VIM's Disclaimer and Transcript
This is a transcription of the conference call which I did
myself. It is as accurate as I was able to do, but since I am human,
there may be mistakes contained herein. I did dispense with many of the greetings
and pleasantries in order to focus on the meat of the presentation. Any
people's names, company names, or drug names listed herein may be grossly misspelled,
for which I apologize in advance, and anyone who would like to proof read and
correct some of my mistakes, I would welcome your help. Thank you,
vic_in_monkeytown
Peregrine Pharmaceuticals
Conference
Call
June 8, 2001
Opening Remarks
Good morning, everyone, and I would like to thank
everyone for joining me on this conference call. As this is the first
conference call that I have participated in since becoming CEO in April, I
would first like to say that I am pleased to be here and that I'm honored and
excited about heading Peregrine Pharmaceuticals.
Earlier today, we released an
announcement concerning our direct targeting agent Oncolym. I wanted to
hold this conference call in order to directly address any questions that our
shareholders might have about this announcement, and any other questions that
are of concern to you right now. I'll make a short statement first and
then I'll open the floor for questions.
As the press release explained,
Peregrine is taking over the development of Oncolym from Schering AG
Germany. As part of this agreement we are reacquiring the world-wide
marketing rights and distribution rights to the drug. Though we regret
that Schering will no longer be working with us as a licensing partner, we believe
that this transaction is the best for the Oncolym project. Peregrine has
already conducted extensive clinical trials on Oncolym, in which 114 patients
received therapeutic doses of the drug before Schering licensed the technology
from us. Based on this prior clinical data and in reaction to competition
in the lymphoma marketplace, Schering decided to reposition the drug as a one
dose protocol. We are highly optimistic of Oncolym's potential under a
one dose protocol and believe it has significant characteristics that will make
it a competitive product for the treatment of B-cell lymphoma.
Furthermore, after reviewing Schering's development program, we are confidant
that we can seamlessly assume management of their program and that we can do so
at a cost effective level. Under our arrangement with Schering, we were
paying 20% of the development costs which translated into payments by Peregrine
of approximately $1.7 million since 1999. We anticipate that by
proceeding with the phase I/II on our own, we will have a budget of
approximately $700,000 plus the cost of our drug, spread over the next
year. This amount includes the cost for hiring one additional employee to
manage the study. The reason for this is simply that we are a smaller company
and we have significant experience in radiopharmaceutical drug
development. In addition, Schering has laid the groundwork for the study
that will negate the need for substantial expenditures by Peregrine. We
had already budgeted for 2 additional Cotara clinical studies to be initiated
this year, so the Oncolym trial will now take the place of one of them and when
our cash position is increased, we will initiate the additional Cotara study
that had already been planned.
In addition, we are going
to be actively exploring licensing and joint venture opportunities for
Oncolym. We will be publicizing the availability of the drug for
licensing at the Bio-2001 biotechnology convention which is taking place a
little bit later this month in San Diego, and we will also contact groups which
have shown an interest in Oncolym in the past as well as companies that we know
are actively seeking clinical stage products. We have had interest from
several foreign entities for licensing Oncolym in certain geographic areas over
the seas, and we will pursue all of these opportunities.
Even though Oncolym was the
focus of today's announcement, I want to highlight some of the other things
going on at Peregrine.
This year, we have launched 5
phase I's for Cotara this year at Stanford University and the Mayo
Clinic. These studies are actively recruiting patients. Our
association with research institutions of this caliber provides an important
validation of the potential of our technology. We are also compiling the
data on our Phase II brain cancer trial and remain confident that we will move
into a phase III with that by the end of this year.
We are also anticipating that
our Chinese partner, Brilliance Shanghai Pharmaceuticals, will receive
regulatory approval to market Tumor Necrosis Therapy in China sometime this
year. I know that many of you are as eager as we are in anticipation of
this achievement. It will be a very important validation of what we have
been working on for so long. Peregrine will provide any assistance requested
by Brilliance in their commercialization efforts of TNT in the Peoples Republic
of China. As soon as we are informed by Brilliance of their
government's decision, we will make an announcement.
We are also working on
potential licensing and joint venture opportunities for our TNT platform as a
targeted delivery molecule for a variety of anti-cancer compounds. We are
preparing the fully human TNT clone for entry into human clinical
studies. This clone will be the backbone of our licensing and joint
venture programs for the TNT platform.
I remain very excited about the
potential of our Vascular Targeting Agent platform technology being developed
through our joint venture, Arcus Therapeutics. Vascular Targeting Agent
technology represents a new generation of anti-cancer drugs, and I am confident
that Vascular Targeting Agent technology will eventually be recognized as one
of the most promising new approaches to cancer therapy. Peregrine and
Arcus intend to work harder to bring this Vascular Targeting Agent technology
into the mainstream. We are actively pursuing licensing opportunities
with multiple parties for the Vascular Targeting Agent technology platform.
We are also preparing our
anti-angiogenesis and our non-conjugated therapeutic antibody programs for
human clinical studies. Now we haven't publicized these technologies
much, but they are none the less very important technologies in our anti-cancer
arsenal. We believe these technologies may eventually prove to have
significant market potential, and represent excellent joint venture and
licensing opportunities for Peregrine.
We are conducting the final
toxicology and pre-clinical efficacy studies on our lead compound for our vasopermeation
enhancement technology platform. Our lead compound will be our fully
human TNT antibody with our proprietary permeation enhancement peptide
vaso-active compound attached. We expect to enter this compound into
clinical studies in the first half of next year.
We have been working diligently
to prepare our manufacturing facility for potential contract
manufacturing. Due to the extreme shortage of monoclonal antibody
production capacity worldwide, we believe this can be a viable positive cash
flow creating business for Peregrine. We intend to aggressively pursue
contract manufacturing opportunities. We will release more details of our
plans and projections for our manufacturing facility when we sign our first
contract.
As many of you know, I have
been conducting an extensive road show. Every other week I present
Peregrine's business plans in a new city. In all, I have given over 40
presentations to investment bankers and institutions. Reception has been
very positive from both groups. Many of these groups are conducting more
due diligence on the company and I am confident will create significant buying
in the future. I am certain that Peregrine is now on the radar screen of
entities that have never heard our story before. As we continue to make
progress in the advancement of our business plans, I am confident more
parties will become active in building a position in our company. I
intend to continue this road show until I have covered the entire United States
and Europe.
As part of the road show, I
have been in discussions with several parties about equity investment in
Peregrine. I am confident we will be able to obtain the financing we need
to continue with our aggressive development plans. Along with equity we
will fund our operations through manufacturing and licensing revenue.
Once we have tested the market for contract manufacturing, we will be better
able to predict how much revenue contract manufacturing can generate. If
the contract manufacturing market is as strong as we believe it is, our goal
would be to fund all of our operations from contract manufacturing cash flow.
In closing, I would like to say
that Peregrine Pharmaceuticals has assembled a very impressive pipeline of very
broad platform technologies that I believe have the ability to generate
tremendous value for the shareholders. I personally have been a large
investor in the company since 1989, and never have I been so confident about
the future of the company. With that said, I would like to open the floor
for questions.
Questions and Answers (Q. & A.) [ Ed's
Answers ]
Nick Fratello, Global Capital
Securities:
Q: Do you feel that we can move Oncolym
faster with a different partner as oppose to Schering? Were there some
delays going on in their development schedule?
A: We think that, first off, we
would like to get control of the technology and really move it faster on our
own as we look for another partner. I think the real goal of the
technology is that we would like to have a partner before the pivotal study,
mainly because we are just not going to be able to compete from a marketing
standpoint with much larger companies that are already in the marketplace, so
we think we can move along the phase I/II very quickly on our part, mainly
because we have a lot of experience in the radiopharmaceutical field and we
are, you know, just a much smaller company. Then I think as time goes by
here in the phase I/II, that it will take some time to get a joint venture on
or a licensing partner on board, so that gives us time to move the technology
maybe a little quicker.
Robert Brower, Private Investor:
Q: I am relieve to here that we're looking
at alternative forms of financing. Is it fairly far advanced? Are
we looking at direct investment? Can you elaborate a little bit on that?
A: Well as you know I have been
giving an extensive road show talking to a lot of difference mainly
institutions and investment bankers. From the investment banking side, we
are still probably a little premature for getting a tremendous amount of
interest from investment bankers just mainly because our stock price is so low,
but they have all showed interest and really are watching us. We have
provided additional data to several of the analysts that are out there for
large banks and we know that we are on their radar screens. So what we
really have targeted is to try to get large institutions to invest in the
company. As you know, there is not a lot of institutional ownership at
Peregrine, and I would like to see that ownership rise to probably 15 to 20
percent if not higher of the company, and to do that I think you need to get a
quality investor on board that will be recognized by everybody, that has done a
significant amount of due diligence, and is making a tremendous bet on the
company as it moves forward. I have worked diligently about attracting
that type of investor, and that's who we are really trying to bring on board.
Same Questioner:
Q: And then I guess the strategy might be
to hand it off to more traditional investor such as or traditional capital
raiser like an investment bank?
A: Exactly, Bob. I mean, the real goal here is that
we probably have to take it into the $3 range before the larger investment
banks are going to start taking interest, and the goal would be to position the
company as we get the stock price up into the $8 - $15 range, the big banks
could come in and raise us some significant capital, and when I mean
significant capital, $50 million or higher, and that would really allow us to
take the drug to the market ourselves, market our Cotara drug, basically do
everything that we would want to do internally and become a fully integrated
pharmaceutical company. Obviously, if that doesn't work, then we will
take these technologies through a little bit later stage and then we will find
licensing partners for them, after we have created value by the clinical data.
John Welch, HFBC
Q: Should we get full approval in China,
would that mean that we can pursue a fast track program or would the FDA allow
to be fast tracked at that time?
A: Really, from a regulatory
standpoint, what happens in China will really not affect the US. The main
reason for that is that they are using a different clone in China then we are
using here. The reason we did that is that, in 1995 when we licensed this
technology to the Chinese, we were just really getting our plans laid for our
TNT-1 clinical program in the United States, and under FDA regulations if there
is a problem with your product anywhere in the world, you must report that to
the FDA, and we didn't want a situation to where they had a problem with our
drug in China and it would stop our US program, so they are using basically a
little different clone over there, its called our TNT-3 clone, and it targets
single stranded DNA versus our histone complex on DNA which is what our TNT-1
program targets, so I really don't expect it to have any effect on the US from
a regulatory standpoint. What it really does for us is puts us in the
position of knowing the technology works, that it is approved in a country,
and, of course, receiving revenue from the sales overseas.
Pat Ryan, AG Edwards:
Q: The clinical trials in China, or the way
they used it in China, I sure if it was in a formal type clinical trial but,
were there any particular types of cancer that Brilliance is saying that this
is where is worked best and this is the types of responses we got that you can
share with us?
A. You know, I have personally
only seen spotty data. I think 2 or 3 years ago we released some data on
brain cancer from the study they did over there. We released that they
had told us that they got 7 of 8 complete remissions in primary brain cancer,
and the data the we have seen there, you know, between then, has been from, you
know, our researchers going over there and getting a look see at the
data. We haven't really been able to bring data our of China and really
go through it like you would want to from a scientific standpoint, so I would
say that from our standpoint we have, you know, pretty much anecdotal
data. What I will tell you is that there are several cancers that they
believe that this drug works very will on, and it may necessarily be a way
around the way they administered the drug. Administration of the drug can
be just as critical as the drug working properly itself, and they have been
able to, based on the flexibility of their regulatory stance in China, they
have been able to really experiment with different ways to administer the
drug. They can do things a lot faster over there than we could ever dream
of doing here in the United States, so based on that, I really would hate
to go out on a limb and tell you things. I can tell that there are
several very large cancers they have done well on. They intend on
releasing that data at some point and time after they get their approval, and
then I guess we will all see it at the same time.
Myron Greenspan, Shareholder:
Q. Thank you for the information. My
experience with CEO's are mostly financial people, but you seem to be really on
top of the technology as well, which makes us stock holders feel good.
A. Well, really I am from a
financial background, but I think the technology we have is very exciting and it’s
a hobby of mine to learn more about it.
Q. My question is really a very
simple basic question. I have owned this stock for about 2 and 1/2
years. I am long the stock, I know the pipeline very well, and I don't
understand with all of your predecessor's trips and your trips why the stock
price is not higher than it is. That would be my primary question.
A. Well, I think that, first
off, it’s a series of small steps that we have to take here. I don't
think any of my predecessors have ever done the type of road show that I am
conducting right now. I am relentless in doing this. We are doing
lots of meetings. Every other week we are meeting with new groups.
Now, you have to understand that I have targeted the institutional
investor. Institutional investors are a lot more diligent in their due
diligence, and they don't care about getting a stock at $2 or $3 or $4, or $5,
what they care about is insuring that they have done the proper amount of due
diligence, and they realize that if they hold the stock for 4 or 5 years that
the upside is very big, so if you are looking at the current stock price and
the trading that has happened with the stock price. When I came on board,
the stock was about $1.25 and we have been up around $1.75 so obviously
something is starting to work, but it’s a process. Its not going to
happen overnight, and to be frank with you, I don't want it to happen overnight
because when you have very fast rises in the stock, you are always going to see
the stock do a major pullback. I would much rather see a nice steady rise
in the stock, building bases as we go up, and eventually we are going to get
there. I think we have some very critical stuff happening this year,
especially through the summer, and I am confident that we will get up to the
levels that you will be very happy with, at least that I'll be happy with. You
have to understand that I have been in this thing since 1992. I want to
move it forward. I want to make as much money as you do. And more
importantly, I want to help cancer patients that can possibly be helped with
our drugs.
Same Questioner:
Q: Absolutely, cancer has touched every
family that I know. One last question, I have, and again this is not
bashing the technology but, one of the things that has worried me since the
genetics technology has come about in the past year or so, that our technology
might become somewhat antiquated with the human genome technology that I read
about every day. Do you have any remarks about the competition of that
sort of technology?
A. I could probably spend the 3
and 1/2 hours talking to you about the prospects of genetics. I think its
pretty standard that investors really need to, when you think about new
technologies that are coming to the market, you have to take yourself back and
say, what's realistic? You know, the news media really front runs this,
because when things are in the news. the news media makes things seem like the
whole world is crashing around us, but, you know, I want to remind everyone
that monoclonal antibodies were invented in 1973, OK? The first products
have really started to come to market in the last 3 to 5 years. It takes
decades to move new technology platforms into the marketplace. So I know
that everyone is making it seem like our technologies will be obsolete, but
that can't be farther from the truth, we are going to have a very, very good
run with the biologics. The monoclonal antibodies are moving in to the
forefront of the treatment business, and they will remain there probably for
several decades before you start seeing some really significant gene therapy
technologies come out. Now one thing that this also highlights, I think,
one of the aspects of our drug development programs that you should take into
consideration. And mainly it is this, that if you look and I am sure you
are reading everyday that they have identified a new genetic marker for this
cancer and for that cancer, but what we have done at Peregrine is said look, we
don't believe that cancer should be treated as a hundred or 200 different
diseases, we believe that cancer can be treated as one disease, and that's what
we have developed is technologies that treat cancer as basically one
disease. So we believe there is a tremendous amount of value in those
type of technologies and we think our technology platforms will withstand not
only the test of competition but the test of time. And don't forget, we
have got a pipeline, we've got our vascular targeting agent technologies,
we've got a lot of stuff in the pipeline here that can compete and fill our
pipeline for many years to come, so I'm not too worry about any threat from the
genetic side.
Yaya Fishani, Shareholder
Q. The question really is in regards to
China again. I thought that we were talking about China getting approval
this summer. Now it appears that we are pushing it off to sometime this
year...
A. Well, I say sometime this
year because I don't know. They may get approval by the end of the
summer. I would hate to promise you that they get approval by the end of
the summer and then they don't. I believe they will, but I don't know, so
your guess is as good as mine when they are going to get approval, but they
have told us that they believe it will be for sure by the end of the year.
If they do get approval, how
fast would you get a revenue stream coming from China? We are in discussion
with the Chinese right now about what their needs are. I will tell from
our standpoint that we can manufacture clone for them very rapidly. Then
it will be really about how quickly they can get their marketing launched over
there, and get the radiolabelling process in place. We have developed at
Peregrine a pretty innovative radiolabelling mechanism, and we would like to
get that transferred to the Chinese so those are some of the things we are
having discussions with them with, but I think that probably their goal is to
start sales early next year if they get approval this summer, and of course if
they get approval at the end of the year, then you are probably looking at
mid-next year.
Terry Dye, Private Investor
Q. I have a question on Arcus. With
the recent news on Oxigene's financial problems, will this affect the setup?
A. Well, I don't know. I
tell you what, if I had $24 million in cash, we'd probably all be doing back
flips down main street. I don't think that 2 years of cash is a problem
for them. We are really their major project right now, so I am not concerned
in the least of the cash position of Oxigene. I think they have a sound
cash position of 2 years of cash in the bank I know you read the Reuters
article, and it’s probably of concern to everybody, but its really not of
concern to us and I don't believe its of concern to Oxigene. You know, I
think that, well, lets say that the worse happened two years from now that they
defaulted on the loan, well, you know, hopefully we're in a lot better
financial position to take over the project and that's exactly what we'd do.
Same Questioner:
Q. So we do have a back door to . . .
A. Oh, sure, if they default on
it, then it all comes right back to us, so as long as we are in the position to
fund the project moving forward, we'll be OK, but I really don't think that's
an issue here. 2 years is a long time to happen. Oxigene has some
pretty good drugs in the development program. I know that their
Combretestatin is being studied by Bristol Myers Squibb, and they are going to
get milestones based on that, and, you know, the financing market will probably
come back around in the next 2 years that would allow them to tap into the
equity markets a little more, so I'm not too concerned about that. 2
years of capital is a pretty good position to be in. I wish I had two years
of cash in the bank right now.
Same Questioner:
Q. And something else, on our Oncolym
trials, I realize the protocols have changed. Are we able to use any of
the information from our original trials to help us along on that or has
Schering been using any of that?
A. Most Certainly. Any
time you've treated patients with therapeutic doses of your drug, you can use
that data, so that data is going to be very important. Not only has it
been important in formalizing the phase I/II protocols, but it will definitely
be used in the registration of the drug. You have to understand we have
already done the toxicity profiles and everything on it, so we are pretty much
dealing with a known, we are just trying to see if this one dose protocol is
going to equal the efficacy we saw with the two dose protocol.
Joseph Sunacorsky, Private Investor:
Q. I am interested in the split with
Schering. I know that when you joined with Schering that stock, I am
looking at this from a stock point of view, I think did quite well. What
do you think the impact of the split with Schering is going to have on the
stock short term?
A. Well, I don't know.
Only the stock market could tell you that. I wish I had a crystal
ball. What I can tell you is that we basically have got a product back in
our pipeline. It isn't going to cost us a whole lot of money to move it
forward. You've got to understand, we are a small, we're a nimble
company. We're very efficient at running clinical studies. We have
an excellent clinical program going for our Cotara. We have 5 phase I's
and a phase II running with our Cotara. So a lot of the resources that
you need, just because they are both radiopharmaceuticals, can be spread across
both of the products, so we are really not looking at a whole lot of expenditure
for us to move the project forward, and we now have full control of the
project, so I don't view this as a negative, this is a positive. And
don't forget that Schering has basically already left about $1.3 million on the
table that they gave us 3 million up front. We have spent 1.7 million of
that back into the study, so we are up net 1.3 million from where we started
and we have basically full control of our project back. I think the real
message that should be read by the shareholders here is that I like Oncolym as
a product, but it is one product in a multitude of products that we have
here. We have tremendous technology platforms that we can generate
revenue, not only from selling our own products to the market, but we can
generate revenue from licensing opportunities, joint venture
opportunities. And Oncolym really I would consider more of a niche
product. It can only work on B-cell lymphoma where all of our other
products really are applicable across tumor types, so they have much higher potential.
So if I were to sit back and do a NPV (net present value) and the portion of
that related to Oncolym, then I would say that it wouldn't be a significant
portion of our market cap, and I think you've probably seen with the
trading today that that's what the market is reading it as, too.
Same Questioner:
Q. I haven't seen it, but thank you, and I
just have one other question, Ed, real quick. What is one dose protocol?
A. Basically, when we
originally took our Oncolym product into phase I and phase II, we did two
doses, which means you got a dose of the drug and you waited basically 60 - 90
days and you came back and you received another dose of the drug. When
Schering came in and took over the program, there were two factors at weigh here.
One, we looked at all of the data from our 114 patients that received a
therapeutic dose, and said look, most of the patients had great responses at
the first dose. If they didn't respond at the first dose, the second dose
probably wouldn't make a difference. If they did respond, the second dose
may have increased the efficacy enough, the first dose got you to the point to
where you think you could get approval on it. So it made sense because
Corixa's drug is going to be a one dose protocol and you would be taking a
product into the market that was already at a marketing disadvantage by having
to use two doses in the protocol, so I think it was a strategic decision that
was made that let's back it off to a one dose protocol, we think the efficacy
will be there to get the product approved, and then we can more effectively
compete in the marketplace with Corixa and potentially with Zevalin.
Richard Jakes, Private Investor:
Q. In earlier presentations, you said there
might be as many as 5 or 6 partnerships this year. I would like any kind
of progress update you can give on that, and have the folks at the headquarters
looked at our potential of staying in the Russell today?
A. I have looked at staying in
the Russell, and it’s a pretty secretive process in itself. We'll know at
5 o'clock today whether we are in the Russell. I thinks what's working in
our favor is there has been a tremendous amount of technology stocks that have
absolutely gotten hammered over the last year, so I would say our odds are
pretty good of staying in. I don't know, I have no way of knowing what
that cut off is, I think that's a very secretive thing, but I believe at 5
o'clock eastern time today that is posted on the Russell web site, so you'll
know as soon as I do. What was the other part of your question?
Same Questioner:
Q. The partnerships that you
alluded to in investor presentations, how is that progressing?
A. It’s progressing actually
well. You have to understand that a lot of the low hanging fruit has been
picked off of the tree in the partnership arena, and now I am really dealing
with much larger companies on potential partnerships. These companies do
a heck of a lot more due diligence. They are a lot slower to deal with,
so its going to take a little time to get some of the bigger ones closed.
We are advancing pretty quickly on some of the smaller ones, so I think I can
still meet that milestone, I just can't give you the exact time frames.
When the deal gets done, you'll be the first to know.
Bruce Adams, Private Investor:
Q. I have 3 simple questions. First,
the Mexico trials. Can you tell us anything about those briefly.
Are they on-going? Is there anything else to be learned from Mexico?
A. The Mexico trials are done,
and the data will be released or the majority of the data will be released at
the Society of Nuclear Medicine which is later this month, and we will post on
our web site the actual poster presentation. So you will be able to see
exactly what was done in Mexico, the results that they got from the study, in
detail, as much detail as anyone will have, so look for the announcement that
we'll do when the Society of Nuclear Medicine comes around and then you can go
to our web site and pull down the poster presentation. I am currently
putting on the web site a new section to try to get more scientific data into
your hands so that you can research it and review it any time you want to, so
that should be coming up on the web site here very soon. We are going to
work a lot harder. I know I have missed a couple of opportunities here of
getting the word out about some of our technologies and some of these
presentations. It's totally my responsibility and it’s my fault that it
hasn't been followed up properly, and we will correct that in the future.
Same Questioner:
Q. The second question is, and I may have
missed this, but would you say something more about the time tables for the
Oncolym trials I and II, and my last question relates to that, are these
studies going to be conducted mostly in Europe or also in the United States,
and where?
A. Concerning the Oncolym, we
think it will be at least a year in the current phase I/II. I don't
know. We have to get our hands around it, and I really going to be very
cautious about giving you a time frame until Dr. Chew has had a chance to get
into all the centers and talk to everybody, and he'll have a much better idea
of exactly what the time lines are, but I would say at least a year before we
are through with the phase I/II, and we will give you an update a little bit
later after Dr. Chew has full control over it and has spent time with all the
investigators in all the centers.
Same Questioner:
Q. OK, and the last part was, where are
these studies being conducted, in Europe only, or will they be expanded to the
United States?
A. They are all in the
US. We have 9 sites that are open and running for Oncolym, and one that
will come on board probably within the next 30 days. And as we move it
probably into the pivotal studies, we will probably open at least 20, maybe 30
centers.
Joe Beechy, Private Investor:
Q. You talked about China. I am
wondering what kind of revenue could the success in China create for Peregrine?
A. We have a 10% profit share
with Chine, so 10% of the profits that come out of China go directly to
Peregrine. What I am trying to accomplish is that, our goal is to help
them get this drug manufactured and marketed in China as soon as
possible. They currently don't have manufacturing capabilities and we do,
so we think there is an opportunity there for us to manufacture while they
build our their manufacturing facility. The regulations in China are a
little bit different. I won't say its better or worse than the US, but from
an investor standpoint, it holds a lot less risk than the process in the United
States in the fact that in China they let you get the drug approved and then
you are able to build the manufacturing facility and all that infrastructure,
which really from a risk standpoint is a much better way to go. I am sure
that the FDA has its reasons, and I know the reasons, for having the
manufacturing infrastructure in place before you get approval. So it’s
probably going to take them at least a year and a half to 3 years to build out
all their manufacturing infrastructure. In the meantime, I would like to
be in the position to contract manufacture for them. We can ship antibody
to them manufactured here at our current facility, and that is where I really
think our near term revenue potential is going to come from the
collaboration. So my goal is to enter into contract with them. We
are in discussions with them. I can't make any guarantees. What I can
tell you is that, if we don't hook them on as a partner, there is plenty of
other business out there that we are going to go after, but our real goal would
be to get the TNT marketed and make it a big drug in the Peoples Republic of
China, and generate some manufacturing revenue from that.
Same Questioner:
Q. And one last thing about the road show,
are you going to be in San Diego this month?
A. Actually, I had planned on
doing 2 days in San Diego a little bit later this month, actually, around the
bio-conference. I had two days planned. I had to cancel them
because I have several meetings with some investors, but I will come back
to San Diego for sure. It’s a hot area, and I will be there.
Basically, if you are anywhere in the United States, I am going to be somewhere
in your area in the next year.
Shelton Blackman, Private Investor:
Q. I was wondering, what was our price to
reacquire Oncolym?
A. A big fat zero.
Jim Wade, Private Investor:
Q. I am very interested in the contract
manufacturing facility. I know previously you guys have had some
experience with the manufacturing facility, I think it was a year or two ago,
and guess I am really interested in what kind of initially capital outlay are
you guys expecting to get up and running, and in addition to that, what type of
time from are you looking for a revenue stream?
A. OK,
manufacturing... You know, it’s ironic. This manufacturing facility
that we've built here is really a very fine asset, and the people who built it
did a superb job at designing it and at building it. Its really a first
rate facility. It’s also a facility that about ran this company out of
business in the past. The market has now changed. All of a sudden
monoclonal antibodies are the hot new drugs. Everyone in the world is
developing some kind of monoclonal antibody program, and now no one can find
any place that will manufacture the drug, and more importantly, its very
difficult to get early clinical trial and pre-clinical trial lots of antibody
made by anybody. The larger companies just don't do it, or you have to
wait a minimum of 2 years. So as we announced, I think, in '99 when I
came back in on the board of directors that we were going to mothball the
facility and we were going to put it up for sale. Now, we really didn't
mothball the facility because it was worth more if we could bring somebody into
it and say look, you've got a facility that you could step into and
operate. So although we cut back the staffing on it, we cut back, most of
the staffing was related around paperwork, but not necessarily around people
who actually operate the facility and manufacture the drug. So, we had
cut back in the areas, and what we really did during this timeframe, over the
past year and 1/2, was we implemented new types of manufacturing. And
what I mean by that is we are now using a lot of disposables in the
process. It raises the per batch run cost of the drug slightly, but it
eliminates a tremendous amount of validation and cleaning work that has to be
done in these manufacturing processes. So we are really much more
efficient in our manufacturing and we are able to manufacture using fewer
people. I think the disposable is going to be the wave of the future for
a small facility like this.
As for our capital outlay, we
really are not going to have hardly any capital outlay. The facility is ready
to go. We manufacture our own drugs in there right now. What I will
tell you is that right now we have in the facility a 100 liter reactor, a 300
liter reactor and a 30 liter reactor. What we would like to do is replace
that other 30 lithe reactor with a 300 liter reactor. That whole think
was probably cost around $400 grand, and we would do that solely out of cash
flow from contract manufacturing. Now, I am not going to lock in a price
right here for what we can get per run, but I can tell you with those three
bioreactors, if we ran 20 runs per year with each of them, the not only could
we fully fund all of Peregrine's operations, but we would make a profit, too,
so that is our goal to try to do that. Now, first off, we want to hold
back signing too many deals with people until we find out exactly what the
Chinese want to do. We want to make sure that we can deliver drug to the
Chinese to support the launch of our TNT drug in China. If they in fact
decide that they want to use a Chinese manufacturer then we will fill that
pipeline with US companies, and we do have interest here, so we are working out
all the details on the manufacturing and probably what we will do is that we
will do what we call a rolling hire, which is we will max out our capacity of
personnel at the facility. When we are overworked we will bring on one
more person, but we are going to do that all out of cash flow, so I don't view
any additional outlay of cash from our equity. It’s really going to fund
itself through cash flow.
Same Questioner:
Q. Excellent, now I have to question you
because I am just trying get a flavor for exactly the revenue streams coming on
next year, and it sounds like it's going to be the middle of the year where
potentially we get not only the potential revenue streams from China, but also
for the manufacturing facility..
A. I tell you what, I need to
sign my first manufacturing deal and then I will come clean with all the
details of the numbers of what we are charging per run, and that will be part
of the process of letting everyone know that we can manufacture antibody for
them. We have very good timelines, I mean, you are looking at a 2 year
wait for all the other manufacturers in the industry and we can get the drug
out there pretty quickly for people, so I think we can fill that pipeline, but
I don't want to lock in a price. We are going to charge what the market
will bear, so when I have a contract in hand and I know what the market will
bear, then I will come clean on what the details are.
Corrine Kodia, Eisner
Securities:
Q. Just a couple of questions. One,
the relationship with Schering to take back the licensing. How did this
originate? Was it a difference of opinion, were they dragging their feet,
or was it that nothing was happening?
A. I think it was more of
a mutual agreement. I don't know if you know too much about
Schering. Schering has new management here in the United States, and they
have a very, very aggressive program of which I believe they are looking for 40
percent growth per year for the next 5 years. To meet that they had to
have things moving very quickly. Now, I am not sure if from their
standpoint they said well, you know, maybe Oncolym is moving too slow for some
of the other stuff they want to do, or maybe they just said look, you know, it
better off if we let Peregrine run with this for a while, and maybe they can
step back in later. I don't know exactly what the deal was. I do
know that what we thought was that with the deal we had with them, we were
responsible for 20%, and there was really no cap on that. There was
really no cap on how much we would be responsible for, so it is really hard for
us to predict in the future what we are going to be paying for our 20% of this,
and remember we also pay all of the drug cost involved with this. So we
think its beneficial for both us and for Schering. I think Schering would
be a great marketing partner for the drug when it gets in the market.
They already have a very good franchise in the lymphoma area. And if we
move this thing along quickly, it may go back to them in the future when we
have a lot more data that's further along, and see if they want to market this,
but I think really there are a lot of people out there looking for drugs.
We are going to move it along in the clinical trials as quickly as we
can. We are pretty efficient at doing this, and then we will find a
partner for it.
Same Questioner:
Q. Have you been in your road shows out in
the Boston area?
A. Yes, I have. I was
actually there I guess 3 weeks ago, had some great meetings in Boston. I
will be visiting Boston again. There's a tremendous amount of
institutional investors that have a high interest in Biotech. I am sorry
that I didn't come by and see you, but if you could, email me at [email protected],
and next time we come by I will make sure I come in and see you.
Same Questioner:
Q. Just one final little question.
While there is so much enthusiasm and there's real facts that you have been
able to present, why would Dr. Chew sell shares? It was not a big amount,
but he was an insider selling shares at the moment.
A. Well, I really don't want to
discuss any personal situation with anyone in the company. I think Dr.
Chew is well behind this company. He is probably the most important
person in the company. Right now, I consider him even more important than
I am, because these clinical studies are critical to the company, so I wouldn't
read that any certain way in that Dr. Chew needed some cash, so don't read
anything into his belief in what's going on. I would like everyone to not
sell the stock, but also you know people have families. People have stuff
going on that they have to take care of. I think if you look at the
dollar value of it, it wasn't very significant in the big picture.
Paul Ernst, Ernst Report:
Q. With regards to lymphoma, I believe
everyone on the market now, the Idec and Corixa is targeting the CD-20 antigen,
and I am aware of some failures on that especially on retreats. Sometimes
this is due to antigen shift, but in the case of Idec I know that even without
the antigen shift Rituxan is failing on some retreats. I know we have a
target different from ..., and does that position us in the marketplace, and I
believe Amgen also has a CD-20 target. Can you speak to that?
A. You bet I can, and that has
really been the basis of the value for Oncolym and why we are convinced that it
will compete effectively in the marketplace. The simple fact of the
matter is that we are targeting a different antigen. Our antigen site is
highly specific to B-cell lymphomas. It is really not expressed anywhere
but on the surface of B-cell lymphomas. It is expressed in high volumes
on B-cell lymphomas. So even if we slip the drug into the market and all
we do is mop up what the CD-20 market can't get, I think you have a very
valuable asset right there, and that is how the drug it being positioned.
We are going after these harder to treat cancers. We are confident that
Idec is going to take Rituxan into the intermediate and high grades. We
haven't seen any data on that, so as soon as we see the data we will see how
effective they are. Just based on the type of data you see out of low
grade, all these patients are relapsing eventually and we know that they are
going to be in the marketplace for Oncolym. Oncolym, I believe, is very
well positioned for that marketplace just because of the statement of the
antigen. The antigen really doesn't modulate, we haven't seen any problem
with modulation of the antigen, and I think we will be well positioned to
capture a significant portion of that market.
Same Questioner:
Q. I saw your predecessor in Denver.
Do you have any plans to come to?
A. Actually, I was in Denver, I
met with an investment bank there a couple of weeks ago, and I do have plans, I
believe, in the fall to get back to Denver, September. I want to get back
there before September.
Same Questioner:
Q. I believe that was Nick. I could
hook up with him if I wanted a recap, huh?
A. Most certainly, I met with
Nick's analyst there in Denver, but we have a big investor base in Denver, and
I would be more than willing to stop back by if you have an interest and can
put the people in the room to hear the story.
Nick Fratello, Global Capital Securities:
Q. Well, I'm back, Ed. The questions
I had, some of them were covered, particularly about the manufacturing
facility. One of the things I guess I wanted to ask about was this, you
mentioned that 20 runs per year would fully fund the company and possibly make
a profit. I guess what I am wondering is what is the capacity of the
plant. Have you calculated that? How many runs do you think you
could do in a year?
A. Well, as I said, we want to
change out our 30 liter with another 300 liter, and based on that I think its
realistic that you could do 20-24 runs a year per reactor, so really you are
looking at 75 runs a year would be I think a pretty good ballpark, and we will
charge per run. So basically, when you come in, we will run your
clone. We have to do some work on the clone and we will charge an hourly
rate on that, and then when the clone is ready to go into the reactor, then we
charge basically per run, so whether you are choosing the 100 or the 300, I
don't think will have a big differential. What's really good about these
is these are the types of levels that you need to do your pre-clinical and
phase I/II studies. You don't need a 1000 liter run to do these types of
studies. You need probably a couple of 100 liter runs or a couple of 300
liter runs to give you enough clone to do all of your work. We think we
can compete very effectively with everybody that is out there. Like I
said, I am going to hold off giving you a price on what I can charge, but I
will tell you that if we can max out this facility we can be a profitable
company based on it.
Same Questioner:
Q. So a 300 liter reactor generates a 300
liter amount of product, is that how that works?
A. No, it works like this, it
all works on the yield of your clone. So your growing a 300 liter batch
and whatever the purified yield on your clone is, is how much you get out of
it, so that is particularly strictly based on the production capacity of
your monoclonal antibody. Some clones produce a lot more than other
clones. So if you have a poor producing clone...One of the first things
that we do when we get the clone in is see how it produces and we try to
maximize it, we try to do what they call optimizing the production of the
clone, which is you play around with the clone a little bit, you try to find
some higher producing clones that are in there, and use those. So there
are a lot of things that we can do to try to increase the production of the
clone, but its solely based on your clone. Some clones, even our own
clones, some of them produce 3 or 4 times more than other ones.
Steven Carlson, Private
Investor
Q. A couple of months or so ago, you
mentioned a 50 million dollar figure to continue the testing. My understanding
from what you've said today is that outside of manufacturing, equity issue is
the way you would raise that money. Is there a minimum that you would set
a stock price at before you would do that?
A. Well, first off, let me
correct you on what I said. I said we need 50 million to take Cotara the
distance, and that means to market Cotara as our own company, OK, so there's a
big difference there. I don't need 50 million to get Cotara through the
clinical studies. We believe the clinical studies, the phase III for
Cotara is going to cost probably somewhere in the tune of 8 million
dollars. So the 50 million dollars, really what I want to do here is
raise it in several tranches. We would like to be able to raise 50
million or higher probably next year sometime through a traditional investment
bank large secondary offering, you know, with the research and that whole
bit. But to move the company forward, we are looking at probably we need
as we start our pivotal study later this year, we are going to need around a
million to a million two fifty a month to run the company at our current
rate. So, you know, we're pretty lean and mean here. You know, we
have to give up on sides, which means we can't spend as much money as we'd like
to moving things as quickly as we'd like to in some areas, but we are focused
on clinical studies, getting that data our there, proving these technologies
work, and more importantly, generating revenue for the shareholders. So
the 50 million, I would like to see double digits before I would go into that
big of an offering, and I think we are fully capable of achieving that double
digits. I made a bet when I came on as CEO. I've got options that
vest at $10 a share. I've got additional options that vest at $20 a
share, and I've got additionally options that vest at $30 a share. I
intend to capture all of these options while I am CEO of this company, so I
have basically decided to put my money where my mouth is. I know what the
capability of this company is to develop market cap and value for the
shareholders and I intend to work diligently to create that. But the 50
million dollar raise, I want to do it in the double digits range.
David Mack, PPHM.NET
Q. Most of my questions have been answered,
but you had mentioned in the earlier part of your presentation a couple of
lesser known platforms, and I was wondering I guess you are going to be looking
at some possible partnering in that area, and when might we be hearing
something more about these technologies?
A. Well, I was hoping someone
would bring that question up because I can't wait to talk about them.
Actually, you know, when I go out and give presentations to people I have an
hour basically, that I have to give a presentation. And we have so much
technology that it is practically impossible for me to include them in these
presentations. So really we haven't worked really hard at exposing them.
Our lead compound, which would
be our 2c3, which I know you have all heard of, is our anti-angiogenesis
drug. We want to move that into clinical studies. I think the
important thing to remember about these other approaches, they are going to be
what we call nonconjugated antibody, or other people maybe call them naked
antibodies. Big pharmas love naked antibodies. They are easy and
cheap to manufacture. They can put a 30000 liter reactor on line and pump
these things out day after day, and that's really what Rituxan and Herceptin,
both of those drugs are naked antibodies, so the big pharmas love them, and
those are the types of companies we will target with these programs.
The other one, we'll release
more data on the other ones a little bit later. I don't want to kill a
surprise that will be coming up later this year. We will know a lot more
about it from a scientific standpoint a little bit later this year, but these
are two very exciting programs, and what our goals is, we need to produce human
antibodies for these things and then get them into the pre-clinical works so we
have enough data to take to the big pharma and get their interest.
Now, our goal on these
technologies is...one of the things about licensing is you have to be careful
on getting to what I call 'aggressive' on the licensing side. You know,
hey, I can make a lot of people happy by going out and licensing these
technologies to people, but you have to understanding, early stage products,
you are not able to get a whole lot of up front money, a whole lot of milestone
money, and more importantly, you get very little royalty. In an early
pre-clinical stage, you are lucky to get somewhere in the 2-6 % royalty
range. We would love to see that into double digits, and to do that you
have to either structure your agreement so that your are more like a joint
venture or a joint development agreement versus just a straight out licensing
of the technology. So I think with these drugs, I would like to be in a
position to do more of a joint development or a joint venture with them versus
just strictly out licensing them, and to do that I need to have a little bit
more data in my hand to give me a little bit more leverage.
But keep your eye on the tape,
we are going to tell you exactly what these technologies are, release some
exciting pre-clinical data about them, and then we'll start bringing them into
the mainstream of our programs.
Same Questioner:
Q. Well, thanks, Ed, and I also wanted to
comment, I am really glad that you have got a first class web site going for us
now, too.
A. We've got a lot more work to
do on the web site. I want to get more scientific data on there for you
to do your due diligence. It also helps us when we are out talking to
sophisticated institutional investors. I can point them to the web site,
and they can instantly pull down all the published articles, so we've got a
long way to go on the web site. We've working videos in it, so it’s a lot
easier for everyone to understand. We've added some flash video to it,
because some of the other videos were a little big and bulky for people on
their computers. The flash videos can be run by about anybody, and we
will continue to expand the web site. It’s just a matter of time and
money right now.
Steven Powell, Steiffel-Niclaus
Q. I just want to go back briefly to the
manufacturing process here. It seems like you are holding back on going
forward with that until you know more from China, you've stated that.
Outside of that market, what would you estimate the size of the US market?
A. Well, there are
probably 250 that we know of, 250 monoclonal antibodies that are in clinical
trials, and I couldn't even begin to tell you how many are under
development. My guess is there are probably 3 times as many. What
we are targeting is not the products that are in later stage, but products that
are really on the benchtop, ready to go into pre-clinical and human clinical
studies. So we are really being choosy on the market we are going
after. We are doing that mainly for a reason, because regulations allow
us a lot easier to work in this market, and two, we want short
runs. We want to do a run or a couple of runs for a person and then go on
to the next person. And the reason we want to do this is that, you know,
eventually, we are going to have to manufacture drug for ourselves. And
that means that I don't want to get into any long term contracts with anybody
because we need to manufacture Cotara for the United States. So I think
in the near term we can rock and roll on the contract manufacturing
side. Really, I think we can make a profit at this business. I need
a little bit more time to let you know exactly for sure. We think we can
make a profit at it. But also, the people who were here prior I think did
a very good job at laying out the plans for expansion of that facility, and we
basically have another 4000 square feet that we can build out in that facility
and put in some bigger reactors, a 1500 liter, a couple of 300's, a 30 feeder
reactor in there, and we could possibly move our future production of Cotara
into that larger facility, and continue to operate a business on the contract manufacturing
side that we are planning to do right now, so we have a lot of options, but we
want to fund all of that through cash flow. We don't want to really spend
any of our current cash to do that, so it’s going to move a little bit slower,
only because I am not throwing a lot of resources at it. I think as I get
resources in hand, I can speed that up a little bit, but I think the real goal
is to let it be a self funding operation.
Same Questioner:
Q. Can you estimate the size of that market
currently, if possible?
A. It’s huge. I am
confident we can fill out all our capacity. And if we had two facilities
we would probably fill out both of them. And I am not going to lock
myself into a price on what I am going to charge per run, but I will tell you
we can do probably 75 runs in this facility a year, and that would be
comfortably. I will give you a little bit more data later, once I have
signed my first contract and ready to lock in a price. I am going to
charge what the market will bear, but it is substantial.
Same Questioner:
Q. A question with respect to, in China,
once TNT is up and running and such, treatments per patient, does that affect
your manufacturing. So if they are giving, you know, 2, 3 or 4 treatments
to a patient, does that increase your manufacturing?
A, I would assume that it
would. Yes, it will. We probably have the ability to manufacture for them
for about 2 years, based on the projections that we have seen. They have some
very aggressive projections there...
Same Questioner:
Q. Could you share those?
A. I won't share those with
you. I will save that for their IPO. They are positioning for an
IPO, and you'll know everything about what their business plans are, but they
really have some very aggressive plans for TNT in China, and I think that
they'll outgrow us probably within two years of being in the market, which
works perfect for us, because really two years from now we need to be cranking
full bore on manufacturing Cotara for the United States.
Robert Brower, Private Investor
Q. Just a follow on question. In
reading the China news announcement again, I wonder if you could verify if this
is a true statement. If Cotara is approved in China, would it be the most
broadly applied monoclonal antibody cancer treatment in the world at that time,
I mean, if you are applying this to all cancers, I can't think of another
monoclonal that is that broad.
A. Well, you're putting
me on the spot here. I would have to research every drug in the world to
give you the exact truth on that statement, but I would say that I'd be pretty
shocked to find any other drug in the world that gets as broad approval as what
they are looking for, now that doesn't mean that they are going to get
that. You know, we've been told that they are getting approval for life
threatening cancer, which we believe that really includes about every
cancer. If they in fact do achieve that approval, I would say that
that is very significant. But I will hold a little bit short of maybe saying
that we are the only drug in the world, but I would like to know of another one
that has that type of labeling.
I guess we could say its very
broad approval for a monoclonal, anyway. If they get that type of approval, I
would say its spectacular from my standpoint, which really would validate what
we have been saying about our Cotara, I mean our Tumor Necrosis Therapy
technology from day 1, is that we believe that we can treat cancers as one
single disease, not as a multitude of diseases. And we are going to do
that with one clone. And I think that is what is significant about our
technology. And we have 3 technology platforms that work along these
lines. So we are excited about that project in China. We will do
anything we can to help them get that commercialized and help them dominate the
cancer market for many years to come.
Sampson Evans, Private Investor
Q. Basically, I would like to know why
there was no follow up to ASCO and AACR, when we were told that we were going
to be in ASCO and in other places, there is never any follow up on the data
presented at these conferences. Can you tell us why?
A. Well, I think mainly I
will tell you that we dropped the ball on that, and I've gotten a tremendous
amount of emails about that. It is totally my fault. I accept full
responsibility for it. We will not let it happen again. We will
follow through on all these announcements and try much harder to get the
technology into the forefront. I think one of the things that makes it
difficult to do the type of follow up that these people have been asking me to
do, is that not just anybody can write the type of scientific follow up that
you are looking for. I have 25 people at this company. I am running
a manufacturing facility. I am running 6 clinical trials as well as road
shows and I am a public company, so we are stretched pretty thin on taking one
of my Ph D level people to write the type of data that we think needs to be out
there. I am working with the Atkins Group right now and we are trying to
figure out a way we can hire and get somebody more or less on a contract basis
to do the type of research that we are looking for, which is compare to other
stuff that is out there. I mean, its not like this data is just sitting
out there, you have to go into databases at cancer centers and pull out data to
do these type of comparisons. But we will focus a lot more in the future
on giving you the type of follow up that you are looking for. I know what
you are asking for and I agree 100%. I dropped the ball on it, and I
accept full responsibility for it.
Same Questioner:
Q. OK, the other question I've got is
Supergen and Scotia. What's the story there? Are we making any
progress with them?
A. Yes, we are. I know
that with Scotia has went into receivership in England, which actually is free
money to us, because as part of the contract if they go into any type of
bankruptcy proceeding, we will get the technologies back, so we are in the
process of legally regaining access to our technology, and we have already
started discussions with several other photodynamic therapy companies about
using our vascular targeting as the targeting of photodynamic therapy, so the
Scotia project is not moving forward, and we are in the process of trying to
regain our technology from that standpoint.
Supergen, they are moving
forward, I haven't really had an update from them on what they are doing, but I
think Supergen is a pretty aggressive company, so I am sure they are moving
these projects forward.
Same Questioner:
Q. The last question I have got is, as you
know, we have about 100 million shares outstanding. Are you looking at
all or considering a reverse split to shore up the share price, or is this not
even under consideration?
A. Well, you know, I am going
to have to be a little selfish right now. It has been my experience in
the past, reverse splits on shoring up the share price is a failed process.
Very few companies ever achieve it. Typically, when you do a reverse
split, the stock goes right back down to where it was. It is not viewed
as a positive thing. What it really does is wipe out the old investors in
favor of new people. And since I am an old investor, and I don't really
particularly want to be wiped out. I've taken all the risk in this deal,
and I am not willing to wipe myself out in favor or new people. I think
there are plenty of new people there to come on board. You have to
understand that I don't think the amount of shares outstanding is affecting our
ability to move this company forward, nor do I believe it prohibits in any way
our ability to create value. The fact that you really need to look at is
the market capitalization of the company. I think we are still low on our
market capitalization, but the shares outstanding time the price is what tells
it. But I think that if you are wanting to do some type of
recapitalization, that that type of recapitalization would come in the form of
doing a secondary offering in which the bankers come in and say OK, we are
going to bring X amount of money in and this is going to buy X amount of the
company. Let's recapitalize the company, and everyone knows with
certainty that we go into this transaction what the old guys are going to own
and what the new guys are going to own, and that's really the only way that would
be acceptable to me to do a reverse split. If you are looking for one,
that is about the only way that I could see one getting through, unless of
course the shareholders want me to do one. They would have to put it on
the slate and vote it for themselves.
Davis Marshall, Private
Investor
Q. Do you want us to get together on the
net and write the PR's for you?
A. Well, actually, if I
could talk 'golfdad' into doing some of our follow ups, I would be very happy
with that, so if any of you can help prod 'golfdad' into doing that, I would
love to see it.
Same Questioner:
Q. We'll work on it. You talked about
the human TNT and vasopermeation. I am glad to hear that, the first half
of next year. Do you think that will be an easy trial?
A. No, it won't. That's
one for sure that we will look to partner with people. I think the real
thing that you have to do is get the human clone into human studies.
Actually, Dr Epstein's lab is working very hard on all the pre-clinical.
We are comparing the vasopermeation enhancement with about I think 7 different
chemo drugs, and we are showing in animal studies that is does increase the
permeability, so it is I think working, and the idea is have the clone ready to
go, have it characterized, have the cell bank laid down for manufacturing, and
then I think we've built a little bit more value with it to take it into phase
I. We may take it into phase I ourselves and build a little value there,
that we have some more data to show the big pharmas, but that type of study
would probably be a couple of thousand patient study, and its way out of our
capabilities, so that's one we definitely will want to partner, and more
importantly I think what's important to remember about that drug is its really
going to be much more powerful in the hands of a company that is really
experienced in market chemotherapy drugs. So that is our long term goal
for the drug, and our short term is to get into human clinical studies and get
some preliminary data on it, but the pre-clinical studies look very good right
now. We are pretty excited about that.
Same Questioner:
Q. Are you looking for non-exclusive
licensing?
A. Oh, no, I can't imagine
anyone taking a non-exclusive on that, they'd want an exclusive. What I
hope happens with it is that it works good enough that people lose their
interest in their chemo drugs, and say, hey, I'd much rather sell a
pretreatment to every single chemotherapy treatment that's ever being
done. That's a pretty big drug in itself. It’s just a matter of
convincing people that there is more value in the enhancement than there is in
selling the drug itself. Data will either prove it or disprove it, and
that's why you do the studies, to know whether it’s going to work to that level
or not.
Well, it's another pipeline. We
have a tremendous pipeline.
John Hartselle, T.D. Bank
Q. You had mentioned 10% of the
profits. Are you referring to Brilliance pharmaceutical's profits on the
sale of TNT to all the tumor types in China?
A. That's correct, we
have a 10% profit share with Brilliance Shanghai Pharmaceuticals through Cancer
Therapeutics.
Same Questioner:
Q. Whoa!......I guess you would be a little
hesitant to tell us those numbers, but whoa, that's an enormous number, Ed.
Well, we hope so.
A. It just depends on how much
drug they can sell in China.
Same Questioner:
Q. We shouldn't gloss over that, because
that's something we should be pumping out to the rest of the world, or at least
to the investment community. That's an enormous number.
A. Well, I think we will pump
that out at the right time, and I think when they do their IPO is the best time
to pump it out, because then we're pumping out real numbers. Right now, I
am pumping out a hope, wish, and a dream, and I can't give you any firm
numbers, and when they come out with their IPO and they do all their
projections, then its someone else telling you what the number is, and I'd feel
much more comfortable doing it that way. So that's why I have never
really touted it. The agreement was made public in '95, so I mean, its
public knowledge that its out there, but to start attaching a number to it, I
do it internally myself sometimes, run different models on it for fun, but
let's wait to see what they come out with with their bankers and then we will
be able to really put some type of validation to it.
Same Questioner:
Q. Well, was that 10% in that agreement
that we just announced, so its been reconfirmed?
A. We didn't change anything
except giving them more exclusivity, longer exclusivity, basically extended
them to 2016 on their exclusivity.
Same Questioner:
Q. Right, and now that profit is going to
paid out of the supposed public company that they are going to be setting up?
A. Exactly.
Same Questioner:
Q. So, very good. So it’s a
public entity that's paying us the money, so there wouldn't be any question
about payment then?
A. Well, right now they are a
private entity, but when they go public, yes, then, you know, that will be
there.
Jeff Hode, Wodchong Capital
Q. Just a couple of quick questions, a
couple of them were already answered but I am interested in, you've been there
since 1992, what is your share ownership and your approximately cost of the
stock that you own? And the second question is analytical coverage.
I know you talk to investment bankers and analysts. Is there an
opportunity possibly to get a report written about the company, and what kind
of milestones do you have to jump through to get that kind of coverage?
A. We've had discussion
with multiple bankers. First off, let me address mine. I think
fully diluted, I'll own about 9% of the company right now, based on the current
structure. My average cost is, I think the first deal I did with
Peregrine, I bought stock at $1.20, and the second deal I did I bought stock at
$1.35, and everything else was related to our transaction with Biotechnology
Development. So I am not anywhere near the type of profit I need to see
off of the investment.
The second part of your
question is about the analyst coverage. Mainly, I think what it really
revolves around is that everyone seems to like our story. We've got a
tremendous amount of shots on goal here. This isn't a one product company
in one little market. This is a company that has a multitude of
products. We've got a lot of shots on goal. A couple of these are
going to make it into the goal and generate a lot of value. I think
that's very apparent. And more importantly, working in our favor is that
monoclonal antibodies are on fire right now. People are really buying
into the fact that monoclonals are going to be very, very important revenue
generate for the biotechnology industry. So we are very well
positioned. We truly are a monoclonal antibody company. Just about
everything we do is based around monoclonals, and the fact that we have our own
manufacturing I think strengthens the story, so I think the story is well
received. I am trying basically a two approach process. I'm trying
to get some of the smaller and regional investment banks, who don't mind doing
a research report on a 2 or 3 dollar stock, get them on first and then the
bigger guys are going to come into play I think as we approach that 5 dollar
range, you know, the 3 to 5 hundred million dollar market cap, then we'll work
on that. So it’s a process. Its not going to happen overnight, but
I am confident that it will happen, and I'll focus on the regional banks right
now, get some research reports out of them, and then hopefully we can move up
into the range where the big boys will come in and pick up coverage on us.
Christopher Smith, Private Investor
Q. A topic that is near and dear to my
heart. At the end of last year, there was a PR that announced 2 patents
on truncated tissue factor and vascular targeting, that were specifically
stated outside of Arcus. What is our development plans with that?
A. Well, everything to do
with the truncated tissue factor is within Arcus. Any conjugated vascular
targeting agent is within Arcus. So the only thing that is outside of
Arcus is nonconjugated antibodies for vascular targeting. So that's our
lead compound within Arcus is going to be an antibody that uses the truncated
tissue factor as the coagulation effector, so that is the lead compound for
Arcus Therapeutics. We will move that into the clinic as soon as we can.
Same Questioner:
Q. Ok, and I have one other question for
you, and that is are we looking to potentially take some of our other
technology to China, because of their regulations and approval process?
A. You're killing my thunder
here. Yes, that's one of the things that we want to do. We'd love
to fill their pipeline with everything that we can. I think that the
Chinese have a real unique opportunity here. They've got pretty much a very
undeveloped pharmaceutical market in comparison to the US and many western
countries. We'd love to get as much of our technologies as we can into
their hands and help them build a mega-company. So that's our goal.
We're going along at their pace. They're calling all the shots right now,
but we think we are pretty confident that as they start moving into that arena
of getting into the public markets, that they are going to need a broader
pipeline, and that's one thing we have is broad pipeline of technologies, so
that's one of my goals is to get our technology into their hands and work with
them, but it is going to be really driven from their side.
Joe Griffith, Private Investor
Q. Can you tell us a little bit about the
ongoing phase I trials, how those are going?
A. All the phase I's are
enrolling right now. I think we've been through several cohorts in one of
the cancers and we are finishing up cohorts in the other, so they are moving
pretty rapidly. We are in some cancers that is pretty easy to find patients,
so I think they will progress as we had planned, and as soon as they get done
we will move into the next phase.
Same Questioner:
Q. When might we see that next phase?
A. I don't know. Its all
based on enrollment, and we don't know what the maximum tolerated dose is going
to be, too, so we are flying blind here. We don't know exactly where its
going to top out at. What you are looking for in your phase I is you
basically give a dose at one level. You wait awhile, then you up the dose
and you treat 3 patients at that level, then you wait awhile and you up the
dose and you treat 3 patients. So its called the maximum tolerated dose
is what we are looking for. And we don't know what that maximum tolerated
dose is going to be, so I can't give you a firm date on when that's going to
happen, but I would say that about a year would be the outside of what it will
take.
Terry Dye, Private Investor
Q: On our percentage of the profits from
Brilliance, our manufacturing would be on top of that, correct? We would
get manufacturing monies plus the 10% profit?
A. Yes, the manufacturing
will be a completely separate agreement, and I would envision a short term
agreement with them. They have full intentions of bringing up a full GMP
facility in China, and to frank with you, I'd like to reverse it in the future
and have them contract manufacture for us. But we will cross that bridge
when we get there, but that will be a completely separate agreement from the
10% profit share. That will be something that we have to negotiate on the
side, but the 10% profit share was in our original licensing agreement with
them.
Same Questioner:
Q. OK, and on the tTF, I was in contact
with Dr. Thorpe on what other uses, and he included non-solid types of tumors,
leukemias and everything. Would that still be under Arcus or would that
be under Peregrine?
A. I believe the nonconjugated
tTF would be under Peregrine. I have to see some more data on that before
we would move that forward, but Dr. Thorpe has got some tremendous research
going on over there, and there is a lot of stuff he's working on that we
haven't even told you about that we find very exciting, so we look forward to
getting a whole bunch more products out of Dr. Thorpe into the future, and we
are very excited about working with the University of Texas, Southwestern.
Well, I'd better do some
digging then, I've been lagging behind here. I don't think he's published it
yet, we need patents first. I don't allow publishing until the patents
are filed.
Otto Knopp, Private Investor
Q. Hi Ed, I just want to thank you, you've
answered all the questions I could think of today, and I just want to thank you
for taking control of the company, and you are just doing a tremendous job.
A, Thank you, and I am
sorry I have gapped this off. I would like to do this at least once a
quarter. It keeps the rumor mill at bay. I think it’s the best
thing to do, to keep the information flow from the company with the
shareholders so you all know what our plans are and how we are going
forward. You know, there are competitive issues that come into
play. I know a lot of times you think we don't publicize things like we
should, but, you know, there are competitors out there, there are patent issues
that are in play, and a lot of time we do things for a reason, not just to not
keep you informed. I'll work a lot harder at keeping you informed, and I
think as you see now, I've pretty much cut off all the leaks in the company,
and news is a surprise to everybody. We are all on equal footing on the
news side, and I am pretty happy about that. I think in the future, I am
looking forward to a very exciting year for the company and a lot of stuff
going on behind the scenes here.
Yaya Fishani, Private Investor
Q. What is the time line on this public
offering in China? And number two, there is a company called Immunogen, I
don't know if you know them or they know you, it looks like a perfect fit
between you two guys...
A. Public offering in
China, I don't know. They have their own time lines and haven't really
relayed them to me. My guess is that they need to raise money for the
manufacturing, that they are going to do that probably within 3 to 6 months
after approval.
As for a merger with another
company, At these prices I wouldn't even consider it. Obviously, if
anything decent came is as an offer, we'd put it in front of the shareholders
as a vote. But the way I look at it is we're first and goal. We're
on the 10 yard line, and I don't think now is the time to hand off the
ball. Its time to take it in for the touchdown, and make the money for
the people that have taken the risk in this company.
Joe Griffith, Private
Investor
Q. One more question, a while ago in one of
your presentations, you had mentioned using Cotara in people's pets. Any
comment on that?
A. Yes, We think there is
actually quite a large market for veterinary uses of TNT. You have to
understand, we target a universal antigen, so it doesn't matter if it’s in an
animal or a human, the antigen that we target exists in both. Right now,
its not a high priority just because we don't have the resources to move it
forward, but what we'd like to do is, probably at least one a week if not more
that we get calls in here about people wanting their prize horse or their bull
or their dog treated with our drug, and there is obviously some veterinarians
out there that are aware that we can do this, so I'd like to maybe develop a
little more pre-clinical work on it, if I get the resources in place to do
that, and then maybe either spin that off as a separate company, or probably
find a company that has significant experience in veterinary medicine, and try
to license that to them or do some sort of joint venture. Right now I
don't have the resources to look at it, but I think its a lot bigger market
than most people think.
Same Questioner:
Q. One more thought. What about
Cotara as an imaging agent, how's that going?
A. Cotara and the imaging
agent. As we announced earlier, we have started a preclinical work with
Paul Scherrer Institute in Switzerland for PET imaging agents. We are
going to continue to do our preclinical on that and see how that comes out, and
we are also exploring other types of imaging agents that we may possibly use
for Cotara. The real key was getting that human TNT backbone ready, and
that's what's going to be the basis for any imaging agent. That human TNT
was critical to get the master cell bank laid down for that and get really all
the pre-toxicology work done for it so we can move it into human studies, and
that will be the backbone for our VEA, for our imaging and enhancing agents,
and for all other types of licensing opportunities in the future.
Closing Remarks
OK, I think with that I've got
a lot of work to do. I appreciate everyone coming on board and showing an
interest in the conference call. I do promise to do additional conference
calls on a timely basis for you, if anything just to keep the rumor mill at bay,
but I am very excited about the prospects of the company and you have my
guarantee that I will not stop until everyone has heard about Peregrine
Pharmaceuticals. With that, thank you.
PPHM.NET wishes to thank
Vic on behalf of all "Clonies" and "Peregriners", for
his tireless efforts to get this all transcribed.