Aethlon Medical Releases Shareholder Update
SAN DIEGO, April 24, 2017 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), today released the following shareholder update authored by its Chairman and CEO, Jim Joyce.
I first want to express my appreciation for your overwhelming participation in our annual meeting, which was held in Houston on March 30th. I am pleased to report the participation of 93.5% or 7,441,591 of the 7,961,923 shares that were entitled to vote. There were no votes cast against our slate of directors and just 62,256 shares cast against the reappointment of our auditors.
Additionally, if you did not see the 8-K that was filed with the SEC on March 22nd, we disclosed that we sold 575,000 shares of our common stock at $3.50 to a single life science-focused institutional investor. The resulting net proceeds of approximately $1.85 million will augment our March 31st fiscal year-end balance sheet, which will be reflected in our annual 10-K filing.
As you are likely aware, we disclosed on March 13th that we concluded our FDA-approved feasibility study of our Hemopurifier®. We have since provided FDA with a summary report of the study and are now assembling a detailed final report for submission back to the agency. We believe the Hemopurifier can address a significant unmet need in global health and biodefense. More specifically, it provides a therapeutic strategy to address a broad-spectrum of viral pathogens that are not addressed with antiviral drug therapies, including natural occurring pandemic threats and agents of bioterrorism.
In regards to next steps with FDA, we have placed a high priority on leveraging regulatory pathways that have recently emerged to accelerate the advancement of medical devices in the United States.
In this regard, 2016 represented the first full year of operation for the FDA's Expedited Access Pathway (EAP) program, which was created to speed the development and availability of medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly-debilitating diseases or conditions.
On December 13, 2016, the EAP program was further enhanced when the 21st Century Cures Act was signed into law. The legislation established a designation for "breakthrough" technologies that address diseases or conditions for which no cleared or approved alternatives exist and whose availability is in the best interest of patients.
We plan to submit an FDA application to advance our Hemopurifier under the EAP program as a broad-spectrum treatment countermeasure against life-threatening viruses that are not addressed with an approved antiviral drug. Of the hundreds of viruses that are infectious to humans, only nine are addressed with an approved antiviral drug agent. While there is no assurance that we will receive an EAP designation, I can assure you that our application will reflect our mission to address unmet needs in global health and biodefense.
To learn more about our device and the need for therapies to address life-threatening and irreversibly-debilitating viruses, I encourage you to review the report entitled, "Human Viruses & the Limitation of Antiviral Drug Agents," which can be accessed at: http://aethlonmedical.investorroom.com/file.php/155/Human+Viruses-final.pdf.
Since bringing our feasibility study to a conclusion, we have also requested a meeting with the Biomedical Advanced Research and Development Authority (BARDA). BARDA is a U.S. government agency whose mission is to develop and procure medical countermeasures for the Strategic National Stockpile that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) incidents. This includes pandemic strains of influenza and other high-threat viral pathogens.
You may recall that one of our stated objectives is to fulfill the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2016 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. Based on previous pre-clinical and human clinical outcomes, we believe our Hemopurifier is a leading broad-spectrum candidate to address viral pathogens that remain beyond the reach of traditional disease-specific drugs and vaccines. In this regard, the HHS PHEMCE initiative is managed by BARDA.
Prior to closing out my letter, I encourage you to listen to an interview on National Public Radio that was conducted earlier this month. The interview is quite informative as it provides the historic backdrop of our exosome research, references our first data in Alzheimer's disease and discusses a forthcoming study of Chronic Traumatic Encephalopathy (CTE) in former NFL players that will be conducted by our Exosome Sciences subsidiary.
The 27-minute interview begins at minute six of the program and ends at minute 33 and can be accessed online at https://www.podomatic.com/podcasts/technation/episodes/2017-03-31T04_14_59-07_00.
About Aethlon Medical, Inc.
Aethlon Medical develops immunotherapeutic technologies to combat infectious disease and cancer. To augment the body's natural immune defenses, the Aethlon Hemopurifier reduces the presence of circulating viruses in infected individuals. The technology provides a first-line candidate defense against viruses that are not addressed with proven drug therapies, including natural occurring pandemic threats and agents of bioterrorism. The Hemopurifier can also be deployed as a strategy to improve the benefit of approved antiviral drug regimens. At present, the Hemopurifier is being advanced in the United States under an FDA approved clinical study. Aethlon Medical is also investigating the potential use of the Hemopurifier to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. Aethlon Medical is also the majority owner of Exosome Sciences, Inc. (ESI), which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer's disease (AD) and Chronic Traumatic Encephalopathy (CTE). ESI's TauSome™ biomarker is being clinically evaluated as the basis for a blood-based test to identify CTE in living individuals. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and Google+.
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," 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. Factors that may contribute to such differences include, without limitation, the Company's ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, including any CTE-related products, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Company's products, including clearance through the 21st Century Cures Act, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. 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, 2016, and in the Company's other filings with the Securities and Exchange Commission. 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.
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
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SOURCE Aethlon Medical, Inc.
Released April 24, 2017