hopefully will be
22:15 announcing his findings in a published
22:18 paper by the end of the year which we
22:20 believe will bring major media attention
22:22 to our company
22:24 okay next question comes in from our
22:27 Ronald so Ronald asks okay I don't know
22:32 if I can use this name here okay so as
22:33 far as I know it's a celebrity name has
22:37 been on leer on limiter 140 as amount of
22:40 therapy against HIV from multiple years
22:43 now he seems to be doing great have you
22:45 contacted him recently asked him to
22:49 testify about how great he's doing
22:52 because of Lee Ron Lee mAb for 140 so
22:56 the question is have I contacted this
22:58 gentleman or the lady I don't know I
23:01 said it's a you know I think you all was
23:03 on the dr. Oz Show oh I see so yeah so
23:09 we we do not talk about any patient
23:12 unless they sign a consent form and
23:15 allow us to talk about their conditioner
23:17 if they don't which me no patient does
23:19 then we can only repeat what the
23:22 celebrities themselves that use this
23:24 product talk about in a public for
23:27 example when Charlie Sheen has spoke
23:29 about that interview and he talked about
23:32 how great he felt we repeated that when
23:36 he stopped talking about it then we
23:37 stopped talking about you know patients
23:39 we cannot talk about any of the patients
23:41 unless they first go public and say
23:43 something and we can only repeat those
23:46 because anybody okay so next question
23:50 again all from Ronald asks recently a
23:53 lady with a test at triple negative
23:55 breast cancer did get liver on the map
23:58 as a treatment will the market be
24:00 informed about how she's were reacting
24:03 to Iran we map the status of her CT see
24:06 if so when do you expect the market to
24:09 inform so that's a very good question
24:13 this CT see that this person is talking
24:15 about obviously that this person is
24:17 educated about that
24:19 it's called circulating tumor cells so
24:22 if you have a tumor cancer cell and the
24:24 cells are going to go travel through
24:27 your bloodstream to go to your long go
24:29 to the liver to metastasize there which
24:32 would then kill the patient
24:33 it has to go through the bloodstream so
24:36 if you are able to
24:37 measure those tumors that are in the
24:39 bloodstream that's just a blood test
24:40 which does their Massimo crystal finale
24:43 I'll talk to FDA and they use this as a
24:46 secondary endpoint now the mass
24:48 democracy finale is our principal
24:50 investigator for this trial but we are
24:53 enrolling only naive population who just
24:56 got triple negative breast cancer or
24:58 were taking care of and it's the cancer
25:02 came back otherwise we cannot enroll
25:04 second or third or fourth line therapy
25:06 because they are terminal patients
25:08 however FDA has asked us to allow
25:12 terminal patients to be enrolled so we
25:15 filed an IND for emergency IND for this
25:18 one patient and we enrolled them into
25:21 the triple negative breast cancer
25:22 expanded access now we are measuring CTC
25:26 but it would take a month or two before
25:27 we are able to compare these two
25:30 different CDC points time or three four
25:33 of them at least and be able to then
25:34 talk about it okay we have a we've about
25:38 five more questions another hope you
25:40 have time okay so Ronald Ronald the asks
25:45 again are you still in talks regarding
25:47 out licensing partnering regarding the
25:50 prognostic a cancer test absolutely as a
25:54 matter of fact after this column
25:56 supposed to Vienna on another call
25:57 because on August 28th we do have a
26:00 meeting with FDA that there are
26:04 interested parties to develop this
26:06 together if we are able to you know have
26:10 the negotiation done with them where we
26:12 are able to partner with them then we go
26:14 forward with them otherwise we will have
26:16 to figure out a plan for ourselves to go
26:18 forward so we are still working with
26:21 them nothing has slowed down on that in
26:23 that regard so that's going forward and
26:25 I'm hoping to talk about that hopefully
26:28 after August 28th FDA MIDI okay another
26:32 question from Kirsten what is your
26:34 current runway with financing on hand
26:36 any expectations to raise equity
26:39 financing so we do need maybe another
26:42 ten million dollars or so to get past be
26:46 a late submission and perhaps get to the
26:49 end of the year you know maybe 50
26:51 million or so would get us to the end of
26:52 the year so we want to be very cautious
26:54 here though our stock has been taken
26:57 beating I mean when you raise two
26:59 hundred million dollars in four or five
27:00 years in the OTC D market
27:03 it's amazing that you could sell almost
27:05 a hundred million shares a year on OTC
27:07 be our volume has been very high so we
27:10 want to be very careful because this
27:11 talk has taken a lot of beating and
27:13 because we're very very close to some
27:15 major inflection point in my opinion and
27:18 now when that happens in a month or two
27:21 months or by the end of the year we
27:23 don't know so will it be fair all the
27:24 fund raising as much as possible we will
27:27 do small fund raising here and there and
27:29 we are engaged always you know trying to
27:32 look at opportunities for a small amount
27:33 just to take us to the next level and
27:35 hopefully see that big jump on the stock
27:38 and then we can bring more funding okay
27:42 next question comes in from Paul Paul
27:49 asks are there any concerns about your
27:51 non dilute of cash requirements to get
27:54 through the PLA so when you say are
27:59 there any really content of a non
28:01 diluted the non dilute evil we just did
28:05 a tender offer which we offer our
28:07 warrant holders to exercise their
28:09 warrant and give him a little bit more
28:11 shares we raised fifteen million dollars
28:14 and we were given out maybe about 17 18
28:18 million new shares so it was a lowest
28:22 dilution we ever had any any of our race
28:25 so that fifty million really got us to
28:28 the point where we are very very close
28:30 now today being able to finish the year
28:33 perhaps with a little bit more raise we
28:36 were hoping to raise 30 at that time
28:38 with tender offer but we did get 15 that
28:40 30 we are working with non derivatives
28:43 fundraising right now and we are hoping
28:46 to be able to announce some of those
28:47 very soon but we want to get the best
28:49 deal we don't wanna you know be hasty
28:52 and rush to anything I mean we do have a
28:55 time on our side because the approval is
28:58 coming and end of you know submitting
29:01 the VLA is coming either
29:03 major milestone that any biotech company
29:05 will spend 10 20 years and billions of
29:08 dollars just to get to this point and
29:10 we're almost there so we want to be very
29:12 cautious and evaluate every Avenue very
29:14 carefully okay uh let's say I think that
29:18 was it the last question we will see and
29:20 if anybody has any questions uh last
29:24 chance to get it in okay I'm not there I
29:28 think that would that was it for the
29:29 questions there's a lot of questions
29:30 tonight again thank you and I want to
29:35 thank everybody who's on the call today
29:39 and the conference today for joining us
29:41 we had some really great companies and
29:45 you know we look forward to having you
29:48 on board for our next event thank you
29:52 again for everybody
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