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CEL-SCI Corporation Reports 2009 Second Fiscal Quarter Financial Results
Date:5/15/2009

VIENNA, Va., May 15 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX: CVM) announced today financial results for its second fiscal quarter for the period ended March 31, 2009.

Financial results:

  • Net loss for three months ended March 31, 2009 was $1,894,753, a decline of 41% compared to a net loss of $3,210,294 during the same quarter in 2008.
  • The net loss per common share for the quarter ended March 31, 2009 was $0.02 compared to $0.03 for the same quarter in 2008.
  • During the six-month period ended March 31, 2009 the Company used cash in operations totaling $57,092 while during the six-month period ended March 31, 2008 it used $10,728,203. For the six months ended March 31, 2009 and 2008, cash provided by financing activities totaled $1,218,734 and $180,443, respectively.

Some of the recent highlights include:

  • Licensing Agreement for Multikine. The Company entered into an agreement with Byron Biopharma ("Byron") under which CEL-SCI has granted Byron an exclusive license to market and distribute the Company's cancer drug Multikine(R) in the Republic of South Africa. Byron will also be responsible for registering the product in the country. CEL-SCI already has existing licensing agreements for Multikine with Teva Pharmaceuticals and Orient Europharma.
  • Launch of cold 4 degrees Celsius Aseptic Filling manufacturing process. The Company launched a new manufacturing process that could allow drugs developed using stem cells and other biological products to maintain their potency and thereby potentially also their shelf life. The availability of this new process developed by CEL-SCI may also significantly accelerate the time to market by eliminating complicated and time consuming validation studies and tests required when these products are filled at room temperature. The use of a cold 4 degrees Celsius fill, as opposed to the normal room temperature fill, significantly increases the probability of maintaining drug activity, potency and thus potentially extending the shelf life of new biological and stem cell produced products.
  • Promising preclinical studies supporting the Company's proprietary L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) vaccine technology. The studies suggest that L.E.A.P.S. could potentially induce protection against illnesses such as swine influenza. In pre-clinical studies using mouse models, several different L.E.A.P.S. conjugates focused on different diseases induced protection and disease improvement. In addition, it was recently presented that the L.E.A.P.S. vaccines work on human cells and that the L.E.A.P.S. vaccines are able to induce cellular responses without excessive amounts of pro-inflammatory cytokines. In the case of prior pandemic influenza, such as the "Spanish Influenza" and more recently in avian flu, patients with stronger immune systems had a greater chance of dying because their immune response was too strong (too many pro-inflammatory cytokines). A L.E.A.P.S. vaccine may be able to work around that problem. While normally cytokines may play a key role in preventing and treating swine flu, in some cases excessive cytokine amounts may exacerbate disease as it appears that, unlike the normal flu which affects the very young and very old most severely, swine flu may be more like the avian flu which hits people in their prime more severely.

CEL-SCI Corporation develops immune-based cancer and infectious disease therapies. Its primary product candidate is Multikine, a next-generation, comprehensive immunotherapy that targets newly diagnosed head and neck cancer. Multikine is cleared by the FDA and the Canadian regulators for a global Phase III clinical trial in newly diagnosed head and neck cancer. In a Phase II long term follow-up trial with Multikine, a 33% improvement in overall survival was observed.

The Company has operations in Vienna, Virginia and Baltimore, Maryland. CEL-SCI's other products, which are currently in pre-clinical stage, have shown protection against a number of diseases in animal tests and are being/have been tested against diseases associated with bio-defense, rheumatoid arthritis, and pandemic flu.

                               CEL-SCI CORPORATION
                   CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                  (unaudited)

                                                        Three Months Ended
                                                             March 31,
                                                      2009               2008
     REVENUE:
       Rent income                                 $19,643                 $-
                      Total Revenue                 19,643                  -
     EXPENSES:
       Research and development, excluding
        depreciation of $101,108 and $97,035
        included below                           1,025,236          1,037,063
       Depreciation and amortization               122,598             79,215
       General and administrative                1,014,399            968,820

                        Total Expenses           2,162,233          2,085,098

     LOSS FROM OPERATIONS                       (2,142,590)        (2,085,098)

     GAIN (LOSS) ON DERIVATIVE INSTRUMENTS         264,554         (1,160,937)

     INTEREST INCOME                                68,160            157,256

     INTEREST EXPENSE                              (84,877)          (121,515)

     NET LOSS BEFORE INCOME TAXES               (1,894,753)        (3,210,294)

     INCOME TAX PROVISION                                -                  -

     NET LOSS                                   (1,894,753)        (3,210,294)

     DIVIDENDS                                           -           (424,815)

     NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $(1,894,753)       $(3,635,109)

     NET LOSS PER COMMON SHARE (BASIC)              $(0.02)            $(0.03)

     NET LOSS PER COMMON SHARE (DILUTED)            $(0.02)            $(0.03)

     WEIGHTED AVERAGE COMMON SHARES
      OUTSTANDING                              124,701,667        116,312,378



                               CEL-SCI CORPORATION
                   CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                  (unaudited)

                                                        Six Months Ended
                                                             March 31,
                                                      2009               2008
     REVENUE:
       Rent income                                 $19,643             $1,530
                        Total Revenue               19,643              1,530
     EXPENSES:
       Research and development, excluding
        depreciation of $165,631 and $97,856
        included below                           2,213,462          2,066,029
       Depreciation and amortization               208,542            133,468
       General and administrative                2,069,525          2,754,569

                        Total Expenses           4,491,529          4,954,066

     LOSS FROM OPERATIONS                       (4,471,886)        (4,952,536)

     GAIN (LOSS) ON DERIVATIVE INSTRUMENTS         656,243           (170,949)

     INTEREST INCOME                               139,397            335,987

     INTEREST EXPENSE                             (169,493)          (265,531)

     NET LOSS BEFORE INCOME TAXES               (3,845,739)        (5,053,029)

     INCOME TAX PROVISION                                -                  -

     NET LOSS                                  $(3,845,739)       $(5,053,029)

     DIVIDENDS                                           -           (424,815)

     NET LOSS AVAILABLE TO COMMON
      SHAREHOLDERS                             $(3,845,739)       $(5,477,844)

     NET LOSS PER COMMON SHARE (BASIC)              $(0.03)            $(0.05)

     NET LOSS PER COMMON SHARE (DILUTED)            $(0.03)            $(0.05)

     WEIGHTED AVERAGE COMMON SHARES
      OUTSTANDING                              123,444,839        116,008,631


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SOURCE CEL-SCI Corporation
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