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VOLUME 06: ISSUE 74
A
Heart To Heart Chat With a Biotech CEO
We
recently sat down with CEL-SCI Corporation (AMEX:
CVM) CEO Geert Kersten to discuss his recent letter to shareholders,
the company's stock price, and what the future might hold. And, what we
learned went well beyond the usual corporate PR stuff. Investors (potential
or current) take note...this is a behind-the-scenes look you won't get
anywhere else.
Q.
You regularly send open letters to shareholders about your company and
its stock, including one on Wednesday (see below). Most corporations wouldn't
bother, so why do you do that?
A.
It's a combination of logic and heart. Stock owners want and deserve to
know how a company is creating value for them. So, the letters accomplish
that in an efficient and logical fashion. All of those letters are also
from the heart. I think it's important for investors to know how CEL-SCI
believes in the value and potential of its work, and equally, how we carefully
evaluate the data before we move forward.
Q.
Has it been worth the effort?
A.
Yes, it's been worth it, which is why I've been writing those letters for
ten years now. It takes a long time, but, in the end it will be soooo sweet.
Investors have to understand that there's a difference between big biotech
companies and the small and mid cap ones. Big biotech companies are already
perceived as a proven entity to the investment community since they have
sales and, mostly, profits. Small-cap and mid cap biotech companies, on
the other hand, need to prove themselves over and over again as they work
through all the pains of developing novel products. Just imagine how forward
looking one has to be to develop a new drug. You can only get a patent,
a prerequisite for raising money, if you have an idea that is totally novel
and unique. Then you have to go out and explain your idea. The letters
let us do that.
Multikine
- CEL-SCI's Cancer Treatment
Q.
And for CEL-SCI, the main drug in development is Multikine. Can you tell
us - in simple terms - what it is and how it works?
A.
Multikine is an immune system boosting drug that has shown very promising
survival results in Phase II studies in head and neck cancer, which has
been our focal point in the first part of our research. Think of it as
an immune system booster that is a copy of a patient's own immune system.
By switching the type of immune cell that attacks the tumor, Multikine
helps the body break tumor tolerance - a scenario where the immune system
does not actively attack the tumor. With Multikine you have a different
and more effective immune response. It's a non-toxic way to help you beat
cancer.
Q.
You mentioned that Multikine is non-toxic. What does that mean?
A.
It means that it does not cause bad things to happen to you as do radiation
and chemotherapy, and many other products.
Q.
And has human testing shown positive results?
A.
It certainly looks that way. So far, 12% of the patients had no tumor remaining
after only a 3 week treatment and 3.5 years after the whole cancer treatment
was finished, survival with Multikine appeared to be much higher. In our
Phase II testing we saw a 65 - 70% chance of survival with Multikine, or
only a 50% chance without it. Phase III will look to verify these early
results in a large number of patients. If we are right there will be many
less deaths from cancer since more patients will be cured with the first
treatment.
Q.
How does Multikine differ from other similar treatments in development
stages out there?
A.
We know of no pharmaceutical drug that works like our product and attacks
the tumor the same way.
The
Opportunity
Q.
Sounds like CEL-SCI is working on something unique. Why do you think bigger,
well-funded companies aren't going down the same treatment avenue?
A.
We have the area patented and they are blocked from doing this. They are
starting to show an interest since we are about to enter Phase III clinical
trials.
Q.
Why do you not go for the chronic cancer treatment market as do so many
of the pharma companies?
A.
With our drug, if proven successful, it's possible to get the cancer with
the first treatment and make a lot of money too. While the market for chronic
cancer therapy is immense, our market is still huge and we should save
the healthcare system money; therefore insurance companies should push
for our product to be used. Our first goal is to beat cancer...the money
will come when we get this product to market, and, if we are right, there
will be plenty to go around.
Q.
And what kind of market is out there? Are we talking $1 million, or $1
billion?
A.
Each year, globally, there are 500,000 new diagnosed cases of head and
neck cancer. Assuming Multikine is used to treat just 10% of them, at about
$25,000 per patient, that would mean about $1.25 billion in sales. Obviously
these are estimates, but that should give you some idea.
Q.
That's enormous potential.
A.
Yes, and in the biotech business, margins are very high. So, the potential
earnings for shareholders are also enormous. That is why I have been buying
the stock during the last 2 years. To get the maximum benefit, the time
to invest, in my opinion, is now when the stock price is depressed. I believe
that we have a risk/reward proposition in CEL-SCI which is very attractive.
Q.
You said the average Multikine treatment per patient would cost around
$25,000? That seems very low for a new cancer therapy.
A.
It is low compared to many of the existing drugs, many of which show very
small survival benefit. That's one of the other exciting parts of our cancer
treatment. If we are right, Multikine will save lives and money. Medical
expenses for a terminal cancer patient in the last year of his or her life
total about $1 million. If we can reduce the number of patients getting
to that terminal stage, we will help patients, insurance companies and
the government payors.
CEL-SCI
Shares
Q.
It certainly seems like Multikine could eventually be an answered prayer
for cancer patients, but let's talk a little bit about what this all means
for shareholders. You contend that now is a good time to consider investing
in CEL-SCI. Why now?
A.
More so than most markets, biotech stocks are cyclical. Biotech followed
pharmaceuticals lower for the last few years, but if you look at Pharma
now, you can see they're on the rise again. That should help boost biotech
stocks as well. But, I've also noticed how the smaller and mid cap biotech
companies move in their own three-year (or so) cycle. This has been true
for over 15 years. As of right now, we're at the low and long end of the
down cycle, and overdue for the expansion (price appreciation) period.
I see biotech coming out of its lull soon...especially with oil stocks
and other sectors starting to fall out of favor. Investors are going to
put their money somewhere, and I think biotech is starting come into favor.
But that's not the only reason that now might be a good time... We are
entering Phase III clinical trials and that is when institutional investors
generally take positions.
Q.
Any other reason now may be a good time to look at CEL-SCI?
A.
My first and foremost goal - at all times - is to create shareholder value.
We can do that by doing things the right way, and doing them when we're
properly funded. We recently got $8 million in funding through the sale
of shares when they were priced at 86 cents, while the overall market and
biotech was suffering. But, just think of the kind of funding we can get
when the market and biotech stocks are moving higher. It's best to wait
for the right environment before making a major funding effort. Maintaining
shareholder value is the motivating factor behind the decision. Doing the
smart thing right now creates the most value later on and, in my opinion,
it pays to be thoughtful and careful when you work in a high risk/high
return field. I have seen too many small companies rush forward to get
things done quickly, and, almost all of them are no longer around. You
get to be big and successful only if you are thoughtful and careful.
Q.
But some investors might say they'll wait until the stock actually starts
to move higher before they buy in. What do you say to them?
A.
I believe that waiting potentially means a missed opportunity. What if
we get a big pharmaceutical partner? What if our bird flu drug is shown
to work and bird flu hits the US? Once small biotech company stocks start
to move (for whatever reason), you typically cannot catch them unless you
are willing to pay up a lot. There have been days when our stock doubled.
We have spent $90 million to get to this advanced point of development
and our Company is valued at only $50 million. I believe that the ground-floor
opportunity is here and now and I have invested in CEL-SCI accordingly.
Q.
Is there anything else you think investors would want to know before we
wrap-up?
A.
To repeat something I mentioned earlier, my primary goals are to help cancer
patients and to create shareholder value. There are several steps to achieving
this: One of them is funding the operation when the time is right, keeping
dilution down. Another one is communicating CEL-SCI's plan and progress
on a regular basis. And obviously, one of the best ways to create value
is in developing a more effective cancer treatment. Survival is the difference;
Multikine has shown great results so far. We're excited to be on the track
we're on, and we hope investors are able to see the big picture of Multikine's
potential. Today we are valued at $50 million, and if we are right, we
should be valued at between $1-3 billion when our drug comes to the market.
Somewhere between $50 million and $1-3 billion is a lot of room for share
appreciation, but it will not all happen the day we show the results from
the Phase III study. So, don't assume Multikine has to be in approved,
full-blown production to benefit shareholders. As you guys at the SmallCap
Digest say, you buy a stock for where the company is going, not where they've
been.
Editor:
We couldn't agree more.
Kersten's
recent letter to shareholders is below.
Dear Fellow Shareholders:
Many of us invest
in biotechnology because of its life changing possibilities and its enormous
potential for financial return. We all know that the development of a biotech
drug takes a long time, is difficult and costs many millions of dollars.
Yet most of us are willing to wait for the potential "home run" on our
investment as long as the data looks good. However, the cyclical and at
times completely illogical treatment of biotechnology stocks by the investment
community challenges the commitment of even the most dedicated of investors.
For this reason
we are very pleased to point out that CEL-SCI's share price has outperformed
the vast majority of its small and mid cap brethrens, albeit with enormous
cyclical volatility, over the last few years. Since high volatility will
never be eliminated from biotech stocks like CEL-SCI, we must learn to
use it to our advantage. I recently purchased more stock in the open market
because I believe that the present price represents a great opportunity.
In the spring
of 2003 CEL-SCI's financial health looked rather bleak, our stock price
hit an all time low and few people believed in our ability to survive,
much less rebound. Nevertheless, despite a stock market environment that
has been quite unfriendly to small and medium sized biotechnology companies
like ours, we have managed to put ourselves on good financial footing and
increased our share price by several hundred percent; and that is after
CEL-SCI's stock price pulled back from its substantially higher level in
the spring of 2006. We survived, and indeed improved our position by persistently
and carefully following our plan for building shareholder value and obeying
the following rule. "FOLLOW THE DATA, THE DATA NEVER LIE."
The data for CEL-SCI's
products point to a very positive future for our company. Furthermore,
based upon our most recent survival data and our cautious and deliberate
way of proceeding, we believe that we will continue to build value for
our shareholders. Management's sizable investment in CEL-SCI gives us added
incentive to do so.
We aim to make
the first line cancer treatment more successful through the addition of
our cancer drug Multikine(r). Multikine will be a major breakthrough in
therapy for cancer patients if we can confirm the increased patient survival
data from our Phase II clinical studies in the planned global Phase III
clinical study that has already received the go-ahead by the Canadian authorities.
Simplistically, would you rather have a 65 - 70% chance of survival with
our Multikine or a 50% chance of survival without our Multikine? When we
can prove this kind of clinical benefit to patients, shareholder value
creation will need no further explanation.
We believe that
the market for Multikine may quickly expand beyond the original head and
neck cancer indication. The product has already been shown to be very safe,
and it is very probable that clinical trials will be conducted with Multikine
to examine its usefulness in treating other diseases in which the affected
patients might benefit by the addition of Multikine to their overall treatment.
Furthermore, the use of Multikine, especially in cancer, would save the
health care system money, most likely a lot of money, as fewer patients
will have recurrence of their cancer, and thus fewer patients will need
to be treated. In short, Multikine could become a very important addition
to current cancer treatments.
In the last 18
months we have achieved a number of very important milestones for Multikine.
We have published the mechanism of action in the Journal of Clinical Oncology,
a highly recognized, leading peer-reviewed cancer publication. We have
been granted an important new patent on Multikine, and we received a no
objection letter (NOL) from the highly regarded Canadian regulators for
our Multikine Global Phase III head and neck cancer clinical trial. Last,
but not least, we presented data at the "Vaccine Discovery and Commercialization"
conference in Philadelphia which indicate that the addition of Multikine
prior to the standard of care treatment resulted in a 33-40% improvement
in the median survival at 3 1/2 years after surgery. Survival is the "gold
standard" for testing in cancer.
Our CEL-1000 drug
has also received a fair amount of attention. It has shown protection in
animals against a number of diseases such as herpes virus, viral encephalitis,
malaria and leishmania. Based on these data, the U.S. government became
interested in its potential for use against avian flu. We believe that
CEL-1000 may have the best avian flu potential in two areas, one, as an
adjuvant to make vaccines more effective and two, as an adjunct to other
antiviral therapies. Either of these uses holds great promise for CEL-1000
as a product.
We cannot say
that the past years have been without difficulties, far from it, but we
have been able to overcome any obstacles that we have encountered. We believe
that future obstacles will also be dealt with in the same manner. If developing
new medicines for cancer were easy, cancer would have been defeated long
ago; after all, President Nixon declared the war on cancer 36 years ago.
Yet cancer is the second leading cause of death in the U.S. today and,
if the trend continues, it is expected to become the leading cause of death
in the next few years.
Today we continue
to believe that our CEL-SCI shares are not fully valued by the market place,
an unhappy occurrence for existing shareholders, but a great opportunity
for new shareholders. This is not an uncommon phenomenon in biotechnology
investing and was seen often during the early days of Amgen or Genentech,
today's leading biotechnology companies. Now almost everybody wishes that
they had been long-term investors in Amgen or Genentech since these companies
turned out to be great investments. In hindsight the successes of these
biotech leaders may appear to have been easy, but an examination of their
early history reveals that things did not always go their way. Until 2003
Genentech seemed to be the only one who believed in Avastin, its new blockbuster
cancer drug. These companies succeeded because they were persistent and
they followed the data. We plan to do the same.
What is the value
of a non-toxic cancer drug that enhances survival? To cancer patients it
is immeasurable. To investors it is so big that they want to be invested
in the company that owns it. That is why I have invested so much of my
own money in CEL-SCI, with new stock purchases just a short time ago.
Our Phase II data
suggest that we have a cancer compound that may significantly increase
survival in patients with advanced primary head and neck cancer. Our Phase
III trial is meant to prove this survival benefit in a statistically significant
manner to get Multikine approved for sale.
In short, we hope
to be able to build significant shareholder value by conducting our important
work in a deliberate and methodical manner and always following the data.
This has worked for us in the past few years and it should continue to
work for us in the future as well. We thank you for your support.
Sincerely yours,
Geert Kersten
Chief Executive
Officer
When used in this
report, the words "intends," "believes," "anticipated" and "expects" and
similar expressions are intended to identify forward-looking statements.
Such statements are subject to risks and uncertainties which could cause
actual results to differ materially from those projected. Factors that
could cause or contribute to such differences include, an inability to
duplicate the clinical results demonstrated in clinical studies, timely
development of any potential products that can be shown to be safe and
effective, receiving necessary regulatory approvals, difficulties in manufacturing
any of the Company's potential products, inability to raise the necessary
capital and the risk factors set forth from time to time in CEL-SCI Corporation's
SEC filings, including but not limited to its report on Form 10- K for
the year ended September 30, 2005. The Company undertakes no obligation
to publicly release the result of any revision to these forward-looking
statements which may be made to reflect the events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events.
CONTACT: Gavin
de Windt of CEL-SCI Corporation, +1-703-506-9460.
We
Value Your Feedback
Got comments, questions or suggestions?
Send 'em on over: Editor@smallcapnetwork.com
If you wish to send a written request
or inquiry, please send it to our physical address:
TGR Group, LLC
4653 Carmel Mtn Rd Suite 308 #402
San Diego, CA 92130
Execute
Sports To Host Mid-Quarter Conference Call
Tuesday,
Execute Sports (OTCBB: EXCS)
announced they would be hosting a conference call in the middle of the
quarter, on September 28th...well before they had any official results
to discuss. What's the hurry? Good question - we don't know either. However,
we are taking Todd Pitcher's statement at face value. He says...
"We...understand
that, as an early-stage player in the marketplace it is important to provide
our investors with visibility and a reasonable level of access to the management
so that they can better understand our business, the implications for our
business in light of various announcements both financial and otherwise
that we have made throughout the quarter and year, and also our business
plan."
We
think it's a good move for Execute. If the company wants to gain favor
and legitimacy with investors, they're going to have to be transparent
as they work through these early stages of their growth. Plus, it's sends
a message they've got nothing to hide.
To
listen in on the call (and we encourage you to do so), the toll-free call
in number is 1-800-819-9193 and for international, it is 1-913-981-4911.
The teleconference call is scheduled for one hour, starting at 1:30 p.m.
PT (4:30 p.m. EST).
The
Commerce Planet Empire Continues To Grow
If
there's one thing we're convinced of, it's Commerce Planet's (OTCBB:
CPNE) ability to nurture new ventures. The fact that the company even
exists at all is proof of the pudding. But, even since we started covering
the company in March, we've observed new ventures coming into the fold.
And more importantly, they all seem to do well under the Planet's guidance.
Case in point - Commerce Planet's wholly-owned subsidiary One Source Imaging.
The company bought
the printing outfit on June 6th. By July, the proverbial bar had already
been raised for the printing unit, as it quickly became a viable
revenue center.
Now,
we reviewed One Source Imaging's history to make a point about Commerce
Planet and its newest venture...if this one is like the rest, it's going
to be a winner (i.e. a viable profit center). In short, the Planet's subsidiary
Customer Loyalty is teaming up with Payment Data Systems (OTCBB:
PYDS) to create ibillpayonline.com. The joint venture will provide
private label bill payment portal services to Commerce Planet. In English,
it just means the Planet will provide a bill payment service to current
(and future) customers clamoring for a bill payment feature on their account.
If it's like most everything else Commerce Planet does, it'll be a winner.
Eagle
Broadband Breaks Ground...Literally, and Figuratively
When
we first profiled Eagle Broadband (AMEX:
EAG) in our September
15th edition, we explained how IPTV was going to be the new era of
television content delivery. And Eagle, with over 200 channels worth of
content to supply to...whoever, was poised to lead the charge. Well, it
wasn't just some philosophical, hopeful, generalization to be realized
at some point in time in the near or distant future. Eagle recently announced
the beginning of construction of its super head-end and satellite farm
in Miami, Florida. The Florida-based head-end operation will collect signals
from over 30 satellites to deliver a broad range of content from more
than 250 cable channels. So, the concept is becoming a reality. Click
here for the full story, and complete explanation of the infrastructure
being built.
Can
the stock be far behind the progress of the company? Other investors seem
to be getting behind the idea...and behind EAG shares as well. The stock
started to perk up a little after we issued the profile on the 15th, and
did so on higher volume. We saw a slight dip into the red Wednesday, but
the bulls were back at it by Thursday.
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L A I M E R:
The Small Cap
Digest, the Small Cap Network, its website and email newsletter (hereafter,
cumulatively referred to as "SCD") , is an independent electronic publication
committed to providing its readers with factual information on select publicly
traded companies. SCD is owned and operated by TGR Group, LLC ("TGR").
TGR is not a registered investment advisor or broker-dealer. All companies
are chosen on the basis of certain financial analysis and other pertinent
criteria with a view toward maximizing the upside potential for investors
while minimizing the downside risk, whenever possible.
Moreover, as detailed below, TGR
accepts compensation from third party consultants and/or companies, which
it features in the publication and circulation of SCD. To the degrees enumerated
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Click
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TGR Group LLC has been paid a fee
of $25,000 and 150,000 shares of newly issued restricted stock by Cel-Sci
for coverage of the Company. Additionally, back in November of 2002, TGR
Group LLC was paid a fee of $25,000 and 250,000 shares of newly issued
restricted stock of Cel-Sci for coverage of the company until November
of 2003. The aforementioned 250,000 restricted shares became free trading
under SEC rule 144 and were sold in the open market prior to the company
entering into a new contract agreement with TGR Group in February of 2006.
TGR Group LLC has been paid a fee
of $30,000 and 300,000 newly issued restricted shares by Execute Sports
for coverage of the company. In addition, one of the prinicipals of TGR
Group purchased 100,000 shares of Execute Sports at a cost of $.25 per
share prior to the public offering. The shares are now eligible to be free
trading.That individual may choose to sell the shares at any time. This
should be viewed as a potential conflict of interest.
TGR Group LLC has been paid a fee
of $60,000 by Commerce Planet for coverage of the company. In addition,
one of the principles of TGR Group LLC is also a principle of MarketByte
LLC. In a separate contractual relationship in 2004, MarketByte LLC was
paid a fee of $25,000 in cash and 750,000 newly issued, restricted shares
by Commerce Planet for coverage of the company. The aforementioned shares
are all currently eligible to be free trading. The term of MarketByte's
obligation to Commerce Planet has expired.
TGR Group, LLC has been paid a fee
of $25,000 cash and 115,000 shares of newly issued restricted stock by
Eagle Broadband for coverage of the Company.
From time to time TGR sells shares
received as compensation for coverage of client companies. Shares received
are sold in the open market. Since the shares are received as compensation
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TGR does not view the sale of the shares as contradictory to any opinions
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and/or the National Association of Securities Dealers ("NASD") at http://www.nasd.com.
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