Business Wire 13-Jul-2018 5:10 PM
CEL-SCI Corporation (NYSE:CVM) reported on a communication received today from the staff of the NYSE American, its current listing exchange, that it considered the Company to be noncompliant with certain listing requirements based on its quarterly report for the period ended March 31, 2018. The Company has been given the opportunity to maintain its listing by submitting a plan of compliance by August 13, 2018. This plan must advise of actions the Company has taken or will take to regain compliance with the continued listing standards by January 14, 2019. The Company intends to submit such a plan by August 13, 2018.
Based on the Company's quarterly report on Form 10-Q for the period ended March 31, 2018, the Company is below compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii) of the listing requirements of the Exchange since it reported a stockholders' equity deficit as of March 31, 2018 and had net losses in its 5 most recent fiscal years ended September 30, 2017. Additional information and provisions regarding the NYSE American requirements are found in Part 10 of its Company Guide.
Geert Kersten, CEO of CEL-SCI said: "Noncompliance with the rules cited above came about a result of our total market capitalization having fallen below $50 million. The Exchange will not normally consider suspending dealings in, or removing from listing, the securities of an issuer which is otherwise below the stockholders' equity criteria in the sections noted above but has a market capitalization of at least $50 million. Therefore one of the ways we can regain compliance is by achieving and maintaining market capitalization of at least $50 million. Since we have a major, almost completed Phase 3 cancer study where the last patient was enrolled almost two years ago, we think that many investors may become interested in our company this summer and fall in anticipation of the conclusion of the study."
The communication and compliance plan has no current effect on the listing of the Company's shares on the Exchange. If the plan is not acceptable or the Company does not make sufficient progress under the plan or reestablish compliance by January 14, 2019, then staff of the Exchange may initiate proceedings for delisting from the NYSE American. The Company may then appeal a staff determination to initiate such proceedings in accordance with the Exchange's Company Guide.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient's immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, in CEL-SCI's pivotal Phase 3 study patients who are newly diagnosed with advanced head and neck cancer are treated first with its lead investigational immunotherapy Multikine (Leukocyte Interleukin, Injection)*, BEFORE they receive surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. CEL-SCI has received patents for Multikine from the US, Europe, China and Japan.
The Company's LEAPS technology is currently being developed as a therapeutic vaccine 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.
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. 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, 2017. 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.
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