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): September 24, 2019

 

Aethlon Medical, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada   001-37487   13-3632859
(State or other jurisdiction   (Commission File Number)   (IRS Employer Identification No.)
of incorporation)        
   

9635 Granite Ridge Drive, Suite 100

San Diego, California

  92123
(Address of principal executive offices)   (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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol Name of each exchange on which registered
Common Stock AEMD The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

     

 

 

Item 8.01 Other Events.

 

On September 24, 2019, the Company issued a press release announcing its collaboration to identify exosomes involved in cancer progression and treatment resistance. The collaborator also announced the collaboration through its own press release. Copies of those press releases are attached as Exhibit 99.1 hereto and are incorporated by reference herein.

 

Item 9.01 Financial Statements and Exhibits

 

(d)       Exhibits

 

Exhibit No. Description
99.1 Press Releases dated September 24, 2019.

 

 

 

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.
       
Dated: September 24, 2019       By:   /s/ James B. Frakes
           

James B. Frakes

Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

 

Aethlon Announces Collaboration to Identify Exosomes Involved in Cancer Progression and Treatment Resistance

 

Exosome based liquid biopsies have potential to transform cancer diagnostics and treatments

 

SAN DIEGO (September 24, 2019) – EXOSOME SCIENCES, a subsidiary of Aethlon Medical, Inc. (Nasdaq: AEMD), announced a research collaboration to identify and characterize exosomes derived from patients with solid tumors such as pancreas cancer, as well as from families with genetically high risk of developing cancer. These cancer-derived exosomes may serve as early markers for cancer diagnostics, cancer progression and treatment resistance.

 

For more information about this partnership please visit: https://www.hoag.org/news/hoag-to-study-unique-early-disease-markers/

 

ABOUT EXOSOME SCIENCES

Exosome Sciences, Inc., a majority owned subsidiary of Aethlon Medical, Inc., is a diagnostic company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression. Aethlon Medical, Inc. is a therapeutic company focused on addressing unmet needs in cancer and infectious diseases. The Aethlon Hemopurifier® is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier® depletes the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The Hemopurifier® is an FDA designated "Breakthrough Device" related to 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 cancer. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com.

 

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, 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 raise additional funds and maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, the risk that the Company’s collaborations with hospitals will not be successful, that the Company’s subsidiary will not be able to commercialize its 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, the Company's ability to complete the development of the Hemopurifier and other 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, 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, 2019, and in the Company's other filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q. 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.

 

Company Contact:

Jim Frakes

Chief Financial Officer

Aethlon Medical, Inc.

858-459-7800 x3300

Jfrakes@aethlonmedical.com

 

Media Contact:

David Schull or Maggie Beller

Russo Partners, LLC

David.Schull@RussoPartnersLLC.com

Maggie.Beller@RussoPartnersLLC.com

212-845-4271

 

 

     

 

 

NEWPORT BEACH, CALIF., September 24, 2019 – Hoag Memorial Hospital Presbyterian announced today the start of a research study to identify and characterize potential early disease markers for cancer diagnostics, cancer progression and treatment resistance.

 

In partnership with Exosome Sciences, a subsidiary of Aethlon Medical, Inc. (Nasdaq: AEMD), scientists will study exosomes in cancer patients and individuals at high genetic risk for cancer. Exosomes are nanoparticles that are abundantly released from cancer cells and provide a snapshot of a tumor’s genetic and protein cargo, making them important targets for non-invasive liquid biopsies in cancer.

 

“Liquid biopsies have the potential to facilitate the early detection of cancer and the assessment of the efficacy of potential treatments in real time. This may prove to be a critical tool in our ongoing efforts to help patients with cancer,” said Michael Demeure, M.D., program director of Precision Medicine at Hoag and the principal investigator on the study at Hoag. “Hoag has an active Hereditary Cancer Program that supports a number of individuals and families at high risk of developing cancer and is committed to achieving breakthroughs in the detection of cancer at its earliest possible and most treatable stage.”

 

“Liquid biopsies are a rapidly developing field of non-invasive tests for patients with and at risk for cancer,” said Timothy Rodell, M.D., CEO of Exosome Sciences and Aethlon Medical, Inc. “Our proprietary exosome diagnostics represent a potentially powerful addition to the liquid biopsy field. This partnership with Hoag may significantly accelerate our development of exosome based liquid biopsies and may provide deep insights into the detection, progression and treatment options for cancer patients and their families. We are delighted to have the opportunity to work with Dr. Demeure and the Hoag team on this project.”

Hoag’s Hereditary Cancer Program and many aspects of its cancer research are supported by philanthropy.

 

For more information on the research studies and clinical trials at Hoag, visit https://www.hoag.org/specialties-services/other-programs-services/clinical-research/available-clinical-trials/.

 

ABOUT HOAG MEMORIAL HOSPITAL PRESBYTERIAN

 

Hoag is an approximately $1 billion nonprofit, regional health care delivery network in Orange County, California, that treats more than 30,000 inpatients and 450,000 outpatients annually. Hoag consists of two acute-care hospitals – Hoag Hospital Newport Beach, which opened in 1952, and Hoag Hospital Irvine, which opened in 2010 – in addition to eight health centers and 11 urgent care centers. Hoag is a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC). Hoag offers a comprehensive blend of health care services that includes five institutes providing specialized services in the following areas: cancer, heart and vascular, neurosciences, women’s health, and orthopedics through Hoag’s affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and two ambulatory surgical centers. Hoag has been named one of the Best Regional Hospitals in the 2019 - 2020 U.S. News & World Report, andBecker’s Healthcare named Hoag as one of the 2018 “100 Great Hospitals in America” – a designation Hoag has received five times. For an unprecedented 23 years, residents of Orange County have chosen Hoag as one of the county’s best hospitals in a local newspaper survey. Visit www.hoag.org for more information.

 

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To download the official press release, please click here.