UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 3, 2016
AETHLON MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Nevada (State or other jurisdiction of incorporation) |
001-37487 (Commission File Number) |
13-3632859 (IRS Employer Identification Number) | ||
9635 Granite Ridge Drive, Suite 100 San Diego, California (Address of principal executive offices) |
92123 (Zip Code) |
Registrant’s telephone number, including area code: (858) 459-7800
Not applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
FORWARD-LOOKING STATEMENTS
This Form 8-K and other reports filed by the registrant from time to time with the Securities and Exchange Commission (collectively, the "Filings") contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, the registrant's management as well as estimates and assumptions made by the registrant's management. When used in the Filings the words "anticipate,” "believe," "estimate," "expect," "future," "intend," "plan" or the negative of these terms and similar expressions as they relate to the registrant or the registrant's management identify forward-looking statements. Such statements reflect the current view of the registrant with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to the registrant's industry, the registrant's operations and results of operations and any businesses that may be acquired by the registrant. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Although the registrant believes that the expectations reflected in the forward-looking statements are reasonable, the registrant cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, the registrant does not intend to update any of the forward-looking statements to conform these statements to actual results.
ITEM 7.01 | REGULATION FD DISCLOSURE. |
Today, June 3, 2016, Mr. James Joyce, Chief Executive Officer of Aethlon Medical, Inc. (the “Company”), presented at the 2nd Annual Sachs Associates Immuno-oncology: BD&L and Investment Forum. A link to the presentation may be accessed on the Company’s website under the investor relations section of the website. The website address is www.aethlonmedical.com. No portion of the website shall be deemed to be incorporated into this Current Report on Form 8-K.
ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS. | |
(d) EXHIBITS | ||
EXHIBIT NO. |
DESCRIPTION | |
99.1 |
Presentation materials – 2nd Annual Sachs Associates Immuno-oncology: BD&L and Investment Forum – June 3, 2016 | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AETHLON MEDICAL, INC. | ||||
By: /s/ James B. Frakes | ||||
James B. Frakes | ||||
Dated: June 3, 2016 | Chief Financial Officer |
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EXHIBIT INDEX
EXHIBIT NO. |
DESCRIPTION |
99.1 |
Presentation materials – 2nd Annual Sachs Associates Immuno-oncology: BD&L and Investment Forum – June 3, 2016 |
Exhibit 99.1
A e thlon Medical, Inc . Nasdaq : AEMD SACHS IMMUNO - ONCOLOGY BD&L INVESTMENT FORUM JUNE 3, 2016 Jim Joyce Chairman, CEO
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FORWARD LOOKING STATEMENTS The following presentation may contain predictions, estimates, and other forward looking statements that involve risks and uncertainties, including whether and when our products are successfully developed and introduced ; market acceptance of the A e thlon ADAPT™ and ELLSA™ platform technologies, the H e mopurifier ® and other product offerings ; regulatory delays, manufacturing delays, and other risks detailed in our SEC filings, which are accessible at www . sec . gov or on our website : www . A e thlonMedical . com
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IMMUNOTHERAPEUTIC TECHNOLOGIES TO COMBAT INFECTIOUS DISEASE & CANCER
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TUMOR - DERIVED EXOSOMES A Basis for Therapeutic and Diagnostic Partnering
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Initiated tumor - derived exosome research in 2006 Considered c ellular debris w ith n o b iological f unction
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2016 Tumor - derived exosomes are significant therapeutic and diagnostic targets
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Tumor - Derived Exosomes
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Tumor - Derived Exosomes A Significant Unmet Medical Need in Cancer • The seeds of cancer metastasis – The mystery of the Soil & Seed Theory of 1889 • Tumor - derived exosomes promote: – Tumorigenesis – Cancer progression – Angiogenesis – Immune - evasion – Resistance to radiation and chemotherapeutic drugs • Exosome load correlates with stage of cancer
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The A e thlon Hemopurifier® Broad - s pectrum e limination of circulating viruses, bacterial toxins and tumor - derived exosomes
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DEPLOYED WITHIN THE GLOBAL INFRASTRUCTURE OF DIALYSIS & CRRT MACHINES
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The A e thlon Hemopurifier® FDA approved IDE study currently being conducted
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The Hemopurifier ® Mechanism of Action • Rapid separation of disease targets from the circulatory blood path • Capture of disease targets through adherence to immune - evasion structure – Lectin - affinity attachment to high - mannose structure that cloaks exosome and pathogen targets from immune surveillance • Normal blood components are returned to the circulatory system
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Previous Human Treatment Experiences
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HIV/AIDS Patient Average viral load reductions > 50% observed during 4hr treatments
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Hepatitis C Virus (HCV)
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HCV Treatment Summary • Demonstrated successful use in interferon - based cure strategy • Up to 300 billion HCV copies captured during single six - hour treatments
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Ebola Virus
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Hemopurifier® therapy administration to a comatose Ebola patient with multiple - organ failure
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Dr. Stefan Büttner Holding Hemopurifier® After Ebola Treatment
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Ebola Treatment Data Presented By Dr. Helmut Geiger American Society of Nephrology Annual Meeting • 6.5 hour Hemopurifier® therapy administration • Pre - treatment viral load: 400,000 copies/ml • Post - treatment viral load: 1,000 copies/ml • 242 million of Ebola viruses captured • Patient recovered and returned home
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“Top 25 Best Inventions” “11 Most Remarkable Advances in Healthcare”
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In Vitro Hemopurifier ® Validations • Viruses – Hepatitis C, HIV, Ebola, H1N1 Swine Flu, H5N1 Bird Flu, 1918 Spanish Flu (reconstructed), Monkey Pox, West Nile Virus, Chikungunya and Dengue • Viral Toxins • Ebola glycoprotein ( gp ), HIV gp120, HIV NEF - exosomes • Bacterial Toxins • L ipopolysaccharide (LPS) and L ipoteichoic acid (LTA) • Tumor - derived E xosomes • Breast, Metastatic Melanoma and Ovarian
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Expansive Exosome IP Portfolio Issued & Pending Patents Teach • Therapeutic elimination of exosomes • Isolation of exosomes from bodily fluids – p latform to diagnose and monitor cancer • Exosome harvesting – exosomal delivery of biologic & chemotherapeutic agents
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Partnering/Collaboration Initiatives
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Partnering/Collaboration Initiatives • Therapeutic elimination of exosomes – Preclinical Hemopurifier - d rug study validations • Confirm combination Hemopurifier - drug synergies • Demonstrate non - affinity binding of drug agent • Expand potential therapeutic indications – Clinical program initiatives • Full - circle immuno - oncology treatment regimens • Chemotherapy optimization regimens
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Partnering/Collaboration Initiatives • Therapeutic elimination of exosomes • Isolation of exosomes from bodily fluids – p latform to diagnose and monitor cancer • Exosome harvesting – Exosomal delivery of biologic & chemotherapeutic agents
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ELLSA™ (Enzyme - linked lectin - specific assay) Proprietary broad - spectrum exosome isolation platform
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Partnering/Collaboration Initiatives • Isolation of exosomes from bodily fluids – ELLSA co - development partnerships • ELLSA isolation + antibody step to diagnose and monitor specific disease indications • Urine based proof - of - principal established in HIV
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Partnering/Collaboration Initiatives • Therapeutic elimination of exosomes • Isolation of exosomes from bodily fluids – p latform to diagnose and monitor cancer • Exosome harvesting – Exosomal delivery of biologic & chemotherapeutic agents – Contact management to initiate discussions
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IMMUNOTHERAPEUTIC TECHNOLOGIES TO COMBAT INFECTIOUS DISEASE & CANCER
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Tumor - Derived Exosomes A Basis for Therapeutic & Diagnostic Partnering
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CONTACT: A e thlon Medical, Inc 9635 Granite Ridge Drive Suite 100 San Diego, California 92123 Jim Joyce Chairman & CEO jj@aethlonmedical.com 858.459.7800 x301
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