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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cel Sci Corporation New | AMEX:CVM | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.20 | 13.51% | 1.68 | 1.73 | 1.49 | 1.50 | 382,304 | 00:16:47 |
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2019. The Company also reported key clinical and corporate developments achieved during the quarter.
Clinical and Corporate Developments included:
“During the second quarter of fiscal 2019, we were pleased to receive the IDMC’s recommendation to continue with our Phase 3 study until the appropriate number of events have occurred. Since the IDMC reviews study data that is blinded to us, we believe their recommendation affirms the study’s potential to meet the primary survival endpoint. We believe this is a very positive sign,” stated CEL-SCI CEO, Geert Kersten. “In addition to the Phase 3 head and neck cancer, we continue to advance the development of our LEAPS vaccine platform through new patents, new published scientific papers, and ongoing studies with the National Institutes of Health.”
CEL-SCI reported a net loss of $5.2 million for the six months ended March 31, 2019 versus a net loss of $10.9 million for the six months ended March 31, 2018. CEL-SCI reported a net loss of $6.4 million for the quarter ended March 31, 2019 versus a net loss of $4.7 million for the quarter ended March 31, 2018.
During the six months ended March 31, 2019, the Company’s cash decreased by approximately $4.8 million. Significant components of this decrease included net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $7.8 million and approximately $0.2 million to purchase long term assets. The decrease was offset by net proceeds from the exercise of warrants of approximately $3.3 million.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treats patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine first, BEFORE they receive surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI’s Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation and/or concurrent radiochemotherapy. Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby it is better able to mount an attack on the tumor. The aim of treatment with Multikine is to increase the body’s immune system against the tumor prior to SOC.
The Company’s LEAPS technology is currently being developed as a therapeutic antigen-specific treatment for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2018. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS SIX MONTHS ENDED MARCH 31, 2019 AND 2018 (UNAUDITED) 2019 2018 Grant income $ 277,183 $ 210,586 Operating Expenses: Research and development 5,657,648 5,288,311 General & administrative 3,960,597 4,074,723 Total operating expenses 9,618,245 9,363,034 Operating loss (9,341,062 ) (9,152,448 ) Other income 36,127 35,273 Gain on derivative instruments 4,589,135 196,585 Other non-operating gain (loss) 421,353 (22,109 ) Interest expense, net (907,332 ) (1,953,266 ) Net loss available to common shareholders $ (5,201,779 ) $ (10,895,965 ) Net loss per common share BASIC $ (0.18 ) $ (0.81 ) DILUTED $ (0.19 ) $ (0.81 ) Weighted average common shares outstanding BASIC 28,543,417 13,403,878 DILUTED 28,548,818 13,403,878 See notes to condensed financial statements.CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 2019 AND 2018 (UNAUDITED) 2019 2018 Grant income $ 150,769 $ 114,271 Operating Expenses: Research and development 2,525,460 2,962,297 General & administrative 1,931,909 1,375,410 Total operating expenses 4,457,369 4,337,707 Operating loss (4,306,600 ) (4,223,436 ) Other income 18,216 17,691 (Loss) gain on derivative instruments (967,171 ) 1,154,815 Other non-operating loss (730,823 ) (768,810 ) Interest expense, net (461,303 ) (888,395 ) Net loss available to common shareholders $ (6,447,681 ) $ (4,708,135 ) Net loss per common share BASIC $ (0.22 ) $ (0.31 ) DILUTED $ (0.22 ) $ (0.31 ) Weighted average common shares outstanding BASIC 29,113,910 15,210,296 DILUTED 29,113,910 15,210,296 See notes to condensed financial statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190514005930/en/
Gavin de WindtCEL-SCI Corporation(703) 506-9460
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