Investing to Wealth

CEL-SCI Corp. (AMEX: CVM)

CEL-SCI Corp. (CVM) is engaged in the development of a product called Multikine for the treatment of cancer. It simulates the activities of a healthy person’s immune system, which battles cancer every day. Multikine is multi-targeted; it is the cancer immunotherapy that kills cancer cells in a targeted fashion and activates the general immune system to destroy the cancer. Multikine is a type of immunotherapy in that it is a comprehensive immunotherapy, incorporating both active and passive immune activity. The Company also develops CEL-1000, which is derived from a pre-clinical technology called Ligand Epitope Antigen Presentation System for protection for animals against avian flu, herpes, malaria, viral encephalitis, smallpox, vaccinia and cancer, as well as CEL-2000, for the treatment of rheumatoid arthritis.

CVM was founded in 1983 and is based in Vienna, Virginia.

Source: https://trading.scottrade.com/quotesresearch/ScottradeResearch.aspx?symbol=CVM,

http://www.reuters.com/finance/stocks/incomeStatement?symbol=CVM , http://www.cel-sci.com/investor_relations.html

Financial Summary

CVM has reported limited revenues from operations since its inception in March 1983. The Company has relied upon proceeds realized from the public and private sale of its securities as well as loans from institutional investors and third parties to meet its funding requirements. Funds raised by the Company have been used primarily in connection with the acquisition of an exclusive worldwide license to and purchase of, certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, the repayment of debt, the continuation of Company sponsored research and development and administrative costs, and the construction of laboratory facilities. Inasmuch as the Company does not anticipate realizing significant revenues until such time as it enters into licensing arrangements regarding its technology and know-how or until such time it receives permission to sell its product (which could take a number of years), the Company has been dependent upon the proceeds from the sale of its securities to meet all of its liquidity and capital resource requirements and will have to continue doing so in the future.

During the nine-month periods ended June 30, 2009, and 2008, the Company provided cash totaling $4,860,153 and used cash of $7,831,579, respectively. For the nine months ended June 30, 2009, and 2008, cash used in operating activities totaled $2,539,239 and $4,688,724. For the nine months ended June 30, 2009, and 2008, cash was provided by financing activities totaled $6,985,892 and cash was used by financing activities of $750,597, respectively. Licensing proceeds of $1,249,981 and receipt of short-term loans of $1,060,000 provided funds, as did the June 2009 financing ($5,845,241). The repayment of convertible notes ($630,000), financing costs ($339,330) and the repayment of the short-term loan ($200,000) were used in financing activities during the nine months ended June 30, 2009. For the nine months ended June 30, 2008, cash provided by financing was from the exercise of employee options ($14,403) and a short-term loan ($656,340). Repayment of convertible notes of $765,000 and repayment of the short-term loan ($656,340) used cash in financing activities. For the nine months ended June 30, 2009, cash provided by investing activities was $413,500. For the nine months ended June 30, 2008, $2,392,258 was used in investing activities. For the nine months ended June 30, 2009, and 2008, the use of cash in investing activities consisted of purchases of equipment and legal costs incurred in patent applications, the use of restricted cash and, for the nine months ended June 30, 2009, the sale of the final $200,000 in ARPs.

The Company has two partners who have agreed to participate in and pay for part of the phase III clinical trial for Multikine. However in light of the current capital market environment, the Company believes it is prudent not to start the phase III clinical trial until it has firm commitments in the form of partnerships and/or money raised for a substantial amount of cash to support the phase III clinical trial. Additionally, the Company obtained new financing of $5,845,241 in June of 2009, net of financing costs of $339,329. The Company is currently working toward a transaction that will finance its phase III clinical trial of Multikine. In addition, the Company has put in place a $5 million Equity Line of Credit (see Note D). With this Equity Line of Credit in place, the Company believes it will have the required capital to continue operations through June 2011, even without any potential revenues from contract manufacturing.

During the nine-month period ended June 30, 2009, research and development expenses increased by $791,370 compared to the nine-month period ended June 30, 2008. This increase was due to continuing expenses relating to the preparation for the phase III clinical trial on Multikine. Nine months of amortization of the deferred rent totaled $595,994 and contributed to the increase in research and development expenses. Research and development costs for the three months ended June 30, 2009, include rent expense of $419,354 related to the first six months of fiscal year 2009. During the three-month period ended June 30, 2009, research and development expense increased by $643,937. This increase was principally caused by the nine months of amortization of the deferred rent totaling $595,994, partially offset by the layoff of some personnel in the lab during the financial crisis. The Company is currently rehiring and preparing for the start of the phase III clinical trial.

Source: http://www.cel-sci.com/investor_relations.html

Analyst Consensus

No chart available.

Source: Financial Times.com

No consensus analysis data available.

Source: http://www.reuters.com/finance/stocks/estimates?symbol=CVM

Investment Highlights

CVM announced earlier this month that it has hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its conduct of the upcoming clinical trial of its investigational LEAPS-H1N1 treatment.

The Company last month announced that the U.S Food and Drug Administration (FDA) has indicated that the Company can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients. This followed the very responsive and expedited initial review of CVM’s regulatory submission for this study proposal. Following completion of manufacturing, initiation of this first study is subject to IRB review and approval. In order for FDA to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, the Company said the FDA requested the submission of a detailed follow-up regulatory filing with extensive additional data. Thus, in parallel with ramping up its first study, CVM is proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. Recognizing that it cannot proceed with its next-stage clinical trial without the Agency’s concurrence, CVM anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.

CVM recently entered into definitive agreements to sell 14,285,715 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. Investors will also receive warrants to purchase 4,714,284 shares of CVM’s common stock. The warrants have an exercise price of $1.50 per share and are exercisable at any time after the closing of the transaction and before the second anniversary of the closing. The closing of the offering was expected to take place on or before Monday, September 21, 2009, subject to the satisfaction of customary closing conditions. CVM plans to use the net proceeds from the offering to commence a pivotal phase III clinical trial with its cancer drug Multikine and to rapidly take its new LEAPS - H1N1 compound into human studies for the treatment of hospitalized H1N1 patients.

The shares and warrants are being offered by CVM pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission dated August 12, 2009. Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group Inc. acted as the exclusive placement agent for the transaction.

CVM is currently moving forward as fast as is possible with its proposed dendritic H1N1 treatment for hospitalized H1N1 patients, while proceeding with due caution and taking all necessary steps to meet regulatory requirements; CVM is embarking upon its initial clinical trial.

With regard to the Company’s investigational cancer medicine Multikine, it is preparing to commence the global phase III clinical trial designed to support marketing approval. The validation of the Company’s new manufacturing facility for contract manufacturing operations is nearing completion, and it has expanded that validation to cover the manufacturing of Multikine in the new manufacturing facility as well.

The Company finally has the financial resources to move forward on its programs. The manufacturing facility is coming online, the global phase III cancer trial for Multikine is being launched together with Teva Pharmaceuticals and Orient EuroPharma as two of its main partners, and CVM is racing to develop what it hopes will be the first effective treatment for hospitalized H1N1 patients.

Source: Scottrade.com, Reuters.com, http://www.cel-sci.com/investor_relations.html

Technical Analysis

Source: www.stockcharts.com

Moving Average Price Compare

CVM is trading above its 50-day moving average. This is considered to be the sign of a bullish trend. There is added weight to this indication because the moving average is rising and suggests that there has been buying interest in this stock.

Bollinger Bands

CVM is trading within its Bollinger Bands. This is a normal condition and suggests that the stock is neither overbought nor oversold relative to the recent price action.

MACD

CVM’s MACD is indicating a weak bearish signal. Although the indicator is above the critical level of 0, which implies that the underlying moving averages are bullish, the MACD has crossed below its 9-day moving average or signal line. This suggests that positive momentum has begun to slow.

Comparative Analysis

Source: Reuter.com, Nasdaq.com

Insider Trading Activity

Net Share Purchase Activity

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