Securities and Exchange Commission (SEC) Order for Halt in trading of Aethlon Medical (NASDAQ:AEMD) Stock
February 10, 2020 at 09:01 AM EST
SAN DIEGO, Feb. 10, 2020 /PRNewswire/ -- (NASDAQ:AEMD) -- On February 7, 2020, the Securities and Exchange Commission (SEC) issued an Order of Suspension of Trading (the "SEC Order"), temporarily suspending trading in Aethlon Medical, Inc. ("Aethlon" or the "Company") stock for a period of ten days. The SEC Order stated that the suspension was due to concerns regarding the accuracy and adequacy of information in the marketplace that appeared to be disseminated by third party promotors and recent and unusual market activity since at least January 22, 2020.
Aethlon is aware that certain third party promoters may have made claims about the potential efficacy of its products with respect to coronavirus. The Company neither solicited, had advance knowledge of, nor played any role in the preparation of such reports.
The following sets forth a description of the Company's approaches to viral diseases and the potential application of the Company's products to coronaviruses, including the currently circulating 2019-nCoV strain.
Aethlon is developing the Hemopurifier, a proprietary blood filtration cartridge that potentially can clear both viruses and cancer promoting sub-cellular particles called exosomes, from circulating blood. The Hemopurifier has received two Breakthrough Designations from the Food and Drug Administration (FDA) for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease….". The Company has FDA approved Investigational Device Exemptions (IDEs) for both the investigation of the Hemopurifier for life threatening viral infections and for the investigation of treatment of patients with head and neck cancer in combination with pembrolizumab (Keytruda).
From the first days of the current coronavirus outbreak, Company scientists have been closely monitoring the situation, speaking with our colleagues who may be involved in the care of these patients, and evaluating whether the Hemopurifier could offer any benefit to severely affected patients. Fortunately, the majority of patients to date have not had severe disease, and those with milder disease would not be candidates for treatment with the Hemopurifier. Moreover, if it were ultimately to be used in any outbreak such as the current one, it would almost certainly not be an initial front line treatment.
While the Company has previously evaluated the ability of benchtop versions of the Hemopurifier to bind multiple viruses, including one other member of the coronavirus family, the currently circulating 2019-nCoV virus is not yet widely available for evaluation and, therefore, the Company does not have data showing whether the Hemopurifier could clear it. In addition, it is unclear at this time whether a virus that primarily affects the upper respiratory tract would be ameliorated by clearance from the circulating blood, as the Hemopurifier is designed to do. With all these considerations in mind, the Company intends to continue to monitor the situation closely to evaluate our strategy and develop it as appropriate based on evolving information.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete its planned studies with or the development of its Hemopurifier or that Exosome Sciences' Inc.'s collaboration with Hoag Hospital Systems will be successful, the impact of the SEC Order and the resulting investigation, and other potential products and other risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2019, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Jim Frakes, CFO
SOURCE Aethlon Medical, Inc.