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CEL-SCI CORPORATION Reports
Second Quarter 2008 Financial Results
VIENNA, VA, MAY 16, 2008 - CEL-SCI CORPORATION (AMEX: CVM) reports financial results for the three and six months ended March 31, 2008.
Geert Kersten, Chief Executive Officer of CEL-SCI Corporation said, “We are completely focused on getting our cancer therapy Multikine® into its pivotal Phase III clinical trial. We were unable to start the Phase III study until the completion of our dedicated manufacturing facility for Multikine from which we can supply the Phase III study and subsequent sale of the drug. This facility is expected to be completed in the 3rd quarter of 2008. The Phase III study is designed to replicate the safety and efficacy results seen in the earlier studies and lead to an approval to sell Multikine.”
Mr. Kersten continued, “Our financial results reflect our primary focus on the facility and preparation for the Phase III trial. Our Phase III trial is the first Phase III trial to test the theory that immune stimulation before surgery, radiation and/or chemotherapy will increase survival of cancer patients.”
About Multikine:
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33% at a median of three and a half years following surgery. The U.S. Food and Drug Administration (FDA) gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007.
CEL-SCI is currently building a manufacturing facility for Multikine close to Baltimore, MD. Upon completion of the facility in the 3rd quarter of 2008, CEL-SCI will commence the Phase III clinical trial. Multikine appears to be the first non-toxic cancer drug.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune SIMULATORS". Immune SIMULATORS simulate the way our natural immune system acts in defending us against cancer. As opposed to other immunotherapies which are designed to target a single or limited number of specific antigens or molecules, Immune SIMULATORS are multi-targeted; they simultaneously cause a direct and targeted killing of the specific tumor cells and they activate the immune system to produce a stronger anti-tumor attack on multiple fronts.
Multikine is also the first immunotherapeutic agent being developed as a first-line standard of care treatment for cancer. It is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. Once the patient has advanced disease, or had surgery or has received radiation and/or chemotherapy, the immune system is severely weakened and is less able to mount an effective anti-tumor immune response. Other immunotherapies are administered after the patient has received chemotherapy and/or radiation therapy, which can limit their effectiveness.
The Company’s loss from operations for the quarter ended March 31, 2008 was $2,085,098 versus a loss from operations of $2,012,605 during the same quarter in 2007. The net loss per common share for the quarter ended March 31, 2008 was $0.03 which was unchanged from the same quarter in 2007. The Company’s loss from operations for the six months ended March 31, 2008 was $4,952,536 versus a net loss from operations of $3,592,516 during the same six months in 2007. The Company’s net loss per common share for the six months ended March 31, 2008 was $0.05 which was unchanged from the same six month period in 2007.
During the three month period ended March 31, 2008, research and development charges were $1,037,063 compared to $678,865 during the same period in 2007. During the six month period ended March 31, 2008, research and development expenses were $2,066,029 compared to $1,185,023 during the same period in 2007.
During the three month period ended March 31, 2008, general and administrative expenses were $968,820 compared to $1,316,146 during the same period in 2007. During the six month period ended March 31, 2008, general and administrative expenses were $2,754,569 compared to $2,368,850 during the same period in 2007.
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 tested against diseases associated with bio-defense.
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) |
| |
|
| |
Three Months Ended |
| |
March 31, |
| |
2008
 |
|
2007
|
REVENUE: |
|
|
|
Grant revenue |
$ |
- |
|
$ |
17,917 |
Rent income |
- |
|
6,805 |
Other income |
- |
|
- |
| |
|
|
|
Total Revenue |
- |
|
24,722 |
EXPENSES: |
|
|
|
Research and development, excluding depreciation of
$97,035 and $20,832 included below |
1,037,063 |
|
678,865 |
Depreciation and amortization |
79,215 |
|
42,316 |
General and administrative |
968,820 |
|
1,316,146 |
| |
|
|
|
| |
|
|
|
Total Expenses |
2,085,098 |
|
2,037,327 |
| |
|
|
|
| |
|
|
|
LOSS FROM OPERATIONS |
(2,085,098) |
|
(2,012,605) |
| |
|
|
|
LOSS ON DERIVATIVE INSTRUMENTS |
(1,160,937) |
|
(447,356) |
| |
|
|
|
INTEREST INCOME |
157,256 |
|
77,114 |
| |
|
|
|
INTEREST EXPENSE |
(121,515) |
|
(341,038) |
| |
|
|
|
| |
|
|
|
NET LOSS BEFORE INCOME TAXES |
(3,210,294) |
|
(2,723,885) |
| |
|
|
|
INCOME TAX PROVISION |
- |
|
- |
| |
|
|
|
| |
|
|
|
NET LOSS |
$ |
(3,210,294) |
|
$ |
(2,723,885) |
| |
|
|
|
| |
|
|
|
DIVIDENDS |
(424,815) |
|
- |
| |
|
|
|
| |
|
|
|
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS |
$ |
(3,635,109) |
|
$ |
(2,723,885) |
| |
|
|
|
| |
|
|
|
NET LOSS PER COMMON SHARE (BASIC) |
$ |
(0.03) |
|
$ |
(0.03) |
| |
|
|
|
| |
|
|
|
NET LOSS PER COMMON SHARE (DILUTED) |
$ |
(0.03) |
|
$ |
(0.03) |
| |
|
|
|
| |
|
|
|
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING |
116,312,378 |
|
83,836,076 |
| |
|
|
|
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) |
| |
|
|
Six Months Ended
March 31, |
|
2008
|
|
2007
|
| |
|
|
|
REVENUE: |
|
|
|
Grant revenue |
$ |
- |
|
$ |
31,779 |
Rent income |
1,530 |
|
12,895 |
Other income |
-
|
|
841
|
Total Revenue |
1,530 |
|
45,515 |
| EXPENSES: |
|
|
|
Research and development, excluding depreciation of
$97,856 and $41,794 included below |
2,066,029 |
|
1,185,023 |
Depreciation and amortization |
133,468 |
|
84,158 |
General and administrative |
2,754,569
|
|
2,368,850
|
| |
|
|
|
Total Expenses |
4,954,066
|
|
3,638,031
|
|
|
|
|
| LOSS FROM OPERATIONS |
(4,952,536) |
|
(3,592,516) |
|
|
|
|
GAIN (LOSS) ON DERIVATIVE INSTRUMENTS |
(170,949) |
|
271,891 |
|
|
|
|
INTEREST INCOME |
335,987 |
|
172,665 |
|
|
|
|
INTEREST EXPENSE |
(265,531)
|
|
(688,284)
|
|
|
|
|
| NET LOSS BEFORE INCOME TAXES |
(5,053,029) |
|
(3,836,244) |
|
|
|
|
INCOME TAX PROVISION |
-
|
|
-
|
|
|
|
|
| NET LOSS |
$ |
(5,053,029) |
|
$ |
(3,836,244) |
|
|
|
|
|
|
|
|
DIVIDENDS |
(424,815) |
|
- |
|
|
|
|
|
|
|
|
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS |
|
(5,477,844) |
|
|
(3,836,244) |
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE (BASIC) |
|
(0.05) |
|
|
(0.05) |
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE (DILUTED) |
$ |
(0.05) |
|
$ |
(0.05) |
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING |
116,008,631
|
|
83,377,267
|
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