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CEL-SCI Corp. (AMEX: CVM)

CEL-SCI Corp. (CVM) engages in the development of immune-based cancer and infectious disease therapies. Its lead product, Multikine, the first of a new class of cancer immunotherapy drugs, simulates the activities of a healthy person’s immune system, which battles cancer every day. The drug is cleared by the FDA and the Canadian regulators for a global phase III clinical trial in newly diagnosed head and neck cancer. A 33% improvement in overall survival in a phase II long term follow-up trial with Multikine was observed.

The Company also develops a heteroconjugate technology referred to as L.E.A.P.S. (Ligand Epitope Antigen Presentation System), which is intended to selectively stimulate the human immune system to more effectively fight bacterial, viral and parasitic infections as well as autoimmune, allergies, transplantation rejection and cancer, when it cannot do so on its own. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated, peptide antigens and may provide a new method to treat and prevent certain diseases.

Formed in 1983, the Company has operations in Vienna, Virginia, and Baltimore, Maryland.

Share Statistics (23-Sept-09)			2007	2008	% Chg	Q3′08	Q3 ‘09	% Chg
Symbol	CVM	Revenue, $K	57.00	5.00	91.23%	N/M	N/M	N/M
Current price	$1.93	Gross marg.	N/M	N/M	N/M	N/M	N/M	N/M
52wk Range:	0.14-2.01	Oper. margin	N/M	N/M	N/M	N/M	N/M	N/M
Avg Vol (3m):	6,264,630	Net margin	N/M	N/M	N/M	N/M	N/M	N/M
Market Cap.	288.63M
Shares Outst.	149.55M	EPS, $	-0.099	-0.069	30.30%	-0.017	-0.050	-194.11%

Source: Reuters.com, Q3 2009 Financial Results

Financial Summary

At this stage of Company’s development, CVM is not yet profitable and does not have significant
revenue. For the quarter ended June 30, 2009, the Company reported loss from operations of $3.7 million, a
68.18% increase from the year-ago quarter. It reported a non-cash expense of $2.6 million.

During the three month period ended June 30, 2009, research and development charges were $1.6 million compared to $1.0 million during the same period in 2008, while general and administrative expenses were $1.9 million compared to $1.2 million during the same period in 2008.

As of June 30, 2009, CVM had cash and cash equivalents of $5.6 million.

Year-on-year, revenues fell 91.23% from $57.00k to $5.00k, though the Company grew net income from a loss of $9.63 million to a smaller loss of $7.71 million.

In 2008, the Company’s cash reserves fell by $10.28 million, while Cash Flow from financing totaled $183.00k or 3,660.00% of revenues. It has a Debt to Total Capital ratio of 0.33%, a lower figure than the previous year’s 0.43%.

FINANCIAL STRENGTH

	Company	Industry	Sector	S&P 500
Quick Ratio (MRQ)	0.85	6.76	2.64	0.78
Current Ratio (MRQ)	0.91	7.19	3.15	0.93
LT Debt to Equity (MRQ)	9.72	22.55	23.37	150.73
Total Debt to Equity (MRQ)	48.28	27.51	31.19	234.94
Interest Coverage (TTM)	–	9.47	5.08	23.42

Source: Reuters.com

Analyst Consensus

No analyst covers CVM at this stage of company’s development.

Investment Highlights

CVM is currently in the stage of developing immune-based cancer and infectious disease therapies. The Company looks to improve the treatment of cancer and other diseases by unleashing and empowering the immune system, the body’s natural and most powerful defense system. Unlike traditional cancer therapies such as chemotherapy, radiation and surgery, which are most often highly toxic or damaging, the Company develops therapies are effective and non-toxic to the body’s normal cells and organ systems

The Company believes that Multikine is the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is cleared by the FDA and the Canadian regulators for a global phase III clinical trial in newly diagnosed head and neck cancer.

Aside from cancer, CVM is involved in the research and development of immunotherapy products for the treatment of infectious diseases. Its patented T-cell Modulation Process uses “heteroconjugates” to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS (Ligand Epitope Antigen Presentation System), is intended to selectively stimulate the human immune system to more effectively fight bacterial, viral and parasitic infections as well as autoimmune, allergies, transplantation rejection and cancer, when it cannot do so on its own. The Company has also shown considerable promise as a therapeutic vaccine for rheumatoid arthritis.

Leveraging the LEAPS technology, CVM recently created a potential peptide vaccine/treatment against H1N1 swine flu, positioning itself as a competitive player in the H1N1 arena. On September 16, CVM moved forward when it was advised by the U.S. Food and Drug Administration that it could proceed with its first clinical trial to evaluate the effect of LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients.

CVM aims to address those H1N1-infected patients who are at high risk of dying. Its investigational LEAPS-H1N1 treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu. According to the Company’s report, this is intended to enable stimulation of the specifically-needed immune responses, while avoiding the administration of regions of H1N1, and other viruses, which may exacerbate the problem of cytokine storm, which the CVM’s scientists believe may be involved in the death of some H1N1 patients.

Following the expedited review by the FDA of its initial submission, the Company said it is working on the next phase of the study and is preparing the drug’s follow-up regulatory application. With the Company’s H1N1 flu drug candidate showing great promise, CSM CEO Geert Kersten, in an interview with BioMedReports.Com, stated, “CSM could be the most important company in the world because there will be no one else who has done any work on this at all.”

Looking to commence a pivotal phase III clinical trial with its cancer drug Multikine and to rapidly take its much touted new LEAPS – H1N1 compound into human studies, CSM recently entered into definitive agreements to sell 14.3 million shares of its common stock at a price per share of $1.40 pursuant to a registered direct offering to institutional investors, representing gross proceeds of approximately $19 million.

CVM’s recent developments were into trading highs for the stock. On September 22, CVM set a new 52-week high during today’s trading session when it reached $2.01. Over this period, the share price is up 250.91%. Until recently, CVM’s price hasn’t topped $1 in more than three years.

Technical Analysis

Source: http://stockcharts.com/h-sc/ui

Currently, the MACD for CVM indicates a strong bullish signal for two reasons. First, the MACD is above the signal line, a 9-day moving average. Second, the MACD is above 0 which implies that the underlying moving averages are trending higher.

With share prices currently above the stock’s 13-day moving average, a bullish trend is indicated. Also, a rising moving average signals that there has been buying interest in this stock.

The stock’s Bollinger Bands indicate greater than normal volatility as reflected by an increase in distance between the upper and lower bands. Trading within its Bollinger Bands, the stock reflects neither an overbought nor oversold condition relative to its recent price trend.

Comparative Analysis

Company Name	Ticker	Price per	Mrkt. Cap.	P/E		P/S
Sept-23-2009	symbol	Share, $	$ Mn	2009	2010	2009	2010
Celldex Therapeutics Inc.	CLDX	5.34	85.75	2.73	5.02	7.15	2.99
GlaxoSmithKline plc	GSK	39.31	99,450	10.32	9.90	2.12	2.18
Idera Pharmaceuticals Inc.	IDRA	7.98	187.67	130.837	35.68	5.86	5.68
Alexion Pharmaceuticals Inc.	ALXN	46.67	4,120	59.60	37.61	10.96	8.26
Alfacell Corp.	ACEL	0.24	11.36	N/A	N/A	N/A	0.45
ZymoGenetics Inc.	ZGEN	6.12	424.64	5.98	6.79	3.80	3.49
Biogen Idec Inc.	BIIB	50.89	14,770	12.79	11.57	3.37	3.23
Micromet Inc.	MITI	7.48	513.77	14.80	15.35	21.21	19.56
Seattle Genetics Inc.	SGEN	14.67	1,290	13.34	15.28	3.39	2.43
Dynavax Technologies Corp.	DVAX	2.15	84.64	1.98	4.71	3.25	2.16
Median
CEL-SCI Corp.	CVM	1.93	294.61	N/A	N/A	N/A	N/A

Source: Yahoo! Finance, Analyst Estimates.

Insider Trading Activity

NET SHARE PURCHASE ACTIVITY

Insider Purchases – Last 6 Months
	Shares	Trans
Purchases	N/A	0
Sales	100,00	1
Net Shares Purchased (Sold)	(100,000)	1
Total Insider Shares Held	20.18M	N/A
% Net Shares Purchased (Sold)	(0.5%)	N/A

Net Institutional Purchases – Prior Qtr to Latest Qtr
	Shares
Net Shares Purchased (Sold)	(462,328)
% Change in Institutional Shares Held	(106.3%)

Data provided by Thomson Financial

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