VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) reports financial results for the quarter ended March 31, 2010.
CEL-SCI reported that net loss for the three months ended March 31, 2010 was ($0.7 million) versus a loss of ($2.1 million) during the same three months in fiscal year 2009. Net loss per share was ($0.01) for the three months ended March 31, 2010 versus a loss of ($0.02) during the same three months in fiscal year 2009. The loss during the quarter ended March 31, 2010 was reduced by a gain on derivative instruments of $4.5 million.
Net income available to shareholders for the six months ended March 31, 2010 was $17 million versus a loss of ($4.3 million) during the same six months in fiscal year 2009. Net income per share, basic was $0.09 for the six months ended March 31, 2010 versus a loss of ($0.03) during the same six months in fiscal year 2009. The gain on net income for the six months ended March 31, 2010 was due to derivative accounting.
R&D expenses for the three months ended March 31, 2010 totaled $3.3 million versus R&D expenses of $1.2 million for the same period in fiscal year 2009. R&D expenses for the six months ended March 31, 2010 totaled $6.1 million versus R&D expenses of $2.7 million for the same period in fiscal year 2009.
Geert Kersten, Chief Executive Officer said, “Expenditures during the past two quarters have been relatively high due to the preparations for the start of the pivotal Phase III trial with our cancer drug Multikine®. Net cash used during the quarter totaled approximately $4 million. Despite this we concluded the March 31, 2010 quarter in a very strong financial condition, with more than $34 million in cash and cash equivalents. We are very pleased to have the ability to self-fund our upcoming pivotal study, expected to be the largest head and neck cancer Phase III trial ever conducted, and are working closely with our partners Teva Pharmaceuticals and Orient Europharma towards a successful launch."
About Multikine Cancer Immunotherapy
CEL-SCI is developing Multikine for approval as a first-line indication in newly diagnosed head and neck cancer. To that end, the Company's planned Phase III clinical trial is an 800 patient randomized, controlled clinical study designed to demonstrate that administration of its cancer drug Multikine to head and neck cancer patients before they receive any other conventional cancer treatment will increase their overall survival. 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 and has granted CEL-SCI's Multikine an Orphan Drug Designation for the "neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN)". In early 2010 CEL-SCI finished the validation of its dedicated state of the art commercial-ready manufacturing facility for Multikine.
Multikine is 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.
Multikine is a patented defined mixture of naturally derived cytokines. It 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.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product Multikine is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its L.E.A.P.S. technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
|
CEL-SCI CORPORATION |
||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||
| (unaudited) | ||||||||||
|
Three Months Ended |
||||||||||
| March 31, | ||||||||||
| 2010 | 2009 | |||||||||
| REVENUE: | ||||||||||
| Rent income | $ | 30,600 | $ | 19,643 | ||||||
| Total revenue | 30,600 | 19,643 | ||||||||
| EXPENSES: | ||||||||||
|
Research and development, excluding depreciation of $103,845 and $101,108 included below |
3,340,897 | 1,247,763 | ||||||||
| Depreciation and amortization | 123,303 | 122,598 | ||||||||
| General and administrative | 1,886,758 | 1,014,399 | ||||||||
| Total expenses | 5,350,958 | 2,384,760 | ||||||||
| LOSS FROM OPERATIONS | (5,320,358 | ) | (2,365,117 | ) | ||||||
| GAIN ON DERIVATIVE INSTRUMENTS | 4,519,672 | 264,554 | ||||||||
| INTEREST INCOME | 97,569 | 68,160 | ||||||||
| INTEREST EXPENSE | (41,402 | ) | (84,877 | ) | ||||||
| NET LOSS BEFORE INCOME TAXES | (744,519 | ) | (2,117,280 | ) | ||||||
| INCOME TAX PROVISION | - | - | ||||||||
| NET LOSS | (744,519 | ) | (2,117,280 | ) | ||||||
| MODIFICATION OF SERIES M WARRANTS | (1,432,456 | ) | - | |||||||
| NET LOSS AVAILABLE TO COMMON SHAREHOLDERS | $ | (2,176,975 | ) | $ | (2,117,280 | ) | ||||
| NET LOSS PER COMMON SHARE-BASIC | $ | (0.01 | ) | $ | (0.02 | ) | ||||
| NET LOSS PER COMMON SHARE-DILUTED | $ | (0.03 | ) | $ | (0.02 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-BASIC |
204,173,750 | 124,701,667 | ||||||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-DILUTED |
258,251,010 | 124,701,667 | ||||||||
|
CEL-SCI CORPORATION |
||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||
| (unaudited) | ||||||||||
| For the Six Months Ended | ||||||||||
| March 31, | ||||||||||
| 2010 | 2009 | |||||||||
| REVENUE: | ||||||||||
| Rent income | $ | 60,600 | $ | 19,643 | ||||||
| Total revenue | 60,600 | 19,643 | ||||||||
| EXPENSES: | ||||||||||
|
Research and development, excluding depreciation of $203,429 and $165,631 included below |
6,146,024 | 2,658,516 | ||||||||
| Depreciation and amortization | 242,884 | 208,542 | ||||||||
| General and administrative | 3,244,899 | 2,069,525 | ||||||||
| Total expenses | 9,633,807 | 4,936,583 | ||||||||
| LOSS FROM OPERATIONS | (9,573,207 | ) | (4,916,940 | ) | ||||||
| GAIN ON DERIVATIVE INSTRUMENTS | 27,859,939 | 656,243 | ||||||||
| INTEREST INCOME | 207,788 | 139,397 | ||||||||
| INTEREST EXPENSE | (79,522 | ) | (169,493 | ) | ||||||
| NET INCOME (LOSS) BEFORE INCOME TAXES | 18,414,998 | (4,290,793 | ) | |||||||
| INCOME TAX PROVISION | - | - | ||||||||
| NET INCOME (LOSS) | 18,414,998 | (4,290,793 | ) | |||||||
| MODIFICATION OF SERIES M WARRANTS | (1,432,456 | ) | - | |||||||
| NET INCOME (LOSS) AVAILABLE TO COMMON SHAREHOLDERS | $ | 16,982,542 | $ | (4,290,793 | ) | |||||
| NET INCOME (LOSS) PER COMMON SHARE-BASIC | $ | 0.09 | $ | (0.03 | ) | |||||
| NET LOSS PER COMMON SHARE-DILUTED | $ | (0.01 | ) | $ | (0.03 | ) | ||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-BASIC |
199,516,156 | 123,444,839 | ||||||||
|
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING-DILUTED |
253,593,416 | 123,444,839 | ||||||||
CONTACT:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
KEYWORDS: United States North America Virginia
INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Oncology Pharmaceutical Other Health Research Science General Health
MEDIA:
| Logo |