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VOLUME
02: ISSUE 88
Cel-Sci in the News
Today, just after the market closed,
Cel-Sci Corporation announced its year end financial results. In conjunction,
the company announced an additional round of financing for $1.35 million,
which will provide enough working capital for another year and allow the
company to pursue Stage III trials for its immunotherapy drug Multikine.
Losses came in at expectations. The
company also announced it expected a substantial reduction in overhead
in 2003, as signficant costs were experienced in 2002 in pursuing FDA Approval
of its manufacturing facilities. That process is now nearly complete, and
paves the way for Stage III clinical trials later this year. (See the bottom
of this page for the complete news release)
Detailing Cel-Sci's Vision
Before you read about Virginia-based
Cel-Sci's immunotherapy drug Multikine, take a moment to consider the basic
definition of immunotherapy:
"Treatment to stimulate or
restore the ability of the immune system to fight infection and disease.
Also used to lessen side effects that may be caused by some cancer treatments.
"
The above concept could be expanded
to include immunotherapy drugs' potential to enhance the efficacy of cancer
treatments such as surgery, chemotherapy and radiation.
The course that Cel-Sci is following
in its development of Multikine has been ignored by big pharmaceutical
companies that tend to be more focused on making profits by selling drugs
and therapies to cancer patients in the last six months of life.
Therapies for early detection and
treatment, such as Cel-Sci is developing, are deemed too risky and too
expensive to develop. For big pharma it is, frankly, more profitable to
wade in after the cancer has become incurable. Ironically, the market for
immunotherapy drugs such as Multikine is much larger than those markets
traditionally sold and marketed
to by the pharmaceutical companies.
A Company Thinking Differently
Multikine is not an anti-cancer
drug; it is an immune stimulant. In essence, it supercharges the immune
system making the lymph nodes relay stations to manufacture cancer-killing
cells. The types of cancers that affect the head and neck, historically,
have had a survival rate of less than 50 percent.
Head & neck cancer: Phase
I and Phase II clinical trials encompassing about 160 head & neck cancer
patients have demonstrated dramatic tumor reduction, with over 20-40% of
patients treated with Multikine at the most effective doses and treatment
regimens experiencing a greater than 50% reduction in tumor size, or complete
responses, following treatment. Also, all eight head & neck cancer
patients in a Phase II clinical trial who were treated at one European
center with Multikine in combination with surgery/radiation over 2 years
ago, have NOT had recurrences to date and remain alive. This finding is
very encouraging because it is generally expected that approximately 50%
of such patients would have experienced recurrences at 18-24 months post
treatment. Recurrence of the disease usually leads to death. (www.cel-sci.com)
Therein lies the opportunity for
the folks at Cel-Sci, who have, over the last two decades, brought Multikine
to the point where Phase Three trails should be approved later this year
and begun in 2004-- bringing this revolutionary drug closer to the final
step of FDA approval. The market for head and neck cancer treatments is,
conservatively, $1.5 billion in the US and Europe alone. In Asia, where
the occurrence of this form of cancer is much higher, Cel-Sci has already
developed partnerships. There are more than half a million head and neck
cancer cases diagnosed annually worldwide (over 100,000 in the US alone).
Once other cancers are targeted, the potential market for Multikine rises
exponentially. Unfortunately, demographics will work in Cel-Sci's favor
for many years: as the global population ages, the number of annually diagnosed
cancer cases will only increase.
Immune to Cancer
Multikine replicates a healthy immune
system in those diagnosed with cancer in the early stages. Going forward,
the drug's ability to bolster a compromised immune system will benefit
patients by enhancing the initial treatments for many types of cancer.
Cel-Sci, currently trading at 20
cents and with a market cap of $9.4 million, represents an interesting
speculative investment for both traders and holders. Once Phrase Three
trials are approved-likely later this year-Cel-Sci will move into a new
echelon of acceptance within both the pharmaceutical and investment communities.
CEO Geert Kersten is very confident
about the year ahead and the approval for Phase Three trails. The
company would then be able to publish the type of data that would prove
Multikine's efficacy. Kersten and his team are presently spending 90 percent
of their corporate time completing the administrative tasks necessary for
the FDA to approve Phase Three trials. With the recent injection of $1.35
million of new private funding, the company is well financed for the next
year-the major developmental expenses, totaling $65 million, are already
behind it. As a result, overhead for the coming year will be reduced by
25 percent.
Injecting Simplicity into Cancer
Treatment
The process for administering Multikine
is quite simple. Following diagnosis, as a pre-treatment, the drug is injected
around the tumor, daily, for a period of two weeks followed by a one week
waiting period. The goal is not only to eliminate or shrink a head/neck
tumor, but to eliminate the localized cancer cells around it that can be
missed during surgery. The recurrence of the tumor is greatly reduced,
as the localized cells are the sites where the cancer, historically, has
returned and in a majority of cases, ultimately killed the patient. The
next sites are the lymph nodes --where more cancer cells can migrate--
which after injection, will trigger the necessary immune response to fight
recurrence. As Multikine is an immunotherapy-based protocol; potentially
effective against several types of cancer such as breast and, as shown
in a Phase One trial, in the treatment of cervical dysplasia/cancer.
Cervical dysplasia in HIV-infected
patients: Results from an ongoing Phase I clinical trial of Multikine in
cervical dysplasia in HPV/HIV co-infected women indicate elimination or
reduction of dysplasia in 71% of the patients and excellent treatment tolerance.
The assumption by the physicians is that a product that shows benefit in
HIV-infected women with cervical dysplasia will show an even better response
in non-HIV-infected women with cervical dysplasia, a world-wide market
of over 20 million women. (www.cel-sci.com)
In essence, Multikine can make fundamental
changes in a patient's ability to respond to cancer. The drug supercharges
the immune system, resulting in the patient's own body becoming the best
weapon in the fight against this horrific disease.
Partners, Papers and Progress
Cel-Sci, while focused on FDA approval
of Phase Three trials later this year is in discussions with several potential
partners. Once that occurs, the company anticipates Multikine will be the
subject of scientific papers and investment analysts' reports, bringing
it the positive attention it has worked toward for the last two decades.
With the shares currently trading at 20 cents-it has challenged 30 cents
a half dozen times in the last several months-it makes a compelling--albeit
speculative-- investment for those who wish to participate in a biotech
company that truly thinks outside the traditional cancer treatment 'box'.
Further information can be found
in our November
Profile of Cel-Sci as well as at the company's website www.cel-sci.com.
Here's the complete text of the news
release for your review:
CEL-SCI Corporation
Announces 2002 Financial Results and $1.35 Million in New Funding
Friday January 10,
4:15 pm ET
Success in Two Key
Areas is Expected to Lead to Significantly Reduced Expenses in Fiscal Year
2003
VIENNA Va., Jan. 10 /PRNewswire-FirstCall/
-- CEL-SCI CORPORATION (Amex: CVM
- News) reports financial
results for the 2002 fiscal year ending September 30, 2002.
During fiscal year 2002,
grant revenues were $384,939 as compared with $293,871 during fiscal year
2001. The Company reported a net loss for fiscal year 2002 of $8,342,244,
or ($0.35) per share, versus a net loss of $10,733,679, or ($0.51) per
share, reported for fiscal year 2001.
CEL-SCI also closed on
the first part of a $1.35 million funding. The second part is expected
to close during the first quarter of this year.
"During fiscal year 2002
we were able to complete our multi-year manufacturing validation program
for our lead product Multikine(TM) and complete our last Phase II clinical
trial of Multikine in the treatment of head & neck cancer," stated
Geert Kersten, Chief Executive Officer of CEL-SCI Corporation. "With these
very expensive achievements behind us, we expect the cash expenditures
for fiscal year 2003 to be reduced even further compared to fiscal year
2002 while we focus on the administrative processes required for the next
step in gaining FDA approval to initiate our Phase III clinical trial in
head & neck cancer."
Multikine is an immunotherapy
drug that is being developed against head & neck cancer and HPV-induced
cervical dysplasia/cancer. The drug has shown very promising tumor responses
in over 190 cancer and HIV+ patients.
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2002 AND 2001
2002 2001
GRANT REVENUE AND OTHER $384,939 $293,871
OPERATING EXPENSES:
Research and development 4,699,909 7,762,213
Depreciation and amortization 226,514 209,121
General and administrative 1,754,332 3,432,437
Total operating expenses 6,680,755 11,403,771
NET OPERATING LOSS (6,295,816) (11,109,900)
INTEREST INCOME 85,322 376,221
INTEREST EXPENSE (2,131,750) --
NET LOSS (8,342,244) (10,733,679)
ACCRUED DIVIDENDS ON
PREFERRED STOCK (202,987) (53,153)
ACCRETION OF BENEFICIAL CONVERSION
FEATURE ON PREFERRED STOCK (1,444,757) (317,419)
NET LOSS ATTRIBUTABLE TO COMMON
STOCKHOLDERS $(9,989,988) $(11,104,251)
NET LOSS PER COMMON SHARE (BASIC) $(0.35) $(0.51)
NET LOSS PER COMMON SHARE (DILUTED) $(0.35) $(0.51)
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING 28,746,341 21,824,273
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, 2002. 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.
Source:
CEL-SCI Corporation
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