The same text without timestamps greetings an
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Posted On: 02/27/2019 5:07:09 AM
The same text without timestamps
greetings and welcome to the Saito dine
investment community conference call at
this time all participants are in a
listen-only mode a question-and-answer
session will follow the formal
presentation if anyone should require
operator assistance during the
conference please press star 0 on your
telephone keypad as a reminder this
conference is being recorded it is now
my pleasure to introduce your host
Michael Mulholland chief financial
officer thank you sir
you may begin thank you hello everyone
and thank you for joining us today this
is Michael Mulholland chief financial
officer of sighted I'm joining us on
today's call is our president and CEO
dr. nadir poor Hassan and our chief
medical officer dr. Richard Castel
before we begin it is essential that we
provide you with important cautionary
language related to certain federal
securities laws our remarks during
today's conference call
will include forward-looking statements
forward-looking statements are not
guarantees of future performance and
involve known and unknown risks and
uncertainties and other factors that are
difficult to predict actual results may
be materially different from any future
results expressed or implied by such
forward-looking statements these risks
and uncertainties include among other
matters statements regarding LaRhonda
Maps potential efficacy in certain
immunology and oncology indications the
company's ongoing ability to raise
additional new capital that clinical
trials may not can commence or proceed
as planned
products that appear promising in early
trials may not subsequently prove to be
viable on safety or efficacy grounds
products may not receive regulatory
approval or market acceptance
competition may reduce the commercial
potential of our products we may
experience product recalls manufacturing
issues or product liability and our
patents may be challenged or
unenforceable
although forward-looking statements help
to provide complete information about
the company forward-looking statements
may be less reliable than historical
information the company undertakes no
obligation to update publicly these
forward-looking statements except as
required by law please refer to our
recent quarterly and annual reports
filed with the Securities and Exchange
Commission for more information about
the risks and uncertainties that could
cause actual results to differ
materially versus our current
expectations I will now turn our call
over to dr. nadir paratha knotter thank
you Mike
thank you everyone for participating in
today's site reliance shareholders
conference call before I update all of
our shareholders their owners of our
company
Cyberdyne I would like to quickly
discuss what I believe is in the minds
of most of our shareholders which is
canceiied align fund itself to get to
revenue the simple and short answer is
we believe we can do this and we believe
we can do this much easier than the last
four years and our resume of raising
funds of close to 170 million dollars in
the last seven years speaks for itself
and this is all thanks to Paulson
investments and great trust they have in
our data science and our mission we also
have a spoken in the past about
non-dilutive fundraising and we are
pursuing that in parallel to all of our
other activities from investors with
less knowledge of biotech and drug
development might think one hundred
seventy million dollars that cited I
raised was a lot of money and why do we
still need more funding to get to
revenue this is a great question and I
like to address that
to answer this question I will now read
a couple of paragraphs from a couple of
different articles which anyone can
access from a simple google search the
first one quote various sources indicate
that it can cause more than 1 billion
dollars to bring one product to the
market another article I will quote is
from John Hopkins Bloomberg School of
Public Health called clinical trials
that support FDA approvals of new drugs
have a median cost of 19 million dollars
according to a new study by a team
including researchers from John Hopkins
Bloomberg School of Public Health the 19
million medians figure represents less
than 1% of the average total cost of
developing a new drug which in recent
years have been estimated as between 2
to 3 billion dollars if we accept these
numbers and if we use the lower figure
of 2 billion then we have used less than
10% to get to where we are today
this means excited I had about 170
million dollars worth of expenses in the
last almost 10 years and produce all the
opportunities that many may call it too
good to be true I agree that all we have
accomplished is too good but not too
good to be true but simply true because
facts are clear and those who check the
facts carefully like pulse on investment
I agreed with me because they rely on
facts in today's call I would like to
cover another very important fact about
the amount of expenses cited I had to
get to the point we are today and that
is not only we have produced all the
current opportunities for our
shareholders but we also have about 200
million dollars worth of Lear on the map
GMP products
that more than half our commercial or
phase three great product this is
evaluated at $120,000 per patient per
year current price for the same
indication now please let me stay this
fax one more time even though it seems
too good to be true but it is true while
it is too good that we used less than
10% of what normally take to have the
following opportunities one mono therapy
successful investigative trial in my
opinion that could lead to first phase
three pivotal trial of HIV for the only
sub-q weekly injectable humanized
monoclonal antibody for HIV space and
number two or be la that everybody knows
about biologic license applications we
are hopeful that if all goes well we
will be having revenue from that that
path in 2020 number three is GVHD
Phase two since the GVHD
graft-versus-host disease with orphan
drug designation already given to us
number four phase one B - two triple
negative breast cancer with orphan drug
designation file number five with the
prognostic test that could be in
licensing agreements this year and
number six eight preclinical trials that
was just recently announced that we are
engaging - in and the last is an amazing
amount of commercial / Phase three
product that could give us back quite a
bit of or expenses that we have used to
get to this point when we get revenue so
with all these explanation in regards to
our expenses I will now update you on
current sided ice activity
my first item of update is the subject
of non-dilutive financing in regards to
commercializing lire on the maps I
designed do have a plan for
commercializing of lire on the map
program for you that could also lead to
non diluted financing sorry rank
currently is in discussions with
commercialization pharmaceuticals the
right of sales of lire on the map with
different pharmaceuticals and as of now
we are evaluating offers for the right
of commercialization of the only map for
certain indication for several millions
of dollars of upfront payment and
milestone payments we are in the process
of evaluating our counteroffer to these
offers detail of whether we accept or
reject any of these offers will be
shared with everyone at an appropriate
time because of the interest like this
in commercialization rights for pro lire
on the map we are now interviewing
appropriate candidates to hire a
full-time business development person to
be 100% focused in exploring all the
opportunities for literally map for
commercialized commercialization in US
or Europe this person will be in charge
of this program and this is a new role
that we will have inside of that other
non-dilutive fundraising potential will
be covered by doctor to stern in regards
to or prognostic tips in regards to
making product for large revenue after
launch and where is sighted I'm going to
get funding to produce half a billion
dollar water product to kick off our
revenues in most likely 2020 I'm very
pleased so now that sided ein currently
is in discussions with a major biologic
CMO a large biological manufacturing
company this company has given us an
offer
to produce over 500 million dollars
worth of commercial product this amount
is again based on 120,000 per year per
session and the half a billion of
LaRhonda map can be delivered in the
second half of 2020
with delayed payment to late 2020 we
don't have to pay a single dime till the
product is sent to us we like this deal
and are in the process of signing the
final agreement and this should put an
end to it speculation of how would sited
I supply the product to the market
without having any funds for this
purpose this I could say is our first
non-dilutive effort saving Saturday from
the elusive rays of significant amount
in order to have enough lire on the map
for commercialization so now I will
update everyone with our combination
therapy and mono therapy trial so our
PLA is delayed and everyone had seen in
our PowerPoint we have changed at the
second quarter and it might even become
third quarter so let me tell you why as
we work with FDA we have to obey
everything the FDA says which is very
logical and is for the safety of people
in the world
the FDA has read our press releases out
of it and they realize that we have said
that our seven hundred milligram dose
has much better efficacy than 350
milligram
the population that we're going to
submit be la for or included in the
population is patients who have unmet
medical needs they don't have enough
regimen and practically they're on
functional mono therapy when they take
for one for FDA indicated that so you
have two choices one is to redo the
whole trial which would take four to
five
with a 700 milligram but they also
articulated a very good situation for us
they said why don't you just take a
hundred patients from your mono therapy
dad were injected with 700 milligram
which could delay us four to six months
from March time that we give out and
then we will be okay and we will approve
this if all things are in place and if
everything is good with them they will
not make seven hundred milligram an
issue and it was approved this product
for 700 milligram now this is huge for
us because this could give us a better
outcome for the for the result and the
patients could benefit more from our
product but it happens that it would
delay us to second quarter in the second
quarter or maybe end up second third
quarter the reason I say second quarter
or third quarter is because once we
produced a hundred patients data we will
have to see how fast we can get that
data that they asked for and how long
each patient has to go for we are in
discussions with FDA and worst case
scenario is end of third quarter best
case scenario at the end of second
quarter as always we will work very hard
and non-stop to make sure we can make
the best time that as possible as
everyone knows it took us four and a
half years to take a path of that would
have take twenty years with the old path
progeny has in place for pro-1 for the
only map so hopefully our resume is
strong and we will be able to get this
to the finish line of getting be a late
submission quickly as possible in
regards to mono therapy trial we are to
present at CROI on march 4th our
abstract was accepted and we are excited
to go back to croy and say that our last
trial that we presented at CROI that had
only 40% responders rate now is change
and there with a seven hundred milligram
we have much better data and 525
milligram
so that we will follow through but we
are working on our pivotal trial and
once we submit our first part of our BL
a which is already complete
one third of a non-clinical section then
we will follow with our protocol for a
mono therapy pivotal trial so in regards
to our next update which is
graft-versus-host disease we have dr.
Castel who have interviewed the
principal investigators and we are now
ready to reinitiate and we have order RC
or to reinitiate the graft-versus-host
disease hopefully to have data interim
result to look at we also have orphan
drug designation for this indication and
we are going forward as before in
regards to triple negative breast cancer
and other results that we received that
was very positive I will now pass it
over to dr. Paz tell dr. Purcell I think
you Donna um it's good afternoon
everybody
I have three items to touch on as
updates since the last investor
conference the first is to speak briefly
about the prognostic test that can lead
to speak about the new indications in
different cancers for more on the map
and the third is to update the investors
on the orphan drug designation
application to the FDA was recently
filed the prognostic test is a test that
was acquired by Cyberdyne a technology
which is a high very high predictive
value for determining the outcome of the
patient's prostate cancer based on a
gene signature has an algorithm the
current process is we are developing a
kit in collaboration with a strategic
partner and completing analytical
validation with the intent of submitting
a 510 K to the FDA
the second area to to mention is that
based on recent preclinical studies
looking at cancer metastasis and
cooperative studies looking at the
expression of CC
five in a number of different cancers
sited on has elected to conduct
metastatic analyses using a number of
different types of cancers the purpose
of this is we believe that ccr5 is an
important mechanism guiding cancer
metastasis that this may be a general
principle relevant to a variety of
different types of cancers that
overexpressed ccr5 and cited ein has
acquired a research laboratory which has
sophisticated technologies in order to
test this hypothesis i with created a
hierarchy of need focusing on prostate
cancer pancreatic cancer melanoma colon
cancer and lung because these particular
types of metastatic cancers kill
patients quite rapidly and again the
results are based on the strategy is
based on the findings we have in highly
anesthetic human triple negative breast
cancer preclinical studies so again in
order for any cost-effective series and
studies with the intent to use mechanism
of action ccr5 dependent metastasis of
cancers as the over action strategy
the third element i would like to update
investors honors the recent submission
to the FDA of an orphan drug designation
caller on a map based on preclinical
studies the results of these studies
which were using human breast cancer in
a xenograph mouse model demonstrated a
greater than 98% reduction in the
metastatic tumor volume of these animals
and because this was conducted over a
six-week period of time so although the
untreated animal untreated animals
developed massive metastases at six
weeks we were unable to formally to tear
the tester season one I treated mice
clearly will continue to update the
investors on these particular studies
that these provided the compelling and
rational basis for a submission of
orphan drug designation with the FDA
this was announced February 20th so
these are the three highlights from the
oncology component of the company or
which has been positive progress since
the last update and again thank you so
much for you for your time and interest
today back to you know Ellie thank you
dr. Purcell
operator can you please go to Question
and Answer absolutely ladies and
gentlemen at this time we will be
conducting the question-and-answer
session if you would like to ask a
question please press star 1 on your
telephone keypad
the confirmation tone will indicate that
your line is in the question queue you
may press star 2 if you would like to
remove your question from the queue for
participants using speaker equipment and
baby necessary to pick up your handset
before pressing the star keene our first
question is coming from the line of yi
Chen what HD wainwright please proceed
with your question thank you for taking
my question my question is as you plan
to advance rata map into preclinical
studies in multiple cancer indications
what are the timeframes after which we
can expect to see some print preclinical
results thank you dr. Chen for your
question
as I have said before and we are
confident on that that this year we will
have interim results and could be in the
second quarter
that's a little bit you know short
timeframe that's best-case scenario but
worst-case scenario I believe we will
have interim result in third quarters
okay and if you observed positive
results in multiple cancer models
do you rather advanced candidate into
all indications or would you pick one
cancer one or two cancer indications
that are the most promising dr. Patel
could you please answer the following
questions yes it has been an approval
now on one occasion by the FDA of
mechanism as the rationale for treatment
so in this case the rationale would be
cancer type agnostic ccr5 mechanism
mediated cancer and I think this has
been the rationale for more recent drug
approvals for example checkpoint
inhibitors which are PDL one positive
tumors similarly I think the rationale
here and certainly a cultural shift and
a strong push from FDA is to consider
mechanism based therapies in an organ
agnostic way we're going shifting here
from a concept of thinking about
melanoma or pancreatic cancer prostate
cancer rather ccr5 positive metastatic
cancer and testing patients for ccr5 in
their tumor and we're circulating tumor
cells and initiating therapy based on
those criterion that answers your
question yes thank you for the
clarification Thanks Thank You our next
question from the line of Krishna choir
a private investor please proceed with
your question yes sir don't we thank you
all for taking my call as you mentioned
financing through Paulson has been a
billable component cheap the successes
that I'm and tujhe financing is
something that sever means to be a big
question mark
so I find it concerning disconcerning
the recent pay raise
that the executives have ordered
themselves have you rationalized how do
you get to the shareholders not this was
an appropriate take with yourselves
absolutely thank you for your question
and I'd be delighted to answer that
first allow me to remind all our
stockholder everybody that are all
compensation matters for senior
management are handled by compensation
committee of the board of directors
which is compromised comprised solely of
independent directors now it was the
Compensation Committee determination
that management has achieved
extraordinary milestones in recent
months specifically six months for the
long-term benefit of the company and its
shareholders this accomplishment I'd
like to share with everyone
first the completion of an all-stock
acquisition of precision and it's smooth
transition into our company we firmly
believe this acquisition may potentially
reshape and redefine Cyberdyne future
this acquisition brought to our company
first one of the world's pre-eminent
oncologist dr. Richard Estelle who also
served as our chief medical officer and
will also oversee the lead all and undid
all the cancer and other immunological
indications for Leon dmap second one was
a pro portfolio of intellectual property
that provided protection in certain
areas of science that is currently being
explored by Big Pharma
next was a prognostic test in the
prostate prostate cancer area which has
the opportunity to provide a licensing
opportunity and the last was also has
announced last week we now have our own
laboratory facilities which will enable
our company to accelerate evaluating
preclinical and cancer indication now
that's just for the acquisition of the
process in the next accomplishment was
the initiation of Phase one B - to human
trial for triple negative breast cancer
which is truly a significant milestone
stunning results from our mouse model
that prompted not only to fight for
orphan drug designation but initiate
eight new preclinical studies that could
put this little company on eight Phase
two for only a half one and a half to
two million dollars the next
accomplishment was since we announced
our intention to acquire prestige in in
late August 2018 we have raised
approximately 40 million dollars on
terms which have saved the company
approximately 40 million shares of
dilution compared to the offering terms
in the prior 18 months to that so we
paid 27 million shares for all the stuff
we have received from processing
acquisition and pay 27 million from this
40 million saving that transgene cause
that is specifically dr. Richard Castel
truly amazing in my opinion management
has been actively engaged in discussion
with several parties for licensing
agreement as I Anna and as I just
mentioned we now have offers on the
table for significant amount of upfront
non diluted cash and milestones now we
will send our counteroffer and the
shareholders will know exact situation
with these offers at the appropriate
time and then lastly the management has
made advancement in his preparation for
commercialization post anticipated
approval now before we thought we're
going to need maybe 50 60 million
dollars to make enough product for 2020
revenue hopefully potential that we
might have if you have approval so now
having a situation where we were able to
negotiate with a very large biological
manufacturing to give us half a billion
dollar water product without any payment
that's that's what I call non diluting
that's what I call amazing
accomplishment and that's not me saying
that this is the compensation committee
day
they realize that this was extraordinary
and the amount of race I was given is
maybe few percentage five percent of
what we raise so with what we raise with
what we say it's amazing I think
encouraging the management to stay on
the same track and continuously produce
what we have was important to them I
assume and they made that decision next
question please
Thank You our next question is from the
line of David Callahan a private
investor please just leave with your
question David since the very beginning
and I thank you and your team for all
the great progress you have done with
the HIV and the cancer but I have a
question on the article that came out
and seeking alpha and it if it's too
good to be true and it's probably too
good to be true would you expound on
that a little bit
definitely David and thank you for being
one of the original investors who helped
me to be able to purchase Lear on the
map which we now enjoy all its benefits
before I indicated that when I heard
that there was a negative article about
us know about a few months ago I wanted
to read it I wanna know what is negative
about this progress that we have made
and as I read it I realized that facts
were not correct I reached out to the
very honest and author who was a very
good man in my opinion to be able to
look at the fact and after he looks at
the fact he came back and we tracked his
writing and wrote another article after
interviewing me and dr. Postel and I was
very pleased with that but this article
doesn't say the fact or you know
different than what we're saying they're
just saying that the facts are too good
to be true and I believe that these are
too good but they are all true and I
like to mention see of this for example
or be a late submission that is ready to
go
that's not fiction that's a fact we had
our primary endpoint we are one of the
five
according to the website that say there
is only one out of 5,000 make it we are
one of those we hit our primary end
point we finish the trial with 81%
responders right to suppress white
although and we're very proud of that
and then the article goes on and says
there is sa EES don't these doesn't this
company realize sa is happening even in
placebo well that's correct but we put
the SA under the column where it says
related to pro 140 lire on Lima if a
patient is in a clinical trial and God
forbid they get hit by their core and
break their leg that's let's say EE but
it's not related to the drug so when
it's not really related to the drug then
we call it these are this product has
zero serious adverse event in the last
670 patient that we're using it so the
the person who said SAE there has to be
something I want to make sure that we
give that information the next thing
that article says which I read it very
carefully says this company has negative
200 million dollars in deficit and I
explained that very clearly we're proud
of how much money we were able to use
and number of accomplishment and I'd
like to know if there's any other
company who has come close to that
milestone that we have achieved and then
there the article also says how do you
how are they going to commercialize this
product is the problem for you going to
commercialize itself well as I said
right now there is many offers on the
table that we were working I believe
zoom up the last product that was
humanized monoclonal antibody got
commercialized they made a deal with
another company and they so I mean this
is a very simple thing but please if if
you think it's too good to be true
my suggestion is check the fact if the
facts are we have B la then check the
box if you have the mono therapy trial
successful where we believe it's
successful and pivotal trial come check
the box if GB HD has received orphan
drug designation and green light for a
face to check the box and if triple
negative breast cancer is a new cancer
world that we are entering with lots of
good data check the box and if the day
from mouse came that the hey they
suppress I mean I'm sorry the the
metastases did not happen and it's
compared to morale rock and we keep
rockin data study and Mahabharat
finishing that kind of study has already
been used in human and eliminated
Chancellor from some of the patients
this is a stunning and yes it's too good
but it's also true it's not too good to
be true and then they're saying that how
they're going to get the product because
of the finances well we just explained
half a billion dollar water product is
offered to us to be made by a very
credible CMO and we are very excited
because the payments for it is deferred
to the end of 2020 but thanks for your
question Dave next question please thank
you once again ladies and gentlemen to
ask a question at this time please press
star 1 on your telephone keypad our next
question from the line of shanku pottier
a private investor please proceed with
your question thank you thank you dr.
poore asan and dr. pastel it was
actually as a pleasure meeting you in
person at noble khan last month i wanted
to ask a question that you know that I
had asked there and can you further
clarify or describe some of the out
licensing activities that you might do
and specifically whether these
partnerships that you're looking for are
in specific fields of use and whether
the partners are already in these fields
of use so a transition you know with
Lorana lab might be easier or is this
opt or is this going to be a field of
use that is also new to the partner
company that's a very good question I
appreciate that shine it was great
meeting you at the conference we are
working with few different
commercialization company few of them
have told us that they are already in
HIV and they are
very happy to go to HIV the ones that
haven't been in HIV so that was no
problem but very soon we will put a
PowerPoint we will place the power point
in our website for everyone to see the
exact plan for commercialization this is
not a simple powerpoints and very
complex and very detailed we are working
right now with some very incredible
business development people who have
done many deals in this field and they
can't wait to do deals for us but the
talk that we have with these folks it is
all about HIV GVHD
cancer and the potential for other
cancers besides triple negative breast
cancer and everything is on the table
and we are very happy that we see they
are there are offers there are people
who really say hey we all definitely
understand this there are very large
pharmaceuticals that are coming to the
table and there are very large
manufacturing which companies are saying
that they're willing to risk and make
all the product for us even though we
don't have approval yet but they're
willing to start that process for half a
billion dollar worth of products so it's
a major thing ee thank you for your
question any other questions thank you
we have a few additional questions our
next question is in the line of Greg
garner with millennium please proceed
with your question thank you for taking
my question thanks for doing the webcast
gentleman a couple items that just on
the the FDA wanting to extend the or the
additional tests you know testing with a
hundred patients has that started
already or is it something they don't
need started rolling I'm just wondering
well Greg that's a great question thank
you for that we have already started
injecting patient with 700 milligram
quite a bit of time before even the FDA
asked for that data so we are working on
that very carefully there is a timeline
that they want these patients to pass
certain points and we're going to be
negotiating with FDA at this time we are
accepting everything FDA said but
hopefully in future if we're able to get
better timeline then we can do it faster
but we do have some patients already
with 700 milligrams
their data and we are going to have a
much firmer timeline and announced that
at the given time but right now
worst-case scenario end of third quarter
best-case scenario second quarter that's
all I can say but I'm very very thankful
to the agency for not making us go and
redo the whole trial with 700 milligram
that would have it take four to five
years thank you the next question thank
you the next question is from the line
of Matt Salter a private investor please
proceed with your question
yeah good afternoon not her thanks for
taking my call I heard you talk about in
fact we've got we've got a situation
where we can commercialize about 500
million dollars of product that would be
actually the market value what is the
cost to produce 500 million dollars of
the product so the cost analysis comes
out to be where our cost of good is very
small but usually the companies don't
talk about the cost of good because
there are other costs involved but I can
tell you that we are very close to Big
Pharma's cost of good at certain level
with the certain conditions which means
we have to do a much bigger run through
that for example instead of doing a
2,000 liter runs we need 15,000 liter
runs obviously when we are doing deal
with a big manufacturing company they
are going to do it at a much higher
scale we want to have pre prefilled
syringe which that will say was 20 30
percent of the cost because you don't
have to have waste in each a while so
there are many things I've worked with
we we are very confident that our cost
is aligned with other HIV products but
I'm just not going to be able to give
you exact cost oh good I do know
nobody's like that cost of good and I'm
very proud of it but it is for your
comfort it is in line with other
pharmaceutical HIV products okay you
know I can I can definitely understand
that and respect that there was some
talk of possibly having a patch instead
of a syringe is that something that was
just maybe a rumor as there been any
talks about that absolutely nothing
because we have approval for certain
paths with by a read up and we
we have approval to do phase three with
certain things we finished phase three
now that phase three however we did that
that's the one that's going to be looked
at by FDA to give us up for work and the
label would be exactly what was in the
under protocol for Phase three so no
patches will be looked at this time for
us we're just going to go straight with
the sub-q which we believe most of the
patients or maybe all of them have told
us that that they do not have problem
with the pain okay well well thank you
another question on the pointing I think
Paulson has definitely been a good
friend and they we've raised a
tremendous amount of money through
Paulson no question about it and
obviously if we can go to non diluted
route that's going to be something would
be quite positive to the share price
because it seems like the the share
price is really tied to these raises and
I think one thing from a shareholder
standpoint is that you know many of us
invested in higher terms than what we're
now raising money out which is difficult
but it is part of the part of the
landscape so when we talked about moving
forward this commercialization and
upfront payments are we looking at a
situation that that might be substantial
enough to veer away from the Paulson
raises or the Paulson raises something
that we intend to go forward with on a
continual basis I mean for example I
noticed there's a breast cancer event
down in Hollywood coming up this week
and it looks like that's probably a
prelude to another Paulson raised where
where are we at with this in terms of
where you think we're going to go with
the future of financing I mean obviously
you don't know for sure but is the plan
to tie to veer away from that with the
with the commercialization and the
upfront payments or am i off base there
no that's a great question and let me
answer there was several parts to it
first of all in regards to how much we
need to get to revenue that number is
not gigantic that's just a you know
percentage of what we already raised and
Mike Mulholland can't weigh in on that
at the later time perhaps but you also
said that if we do commercialization
deal with a commercial
a pharmaceutical that would be non
diluted but it is enough we are not in
liberty of talking about that at this
time because of the CD age we have
signed but I want to just mention one
thing horse and raise all these funds
for a product that was in phase two with
a small potential and they're funding
the tremendous amount of work but I
don't want to take credit for something
Paulson did which is in regards to cross
the gene Paulson has been our partner
they have done all of these things that
we are enjoying from precision because
of pulse on telling us this is the path
that would help everybody and they the
senior management at Council have been
shoulder to shoulder working with us and
helping and guiding us so I want to make
sure everybody gets that because a lot
of people think oh Paulson is raising
funds and blah blah you know I want to
make sure that everybody understands
Paulson allowed me to do things with our
management team all of us as a united
front that we could have never
accomplished not just the money but with
the path of going forward so with that I
can tell you that we they won possum
they want us to raise this money they
don't want us to raise money they don't
want us to go and raise another funny
they're telling us it's time to stop
raising funds and try to materialize one
of these deals they're helping us with
these deals event so we can't go forward
without raising funds because they want
the shareholders that came through them
to have maximum benefit and we're
working together and we look forward to
put out some news that would give you
more clarity about what I'm saying thank
you okay so to be clear so it sort of be
clear the Paulson is actually saying you
know what look we've come a long ways if
we can find ways to raise funds non
diluted we would encourage that because
is that what I'm hearing from you is
that that absolutely yes absolutely
because one of the one of the most
difficult parts of this investment is
the time of these raises to the share
price it seems like whatever news comes
out no matter how positive it is it's
basically the rinse and repeat deal to
where we're going to buy the shares but
we're going to go ahead and sell them in
favor of the warrants and this cycle
continues so obviously from a
shareholder perspective and a value
perspective I think what the
shareholders are really hoping for and
wants to see is when is that arbitrage
going to be broken to where we actually
break out and see the real value of what
LaRhonda mob is because what it feels
like right now is it from from a share
price perspective it we're getting a
different signal saying you know what
will the market sees are completely
different but actually that whole
dynamic is tied towards these raises
which you know what it's a little
deflating to the shareholder I love
what's going on with the science I know
how hard you guys are working but I
think we're the shareholders is coming
from is that when can we break that you
know break out of that that that
paradigm so to speak so what I'm hearing
is is that you guys are working hard to
go in that direction absolutely and just
for your comforting and I want to just
say it is that when they're giant like
Gilead take from 1992 to 1999 seven
years of deluding themselves I did know
very low prices below $1 sometimes they
were at 29 cents average per in a whole
year you realize it took him seven years
to get things moving forward we have
taken four and a half years to get to
this point and having eight potential
phase two in cancer arena and having
triple negative breast cancer initiated
and grabbed by Cisco's and all of these
are giving us potential to raise money
with at this level just a little bit
more just to get to revenue now with the
stock price move if we get to revenue or
if we file our B la well I can elaborate
on what the stock will do but I can tell
you that when a company starts selling
half a billion dollars that's going to
change the whole thing now when would
everybody give us credit I'm not focused
on that even though I feel the pain of
every shareholders I get up every
morning hoping that people will give us
credit but I'm not
stop making sure that everything is in
place for us to have success and the way
we're going we hit our primary end point
we don't think something that everybody
could take some comfort but the stock
price is in our mind that's why Paul
Sartre has also accepted to help us with
the event that we are putting on
February 28th not that we are going to
raise money from the because for this
event that's absolutely not the case
we're not even allowed to have anybody
in that place to participate in any
fundraising because of SEC rules and
regulations which we follow very closely
so we are wanting to have enough
visibility so people can see what we
have and those people who check out our
science and just dig in a little bit to
go while we impress but thank you for
your question any other questions thank
you our next question is from the line
of Harry Fannin Zia what's Healthcare
Capital Advisors pleased to see with
your question the progress that you're
making but I wanted to just to follow up
on a comment that I think nadir you
started with it
you if you could get a product to market
on 170 million is that is very capital
efficient but we don't have a product to
market yet so my question is what is the
anticipated time and capital necessary
to hit these value creating milestones
that you've talked about and do we have
enough capital in the bank or with the
amount of capital we have in the bank
how far can we get can we get three
months or two years or somewhere in
between so it's good so we we have we
have a situation right here that's very
complex but we need to make sure we
raise funds at the right price we have
offered that we have rejected before the
lower valuation that people wanted to
give us one we're fighting for every
inch right now but do we do we raise the
funds
I mean how much more money do we need to
get to revenue perhaps that's the
question that you want me to answer is
that right well I also just want to know
how long can we last at the current firm
oh so we don't raise quite a bit of
money to have 12 months of 24 months
cash on hand because we believe our
company is undervalued big-time and if I
was going to accept the offer which I
rejected it before for 20 million at 30
cents or 20 cents
I think the shareholders would have
valid arguments saying that I didn't do
my work the right way I have to keep
what I have the price of this shares
right now add and try to raise the
awareness about our company so hopefully
we can be evaluated at a different price
but timing is also everything I know
every shareholder wants us to be having
revenue in 2020 should I slow down our
fundraising and just try to bring ever
more visibility and slow down all the
processes so we can get perhaps
commercial in 2021 but we spent some
money at this to get publicity and and
you have a higher value that's not the
path we chosen we said we're going to go
forward and if we have to be deluded
another 20% perhaps I will just I'm just
throwing numbers you know then to get to
revenue and have all these indications
come true for us that we are working on
then that I think that's what we have to
do but we're not talking about time in
December Mikey would you elaborate yeah
I think the key message that not ours
trying to share here is one of
incremental capital raises which is
founded on the premise of our valuation
incrementing up we heard you and we
understand very well the overall impact
on the valuation of the company for
cereal raises at 50 cents
however it's important to to appreciate
that
we believe we have a number of clinical
developments between now and the balance
of the year that that is going to that
has a strong potential of possibly
having a very positive effect on the
valuation of the company and that's why
we are looking at we are raising capital
at a very judicious pace to ensure that
we're being as opportunistic as possible
on what we believe our future valuation
catalysts for the shareholders okay
thank you for your question next
question please this is the last
question please thank you our final
question will come from the line of
Ashley Daniel a private investor please
proceed with your question yes go ahead
yeah so one of the reasons I believe the
price is getting affected is because of
the exchange do you have any plans to
move it to some Nasdaq or New York Stock
Exchange or one of the bigger ones
absolutely great question so we believe
that we need to get to $2 level or $4
levels either from New York Stock
Exchange or Nasdaq we believe we like to
give ourself a chance to do this
organically not reverse split and we
believe we have plenty of plenty of
opportunities hopefully to make that
possibly happen now for that reason Mike
Mulholland our CFO is working very hard
to file the application for both Nasdaq
and New York Stock Exchange because if
that opportunity arises we want to make
sure we're completely ready and move
forward to the exchange where we help we
are held hostage in my opinion
OTC B I mean the amount of shares that
we sold in the past as a last caller
elaborated about people selling and
keeping the warrants this is the way it
is and we need to be able to have said
you know buying power in the market
that's what we need visibility but in
the higher exchange there will be
institutions involved and those t
will not be a problem but our our -
stones that coming up convinced us that
we need to wait a little bit and let
this talk get to those levels
organically do you think you have some
sort of timeline in which you're gonna
hit your milestones any kind of
indication at what period can given one
of the bigger exchanges yeah so the
triple negative breast cancer result
that to me was stunning in a mice model
and if if mera Bharat leaves the same
mouse model and then it was great and
then went right to human trial in
Germany and in German the group showed
that some of the patients had metastases
cancer metastases disappeared to me if
we're able to do that kind of thing and
have interim results that is strong I
think we this is a milestone that will
really be interesting to us in regards
to graft-versus-host disease we
reinitiated to hope to see that
elimination of graft versus host in the
mice model with that panel to be the
same way in the human model we will find
the human studies we would see about
that and the preclinical studies of all
the other a cancer indication or you
know followed very carefully we do have
BL a submission our first component
should be submitted soon we do have mono
therapy if we are able to get pivotal
tried this would be the first mono
therapy ever in the world of HIV with a
humanized monoclonal antibody self
injectable once a week so these are
pretty powerful milestones so let us get
there and we want to hopefully get there
before second quarter on some of them
and before third quarter under others so
as per the milestone and timeline we
were working it I am the founder Kristin
to dr. Patel people Pfizer brought Mary
crack and their own women we know what
is the major difference and why is that
our only map or the pro one party is
showing better results or a much better
effective rate there
Fiser grunts okay yes I hope you can
hear me yes I think that yes so there's
not been a direct head-to-head
comparison in patience of these
different therapies you know the way I'd
characterize it is that we have
preclinical data using specific doses
and I can only say that based on the
doses that we used in the preclinical
studies we've been able to see a more
sustained suppression of the metastatic
phenotype so there are a number of
different variables that could be
responsible for this thing including the
dose of therapy and bioavailability and
other issues that we don't really
understand but I'd say that it is not
there my intention to imply that one is
the superior technology than the other
this is certainly not been exhaustively
examined by any by any stretch we're
going to refer to a single study that
we've conducted a preclinical study and
I think that there's enormous
opportunities the important point to
take home really is the principle that
in the case of ccr5 it plays an
absolutely important role in cancer
metastasis and that small molecule
inhibitors of ccr5 and a humanized
monoclonal antibody have demonstrated a
substantial efficacy in these
preclinical studies again we're in Zinna
graft model for human cancer so again
emphasize that none of my comments were
or should be construed to state that
with in any way compare these directly
nor have we determined whether or not
they would have similar or superior
efficacy in the clinical studies because
those clinical studies have not been
conducted rather I'd say this is a
message of theirs profound opportunity
in the
ccr5 cancer metastasis space I hope
that's helpful answer to the question of
course thank you thank you thank you and
with that we would like to wrap it up
operator no more question announced but
I'll just gives you more comments about
finishing comments so thank you again
everyone for being on the call today to
summarize we have our blh submission it
could happen
the full amount by the end of second
quarter best-case scenario worst-case
scenario end of third quarter
monotherapy pivotal trial is being
worked on triple negative breast cancer
the initiation of the patient's
injection could happen any week now and
the interim results we hope to have in
third quarter with the regards to grab
purses hostesses we reinitiated our
study in regards to manufacture product
we had some good results to tell our
shareholders and in regards to
commercialization of four one four there
are opportunities that we are evaluating
at this time with that I want to thank
everybody again and have a great day
greetings and welcome to the Saito dine
investment community conference call at
this time all participants are in a
listen-only mode a question-and-answer
session will follow the formal
presentation if anyone should require
operator assistance during the
conference please press star 0 on your
telephone keypad as a reminder this
conference is being recorded it is now
my pleasure to introduce your host
Michael Mulholland chief financial
officer thank you sir
you may begin thank you hello everyone
and thank you for joining us today this
is Michael Mulholland chief financial
officer of sighted I'm joining us on
today's call is our president and CEO
dr. nadir poor Hassan and our chief
medical officer dr. Richard Castel
before we begin it is essential that we
provide you with important cautionary
language related to certain federal
securities laws our remarks during
today's conference call
will include forward-looking statements
forward-looking statements are not
guarantees of future performance and
involve known and unknown risks and
uncertainties and other factors that are
difficult to predict actual results may
be materially different from any future
results expressed or implied by such
forward-looking statements these risks
and uncertainties include among other
matters statements regarding LaRhonda
Maps potential efficacy in certain
immunology and oncology indications the
company's ongoing ability to raise
additional new capital that clinical
trials may not can commence or proceed
as planned
products that appear promising in early
trials may not subsequently prove to be
viable on safety or efficacy grounds
products may not receive regulatory
approval or market acceptance
competition may reduce the commercial
potential of our products we may
experience product recalls manufacturing
issues or product liability and our
patents may be challenged or
unenforceable
although forward-looking statements help
to provide complete information about
the company forward-looking statements
may be less reliable than historical
information the company undertakes no
obligation to update publicly these
forward-looking statements except as
required by law please refer to our
recent quarterly and annual reports
filed with the Securities and Exchange
Commission for more information about
the risks and uncertainties that could
cause actual results to differ
materially versus our current
expectations I will now turn our call
over to dr. nadir paratha knotter thank
you Mike
thank you everyone for participating in
today's site reliance shareholders
conference call before I update all of
our shareholders their owners of our
company
Cyberdyne I would like to quickly
discuss what I believe is in the minds
of most of our shareholders which is
canceiied align fund itself to get to
revenue the simple and short answer is
we believe we can do this and we believe
we can do this much easier than the last
four years and our resume of raising
funds of close to 170 million dollars in
the last seven years speaks for itself
and this is all thanks to Paulson
investments and great trust they have in
our data science and our mission we also
have a spoken in the past about
non-dilutive fundraising and we are
pursuing that in parallel to all of our
other activities from investors with
less knowledge of biotech and drug
development might think one hundred
seventy million dollars that cited I
raised was a lot of money and why do we
still need more funding to get to
revenue this is a great question and I
like to address that
to answer this question I will now read
a couple of paragraphs from a couple of
different articles which anyone can
access from a simple google search the
first one quote various sources indicate
that it can cause more than 1 billion
dollars to bring one product to the
market another article I will quote is
from John Hopkins Bloomberg School of
Public Health called clinical trials
that support FDA approvals of new drugs
have a median cost of 19 million dollars
according to a new study by a team
including researchers from John Hopkins
Bloomberg School of Public Health the 19
million medians figure represents less
than 1% of the average total cost of
developing a new drug which in recent
years have been estimated as between 2
to 3 billion dollars if we accept these
numbers and if we use the lower figure
of 2 billion then we have used less than
10% to get to where we are today
this means excited I had about 170
million dollars worth of expenses in the
last almost 10 years and produce all the
opportunities that many may call it too
good to be true I agree that all we have
accomplished is too good but not too
good to be true but simply true because
facts are clear and those who check the
facts carefully like pulse on investment
I agreed with me because they rely on
facts in today's call I would like to
cover another very important fact about
the amount of expenses cited I had to
get to the point we are today and that
is not only we have produced all the
current opportunities for our
shareholders but we also have about 200
million dollars worth of Lear on the map
GMP products
that more than half our commercial or
phase three great product this is
evaluated at $120,000 per patient per
year current price for the same
indication now please let me stay this
fax one more time even though it seems
too good to be true but it is true while
it is too good that we used less than
10% of what normally take to have the
following opportunities one mono therapy
successful investigative trial in my
opinion that could lead to first phase
three pivotal trial of HIV for the only
sub-q weekly injectable humanized
monoclonal antibody for HIV space and
number two or be la that everybody knows
about biologic license applications we
are hopeful that if all goes well we
will be having revenue from that that
path in 2020 number three is GVHD
Phase two since the GVHD
graft-versus-host disease with orphan
drug designation already given to us
number four phase one B - two triple
negative breast cancer with orphan drug
designation file number five with the
prognostic test that could be in
licensing agreements this year and
number six eight preclinical trials that
was just recently announced that we are
engaging - in and the last is an amazing
amount of commercial / Phase three
product that could give us back quite a
bit of or expenses that we have used to
get to this point when we get revenue so
with all these explanation in regards to
our expenses I will now update you on
current sided ice activity
my first item of update is the subject
of non-dilutive financing in regards to
commercializing lire on the maps I
designed do have a plan for
commercializing of lire on the map
program for you that could also lead to
non diluted financing sorry rank
currently is in discussions with
commercialization pharmaceuticals the
right of sales of lire on the map with
different pharmaceuticals and as of now
we are evaluating offers for the right
of commercialization of the only map for
certain indication for several millions
of dollars of upfront payment and
milestone payments we are in the process
of evaluating our counteroffer to these
offers detail of whether we accept or
reject any of these offers will be
shared with everyone at an appropriate
time because of the interest like this
in commercialization rights for pro lire
on the map we are now interviewing
appropriate candidates to hire a
full-time business development person to
be 100% focused in exploring all the
opportunities for literally map for
commercialized commercialization in US
or Europe this person will be in charge
of this program and this is a new role
that we will have inside of that other
non-dilutive fundraising potential will
be covered by doctor to stern in regards
to or prognostic tips in regards to
making product for large revenue after
launch and where is sighted I'm going to
get funding to produce half a billion
dollar water product to kick off our
revenues in most likely 2020 I'm very
pleased so now that sided ein currently
is in discussions with a major biologic
CMO a large biological manufacturing
company this company has given us an
offer
to produce over 500 million dollars
worth of commercial product this amount
is again based on 120,000 per year per
session and the half a billion of
LaRhonda map can be delivered in the
second half of 2020
with delayed payment to late 2020 we
don't have to pay a single dime till the
product is sent to us we like this deal
and are in the process of signing the
final agreement and this should put an
end to it speculation of how would sited
I supply the product to the market
without having any funds for this
purpose this I could say is our first
non-dilutive effort saving Saturday from
the elusive rays of significant amount
in order to have enough lire on the map
for commercialization so now I will
update everyone with our combination
therapy and mono therapy trial so our
PLA is delayed and everyone had seen in
our PowerPoint we have changed at the
second quarter and it might even become
third quarter so let me tell you why as
we work with FDA we have to obey
everything the FDA says which is very
logical and is for the safety of people
in the world
the FDA has read our press releases out
of it and they realize that we have said
that our seven hundred milligram dose
has much better efficacy than 350
milligram
the population that we're going to
submit be la for or included in the
population is patients who have unmet
medical needs they don't have enough
regimen and practically they're on
functional mono therapy when they take
for one for FDA indicated that so you
have two choices one is to redo the
whole trial which would take four to
five
with a 700 milligram but they also
articulated a very good situation for us
they said why don't you just take a
hundred patients from your mono therapy
dad were injected with 700 milligram
which could delay us four to six months
from March time that we give out and
then we will be okay and we will approve
this if all things are in place and if
everything is good with them they will
not make seven hundred milligram an
issue and it was approved this product
for 700 milligram now this is huge for
us because this could give us a better
outcome for the for the result and the
patients could benefit more from our
product but it happens that it would
delay us to second quarter in the second
quarter or maybe end up second third
quarter the reason I say second quarter
or third quarter is because once we
produced a hundred patients data we will
have to see how fast we can get that
data that they asked for and how long
each patient has to go for we are in
discussions with FDA and worst case
scenario is end of third quarter best
case scenario at the end of second
quarter as always we will work very hard
and non-stop to make sure we can make
the best time that as possible as
everyone knows it took us four and a
half years to take a path of that would
have take twenty years with the old path
progeny has in place for pro-1 for the
only map so hopefully our resume is
strong and we will be able to get this
to the finish line of getting be a late
submission quickly as possible in
regards to mono therapy trial we are to
present at CROI on march 4th our
abstract was accepted and we are excited
to go back to croy and say that our last
trial that we presented at CROI that had
only 40% responders rate now is change
and there with a seven hundred milligram
we have much better data and 525
milligram
so that we will follow through but we
are working on our pivotal trial and
once we submit our first part of our BL
a which is already complete
one third of a non-clinical section then
we will follow with our protocol for a
mono therapy pivotal trial so in regards
to our next update which is
graft-versus-host disease we have dr.
Castel who have interviewed the
principal investigators and we are now
ready to reinitiate and we have order RC
or to reinitiate the graft-versus-host
disease hopefully to have data interim
result to look at we also have orphan
drug designation for this indication and
we are going forward as before in
regards to triple negative breast cancer
and other results that we received that
was very positive I will now pass it
over to dr. Paz tell dr. Purcell I think
you Donna um it's good afternoon
everybody
I have three items to touch on as
updates since the last investor
conference the first is to speak briefly
about the prognostic test that can lead
to speak about the new indications in
different cancers for more on the map
and the third is to update the investors
on the orphan drug designation
application to the FDA was recently
filed the prognostic test is a test that
was acquired by Cyberdyne a technology
which is a high very high predictive
value for determining the outcome of the
patient's prostate cancer based on a
gene signature has an algorithm the
current process is we are developing a
kit in collaboration with a strategic
partner and completing analytical
validation with the intent of submitting
a 510 K to the FDA
the second area to to mention is that
based on recent preclinical studies
looking at cancer metastasis and
cooperative studies looking at the
expression of CC
five in a number of different cancers
sited on has elected to conduct
metastatic analyses using a number of
different types of cancers the purpose
of this is we believe that ccr5 is an
important mechanism guiding cancer
metastasis that this may be a general
principle relevant to a variety of
different types of cancers that
overexpressed ccr5 and cited ein has
acquired a research laboratory which has
sophisticated technologies in order to
test this hypothesis i with created a
hierarchy of need focusing on prostate
cancer pancreatic cancer melanoma colon
cancer and lung because these particular
types of metastatic cancers kill
patients quite rapidly and again the
results are based on the strategy is
based on the findings we have in highly
anesthetic human triple negative breast
cancer preclinical studies so again in
order for any cost-effective series and
studies with the intent to use mechanism
of action ccr5 dependent metastasis of
cancers as the over action strategy
the third element i would like to update
investors honors the recent submission
to the FDA of an orphan drug designation
caller on a map based on preclinical
studies the results of these studies
which were using human breast cancer in
a xenograph mouse model demonstrated a
greater than 98% reduction in the
metastatic tumor volume of these animals
and because this was conducted over a
six-week period of time so although the
untreated animal untreated animals
developed massive metastases at six
weeks we were unable to formally to tear
the tester season one I treated mice
clearly will continue to update the
investors on these particular studies
that these provided the compelling and
rational basis for a submission of
orphan drug designation with the FDA
this was announced February 20th so
these are the three highlights from the
oncology component of the company or
which has been positive progress since
the last update and again thank you so
much for you for your time and interest
today back to you know Ellie thank you
dr. Purcell
operator can you please go to Question
and Answer absolutely ladies and
gentlemen at this time we will be
conducting the question-and-answer
session if you would like to ask a
question please press star 1 on your
telephone keypad
the confirmation tone will indicate that
your line is in the question queue you
may press star 2 if you would like to
remove your question from the queue for
participants using speaker equipment and
baby necessary to pick up your handset
before pressing the star keene our first
question is coming from the line of yi
Chen what HD wainwright please proceed
with your question thank you for taking
my question my question is as you plan
to advance rata map into preclinical
studies in multiple cancer indications
what are the timeframes after which we
can expect to see some print preclinical
results thank you dr. Chen for your
question
as I have said before and we are
confident on that that this year we will
have interim results and could be in the
second quarter
that's a little bit you know short
timeframe that's best-case scenario but
worst-case scenario I believe we will
have interim result in third quarters
okay and if you observed positive
results in multiple cancer models
do you rather advanced candidate into
all indications or would you pick one
cancer one or two cancer indications
that are the most promising dr. Patel
could you please answer the following
questions yes it has been an approval
now on one occasion by the FDA of
mechanism as the rationale for treatment
so in this case the rationale would be
cancer type agnostic ccr5 mechanism
mediated cancer and I think this has
been the rationale for more recent drug
approvals for example checkpoint
inhibitors which are PDL one positive
tumors similarly I think the rationale
here and certainly a cultural shift and
a strong push from FDA is to consider
mechanism based therapies in an organ
agnostic way we're going shifting here
from a concept of thinking about
melanoma or pancreatic cancer prostate
cancer rather ccr5 positive metastatic
cancer and testing patients for ccr5 in
their tumor and we're circulating tumor
cells and initiating therapy based on
those criterion that answers your
question yes thank you for the
clarification Thanks Thank You our next
question from the line of Krishna choir
a private investor please proceed with
your question yes sir don't we thank you
all for taking my call as you mentioned
financing through Paulson has been a
billable component cheap the successes
that I'm and tujhe financing is
something that sever means to be a big
question mark
so I find it concerning disconcerning
the recent pay raise
that the executives have ordered
themselves have you rationalized how do
you get to the shareholders not this was
an appropriate take with yourselves
absolutely thank you for your question
and I'd be delighted to answer that
first allow me to remind all our
stockholder everybody that are all
compensation matters for senior
management are handled by compensation
committee of the board of directors
which is compromised comprised solely of
independent directors now it was the
Compensation Committee determination
that management has achieved
extraordinary milestones in recent
months specifically six months for the
long-term benefit of the company and its
shareholders this accomplishment I'd
like to share with everyone
first the completion of an all-stock
acquisition of precision and it's smooth
transition into our company we firmly
believe this acquisition may potentially
reshape and redefine Cyberdyne future
this acquisition brought to our company
first one of the world's pre-eminent
oncologist dr. Richard Estelle who also
served as our chief medical officer and
will also oversee the lead all and undid
all the cancer and other immunological
indications for Leon dmap second one was
a pro portfolio of intellectual property
that provided protection in certain
areas of science that is currently being
explored by Big Pharma
next was a prognostic test in the
prostate prostate cancer area which has
the opportunity to provide a licensing
opportunity and the last was also has
announced last week we now have our own
laboratory facilities which will enable
our company to accelerate evaluating
preclinical and cancer indication now
that's just for the acquisition of the
process in the next accomplishment was
the initiation of Phase one B - to human
trial for triple negative breast cancer
which is truly a significant milestone
stunning results from our mouse model
that prompted not only to fight for
orphan drug designation but initiate
eight new preclinical studies that could
put this little company on eight Phase
two for only a half one and a half to
two million dollars the next
accomplishment was since we announced
our intention to acquire prestige in in
late August 2018 we have raised
approximately 40 million dollars on
terms which have saved the company
approximately 40 million shares of
dilution compared to the offering terms
in the prior 18 months to that so we
paid 27 million shares for all the stuff
we have received from processing
acquisition and pay 27 million from this
40 million saving that transgene cause
that is specifically dr. Richard Castel
truly amazing in my opinion management
has been actively engaged in discussion
with several parties for licensing
agreement as I Anna and as I just
mentioned we now have offers on the
table for significant amount of upfront
non diluted cash and milestones now we
will send our counteroffer and the
shareholders will know exact situation
with these offers at the appropriate
time and then lastly the management has
made advancement in his preparation for
commercialization post anticipated
approval now before we thought we're
going to need maybe 50 60 million
dollars to make enough product for 2020
revenue hopefully potential that we
might have if you have approval so now
having a situation where we were able to
negotiate with a very large biological
manufacturing to give us half a billion
dollar water product without any payment
that's that's what I call non diluting
that's what I call amazing
accomplishment and that's not me saying
that this is the compensation committee
day
they realize that this was extraordinary
and the amount of race I was given is
maybe few percentage five percent of
what we raise so with what we raise with
what we say it's amazing I think
encouraging the management to stay on
the same track and continuously produce
what we have was important to them I
assume and they made that decision next
question please
Thank You our next question is from the
line of David Callahan a private
investor please just leave with your
question David since the very beginning
and I thank you and your team for all
the great progress you have done with
the HIV and the cancer but I have a
question on the article that came out
and seeking alpha and it if it's too
good to be true and it's probably too
good to be true would you expound on
that a little bit
definitely David and thank you for being
one of the original investors who helped
me to be able to purchase Lear on the
map which we now enjoy all its benefits
before I indicated that when I heard
that there was a negative article about
us know about a few months ago I wanted
to read it I wanna know what is negative
about this progress that we have made
and as I read it I realized that facts
were not correct I reached out to the
very honest and author who was a very
good man in my opinion to be able to
look at the fact and after he looks at
the fact he came back and we tracked his
writing and wrote another article after
interviewing me and dr. Postel and I was
very pleased with that but this article
doesn't say the fact or you know
different than what we're saying they're
just saying that the facts are too good
to be true and I believe that these are
too good but they are all true and I
like to mention see of this for example
or be a late submission that is ready to
go
that's not fiction that's a fact we had
our primary endpoint we are one of the
five
according to the website that say there
is only one out of 5,000 make it we are
one of those we hit our primary end
point we finish the trial with 81%
responders right to suppress white
although and we're very proud of that
and then the article goes on and says
there is sa EES don't these doesn't this
company realize sa is happening even in
placebo well that's correct but we put
the SA under the column where it says
related to pro 140 lire on Lima if a
patient is in a clinical trial and God
forbid they get hit by their core and
break their leg that's let's say EE but
it's not related to the drug so when
it's not really related to the drug then
we call it these are this product has
zero serious adverse event in the last
670 patient that we're using it so the
the person who said SAE there has to be
something I want to make sure that we
give that information the next thing
that article says which I read it very
carefully says this company has negative
200 million dollars in deficit and I
explained that very clearly we're proud
of how much money we were able to use
and number of accomplishment and I'd
like to know if there's any other
company who has come close to that
milestone that we have achieved and then
there the article also says how do you
how are they going to commercialize this
product is the problem for you going to
commercialize itself well as I said
right now there is many offers on the
table that we were working I believe
zoom up the last product that was
humanized monoclonal antibody got
commercialized they made a deal with
another company and they so I mean this
is a very simple thing but please if if
you think it's too good to be true
my suggestion is check the fact if the
facts are we have B la then check the
box if you have the mono therapy trial
successful where we believe it's
successful and pivotal trial come check
the box if GB HD has received orphan
drug designation and green light for a
face to check the box and if triple
negative breast cancer is a new cancer
world that we are entering with lots of
good data check the box and if the day
from mouse came that the hey they
suppress I mean I'm sorry the the
metastases did not happen and it's
compared to morale rock and we keep
rockin data study and Mahabharat
finishing that kind of study has already
been used in human and eliminated
Chancellor from some of the patients
this is a stunning and yes it's too good
but it's also true it's not too good to
be true and then they're saying that how
they're going to get the product because
of the finances well we just explained
half a billion dollar water product is
offered to us to be made by a very
credible CMO and we are very excited
because the payments for it is deferred
to the end of 2020 but thanks for your
question Dave next question please thank
you once again ladies and gentlemen to
ask a question at this time please press
star 1 on your telephone keypad our next
question from the line of shanku pottier
a private investor please proceed with
your question thank you thank you dr.
poore asan and dr. pastel it was
actually as a pleasure meeting you in
person at noble khan last month i wanted
to ask a question that you know that I
had asked there and can you further
clarify or describe some of the out
licensing activities that you might do
and specifically whether these
partnerships that you're looking for are
in specific fields of use and whether
the partners are already in these fields
of use so a transition you know with
Lorana lab might be easier or is this
opt or is this going to be a field of
use that is also new to the partner
company that's a very good question I
appreciate that shine it was great
meeting you at the conference we are
working with few different
commercialization company few of them
have told us that they are already in
HIV and they are
very happy to go to HIV the ones that
haven't been in HIV so that was no
problem but very soon we will put a
PowerPoint we will place the power point
in our website for everyone to see the
exact plan for commercialization this is
not a simple powerpoints and very
complex and very detailed we are working
right now with some very incredible
business development people who have
done many deals in this field and they
can't wait to do deals for us but the
talk that we have with these folks it is
all about HIV GVHD
cancer and the potential for other
cancers besides triple negative breast
cancer and everything is on the table
and we are very happy that we see they
are there are offers there are people
who really say hey we all definitely
understand this there are very large
pharmaceuticals that are coming to the
table and there are very large
manufacturing which companies are saying
that they're willing to risk and make
all the product for us even though we
don't have approval yet but they're
willing to start that process for half a
billion dollar worth of products so it's
a major thing ee thank you for your
question any other questions thank you
we have a few additional questions our
next question is in the line of Greg
garner with millennium please proceed
with your question thank you for taking
my question thanks for doing the webcast
gentleman a couple items that just on
the the FDA wanting to extend the or the
additional tests you know testing with a
hundred patients has that started
already or is it something they don't
need started rolling I'm just wondering
well Greg that's a great question thank
you for that we have already started
injecting patient with 700 milligram
quite a bit of time before even the FDA
asked for that data so we are working on
that very carefully there is a timeline
that they want these patients to pass
certain points and we're going to be
negotiating with FDA at this time we are
accepting everything FDA said but
hopefully in future if we're able to get
better timeline then we can do it faster
but we do have some patients already
with 700 milligrams
their data and we are going to have a
much firmer timeline and announced that
at the given time but right now
worst-case scenario end of third quarter
best-case scenario second quarter that's
all I can say but I'm very very thankful
to the agency for not making us go and
redo the whole trial with 700 milligram
that would have it take four to five
years thank you the next question thank
you the next question is from the line
of Matt Salter a private investor please
proceed with your question
yeah good afternoon not her thanks for
taking my call I heard you talk about in
fact we've got we've got a situation
where we can commercialize about 500
million dollars of product that would be
actually the market value what is the
cost to produce 500 million dollars of
the product so the cost analysis comes
out to be where our cost of good is very
small but usually the companies don't
talk about the cost of good because
there are other costs involved but I can
tell you that we are very close to Big
Pharma's cost of good at certain level
with the certain conditions which means
we have to do a much bigger run through
that for example instead of doing a
2,000 liter runs we need 15,000 liter
runs obviously when we are doing deal
with a big manufacturing company they
are going to do it at a much higher
scale we want to have pre prefilled
syringe which that will say was 20 30
percent of the cost because you don't
have to have waste in each a while so
there are many things I've worked with
we we are very confident that our cost
is aligned with other HIV products but
I'm just not going to be able to give
you exact cost oh good I do know
nobody's like that cost of good and I'm
very proud of it but it is for your
comfort it is in line with other
pharmaceutical HIV products okay you
know I can I can definitely understand
that and respect that there was some
talk of possibly having a patch instead
of a syringe is that something that was
just maybe a rumor as there been any
talks about that absolutely nothing
because we have approval for certain
paths with by a read up and we
we have approval to do phase three with
certain things we finished phase three
now that phase three however we did that
that's the one that's going to be looked
at by FDA to give us up for work and the
label would be exactly what was in the
under protocol for Phase three so no
patches will be looked at this time for
us we're just going to go straight with
the sub-q which we believe most of the
patients or maybe all of them have told
us that that they do not have problem
with the pain okay well well thank you
another question on the pointing I think
Paulson has definitely been a good
friend and they we've raised a
tremendous amount of money through
Paulson no question about it and
obviously if we can go to non diluted
route that's going to be something would
be quite positive to the share price
because it seems like the the share
price is really tied to these raises and
I think one thing from a shareholder
standpoint is that you know many of us
invested in higher terms than what we're
now raising money out which is difficult
but it is part of the part of the
landscape so when we talked about moving
forward this commercialization and
upfront payments are we looking at a
situation that that might be substantial
enough to veer away from the Paulson
raises or the Paulson raises something
that we intend to go forward with on a
continual basis I mean for example I
noticed there's a breast cancer event
down in Hollywood coming up this week
and it looks like that's probably a
prelude to another Paulson raised where
where are we at with this in terms of
where you think we're going to go with
the future of financing I mean obviously
you don't know for sure but is the plan
to tie to veer away from that with the
with the commercialization and the
upfront payments or am i off base there
no that's a great question and let me
answer there was several parts to it
first of all in regards to how much we
need to get to revenue that number is
not gigantic that's just a you know
percentage of what we already raised and
Mike Mulholland can't weigh in on that
at the later time perhaps but you also
said that if we do commercialization
deal with a commercial
a pharmaceutical that would be non
diluted but it is enough we are not in
liberty of talking about that at this
time because of the CD age we have
signed but I want to just mention one
thing horse and raise all these funds
for a product that was in phase two with
a small potential and they're funding
the tremendous amount of work but I
don't want to take credit for something
Paulson did which is in regards to cross
the gene Paulson has been our partner
they have done all of these things that
we are enjoying from precision because
of pulse on telling us this is the path
that would help everybody and they the
senior management at Council have been
shoulder to shoulder working with us and
helping and guiding us so I want to make
sure everybody gets that because a lot
of people think oh Paulson is raising
funds and blah blah you know I want to
make sure that everybody understands
Paulson allowed me to do things with our
management team all of us as a united
front that we could have never
accomplished not just the money but with
the path of going forward so with that I
can tell you that we they won possum
they want us to raise this money they
don't want us to raise money they don't
want us to go and raise another funny
they're telling us it's time to stop
raising funds and try to materialize one
of these deals they're helping us with
these deals event so we can't go forward
without raising funds because they want
the shareholders that came through them
to have maximum benefit and we're
working together and we look forward to
put out some news that would give you
more clarity about what I'm saying thank
you okay so to be clear so it sort of be
clear the Paulson is actually saying you
know what look we've come a long ways if
we can find ways to raise funds non
diluted we would encourage that because
is that what I'm hearing from you is
that that absolutely yes absolutely
because one of the one of the most
difficult parts of this investment is
the time of these raises to the share
price it seems like whatever news comes
out no matter how positive it is it's
basically the rinse and repeat deal to
where we're going to buy the shares but
we're going to go ahead and sell them in
favor of the warrants and this cycle
continues so obviously from a
shareholder perspective and a value
perspective I think what the
shareholders are really hoping for and
wants to see is when is that arbitrage
going to be broken to where we actually
break out and see the real value of what
LaRhonda mob is because what it feels
like right now is it from from a share
price perspective it we're getting a
different signal saying you know what
will the market sees are completely
different but actually that whole
dynamic is tied towards these raises
which you know what it's a little
deflating to the shareholder I love
what's going on with the science I know
how hard you guys are working but I
think we're the shareholders is coming
from is that when can we break that you
know break out of that that that
paradigm so to speak so what I'm hearing
is is that you guys are working hard to
go in that direction absolutely and just
for your comforting and I want to just
say it is that when they're giant like
Gilead take from 1992 to 1999 seven
years of deluding themselves I did know
very low prices below $1 sometimes they
were at 29 cents average per in a whole
year you realize it took him seven years
to get things moving forward we have
taken four and a half years to get to
this point and having eight potential
phase two in cancer arena and having
triple negative breast cancer initiated
and grabbed by Cisco's and all of these
are giving us potential to raise money
with at this level just a little bit
more just to get to revenue now with the
stock price move if we get to revenue or
if we file our B la well I can elaborate
on what the stock will do but I can tell
you that when a company starts selling
half a billion dollars that's going to
change the whole thing now when would
everybody give us credit I'm not focused
on that even though I feel the pain of
every shareholders I get up every
morning hoping that people will give us
credit but I'm not
stop making sure that everything is in
place for us to have success and the way
we're going we hit our primary end point
we don't think something that everybody
could take some comfort but the stock
price is in our mind that's why Paul
Sartre has also accepted to help us with
the event that we are putting on
February 28th not that we are going to
raise money from the because for this
event that's absolutely not the case
we're not even allowed to have anybody
in that place to participate in any
fundraising because of SEC rules and
regulations which we follow very closely
so we are wanting to have enough
visibility so people can see what we
have and those people who check out our
science and just dig in a little bit to
go while we impress but thank you for
your question any other questions thank
you our next question is from the line
of Harry Fannin Zia what's Healthcare
Capital Advisors pleased to see with
your question the progress that you're
making but I wanted to just to follow up
on a comment that I think nadir you
started with it
you if you could get a product to market
on 170 million is that is very capital
efficient but we don't have a product to
market yet so my question is what is the
anticipated time and capital necessary
to hit these value creating milestones
that you've talked about and do we have
enough capital in the bank or with the
amount of capital we have in the bank
how far can we get can we get three
months or two years or somewhere in
between so it's good so we we have we
have a situation right here that's very
complex but we need to make sure we
raise funds at the right price we have
offered that we have rejected before the
lower valuation that people wanted to
give us one we're fighting for every
inch right now but do we do we raise the
funds
I mean how much more money do we need to
get to revenue perhaps that's the
question that you want me to answer is
that right well I also just want to know
how long can we last at the current firm
oh so we don't raise quite a bit of
money to have 12 months of 24 months
cash on hand because we believe our
company is undervalued big-time and if I
was going to accept the offer which I
rejected it before for 20 million at 30
cents or 20 cents
I think the shareholders would have
valid arguments saying that I didn't do
my work the right way I have to keep
what I have the price of this shares
right now add and try to raise the
awareness about our company so hopefully
we can be evaluated at a different price
but timing is also everything I know
every shareholder wants us to be having
revenue in 2020 should I slow down our
fundraising and just try to bring ever
more visibility and slow down all the
processes so we can get perhaps
commercial in 2021 but we spent some
money at this to get publicity and and
you have a higher value that's not the
path we chosen we said we're going to go
forward and if we have to be deluded
another 20% perhaps I will just I'm just
throwing numbers you know then to get to
revenue and have all these indications
come true for us that we are working on
then that I think that's what we have to
do but we're not talking about time in
December Mikey would you elaborate yeah
I think the key message that not ours
trying to share here is one of
incremental capital raises which is
founded on the premise of our valuation
incrementing up we heard you and we
understand very well the overall impact
on the valuation of the company for
cereal raises at 50 cents
however it's important to to appreciate
that
we believe we have a number of clinical
developments between now and the balance
of the year that that is going to that
has a strong potential of possibly
having a very positive effect on the
valuation of the company and that's why
we are looking at we are raising capital
at a very judicious pace to ensure that
we're being as opportunistic as possible
on what we believe our future valuation
catalysts for the shareholders okay
thank you for your question next
question please this is the last
question please thank you our final
question will come from the line of
Ashley Daniel a private investor please
proceed with your question yes go ahead
yeah so one of the reasons I believe the
price is getting affected is because of
the exchange do you have any plans to
move it to some Nasdaq or New York Stock
Exchange or one of the bigger ones
absolutely great question so we believe
that we need to get to $2 level or $4
levels either from New York Stock
Exchange or Nasdaq we believe we like to
give ourself a chance to do this
organically not reverse split and we
believe we have plenty of plenty of
opportunities hopefully to make that
possibly happen now for that reason Mike
Mulholland our CFO is working very hard
to file the application for both Nasdaq
and New York Stock Exchange because if
that opportunity arises we want to make
sure we're completely ready and move
forward to the exchange where we help we
are held hostage in my opinion
OTC B I mean the amount of shares that
we sold in the past as a last caller
elaborated about people selling and
keeping the warrants this is the way it
is and we need to be able to have said
you know buying power in the market
that's what we need visibility but in
the higher exchange there will be
institutions involved and those t
will not be a problem but our our -
stones that coming up convinced us that
we need to wait a little bit and let
this talk get to those levels
organically do you think you have some
sort of timeline in which you're gonna
hit your milestones any kind of
indication at what period can given one
of the bigger exchanges yeah so the
triple negative breast cancer result
that to me was stunning in a mice model
and if if mera Bharat leaves the same
mouse model and then it was great and
then went right to human trial in
Germany and in German the group showed
that some of the patients had metastases
cancer metastases disappeared to me if
we're able to do that kind of thing and
have interim results that is strong I
think we this is a milestone that will
really be interesting to us in regards
to graft-versus-host disease we
reinitiated to hope to see that
elimination of graft versus host in the
mice model with that panel to be the
same way in the human model we will find
the human studies we would see about
that and the preclinical studies of all
the other a cancer indication or you
know followed very carefully we do have
BL a submission our first component
should be submitted soon we do have mono
therapy if we are able to get pivotal
tried this would be the first mono
therapy ever in the world of HIV with a
humanized monoclonal antibody self
injectable once a week so these are
pretty powerful milestones so let us get
there and we want to hopefully get there
before second quarter on some of them
and before third quarter under others so
as per the milestone and timeline we
were working it I am the founder Kristin
to dr. Patel people Pfizer brought Mary
crack and their own women we know what
is the major difference and why is that
our only map or the pro one party is
showing better results or a much better
effective rate there
Fiser grunts okay yes I hope you can
hear me yes I think that yes so there's
not been a direct head-to-head
comparison in patience of these
different therapies you know the way I'd
characterize it is that we have
preclinical data using specific doses
and I can only say that based on the
doses that we used in the preclinical
studies we've been able to see a more
sustained suppression of the metastatic
phenotype so there are a number of
different variables that could be
responsible for this thing including the
dose of therapy and bioavailability and
other issues that we don't really
understand but I'd say that it is not
there my intention to imply that one is
the superior technology than the other
this is certainly not been exhaustively
examined by any by any stretch we're
going to refer to a single study that
we've conducted a preclinical study and
I think that there's enormous
opportunities the important point to
take home really is the principle that
in the case of ccr5 it plays an
absolutely important role in cancer
metastasis and that small molecule
inhibitors of ccr5 and a humanized
monoclonal antibody have demonstrated a
substantial efficacy in these
preclinical studies again we're in Zinna
graft model for human cancer so again
emphasize that none of my comments were
or should be construed to state that
with in any way compare these directly
nor have we determined whether or not
they would have similar or superior
efficacy in the clinical studies because
those clinical studies have not been
conducted rather I'd say this is a
message of theirs profound opportunity
in the
ccr5 cancer metastasis space I hope
that's helpful answer to the question of
course thank you thank you thank you and
with that we would like to wrap it up
operator no more question announced but
I'll just gives you more comments about
finishing comments so thank you again
everyone for being on the call today to
summarize we have our blh submission it
could happen
the full amount by the end of second
quarter best-case scenario worst-case
scenario end of third quarter
monotherapy pivotal trial is being
worked on triple negative breast cancer
the initiation of the patient's
injection could happen any week now and
the interim results we hope to have in
third quarter with the regards to grab
purses hostesses we reinitiated our
study in regards to manufacture product
we had some good results to tell our
shareholders and in regards to
commercialization of four one four there
are opportunities that we are evaluating
at this time with that I want to thank
everybody again and have a great day
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