UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended March 31, 2016
OR
[_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to __________
COMMISSION FILE NUMBER 001-37487
AETHLON MEDICAL, INC.
(Exact name of registrant as specified in its charter)
NEVADA
(State or other jurisdiction of
incorporation or organization)
9635 Granite Ridge Drive, Suite 100
San Diego, California
(Address of principal executive office)
13-3632859
(I.R.S. Employer
Identification No.)
92123
(Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (858) 459-7800
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE EXCHANGE ACT:
TITLE OF EACH CLASS
NAME OF EACH EXCHANGE ON WHICH REGISTERED
COMMON STOCK, $.001 PAR VALUE
THE NASDAQ STOCK MARKET LLC
SECURITIES REGISTERED UNDER SECTION 12(g) OF THE EXCHANGE ACT:
NONE
(TITLE OF CLASS)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [_] No [X]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes [_] No [X]
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes [X] No [_]
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes [X] No [_]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. [X]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the
Exchange Act.
Large accelerated filer [_]
Non accelerated filer [_]
(Do not check if a smaller reporting company)
Accelerated filer [_]
Smaller reporting company [X]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [_] No [X]
The aggregate market value of the common stock held by non-affiliates of the registrant as of September 30, 2015 was approximately $49
million, computed by reference to the closing sale price of the common stock of $7.16 per share on the Nasdaq Capital Market on
September 30, 2015. Shares of common stock held by each executive officer and director and by each person who owns 10% or more of the
outstanding common stock have been excluded in that such persons may be deemed to be affiliates. The determination of affiliate status is
not necessarily a conclusive determination for other purposes.
The number of shares of the common stock of the registrant outstanding as of June 29, 2016 was 7,622,393.
Explanatory Note: On April 14, 2015, the registrant completed a 1-for-50 reverse stock split. Accordingly, the registrant’s authorized
common stock was reduced from 500,000,000 shares to 10,000,000 shares, and each 50 shares of outstanding common stock held by
stockholders were combined into one share of common stock. This Form 10-K reflects, and the accompanying consolidated financial
statements and accompanying notes have been retroactively revised to reflect, such reverse stock split as if it had occurred on April 1,
2014. All shares and per share amounts have been revised accordingly.
TABLE OF CONTENTS
PART I.
PAGE
Item 1.
Description of Business
Item 1A.
Risk Factors
Item 1B.
Unresolved Staff Comments
Item 2.
Properties
Item 3.
Legal Proceedings
Item 4.
Mine Safety Disclosures
Item 5.
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
PART II.
Item 6.
Selected Financial Data
Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 7A
Quantitative and Qualitative Disclosures about Market Risk
Item 8.
Financial Statements
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A.
Controls and Procedures
Item 9B.
Other Information
Item 10.
Directors, Executive Officers and Corporate Governance
Item 11.
Executive Compensation
PART III.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13.
Certain Relationships and Related Transactions and Director Independence
Item 14.
Principal Accounting Fees and Services
Item 15.
Exhibits, Financial Statements
Signatures
Certifications
PART IV.
ii
1
12
31
31
31
31
32
35
35
44
44
44
44
44
45
48
53
54
56
57
63
ITEM 1. DESCRIPTION OF BUSINESS
Overview and Corporate History
PART I
We are a leading developer of immunotherapeutic technologies to combat infectious disease and cancer. To augment the body's
natural immune defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune
system and not well addressed by traditional drug therapies. The technology captures circulating viruses, bacterial toxins and cancer
promoting exosomes through affinity attachment to a unique structure that cloaks these targets from immune detection. At present, the
Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc., or
Exosome, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. In addition, we
operate under a Department of Defense contract through the Defense Advanced Research Projects Agency, or DARPA, related to the
development of a sepsis treatment device. We also operate under a second Department of Defense contract as a subcontractor.
Aethlon Medical was formed on March 10, 1999. Our executive offices are located at 9635 Granite Ridge Drive, Suite 100, San
Diego, California 92123. Our telephone number is (858) 459-7800. All references to “us” or “we” are references to Aethlon Medical, Inc.,
combined with its majority-owned subsidiary, Exosome Sciences, Inc.
Target Market and Strategy
Our primary therapeutic business segment is divided into two areas. First, we are advancing our lead product, the Aethlon
Hemopurifier, which targets the removal of circulating viruses and shed glycoproteins to treat infectious viral pathogens. In oncology
indications, the Hemopurifier targets the removal of circulating exosomes, which are released to promote cancer progression and to seed the
spread of metastasis.
The second focus is government contracting. We operate under two Department of Defense contracts related to a program entitled
“Dialysis-Like Therapeutics.” One is a contract with DARPA, and the other is a subcontract with Battelle Memorial Institute.. Under these
contracts, our tasks include the development of a dialysis-like device to prevent sepsis, a fatal bloodstream infection that is often the cause
of death in combat-injured soldiers. Specific to the Hemopurifier, the program has focused on validating the capture of viral pathogens and
bacterial toxins.
The third facet of our business is conducted through Exosome, which is our diagnostic business segment and is developing
exosome-based products to diagnose and monitor life-threatening disease conditions.
We initially developed the Hemopurifier as a broad-spectrum countermeasure to address the many infectious viral pathogens that
are not addressed with antiviral drugs. We also envision our technology serving as an adjunct therapy to improve the benefit of infectious
disease and cancer therapy regimens marketed by pharmaceutical organizations. For example, a clinical trial protocol administered at the
Medanta Medicity Institute in India was designed to treat Hepatitis C patients as they began their standard of care drug regimen as a means
to reduce the time it normally takes for the virus to become undetectable in the patient’s blood. At completion of the Medanta Medicity
study, we reported that patients who received the Hemopurifier therapy protocol had higher rapid virologic response and sustained
virologic response rates as compared to what would normally be expected for Hepatitis C virus infected individuals who receive standard of
care interferon-ribavirin drug therapy alone.
Our Lead Device: The Aethlon Hemopurifier
The Aethlon Hemopurifier is a device that selectively targets the rapid elimination of circulating viruses and tumor-secreted
exosomes that promote cancer progression. More specifically, the Hemopurifier addresses antiviral drug-resistance in Hepatitis C virus and
Human Immunodeficiency Virus-infected individuals; serves as a countermeasure against viral pathogens not addressed by drug or vaccine
therapies; and, we believe, represents the first therapeutic strategy to address cancer promoting exosomes. In clinical studies conducted in
India, safety and efficacy observations of Hemopurifier therapy have been observed in both Hepatitis C virus and Human
Immunodeficiency Virus-infected individuals. We are currently conducting the first U.S. Food and Drug Administration, or FDA,
approved studies of Hemopurifier therapy in the U.S.
The Scientific Mechanism of the Hemopurifier
The Hemopurifier is an extracorporeal (situated or occurring outside the body) device designed for the single-use removal of
viruses, viral toxins, and deleterious exosomes from the circulatory system of treated patients. Delivery of Hemopurifier therapy can occur
through the established infrastructure of continuous renal replacement therapy and dialysis instruments routinely found in hospitals and
clinics worldwide. Most extracorporeal techniques, including dialysis and plasmapheresis, are designed to solely remove circulating
particles by molecule size, which results in the elimination of disease targets as well as blood components required for health.
1
However, the Hemopurifier is an interactive technology that incorporates a lectin affinity agent that binds to a unique high
mannose signature that is abundant on the surface of tumor-derived exosomes and glycoproteins that reside on the outer membrane of
infectious viruses. The Hemopurifier is designed to provide a broad-spectrum mechanism to reduce the presence of certain cancer and
infectious disease related particles. To date, clinical treatment protocols have administered Hemopurifier therapy for periods lasting from
three to six and one half hours in duration.
The Hemopurifier - Antiviral Drug-Resistance; Planned U.S. Clinical Trials
The Hemopurifier provides a novel methodology to target mutant viral strains that trigger antiviral drug resistance in both Human
Immunodeficiency Virus and Hepatitis C virus infections. In Hepatitis C virus care, we believe the Hemopurifier is positioned to address
drug resistance associated with emerging all-antiviral therapies and also to accelerate Hepatitis C virus depletion at the outset of
peginterferon+ribavirin therapy.
Based on previous studies we conducted in India, safety and efficacy observations of Hemopurifier therapy have been observed in
both disease conditions. As a result of these outcomes, we have initiated the first FDA-approved feasibility study of Hemopurifier therapy
in the U.S. The feasibility study is being conducted on Hepatitis C virus-infected patients at DaVita MedCenter Dialysis in Houston, Texas.
The principal investigator for the study is Dr. Ronald Ralph, who replaced Dr. Stephen Z. Fadem as principal investigator in late 2015.
Successful completion of this study will permit us to initiate further stage studies that are required for market clearance to treat
Hepatitis C virus and other viral pathogens in the U.S. Our feasibility study protocol calls for the enrollment of ten Hepatitis C virus-
infected end stage renal disease patients who have not received any pharmaceutical therapy for their Hepatitis C virus infection for at least
30 days. The protocol will consist of a control phase of three consecutive standard dialysis treatments during week one followed by the
inclusion of our Hemopurifier during a total of six dialysis sessions conducted during weeks two and three. The rate of adverse events
observed during the Hemopurifier therapy phase will be compared to the rate experienced during the control phase. Per-treatment changes
of viral load will be observed through quantitative polymerase chain reaction analysis. Additionally, we plan to measure the number of
viral copies of Hepatitis C virus captured within the Hemopurifier during each treatment session.
On February 14, 2014, we entered into an agreement with Total Renal Research, Inc. (dba DaVita Clinical Research). Pursuant to
the agreement, Da Vita Clinical Research is conducting site management administrative services for a study. The agreement with DaVita
Clinical Research requires us to pay certain expenses related to the study protocol projected to be less than $200,000, including certain
start-up and close-out costs, patient compensation and project management fees. Additional activities and completion of this clinical trial
will require us to pay additional costs estimated to be $650,000. We will also be responsible for the fees for any third-party consulting
physicians, including Dr. Ralph, utilized in connection with the study and other pass-through expenses if incurred. The work order under
this agreement was effective as of May 16, 2014 and will continue in effect until completion of the services being provided by DaVita
Clinical Research.
The Hemopurifier - Antiviral Studies in India
Previously, we conducted Hepatitis C virus treatment studies at the Apollo Hospital, Fortis Hospital, and most recently the
Medanta Medicity Institute in India.
In the Medanta Medicity Institute study, twelve Hepatitis C virus-infected individuals were enrolled to receive three six-hour
Hemopurifier treatments during the first three days of a 48-week peginterferon+ribavirin treatment regimen. The study was conducted
under the leadership of Dr. Vijay Kher at the Medanta Medicity Institute, a multi-specialty medical institute established to be a premier
center for medical tourism in India. Dr. Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related
adverse events in the twelve treated patients.
Of these twelve patients, ten completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1
patients and two genotype-3 patients. Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of
treatment cure and is defined as undetectable Hepatitis C virus in the blood 24 weeks after the completion of the 48-week
peginterferon+ribavirin drug regimen. Both genotype-3 patients achieved a sustained virologic response, while six of the eight genotype-1
patients achieved a sustained virologic response.
Of the ten patients who completed the full treatment protocol, five also achieved a rapid virologic response, defined as
undetectable Hepatitis C virus in the blood at day 30 of therapy. Rapid virologic response represents the clinical endpoint that best predicts
sustained virologic response cure rates resulting from peginterferon+ribavirin therapy. As a point of reference, the landmark Individualized
Dosing Efficacy vs Flat Dosing to Assess Optimal Pegylated Interferon Therapy study of 3,070 Hepatitis C virus genotype-1 patients
documented that 10.35% (n=318/3070) of peginterferon+ribavirin-treated patients achieved a rapid virologic response. Patients who
achieved a rapid virologic response had sustained virologic response rates of 86.2% (n=274/318) versus sustained virologic response rates
of 32.5% (n=897/2752) in non-rapid virologic response patients. Two of the genotype-1 patients who achieved a rapid virologic response
also achieved an immediate virologic response, defined as undetectable Hepatitis C virus in the blood seven days after initiation of
Hemopurifier-peginterferon+ribavirin treatment protocol. The earliest measured report of undetectable Hepatitis C virus in blood in the
Individualized Dosing Efficacy vs Flat Dosing to Assess Optimal Pegylated Interferon Therapy study was on day 14 of the study.
2
Data from two patients was not included in the reported Hemopurifier-peginterferon+ribavirin dataset. One of these patients was a
genotype-5 patient who discontinued peginterferon+ribavirin therapy at day 180, yet still achieved a sustained virologic response. The
second patient was a genotype-3 patient who also achieved a sustained virologic response, yet was unable to tolerate
peginterferon+ribavirin therapy and discontinued therapy at day 90. Overall, ten of the twelve patients who enrolled in the study achieved a
sustained virologic response and seven of the twelve patients achieved a rapid virologic response.
Hemopurifier - Human Immunodeficiency Virus; Single Proof Study
In addition to treating Hepatitis C virus-infected individuals, we have conducted a single proof-of-principle treatment study related
to the treatment of Human Immunodeficiency Virus. In the study, Hemopurifier therapy reduced viral load by 93% in a Human
Immunodeficiency Virus-Acquired Immunodeficiency Syndrome-infected individual without the administration of antiviral drug
therapy. The study protocol provided for 12 Hemopurifier treatments, each four hours in duration, which were administered over the
course of one month.
Researchers at the Morehouse School of Medicine have since discovered that the Hemopurifier is able to capture exosomes that
transport negative regulatory factor protein, which is reported to suppress the immune response in Human Immunodeficiency Virus-
infected individuals.
The Hemopurifier - Viral Pathogens Not Addressed by Drug Therapies
The protocol design of our forthcoming FDA-approved study was originally designed as a human safety challenge and model for
addressing drug and vaccine resistant bioterror and emerging pandemic threats. In vitro studies conducted by leading government and non-
government researchers have demonstrated that the Hemopurifier is able to capture a broad spectrum of some of the world’s deadliest viral
pathogens. These include: Dengue hemorrhagic fever, Ebola hemorrhagic fever, Lassa hemorrhagic fever, H5N1 avian influenza, H1N1
swine flu virus, the reconstructed 1918 influenza virus, West Nile virus and Vaccinia and Monkeypox, which serve as models for human
smallpox infection. Human efficacy studies are not permissible against high-threat bioterror and pandemic threats.
The following table lists some of the key viral pathogens captured during in vitro studies and the name of the research institute that
ran the study.
Virus Type
Ebola Virus
Dengue Fever
Lassa Hemorrhagic Fever
West Nile Virus
H5N1 Avian Flu
1918-r Spanish Flu
2009 H1N1 Swine Flu
Collaborator
United States Army Medical Research Institute of Infectious
Diseases/Centers for Disease Control
National Institute of Virology/World Health Organization
Southwest Foundation for Biomedical Research
Battelle
Battelle
Battelle
Battelle
The Hemopurifier - Candidate to Treat Cancer
In “Extracellular Vesicles: Emerging Targets for Cancer Therapy,” a review article sponsored by the National Cancer Institute and
published in the July 2014 issue of Trends in Molecular Medicine, we were the sole organization referenced to have a therapeutic candidate
to address tumor-secreted exosomes, which have been discovered to suppress the immune system of cancer patients, seed the creation and
spread of metastasis, promote angiogenesis, trigger resistance to chemotherapy, and transport primary cancer therapeutic targets of the
biopharmaceutical industry. To date, we have received an issued patent that protects the use of our Hemopurifier to remove
immunosuppressive extracellular vesicles or exosomes from the blood of cancer patients. Through internal research and external research
collaborations, we have demonstrated that the affinity lectin immobilized in our Hemopurifier is able to bind exosomes underlying a broad
spectrum of disease indications including cancer.
We believe that Hemopurifier therapy could play a role in the emerging immuno-oncology industry as an adjunct that can combine
with established and emerging cancer therapies without adding drug toxicity. More specifically, we believe that a mechanism to inhibit
exosome immune suppression should be clinically tested in combination with drugs designed to stimulate the immune response.
3
On April 9, 2015, we entered into an investigator-initiated clinical trial agreement with the University of California, Irvine, or
UCI, pursuant to which UCI will conduct a five-year clinical study protocol entitled “Plasma Exosome Concentration in Cancer Patients
Undergoing Treatment.” The protocol will seek to enroll five individuals in each of nine defined tumor types for a total study population of
up to 45 subjects. The tumor types include the following forms of cancer: breast adenocarcinoma, colorectal, gastric and gastroesophageal,
pancreatic, cholangiocarcinoma, lung, head and neck, melanoma and ovarian adenocarcinoma. The principal investigator of the study is
Edward Nelson, M.D. The budget for the protocol provides for (i) $19,032 in startup charges; (ii) $8,039 in protocol-related variable pass-
through charges; and (iii) per subject visit charges of $3,359 per subject, for a total subject visit charge of $151,155 for 45 subjects. We will
bear these costs. UCI may disseminate the results of the clinical trial through presentation and publication but may not disclose any of our
confidential information.
Exosome Sciences, Inc. - Diagnostic Candidates
Through our majority-owned subsidiary Exosome, which is our diagnostic product-oriented business segment, we are developing
exosome-based product candidates to diagnose and monitor neurological disorders and cancer. Since it began operations in 2013, Exosome
researchers have disclosed that they have isolated brain-specific biomarkers associated with Alzheimer's Disease and Chronic Traumatic
Encephalopathy. Specific to Chronic Traumatic Encephalopathy, Exosome is participating in a research collaboration with The Boston
University CTE Center to study the correlation of a biomarker known as tausome with Chronic Traumatic Encephalopathy. The initial
results from that research collaboration were published in an article entitled “Preliminary Study of Plasma Exosomal Tau as a Potential
Biomarker for Chronic Traumatic Encephalopathy” in the Journal of Alzheimer's Disease on April 12, 2016.
Exosome researchers have demonstrated the ability to identify, quantify, and characterize circulating Glioblastoma multiforme
exosomes, which hold promise as a disease biomarker to identify the early detection of this aggressive form of cancer and monitor response
to therapy. We believe that the discovery of circulating glioblastoma multiforme exosomes may offer a potential new paradigm in
glioblastoma multiforme exosomes clinical management through a platform technology to predict tumor regression or progression.
U.S. Government Contract with the Defense Advanced Research Projects Agency
On September 30, 2011, we entered into a $6.8 million multi-year contract with the Defense Advanced Research Projects Agency,
or DARPA, part of the Department of Defense, resulting from our response to a program entitled “Dialysis-Like Therapeutics.” Under this
contract, our tasks include the development of a dialysis-like device to prevent sepsis, a fatal bloodstream infection that is often the cause
of death in combat-injured soldiers.
The initial award from DARPA was a fixed-price contract with potential total payments to us of $6,794,389 over the course of five
years. As noted below, such contract was subsequently reduced by $858,469. Fixed price contracts require the achievement of multiple,
incremental milestones to receive the full award during each year of the contract. Under the terms of the contract, we are required to
perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed
payment amounts.
Originally, only the base year (year one of the contract) was effective for the parties, however, DARPA subsequently exercised
the option on the remaining four years of the contract. The milestones are comprised of planning, engineering and clinical targets, the
achievement of which in some cases will require the participation and contribution of third party participants under the contract. We cannot
assure you that we alone, or with third party participants, will meet such milestones to the satisfaction of the government and in compliance
with the terms of the contract or that we will be paid the full amount of the contract revenues during any year of the remaining contract
term. We commenced work under the contract in October 2011.
In February 2014, DARPA reduced the scope of our contract in years three through five of the contract. The reduction in scope
focused our research on exosomes, viruses and blood processing instrumentation. This scope reduction will reduce the possible payments
under the contract by $858,469 over years three through five.
The DARPA contract requires us to perform certain scientific research and development activities geared toward the achievement
of specific milestones set forth in the contract. During the fiscal years ended March 31, 2016 and March 31, 2015, we recognized revenue
of $863,011 and $630,887, respectively, under the DARPA contract. Based on the DARPA contract, as now in force, we may achieve up to
an additional $387,438 in revenue under the DARPA contract during the fiscal year ending March 31, 2017.
4
Subcontract with Battelle Memorial Institute
We entered into a subcontract agreement with Battelle in March 2013. Battelle was chosen by DARPA to be the prime contractor
on the systems integration portion of the DARPA contract, and we are one of several subcontractors on that systems integration project.
We began generating revenues under the subcontract in the three months ended September 30, 2013. During the fiscal years ended March
31, 2016 and March 31, 2015, we recognized revenue of $23,561 and $131,530, respectively, under the Battelle subcontract. Our expected
future revenue from the subcontract will be at the discretion of Battelle. The Battelle subcontract is our first cost-reimbursable contract.
Our revenue under this contract is a function of cost reimbursement plus an overhead mark-up for hours devoted to the project by
specific employees (with specific hourly rates for those employees), for travel expenses related to the project, for any equipment purchased
for the project and for the cost of any consultants hired by us to perform work on the project. Each payment will require approval by the
program manager at Battelle.
Research and Development Costs
A substantial portion of our operating budget is used for research and development activities. The cost of research and
development, all of which has been charged to operations, amounted to approximately $782,000 and $1,028,000 in the fiscal years ended
March 31, 2016 and 2015, respectively.
Intellectual Property
We currently own or have license rights to a number of U.S. and foreign patents and patent applications and endeavor to
continually improve our intellectual property position. We consider the protection of our technology, whether owned or licensed, to the
exclusion of use by others, to be vital to our business. While we intend to focus primarily on patented or patentable technology, we may
also rely on trade secrets, unpatented property, know-how, regulatory exclusivity, patent extensions and continuing technological
innovation to develop our competitive position. We also own certain trademarks.
Patents
We have been exclusively assigned all rights and title to and interest in an invention and related worldwide patent rights for a
method to treat cancer under an assignment agreement with the London Health Science Center Research, Inc. The invention provides for the
"Depression of anticancer immunity through extracorporeal removal of microvesicular particles" (including exosomes) for which the U.S.
Patent and Trademark Office issued a patent in 2012 (patent #8,288,172) and for which we have filed additional patent applications
domestically and abroad (patent applications #US13/623662, #US14/180093, #US14/185033, #EP7,752,778.6, #HK9,104,740.6,
#IN8139/DELNP/2008 and #CA2644855). Please see the tables below for more information regarding these patents and patent
applications.
The agreement provides for an upfront payment of 800 shares of unregistered common stock and a 2% royalty on any future net
sales. We are also responsible for paying certain patent application and filing costs. Under the assignment agreement, the London Health
Science Center Research, Inc. sold and assigned all of its rights, title and interest in the worldwide patents to us.
The following table lists all of our issued patents and patent applications, including their ownership status:
Patents Issued in the United States
PATENT #
PATENT NAME
9,364,601 Extracorporeal removal of microvesicular particles
8,288,172 Extracorporeal removal of microvesicular particles (exosomes) (method patent)
7,226,429 Method for removal of viruses from blood by lectin affinity hemodialysis
6,528,057 Method for removal of HIV and other viruses from blood
ISSUANCE
DATE
6/14/16
10/16/12
6/5/07
3/4/03
OWNED OR
LICENSED
Owned
Owned
Owned
Licensed
EXPIRATION
DATE
10/2/29
3/30/29
1/20/25
8/30/19
5
APPLICATION #
14/490,418
14/856361
14/790684
13/808561
14/180093
14/185033
62/258340
62/352358
Patent Applications in the United States
APPLICATION NAME
Method for removal of viruses from blood by lectin affinity
hemodialysis
Device and method for purifying virally infected blood
Affinity capture of circulating biomarkers
Methods and compositions for quantifying exosomes
Extracorporeal removal of microvesicular particles
Extracorporeal removal of microvesicular particles
Plasma exosomal tau as a biomarker for chronic traumatic
encephalopathy
Exosomal Tau as a Biomarker for Brain Disorders
Foreign Patents
FILING
DATE
9/18/14
9/16/15
7/02/15
8/14/13
2/13/14
2/20/14
11/20/15
OWNED OR
LICENSED
Owned
Owned
Owned
Owned
Owned
Owned
Owned
6/20/16
Owned
PATENT NAME
PATENT #
2,353,399 Method for removal of viruses from blood by lectin affinity hemodialysis (Russia)
770,344 Method for removal of HIV and other viruses from blood (Australia)
DE69929986Method for removal of HIV and other viruses from blood (Germany)
1,109,564 Method for removal of HIV and other viruses from blood (France)
1,109,564 Method for removal of HIV and other viruses from blood (Great Britain)
1,109,564 Method for removal of HIV and other viruses from blood (Italy)
2342203 Method for removal of HIV and other viruses from blood (Canada)
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (Belgium)
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (Ireland)
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (Italy)
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (Great
Britain)
ISSUANCE
DATE
4/27/09
6/3/04
2/22/06
2/22/06
2/22/06
2/22/06
3/1/11
7/17/13
7/17/13
7/17/13
7/17/13
OWNED OR
LICENSED
Owned
Licensed
Licensed
Licensed
Licensed
Licensed
Licensed
Owned
Owned
Owned
Owned
EXPIRATION
DATE
1/20/24
8/30/19
8/30/19
8/30/19
8/30/19
8/30/19
8/30/19
1/20/24
1/20/24
1/20/24
1/20/24
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (France)
1624785 Method for removal of viruses from blood by lectin affinity hemodialysis (Germany)
2,516,403 Method for removal of viruses from blood by lectin affinity hemodialysis (Canada)
7/17/13
7/17/13
8/12/14
Owned
Owned
Owned
1/20/24
1/20/24
1/20/24
Foreign Patent Applications
APPLICATION #
EP20070752778
9,104,740.6
8139/DELNP/2008
2644855
EP20110804372
APPLICATION NAME
Extracorporeal removal of microvesicular particles (exosomes) (Europe)
Extracorporeal removal of microvesicular particles (exosomes) (Hong Kong)
Extracorporeal removal of microvesicular particles (exosomes) (India)
Extracorporeal removal of microvesicular particles (Canada)
Methods and compositions for quantifying exosomes (Europe)
International Patent Applications
APPLICATION #
PCT/US2016/
028482
PCT/US2015/
017800
APPLICATION NAME
Methods for delivering regional citrate anticoagulation during
extracorporeal blood treatments
Brain specific exosome based diagnostics and extracorporeal
therapies
FILING OWNED OR
LICENSED
DATE
Owned
3/9/07
Owned
3/9/07
Owned
3/9/07
Owned
3/9/07
Owned
7/7/11
FILING
DATE
4/20/16
OWNED OR
LICENSED
Owned
2/26/15
Owned
6
We expect that our ability to enforce our patents and proprietary rights in many countries will be adversely impacted due to
possible changes in law, our lack of familiarity with foreign law, or our lack of professional resources in jurisdictions outside the U.S. We
cannot guarantee that any patents issued or licensed to us, including within the U.S., will provide us with competitive advantages or will
not be challenged by others, or will not expire prior to our successful commercialization of our products. Furthermore, we cannot be certain
that others will not independently develop similar products or will not design around patents issued or licensed to us. We cannot guarantee
that patents that are issued will not be challenged, invalidated or infringed upon or designed around by others, or that the claims contained
in such patents will not infringe the patent claims of others, or provide us with significant protection against competitive products, or
otherwise be commercially valuable. We may need to acquire licenses under patents belonging to others for technology potentially useful or
necessary to us. If any such licenses are required, we cannot be certain that they will be available on terms acceptable to us, if at all. To the
extent that we are unable to obtain patent protection for our products or technology, our business may be materially adversely affected by
competitors who develop substantially equivalent technology.
Trademarks
We have obtained trademark registrations in the U.S. for Hemopurifier, Aethlon Medical, Inc., and the Exosome Sciences Logo
and obtained a trademark registration in India for Hemopurifier. Exosome Sciences, Inc. has applied for the Tausome trademark in the U.S.,
which application is currently pending. We also have common law trademark rights in Aethlon ADAPT™ and ELLSA™.
Licensing and Assignment Agreements
Effective January 1, 2000, we entered into an agreement with a related party under which an invention and related patent rights for
a method of removing Human Immunodeficiency and other viruses from the blood using the Hemopurifier were assigned to us by the
inventors in exchange for an 8.75% royalty to be paid on future net sales of the patented product or process and shares of our common
stock. On March 4, 2003, the related patent (patent #6,528,057) was issued and we issued 3,922 shares of unregistered common stock to
that related party. The license runs for the life of the patent, which expires in August 2019.
On November 7, 2006, we entered into an exclusive assignment agreement with the London Health Science Center Research, Inc.
under which an invention and related patent rights for a method to treat cancer were assigned to us. The invention provides for the
"Extracorporeal removal of microvesicular particles" for which the U.S. Patent and Trademark Office allowed a patent (patent #8,288,172)
in the U.S. as of October 2012. The agreement provides for an upfront payment of 800 shares of unregistered common stock and a 2%
royalty on any future net sales. We are also responsible for paying certain patent application and filing costs. Under the assignment
agreement, we own the patents outright for the life of the patent, which expires in March 2029. Under certain circumstances, ownership of
the patents may revert back to the London Health Science Center Research, Inc. if there is an uncured substantial breach of the assignment
agreement.
Industry
The industry for treating infectious disease and cancer is extremely competitive, and companies developing new treatment
procedures face significant capital and regulatory challenges. Additionally, as the Hemopurifier is a new device, we have the additional
challenge of establishing medical industry support, which will be driven by treatment data resulting from clinical studies of each disease
condition that we pursue. The industry includes pharmaceutical companies and medical device companies competing to treat illnesses on a
worldwide basis.
Competition
We are advancing our Hemopurifier as a treatment strategy to enhance and prolong current drug therapies by removing the viral
strains that cause drug resistance. We are also advancing the Hemopurifier as a tool for cancer treatment in conjunction with existing, and to
be developed, cancer therapies. The Hemopurifier also may prolong life for infected patients who have become drug resistant or have been
infected with a viral pathogen for which there is no drug or vaccine therapy. We believe our Hemopurifier augments the benefit of drug
therapies and should not be considered a competitor to such treatments. However, if the industry considered the Hemopurifier to be a
potential replacement for drug therapy, or a device that limited the need or volume of existing drug therapies, then the marketplace for the
Hemopurifier would be extremely competitive. We believe our Hemopurifier is the sole therapeutic device able to selectively remove
viruses and immunosuppressive proteins from circulation. However, we are aware that Asahi Kasei Kurary Medical based in Japan has
created a double filtration plasmapheresis system that indiscriminately removes particles from blood in a certain molecule range that
includes Hepatitis C virus. Asahi Kasei Kurary Medical is now marketing this device in Japan as an adjunct therapy for Hepatitis C virus.
We may also face competition from producers of antiviral drugs and vaccines.
7
Government Regulation of Medical Devices
The Hemopurifier is subject to regulation by numerous regulatory bodies, primarily the FDA, and comparable international
regulatory agencies. These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the
development, testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance
reporting of medical devices. Devices are generally subject to varying levels of regulatory control, the most comprehensive of which
requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution. Failure to obtain
approval or clearance to market our product and products under development and to meet the ongoing requirements of these regulatory
authorities could prevent us from commercializing the Hemopurifier and future products in the U.S. and elsewhere.
Hemopurifier Investigational Device Exemption and Supplement
In 2013, the FDA approved our investigational device exemption to initiate human clinical studies in the U.S. as a feasibility
study. We were required to reach agreement with the internal review board of DaVita MedCenter Dialysis prior to beginning our U.S.
clinical trial. We are also required to obtain patients' informed consent that complies with both FDA requirements and state and federal
privacy regulations. We, the FDA or the internal review board at each site at which a clinical trial is being performed may suspend a
clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits. Even if a trial is
completed, the results of clinical testing may not demonstrate the safety and efficacy of the device, may be equivocal or may otherwise not
be sufficient to obtain approval of the product. The investigational device exemption is part of the FDA’s clearance process. This process is
discussed in detail in the “Pre-Marketing Regulations in the U.S.” section below.
In December 2014, the FDA approved our request for a supplement to our investigational device exemption to establish a protocol
to clinically investigate the use of the Hemopurifier for the treatment of Ebola-infected patients in the U.S. Under the supplement, we may
treat up to 20 Ebola-infected persons, at no more than 10 institutions in the U.S., using the supplement protocol; however, this is not a
clinical trial. We must clearly distinguish data collected in the supplement protocol from data collected in our chronic Hepatitis C virus
clinical trial (discussed above). Prior to treating Ebola-infected patients, we must comply with specified patient protection procedures
established by the applicable institution including its institutional review board. Also, we must report any unanticipated adverse events
resulting from the supplement protocol to the FDA within 10 working days. Even if the protocol is established, and patients are treated, the
results of such treatments may not demonstrate the safety and efficacy of the device. In addition, we cannot assure you that any Ebola-
infected individuals will be treated under this protocol.
Pre-Marketing Regulations in the U.S.
Unless an exemption applies, each medical device distributed commercially in the U.S. requires either prior 510(k) clearance or
premarket approval, or PMA, from the FDA. The FDA classifies medical devices into one of three classes. Class I devices are subject to
only general controls, such as establishment registration and device listing, labeling, medical device reporting, and prohibitions against
adulteration and misbranding. Class II medical devices generally require prior 510(k) clearance before they may be commercially marketed
in the U.S. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices
deemed not substantially equivalent to a predicate device, are placed in Class III, generally requiring submission of a PMA supported by
clinical trial data. Our Hemopurifier is a Class III product, and we believe that products utilizing our Aethlon ADAPT™ system will be
considered to be Class III products and thus will require submission and approval of a PMA. In the future, we may develop new products
that are considered to be Class II and require the clearance of a 510(k).
510(k) Clearance Pathway
To obtain 510(k) clearance, a premarket notification must be submitted to FDA demonstrating that the proposed device is
substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for
which the FDA has not yet called for the submission of premarket approval applications. FDA’s 510(k) clearance pathway usually takes
from three to twelve months, but it can take significantly longer. The FDA may require additional information, including clinical data, to
make a determination regarding substantial equivalence.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would
constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, require
premarket approval. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), or a
premarket approval, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees
with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until
510(k) clearance or premarket approval is obtained. If the FDA requires a 510(k) holder to seek 510(k) clearance or premarket approval for
any modifications to a previously cleared product, the 510(k) holder also may be required to cease marketing or recall the modified device
until this clearance or approval is obtained.
8
Premarket Approval Pathway
A PMA must be supported by extensive data, including but not limited to data obtained from technical, preclinical and clinical
studies and relating to manufacturing and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device.
After a PMA submission is sufficiently complete, the FDA will accept the application and begin an in-depth review, which
generally takes between one and three years, but may take significantly longer. During this review period, the FDA will typically request
additional information or clarification of the information already provided. Also, an advisory panel of experts from outside the FDA may
be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The
FDA may or may not accept the panel’s recommendation. In addition, the FDA will conduct a pre-approval inspection of the
manufacturing facility to ensure compliance with Quality System Regulation, or QSR. New PMA applications or PMA supplements are
required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the
device’s indication for use, manufacturing process, labeling and design. PMA supplements often require submission of the same type of
information as a PMA application, except that the supplement is limited to information needed to support any changes from the device
covered by the original PMA application and may not require as extensive clinical data or the convening of an advisory panel.
Clinical Trials
Clinical trials are almost always required to support a PMA. To perform a clinical trial in the U.S. for a significant risk device,
FDA requires the device sponsor to file an Investigational Device Exemption, or IDE, application with the FDA and obtain IDE approval
prior to commencing the human clinical trial. An IDE amendment or supplement must also be submitted before initiating a significant
change to the clinical protocol or device under an existing IDE. The IDE application must be supported by appropriate data, such as animal
and laboratory testing results, and any available data on human clinical experience, showing that it is safe to test the device in humans and
that the testing protocol is scientifically sound.
The IDE must be approved in advance by the FDA for a specific number of patients. Clinical trials conducted in the U.S. for
significant risk devices may begin once the IDE application is approved by the FDA and the appropriate institutional review boards, or
IRBs, overseeing the welfare of the research subjects and responsible for that particular clinical trial. Under its regulations, the FDA
responds to an IDE or an IDE amendment within 30 days. The FDA may approve the IDE or amendment, grant an approval with certain
conditions, or identify deficiencies and request additional information. It is common for the FDA to require additional information before
approving an IDE or amendment for a new trial, and thus final FDA approval on a submission may require more than the initial 30 days.
The FDA may also require that a small-scale feasibility study be conducted before a pivotal trial may commence. In a feasibility trial, the
FDA limits the number of patients, sites and investigators that may participate. Feasibility trials are typically structured to obtain
information on safety and to help determine how large a pivotal trial should be to obtain statistically significant results.
Clinical trials are subject to extensive recordkeeping and reporting requirements. Our clinical trials must be conducted under the
oversight of an IRB for the relevant clinical trial sites and must comply with FDA regulations, including but not limited to those relating to
good clinical practices. We are also required to obtain the patients’ informed consent in form and substance that complies with both FDA
requirements and state and federal privacy and human subject protection regulations. We, the FDA or the IRB may suspend a clinical trial
at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. Even if a trial is
completed, the results of clinical testing may not adequately demonstrate the safety and effectiveness of the device or may otherwise not be
sufficient to obtain FDA approval to market the product in the U.S.
9
Post-Marketing Regulations in the U.S.
Should our Hemopurifier device be cleared for market use in the U.S. by the FDA, numerous regulatory requirements continue to
apply. These include:
·
·
·
the FDA's Quality System Regulation which requires manufacturers, including third-party manufacturers, to follow stringent
design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
labeling regulations and FDA prohibitions against the promotion of products for un-cleared, unapproved or off-label uses;
clearance or approval of product modifications that could significantly affect safety or efficacy or that would constitute a major
change in intended use;
· medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or
contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious
injury if the malfunction were to recur;
·
·
product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action; and
post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety
and effectiveness data for the device.
The regulations also require that we report to the FDA any incident in which our product may have caused or contributed to a
death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to
death or serious injury.
We will also be required to register with FDA as a medical device manufacturer within 30 days of commercial distribution of our
products and must obtain all necessary state permits or licenses to operate our business. As a manufacturer, we are subject to announced and
unannounced inspections by FDA to determine our compliance with quality system regulation and other regulations, and these inspections
may include the manufacturing facilities of our suppliers. Failure by us or by our suppliers to comply with applicable regulatory
requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:
·
·
·
·
·
·
·
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications for repair, replacement, refunds;
recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for premarket approval of new products or modified products;
operating restrictions;
· withdrawing PMA approvals that have already been granted;
·
·
refusal to grant export approval for our products; or
criminal prosecution.
Compliance with U.S. Health Care Laws
Should our Hemopurifier device be cleared for market use in the U.S. by the FDA, we must comply with various U.S. federal and
state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback regulations, as well as other healthcare
laws in connection with the commercialization of our products. Fraud and abuse laws are interpreted broadly and enforced aggressively by
various state and federal agencies, including the U.S. Department of Justice, the U.S. Office of Inspector General for the Department of
Health and Human Services and various state agencies.
10
The U.S. federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, as amended, prohibits persons, including a medical device
manufacturer (or a party acting on its behalf), from knowingly or willfully soliciting, receiving, offering or paying remuneration, directly or
indirectly, in exchange for or to induce either the referral of an individual for a service or product or the purchasing, ordering, arranging for,
or recommending the ordering of, any service or product for which payment may be made by Medicare, Medicaid or any other federal
healthcare program. This statute has been interpreted to apply to arrangements between medical device manufacturers on one hand and
healthcare providers on the other. The term “remuneration” is not defined in the federal Anti-Kickback Statute and has been broadly
interpreted to include anything of value, such as cash payments, gifts or gift certificates, discounts, waiver of payments, credit
arrangements, ownership interests, the furnishing of services, supplies or equipment, and the provision of anything at less than its fair
market value. Courts have broadly interpreted the scope of the law, holding that it may be violated if merely one purpose of an arrangement
is to induce referrals, irrespective of the existence of other legitimate purposes. The Anti-Kickback Statute prohibits many arrangements
and practices that are lawful in businesses outside of the healthcare industry. Although there are a number of statutory exemptions and
regulatory safe harbors protecting certain business arrangements from prosecution, the exemptions and safe harbors are drawn narrowly,
and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do
not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from federal
Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the recently enacted Patient Protection and
Affordable Care Act of 2010 and the Health Care and Education Affordability Reconciliation Act of 2010, collectively, the Affordable
Care Act or ACA, which, among other things, amends the intent requirement of the federal Anti-Kickback Statute such that a person or
entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In
addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal
Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (discussed below) or the civil
monetary penalties statute, which imposes fines against any person who is determined to have presented or caused to be presented claims to
a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or
fraudulent. In addition to the federal Anti-Kickback Statute, many states have their own anti-kickback laws. Often, these laws closely
follow the language of the federal law, although they do not always have the same scope, exceptions, safe harbors or sanctions. In some
states, these anti-kickback laws apply not only to payments made by government healthcare programs but also to payments made by other
third-party payors, including commercial insurance companies.
We may also be subject to various federal and state marketing laws, such as the federal Physician Payments Sunshine Act, which
generally require certain types of expenditures in the U.S. and the particular states to be tracked and reported. The federal Physician
Payment Sunshine Act, being implemented as the Open Payments Program, requires certain pharmaceutical and medical device
manufacturers to engage in extensive tracking of payments or transfers of value to physicians and teaching hospitals, maintenance of a
payments database, and public reporting of the payment data. Device manufacturers with products for which payment is available under
Medicare, Medicaid or the State Children’s Health Insurance Program are required to track and report such payments. Moreover, several
states have enacted legislation requiring pharmaceutical and medical device companies to establish marketing compliance programs or even
prohibit providing meals to prescribers or other marketing related activities. Compliance with such requirements may require investment in
infrastructure to ensure that tracking and reporting is performed properly. Although compliance programs can mitigate the risk of
investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
International Regulation
International development and sales of medical devices are subject to foreign government regulations, which vary substantially
from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA
approval, and the requirements may differ. For example, the primary regulatory authority with respect to medical devices in Europe is that
of the European Union. The unification of these countries into a common market has resulted in the unification of laws, standards and
procedures across these countries, which may expedite the introduction of medical devices like those we are offering and developing.
The European Union has adopted numerous directives and standards regulating the design, manufacture, clinical trials, labeling
and adverse event reporting for medical devices. Devices that comply with the requirements of relevant directives will be entitled to bear
CE Conformity Marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can
be commercially distributed throughout the European Union. Actual implementation of these directives, however, may vary on a country-
by-country basis.
To date, we have not begun any process to obtain the CE Mark and have no immediate plans to test or commercialize the
Hemopurifier in any European Union countries.
Manufacturing
Manufacturing of our Hemopurifier occurs in collaboration with a contract manufacturer based in San Diego, California that is
compliant with the Good Manufacturing Practice regulations promulgated by the FDA. Our contract manufacturer is registered with the
FDA. We also have received an export license from the FDA that allows the export our Hemopurifier for commercial purposes to India. To
date, our manufacture of the Hemopurifier has been limited to quantities necessary to support our clinical studies.
11
Sources and Suppliers
We are not dependent on any specific vendors for the materials used in our Hemopurifier. The key raw materials in the
Hemopurifier include the affinity lectin Galanthus nivalis agglutinin, pharmaceutical grade diatomaceous earth, plasmapheresis cartridges
and certain chemical binding agents. The affinity lectin is available from several life science supply companies in the U.S. Diatomaceous
earth is available from several life science supply companies in the U.S. To date, we have purchased plasmapheresis cartridges from one
vendor in Europe however similar cartridges are commercially available from vendors on a worldwide basis should that European vendor
cease to be available for any reason, including prohibitive pricing. The chemical binding agents are available from a number of life science
supply companies on a worldwide basis. We typically purchase our raw materials on purchase order basis. Therefore, we remain subject to
risks of supply shortages and price increases that potentially could materially adversely affect our financial condition and operating results
if and when we begin large scale manufacture of the Hemopurifier.
The key raw materials used by Exosome Sciences, Inc. in its research are blood samples supplied by research partners and a
number of chemical and lab products commercially available from vendors on a worldwide basis. Exosome Sciences, Inc. is not dependent
on any specific vendors for the materials used in its research activities.
Sales and Marketing
We do not currently have any sales and marketing capability. With respect to commercialization efforts in the future, we intend to
build or contract for distribution, sales and marketing capabilities for any product candidate that is approved. From time to time, we have
had and are having strategic discussions with potential collaboration partners for our product candidates, although no assurance can be
given that we will be able to enter into one or more collaboration agreements for our product candidates on acceptable terms, if at all.
Product Liability
The risk of product liability claims, product recalls and associated adverse publicity is inherent in the testing, manufacturing,
marketing and sale of medical products. We have limited clinical trial liability insurance coverage. We cannot assure you that future
insurance coverage will be adequate or available. We may not be able to secure product liability insurance coverage on acceptable terms or
at reasonable costs when needed. Any liability for mandatory damages could exceed the amount of our coverage. A successful product
liability claim against us could require us to pay a substantial monetary award. Moreover, a product recall could generate substantial
negative publicity about our products and business and inhibit or prevent commercialization of other future product candidates.
Employees
We have five full-time employees consisting of our Chief Executive Officer, our President, our Chief Financial Officer, a research
scientist and an executive assistant. We utilize, whenever appropriate, consultants in order to conserve cash and resources.
We believe our employee relations are good. None of our employees are represented by a labor union or are subject to collective-
bargaining agreements.
ITEM 1A. RISK FACTORS
An investment in our securities involves a high degree of risk. You should carefully consider the risks described below as well as
the other information in this Annual Report before deciding to invest in or maintain your investment in our company. The risks described
below are not intended to be an all-inclusive list of all of the potential risks relating to an investment in our securities. Any of the risk
factors described below could significantly and adversely affect our business, prospects, financial condition and results of operations.
Additional risks and uncertainties not currently known or that are currently considered to be immaterial may also materially and adversely
affect our business. As a result, the trading price or value of our securities could be materially adversely affected and you may lose all or
part of your investment.
Risks Relating to Our Financial Position and Need for Additional Capital
We have incurred significant losses and expect to continue to incur losses for the foreseeable future.
We have never been profitable. We have generated revenues during the fiscal years ended March 31, 2016 and March 31, 2015, in
the amounts of $886,572, and $762,417, respectively, primarily from our contract with the Defense Advanced Research Projects Agency,
or DARPA. However, our revenues continue to be insufficient to cover our cost of operations. Future profitability, if any, will require the
successful commercialization of our Hemopurifier technology, other products that may emerge from our Aethlon ADAPT platform or from
additional government contract or grant income. We cannot assure you when or if we will be able to successfully commercialize one or
more of our products, or if commercialization is successful, whether we will ever be profitable.
12
We have received an explanatory paragraph from our auditors regarding our ability to continue as a going concern.
Our independent registered public accounting firm noted in their report accompanying our financial statements for our fiscal year
ended March 31, 2016 that we have a significant accumulated deficit and that a significant amount of additional capital will be necessary to
advance the development of our products to the point at which we may become commercially viable. Our independent registered public
accounting firm stated that those conditions raised substantial doubt about our ability to continue as a going concern. Note 1 to our financial
statements for the year ended March 31, 2016 describes management's plans to address these matters. We cannot assure you that our
business plans will be successful in addressing these issues. This explanatory paragraph about our ability to continue as a going concern
could affect our ability to obtain additional financing at favorable terms, if at all, as it may cause investors to lose faith in our long-term
prospects. If we cannot successfully continue as a going concern, our shareholders may lose their entire investment.
We will require additional financing to sustain our operations, and without it, we will not be able to continue operations.
We raised $5,591,988 in net proceeds from a financing in June 2015. That amount, coupled with previously existing funds on hand
and expected revenues from our government contracts, has financed our operations into the first quarter of the fiscal year ending March 31,
2017. However, we will require significant additional financing to complete the current and expected additional future clinical trials in the
U.S., as well as fund all of our continued research and development activities for the Hemopurifier and products on our Aethlon ADAPT
platform through the remainder of the fiscal year ending March 31, 2017. In addition, as we expand our activities, our overhead costs to
support personnel, laboratory materials and infrastructure will increase. Should the financing we require to sustain our working capital
needs be unavailable to us on reasonable terms, if at all, when we require it, we may be unable to support our research and FDA clearance
activities including our planned clinical trials. The failure to implement our research and clearance activities would have a material adverse
effect on our ability to commercialize our products.
We will need to raise additional funds through debt or equity financings in the future to achieve our business objectives and to satisfy
our cash obligations, which would dilute the ownership of our existing stockholders.
We will need to raise additional funds through debt or equity financings in order to complete our ultimate business objectives,
including funding working capital to support development and regulatory clearance of our products. We also may choose to raise additional
funds in debt or equity financings if they are available to us on reasonable terms to increase our working capital and to strengthen our
financial position. Any sales of additional equity or convertible debt securities would result in dilution of the equity interests of our existing
stockholders, which could be substantial. Also, new investors may require that we and certain of our stockholders enter into voting
arrangements that give them additional voting control or representation on our Board of Directors.
Risks Related to Our Business Operations
We face intense competition in the medical device industry.
We compete with numerous U.S. and foreign companies in the medical device industry, and many of our competitors have greater
financial, personnel and research and development resources than we do. Our competitors are developing vaccine candidates, which could
compete with the Hemopurifier medical device candidates we are developing. Our commercial opportunities will be reduced or eliminated
if our competitors develop and market products for any of the diseases we target that:
·
·
·
·
·
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are more effective;
have fewer or less severe adverse side effects;
are better tolerated;
are more adaptable to various modes of dosing;
are easier to administer; or
are less expensive than the products or product candidates we are developing.
Even if we are successful in developing the Hemopurifier and other Aethlon ADAPT based-products, and obtain FDA and other
regulatory approvals necessary for commercializing them, our products may not compete effectively with other successful products.
Researchers are continually learning more about diseases, which may lead to new technologies for treatment. Our competitors may succeed
in developing and marketing products that are either more effective than those that we may develop, alone or with our collaborators, or that
are marketed before any products we develop are marketed. Our competitors include fully integrated pharmaceutical companies and
biotechnology companies as well as universities and public and private research institutions. Many of the organizations competing with us
have substantially greater capital resources, larger research and development staffs and facilities, greater experience in product development
and in obtaining regulatory approvals, and greater marketing capabilities than we do. If our competitors develop more effective
pharmaceutical treatments for infectious disease or cancer, or bring those treatments to market before we can commercialize the
Hemopurifier for such uses, we may be unable to obtain any market traction for our products, or the diseases we seek to treat may be
substantially addressed by competing treatments. If we are unable to successfully compete against larger companies in the pharmaceutical
industry, we may never generate significant revenue or be profitable.
13
We have limited experience in identifying and working with large scale contracts with medical device manufacturers; manufacture of
our devices must comply with good manufacturing practices in the U.S.
To achieve the levels of production necessary to commercialize our Hemopurifier and other future Aethlon ADAPT-based
products, we will need to secure large scale manufacturing agreements with contract manufacturers which comply with good
manufacturing practice standards and other standards prescribed by various federal, state and local regulatory agencies in the U.S. and any
other country of use. We have limited experience coordinating and overseeing the manufacture of medical device products on a large scale.
We cannot assure you that manufacturing and control problems will not arise as we attempt to commercialize our products or that such
manufacturing can be completed in a timely manner or at a commercially reasonable cost. In addition, we cannot assure you that we will be
able to adequately finance the manufacture and distribution of our products on terms acceptable to us, if at all. If we cannot successfully
oversee and finance the manufacture of our products when they have obtained regulatory clearances, we may never generate revenue from
product sales and we may never be profitable.
Our Aethlon ADAPT technology may become obsolete.
Our Aethlon ADAPT products may be made unmarketable by new scientific or technological developments where new treatment
modalities are introduced that are more efficacious and/or more economical than our Aethlon ADAPT products. The homeland security
industry is growing rapidly with many competitors that are trying to develop products or vaccines to protect against infectious disease. Any
one of our competitors could develop a more effective product which would render our technology obsolete. Further, our ability to achieve
significant and sustained penetration of our key target markets will depend upon our success in developing or acquiring technologies
developed by other companies, either independently, through joint ventures or through acquisitions. If we fail to develop or acquire, and
manufacture and sell, products that satisfy our customers’ demands, or we fail to respond effectively to new product announcements by our
competitors by quickly introducing competitive products, then market acceptance of our products could be reduced and our business could
be adversely affected. We cannot assure you that our products will remain competitive with products based on new technologies.
Our use of hazardous materials, chemicals and viruses exposes us to potential liabilities for which we may not have adequate insurance.
Our research and development involves the controlled use of hazardous materials, chemicals and viruses. The primary hazardous
materials include chemicals needed to construct the Hemopurifier cartridges and the infected plasma samples used in preclinical testing of
the Hemopurifier. All other chemicals are fully inventoried and reported to the appropriate authorities, such as the fire department, who
inspect the facility on a regular basis. We are subject to federal, state, local and foreign laws governing the use, manufacture, storage,
handling and disposal of such materials. Although we believe that our safety procedures for the use, manufacture, storage, handling and
disposal of such materials comply with the standards prescribed by federal, state, local and foreign regulations, we cannot completely
eliminate the risk of accidental contamination or injury from these materials. We have had no incidents or problems involving hazardous
chemicals or biological samples. In the event of such an accident, we could be held liable for significant damages or fines.
We currently carry a limited amount of insurance to protect us from damages arising from hazardous materials. Our product
liability policy has a $3,000,000 limit of liability that would cover certain releases of hazardous substances away from our facilities. For our
facilities, our property policy provides $25,000 in coverage for contaminant clean-up or removal and $50,000 in coverage for damages to
the premises resulting from contamination. Should we violate any regulations concerning the handling or use of hazardous materials, or
should any injuries or death result from our use or handling of hazardous materials, we could be the subject of substantial lawsuits by
governmental agencies or individuals. We may not have adequate insurance to cover all or any of such claims, if any. If we were
responsible to pay significant damages for violations or injuries, if any, we might be forced to cease operations since such payments could
deplete our available resources.
Our success is dependent in part on a few key executive officers.
Our success depends to a critical extent on the continued services of our Chief Executive Officer, James A. Joyce, and our
President, Rodney S. Kenley. If one or both of these key executive officers were to leave us, we would be forced to expend significant time
and money in the pursuit of a replacement, which would result in both a delay in the implementation of our business plan and the diversion
of limited working capital. The unique knowledge and expertise of these individuals would be difficult to replace within the biotechnology
field. We can give you no assurances that we can find satisfactory replacements for these key executive officers at all, or on terms that are
not unduly expensive or burdensome to us. Although Mr. Joyce has signed an employment agreement providing for his continued service to
us, that agreement will not preclude him from leaving us should we be unable to compete with offers for employment he may receive from
other companies. We do not currently carry key man life insurance policies on any of our key executive officers which would assist us in
recouping our costs in the event of the loss of those officers. If any of our key officers were to leave us, it could make it impossible, if not
cause substantial delays and costs, to implement our long term business objectives and growth.
14
Our inability to attract and retain qualified personnel could impede our ability to achieve our business objectives.
We have five full-time employees consisting of our Chief Executive Officer, our President, our Chief Financial Officer, a research
scientist and an executive assistant. We utilize, whenever appropriate, consultants in order to conserve cash and resources.
Although we believe that these employees and consultants will be able to handle most of our additional administrative, research
and development and business development in the near term, we will nevertheless be required over the longer-term to hire highly skilled
managerial, scientific and administrative personnel to fully implement our business plan and growth strategies, including to mitigate the
material weakness in our internal control over financial reporting described above. Due to the specialized scientific nature of our business,
we are highly dependent upon our ability to attract and retain qualified scientific, technical and managerial personnel. Competition for these
individuals, especially in San Diego, California, where many biotechnology companies are located, is intense and we may not be able to
attract, assimilate or retain additional highly qualified personnel in the future. We cannot assure you that we will be able to engage the
services of such qualified personnel at competitive prices or at all, particularly given the risks of employment attributable to our limited
financial resources and lack of an established track record. Also, if we are required to attract personnel from other parts of the U.S. or
abroad, we may have significant difficulty doing so due to the high cost of living in the Southern California area and due to the costs
incurred with transferring personnel to the area. If we cannot attract and retain qualified staff and executives, we will be unable to develop
our products and achieve regulatory clearance, and our business could fail.
We plan to grow rapidly which will strain our resources; our inability to manage our growth could delay or derail implementation of
our business objectives.
We will need to significantly expand our operations to implement our longer-term business plan and growth strategies. We will
also be required to manage multiple relationships with various strategic partners, technology licensors, customers, manufacturers and
suppliers, consultants and other third parties. This expansion and these expanded relationships will require us to significantly improve or
replace our existing managerial, operational and financial systems, procedures and controls; to improve the coordination between our
various corporate functions; and to manage, train, motivate and maintain a growing employee base. The time and costs to effectuate these
steps may place a significant strain on our management personnel, systems and resources, particularly given the limited amount of financial
resources and skilled employees that may be available at the time. We cannot assure you that we will institute, in a timely manner or at all,
the improvements to our managerial, operational and financial systems, procedures and controls necessary to support our anticipated
increased levels of operations and to coordinate our various corporate functions, or that we will be able to properly manage, train, motivate
and retain our anticipated increased employee base. If we cannot manage our growth initiatives, we will be unable to commercialize our
products on a large scale in a timely manner, if at all, and our business could fail.
As a public company with limited financial resources undertaking the launch of new medical technologies, we may have difficulty
attracting and retaining executive management and directors.
The directors and management of publicly traded corporations are increasingly concerned with the extent of their personal
exposure to lawsuits and stockholder claims, as well as governmental and creditor claims which may be made against them, particularly in
view of recent changes in securities laws imposing additional duties, obligations and liabilities on management and directors. Due to these
perceived risks, directors and management are also becoming increasingly concerned with the availability of directors’ and officers’
liability insurance to pay on a timely basis the costs incurred in defending such claims. While we currently carry directors’ and officers’
liability insurance, such insurance is expensive and difficult to obtain. If we are unable to continue or provide directors’ and officers’
liability insurance at affordable rates or at all, it may become increasingly more difficult to attract and retain qualified outside directors to
serve on our Board of Directors. We may lose potential independent board members and management candidates to other companies in the
biotechnology field that have greater directors’ and officers’ liability insurance to insure them from liability or to biotechnology companies
that have revenues or have received greater funding to date which can offer greater compensation packages. The fees of directors are also
rising in response to their increased duties, obligations and liabilities. In addition, our products could potentially be harmful to users, and we
are exposed to claims of product liability including for injury or death. We have limited insurance and may not be able to afford robust
coverage even as our products are introduced into the market. As a company with limited resources and potential exposures to management,
we will have a more difficult time attracting and retaining management and outside independent directors than a more established public or
private company due to these enhanced duties, obligations and potential liabilities.
15
If we fail to comply with extensive regulations of U.S. and foreign regulatory agencies, the commercialization of our products could be
delayed or prevented entirely.
Our Hemopurifier products are subject to extensive government regulations related to development, testing, manufacturing and
commercialization in the U.S. and other countries. The determination of when and whether a product is ready for large-scale purchase and
potential use will be made by the U.S. Government through consultation with a number of governmental agencies, including the FDA, the
National Institutes of Health, the Centers for Disease Control and Prevention and the Department of Homeland Security. Our product
candidates are in the pre-clinical and clinical stages of development and have not received required regulatory approval from the FDA, or
any foreign regulatory agencies, to be commercially marketed and sold. The process of obtaining and complying with FDA and other
governmental regulatory approvals and regulations in the U.S. and in foreign countries is costly, time consuming, uncertain and subject to
unanticipated delays. Obtaining such regulatory approvals, if any, can take several years. Despite the time and expense exerted, regulatory
approval is never guaranteed. We also are subject to the following risks and obligations, among others:
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the FDA may refuse to approve an application if they believe that applicable regulatory criteria are not satisfied;
the FDA may require additional testing for safety and effectiveness;
the FDA may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them;
if regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its
distribution; and
the FDA may change their approval policies and/or adopt new regulations.
Failure to comply with these or other regulatory requirements of the FDA may subject us to administrative or judicially imposed
sanctions, including:
· warning letters;
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civil penalties;
criminal penalties;
injunctions;
product seizure or detention;
product recalls; and
total or partial suspension of productions.
Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.
Our business prospects will depend on our ability to complete studies, clinical trials, obtain satisfactory results, obtain required
regulatory approvals and successfully commercialize our Hemopurifier product candidates. Completion of our clinical trials, announcement
of results of the trials and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:
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serious adverse events related to our medical device candidates;
unsatisfactory results of any clinical trial;
the failure of our principal third-party investigators to perform our clinical trials on our anticipated schedules; and
different interpretations of our pre-clinical and clinical data, which could initially lead to inconclusive results.
Our development costs will increase if we have material delays in any clinical trial or if we need to perform more or larger clinical
trials than planned. If the delays are significant, or if any of our product candidates do not prove to be safe or effective or do not receive
required regulatory approvals, our financial results and the commercial prospects for our product candidates will be harmed. Furthermore,
our inability to complete our clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval.
16
If we or our suppliers fail to comply with ongoing FDA or foreign regulatory authority requirements, or if we experience unanticipated
problems with our products, these products could be subject to restrictions or withdrawal from the market.
Any product for which we obtain clearance or approval, and the manufacturing processes, reporting requirements, post-approval
clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections
by the FDA and other domestic and foreign regulatory bodies. In particular, we and our third-party suppliers may be required to comply
with the FDA’s Quality System Regulation, or QSR. These FDA regulations cover the methods and documentation of the design, testing,
production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products. Compliance with applicable
regulatory requirements is subject to continual review and is monitored rigorously through periodic inspections by the FDA. If we, or our
manufacturers, fail to adhere to QSR requirements in the U.S., this could delay production of our products and lead to fines, difficulties in
obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which
could, in turn, have a material adverse effect on our financial condition or results of operations.
In addition, the FDA assesses compliance with the QSR through periodic announced and unannounced inspections of
manufacturing and other facilities. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered
by the FDA, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result
in any of the following enforcement actions:
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
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· withdrawing 510(k) clearances or premarket approvals that have already been granted;
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refusal to grant export approval for our products; or
criminal prosecution.
Any of these sanctions could have a material adverse effect on our reputation, business, results of operations and financial
condition. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable
regulatory requirements, which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.
If our products, or malfunction of our products, cause or contribute to a death or a serious injury, we will be subject to medical device
reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
Under the FDA medical device reporting regulations, medical device manufacturers are required to report to the FDA information
that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or
contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. If we fail to report these
events to the FDA within the required timeframes, or at all, FDA could take enforcement action against us. Any such adverse event
involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action,
such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a
lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation
and financial results.
Our products may in the future be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA
or another governmental authority, including a third-country authority, or the discovery of serious safety issues with our products,
could have a significant adverse impact on us.
The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the
event of material deficiencies or defects in design or manufacture. In this case, the FDA, the authority to require a recall must be based on
an FDA finding that there is reasonable probability that the device would cause serious injury or death. In addition, foreign governmental
bodies have the authority to require the recall of our products in the event of material deficiencies or defects in design or manufacture.
Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. The FDA requires that
certain classifications of recalls be reported to the FDA within 10 working days after the recall is initiated. A government-mandated or
voluntary recall by us or one of our international distributors could occur as a result of an unacceptable risk to health, component failures,
malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert
managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition, which could
impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be
subject to liability claims, be required to bear other costs, or take other actions that may have a negative impact on our future sales and our
ability to generate profits. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or
another third-country competent authority. We may initiate voluntary recalls involving our products in the future that we determine do not
require notification of the FDA or another third-country competent authority. If the FDA disagrees with our determinations, they could
require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect
our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they were.
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We are also required to follow detailed recordkeeping requirements for all firm-initiated medical device corrections and removals.
In addition, in December of 2012, the FDA issued a draft guidance intended to assist the FDA and industry in distinguishing medical device
recalls from product enhancements. Per the guidance, if any change or group of changes to a device addresses a violation of the Federal
Food, Drug, and Cosmetic Act, that change would generally constitute a medical device recall and require submission of a recall report to
the FDA.
We outsource almost all of our operational and development activities, and if any party to which we have outsourced certain essential
functions fails to perform its obligations under agreements with us, the development and commercialization of our lead product
candidate and any future product candidates that we may develop could be delayed or terminated.
We generally rely on third-party consultants or other vendors to manage and implement the day-to-day conduct of our operations,
including conducting clinical trials and manufacturing our current product candidates and any future product candidates that we may
develop. Accordingly, we are and will continue to be dependent on the timeliness and effectiveness of their efforts. Our dependence on
third parties includes key suppliers and third party service providers supporting the development, manufacture and regulatory approval of
our products as well as support for our information technology systems and other infrastructure. While our management team oversees
these vendors, failure of any of these third parties to meet their contractual, regulatory and other obligations or the development of factors
that materially disrupt the performance of these third parties could have a material adverse effect on our business. For example, all of the
key oversight responsibilities for the development and manufacture of our lead product candidate are conducted by our management team
but all activities are the responsibility of third party vendors.
If a clinical research organization that we utilize is unable to allocate sufficient qualified personnel to our studies in a timely
manner or if the work performed by it does not fully satisfy the requirements of the FDA or other regulatory agencies, we may encounter
substantial delays and increased costs in completing our development efforts. Any manufacturer that we select may encounter difficulties in
the manufacture of new products in commercial quantities, including problems involving product yields, product stability or shelf life,
quality control, adequacy of control procedures and policies, compliance with FDA regulations and the need for further FDA approval of
any new manufacturing processes and facilities. If any of these occur, the development and commercialization of our product candidates
could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue such
development and commercialization on our own. If we rely on only one source for the manufacture of the clinical or commercial supplies
of any of our product candidates or products, any production problems or supply constraints with that manufacturer could adversely impact
the development or commercialization of that product candidate or product.
If we or our contractors or service providers fail to comply with regulatory laws and regulations, we or they could be subject to
regulatory actions, which could affect our ability to develop, market and sell our product candidates and any other or future product
candidates that we may develop and may harm our reputation.
If we or our manufacturers or other third party contractors fail to comply with applicable federal, state or foreign laws or
regulations, we could be subject to regulatory actions, which could affect our ability to develop, market and sell our current product
candidates or any future product candidates under development successfully and could harm our reputation and lead to reduced or non-
acceptance of our proposed product candidates by the market. Even technical recommendations or evidence by the FDA through letters,
site visits, and overall recommendations to academia or biotechnology companies may make the manufacturing of a clinical product
extremely labor intensive or expensive, making the product candidate no longer viable to manufacture in a cost efficient manner. The mode
of administration may make the product candidate not commercially viable. The required testing of the product candidate may make that
candidate no longer commercially viable. The conduct of clinical trials may be critiqued by the FDA, or a clinical trial site’s Institutional
Review Board or Institutional Biosafety Committee, which may delay or make impossible clinical testing of a product candidate. The
Institutional Review Board for a clinical trial may stop a trial or deem a product candidate unsafe to continue testing. This may have a
material adverse effect on the value of the product candidate and our business prospects.
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We will need to outsource and rely on third parties for the clinical development and manufacture, sales and marketing of our current
product candidates or any future product candidates that we may develop, and our future success will be dependent on the timeliness
and effectiveness of the efforts of these third parties.
We do not have the required financial and human resources to carry out on our own all the pre-clinical and clinical development
for our current product candidates or any other or future product candidates that we may develop, and do not have the capability and
resources to manufacture, market or sell our current product candidates or any future product candidates that we may develop. Our
business model calls for the partial or full outsourcing of the clinical and other development and manufacturing, sales and marketing of our
product candidates in order to reduce our capital and infrastructure costs as a means of potentially improving our financial position. Our
success will depend on the performance of these outsourced providers. If such providers fail to perform adequately, our development of
product candidates may be delayed and any delay in the development of our product candidates would have a material and adverse effect
on our business prospects.
We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial
burden upon us should we be sued.
Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and
marketing of medical devices. We cannot be sure that claims will not be asserted against us. A successful liability claim or series of claims
brought against us could have a material adverse effect on our business, financial condition and results of operations.
We cannot give assurances that we will be able to continue to obtain or maintain adequate product liability insurance on
acceptable terms, if at all, or that such insurance will provide adequate coverage against potential liabilities. Claims or losses in excess of
any product liability insurance coverage that we may obtain could have a material adverse effect on our business, financial condition and
results of operations.
Our Hemopurifier products may be used in connection with medical procedures in which it is important that those products
function with precision and accuracy. If our products do not function as designed, or are designed improperly, we may be forced by
regulatory agencies to withdraw such products from the market. In addition, if medical personnel or their patients suffer injury as a result of
any failure of our products to function as designed, or our products are designed inappropriately, we may be subject to lawsuits seeking
significant compensatory and punitive damages. The risk of product liability claims, product recalls and associated adverse publicity is
inherent in the testing, manufacturing, marketing and sale of medical products. We have recently obtained general clinical trial liability
insurance coverage. We cannot give assurances that our insurance coverage will to be adequate or available. We may not be able to secure
product liability insurance coverage on acceptable terms or at reasonable costs when needed. Any product recall or lawsuit seeking
significant monetary damages may have a material effect on our business and financial condition. Any liability for mandatory damages
could exceed the amount of our coverage. Moreover, a product recall could generate substantial negative publicity about our products and
business and inhibit or prevent commercialization of other future product candidates.
We have not received, and may never receive, approval from the FDA to market a medical device in the United States.
Before a new medical device can be marketed in the U.S., it must first receive either premarket approval, or a PMA, or 510(k)
clearance from the FDA, unless an exemption exists. A PMA submission, which is a higher standard than a 501(k) clearance, is used to
demonstrate to the FDA that a new or modified device is safe and effective. The 510(k) is used to demonstrate that a device is “substantially
equivalent” to a predicate device (one that has been cleared by the FDA). We expect that any product we seek regulatory approval for will
require a PMA. The FDA approval process involves, among other things, successfully completing clinical trials and filing for and obtaining
a PMA. The PMA process requires us to prove the safety and effectiveness of our products to the FDA’s satisfaction. This process, which
includes preclinical studies and clinical trials, can take many years and requires the expenditure of substantial resources and may include
post-marketing surveillance to establish the safety and efficacy of the product. Notwithstanding the effort and expense incurred, the
process may never result in the FDA granting a PMA. Data obtained from preclinical studies and clinical trials are subject to varying
interpretations that could delay, limit or prevent regulatory approval. Delays or rejections may also be encountered based upon changes in
governmental policies for medical devices during the period of product development. The FDA can delay, limit or deny approval of a PMA
application for many reasons, including:
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our inability to demonstrate safety or effectiveness to the FDA’s satisfaction;
insufficient data from our preclinical studies and clinical trials to support approval;
failure of the facilities of our third-party manufacturer or suppliers to meet applicable requirements;
inadequate compliance with preclinical, clinical or other regulations;
our failure to meet the FDA’s statistical requirements for approval; and
changes in the FDA’s approval policies, or the adoption of new regulations that require additional data or additional clinical
studies.
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Modifications to products that are approved through a PMA application generally need FDA approval. Similarly, some
modifications made to products cleared through a 510(k) may require a new 510(k). The FDA’s 510(k) clearance process usually takes
from three to 12 months, but may last longer. The process of obtaining a PMA is much costlier and uncertain than the 510(k) clearance
process and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA until an approval
is obtained. Any of our products considered to be a class III device, which are considered to pose the greatest risk and the approval of which
is governed by the strictest guidelines, will require the submission and approval of a PMA in order for us to market it in the U.S. We also
may design new products in the future that could require the clearance of a 510(k).
Although we have received approval to proceed with clinical trials in the U.S. under the investigational device exemption, we
cannot assure you that the current approval from the FDA to proceed will not be revoked, that the study will be successful, or that the FDA
PMA approval will eventually be obtained and not revoked. Even if we obtain approval, the FDA or other regulatory authorities may
require expensive or burdensome post-market testing or controls. Any delay in, or failure to receive or maintain, clearance or approval for
our future products could prevent us from generating revenue from these products or achieving profitability. Additionally, the FDA and
other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could
dissuade some physicians from using our products and adversely affect our reputation and the perceived safety and efficacy of our products.
The approval requirements for medical products used to fight bioterrorism are still evolving, and we cannot be certain any products we
develop for such uses would meet these requirements.
We are advancing product candidates under governmental policies that regulate the development and commercialization of
medical treatment countermeasures against bioterror and pandemic threats. While we intend to pursue FDA market clearance to treat
infectious bioterror and pandemic threats, it is often not feasible to conduct human studies against these deadly high threat pathogens. Thus,
we may not be able to demonstrate the effectiveness of our treatment countermeasures through controlled human efficacy studies.
Additionally, a change in government policies could impair our ability to obtain regulatory approval and there is no assurance that the FDA
will approve any of our product candidates.
The Hemopurifier was used to treat one patient suffering from Ebola, and we have received a supplement to our investigational device
exemption to establish protocols to treat Ebola patients in the U.S.; however, you should not construe these events as demonstrating that
the device is effective in treating Ebola.
In October 2014, physicians at the Frankfurt University Hospital in Frankfurt, Germany administered Hemopurifier therapy in a
6.5-hour treatment session to a patient infected with Ebola. This treatment was made on an emergency basis. The patient was administered
Hemopurifier therapy through special approval from The Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel
und Medizinprodukte, BfArM), an independent federal higher authority within the portfolio of the Federal Ministry of Health of Germany.
While we believe the results of the treatment of the Ebola patient in Germany to be positive with respect to the usage of the Hemopurifier to
combat Ebola, no medical organization or regulatory organization, inside or outside the U.S., has cleared the use of the device for Ebola
treatment on a commercial basis.
In addition, although the FDA approved a supplement to our investigational device exemption to establish a protocol for the
treatment of Ebola patients in the U.S., this approval is very limited and the results of such protocol and potential treatments, if any, cannot
be predicted. The usefulness of the Hemopurifier in treating Ebola is still unproven in any clinical or regulatory process in the U.S. or
elsewhere. Even if we enroll patients in the Ebola protocol, the results of such treatments may not demonstrate the safety and efficacy of
the device, may be equivocal or may otherwise not be sufficient to obtain approval of the Hemopurifier for any uses associated with Ebola.
In addition, the approval of the supplement to our investigational device exemption does not in any way ensure clearance or approval of the
Hemopurifier device for any purpose. In April 2015, we submitted a Humanitarian Use Devise submission to the FDA to support market
clearance of the Hemopurifier as a treatment for Ebola virus. If the application is designated by the FDA, we then may submit a
Humanitarian Device Exemption marketing application to the Center for Devices and Radiological Health for marketing review. We
cannot assure you that the Hemopurifier will be proven to be useful in the treatment of Ebola or that it will ever be approved by U.S. or
foreign regulatory agencies for such use, or if approved, successfully commercialized by us for such use. We may never commercialize the
Hemopurifier specifically for use in treating Ebola.
The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.
Any research and development, pre-clinical testing and clinical trial activities involving any products that we are or may develop
will be subject to extensive regulation and review by numerous governmental authorities both in the U.S. and abroad. In the future we may
conduct clinical trials to support approval of new products. Clinical studies must be conducted in compliance with FDA regulations or the
FDA may take enforcement action. The data collected from these clinical studies may ultimately be used to support market clearance for
these products. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product
candidate claims or that the FDA will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials
does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials
and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed
indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our
clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and
generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of
the product candidate’s profile.
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U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product
candidates and to manufacture, market and distribute our products after approval is obtained.
From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions
governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA
regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.
Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future
products. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect
our business and our products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or
interpretations changed, and what the impact of such changes, if any, may be.
Should our products be approved for commercialization, lack of third-party coverage and reimbursement for our devices could delay or
limit their adoption.
In both the U.S. and international markets, the use of medical devices is dependent in part on the availability of reimbursement
from third-party payors, such as government and private insurance plans. Healthcare providers that use medical devices generally rely on
third-party payors to pay for all or part of the costs and fees associated with the medical procedures being performed or to compensate them
for their patient care services. Should our products be approved for commercialization by the FDA, we cannot assure you that our future
products will be considered cost-effective, that reimbursement will be available in other sites or in other countries, including the U.S., if
approved, or that reimbursement will be sufficient to allow sales of our future products on a profitable basis. The coverage decisions of
third-party payors will be significantly influenced by the assessment of our future products by health technology assessment bodies. Such
assessments are outside our control and t we cannot assure you that such evaluations will be conducted or that they will have a favorable
outcome.
If approved for use in the U.S., we expect that any products that we develop will be purchased primarily by medical institutions,
which will in turn bill various third-party payors for the health care services provided to patients at their facility. Payors may include the
Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state
governments to administer Medicaid, other government programs and private insurance plans. The process involved in applying for
coverage and incremental reimbursement from CMS is lengthy and expensive. Further, Medicare coverage is based on our ability to
demonstrate the treatment is “reasonable and necessary” for Medicare beneficiaries. Even if products utilizing our Aethlon ADAPT™
system receive FDA and other regulatory clearance or approval, they may not be granted coverage and reimbursement by any payor,
including by CMS. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state and some
state Medicaid programs may not pay adequate amounts for the procedure necessary to utilize products utilizing our Aethlon ADAPT™
system, or any payment at all. Moreover, many private payors use coverage decisions and payment amounts determined by CMS as
guidelines in setting their coverage and reimbursement policies and amounts. If CMS or other agencies limit coverage or decrease or limit
reimbursement payments for doctors and hospitals, this may affect coverage and reimbursement determinations by many private payors.
Should our products be approved for commercialization, adverse changes in reimbursement policies and procedures by payors may
impact our ability to market and sell our products.
Healthcare costs have risen significantly over the past decade, and there have been and continue to be proposals by legislators,
regulators and third-party payors to decrease costs. Third-party payors are increasingly challenging the prices charged for medical products
and services and instituting cost containment measures to control or significantly influence the purchase of medical products and services.
For example, in the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act of 2010, or collectively, PPACA, among other things, reduced and/or limited Medicare reimbursement to certain
providers. The Budget Control Act of 2011, as amended by subsequent legislation, further reduces Medicare’s payments to providers by 2
percent through fiscal year 2024. These reductions may reduce providers’ revenues or profits, which could affect their ability to purchase
new technologies. Furthermore, the healthcare industry in the U.S. has experienced a trend toward cost containment as government and
private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with service
providers. Legislation could be adopted in the future that limits payments for our products from governmental payors. In addition,
commercial payors such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’
products. Therefore, we cannot be certain that our product or the procedures or patient care performed using our product will be reimbursed
at a cost-effective level. We face similar risks relating to adverse changes in reimbursement procedures and policies in other countries
where we may market our products. Reimbursement and healthcare payment systems vary significantly among international markets. Our
inability to obtain international reimbursement approval, or any adverse changes in the reimbursement policies of foreign payors, could
negatively affect our ability to sell our products and have a material adverse effect on our business and financial condition.
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Should our products be approved for commercialization, our financial performance may be adversely affected by medical device tax
provisions in the healthcare reform laws.
PPACA currently imposes, among other things, an excise tax of 2.3% on any entity that manufactures or imports medical devices
offered for sale in the U.S. Under these provisions, the Congressional Research Service predicts that the total cost to the medical device
industry may be up to $20 billion over the next decade. The Internal Revenue Service issued final regulations implementing the tax in
December 2012, which requires, among other things, bi-monthly payments and quarterly reporting.
The Consolidated Appropriations Act, 2016 (Pub. L. 114-113), signed into law on Dec. 18, 2015, includes a two-year moratorium
on the medical device excise tax imposed by Internal Revenue Code section 4191. Thus, the medical device excise tax does not apply to the
sale of a taxable medical device by the manufacturer, producer, or importer of the device during the period beginning on January 1, 2016,
and ending on December 31, 2017.
Once we market products, we will be subject to this or any future excise tax on our sales of certain medical devices in the U.S. We
anticipate that primarily all of our sales, once commenced, of medical devices in the U.S. will be subject to this 2.3% excise tax following
December 31, 2017.
Risks Related to Our Intellectual Property and Related Litigation
We rely upon licenses and patent rights from third parties which are subject to termination or expiration.
We rely upon third party licenses and ownership rights assigned from third parties for the development of specific uses for our
Hemopurifier devices. For example, we are researching, developing and testing cancer-related applications for our devices under patents
assigned from the London Health Science Center Research, Inc. Should any of our licenses be prematurely terminated for any reason, or if
the patents and intellectual property assigned to us or owned by such entities that we have licensed should be challenged or defeated by
third parties, our research efforts could be materially and adversely affected. We cannot assure you that any of our licenses or patents
assigned to us will continue in force for as long as we require for our research, development and testing of cancer treatments. We cannot
assure you that, should our licenses terminate, should the underlying patents and intellectual property be challenged or defeated, or should
patents and intellectual property assigned to us be challenged or defeated, suitable replacements can be obtained or developed on terms
acceptable to us, if at all. There is also the related risk that we may not be able to make the required payments under any patent license or
assignment agreement, in which case we may lose to ability to use one or more of the licensed or assigned patents.
We could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and efforts,
require us to pay damages, prevent us from selling our commercially available products and/or reduce the margins we may realize from
our products.
The medical devices industry is characterized by extensive litigation and administrative proceedings over patent and other
intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, and the determination is often
uncertain. There may be existing patents of which we are unaware that our products under development may inadvertently infringe. The
likelihood that patent infringement claims may be brought against us increases as the number of participants in the infectious market
increases and as we achieve more visibility in the market place and introduce products to market.
Any infringement claim against us, even if without merit, may cause us to incur substantial costs, and would place a significant
strain on our financial resources, divert the attention of management from our core business, and harm our reputation. In some cases,
litigation may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues
and against whom our patents may provide little or no deterrence. If we were found to infringe any patents, we could be required to pay
substantial damages, including triple damages if an infringement is found to be willful. We also could be required to pay royalties and could
be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. We may not be
able to obtain a license enabling us to sell our products on reasonable terms, or at all, and we cannot assure you that we would be able to
redesign our products in a way that would not infringe those patents. If we fail to obtain any required licenses or make any necessary
changes to our technologies or the products that incorporate them, we may be unable to commercialize one or more of our products or may
have to withdraw products from the market, all of which would have a material adverse effect on our business, financial condition and
results of operations.
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If the combination of patents, trade secrets and contractual provisions upon which we rely to protect our intellectual property is
inadequate, our ability to commercialize our products successfully will be harmed.
Our success depends significantly on our ability to protect our proprietary rights to the technologies incorporated in our products.
We currently have four issued U.S. patents and eight pending U.S. patent applications. We also have fourteen issued foreign patents and
have applied for five additional foreign patents and for seven international patents. Our issued patents begin to expire in 2019, with the last
of these patents expiring in 2029, although terminal disclaimers, patent term extension or patent term adjustment can shorten or lengthen
the patent term. We rely on a combination of patent protection, trade secret laws and nondisclosure, confidentiality and other contractual
restrictions to protect our proprietary technology. However, these may not adequately protect our rights or permit us to gain or keep any
competitive advantage.
The issuance of a patent is not conclusive as to its scope, validity or enforceability. The scope, validity or enforceability of our
issued patents can be challenged in litigation or proceedings before the U.S. Patent and Trademark Office or foreign patent offices where
our applications are pending. The U.S. Patent and Trademark Office or foreign offices may deny or require significant narrowing of claims
in our pending patent applications. Patents issued as a result of the pending patent applications, if any, may not provide us with significant
commercial protection or be issued in a form that is advantageous to us. Proceedings before the U.S. Patent and Trademark Office or
foreign offices could result in adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued
patents. The laws of some foreign countries may not protect our intellectual property rights to the same extent as the laws of the U.S., if at
all. Some of our patents may expire before we receive FDA approval to market our products in the U.S. or we receive approval to market
our products in a foreign country. Although we believe that certain patent applications and/or other patents issued more recently will help
protect the proprietary nature of the Hemopurifier treatment technology, we cannot assure you that this protection will be sufficient to
protect us during the development of that technology.
Our competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that
may issue in the future, which could prevent or limit our ability to market our products and could limit our ability to stop competitors from
marketing products that are substantially equivalent to ours. In addition, competitors may be able to design around our patents or develop
products that provide outcomes that are comparable to our products but that are not covered by our patents.
We have also entered into confidentiality and assignment of intellectual property agreements with all of our employees,
consultants and advisors directly involved in the development of our technology as one of the ways we seek to protect our intellectual
property and other proprietary technology. However, these agreements may not be enforceable or may not provide meaningful protection
for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.
In the event a competitor infringes upon any of our patents or other intellectual property rights, enforcing our rights may be
difficult, time consuming and expensive, and would divert management’s attention from managing our business. We cannot assure you that
we will be successful on the merits in any enforcement effort. In addition, we may not have sufficient resources to litigate, enforce or
defend our intellectual property rights.
We may rely on licenses for new technology, which may affect our continued operations with respect thereto.
As we develop our technology, we may need to license additional technologies to optimize the performance of our products. We
may not be able to license these technologies on commercially reasonable terms or at all. In addition, we may fail to successfully integrate
any licensed technology into our proposed products. Our inability to obtain any necessary licenses could delay our product development
and testing until alternative technologies can be identified, licensed and integrated. The inability to obtain any necessary third-party
licenses could cause us to abandon a particular development path, which could seriously harm our business, financial position and results
of our operations.
New technology may lead to our competitors developing superior products which would reduce demand for our products.
Research into technologies similar to ours is proceeding at a rapid pace, and many private and public companies and research
institutions are actively engaged in the development of products similar to ours. These new technologies may, if successfully developed,
offer significant performance or price advantages when compared with our technologies. There is no assurance that our existing patents or
our pending and proposed patent applications will offer meaningful protection if a competitor develops a novel product based on a new
technology.
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If we are unable to protect our proprietary technology and preserve our trade secrets, we will increase our vulnerability to competitors
which could materially adversely impact our ability to remain in business.
Our ability to successfully commercialize our products will depend on our ability to protect those products and our technology
with domestic and foreign patents. We will also need to continue to preserve our trade secrets. The issuance of a patent is not conclusive as
to its validity or as to the enforceable scope of the claims of the patent. The patent positions of technology companies, including us, are
uncertain and involve complex legal and factual issues. We cannot assure you that our patents will prevent other companies from
developing similar products or products which produce benefits substantially the same as our products, or that other companies will not be
issued patents that may prevent the sale of our products or require us to pay significant licensing fees in order to market our products.
From time to time, we may need to obtain licenses to patents and other proprietary rights held by third parties in order to develop,
manufacture and market our products. If we are unable to timely obtain these licenses on commercially reasonable terms, our ability to
commercially exploit such products may be inhibited or prevented. Additionally, we cannot assure investors that any of our products or
technology will be patentable or that any future patents we obtain will give us an exclusive position in the subject matter claimed by those
patents. Furthermore, we cannot assure investors that our pending patent applications will result in issued patents, that patent protection
will be secured for any particular technology, or that our issued patents will be valid or enforceable or provide us with meaningful
protection.
If we are required to engage in expensive and lengthy litigation to enforce our intellectual property rights, such litigation could be very
costly and the results of such litigation may not be satisfactory.
Although we have entered into invention assignment agreements with our employees and with certain advisors, and we routinely
enter into confidentiality agreements with our contract partners, if those employees, advisors or contract partners develop inventions or
processes independently that may relate to products or technology under development by us, disputes may arise about the ownership of
those inventions or processes. Time-consuming and costly litigation could be necessary to enforce and determine the scope of our rights
under these agreements. In addition, we may be required to commence litigation to enforce such agreements if they are violated, and it is
certainly possible that we will not have adequate remedies for breaches of our confidentiality agreements as monetary damages may not be
sufficient to compensate us. In addition, we may be unable to fund the costs of such litigation to a satisfactory conclusion, which could
leave us without recourse to enforce contracts that protect our intellectual property rights.
Other companies may claim that our technology infringes on their intellectual property or proprietary rights and commence legal
proceedings against us which could be time-consuming and expensive and could result in our being prohibited from developing,
marketing, selling or distributing our products.
Because of the complex and difficult legal and factual questions that relate to patent positions in our industry, we cannot assure
you that our products or technology will not be found to infringe upon the intellectual property or proprietary rights of others. Third parties
may claim that our products or technology infringe on their patents, copyrights, trademarks or other proprietary rights and demand that we
cease development or marketing of those products or technology or pay license fees. We may not be able to avoid costly patent
infringement litigation, which will divert the attention of management away from the development of new products and the operation of our
business. We cannot assure investors that we would prevail in any such litigation. If we are found to have infringed on a third party’s
intellectual property rights, we may be liable for money damages, encounter significant delays in bringing products to market or be
precluded from manufacturing particular products or using particular technology.
Other parties may challenge certain of our foreign patent applications. If such parties are successful in opposing our foreign patent
applications, we may not gain the protection afforded by those patent applications in particular jurisdictions and may face additional
proceedings with respect to similar patents in other jurisdictions, as well as related patents. The loss of patent protection in one jurisdiction
may influence our ability to maintain patent protection for the same technology in other jurisdictions.
Risks Related to U.S. Government Contracts
Our revenues are almost entirely derived from one U.S. Government contract.
We have derived and expect for the near future to continue to derive substantially all of our revenue under our DARPA
contract. If we are unable to meet any of the remaining DARPA contract milestones to the satisfaction of DARPA, if at all, we may not
earn future payments under the contract. Any reduction in our revenues, or the termination of the DARPA contract for any reason, could
have a material and adverse effect on our business and operations. In addition, DARPA has the right to unilaterally cancel the contract at
any time. Upon the completion of the DARPA contract there can be no assurance we will develop other sources of revenue in the short
term.
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We may not obtain additional U.S. Government contracts to further develop our technology.
We can give no assurances that we will be successful in obtaining additional government grants or contracts. The process of
obtaining government contracts is lengthy with the uncertainty that we will be successful in obtaining announced grants or contracts for
therapeutics as a medical device technology. Accordingly, we cannot be certain that we will be awarded any additional U.S. Government
grants or contracts utilizing our Hemopurifier platform technology.
U.S. Government agencies have special contracting requirements including a right to audit us which create additional risks; a negative
audit would be detrimental to us.
Our business plan to utilize the Aethlon ADAPT system is likely to involve contracts with the U.S. Government. Such contracts
typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion,
which subjects us to additional risks. These risks include the ability of the U.S. Government to unilaterally:
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suspend or prevent us for a period of time from receiving new contracts or extending existing contracts based on violations or
suspected violations of laws or regulations;
audit and object to our contract-related costs and fees, including allocated indirect costs;
control and potentially prohibit the export of our products; and
change certain terms and conditions in our contracts.
As a U.S. Government contractor, we are required to comply with applicable laws, regulations and standards relating to our
accounting practices and would be subject to periodic audits and reviews. As part of any such audit or review, the U.S. Government may
review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing,
property, estimating, compensation and management information systems. Based on the results of its audits, the U.S. Government may
adjust our contract-related costs and fees, including allocated indirect costs. In addition, if an audit or review uncovers any improper or
illegal activity, we would possibly be subject to civil and criminal penalties and administrative sanctions, including termination of our
contracts, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S. Government.
We could also suffer serious harm to our reputation if allegations of impropriety were made against us. Although we have not had any
government audits and reviews to date, future audits and reviews could cause adverse effects. In addition, under U.S. Government
purchasing regulations, some of our costs, including most financing costs, amortization of intangible assets, portions of our research and
development costs, and some marketing expenses, would possibly not be reimbursable or allowed under such contracts. Further, as a U.S.
Government contractor, we would be subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits
and other legal actions and liabilities to which purely private sector companies are not.
Our DARPA Contract is a fixed price contract, which may not adequately cover our costs in performance should those costs increase.
Our contract with DARPA is on a firm fixed price basis, which means that we are required to deliver our products at a fixed price
regardless of the actual costs we incur and to absorb any costs in excess of the fixed price. If we have not accurately estimated the costs of
expenses to perform the contract, we may not have positive revenue and we may incur losses to cover our costs. We expect that our future
contracts, if any, with the U.S. Government also may be fixed price contracts. Estimating costs that are related to performance in
accordance with contract specifications is difficult, particularly where the period of performance is over several years. Our failure to
anticipate technical problems, estimate costs accurately or control costs during performance of a fixed price contract could reduce the
profitability of a fixed price contract or cause a loss, which could in turn harm our operating results.
As a U.S. Government contractor, we are subject to a number of procurement rules and regulations.
Government contractors must comply with specific procurement regulations and other requirements. These requirements, although
customary in government contracts, impact our performance and compliance costs. In addition, current U.S. Government budgetary
constraints could lead to changes in the procurement environment, including the Department of Defense’s recent initiative focused on
efficiencies, affordability and cost growth and other changes to its procurement practices. If and to the extent such changes occur, they
could impact our results of operations and liquidity, and could affect whether and, if so, how we pursue certain opportunities and the terms
under which we are able to do so.
In addition, failure to comply with these regulations and requirements could result in reductions of the value of contracts, contract
modifications or termination, and the assessment of penalties and fines, which could negatively impact our results of operations and
financial condition. Our failure to comply with these regulations and requirements could also lead to suspension or debarment, for cause,
from government contracting or subcontracting for a period of time. Among the causes for debarment are violations of various statutes,
including those related to procurement integrity, export control, government security regulations, employment practices, protection of the
environment, accuracy of records and the recording of costs, and foreign corruption. The termination of our government contract as a result
of any of these acts could have a negative impact on our results of operations and financial condition and could have a negative impact on
our reputation and ability to procure other government contracts in the future.
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In fulfilling our U.S. Government contract we depend on a predictable supply of raw materials and components.
We are dependent upon the delivery by suppliers of materials and the assembly by subcontractors of major components and
subsystems used in our products in a timely and satisfactory manner and in full compliance with applicable terms and conditions. Some
products require relatively scarce raw materials. We are generally subject to specific procurement requirements, which may, in effect, limit
the suppliers and subcontractors we may utilize. In some instances, we are dependent on sole-source suppliers. If any of these suppliers or
subcontractors fails to meet our needs, we may not have readily available alternatives. In addition, some of our suppliers or subcontractors
may be impacted by the recent global financial crisis, which could impair their ability to meet their obligations to us. If we experience a
material supplier or subcontractor problem, our ability to satisfactorily and timely complete our clinical trial or delivery obligations could
be negatively impacted which could result in reduced sales, termination of contracts and damage to our reputation and relationships with
clinical trial providers and if applicable, the U.S. Government. We could also incur additional costs in addressing such a problem. Any of
these events could have a negative impact on our results of operations and financial condition.
Risks Relating to Our Common Stock and Our Corporate Governance
Historically we have not paid dividends on our common stock, and we do not anticipate paying any cash dividends in the foreseeable
future.
We have never paid cash dividends on our common stock. We intend to retain our future earnings, if any, to fund operational and
capital expenditure needs of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Furthermore, future
financing instruments may do the same. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for our
common stockholders in the foreseeable future.
Our stock price is speculative, and there is a risk of litigation.
The trading price of our common stock has in the past and may in the future be subject to wide fluctuations in response to factors
such as the following:
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revenue or results of operations in any quarter failing to meet the expectations, published or otherwise, of the investment
community;
reduced investor confidence in equity markets, due in part to corporate collapses in recent years;
speculation in the press or analyst community;
· wide fluctuations in stock prices, particularly with respect to the stock prices for other medical device companies;
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announcements of technological innovations by us or our competitors;
new products or the acquisition of significant customers by us or our competitors;
changes in interest rates;
changes in investors’ beliefs as to the appropriate price-earnings ratios for us and our competitors;
changes in recommendations or financial estimates by securities analysts who track our common stock or the stock of other
medical device companies;
changes in management;
sales of common stock by directors and executive officers;
rumors or dissemination of false or misleading information, particularly through Internet chat rooms, instant messaging, and
other rapid-dissemination methods;
conditions and trends in the medical device industry generally;
the announcement of acquisitions or other significant transactions by us or our competitors;
adoption of new accounting standards affecting our industry;
general market conditions;
domestic or international terrorism and other factors; and
the other factors described in this section.
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Fluctuations in the price of our common stock may expose us to the risk of securities class action lawsuits. Although no such
lawsuits are currently pending against us and we are not aware that any such lawsuit is threatened to be filed in the future, there is no
assurance that we will not be sued based on fluctuations in the price of our common stock. Defending against such suits could result in
substantial cost and divert management’s attention and resources. In addition, any settlement or adverse determination of such lawsuits
could subject us to significant liability.
If at any time our common stock is subject to the Securities and Exchange Commission’s penny stock rules, broker-dealers
may experience difficulty in completing customer transactions and trading activity in our securities may be adversely affected.
If at any time our common stock is not listed on a national securities exchange or we have net tangible assets of $5,000,000 or less
and our common stock has a market price per share of less than $5.00, transactions in our common stock will be subject to the Securities
and Exchange Commission’s, or SEC’s, “penny stock” rules. If our common stock is subject to the “penny stock” rules promulgated under
the Exchange Act, broker-dealers may find it difficult to effectuate customer transactions and trading activity in our securities may be
adversely affected. For any transaction involving a penny stock, unless exempt, the rules require:
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that a broker or dealer approve a person’s account for transactions in penny stocks; and
the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of
the penny stock to be purchased.
In order to approve a person’s account for transactions in penny stocks, the broker or dealer must:
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obtain financial information and investment experience objectives of the person; and
· make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient
knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.
The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the Securities
and Exchange Commission relating to the penny stock market, which, in highlight form:
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sets forth the basis on which the broker or dealer made the suitability determination; and
that the broker or dealer received a signed, written agreement from the investor prior to the transaction.
Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it
more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.
Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and
about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the
rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent
disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
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Our common stock has had an unpredictable trading volume which means you may not be able to sell our shares at or near trading
prices or at all.
Trading in our common shares historically has been volatile and often has been thin, meaning that the number of persons
interested in purchasing our common shares at or near trading prices at any given time may be relatively small or non-existent. This
situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknown to stock
analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that
even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as
ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. As a consequence,
there may be periods of several days or more when trading activity in our shares is minimal, as compared to a seasoned issuer which has a
large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot
give you any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that
current trading levels will be sustained.
The market price for our common stock is volatile; you may not be able to sell our common stock at or above the price you have paid for
them, which may result in losses to you.
The market for our common shares is characterized by significant price volatility when compared to seasoned issuers, and we
expect that our share price will continue to be more volatile than a seasoned issuer for the indefinite future. In fact, during the 52-week
period ended March 31, 2016, the high and low closing sale prices of a share of our common stock were $14.00 and $4.34, respectively.
The volatility in our share price is attributable to a number of factors. First, as noted above, trading in our common shares often has been
thin. As a consequence of this lack of liquidity, the trading of relatively small quantities of shares by our stockholders may
disproportionately influence the price of those shares in either direction. The price for our shares could, for example, decline precipitously
in the event that a large number of our common shares are sold on the market without commensurate demand, as compared to a seasoned
issuer which could better absorb those sales without adverse impact on its share price. Secondly, we are a speculative investment due to our
limited operating history, limited amount of revenue, lack of profit to date, and the uncertainty of future market acceptance for our potential
products. As a consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment
in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts
than would be the case with the stock of a seasoned issuer. The following factors may add to the volatility in the price of our common
shares: actual or anticipated variations in our quarterly or annual operating results; acceptance of our proprietary technology as a viable
method of augmenting the immune response of clearing viruses and toxins from human blood; government regulations, announcements of
significant acquisitions, strategic partnerships or joint ventures; our capital commitments and additions or departures of our key personnel.
Many of these factors are beyond our control and may decrease the market price of our common shares regardless of our operating
performance. We cannot make any predictions or projections as to what the prevailing market price for our common shares will be at any
time, including as to whether our common shares will sustain their current market prices, or as to what effect the sale of shares or the
availability of common shares for sale at any time will have on the prevailing market price.
We cannot assure you that we will be able to comply with the continued listing standards of the NASDAQ Capital Market.
We cannot assure you that we will be able to comply with the listing standards that we are required to meet in order to maintain a
listing of our common stock on the NASDAQ Capital Market. Our failure to meet those requirements may result in our common stock
being delisted from the NASDAQ Capital Market.
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from
regulating the sale of certain securities, which are referred to as “covered securities.” Because our common stock is listed on the NASDAQ
Capital Market, we believe such securities will be covered securities. Although the states would be preempted from regulating the sale of
our securities, in that event, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a
finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Further, our common
stock is no longer listed on the NASDAQ Capital Market, our securities would not be covered securities and we would be subject to
regulation in each state in which we offer our securities.
The Depository Trust Company imposed restrictions upon electronic trading of our common stock, which negatively affected liquidity of
the stock and our ability to raise capital.
In September 2011, The Depository Trust Company placed a "chill" on the electronic clearing of trades in our shares which led to
some brokerage firms being unwilling to accept certificates and/or electronic deposits of our stock. We have since been successful in lifting
the restrictions and our shares now clear electronically making more brokers willing to trade in our common stock. We cannot assure you
that The Depository Trust Company will not again place a chill on our common stock. A chill, if placed on our common stock, would affect
the liquidity of our shares which may make it difficult to purchase or sell shares in the open market. It may also have an adverse effect on
our ability to raise capital since investors may be unable to resell shares into the market. Our inability to raise capital on terms acceptable to
us, if at all, could have a material and adverse effect on our business and operations.
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Our directors and officers own or control approximately 10% of our outstanding common shares which may limit your ability to
propose new management or influence the overall direction of the business; this concentration of control may also discourage potential
takeovers that could otherwise provide a premium to you.
As of June 28, 2016, our officers and directors beneficially own or control approximately 10% of our outstanding common shares
(assuming the exercise of all outstanding options and warrants held by our officers and directors). These persons will have the ability to
substantially influence all matters submitted to our stockholders for approval and to control our management and affairs, including
extraordinary transactions such as mergers and other changes of corporate control, and going private transactions.
A large number of our common shares are issuable upon exercise of outstanding convertible securities which, if exercised or converted,
would be dilutive to your holdings.
As of March 31, 2016, there are outstanding purchase options and warrants entitling the holders to purchase 2,602,639 common
shares at a weighted average exercise price of $7.40 per share. This includes 26,105 warrants that are conditional upon the exercise of other
warrants. As of March 31, 2016, there are 107,468 shares underlying promissory notes convertible into common stock at a weighted
average exercise price of $5.60.
The exercise price for all of our outstanding options and warrants, or the conversion price of our convertible notes, may be less
than your cost to acquire our common shares. In the event of the exercise or conversion of these securities, you could suffer substantial
dilution of your investment in terms of your percentage ownership in us as well as the book value of your common shares. In addition, the
holders of the convertible notes, common share purchase options or warrants may sell common shares in tandem with their exercise or
conversion of those securities to finance that exercise or conversion, or may resell the shares purchased in order to cover any income tax
liabilities that may arise from their exercise of the options or warrants or conversion of the notes.
Our issuance of additional common shares, or convertible securities, would be dilutive to your holdings.
We are entitled under our Articles of Incorporation to issue up to 30,000,000 shares of common stock. We have reserved for
issuance 2,710,107 shares of common stock for existing options, warrants and convertible notes. As of March 31, 2016, we have issued and
outstanding 7,622,393 shares of common stock. As a result, as of March 31, 2016 we had 19,667,500 common shares available for issuance
to new investors or for use to satisfy indebtedness or pay service providers.
Our Board of Directors may generally issue shares of common stock, or options or warrants to purchase those shares, without
further approval by our stockholders based upon such factors as our Board of Directors may deem relevant at that time. It is likely that we
will be required to issue a large amount of additional securities to raise capital to further our development. It is also likely that we will be
required to issue a large amount of additional securities to directors, officers, employees and consultants as compensatory grants in
connection with their services, both in the form of stand-alone grants or under our stock plans. We cannot give you any assurance that we
will not issue additional shares of common stock, or options or warrants to purchase those shares, under circumstances we may deem
appropriate at the time.
Our issuance of additional shares of common stock in satisfaction of services, or to repay indebtedness, would be dilutive to your
holdings.
Our Board of Directors may generally issue shares of common stock to pay for debt or services, without further approval by our
stockholders based upon such factors that our Board of Directors may deem relevant at that time. For the past four fiscal years (ending
March 31, 2016), we issued a total of 1,626,032 shares for debt to reduce our obligations. However, we did not issue any shares as payment
for services in the fiscal year ended March 31, 2016. The average price discount of common stock issued for debt during the previous two
fiscal years, weighted by the number of shares issued for debt in such period was 76% and 43% for the years ended March 31, 2015 and
2014, respectively.
For the past four fiscal years (ending March 31, 2016), we issued a total of 147,001 shares as payment for services. However, we
did not issue any shares as payment for services in the fiscal year ended March 31, 2016. The average price discount (premium) of common
stock issued for services during the previous two fiscal years, weighted by the number of shares issued was (6.6)% and 16.0% for the years
ended March 31, 2015 and 2014, respectively. It is likely that we will issue additional securities to pay for services and reduce debt in the
future, after we increase our authorized shares. We cannot give you any assurance that we will not issue additional shares of common stock
at various discounts under circumstances we may deem appropriate at the time.
29
Our officers and directors are entitled to indemnification from us for liabilities under our articles of incorporation, which could be
costly to us and may discourage the exercise of stockholder rights.
Our Articles of Incorporation contains provisions which eliminate the liability of our directors for monetary damages to our
company and stockholders. Our by-laws also require us to indemnify our officers and directors. We may also have contractual
indemnification obligations under our agreements with our directors, officers and employees. The foregoing indemnification obligations
could result in our company incurring substantial expenditures to cover the cost of settlement or damage awards against directors, officers
and employees that we may be unable to recoup. These provisions and resultant costs may also discourage our company from bringing a
lawsuit against directors, officers and employees for breaches of their fiduciary duties, and may similarly discourage the filing of derivative
litigation by our stockholders against our directors, officers and employees even though such actions, if successful, might otherwise benefit
our company and stockholders.
Our by-laws and Nevada law may discourage, delay or prevent a change of control of our company or changes in our management,
would have the result of depressing the trading price of our common stock.
Provisions of Nevada anti-takeover law (NRS 78.378 et seq.) could have the effect of delaying or preventing a third party from
acquiring us, even if the acquisition arguably could benefit our stockholders. Various provisions of our by-laws may delay, defer or prevent
a tender offer or takeover attempt of us that a stockholder might consider in his or her best interest. Our by-laws may be adopted, amended
or repealed by the affirmative vote of the holders of at least a majority of our outstanding shares of capital stock entitled to vote for the
election of directors, and except as provided by Nevada law, our Board of Directors shall have the power to adopt, amend or repeal the by-
laws by a vote of not less than a majority of our directors. The interests of these stockholders and directors may not be consistent with your
interests, and they may make changes to the by-laws that are not in line with your concerns.
Our authorized but unissued shares of common stock are available for our Board or Directors to issue without stockholder
approval. We may use these additional shares for a variety of corporate purposes, however, faced with an attempt to obtain control of us by
means of a proxy context, tender offer, merger or other transaction our Board of Directors acting alone and without approval of our
stockholders can issue large amounts of capital stock as part of a defense to a take-over challenge.
The existence of the foregoing provisions and other potential anti-takeover measures could limit the price that investors might be
willing to pay in the future for shares of our common stock. They could also deter potential acquirers of our company, thereby reducing the
likelihood that you could receive a premium for your common stock in an acquisition.
We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public
company compliance programs.
As a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public
company reporting. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result
in increased general and administrative expenses and may divert management’s time and attention from product development and
commercialization activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by
regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and
our business may be harmed. These laws and regulations could make it more difficult and costly for us to obtain director and officer
liability insurance for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to
obtain coverage. These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified
members of our Board of Directors, particularly to serve on our audit and compensation committees. In addition, if we are unable to
continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the
quotation of our common stock on the Nasdaq Capital Market or on any other senior market to which we may apply for listing, which
would likely have a material adverse effect on the trading price of our common stock.
If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations
regarding our stock adversely, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish
about us or our business. Our research coverage by industry and financial analysts is currently limited. Even if our analyst coverage
increases, if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline. If one or more of these
analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in
turn could cause our stock price or trading volume to decline.
30
ITEM 1B. UNRESOLVED STAFF COMMENTS
As a Smaller Reporting Company, we are not required to furnish information under this Item 1B.
ITEM 2. PROPERTIES
We currently lease approximately 2,576 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego,
California 92123 under a 39-month gross plus utilities lease that commenced on December 1, 2014 with an initial rental rate of $6,054 per
month. Such lease expires in March 2018. We believe this leased facility will be satisfactory for our office needs over the term of the lease.
We also lease approximately 1,700 square feet of laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego,
California 92121 at the rate of $4,168 per month on a one-year lease that expires in November 2016. We believe this leased facility will be
satisfactory for our laboratory needs over the term of the lease.
Our Exosome Sciences, Inc. subsidiary previously rented approximately 2,055 square feet of office and laboratory space at 11
Deer Park Drive, South Brunswick, New Jersey at the rate of $3,917 per month on a one-year lease that expired in October 2015. In
October 2015, Exosome Sciences, Inc. relocated to a different suite at the same office complex. Exosome Sciences leased that suite,
comprised of approximately 541 square feet of office and laboratory space located at 9 Deer Park Drive, South Brunswick, New Jersey, at
the rate of $1,352 per month on a month-to-month lease basis. In January 2016, we exercised our 30-day notice to terminate the Exosome
Sciences’ lease in New Jersey prior to consolidating our laboratory operations in San Diego.
ITEM 3. LEGAL PROCEEDINGS
We may be involved from time to time in various claims, lawsuits, and/or disputes with third parties or breach of contract actions
incidental to the normal course of our business operations. We are currently not involved in any litigation or any pending legal proceedings.
ITEM 4. MINE SAFETY DISCLOSURES
We have no disclosure applicable to this item.
31
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
MARKET PRICE FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our common stock is quoted on the Nasdaq Capital Market under the trading symbol "AEMD." Trading in our common stock
historically has been volatile and often has been thin. On July 7, 2015, The NASDAQ Stock Market LLC approved our application for
listing our common stock on the Nasdaq Capital Market under the symbol “AEMD,” and we commenced trading on the Nasdaq Capital
Market on July 13, 2015. Previously, our common stock was quoted on the OTCQB Marketplace under the trading symbol “AEMD.”
The following table sets forth for the calendar periods indicated the quarterly high and low closing or bid, as applicable, prices for
our common stock as reported by the Nasdaq Capital Market and/or the OTCQB Marketplace. The prices represent quotations between
dealers, without adjustment for retail markup, mark down or commission, and do not necessarily represent actual transactions.
PERIOD
Calendar 2016:
First Quarter
Calendar 2015:
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Calendar 2014:
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
CLOSING/BID PRICE
HIGH
LOW
$
7.01 $
8.20
11.38
14.00
19.50
28.50
9.00
11.00
13.00
4.34
6.17
6.58
6.51
8.50
6.00
5.00
7.50
8.00
There were approximately 164 record holders of our common stock at June 28, 2016. The number of registered stockholders
includes any beneficial owners of common shares held in street name.
The transfer agent and registrar for our common stock is Computershare Investor Services, located at 350 Indiana Street, Suite
800, Golden, Colorado 80401.
We have not paid any dividends on our common stock to date and do not anticipate that we will pay dividends in the foreseeable
future. Any payment of cash dividends on our common stock in the future will be dependent upon the amount of funds legally available,
our earnings, if any, our financial condition, our anticipated capital requirements and other factors that the board of directors may think are
relevant. However, we currently intend for the foreseeable future to follow a policy of retaining all of our earnings, if any, to finance the
development and expansion of our business and, therefore, do not expect to pay any dividends on our common stock in the foreseeable
future.
Recent Sales of Unregistered Securities
We have sold or issued the following equity securities not registered under the Securities Act of 1933, or Securities Act, in reliance
upon the exemption from registration pursuant to Section 4(a)(2) of the Securities Act or Regulation D of the Securities Act during the
fiscal year ended March 31, 2016 and subsequent thereto through the date of filing this report. Except as stated below, no underwriting
discounts or commissions were payable with respect to any of the following transactions.
Aethlon Medical, Inc. Equity Transactions in the Fiscal Year Ended March 31, 2016.
On June 25, 2015, we sold $6,000,000 of units, comprised of common stock and warrants, to 18 accredited investors at a price of
$6.30 per unit. Each unit consisted of one share of common stock and 0.75 of a five-year warrant to purchase one share of common stock at
an exercise price of $6.30 per share. Accordingly, we issued a total of 952,383 shares of unregistered common stock and warrants to
purchase 714,285 shares of common stock. For its services as sole placement agent for the financing, we paid Roth Capital Partners, LLC
(“Roth”) a cash fee of $285,512 and expense reimbursement of $75,000 and we issued them a five-year warrant to purchase 32,371 shares
of common stock at an exercise price of $6.30 per share. We received $5,591,988 in net proceeds from this financing. As the warrants that
were issued to the investors and to Roth were issued in connection with common stock for cash, they were considered issued in connection
with the financing transaction and the warrant fair value, which was valued using a binomial lattice model, was recorded to additional paid-
in-capital.
32
In connection with the financing, Mr. James Joyce, our Chief Executive Officer, Mr. James Frakes, our Chief Financial Officer
and Dr. Chetan Shah, a director of our company, each agreed to waive their right to exercise certain stock options and warrants held by
them representing the right to acquire 402,318 shares of common stock in the aggregate (the “Waivers”). The Waivers were required in
order to make a sufficient number of shares of common stock available for issuance and the Waivers expired when we amended our
Articles of Incorporation on March 31, 2016, to increase the number of authorized shares of our common stock from 10,000,000 to
30,000,000, following stockholder approval of such amendment at our annual stockholders’ meeting on March 29, 2016.
During the three months ended September 30, 2015, we issued an aggregate of 5,292 shares of common stock to an accredited
investor upon the exercise of previously issued warrants. The warrants were exercised on a cashless or “net” basis. Accordingly, we did not
receive any proceeds from such exercises. The cashless exercise of such warrants resulted in the cancellation of previously issued warrants
to purchase an aggregate of 1,744 shares of common stock.
During the three months ended December 31, 2015, we issued an aggregate of 6,757 unregistered shares of common stock to two
investors upon the exercise of previously issued warrants. The warrants were exercised for cash and we received cash proceeds of $14,766
for an average purchase price of $2.19 per share per the terms of the warrants.
EQUITY COMPENSATION PLANS
SUMMARY EQUITY COMPENSATION PLAN DATA
Equity Compensation Plans
Summary equity compensation plan data
The following table sets forth information, as of March 31, 2016, about our equity compensation plans (including the potential
effect of debt instruments convertible into common stock) in effect as of that date:
(c)
Number of
securities
remaining
available
for future
issuance
under equity
compensation
plans
(excluding
securities
reflected in
column
(a))
(a)
Number of
securities
to be issued
upon exercise
of outstanding
options, warrants
and rights
(1)(2)
(b)
Weighted-
average
exercise price of
outstanding
options,
warrants and
rights
Plan category
Equity compensation plans approved by security holders
– $
–
9,800
Equity compensation plans not approved by security holders (1)(3)
438,547 $
10.94
3,028,845
Totals
438,547 $
10.94
3,038,645
_____________
(1) The description of the material terms of non-plan issuances of equity instruments is discussed in Note 5 to the accompanying
consolidated financial statements.
(2) Net of equity instruments forfeited, exercised or expired.
(3) On March 31, 2016 we had 3,028,845 shares available under our 2010 Stock Incentive Plan.
33
2000 Stock Option Plan
Our 2000 Stock Option Plan provides for the grant of incentive stock options to our full-time employees (who may also be
directors) and nonstatutory stock options to non-employee directors, consultants, customers, vendors or providers of significant services.
The exercise price of any incentive stock option may not be less than the fair market value of the common stock on the date of grant or, in
the case of an optionee who owns more than 10% of the total combined voting power of all classes of our outstanding stock, not be less
than 110% of the fair market value on the date of grant. The exercise price, in the case of any nonstatutory stock option, must not be less
than 75% of the fair market value of the common stock on the date of grant. The amount reserved under the 2000 Stock Option Plan is
10,000 options.
At March 31, 2016, all of the grants previously made under the 2000 Stock Option Plan had expired and 200 common shares had
been issued under the plan, with 9,800 available for future issuance.
2010 Stock Incentive Plan
In August 2010, we adopted the 2010 Stock Incentive Plan, which provides incentives to attract, retain and motivate employees
and directors whose present and potential contributions are important to our success by offering them an opportunity to participate in our
future performance through awards of options, the right to purchase common stock, stock bonuses and stock appreciation rights and other
awards. We initially reserved a total of 70,000 common shares for issuance under the 2010 Stock Incentive Plan.
In August 2010, we filed a registration statement on Form S-8 for the purpose of registering 70,000 common shares issuable under
this plan under the Securities Act, and in July 2012, we filed a registration statement on Form S-8 for the purpose of registering 100,000
common shares issuable under this plan under the Securities Act.
On January 26, 2016, our Board of Directors approved an amendment to the 2010 Stock Incentive Plan to increase the total
number of shares of common stock reserved for issuance under the plan to 3,170,000 shares, subject to amendment of our Articles of
Incorporation to increase our authorized common stock. On March 29, 2016, we held an annual stockholders meeting, at which our
stockholders approved the Amended 2010 Stock Incentive Plan and an amendment of our Articles of Incorporation to increase our
authorized common stock to 30,000,000 shares. On March 31, 2016, we filed a Certificate of Amendment to our Articles of Incorporation
to effect the increase in our authorized common stock. As a result of such amendment, the Amended 2010 Stock Incentive Plan became
effective on March 31, 2016.
At March 31, 2016, we had 3,028,845 shares available under this plan.
2012 Directors Compensation Program
In July 2012, our Board of Directors approved a board compensation program that modifies and supersedes the 2005 Directors
Compensation Program, which was previously in effect. Under the 2012 program, in which only non-employee directors may participate,
an eligible director will receive a grant of $35,000 worth of ten-year options to acquire shares of common stock, with such grant being
valued at the exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first
day of the fiscal year. In addition, under this program, eligible directors will receive cash compensation equal to $500 for each committee
meeting attended and $1,000 for each formal board meeting attended.
In the fiscal year ended March 31, 2013, our Board of Directors granted ten-year options to acquire an aggregate of 33,342 shares
of our common stock, all with an exercise price of $3.80 per share, to our four outside directors under the 2012 program.
In the fiscal year ended March 31, 2014, our Board of Directors granted ten-year options to acquire an aggregate of 31,911 shares
of our common stock, all with an exercise price of $4.10 per share, to our five outside directors under the 2012 program.
In the fiscal year ended March 31, 2015, our Board of Directors granted ten-year options to acquire an aggregate of 11,053 shares
of our common stock, all with an exercise price of $9.50 per share, to our three outside directors under the 2012 program. No stock option
grants were issued to directors during the fiscal year ended March 31, 2016.
34
At March 31, 2016 we had issued 26,757 options under the old 2005 program to outside directors and 79,309 options to employee-
directors, 21,756 outside directors’ options had been forfeited, 5,000 outside directors’ options had been exercised, 79,309 employee-
directors’ options had been forfeited and no options under the old 2005 program remained outstanding.
On June 6, 2014, our Board of Directors approved certain changes to the 2012 program. Under this modified program, a new
eligible director will receive an initial grant of $50,000 worth of options to acquire shares of common stock, with such grant being valued at
the exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first day of the
fiscal year. These options will have a term of ten years and will vest 1/3 upon grant and 1/3 upon each of the first two anniversaries of the
date of grant. In addition, at the beginning of each fiscal year, each existing director eligible to participate in the modified 2012 program
also will receive a grant of $35,000 worth of options valued at the exercise price based on the average of the closing bid prices of the
common stock for the five trading days preceding the first day of the fiscal year. Such options will vest on the first anniversary of the date
of grant. In lieu of per meeting fees, eligible directors will receive an annual board retainer fee of $30,000. The modified 2012 program
also provides for the following annual retainer fees: Audit Committee Chair - $5,000, Compensation Committee chair - $5,000, Audit
Committee member - $4,000, Compensation Committee member - $4,000 and lead independent director - $15,000.
Stand-alone grants
From time to time our Board of Directors grants common stock or common share purchase options or warrants to selected
directors, officers, employees and consultants as equity compensation to such persons on a stand-alone basis outside of any of our formal
stock plans. The terms of these grants are individually negotiated. There were no stock option grants to either employees or directors during
the fiscal year ended March 31, 2016.
ITEM 6. SELECTED FINANCIAL DATA
As a Smaller Reporting Company, we are not required to furnish information under this Item 6.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the consolidated Financial Statements and Notes thereto
appearing elsewhere in this Annual Report.
Overview
We are a medical device company focused on creating innovative devices that address unmet medical needs in cancer, infectious
disease and other life-threatening conditions. At the core of our developments is the Aethlon ADAPT system, a medical device platform
that converges single or multiple affinity drug agents with advanced plasma membrane technology to create therapeutic filtration devices
that selectively remove harmful particles from the entire circulatory system without loss of essential blood components.
In June 2013, the U.S. Food and Drug Administration, or FDA, approved our investigational device exemption application to
initiate a ten-patient human clinical trial in one location in the U.S. to treat dialysis patients who are infected with the Hepatitis C virus.
Successful outcomes of that human trial as well as at least one follow-on human trial will be required by the FDA in order to commercialize
our products in the U.S. The regulatory agencies of certain foreign countries where we intend to sell this device will also require one or
more human clinical trials.
Some of our patents may expire before we receive FDA approval to market our products in the U.S. or we receive approval to
market our products in a foreign country. However, we believe that certain patent applications and/or other patents issued more recently
will help protect the proprietary nature of the Hemopurifier treatment technology.
Through our majority-owned subsidiary, Exosome Sciences, Inc., or Exosome, we are also studying potential diagnostic
techniques for identifying and monitoring neurological conditions and cancer. We consolidate Exosome’s activities in our consolidated
financial statements.
35
Fiscal Years Ended March 31, 2016 and 2015
Results of Operations
Revenues
We recorded government contract revenue in the fiscal years ended March 31, 2016 and 2015. This revenue arose from work
performed under our government contract with the Defense Advanced Research Projects Agency, or DARPA, and our subcontract with
Battelle Memorial Institute, or Battelle, as follows:
DARPA contract
Battelle subcontract
Total government contract revenue
DARPA Contract
Fiscal Year
Fiscal year
Ended 3/31/16
Ended 3/31/15
Change in
Dollars
$
$
863,011 $
23,561
886,572 $
630,887 $
131,530
762,417 $
232,124
(107,969)
124,155
We entered into a contract with DARPA on September 30, 2011. Under the DARPA award, we have been engaged to develop a
therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that often results in the death of combat-injured soldiers.
The award from DARPA was a fixed-price contract with potential total payments to us of $6,794,389 over the course of five years. Fixed
price contracts require the achievement of multiple, incremental milestones to receive the full award during each year of the contract.
Under the terms of the contract, we will perform certain incremental work towards the achievement of specific milestones against which
we will invoice the government for fixed payment amounts.
Originally, only the base year (year one of the contract) was effective for the parties; however, DARPA subsequently exercised
the option on the second, third, fourth and fifth years of the contract. The milestones are comprised of planning, engineering and clinical
targets, the achievement of which in some cases will require the participation and contribution of third party participants under the contract.
We cannot assure you that we alone, or with third party participants, will meet such milestones to the satisfaction of the government and in
compliance with the terms of the contract or that we will be paid the full amount of the contract revenues during any year of the contract
term. We commenced work under the contract in October 2011.
In February 2014, DARPA reduced the scope of our contract in years three through five of the contract. The reduction in scope
focused our research on exosomes, viruses and blood processing instrumentation. This scope reduction reduced the possible payments under
the contract by $858,469 over years three through five.
In the fiscal year ended March 31, 2016, we reported $863,011 in contract revenue for that fiscal year and in the fiscal year ended
March 31, 2015, we reported $630,887 in contract revenue for that fiscal year.
As of March 31, 2016, we had invoiced DARPA for contract payments totaling $5,548,573 over the course of the contract.
Battelle Subcontract
We entered into a subcontract agreement with Battelle in March 2013. Battelle was chosen by DARPA to be the prime contractor
on the systems integration portion of the original DARPA contract, and we are one of several subcontractors on that systems integration
project. The Battelle subcontract is under a time and materials basis and we began generating revenues under the subcontract in the three
months ended September 30, 2013. Our expected future revenue from the subcontract will be at the discretion of Battelle. The Battelle
subcontract is our first cost-reimbursable contract.
Our revenue under this contract is a function of cost reimbursement plus an overhead mark-up for hours devoted to the project by
specific employees (with specific hourly rates for those employees), for travel expenses related to the project, for any equipment purchased
for the project and for the cost of any consultants hired by us to perform work on the project. Each payment will require approval by the
program manager at Battelle.
Operating Expenses
Consolidated operating expenses were $5,271,406 for the fiscal year ended March 31, 2016 compared to $4,755,270 in the fiscal
year ended March 31, 2015, an increase of $516,136. The net increase of $516,136 was due to increases in professional fees of $686,900
and to an increase in general and administrative expense of $21,898, which were partially offset by a decrease in payroll and related
expenses of $192,662.
The $686,900 increase in our professional fees arose from a $815,125 increase in non-DARPA-related professional fees, which
was partially offset by a decrease in DARPA-related professional fees of $36,446 and a decrease in Exosome’s professional fees of
$91,779.
36
The $815,125 increase in our non-DARPA-related professional fees was primarily due to $424,264 of credits and write-offs on
accrued professional fees taken in the fiscal year ended March 31, 2015 as part of a negotiation of payoffs of those accrued fees. There was
no comparable activity in the 2016 period. Without those write-offs in the 2015 period, our non-DARPA-related professional fees in the
2016 period were $390,861 over the pre write-off amount of non-DARPA-related professional fees in the 2015 period. That increase was
due to a combination of an increase in our US clinical trial expenses of $84,212, an increase of scientific consulting expenses of $138,471,
an increase in business development expense of $71,579 and an increase in our legal fees of $125,525, which largely related to work on
financings and related registration statement filings.
The $21,898 increase in general and administrative expenses primarily arose from a $183,819 increase in our general and
administrative expenses, which was partially offset by a $130,233 decrease in general and administrative expenses at Exosome and a
$31,690 decrease in our DARPA-related general and administrative expenses. The $183,819 increase arose from a combination of $100,000
in Nasdaq listing fees and an increase of $70,161 in conference and trade show expenses.
The $192,662 decrease in payroll and related expenses was principally driven by a $258,240 decrease in the payroll and related
expenses of Exosome due to headcount reductions and a $213,637 reduction in our stock-based compensation, which were partially offset
by a $279,215 increase in payroll and related expenses of Aethlon Medical due primarily to salary increases and bonus payments.
Other Expense (Income)
In the fiscal year ended March 31, 2016, we recognized other expenses of $573,782 compared to $2,986,641 of other expense in
the fiscal year ended March 31, 2015. The following table breaks out the various components of our other expense over the fiscal years
ended March 31, 2016 and 2015:
Loss on debt conversion
Interest and other debt expenses
Other (income)
Total other expense
Components of Other Expense
in Fiscal Year Ended
March 31,
2015
March 31,
2016
Change
$
– $
2,753,989 $
(2,753,989)
573,782
452,276
121,506
–
(219,624)
219,624
$
573,782 $
2,986,641 $
(2,412,859)
We recorded a loss on debt conversion of $2,753,989 in the fiscal year ended March 31, 2015, which arose from the conversion to
equity of principal and accrued interest on certain notes payable. There was no comparable loss on debt conversion in the fiscal year ended
March 31, 2016.
Other income for the fiscal year ended March 31, 2015 included a gain of $362,800 related to a reduction in our accrued damages
due to various debt settlements over the fiscal year and a charge of $143,176 for the change in fair value related to the extension of the
warrants of a note holder in exchange for a postponement in the agreed payment date of his notes.
Our interest and other debt expense increased by $121,506 from the fiscal year ended March 31, 2015 to the fiscal year ended
March 31, 2016. The following table breaks out the various components of our interest expense over the fiscal years ended March 31, 2016
and 2015:
Components of Interest Expense and Other Debt
Expenses in Fiscal Year Ended
March 31,
2015
March 31,
2016
Change
Interest expense
$
56,549 $
166,899 $
(110,350)
Amortization of deferred financing costs
144,683
118,147
26,536
Amortization of note discounts
372,550
155,230
217,320
Note restructuring expense
–
12,000
(12,000)
Total interest and other debt expenses
$
573,782 $
452,276 $
121,506
37
As noted in the above table, the primary factor in the $121,506 overall increase in interest and other debt expenses was a $217,320
increase in the amortization of note discounts. That increase was due to a full year of amortization in the fiscal year ended March 31, 2016
compared to a partial year of amortization in the previous fiscal year since the related convertible notes that were assigned the note
discount were funded in November 2014.
As a result of the above factors, our net loss before noncontrolling interests decreased from $6,979,494 for the fiscal year ended
March 31, 2015 to $4,958,616 for the fiscal year ended March 31, 2016.
Liquidity and Capital Resources
At March 31, 2016, we had a cash balance of $2,123,737 and working capital of $1,877,532. This compares to a cash balance of
$855,596 and working capital of $630,420 at March 31, 2015. Between April 1, 2016 and June 28, 2016, we billed $4,635 and collected
$204,106 under our government contracts. Significant additional financing must be obtained in order to provide a sufficient source of
operating capital and to allow us to continue to operate as a going concern. In addition, we will need to raise capital to complete the
approved human clinical trial in the U.S. We anticipate the primary source of this additional financing will be from proceeds of the
Company’s at-the-market offering program.
We raised $5,591,988 in net proceeds from a financing in June 2015. That amount, coupled with previously existing funds on hand
and expected revenues from our government contracts, has financed our operations into the first quarter of the fiscal year ending March 31,
2017. However, we will require significant additional financing to complete the current and expected additional future clinical trials in the
U.S., as well as fund all of our continued research and development activities for the Hemopurifier and products on our Aethlon ADAPT
platform through the remainder of the fiscal year ending March 31, 2017. In addition, as we expand our activities, our overhead costs to
support personnel, laboratory materials and infrastructure will increase. Should the financing we require to sustain our working capital
needs be unavailable to us on reasonable terms, if at all, when we require it, we may be unable to support our research and U.S. Food and
Drug Administration, or FDA, clearance activities including our planned clinical trials. The failure to implement our research and clearance
activities would have a material adverse effect on our ability to commercialize our products.
Future capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials, the
number and breadth of our clinical programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market
developments, as well as our ability to establish collaborative arrangements, effective commercialization, marketing activities and other
arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern,
which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have
incurred continuing losses from operations and at March 31, 2016 had an accumulated deficit of approximately $86,502,000. These factors,
among other matters, raise substantial doubt about our ability to continue as a going concern. A significant amount of additional capital will
be necessary to advance the development of our products to the point at which they may become commercially viable. We intend to fund
operations, working capital and other cash requirements for the fiscal year ending March 31, 2017 through debt and/or equity financing
arrangements as well as through revenues and related cash receipts under our government contracts.
We are currently addressing our liquidity issue by seeking additional investment capital through issuances of common stock under
our existing S-3 registration statement and by applying for additional grants issued by government agencies in the United States. We
believe that our cash on hand and funds expected to be received from additional debt and equity financing arrangements will be sufficient to
meet our liquidity needs for fiscal 2017. However, no assurance can be given that we will receive any funds in addition to the funds we
have received to date.
The successful outcome of future activities cannot be determined at this time and there is no assurance that, if achieved, we will
have sufficient funds to execute our intended business plan or generate positive operating results.
The consolidated financial statements do not include any adjustments related to this uncertainty and as to the recoverability and
classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to
continue as a going concern.
Cash Flows
Cash flows from operating, investing and financing activities, as reflected in the accompanying Consolidated Statements of Cash
Flows, are summarized as follows (in thousands):
Cash (used in) provided by:
Operating activities
Investing activities
Financing activities
(In thousands)
For the year ended
March 31,
2016
March 31,
2015
$
(4,329) $
(9)
5,607
(5,049)
–
4,655
Net increase (decrease) in cash
Net Cash from Operating Activities.
$
1,269 $
(394)
We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was approximately
$4,329,000 in fiscal 2016 compared to net cash used in operating activities of approximately $5,049,000 in fiscal 2015, a decrease of
approximately $720,000. The $720,000 decrease was primarily due to the combination of the use of approximately $1,802,000 in fiscal
2015 to pay down accounts payable, related party payables and other current liabilities and an increase in fiscal 2016 in the cash used in
operations before changes in operating assets and liabilities of approximately $1,017,000.
38
Net Cash from Investing Activities.
During the fiscal year ended March 31, 2016, we purchased approximately $9,000 of equipment while in the fiscal year ended
March 31, 2015 we did not use any cash for purchases of equipment.
Net Cash from Financing Activities.
Net cash generated from financing activities increased from approximately $4,655,000 in the fiscal year ended March 31, 2015 to
approximately $5,607,000 in the fiscal year ended March 31, 2016. The net cash provided by financing activities in fiscal 2016 was all
from the issuance of common stock, while the net cash provided by financing activities in fiscal 2015 arose from approximately $4,763,000
from the issuance of common stock and $415,000 from the issuance of notes payable, which was partially offset by approximately
$523,000 in repayments of notes payable in cash.
At the date of this filing, we plan to invest significantly into purchases of our raw materials and into our contract manufacturing
arrangement.
Current Events
Common Stock Sales Agreement with H.C. Wainwright
On June 28, 2016, we entered into a Common Stock Sales Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC
(“H.C. Wainwright”) which establishes an at-the-market equity program pursuant to which we may offer and sell shares of our common
stock from time to time as set forth in the Agreement. The Agreement provides for the sale of shares of our common stock having an
aggregate offering price of up to $12,500,000 (the “Shares”).
Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright will use its commercially reasonable efforts
consistent with its normal trading and sales practices to sell the Shares from time to time, based upon our instructions. We have provided
H.C. Wainwright with customary indemnification rights, and H.C. Wainwright will be entitled to a commission at a fixed rate equal to three
percent (3.0%) of the gross proceeds per Share sold. In addition, we have agreed to pay certain expenses incurred by H.C. Wainwright in
connection with the Agreement, including up to $50,000 of the fees and disbursements of their counsel. The Agreement will terminate upon
the sale of all of the Shares under the Agreement unless terminated earlier by either party as permitted under the Agreement.
Sales of the Shares, if any, under the Agreement shall be made in transactions that are deemed to be “at the market offerings” as
defined in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq
Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell any of the Shares, and, at any
time, we may suspend offers under the Agreement or terminate the Agreement.
Amendment of November 2014 Investment Documents
On June 27, 2016, we and certain investors (the “Investors”) entered into Amendments (the “Amendments”) to our November
2014 convertible notes in the original principal amount of $527,780 (the “Notes”) and Class A Common Stock Purchase Warrants to
purchase an aggregate of 47,125 shares of common stock (the “Existing Warrants”) issued and sold by us to the Investors under a
Subscription Agreement dated November 6, 2014. The Amendments provide that the Maturity Date (as defined in the Notes) is extended
from June 1, 2016 to July 1, 2017 and that the Conversion Price (as defined in the Notes) is reduced from $5.60 per share of common stock
to $5.00 per share of common stock. In addition, we reduced the purchase price (as defined in the Existing Warrants) from $8.40 per share
to $5.00 per share. In connection with these modifications, each of the Investors signed a Consent and Waiver providing its consent under
certain restrictive provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under a Securities
Purchase Agreement dated June 23, 2015, (the “2015 SPA”) to which we, the Investors and certain other investors are parties, in order to
facilitate the at-the-market equity program described above.
The Amendments also increase the principal amount of the Notes to $692,811.23 (in the aggregate) to (i) include accrued and
unpaid interest through June 15, 2016, and (ii) increase the principal amount by $80,000 (in the aggregate) as an extension fee for the
extended maturity date of the Notes set forth above. With respect to each Note, we entered into an Allonge to Convertible Promissory Note
(each, an “Allonge”) reflecting the changes in the principal amount, Maturity Date and Conversion Price of the Note.
We also issued to the Investors new warrants (the “New Warrants”) to purchase an aggregate of 30,000 shares of common stock
with a Purchase Price (as defined in the New Warrants) of $5.00 per share of common stock. We issued the New Warrants in substantially
the same form as the Existing Warrants, and the New Warrants will expire on November 6, 2019, the same date on which the Existing
Warrants will expire.
39
Amendment of December 2014 Warrants
On June 27, 2016, we and certain investors (the “Unit Investors”) entered into Consent and Waiver and Amendment agreements
(the “CWAs”), relating to an aggregate of 264,000 Warrants to Purchase Common Stock (the “Unit Warrants”) we had issued to the Unit
Investors on December 2, 2014 pursuant to a Securities Purchase Agreement dated November 26, 2014 (the “2014 SPA”). In the CWAs,
each of the Unit Investors provided its consent under certain restrictive provisions, and waived certain rights, including a right to participate
in certain offerings made by us, under the 2014 SPA in order to facilitate the at-the-market equity program described above. Pursuant to the
CWAs, we reduced the Exercise Price (as defined in the Unit Warrants) from $15.00 per share of common stock to $5.00 per share of
common stock. At any time that the shares of common stock underlying the Unit Warrants are covered by an effective registration
statement that permits the public resale of the shares, if the Unit Investors exercise the Unit Warrants, they must do so in a cash exercise,
which could yield up to $1,320,000 in proceeds to us.
On June 27, 2016, each of the Unit Investors also entered into a Consent and Waiver providing its consent under certain
provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under the 2015 SPA in order to
facilitate the at-the market equity program described above.
Critical Accounting Policies
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United
States of America (“GAAP”) requires us to make a number of estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect
the reported amounts of expenses during the reporting period. On an ongoing basis, we evaluate estimates and assumptions based upon
historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the
circumstances; however, actual results may differ from these estimates under different future conditions. We believe that the estimates and
assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most
difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical
accounting estimates relate to revenue recognition, stock purchase warrants issued with notes payable, beneficial conversion feature of
convertible notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation
allowance, and contingencies.
Fair Value Measurements
We measure the fair value of applicable financial and non-financial instruments based on the following fair value hierarchy:
·
·
·
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated by market data.
The hierarchy noted above requires us to minimize the use of unobservable inputs and to use observable market data, if available,
when determining fair value.
The fair value of derivative liabilities was determined based on unobservable inputs that are not corroborated by market data,
which is a Level 3 classification. We recorded derivative liabilities on our balance sheet at fair value with changes in fair value recorded in
our consolidated statements of operations. At March 31, 2016, we had no derivative liabilities.
40
Revenue Recognition
With respect to revenue recognition, we entered into a government contract with DARPA and have recognized revenue during the
fiscal years ended March 31, 2016 and 2015 of $863,011 and $630,887, respectively, under such contract. We adopted the Milestone
method of revenue recognition for the DARPA contract under Financial Accounting Standards Board’s Accounting Standards Codification
(“ASC”) 605-28 “Revenue Recognition – Milestone Method” and we believe we meet the requirements under ASC 605-28 for reporting
contract revenue under the Milestone Method for the fiscal years ended March 31, 2016 and 2015.
We also recognize revenue for a secondary smaller contract under a time and materials non-fixed price basis where we recognize
revenue as the services are performed.
Stock Purchase Warrants
We grant warrants in connection with the issuance of certain notes payable and other financing transactions. When such warrants
are classified as equity, we measure the relative estimated fair value of such warrants which represents a discount from the face amount of
the notes payable. Such discounts are amortized to interest expense over the term of the notes. We analyze such warrants for classification
as either equity or derivative liabilities and value them based on binomial lattice models.
Beneficial Conversion Feature of Notes Payable
The convertible feature of certain notes payable provides for a rate of conversion that is below market value. Such feature is
normally characterized as a "beneficial conversion feature” of which we measure the estimated fair value in circumstances in which the
conversion feature is not required to be separated from the host instrument and accounted for separately, and record that value in the
consolidated financial statements as a discount from the face amount of the notes. Such discounts are amortized to interest expense over the
term of the notes.
Share-based Compensation
We account for share-based compensation awards using the fair-value method and record such expense based on the grant date
fair value in the consolidated financial statements over the requisite service period.
Derivative Instruments
We evaluate free-standing derivative instruments (or embedded derivatives) to properly classify such instruments within equity or
as liabilities in our financial statements. Our policy is to settle instruments indexed to our common shares on a first-in-first-out basis.
The classification of a derivative instrument is reassessed at each reporting date. If the classification changes as a result of events
during a reporting period, the instrument is reclassified as of the date of the event that caused the reclassification. There is no limit on the
number of times a contract may be reclassified.
Instruments classified as derivative liabilities are remeasured each reporting period (or upon reclassification) and the change in fair
value is recorded on our consolidated statement of operations in other expense (income). We had no derivative instruments at March 31,
2016 and at March 31, 2015.
Income Taxes
Deferred tax assets are recognized for the future tax consequences attributable to the difference between the consolidated
financial statements and their respective tax basis. Deferred income taxes reflect the net tax effects of (a) temporary differences between
the carrying amounts of assets and liabilities for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax
credit carryforwards. We record a valuation allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in
the foreseeable future, it is more likely than not that some portion of the deferred tax assets may not be realized.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect
on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or
capital resources that is material to investors.
41
Convertible Notes Payable and Warrants
NOVEMBER 2014 10% CONVERTIBLE NOTES
In November 2014, we entered into a subscription agreement with two accredited investors providing for the issuance and sale of (i)
convertible promissory notes in the aggregate principal amount of $527,780 and (ii) five year warrants to purchase up to 47,123 shares of
common stock at a fixed exercise price of $8.40 per share. These notes bear interest at the annual rate of 10% and mature on April 1, 2016.
The aggregate gross cash proceeds to us were $415,000 after subtracting legal fees of $35,000; the balance of the principal amount of the
notes represents a $27,780 due diligence fee and an original issuance discount. We recorded deferred financing costs of $112,780 to reflect
the legal fees, due diligence fee and original issuance discount and will amortize those costs over the life of the notes using the effective
interest method.
The estimated relative fair value of warrants issued in connection with the November 2014 10% Convertible Notes was recorded as a debt
discount and is amortized as additional interest expense over the term of the underlying debt. We recorded debt discount of $240,133 based
on the relative fair value of these warrants. In addition, as the effective conversion price of the debt was less than market price of the
underlying common stock on the date of issuance, we recorded an additional debt discount of $287,647 related to the beneficial conversion
feature. As of December 31, 2015, the $527,780 principal amount outstanding under this agreement is presented net of unamortized debt
discount of $93,137.
These notes are convertible at the option of the holders into shares of our common stock at a fixed price of $5.60 per share, for up to an
aggregate of 94,246 shares of common stock for the principal balance and the accrued interest through March 31, 2016 is convertible into
an additional 13,222 shares for a total amount of 107,468 shares. There are no registration requirements with respect to the shares of
common stock underlying the notes or the warrants.
The pricing on both the conversion price and on the warrant exercise price reflected a negotiation that began in September 2014 and
continued through funding in November 2014. During that period of time the price of our common stock rose significantly, which
complicated the pricing negotiations. We ended up with pricing the notes and warrants at levels consistent with our prior equity unit
issuances in October 2014.
Amendments of Convertible Promissory Note Terms
On November 12, 2015, we entered into an Amendment of Terms with the two investors that participated in the November 2014 10%
Convertible Notes. The Amendment of Terms modifies the terms of the subscription agreement, notes and warrants to, among other things,
extend the maturity date of the notes from April 1, 2016 to June 1, 2016, temporarily reduce the number of shares that we must reserve with
respect to conversion of the notes, and temporarily suspend the time period during which one of the investors may exercise its warrants in
order to provide us with additional authorized shares to issue as part of our ordinary business operations. In exchange for the investors’
agreements in the Amendment of Terms, we paid one of the investors a cash fee of $90,000, which we recorded as deferred financing costs
and will amortize over the remaining term of the notes. During the fiscal year ended March 31, 2016, $62,308 of amortization related to the
amendment has been included in interest expense in the accompanying consolidated statements of operations.
On June 27, 2016, the maturity date of the November 2014 10% Convertible Notes was extended through July 1, 2017 (see Recent
Developments above). Therefore, we classified the notes as non-current liabilities.
AMENDED AND RESTATED SERIES A 12% CONVERTIBLE NOTES
In June 2010, we entered into Amended and Restated Series A 12% Convertible Promissory Notes (the "Amended and Restated Notes")
with the holders of certain promissory notes previously issued by us, extending the due date to December 31, 2010 on the aggregate
principal balance of $900,000. During the fiscal year ended March 31, 2013, the holders of $15,000 of the Notes converted their principal
and related accrued interest into common stock. During the fiscal year ended March 31, 2015, the holders of the remaining $885,000 of the
Notes converted their principal and related accrued interest into common stock. There was no balance remaining at March 31, 2015.
The following transactions related to the Amended and Restated Notes impacted our consolidated statements of operations and statements
of cash flows in the fiscal year ended March 31, 2015.
Weiner Note Conversion
On June 24, 2014, we entered into an agreement with the Ellen R. Weiner Family Revocable Trust (the “Trust”), a holder of a Series A
12% Convertible Note (the “Note”), which previously was classified as being in default. As per the agreement, the Trust converted past due
principal of $660,000 and accrued interest balance of $343,200 into unregistered common stock, representing all amounts outstanding to
the Trust.
42
Additionally, the Trust agreed to waive anti-dilution price protection underlying warrants previously issued to the Trust. On June 26, 2014,
three other parties who held similar warrants also agreed to waive their anti-dilution price protection.
Under its agreement, the Trust converted the entire $1,003,200 past due principal and interest balance on the Note, which previously was in
default, into an aggregate of 466,365 unregistered shares of our common stock and five-year warrants to acquire up to 136,190 shares of our
common stock at an exercise price of $2.10 per share (which exercise price was the result of certain contractual price adjustments
previously made during 2011) and up to 7,944 shares of our common stock at an exercise price of $5.40 per share (collectively, the
“Conversion Securities”). Based on the fair value of the warrants and shares issued to the Trust for the accrued interest, we recorded a loss
on settlement of notes of $1,791,421 during the fiscal year ended March 31, 2015.
In exchange for the Trust’s conversion in full of the Note and accrued interest and for the waivers of anti-dilution price protection in the
previously issued warrants, in addition to the Conversion Securities, we issued to the Trust 1,500 unregistered shares of common stock as a
service fee, changed the exercise price of all of the previously issued warrants to $2.10 per share and extended the expiration date of all of
the previously issued warrants to July 1, 2018. We valued the 1,500 share service fee at $12,000 based on our closing price on the date of
the agreement and recorded that value as interest expense during the June 2014 period.
Bird Estate Extension
On July 8, 2014, we executed a written restructuring agreement (the “Agreement”) with the Estate of Allan Bird (the “Estate”), a holder of
a Series A 12% Convertible Note (the “Note”), which previously was classified as being in default. Since the negotiations for the
Agreement were completed in the month of June, we recorded the impact of the Agreement as of June 30, 2014. In the Agreement, the
Estate agreed to extend the expiration date of the Note to April 1, 2016, to convert approximately $116,970 of accrued interest to equity,
and to waive anti-dilution price protection underlying the Note and warrants previously issued to the Estate.
Under the Agreement, the Estate converted the entire $116,970 past due interest balance on the Note, which previously was in default, into
an aggregate of 51,837 unregistered shares of our common stock. The Estate received five-year warrants to acquire up to 46,429 shares of
our common stock at an exercise price of $2.10 per share (which exercise price was the result of certain contractual price adjustments
previously made during 2011). Based on our common stock prices during a period of negotiation with the Estate including during calendar
year 2013, the Estate also received five-year warrants to acquire up to 2,708 shares of our common stock at an exercise price of $5.40
(collectively known as the “Conversion Securities”). Based on the fair value of the warrants and shares issued to the Estate for the accrued
interest, we recorded a loss on settlement of notes of $663,209 during the fiscal year ended March 31, 2015.
In exchange for the Estate’s extension of the Note, conversion of accrued interest and for the waivers of anti-dilution price protection in the
previously issued warrants, in addition to the Conversion Securities, we also issued to the Estate 500 unregistered shares of common stock
as an extension fee and extended the expiration date of all of the previously issued warrants to July 1, 2018. We valued the 500 share
extension fee at $4,500 based on our closing price and recorded that value as a deferred financing cost, which we will amortize over the
extended two year life of the Note.
Bird Estate Conversion
In November 18, 2014, we issued an aggregate of 112,500 shares of common stock to the Estate upon the conversion of an aggregate of
$236,250 representing all $225,000 of unpaid principal and $11,250 of unpaid accrued interest due under the Note. The conversion price
per share was $2.10.
Securities Issued for Services
Historically, we have issued securities in payment of services to reduce our obligations and to avoid using our cash resources. In
the fiscal year ended March 31, 2016 we did not issue any securities in the payment of services. In the fiscal year ended March 31, 2015 we
issued 27,654 common shares for services of which 8,587 were unregistered and were for investor relations services and corporate
communications services. Included in the 27,654 common shares issued for services are 19,068 shares, registered under Form S-8
registration statements, which were issued as follows: 693 for financial consulting, 6,425 for scientific consulting and 11,950 for legal
services. The average price (premium) discount of common shares issued for these services, weighted by the number of shares issued for
services in this period, was approximately (6.6)%.
43
Securities Issued for Debt
Historically, we have also issued securities for debt to reduce our obligations to avoid using our cash resources. In the fiscal year
ended March 31, 2016 we did not issue any securities for debt. In the fiscal year ended March 31, 2015 we issued 948,728 unregistered
common shares for repayment in full of notes, including accrued interest, in the aggregate amount of $2,273,032. The average price
discount of the common stock issued for debt was approximately 75.6%.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a Smaller Reporting Company, we are not required to furnish information under this Item 7A.
ITEM 8. FINANCIAL STATEMENTS
The consolidated financial statements listed in the accompanying Index to Financial Statements are attached hereto and filed as a
part of this Report under Item 15.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934, as amended (the Exchange Act)),, that are designed to ensure that information required to be disclosed, in our Exchange Act
reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such
information is accumulated and communicated to our management, including our principal executive officer and our principal financial
officer, as appropriate, to allow timely decisions regarding required disclosures.
In designing and evaluating the disclosure controls and procedures, we recognized that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we were required
to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as
of the end of the period covered by this report under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
Based on our evaluation and subject to the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that
there were no material weaknesses in our disclosure controls and procedures and that such disclosure controls and procedures were
effective as of the end of the period covered by this report in providing reasonable assurance of achieving the desired control objectives,
and therefore there were no corrective actions taken.
Internal Control over Financial Reporting
(a) Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles.
Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief
Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of March 31, 2016.
According to the guidelines established by Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission, one or more material weaknesses renders a company’s internal control over financial reporting ineffective.
Based on this evaluation, we have concluded that our internal control over financial reporting was effective as of March 31, 2016.
(b) Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended March 31, 2016 that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
We have no disclosure applicable to this item.
44
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Section 16(a) Beneficial Ownership Reporting Compliance
PART III
Section 16(a) of the Securities Exchange Act of 1934 requires our officers, directors, and persons who own more than 10% of a
registered class of our equity securities to file reports of ownership and changes in ownership with the Securities and Exchange
Commission. Officers, directors, and greater than 10% beneficial owners are required by Securities and Exchange Commission regulation
to furnish the Company with copies of all Section 16(a) forms they file. Based solely on our review of copies of the Section 16(a) reports
filed for the fiscal year ended March 31, 2016, we believe that all filing requirements applicable to our officers, directors, and greater than
10% beneficial owners were complied with.
The names, ages and positions of our directors and executive officers as of June 28, 2016 are listed below:
DIRECTORS AND EXECUTIVE OFFICERS
NAMES
James A. Joyce (1)
Rodney S. Kenley (2)
TITLE OR POSITION
Chairman, Chief Executive Officer and Secretary
President and Director
James B. Frakes (3)
Chief Financial Officer and Senior Vice President - Finance
Franklyn S. Barry, Jr.
Edward G. Broenniman
Director
Director
AGE
54
66
59
76
79
Chetan S. Shah, MD
_______________
(1) Effective June 1, 2001, Mr. Joyce was appointed our President and Chief Executive Officer, replacing Mr. Barry, who continues as a
member of the Board of Directors. Mr. Joyce resigned from the position of President upon the appointment of Mr. Kenley to such position
on October 27, 2010.
Director
47
(2) Effective October 27, 2010, Mr. Kenley was appointed as our President.
(3) Effective September 27, 2010, Mr. Frakes was appointed as our Chief Financial Officer.
Certain additional information concerning the individuals named above is set forth below. This information is based on
information furnished us by each individual noted.
James A. Joyce, Chairman, CEO and Secretary.
Mr. Joyce is the founder of Aethlon Medical, Inc. and has been the Chairman of the Board and Secretary since March 1999. On
June 1, 2001, our Board of Directors appointed Mr. Joyce to the additional role of CEO. Mr. Joyce also serves as the Executive Chairman
of Exosome Sciences, Inc. In 1992, Mr. Joyce founded and was the sole stockholder of James Joyce & Associates, an organization that
provided management consulting and corporate finance advisory services to CEOs and CFOs of publicly traded companies. Previously,
from 1989 to 1991, Mr. Joyce was Chairman and Chief Executive Officer of Mission Labs, Inc. Prior to that Mr. Joyce was a principal in
charge of U.S. operations for London Zurich Securities, Inc. Mr. Joyce is a graduate of the University of Maryland. We believe that Mr.
Joyce is qualified to serve as our director because of his role in founding our company and his prior experience, including his experience in
the extracorporeal industry and in the financial markets.
45
Rodney S. Kenley, President and Director
Mr. Kenley has been President and a Director since October 2010. He has 38 years of experience in healthcare, most of which
have been spent in the extracorporeal blood purification arena. Mr. Kenley held several positions at Baxter Healthcare (Travenol) from
1977 through 1990 including International Marketing Manager, Business Unit Manager for Peritoneal and Hemodialysis products, Manager
of New Business Development, Director of Worldwide Product Planning, Director of Advanced Product Development, and VP of
Electronic Drug Infusion. Mr. Kenley founded Aksys Ltd. in January 1991 to develop and commercialize his concept of a daily home
hemodialysis system which was commercially launched in 2002 as the PHD system. In 2004, Mr. Kenley initiated the development of a
second-generation home hemodialysis system in partnership with DEKA Research & Development Corporation in Manchester, New
Hampshire. In 2007, the assets of Aksys Ltd. were acquired by DEKA, where Mr. Kenley was employed prior to joining Aethlon Medical,
Inc. Mr. Kenley received his Bachelor of Arts degree in Biology and Chemistry from Wabash College, a Master’s of Science degree in
Molecular Biology from Northwestern University and a Masters of Management from the Kellogg School of Management, also at
Northwestern University. We believe that Mr. Kenley is qualified to serve as our director as a result of his experience in developing
extracorporeal blood purification products.
James B. Frakes, Chief Financial Officer and Senior Vice President – Finance
Mr. Frakes joined Aethlon Medical, Inc. in January 2008 and brought 16 consecutive years of financial responsibility for publicly
traded companies, as well as specific knowledge and experience in equity and debt transactions, acquisitions, public reporting and
Sarbanes-Oxley Section 404 internal control requirements. Mr. Frakes also serves as the Chief Financial Officer of Exosome Sciences, Inc.
He previously served as the CFO for Left Behind Games Inc., a start-up video game company. Prior to 2006, he served as CFO of NTN
Buzztime, Inc., an interactive entertainment company. Mr. Frakes received an MBA from the University of Southern California and
completed his BA with Honors at Stanford University.
Franklyn S. Barry, Jr., Director
Mr. Barry was President and Chief Executive Officer of Hemex, Inc. from April 1997 through May 31, 2001 and our President
and CEO from March 10, 1999 to May 31, 2001, when he returned to consulting until he retired in 2013. He became a director of Aethlon
Medical, Inc. on March 10, 1999. From 1994 to April 1997, Mr. Barry was a private consultant. Included among his prior experiences are
tenures as President of Fisher-Price and as co-founder and CEO of Software Distribution Services, which today operates as Ingram Micro-
D, an international distributor of personal computer products. Mr. Barry serves on the Board of Directors of Merchants Mutual Insurance
Company. We believe that Mr. Barry is qualified to serve as our director because of his extensive management experience.
Edward G. Broenniman, Director
Mr. Broenniman became a director of Aethlon Medical, Inc. in March 1999. He has been the Managing Director of The Piedmont
Group, LLC, a venture advisory firm, since 1978. Mr. Broenniman recently served on the Board of Directors of publicly traded QuesTech
(acquired by CACI International), and currently serves on the Boards of two privately held firms. His nonprofit Boards are the Dingman
Center for Entrepreneurship's Board of Advisors at the University of Maryland, the National Association of Corporate Directors, National
Capital Chapter and the Board of the Association for Corporate Growth, National Capital Chapter. We believe that Mr. Broenniman is
qualified to serve as our director because of his extensive management experience.
Chetan S. Shah, MD, Director
Dr. Shah became a director of Aethlon Medical, Inc. in June 2013. Dr. Shah is a board certified Otolaryngologist. He is an
Advisory Board Member at The Bank of Princeton, and a partner and Board member of the Surgery Center at Hamilton as well as
Physician Management Systems and Princeton Eye & Ear, which he founded in 2009. Dr. Shah serves on the board of two other private
companies. He holds teaching positions and serves on multiple hospital committees in the area and is on the Audiology and Speech
Language Pathology Committee for the State of New Jersey. He also is a member of the Board of Medical Examiners for the State of New
Jersey. Dr. Shah received his Bachelor’s degree and Medical Degree from Rutgers University and Robert Wood Johnson Medical School.
We believe that Dr. Shah is qualified to serve as our director because of his medical background as both a board certified Otolaryngologist
and a member of various medical boards and hospital committees in New Jersey.
Board of Directors
Our Board of Directors has the responsibility for establishing broad corporate policies and for overseeing our overall performance.
Members of the Board of Directors are kept informed of our business activities through discussions with the CEO, President and other
officers, by reviewing analyses and reports sent to them, and by participating in Board and committee meetings. Our bylaws provide that
each of the directors serves for a term that extends to our next annual meeting of stockholders. Our Board of Directors presently has an
Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee, on each of which Messrs. Barry
and Broenniman and Dr. Shah serve. Mr. Barry is Chairman of the Audit Committee, Mr. Broenniman is Chairman of the Nominating and
Corporate Governance Committee, and Dr. Shah is Chairman of the Compensation Committee.
46
In July 2012, our Board of Directors approved a board compensation program that modifies and supersedes the 2005 Directors
Compensation Program, which was previously in effect. Under the 2012 program, in which only non-employee directors may participate,
an eligible director will receive a grant of $35,000 worth of ten-year options to acquire shares of common stock, with such grant being
valued at the exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first
day of the fiscal year. In addition, under this program, eligible directors will receive cash compensation equal to $500 for each committee
meeting attended and $1,000 for each formal board meeting attended.
In the fiscal year ended March 31, 2013, our Board of Directors granted ten-year options to acquire an aggregate of 33,342 shares
of our common stock, all with an exercise price of $3.80 per share, to our four outside directors under the 2012 program.
In the fiscal year ended March 31, 2014, our Board of Directors granted ten-year options to acquire an aggregate of 31,911 shares
of our common stock, all with an exercise price of $4.10 per share, to our five outside directors under the 2012 program.
In the fiscal year ended March 31, 2015, our Board of Directors granted ten-year options to acquire an aggregate of 11,053 shares
of our common stock, all with an exercise price of $9.50 per share, to our three outside directors under the 2012 program.
There were no issuances of stock options to our outside directors in the fiscal year ended March 31, 2016.
At March 31, 2016 we had issued 26,757 options under the old 2005 program to outside directors and 79,309 options to employee-
directors, 21,756 outside directors’ options had been forfeited, 5,000 outside directors’ options had been exercised, 79,309 employee-
directors’ options had been forfeited and no options under the old 2005 program remained outstanding.
On June 6, 2014, our Board of Directors approved certain changes to the 2012 program. Under this modified program, a new
eligible director will receive an initial grant of $50,000 worth of options to acquire shares of common stock, with such grant being valued at
the exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first day of the
fiscal year. These options will have a term of ten years and will vest 1/3 upon grant and 1/3 upon each of the first two anniversaries of the
date of grant. In addition, at the beginning of each fiscal year, each existing director eligible to participate in the modified 2012 program
also will receive a grant of $35,000 worth of options valued at the exercise price based on the average of the closing bid prices of the
common stock for the five trading days preceding the first day of the fiscal year. Such options will vest on the first anniversary of the date
of grant. In lieu of per meeting fees, eligible directors will receive an annual board retainer fee of $30,000. The modified 2012 program
also provides for the following annual retainer fees: Audit Committee Chair - $5,000, Compensation Committee chair - $5,000, Audit
Committee member - $4,000, Compensation Committee member - $4,000 and lead independent director - $15,000.
Family Relationships
There are no family relationships between or among the directors, executive officers or persons nominated or chosen by us to
become directors or executive officers.
There are no arrangements or understandings between any two or more of our directors or executive officers or between any of
our directors or executive officers and any other person pursuant to which any director or officer was or is to be selected as a director or
officer, and there is no arrangement, plan or understanding as to whether non-management stockholders will exercise their voting rights to
continue to elect the current Board of Directors. There are also no arrangements, agreements or understandings between non-management
stockholders that may directly or indirectly participate in or influence the management of our affairs.
Involvement in Legal Proceedings
To the best of our knowledge, during the past ten years, none of the following occurred with respect to a present or former director
or executive officer of our company: (1) any bankruptcy petition filed by or against such person or any business of which such person was a
general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a
criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being
subject to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of any competent jurisdiction,
permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or
banking activities; (4) being found by a court of competent jurisdiction (in a civil action), the Securities and Exchange Commission or the
Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been
reversed, suspended or vacated; and (5) being the subject of, or a party to, any federal or state judicial or administrative order, judgment,
decree or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of any federal or state securities or
commodities law or regulation, law or regulation respecting financial institutions or insurance companies or law or regulation prohibiting
mail or wire fraud or fraud in connection with any business entity; or (6) being the subject of, or a party to, any sanction or order, not
subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Securities Exchange
Act of 1934), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange,
association, entity or organization that has disciplinary authority over its members or associated persons.
47
Code of Ethics
On February 23, 2005, the Board of Directors approved a "Code of Business Conduct and Ethics,” which applies to our principal
executive officer, our principal financial officer, our principal accounting officer and persons performing similar tasks. Our Code of
Business Conduct and Ethics is available on our company website at www.aethlonmedical.com.
Audit Committee and Audit Committee Financial Expert
Our Board of Directors formed an Audit Committee in May of 1999. Mr. Franklyn S. Barry, Jr. (the Chairman of the Audit
Committee), Mr. Edward Broenniman and Dr. Chetan S. Shah serve as members of the Audit Committee. The Board of Directors has
determined that each of Mr. Broenniman and Mr. Barry is an "audit committee financial expert" as that term is defined by Item 407 of
Regulation S-K. Each of Mr. Broenniman, Mr. Barry and Dr. Shah meets the NASDAQ Stock Market's independence standards for
members of such audit committees.
ITEM 11. EXECUTIVE COMPENSATION
EXECUTIVE COMPENSATION
The following executive compensation disclosure reflects all compensation awarded to, earned by or paid to the executive officers
below for the fiscal years ended March 31, 2016 and March 31, 2015. The following table summarizes all compensation for fiscal years
2016 and 2015 received by our Chief Executive Officer, and our three most highly compensated executive officers who earned more than
$100,000 in fiscal year 2016.
SUMMARY COMPENSATION TABLE FOR 2016 AND 2015 FISCAL YEARS
NAMED EXECUTIVE
OFFICER AND PRINCIPAL
POSITION
James A. Joyce (1)
CHIEF EXECUTIVE
OFFICER
YEAR
SALARY
($)
BONUS
($)
2016 $ 370,417 $ 275,000 $
$
2015
$ 347,500
95,000
$
STOCK
AWARDS
($)
OPTION
AWARDS
($)(5)
– $
$
–
– $
$
246,000
Richard H. Tullis, PhD (2)
VICE PRESIDENT AND
CHIEF SCIENCE OFFICER
James B. Frakes (3)
CHIEF FINANCIAL
OFFICER AND SVP-
FINANCE
2016 $ 188,000 $
$
2015
$ 195,000
– $
$
5,000
– $
$
–
– $
$
8,200
2016 $ 226,429 $ 125,000 $
$
2015
$ 206,250
31,500
$
– $
$
–
– $
$
41,000
NON-
EQUITY
INCENTIVE
PLAN
COMPEN-
SATION
($)
NON-
QUALIFIED
DEFERRED
COMPEN-
SATION
EARNINGS
($)
ALL
OTHER
COMP.
($)
TOTAL
($)
– $
$
–
– $
$
–
– $
$
–
– $
$
–
– $
$
–
– $
$
–
– $ 645,417
$ 688,500
–
– $ 188,000
$ 208,200
–
– $ 351,429
$ 278,750
–
2016 $ 268,750 $
2015 $ 257,500 $
Rodney S. Kenley (4)
PRESIDENT
_______________
(1) The aggregate number of stock awards and stock option awards issued to Mr. Joyce and outstanding as of March 31, 2016 is 68,000 and
210,000, respectively. Mr. Joyce received a $5,000 salary increase from $325,000 to $330,000 effective July 1, 2013. In June 2014, Mr.
Joyce received a $20,000 salary increase from $330,000 to $350,000. In September 2015, Mr. Joyce received a $35,000 salary increase
from $350,000 to $385,000.
50,000 $
15,000 $
– $
41,000 $
– $ 318,750
– $ 313,500
– $
– $
– $
– $
– $
– $
48
(2) The aggregate number of stock awards and stock option awards issued to Dr. Tullis and outstanding as of March 31, 2016 is zero and
46,000, respectively. On November 7, 2014, we paid Dr. Tullis $5,000 for accrued expenses reimbursable to him. In January 2015, we paid
Dr. Tullis $93,377 in payment of accrued salary. Dr. Tullis resigned as an employee effective February 9, 2016 and is now a consultant to
the Company.
(3) Mr. Frakes was appointed as Chief Financial Officer on September 27, 2010 after previously serving as Senior Vice President-Finance
on a part-time basis. The aggregate number of stock awards and stock option awards issued to Mr. Frakes and outstanding as of March 31,
2016 is zero and 25,000, respectively. In June 2014, Mr. Frakes received a $30,000 salary increase from $180,000 to $210,000. In
September 2015, Mr. Frakes received a $25,000 salary increase from $210,000 to $235,000.
(4) Mr. Kenley was appointed President on October 27, 2011. The aggregate number of stock awards and stock option awards issued to
Mr. Kenley and outstanding as of March 31, 2016 is zero and 35,000, respectively. In June 2014, Mr. Kenley received a $20,000 salary
increase from $240,000 to $260,000. In September 2015, Mr. Kenley received a $15,000 salary increase from $260,000 to $275,000.
(5) See note 5 to our financial statements for the years ended March 31, 2016 and 2015 regarding the assumptions made in valuing the
stock option awards in the above table.
Employment Agreements
We entered into an employment agreement with Mr. Joyce effective April 1, 1999. Effective June 1, 2001, Mr. Joyce was
appointed President and Chief Executive Officer and his base annual salary was increased from $120,000 to $180,000. Effective January 1,
2005, Mr. Joyce's salary was increased from $180,000 to $205,000 per year. Under the terms of the agreement, his employment continues
at a salary of $205,000 per year for successive one-year periods, unless given notice of termination 60 days prior to the anniversary of his
employment agreement. Effective April 1, 2006. Mr. Joyce's salary was increased from $205,000 to $240,000. His salary was subsequently
increased to $265,000 per year and effective May 1, 2008, his salary was increased from $265,000 to $290,000 per year. Effective April 1,
2010, his salary was increased from $290,000 to $325,000 per year. Effective July 2013, his salary was increased from $325,000 to
$330,000 per year. In June 2014, his salary was increased from $330,000 to $350,000 per year. In September 2015, Mr. Joyce received a
$35,000 salary increase from $350,000 to $385,000.
During the fiscal year ended March 31, 2016, Mr. Joyce earned bonuses totaling $100,000 from us, excluding a retention bonus
(see below) and bonuses totaling $75,000 from Exosome Sciences, Inc. During the fiscal year ended March 31, 2015, Mr. Joyce earned
bonuses totaling $50,000 from us and bonuses totaling $45,000 from Exosome Sciences, Inc. All of those bonuses were based upon targets
established by our compensation committee.
Mr. Joyce's employment agreement provides for medical insurance and disability benefits, and one year of severance pay if his
employment is terminated by us without cause or due to change in our control before the expiration of the agreement, and allows for bonus
compensation and stock option grants as determined by our Board of Directors. The agreement also contains restrictive covenants
preventing competition with us and the use of confidential business information, except in connection with the performance of his duties
for us, for a period of two years following the termination of his employment with us.
We entered into an employment agreement with Dr. Tullis effective January 10, 2000. Effective June 1, 2001, Dr. Tullis was
appointed our Chief Science Officer (CSO). His compensation under the agreement was modified in June 2001 from $80,000 to $150,000
per year. Effective January 1, 2005, Dr. Tullis' salary was increased from $150,000 to $165,000 per year. Under the terms of the agreement,
his employment continues at a salary of $165,000 per year for successive one-year periods, unless given notice of termination 60 days prior
to the anniversary of his employment agreement. Dr. Tullis was granted 5,000 stock options to purchase our common stock in connection
the completing certain milestones, such as the initiation and completion of certain clinical trials, the submission of proposals to the U.S.
Food and Drug Administration, or FDA, and the filing of a patent application. Effective April 1, 2006, Dr. Tullis’ salary was increased to
$180,000 per year. Effective April 1, 2010, his salary was increased from $180,000 to $195,000 per year.
During the fiscal year ended March 31, 2015, Dr. Tullis earned a bonus of $5,000 from us. The bonus was based upon targets
established by our compensation committee.
In February 2016, we entered into a part-time consulting agreement with Dr. Tullis. Under that agreement, Dr. Tullis will retain
his title of CSO and will continue to provide services under the terms of a consulting agreement with us. In connection with the change in
his employment, Dr. Tullis resigned as our Vice President. Under the consulting agreement, Tullis will render approximately twenty (20)
hours per week of such services, for which we will pay him a consulting fee of $10,000 per month. The term of the consulting agreement is
for an initial sixty-day period and, unless terminated earlier by either party, shall automatically extend for additional one-month periods.
Either party to the consulting agreement may terminate it upon 30 days’ prior written notice to the other party. Concurrently with the entry
into the consulting agreement, Dr. Tullis and the Company mutually agreed to terminate his employment agreement with us.
49
On September 27, 2010, Mr. Frakes was appointed our Chief Financial Officer. We have not entered into a written employment
agreement with Mr. Frakes. As Chief Financial Officer, Mr. Frakes received an annual salary initially set at $180,000 and medical
insurance benefits. In June 2014, his salary was increased from $180,000 to $210,000 per year. In September 2015, Mr. Frakes received a
$25,000 salary increase from $210,000 to $235,000.
During the fiscal year ended March 31, 2016, Mr. Frakes earned bonuses totaling $75,000 from us, excluding a retention bonus
(see below) and during the fiscal year ended March 31, 2015, Mr. Frakes earned bonuses totaling $30,000 from us and a bonus of $1,500
from Exosome Sciences, Inc. All of those bonuses were based upon targets established by our compensation committee.
Mr. Kenley was appointed our President on October 27, 2010. Pursuant to a written offer of employment executed by us and Mr.
Kenley, he received an annual salary initially set at $240,000 and medical insurance benefits. In June 2014, his salary was increased from
$240,000 to $260,000 per year. In September 2015, Mr. Kenley received a $15,000 salary increase from $260,000 to $275,000.
During the fiscal year ended March 31, 2016, Mr. Kenley received a retention bonus (see below) and during the fiscal year ended
March 31, 2015, Mr. Kenley earned bonuses totaling $15,000 from us. All of those bonuses were based upon targets established by our
compensation committee.
Retention Agreements
On October 16, 2015, following a recommendation of our Compensation Committee, we approved retention bonus grants to three
of our executive officers under a newly established Aethlon Senior Management Retention Program to maintain management stability
going forward. The Board approved a $100,000 retention bonus for Mr. James A. Joyce, our Chief Executive Officer, a $50,000 retention
bonus for Mr. Rodney S. Kenley, our President, and a $50,000 retention bonus for Mr. James B. Frakes, our Chief Financial Officer.
In connection with the bonus granted to Mr. Joyce, we entered into an amendment of Mr. Joyce’s Employment Agreement dated
April 1, 1999. Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Joyce’s
employment with us for “Cause” (as defined in his employment agreement) or Mr. Joyce terminates his employment with us other than for
“Good Reason” (as defined in his employment agreement), Mr. Joyce must repay in full the amount of the bonus received from us. In the
event of his death or disability or termination by us other than for “Cause” or termination by Mr. Joyce for “Good Reason,” Mr. Joyce will
not be required to repay any portion of the bonus received by him.
In connection with the bonus granted to Mr. Kenley, we entered into an amendment of Mr. Kenley’s Offer Letter dated October
27, 2010. Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Kenley’s employment
with us for “Cause” (as defined in the amendment) or Mr. Kenley terminates his employment with us other than for “Good Reason” (as
defined in the amendment), Mr. Kenley must repay in full the amount of the bonus received from us. In the event of his death or disability
or termination by us other than for “Cause” or termination by Mr. Kenley for “Good Reason,” Mr. Kenley will not be required to repay any
portion of the bonus received by him.
In connection with the bonus granted to Mr. Frakes, we entered into a Retention Bonus Agreement with Mr. Frakes. Pursuant to
the agreement, if within two years of the effective date of the agreement, we terminate Mr. Frakes’ employment with us for “Cause” (as
defined in the agreement) or Mr. Frakes terminates his employment with us other than for “Good Reason” (as defined in the agreement),
Mr. Frakes must repay in full the amount of the bonus received from us. In the event of his death or disability or termination by us other
than for “Cause” or termination by Mr. Frakes for “Good Reason,” Mr. Frakes will not be required to repay any portion of the bonus
received by him.
50
Outstanding Equity Awards at 2016 Fiscal Year-End
The following table sets forth certain information concerning stock option awards granted to our named executive officers.
OUTSTANDING EQUITY AWARDS AT 2016 FISCAL YEAR END
OPTIONS AWARDS
NUMBER OF
SECURITIES
UNDERLYING
UNEXERCISED
OPTIONS
EXERCISABLE
(#)
50,000(1)
40,000(2)
50,000(3)
20,000(4)
20,000(7)
NUMBER OF
SECURITIES
UNDERLYING
UNEXERCISED
OPTIONS
UNEXERCISABLE
(#)
–
–
–
20,000
10,000
15,000(5)
20,000(6)
5,000(4)
666(7)
10,000(6)
5,000(4)
3,334(7)
20,000(6)
5,000(4)
3,334(7)
–
–
5,000
334
–
5,000
1,666
–
5,000
1,666
NAME
James A. Joyce
Richard H. Tullis
James B. Frakes
Rodney S. Kenley
EQUITY
INCENTIVE PLAN
AWARDS
NUMBER OF
SECURITIES
UNDERLYING
UNEXERCISED
UNEARNED
OPTIONS
UNEXERCISABLE
(#)
–
–
–
–
–
–
–
–
–
–
–
OPTION
EXERCISE
PRICE
($)
18.00
12.50
12.50
5.00
9.50
20.50
12.50
5.00
9.50
12.50
5.00
9.50
12.50
5.00
9.50
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
DATE OF
OPTION
EXPIRATION
09/21/17
02/21/19
09/27/20
07/01/23
06/06/24
06/14/18
09/27/20
07/01/23
06/06/24
09/27/20
07/01/23
06/06/24
10/27/20
7/01/23
06/06/24
Note: We have omitted the stock awards columns of the above table because we have no disclosure applicable to those columns.
(1) The option vested 20,000 shares at grant, with 10,000 shares vesting each annual anniversary date through June 13, 2010 and as a result
of an Option Suspension Agreement with us, the expiration date was extended by 100 days.
(2) The option vested 20,000 at grant, with 10,000 shares vesting on December 31, 2009 and December 31, 2010 and as a result of an
Option Suspension Agreement with us, the expiration date was extended by 100 days.
(3) The option was fully vested as of September 27, 2013.
(4) This option vests ratably on July 1, 2014, July 1, 2015 and July 1, 2016.
(5) This option was fully vested as of December 15, 2011.
(6) This option was fully vested as of October 27, 2014.
(7) This option vests ratably on June 6, 2014, June 6, 2015 and June 6, 2016.
51
Director Compensation for 2016 Fiscal Year
The following director compensation disclosure reflects all compensation awarded to, earned by or paid to the directors below for
the fiscal year ended March 31, 2016.
Fees
Earned
or Paid in
Cash
($)
James A. Joyce (1)
Richard H. Tullis (2)
Rodney S. Kenley (3)
Edward G. Broenniman (4)
Franklyn S. Barry, Jr. (5)
Chetan S. Shah, MD (6)
$
$
$
$
$
$
–
–
–
38,000
39,000
39,000
Stock
Awards
($)
Option
Awards
($)
–
–
–
–
–
–
–
–
–
–
–
–
Non-Equity
Incentive
Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All
Other
Compensation
($)
–
–
–
–
–
–
–
–
–
–
–
–
– $
– $
– $
– $
– $
– $
Total
($)
–
–
–
38,000
39,000
39,000
(1) All compensation received by Mr. Joyce in fiscal year 2016 is disclosed in the Summary Compensation Table above. Mr. Joyce
received no compensation as a director in fiscal year 2016.
(2) All compensation received by Dr. Tullis in fiscal year 2016 is disclosed in the Summary Compensation Table above. Dr. Tullis
received no compensation as a director in fiscal year 2016. Dr. Tullis resigned from the Board of Directors effective June 5, 2015.
(3) All compensation received by Mr. Kenley in fiscal year 2016 is disclosed in the Summary Compensation Table above. Mr. Kenley
received no compensation as a director in fiscal year 2016.
(4) The aggregate number of stock awards and options awards issued and outstanding as of March 31, 2016 are 0 and 43,431. Mr.
Broenniman received stock option grants of 3,684 shares on June 6, 2014, 8,537 shares on March 14, 2014, and 9,211 shares on July 24,
2012 for his service as an outside director. The June 2014 option vested 3,684 shares on March 31, 2015, the March 2014 option vested all
8,537 shares at grant and the 2012 option vested 3,961 at grant, with 5,250 vesting in the June 2013 quarter. On October 21, 2014 and
November 7, 2014, we paid Mr. Broenniman an aggregate of $10,063 for accrued Board of Directors fees and expenses reimbursable to
him. In January 2015, we paid $84,500 to Mr. Broenniman in payment of accrued Board of Directors fees and amounts accrued for services
rendered to us by him prior to the 1999 reorganization among Aethlon, Inc., Hemex, Inc. and us. In January 2016 we paid $39,000 to Mr.
Broenniman in payment of accrued Board of Directors fees for the fiscal year ended March 31, 2015 and in April 2016 we paid $38,000 to
Mr. Broenniman in payment of accrued Board of Directors fees for the fiscal year ended March 31, 2016.
(5) The aggregate number of stock awards and options awards issued and outstanding as of March 31, 2016 are 0 and 41,431. Mr. Barry
received stock option grants of 3,684 shares on June 6, 2014, 8,537 shares on March 14, 2014 and 9,211 shares on July 24, 2012 for his
service as an outside director. The June 2014 option vested 3,684 shares on March 31, 2015, the March 2014 option vested all 8,537 shares
at grant and the 2012 option vested 3,961 at grant, with 5,250 vesting in the June 2013 quarter. On October 21, 2014 and November 7,
2014, we paid Mr. Barry an aggregate of $10,944 for accrued Board of Directors fees and expenses reimbursable to him. In January 2015,
we paid $271,810 to Mr. Barry in payment of accrued director fees and amounts accrued for services rendered to us by him prior to the
1999 reorganization among Aethlon, Inc., Hemex, Inc. and us. In October 2015 we paid $39,000 to Mr. Barry in payment of accrued Board
of Directors fees for the fiscal year ended March 31, 2015 and in April 2016 we paid $39,000 to Mr. Barry in payment of accrued Board of
Directors fees for the fiscal year ended March 31, 2016.
(6) The aggregate number of stock awards and options awards issued and outstanding as of March 31, 2016 are 0 and 11,205. Dr. Shah
received stock option grants of 3,684 on June 6, 2014 and 7,520 shares on July 24, 2012 for his service as an outside director. The June
2014 option vested 3,684 shares on March 31, 2015, and the 2014 option vested all 7,520 shares at grant. In January 2015, we paid $14,500
to Dr. Shah in payment of accrued director fees. In October 2015 we paid $39,000 to Dr. Shah in payment of accrued Board of Directors
fees for the fiscal year ended March 31, 2015 and in April 2016 we paid $39,000 to Dr. Shah in payment of accrued Board of Directors fees
for the fiscal year ended March 31, 2016.
Directors Compensation Program
We maintain a board compensation program, in which only non-employee directors may participate. Please see the “Equity
Compensation Plans – 2012 Directors Compensation Program” section of this Report for more information on the program.
52
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The following table sets forth information as of June 28, 2016, with respect to the ownership of our common stock, by (i) each
person known by us to be the beneficial owner of more than five percent (5%) of the outstanding shares of each class of our capital stock,
(ii) each of our directors and director nominees (if any), (iii) each of our named executive officers and (iv) all of our executive officers and
directors as a group. The term "executive officer" is defined as the President/Chief Executive Officer, Secretary, Chief Financial
Officer/Treasurer, any vice-president in charge of a principal business function (such as administration or finance), or any other person who
performs similar policy making functions for us. We believe that each individual or entity named has sole investment and voting power
with respect to shares of common stock indicated as beneficially owned by them, subject to community property laws where applicable,
excepted where otherwise noted:
TITLE OF CLASS
NAME AND ADDRESS
James A. Joyce, Chief Executive Officer and Director
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
Rodney S. Kenley, President and Director
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
James B. Frakes, Chief Financial Officer
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
Franklyn S. Barry, Jr., Director
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
Edward G. Broenniman, Director
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
Chetan Shah, MD, Director (11)
9635 Granite Ridge Drive, Suite 100
San Diego, CA 92123
Ellen R Weiner Family Revocable Trust (11)
10300 W. Charleston Blvd. #13-222
Las Vegas, NV 89135
Alpha Capital Anstalt
Lettstrasse 32, FL-9490 Vaduz,
Furstentums, Liechtenstein
Sachs Investment Group, LLC (11)
1346 S. Third St., Louisville, KY 40208
All Current Directors and Executive Officers as a Group (7
members)
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
Common Stock
* Less than 1%
AMOUNT AND NATURE
OF BENEFICIAL
OWNERSHIP (1)(2)
PERCENT OF
BENEFICIAL
OWNERSHIP
256,000 shares (3)
3.3%
28,734 shares (4)
18,534 shares (5)
43,553 shares (6)
49,075 shares (7)
387,828 shares (8)
708,335 shares (9)
388,841 shares (10)
791,205 shares
783,724 shares
*
*
*
*
5.0%
9.0%
4.99%
10.4%
9.7%
(1) Based on 7,622,393 shares of common stock outstanding on our transfer records as of June 28, 2016.
(2) Calculated pursuant to Rule 13d-3(d)(1) of the Securities Exchange Act of 1934. Under Rule 13d-3(d)(1), shares not outstanding that
are subject to options, warrants, rights or conversion privileges exercisable by a person within 60 days are deemed outstanding for the
purpose of calculating the number and percentage owned by such person but not deemed outstanding for the purpose of calculating the
percentage owned by each other person listed. Except where otherwise noted, we believe that each individual or entity named has sole
investment and voting power with respect to the shares of common stock indicated as beneficially owned by such person, subject to
community property laws, where applicable.
53
(3) Includes 50,000 stock options exercisable at $18.00 per share, 90,000 stock options exercisable at $12.50 per share, 20,000 stock
options exercisable at $5.00 per share and 20,000 stock options exercisable at $9.50 per share.
(4) Includes 20,000 stock options exercisable at $12.50 per share, 5,000 stock options exercisable at $5.00 per share and 3,334 stock options
exercisable at $9.50 per share.
(5) Includes 10,000 stock options exercisable at $12.50 per share, 5,000 stock options exercisable at $5.00 per share and 3,334 stock
options exercisable at $9.50 per share.
(6) Includes 10,000 stock options exercisable at $20.50 per share, 10,000 stock options exercisable at $12.50 per share, 9,211 stock options
exercisable at $3.80 per share, 8,537 stock options exercisable at $4.10 per share and 3,684 stock options exercisable at $9.50 per share.
(7) Includes 10,000 stock options exercisable at $20.50 per share, 12,000 stock options exercisable at $12.50 per share, 9,211 stock options
exercisable at $3.80 per share, 8,537 stock options exercisable at $4.10 per share and 3,684 stock options exercisable at $9.50 per share.
(8) Includes warrants to purchase 109,322 shares of common stock at exercise prices ranging from $4.65 per share to $6.60 per share, and
11,205 stock options exercisable at $9.50 per share.
(9) Includes common stock issuable upon exercise of warrants held by the Ellen R. Weiner Family Revocable Trust. The trust owns
235,934 warrants to purchase common shares at prices ranging from $2.10 to $5.40 per share.
(10) Includes certain shares issuable upon the conversion of convertible notes and exercise of warrants held by Alpha Capital Anstalt
(“Alpha”). Alpha owns a convertible note in the principal amount of $543,602.78 convertible into 108,721 shares of common stock at
$5.00 and warrants to purchase 357,307 shares of common stock at an exercise price of $5.00 per share. Alpha’s beneficial ownership is
limited contractually to the extent that exercise of such notes and warrants would cause the aggregate number of shares of common stock
beneficially owned by Alpha to exceed 4.99% of our outstanding shares. Accordingly, beneficial ownership for Alpha does not reflect
296,000 shares underlying such notes and warrants that would cause the number of shares beneficially owned by Alpha to be 8.47% of our
outstanding shares.
(11) More-than-5% stockholder.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The following describes all transactions since April 1, 2014, and all proposed transactions, in which we were or are to be a
participant and the amount involved exceeds the lesser of $120,000 or one percent of the average of our total assets at year-end for the last
two completed fiscal years, and in which any related person had or will have a direct or indirect material interest.
In July 2013, we borrowed $400,000 from Mr. Phillip Ward, one of our former directors, and Dr. Shah under 90-day notes bearing
10% interest. If we did not pay back those loans by October 9, 2013, then the notes would bear interest at a penalty rate of 12% and the
noteholders would have the right at their discretion (i) to convert their principal and accrued interest into shares of common stock at $4.40
per share and (ii) to receive warrants to purchase common stock equal to 50% of the principal converted under the notes, with an exercise
price of $6.60 per share. We subsequently repaid Mr. Ward’s note in cash. That repayment extinguished all potential common stock and
warrant issuance provisions of Mr. Ward’s note. On July 24, 2014, we issued to Dr. Shah an aggregate of 50,079 shares of unregistered
common stock and a seven-year warrant to purchase up to 25,040 shares of common stock at an exercise price of $6.60 per share upon the
conversion of an aggregate of $220,349 of unpaid principal and accrued interest due under his note. The amount converted represented the
entire amount outstanding under Dr. Shah’s note.
On June 6, 2014, our Board of Directors granted to our directors and our Chief Financial Officer ten-year options to acquire an
aggregate of 52,053 shares of our common stock at an exercise price of $9.50 per share.
In July 2014, Exosome Sciences, Inc. paid a bonus of $15,000 to Mr. Joyce.
In October 2014, Exosome Sciences, Inc. paid bonuses of $15,000 to Mr. Joyce and $1,500 to Mr. Frakes.
On October 20, 2014, we issued to Dr. Shah 42,222 shares of common stock and three-year warrants to acquire up to 42,222
shares of common stock with exercise prices ranging from $4.65 to $5.50 per share. The common stock and warrants were issued to Dr.
Shah upon his cash exercise, for an aggregate of $214,000, of previously issued warrants for 42,222 shares held by him.
On October 21, 2014 and November 7, 2014, we paid Mr. Franklyn Barry and Mr. Edward Broenniman, two of our outside
directors, an aggregate of $10,944 and $10,063, respectively, for accrued Board of Directors fees and expenses reimbursable to them. On
November 7, 2014, we paid Dr. Tullis $5,000 for accrued expenses reimbursable to him.
In December 2014, we paid bonuses of $25,000 to Mr. Joyce, $15,000 to Mr. Kenley, $15,000 to Mr. Frakes and $5,000 to Dr.
Tullis.
In December 2014, Exosome Sciences, Inc. paid Mr. Joyce a bonus of $15,000.
54
In January 2015, we made the following payments to certain of our officers and directors:
·
·
·
·
·
bonuses of $25,000 to Mr. Joyce and $15,000 to Mr. Frakes;
$93,377 to Dr. Tullis in payment of accrued salary;
$14,500 to Dr. Shah in payment of accrued director fees;
$84,500 to Mr. Broenniman in payment of accrued director fees and amounts accrued for services rendered to us prior to the
1999 reorganization among Aethlon, Inc., Hemex, Inc. and us; and
$271,810 to Mr. Barry in payment of accrued director fees and amounts accrued for services rendered to us prior to the 1999
reorganization among Aethlon, Inc., Hemex, Inc. and us.
In June 2015, Mr. James Joyce, our Chief Executive Officer, Mr. James Frakes, our Chief Financial Officer and Dr. Chetan Shah,
a director of our company, agreed to waive their rights to acquire an aggregate of 402,318 shares of common stock underlying certain stock
options and warrants held by them. Those waivers were required in order to make a sufficient number of shares of common stock available
for issuance upon the exercise of the warrants issued in our June 2015 financing. Those waivers expired when we amended our Articles of
Incorporation on March 31, 2016, to increase sufficiently the number of authorized shares of common stock available for issuance
following approval of that measure at our annual stockholders’ meeting on March 29, 2016.
In September 2015, the Compensation Committee approved and we paid bonuses of $100,000 and $75,000 to Mr. Joyce and Mr.
Frakes, respectively, for achieving an agreed milestone event of achieving a Nasdaq listing.
Retention Agreements
On October 16, 2015, following a recommendation of our Compensation Committee, we approved retention bonus grants to three
of our executive officers under a newly established Aethlon Senior Management Retention Program to maintain management stability
going forward. The Board approved a $100,000 retention bonus for Mr. James A. Joyce, our Chief Executive Officer, a $50,000 retention
bonus for Mr. Rodney S. Kenley, our President, and a $50,000 retention bonus for Mr. James B. Frakes, our Chief Financial Officer.
In connection with the bonus granted to Mr. Joyce, we entered into an amendment of Mr. Joyce’s Employment Agreement dated
April 1, 1999. Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Joyce’s
employment with us for “Cause” (as defined in his employment agreement) or Mr. Joyce terminates his employment with us other than for
“Good Reason” (as defined in his employment agreement), Mr. Joyce must repay in full the amount of the bonus received from us. In the
event of his death or disability or termination by us other than for “Cause” or termination by Mr. Joyce for “Good Reason,” Mr. Joyce will
not be required to repay any portion of the bonus received by him.
In connection with the bonus granted to Mr. Kenley, we entered into an amendment of Mr. Kenley’s Offer Letter dated October
27, 2010. Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Kenley’s employment
with us for “Cause” (as defined in the amendment) or Mr. Kenley terminates his employment with us other than for “Good Reason” (as
defined in the amendment), Mr. Kenley must repay in full the amount of the bonus received from us. In the event of his death or disability
or termination by us other than for “Cause” or termination by Mr. Kenley for “Good Reason,” Mr. Kenley will not be required to repay any
portion of the bonus received by him.
In connection with the bonus granted to Mr. Frakes, we entered into a Retention Bonus Agreement with Mr. Frakes. Pursuant to
the agreement, if within two years of the effective date of the agreement, we terminate Mr. Frakes’ employment with us for “Cause” (as
defined in the agreement) or Mr. Frakes terminates his employment with us other than for “Good Reason” (as defined in the agreement),
Mr. Frakes must repay in full the amount of the bonus received from us. In the event of his death or disability or termination by us other
than for “Cause” or termination by Mr. Frakes for “Good Reason,” Mr. Frakes will not be required to repay any portion of the bonus
received by him.
Mr. Joyce received quarterly bonus payments of $15,000 from Exosome throughout the fiscal year ended March 31, 2016 per
targets set by the Compensation Committee.
In October 2015, we paid accrued Board fees from the fiscal year ended March 31, 2015 of $39,000 each to Mr. Barry and Dr.
Shah and paid Mr. Broenniman his accrued fiscal 2015 Board fees in January 2016.
In April 2016, we paid accrued Board fees from the fiscal year ended March 31, 2016 to Mr. Barry, Mr. Broenniman and Dr. Shah.
Director Independence
Each of Mr. Barry, Mr. Broenniman and Dr. Shah is an independent director as that term is defined by NASDAQ Stock Market
Rule 5605(a)(2). We currently have a compensation committee, a nominating and corporate governance committee and an audit committee.
Of the members of our Board of Directors, each of Mr. Barry, Mr. Broenniman and Dr. Shah meets the NASDAQ Stock Market's
independence standards for members of such committees.
55
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The following table presents fees for professional services billed by Squar Milner LLP ("Squar Milner") for the fiscal years ended
March 31, 2016 and 2015:
Audit Fees (1)
Audit Related Fees (2)
Tax Fees (3)
All Other Fees (4)
Fiscal Year
2016
Fiscal Year
2015
$
$
97,000 $
21,000
6,325
–
124,325 $
97,000
72,840
3,380
–
173,220
(1) Audit Fees include fees and expenses for professional services rendered in connection with the audit of our financial statements for
fiscal 2016 and 2015 and for reviews of the financial statements included in each of our quarterly reports on Form 10-Q during fiscal 2016
and 2015.
(2) Audit Related Fees consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or
review of our financial statements and are not reported under “Audit Fees.” Included in Audit Related Fees for fiscal 2016 and 2015 are
fees and expenses related to reviews of registration statements and SEC filings other than Forms 10-K and 10-Q.
(3) Tax Fees include the aggregate fees billed during fiscal year 2016 and 2015 for professional services for preparation of income tax
returns.
(4) All Other Fees consist of fees paid for products and services other than the services reported above. No such fees were billed by Squar
Milner for fiscal 2016 or 2015.
Policy on Audit Committee Pre-approval of Audit and Permissible Non-audit Services of Independent Auditor
Our audit committee of the Board of Directors is responsible for pre-approving all audit, audit-related, tax and other permitted
non-audit services to be performed for us by our independent auditor. The audit committee approved all of the services for which Squar
Milner billed us as set forth in the above table.
56
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENTS
The following documents are filed as part of this report on Form 10-K:
1. Consolidated Financial Statements for the years ended March 31, 2016 and 2015:
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Stockholders' Deficit
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
2. Exhibits
2.1
2.2
Agreement and Plan of Reorganization Between Aethlon Medical, Inc. (formerly, Bishop Equities, Inc.) and Aethlon, Inc. dated
March 10, 1999 (1)
Agreement and Plan of Reorganization Between Aethlon Medical, Inc. (formerly, Bishop Equities, Inc.) and Hemex, Inc. dated March
10, 1999 (1)
3.1
Articles of Incorporation of Aethlon Medical, Inc., as amended (2)
3.2
Bylaws of Aethlon Medical, Inc., as amended (35)
4.1
Form of Common Stock Certificate (3)
4.2
Form of Amended and Restated Warrant dated June 14, 2010 (12)
4.3
Form of Amended and Restated Warrant dated June 14, 2010 (QB) (12)
4.4
Form of Common Stock Purchase Warrant dated March 29, 2012 and April 15, 2012 (14)
4.5
Form of Common Stock Purchase Warrant dated June 19, 2012 (15)
4.6
Form of Common Stock Purchase Warrant dated August 29, 2012 (16)
4.7
Form of Common Stock Purchase Warrant dated October, November and December 2012 (17)
4.8
Form of Common Stock Purchase Warrant dated June 14, 2013 (18)
4.9
Form of Common Stock Purchase Warrant October 30, 2013 (19)
4.10 Form of Common Stock Purchase Warrant November 12, 2013 (20)
4.11 Form of Common Stock Purchase Warrant December 10, 2013 (21)
4.12 Form of Common Stock Purchase Warrant December 30, 2013 (22)
57
4.13 Form of Amendment to Notes and Warrants dated March 31, 2014 (23)
4.14 Form of Common Stock Purchase Warrant dated June 24, 2014 (24)
4.15 Form of Common Stock Purchase Warrant dated July 8, 2014 (25)
4.16 Form of Common Stock Purchase Warrant dated July 24, 2014 (26)
4.17 Form of Common Stock Purchase Warrant issued August and September 2014 (27)
4.18 Form of Class A Common Stock Purchase Warrant dated November 6, 2014 (27)
4.19 Form of Convertible Promissory Note dated November 6, 2014 (27)
4.20 Form of Common Stock Purchase Warrant issued December 2, 2014 (29)
4.21 Form of Purchase Agent Warrant dated December 2, 2014 (30)
4.22 Form of Warrant to Purchase Common Stock issued June 25, 2015 (32)
4.23 Form of Purchase Agent Warrant issued June 25, 2015 (33)
4.24 Form of Amendment to Notes and Warrants dated June 27, 2016 (40)
4.25 Form of Allonge to Convertible Promissory Note dated June 27, 2016 (40)
4.26 Form of Class A Common Stock Purchase Warrant issued June 27, 2016 (40)
4.27 Form of Consent and Waiver and Amendment dated June 27, 2016 (40)
10.1
2000 Stock Option Plan (34)++
10.2 Amended 2010 Stock Incentive Plan (4)
10.3
2005 Directors Compensation Program (34)++
10.4
2012 Directors Compensation Program, as amended on June 6, 2014 (34)++
10.5 Employment Agreement between Aethlon Medical, Inc. and James A. Joyce dated April 1, 1999 (5)++
10.6 Patent License Agreement by and amongst Aethlon Medical, Inc., Hemex, Inc., Dr. Julian L. Ambrus and Dr. David O. Scamurra (6)
10.7 Employment Agreement by and between Aethlon Medical, Inc. and Dr. Richard H. Tullis dated January 10, 2000 (6)++
10.8 Stock Option Agreement by and between Aethlon Medical, Inc. and James A Joyce dated February 23, 2005 (7)++
10.9 Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated February 23, 2005 (7)++
10.10 Stock Option Agreement by and between Aethlon Medical, Inc. and Franklyn S. Barry, Jr. dated February 23, 2005 (7)++
10.11 Stock Option Agreement by and between Aethlon Medical, Inc. and Ed Broenniman dated February 23, 2005 (7)++
10.12 Stock Option Agreement by and between Aethlon Medical, Inc. and James A. Joyce dated September 9, 2005 (8)++
10.13 Stock Option Agreement by and between Aethlon Medical, Inc. and James A. Joyce dated June 13, 2007 (9)++
10.14 Stock Option Agreement by and between Aethlon Medical, Inc. and James A. Joyce dated December 15, 2008 (10)++
10.15 Stock Option Agreement by and between Aethlon Medical, Inc. and Franklyn S. Barry dated December 15, 2008 (10)++
10.16 Stock Option Agreement by and between Aethlon Medical, Inc. and Edward G. Broenniman dated December 15, 2008 (10)++
10.17 Stock Option Agreement by and between Aethlon Medical, Inc. and Richard H. Tullis dated December 15, 2008 (10)++
58
10.18 Standard Industrial Net Lease by and between Sorrento Business Complex and Aethlon Medical, Inc. dated September 28, 2009 (11)
10.19 Offer of Employment by and between Aethlon Medical, Inc. and Rodney S. Kenley dated October 27, 2010 (13)++
10.20 Stock Option Agreement of Rodney S. Kenley dated October 27, 2010 (13)++
10.21 Unit Subscription Agreement dated March 29, 2012 and April 5, 2012 (14)
10.22 Unit Subscription Agreement dated June 19, 2012 (15)
10.23 Unit Subscription Agreement dated August 29, 2012 (16)
10.24 Unit Subscription Agreement dated October, November and December 2012 (17)
10.25 Unit Subscription Agreement dated June 14, 2013 (18)
10.26 Form of Unit Purchase Agreement dated October 30, 2013 (19)
10.27 Form of Subscription Agreement October 30, 2013 (19)
10.28 Form of Unit Purchase Agreement dated November 12, 2013 (20)
10.29 Form of Subscription Agreement November 12, 2013 (20)
10.30 Form of Unit Purchase Agreement dated December 10, 2013 (21)
10.31 Form of Subscription Agreement December 10, 2013 (21)
10.32 Form of Unit Purchase Agreement dated December 30, 2013 (22)
10.33 Form of Subscription Agreement December 30, 2013 (22)
10.34 Form of Restructuring Agreement dated June 24, 2014 (24)
10.35 Form of Restructuring Agreement dated June 24, 2014 (24)
10.36 Form of Restructuring Agreement dated July 8, 2014 (25)
10.37 Second Amendment to Standard Industrial Net Lease by and between Sorrento Business Complex and Aethlon Medical, Inc. dated
October 10, 2014 (3)
10.38 Form of Subscription Agreement dated November 6, 2014 (27)
10.39 Office Lease between T-C Stonecrest LLC and Aethlon Medical, Inc. dated November 13, 2014 (28)
10.40 Securities Purchase Agreement dated November 26, 2014 (29)
10.41 Registration Rights Agreement dated November 26, 2014 (29)
10.42 DARPA Contract dated September 30, 2011 (3) (Portions of this exhibit have been omitted pursuant to a request for confidential
treatment.)
10.43 DARPA Contract Extension dated August 8, 2012 (3)
10.44 DARPA Contract Extension dated September 15, 2013 (3)
10.45 DARPA Contract Extension dated September 29, 2014 (3)
10.46 DARPA Contract Modification dated March 12, 2015 (34) (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment.)
59
10.47 UCI Clinical Trial Agreement signed April 9, 2015 (31)
10.48 Protocol for UCI Clinical Trial (31)
10.49 Budget for UCI Clinical Trial (31)
10.50 DaVita Master Services Agreement (35)
10.51 First Amendment to DaVita Master Services Agreement (35)
10.52 Work Order #1 under DaVita Master Services Agreement (35) (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment.)
10.53 Securities Purchase Agreement dated June 23, 2015 (32)
10.54 Registration Rights Agreement dated June 23, 2015 (32)
10.55 DARPA Contract Extension dated September 25, 2015 (36)
10.56 Amendment No. 1 to Joyce Employment Agreement dated October 16, 2015 (37)++
10.57 Amendment No. 1 to Kenley Offer Letter dated October 16, 2015 (37)++
10.58 Retention Bonus Agreement dated October 16, 2015 (37)++
10.59 Third Amendment to Standard Industrial Net Lease dated October 21, 2015 (38)
10.60 Amendment of Terms dated November 12, 2015 (38)
10.61 Consulting Agreement dated February 9, 2016 (39)
10.62 Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated September 27, 2010 *++
10.63 Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated July 1, 2013 *++
10.64 Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated June 6, 2014 *++
10.65 Amendment No. 1 to Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated December 15, 2008
*++
10.66 Amendment No. 1 to Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated September 27, 2010
*++
10.67 Amendment No. 1 to Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated July 1, 2013 *++
10.68 Amendment No. 1 to Stock Option Agreement by and between Aethlon Medical, Inc. and Richard Tullis dated June 6, 2014 *++
10.69 Common Stock Sales Agreement dated June 28, 2016 between Aethlon Medical, Inc. and H.C. Wainwright & Co., LLC (40)
10.70 Form of Consent and Waiver dated June 27, 2016 (40)
14
Code of Ethics (29)
21.1 List of subsidiaries (3)
23.1 Consent of Independent Registered Public Accounting Firm (Squar, Milner, Peterson, Miranda & Williamson, LLP) *
31.1 Certification of our Chief Executive Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to
Section 302 of the Sarbanes Oxley Act of 2002.*
60
31.2 Certification of our Chief Financial Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to
Section 302 of the Sarbanes Oxley Act of 2002.*
32.1 Statement of our Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)*
32.3 Statement of our Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)*
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
101.PRE
XBRL Instance Document*
XBRL Schema Document*
XBRL Calculation Linkbase Document*
XBRL Definition Linkbase Document*
XBRL Label Linkbase Document*
XBRL Presentation Linkbase Document*
* Filed herewith
++ Indicates a management contract or compensatory plan or arrangement
(1) Filed with the Company's Current Report on Form 8-K/A dated March 26, 1999 and incorporated by reference.
(2) Filed with the Company's Registration Statement on Form S-3 (File No. 333-211151) filed on May 5, 2016 and incorporated by
reference.
(3) Filed with the Company’s Registration Statement on Form S-1 (File No. 333-201334) filed on December 31, 2014 and incorporated by
reference.
(4) Filed with the Company’s Current Report on Form 8-K dated March 30, 2016 and incorporated by reference.
(5) Filed with the Company's Annual Report on Form 10-KSB filed on July 15, 1999 for the year ended March 31, 1999 and incorporated
by reference.
(6) Filed with the Company's Annual Report on Form 10-KSB/A filed on September 10, 2004 for the year ended March 31, 2004 and
incorporated by reference.
(7) Filed with the Company's Annual Report on Form 10-KSB filed on July 14, 2005 for the year ended March 31, 2005 and incorporated
by reference.
(8) Filed with the Company's Current Report on Form 8-K filed on September 12, 2005 and incorporated by reference.
(9) Filed with the Company’s Registration Statement on Form S-8 (File No. 333-168483) filed on August 2, 2010 and incorporated by
reference.
(10) Filed with the Company's Current Report on Form 8-K dated December 19, 2008 and incorporated by reference.
(11) Filed with the Company’s Quarterly Report on Form 10-Q filed on November 16, 2009 for the period ended September 30, 2009 and
incorporated by reference.
(12) Filed with the Company’s Annual Report on Form 10-K filed on July 2, 2010 for the year ended March 31, 2010 and incorporated by
reference.
(13) Filed with the Company’s Current Report on Form 8-K dated November 1, 2010 and incorporated by reference.
(14) Filed with the Company’s Current Report on Form 8-K dated April 6, 2012 and incorporated by reference.
(15) Filed with the Company’s Current Report on Form 8-K dated June 27, 2012 and incorporated by reference.
(16) Filed with the Company’s Current Report on Form 8-K dated September 6, 2012 and incorporated by reference.
(17) Filed with the Company’s Quarterly Report on Form 10-Q filed on February 12, 2013 for the period ended December 31, 2012 and
incorporated by reference.
61
(18) Filed with the Company’s Quarterly Report on Form 10-Q filed on August 13, 2013 for the period ended June 30, 2013 and
incorporated by reference.
(19) Filed with the Company’s Current Report on Form 8-K dated November 6, 2013 and incorporated by reference.
(20) Filed with the Company’s Current Report on Form 8-K dated November 20, 2013 and incorporated by reference.
(21) Filed with the Company’s Current Report on Form 8-K dated December 16, 2013 and incorporated by reference.
(22) Filed with the Company’s Current Report on Form 8-K dated January 7, 2014 and incorporated by reference.
(23) Filed with the Company’s Current Report on Form 8-K dated April 4, 2014 and incorporated by reference.
(24) Filed with the Company’s Current Report on Form 8-K dated June 30, 2014 and incorporated by reference.
(25) Filed with the Company’s Current Report on Form 8-K dated July 10, 2014 and incorporated by reference.
(26) Filed with the Company’s Current Report on Form 8-K dated July 28, 2014 and incorporated by reference.
(27) Filed with the Company’s Quarterly Report on Form 10-Q filed on November 10, 2014 for the period ended September 30, 2014 and
incorporated by reference.
(28) Filed with the Company’s Current Report on Form 8-K/A dated November 19, 2014 and incorporated by reference.
(29) Filed with the Company’s Current Report on Form 8-K dated November 28, 2014 and incorporated by reference.
(30) Filed with the Company’s Current Report on Form 8-K dated December 3, 2014 and incorporated by reference.
(31) Filed with the Company’s Current Report on Form 8-K dated April 15, 2015 and incorporated by reference.
(32) Filed with the Company’s Current Report on Form 8-K dated June 24, 2015 and incorporated by reference.
(33) Filed with the Company’s Current Report on Form 8-K dated June 26, 2015 and incorporated by reference.
(34) Filed with the Company's Registration Statement on Form S-1 (File No. 333-203487) filed on April 17, 2015 and incorporated by
reference.
(35) Filed with the Company’s Annual Report on Form 10-K filed on June 26, 2015 for the year ended March 31, 2015 and incorporated
by reference.
(36) Filed with the Company’s Current Report on Form 8-K dated September 28, 2015 and incorporated by reference.
(37) Filed with the Company’s Current Report on Form 8-K dated October 22, 2015 and incorporated by reference.
(38) Filed with the Company’s Quarterly Report on Form 10-Q filed on November 16, 2015 for the period ended September 30, 2015 and
incorporated by reference.
(39) Filed with the Company’s Current Report on Form 8-K dated February 16, 2016 and incorporated by reference.
(40) Filed with the Company’s Current Report on Form 8-K dated June 28, 2016 and incorporated by reference.
62
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized, on the 29th day of June, 2016.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the dates indicated.
By:
/s/ JAMES A. JOYCE
James A. Joyce
Chairman, Chief Executive Officer
Signature
Title
/s/ JAMES A. JOYCE
James A. Joyce
/s/ JAMES B. FRAKES
James B. Frakes
/s/ FRANKLYN S. BARRY, JR.
Franklyn S. Barry, Jr.
/s/ EDWARD G. BROENNIMAN
Edward G. Broenniman
/s/ RODNEY S. KENLEY
Rodney S. Kenley
/s/ CHETAN S. SHAH
Chetan S. Shah
Chairman of the Board, Chief Executive Officer
and Principal Executive Officer
Chief Financial Officer and Principal Accounting
Officer
Director
Director
Director
Director
63
Date
June 29, 2016
June 29, 2016
June 29, 2016
June 29, 2016
June 29, 2016
June 29, 2016
AETHLON MEDICAL, INC. AND SUBSIDIARY
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of March 31, 2016 and 2015
Consolidated Statements of Operations for the Years Ended March 31, 2016 and 2015
Consolidated Statements of Equity (Deficit) for the Years Ended March 31, 2016 and 2015
Consolidated Statements of Cash Flows for the Years Ended March 31, 2016 and 2015
Notes to Consolidated Financial Statements
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Aethlon Medical, Inc. and Subsidiary
We have audited the accompanying consolidated balance sheets of Aethlon Medical, Inc. and Subsidiary (the "Company") as of March 31,
2016 and 2015 and the related consolidated statements of operations, equity (deficit), and cash flows for each of the two years in the period
ended March 31, 2016. These financial statements are the responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate
in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the
Company as of March 31, 2016 and 2015, and the results of their operations and their cash flows for each of the two years in the period
ended March 31, 2016, in conformity with U.S. generally accepted accounting principles.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in
Note 1 to the financial statements, during 2015 the Company incurred a net loss and generated negative cash flows from operating activity
and as of March 31, 2016 had an accumulated deficit of approximately $86,502,000. These factors raise substantial doubt about the
Company's ability to continue as a going concern. Management's plans regarding these matters are also described in Note 1. The
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not
modified with respect to this matter.
/s/ SQUAR MILNER LLP (formerly SQUAR, MILNER, PETERSON, MIRANDA & WILLIAMSON, LLP)
SAN DIEGO, CALIFORNIA
JUNE 29, 2016
F-2
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
ASSETS
CURRENT ASSETS
Cash
Accounts receivable
Deferred financing costs
Prepaid expenses and other current assets
TOTAL CURRENT ASSETS
Property and equipment, net
Patents, net
Other assets
TOTAL ASSETS
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
Due to related parties
Other current liabilities
TOTAL CURRENT LIABILITIES
Convertible notes payable, noncurrent portion
TOTAL LIABILITIES
COMMITMENTS AND CONTINGENCIES (Note 12)
March 31, 2016 March 31, 2015
$
2,123,737 $
199,471
27,641
53,294
855,596
193,341
82,324
73,135
2,404,143
1,204,396
36,038
94,161
22,415
56,091
103,325
16,776
$
2,556,757 $
1,380,588
$
244,804 $
145,112
136,695
526,611
527,780
1,054,391
342,133
146,112
85,731
573,976
155,229
729,205
STOCKHOLDERS’ EQUITY
Common stock, $0.001 par value, 30,000,000 and 10,000,000 shares authorized at March
31, 2016 and 2015, respectively; 7,622,393 and 6,657,046 issued and outstanding at
March 31, 2016 and 2015, respectively
Additional paid-in capital
Accumulated deficit
TOTAL AETHLON MEDICAL, INC STOCKHOLDERS’ EQUITY BEFORE
NONCONTROLLING INTERESTS
NONCONTROLLING INTERESTS
TOTAL STOCKHOLDERS’ EQUITY
7,621
88,047,142
(86,502,043)
6,657
82,238,507
(81,629,714)
1,552,720
(50,354)
1,502,366
615,450
35,933
651,383
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
2,556,757 $
1,380,588
See accompanying notes to the consolidated financial statements.
F-3
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended March 31,
2016
2015
$
886,572 $
886,572
762,417
762,417
2,259,096
2,083,297
929,013
5,271,406
1,572,196
2,275,959
907,115
4,755,270
(4,384,834)
(3,992,853)
–
–
573,782
573,782
2,753,989
(219,624)
452,276
2,986,641
REVENUES:
Government contract revenue
Total revenues
OPERATING EXPENSES
Professional fees
Payroll and related expenses
General and administrative
OPERATING LOSS
OTHER (INCOME) EXPENSE
Loss on debt conversion
Other income
Interest and other debt expenses
Total other expense
NET LOSS BEFORE NONCONTROLLING INTERESTS
(4,958,616)
(6,979,494)
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS
(86,287)
(182,337)
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
Basic and diluted net loss per share available to common stockholders
$
$
(4,872,329) $
(6,797,157)
(0.66) $
(1.22)
Weighted average number of common shares outstanding - basic and diluted
7,393,695
5,594,447
See accompanying notes to the consolidated financial statements.
F-4
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF EQUITY (DEFICIT)
FOR THE YEARS ENDED MARCH 31, 2016 AND 2015
ATTRIBUTABLE TO AETHLON MEDICAL, INC.
COMMON STOCK
SHARES
AMOUNT
ADDITIONAL
PAID IN
CAPITAL
ACCUMULATED
DEFICIT
NON-
CONTROLLING
INTERESTS
TOTAL
EQUITY
(DEFICIT)
4,499,480 $
4,497 $
59,879,624 $
(74,832,557) $
218,270 $ (14,730,166)
BALANCE - MARCH 31,
2014
Issuances of common stock
upon conversions of notes
payable and convertible
notes payable and related
accrued interest
Issuance of common stock
for cash - Aethlon
Issuance of common stock
for services
Extension of warrants
Reclassification of derivative
liability into equity
Issuance of common stock
under cashless warrant
exercises
Debt discount recorded in
connection with beneficial
conversion feature
Issuance of common stock
for deferred financing costs
Issuance of common stock
and warrants related to
extinguishment of debt
Stock-based compensation
expense
Net loss
BALANCE - MARCH 31,
2015
Issuances of common stock
for cash
Issuance of common stock
under cashless warrant
exercises
Issuance of common stock
due to rounding up from
reverse split
Stock-based compensation
expense
Net loss
BALANCE - MARCH 31,
2016
948,728
949
2,272,083
541,361
542
4,762,611
27,654
–
–
28
–
225,130
143,363
–
10,679,067
433,907
434
(434)
–
500
–
1
527,780
4,499
205,416
206
3,328,303
–
–
–
–
416,481
959,140
958
5,605,797
5,292
915
–
–
5
1
–
–
(5)
(1)
202,844
–
–
–
–
–
–
–
–
–
–
–
2,273,032
–
4,763,153
–
–
225,158
143,363
–
10,679,067
–
–
–
–
527,780
4,500
–
3,328,509
–
416,481
–
–
–
–
–
5,606,755
–
–
–
–
–
202,844
–
(6,797,157)
(182,337)
(6,979,494)
6,657,046 $
6,657 $
82,238,507 $
(81,629,714) $
35,933 $
651,383
–
(4,872,329)
(86,287)
(4,958,616)
7,622,393 $
7,621 $
88,047,142 $
(86,502,043) $
(50,354) $
1,502,366
See accompanying notes to the consolidated financial statements.
F-5
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED MARCH 31, 2016 AND 2015
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Loss on extension of warrants
Loss on debt conversion
Fair market value of equity instruments issued for services
Stock based compensation
Amortization of debt discount and deferred financing costs
Changes in operating assets and liabilities:
Accounts receivable
Prepaid expenses and other current assets
Other assets
Accounts payable and other current liabilities
Due to related parties
Net cash used in operating activities
Cash flows from investing activities:
Purchases of property and equipment
Net cash used in investing activities
Cash flows from financing activities:
Principal repayments of notes payable
Proceeds from the issuance of convertible notes payable
Net proceeds from the issuance of common stock
Net cash provided by financing activities
Net increase (decrease) in cash
Cash at beginning of year
Cash at end of year
Supplemental disclosure of cash flow information - Cash paid during the year for:
Interest
Supplemental information of non-cash investing and financing activities:
Conversion of debt, accrued liabilities and accrued interest to common stock
Reclassification of accrued interest to convertible notes payable
Recording deferred financing costs associated with convertible notes payable
Reclassification of warrant derivative liability into equity
Issuance of shares under cashless warrant exercises
Creation of debt discount on convertible notes payable
2016
2015
$
(4,958,616) $
(6,979,494)
38,524
–
–
–
202,844
517,233
(6,130)
19,841
(95,638)
(46,365)
(1,000)
(4,329,307)
37,352
143,363
2,753,989
225,158
416,481
273,377
(98,164)
(22,436)
2,212
(1,108,294)
(692,958)
(5,049,414)
(9,307)
(9,307)
–
–
–
–
5,606,755
5,606,755
(523,422)
415,000
4,763,153
4,654,731
1,268,141
(394,683)
855,596
1,250,279
$
2,123,737 $
855,596
$
$
$
$
$
$
$
– $
480,701
– $
– $
– $
– $
5 $
– $
2,273,032
25,766
117,280
10,679,067
434
527,780
See accompanying notes to the consolidated financial statements.
F-6
Aethlon Medical, Inc. and Subsidiary
Notes to Consolidated Financial Statements
1. ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION
Aethlon Medical, Inc. and subsidiary (“Aethlon”, the “Company”, “we” or “us”) is a medical device company focused on creating
innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions. At the core of our
developments is the Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, a medical device platform that
converges single or multiple affinity drug agents with advanced plasma membrane technology to create therapeutic filtration devices that
selectively remove harmful particles from the entire circulatory system without loss of essential blood components. On June 25, 2013, the
United States Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) that allows us to initiate human
feasibility studies of the Aethlon Hemopurifier® in the U.S. Under the feasibility study protocol, we will enroll ten end-stage renal disease
patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of
this study will allow us the opportunity to initiate pivotal studies that are required for market clearance to treat HCV and other disease
conditions in the U.S.
Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we intend to sell
this device. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe
that certain patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier(R)
treatment technology.
In October 2013, our subsidiary, Exosome Sciences, Inc. (“ESI”), commenced operations with a focus on advancing exosome-based
strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions.
Our common stock is quoted on the Nasdaq Capital Market under the symbol “AEMD.”
REVERSE STOCK SPLIT
On April 14, 2015, the Company completed a 1-for-50 reverse stock split. Accordingly, authorized common stock was reduced from
500,000,000 shares to 10,000,000 shares, and each 50 shares of outstanding common stock held by stockholders were combined into one
share of common stock. The accompanying consolidated financial statements and accompanying notes have been retroactively revised to
reflect such reverse stock split as if it had occurred on April 1, 2014. All shares and per share amounts have been revised accordingly.
LIQUIDITY AND GOING CONCERN
The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which
contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have
incurred continuing losses from operations and at March 31, 2016 had an accumulated deficit of approximately $86,502,000. These factors,
among other matters, raise substantial doubt about our ability to continue as a going concern. A significant amount of additional capital will
be necessary to advance the development of our products to the point at which they may become commercially viable. We intend to fund
operations, working capital and other cash requirements for the fiscal year ending March 31, 2017 through debt and/or equity financing
arrangements as well as through revenues and related cash receipts under our government contracts (see Note 9).
We are currently addressing our liquidity issue by seeking additional investment capital through issuances of common stock under our
existing S-3 registration statement and by applying for additional grants issued by government agencies in the United States. We believe
that our cash on hand and funds expected to be received from additional debt and equity financing arrangements will be sufficient to meet
our liquidity needs for fiscal 2017. However, no assurance can be given that we will receive any funds in addition to the funds we have
received to date.
The successful outcome of future activities cannot be determined at this time and there is no assurance that, if achieved, we will have
sufficient funds to execute our intended business plan or generate positive operating results.
The consolidated financial statements do not include any adjustments related to this uncertainty and as to the recoverability and
classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to
continue as a going concern.
F-7
PRINCIPLES OF CONSOLIDATION
The accompanying consolidated financial statements include the accounts of Aethlon Medical, Inc. and its majority-owned and controlled
subsidiary, ESI. All significant intercompany balances and transactions have been eliminated in consolidation. The Company has classified
the noncontrolling interests in ESI as part of consolidated net loss in the fiscal years ended March 31, 2016 and 2015 and includes the
accumulated amount of noncontrolling interests as part of equity.
The losses at ESI during the fiscal year ended March 31, 2015 reduced the noncontrolling interests on our consolidated balance sheet by
$86,287 from $35,933 at March 31, 2015 to $(50,354) at March 31, 2016.
RISKS AND UNCERTAINTIES
We operate in an industry that is subject to intense competition, government regulation and rapid technological change. Our operations are
subject to significant risk and uncertainties including financial, operational, technological, regulatory, and including the potential risk of
business failure.
USE OF ESTIMATES
We prepare our consolidated financial statements in conformity with accounting principles generally accepted in the United States of
America (“GAAP”), which requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of
revenues and expenses during the reporting periods. Significant estimates made by management include, among others, realization of long-
lived assets, valuation of derivative liabilities, estimating fair value associated with debt and equity transactions and valuation of deferred
tax assets. Actual results could differ from those estimates.
CASH AND CASH EQUIVALENTS
Accounting standards define “cash and cash equivalents” as any short-term, highly liquid investment that is both readily convertible to
known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest
rates. For the purpose of financial statement presentation, we consider all highly liquid investment instruments with original maturities of
three months or less when purchased, or any investment redeemable without penalty or loss of interest to be cash equivalents. As of March
31, 2015 and 2014, we had no assets that were classified as cash equivalents.
FAIR VALUE OF FINANCIAL INSTRUMENTS
The carrying amount of our cash, accounts receivable, accounts payable, and other current liabilities approximates their estimated fair
values due to the short-term maturities of those financial instruments. The carrying amount of the notes payable approximates their fair
value due to the short maturity of the notes and since the interest rates approximate current market interest rates for similar instruments.
Management has concluded that it is not practical to determine the estimated fair value of amounts due to related parties because the
transactions cannot be assumed to have been consummated at arm's length, the terms are not deemed to be market terms, there are no
quoted values available for these instruments, and an independent valuation would not be practicable due to the lack of data regarding
similar instruments, if any, and the associated potential costs.
We follow Financial Accounting Standard Board’s (“FASB”) Accounting Standards Codification (“ASC”) FASB ASC 820, “Fair Value
Measurements and Disclosures” (“ASC 820”) in connection with financial assets and liabilities measured at fair value on a recurring basis
subsequent to initial recognition.
ASC 820 requires that assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated by market data.
F-8
The hierarchy noted above requires us to minimize the use of unobservable inputs and to use observable market data, if available, when
determining fair value.
We do not have any assets or liabilities that are measured at fair value on a recurring basis and, during the years ended March 31, 2016 and
2015, did not have any assets or liabilities that were measured at fair value on a nonrecurring basis.
CONCENTRATIONS OF CREDIT RISKS
Cash is maintained at one financial institution in checking accounts and related cash management accounts. Accounts at this institution are
secured by the Federal Deposit Insurance Corporation up to $250,000. Our March 31, 2016 cash balances were approximately $1,885,000
over such insured amount. We do not believe that the Company is exposed to any significant risk with respect to its cash.
All of our accounts receivable at March 31, 2016 and 2015 and all of our revenue in the fiscal years ended March 31, 2016 and 2015 were
directly from the U.S. Department of Defense or from a subcontract under Battelle, which is a prime contractor with the U.S. Department of
Defense.
PROPERTY AND EQUIPMENT
Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the
related assets, which range from two to five years. Repairs and maintenance are charged to expense as incurred while improvements are
capitalized. Upon the sale or retirement of property and equipment, the accounts are relieved of the cost and the related accumulated
depreciation with any gain or loss included in the consolidated statements of operations.
INCOME TAXES
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the difference between the consolidated
financial statements and their respective tax basis. Deferred income taxes reflect the net tax effects of (a) temporary differences between
the carrying amounts of assets and liabilities for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax
credit carryforwards. We record a valuation allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in
the foreseeable future, it is more likely than not that some portion of the deferred tax assets may not be realized.
LONG-LIVED ASSETS
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that their carrying amounts may not
be recoverable. If the cost basis of a long-lived asset is greater than the projected future undiscounted net cash flows from such asset, an
impairment loss is recognized. We believe no impairment charges were necessary during the fiscal years ended March 31, 2016 and 2015.
LOSS PER SHARE
Basic loss per share is computed by dividing net income available to common stockholders by the weighted average number of common
shares outstanding during the period of computation. Diluted loss per share is computed similar to basic loss per share except that the
denominator is increased to include the number of additional common shares that would have been outstanding if potential common shares
had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss
per share are the same, and additional potential common shares have been excluded as their effect would be antidilutive.
As of March 31, 2016 and 2015, a total of 2,710,107 and 2,030,448 potential common shares, consisting of shares underlying outstanding
stock options, warrants and convertible notes payable were excluded as their inclusion would be antidilutive.
SEGMENTS
Historically, we operated in one segment that was based on our development of therapeutic devices. However, in the December 2013
quarter, we initiated the operations of ESI to develop diagnostic tests. As a result, we now operate in two segments, Aethlon for therapeutic
applications and ESI for diagnostic applications (See Note 10).
We record discrete financial information for ESI and our chief operating decision maker reviews ESI’s operating results in order to make
decisions about resources to be allocated to the ESI segment and to assess its performance.
F-9
DEFERRED FINANCING COSTS
Costs related to the issuance of debt are capitalized and amortized to interest expense over the life of the related debt using the effective
interest method. We recorded amortization expense related to our deferred financing costs of $144,683 and $118,147 during the fiscal years
ended March 31, 2016 and 2015, respectively.
REVENUE RECOGNITION
DARPA Contract -- We entered into a government contract with DARPA and have recognized revenue of $863,011 and $630,887 under
that contract during the fiscal years ended March 31, 2016 and 2015, respectively. We adopted the Milestone method of revenue
recognition for the DARPA contract under ASC 605-28 “Revenue Recognition – Milestone Method” (“ASC 605-28”) and we believe we
meet the requirements under ASC 605-28 for reporting contract revenue under the Milestone Method for the fiscal years ended March 31,
2016 and 2015.
We identify the deliverables included within the contract and evaluate which deliverables represent separate units of accounting based on if
certain criteria are met, including whether the delivered element has standalone value to the collaborator. The consideration received is
allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units.
A milestone is an event having all of the following characteristics:
(1) There is substantive uncertainty at the date the arrangement is entered into that the event will be achieved. A vendor’s assessment that it
expects to achieve a milestone does not necessarily mean that there is not substantive uncertainty associated with achieving the milestone.
(2) The event can only be achieved based in whole or in part on either: (a) the vendor’s performance; or (b) a specific outcome resulting
from the vendor’s performance.
(3) If achieved, the event would result in additional payments being due to the vendor.
A milestone does not include events for which the occurrence is either: (a) contingent solely upon the passage of time; or (b) the result of a
counterparty’s performance.
The policy for recognizing deliverable consideration contingent upon achievement of a milestone must be applied consistently to similar
deliverables.
The assessment of whether a milestone is substantive is performed at the inception of the arrangement. The consideration earned from the
achievement of a milestone must meet all of the following for the milestone to be considered substantive:
(1) The consideration is commensurate with either: (a) the vendor’s performance to achieve the milestone; or (b) the enhancement of the
value of the delivered item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone;
(2) The consideration relates solely to past performance; and
(3) The consideration is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration)
within the arrangement.
A milestone is not considered substantive if any portion of the associated milestone consideration relates to the remaining deliverables in
the unit of accounting (i.e., it does not relate solely to past performance). To recognize the milestone consideration in its entirety as
revenue in the period in which the milestone is achieved, the milestone must be substantive in its entirety. Milestone consideration cannot
be bifurcated into substantive and nonsubstantive components. In addition, if a portion of the consideration earned from achieving a
milestone may be refunded or adjusted based on future performance, the related milestone is not considered substantive.
Battelle Subcontract -- We entered into a subcontract agreement with Battelle Memorial Institute (“Battelle”) in March 2013. Battelle was
chosen by DARPA to be the prime contractor on the systems integration portion of the original DARPA contract and we are one of several
subcontractors on that systems integration project. The Battelle subcontract is cost-reimbursable under a time and materials basis. We began
generating revenues under the subcontract during the three months ended September 30, 2013 and for the fiscal years ended March 31,
2016 and 2015, we recorded revenue of $23,561 and $131,530, respectively, under the Battelle subcontract.
F-10
Our revenue under this contract is a function of cost reimbursement plus an overhead mark-up for hours devoted to the project by specific
employees (with specific hourly rates for those employees). Battelle engages us as needed. Each payment requires approval by the program
manager at Battelle.
STOCK-BASED COMPENSATION
Employee stock options and rights to purchase shares under stock participation plans are accounted for under the fair value method.
Accordingly, share-based compensation is measured when all granting activities have been completed, generally the grant date, based on
the fair value of the award. The exercise price of options is generally equal to the market price of the Company's common stock (defined as
the closing price as quoted on the Nasdaq Capital Market or OTCBB on the date of grant). Compensation cost recognized by the Company
includes (a) compensation cost for all equity incentive awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair
value estimated in accordance with the original provisions of the then current accounting standards, and (b) compensation cost for all equity
incentive awards granted subsequent to March 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of
subsequent accounting standards. We use a Binomial Lattice option pricing model for estimating fair value of options granted (see Note 5).
The following table summarizes share-based compensation expenses relating to shares and options granted and the effect on loss per
common share during the years ended March 31, 2016 and 2015:
Vesting of Stock Options
Total Stock-Based Compensation Expense
Fiscal Years Ended
March 31, 2016 March 31, 2015
416,481
$
416,481
$
202,844 $
202,844 $
Weighted average number of common shares outstanding – basic and diluted
7,393,695
5,594,447
Basic and diluted loss per common share
$
(0.03) $
(0.07)
We account for transactions involving services provided by third parties where we issue equity instruments as part of the total
consideration using the fair value of the consideration received (i.e. the value of the goods or services) or the fair value of the equity
instruments issued, whichever is more reliably measurable. In transactions, when the value of the goods and/or services are not readily
determinable and (1) the fair value of the equity instruments is more reliably measurable and (2) the counterparty receives equity
instruments in full or partial settlement of the transactions, we use the following methodology:
a) For transactions where goods have already been delivered or services rendered, the equity instruments are issued on or about the date the
performance is complete (and valued on the date of issuance).
b) For transactions where the instruments are issued on a fully vested, non-forfeitable basis, the equity instruments are valued on or about
the date of the contract.
c) For any transactions not meeting the criteria in (a) or (b) above, we re-measure the consideration at each reporting date based on its then
current stock value.
We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual
forfeiture experience. The effect of adjusting the forfeiture rate for all expense amortization after March 31, 2006 is recognized in the
period the forfeiture estimate is changed. The effect of forfeiture adjustments for the fiscal year ended March 31, 2016 was insignificant.
PATENTS
Patents include both foreign and domestic patents. We capitalize the cost of patents, some of which were acquired, and amortize such costs
over the shorter of the remaining legal life or their estimated economic life, upon issuance of the patent. The unamortized costs of patents
are subject to our review for impairment under our long-lived asset policy above.
STOCK PURCHASE WARRANTS
We grant warrants in connection with the issuance of convertible notes payable and the issuance of common stock for cash. When such
warrants are classified as equity and issued in connection with debt, we measure the relative estimated fair value of such warrants and
record it as a discount from the face amount of the convertible notes payable. Such discounts are amortized to interest expense over the
term of the notes using the effective interest method. Warrants issued in connection with common stock for cash, if classified as equity, are
considered issued in connection with equity transactions and the warrant fair value is recorded to additional paid-in-capital.
F-11
DERIVATIVE INSTRUMENTS
We evaluate free-standing derivative instruments (or embedded derivatives) to properly classify such instruments within equity or as
liabilities in our financial statements. Our policy is to settle instruments indexed to our common shares on a first-in-first-out basis.
The classification of a derivative instrument is reassessed at each reporting date. If the classification changes as a result of events during a
reporting period, the instrument is reclassified as of the date of the event that caused the reclassification. There is no limit on the number of
times a contract may be reclassified.
Instruments classified as derivative liabilities are remeasured each reporting period (or upon reclassification) and the change in fair value is
recorded on our consolidated statement of operations in other (income) expense. We had no derivative liabilities at either March 31, 2016
or March 31, 2015.
BENEFICIAL CONVERSION FEATURE OF CONVERTIBLE NOTES PAYABLE
The convertible feature of certain notes payable provides for a rate of conversion that is below market value. Such feature is normally
characterized as a "Beneficial Conversion Feature" ("BCF"). We measure the estimated fair value of the BCF in circumstances in which the
conversion feature is not required to be separated from the host instrument and accounted for separately, and record that value in the
consolidated financial statements as a discount from the face amount of the notes. Such discounts are amortized to interest expense over the
term of the notes.
RESEARCH AND DEVELOPMENT EXPENSES
Our research and development costs are expensed as incurred. We incurred approximately $782,000 and $1,028,000 of research and
development expenses for the years ended March 31, 2016 and 2015, respectively, which are included in various operating expenses in the
accompanying consolidated statements of operations.
OFF-BALANCE SHEET ARRANGEMENTS
We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect
on our consolidated financial statements.
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS
Management is evaluating significant recent accounting pronouncements that are not yet effective for us, including the new accounting
standard on improvements to employee share based payment accounting, FASB Accounting Standards Update (“ASU”) 2016-09 (Topic
718), the new accounting standard related to leases, ASU 2016-02 (Topic 842), the new accounting standard for recognition and
measurement of financial assets and financial liabilities, ASU 2016-01, the new accounting standard on imputation of interest, simplifying
the presentation of debt issuance costs, ASU 2015-03, the new accounting standard on extraordinary and unusual items on income
statements, ASU 2015-01, the new accounting standard related to presentation of financial statements - going concern qualifications, ASU
2014-15, and the new accounting standard on revenue recognition, ASU 2014-09 (Topic 606),and have not yet concluded whether any such
pronouncements will have a significant effect on our future consolidated financial statements.
2. PROPERTY AND EQUIPMENT
Property and equipment, net, consist of the following:
Furniture and office equipment, at cost
Accumulated depreciation
March 31, 2016 March 31, 2015
385,088
$
(328,997)
56,091
394,395 $
(358,357)
36,038 $
$
Depreciation expense for the years ended March 31, 2016 and 2015 approximated $29,000 and $28,000, respectively.
F-12
3. PATENTS
Patents consist of the following:
Patents
Accumulated amortization
March 31, 2016 March 31, 2015
211,645
$
(108,320)
103,325
211,645 $
(117,484)
94,161 $
$
Amortization expense for patents for the years ended March 31, 2016 and 2015 approximated $9,000. Future amortization expense on
patents is estimated to be approximately $9,000 per year based on the estimated life of the patents. The weighted average remaining life of
our patents is approximately 4.8 years.
4. CONVERTIBLE NOTES PAYABLE
Convertible Notes Payable consisted of the following at March 31, 2016:
Convertible Notes Payable – Non-Current Portion:
November 2014 10% Convertible Notes
Total Convertible Notes Payable – Non-Current Portion
Total Convertible Notes Payable
$
Principal
Accrued Interest
527,780
527,780
527,780 $
74,036
74,036
74,036
During the fiscal year ended March 31, 2016, we recorded interest expense of $52,778 related to the contractual interest rates of our
convertible notes, interest expense of $372,550 related to the amortization of debt discounts on the convertible notes and interest expense of
$144,683 related to the amortization of deferred financing costs for a total of $570,011. Accrued interest is included in other current
liabilities (see Note 7).
Convertible Notes Payable consisted of the following at March 31, 2015:
Principal
Unamortized
Discount
Net
Amount
Accrued
Interest
Convertible Notes Payable – Non-Current
Portion:
November 2014 10% Convertible Notes
Total Convertible Notes Payable – Non-Current
Portion
Total Convertible Notes Payable
$
$
527,780 $
(372,551) $
155,229 $
527,780
527,780 $
(372,551)
(372,551) $
155,229
155,229 $
21,258
21,258
21,258
During the fiscal year ended March 31, 2015, we recorded interest expense of $24,625 related to the contractual interest rates of our
convertible notes, interest expense of $155,230 related to the amortization of debt discounts on the convertible notes and interest expense of
$118,147 related to the amortization of deferred financing costs for a total of $298,002.
NOVEMBER 2014 10% CONVERTIBLE NOTES
In November 2014, we entered into a subscription agreement with two accredited investors providing for the issuance and sale of (i)
convertible promissory notes in the aggregate principal amount of $527,780 and (ii) five year warrants to purchase up to 47,123 shares of
common stock at a fixed exercise price of $8.40 per share. These notes bear interest at the annual rate of 10% and originally matured on
April 1, 2016.
The aggregate gross cash proceeds to us were $415,000 after subtracting legal fees of $35,000; the balance of the principal amount of the
notes represents a $27,780 due diligence fee and an original issuance discount. We recorded deferred financing costs of $112,780 to reflect
the legal fees, due diligence fee and original issuance discount and will amortize those costs over the life of the notes using the effective
interest method.
These notes are convertible at the option of the holders into shares of our common stock at a fixed price of $5.60 per share, for up to an
aggregate of 94,246 shares of common stock. There are no registration requirements with respect to the shares of common stock underlying
the notes or the warrants.
The estimated relative fair value of warrants issued in connection with the November 2014 10% Convertible Notes was recorded as a debt
discount and is amortized as additional interest expense over the term of the underlying debt. We recorded debt discount of $240,133 based
on the relative fair value of these warrants. In addition, as the effective conversion price of the debt was less than market price of the
underlying common stock on the date of issuance, we recorded an additional debt discount of $287,647 related to the beneficial conversion
feature.
F-13
Initial Amendment of Convertible Promissory Note Terms
On November 12, 2015, we entered into an amendment of terms (“Amendment of Terms”) with the two investors that participated in the
November 2014 10% Convertible Notes. The Amendment of Terms modifies the terms of the subscription agreement, notes and warrants
to, among other things, extend the maturity date of the notes from April 1, 2016 to June 1, 2016, temporarily reduce the number of shares
that we must reserve with respect to conversion of the notes, and temporarily suspend the time period during which one of the investors
may exercise its warrants. In exchange for the investors’ agreements in the Amendment of Terms, we paid one of the investors a cash fee of
$90,000, which we recorded as deferred financing costs and will amortize over the remaining term of the notes. During the fiscal year
ended March 31, 2016, $62,308 of amortization related to the amendment has been included in interest expense in the accompanying
consolidated statements of operations.
Second Amendment and Extension of Convertible Promissory Notes
On June 27, 2016, the maturity date of the November 2014 10% Convertible Notes was extended through July 1, 2017 (see Note 11).
Therefore, we classified the notes as non-current liabilities on our March 31, 2016 balance sheet.
AMENDED AND RESTATED SERIES A 12% CONVERTIBLE NOTES
In June 2010, we entered into Amended and Restated Series A 12% Convertible Promissory Notes (the "Amended and Restated Notes")
with the holders of certain promissory notes previously issued by us, extending the due date to December 31, 2010 on the aggregate
principal balance of $900,000. During the fiscal year ended March 31, 2013, the holders of $15,000 of the Notes converted their principal
and related accrued interest into common stock. During the fiscal year ended March 31, 2015, the holders of the remaining $885,000 of the
Notes converted their principal and related accrued interest into common stock. There was no balance remaining at March 31, 2015.
The following transactions related to the Amended and Restated Notes impacted our consolidated statements of operations and statements
of cash flows in the fiscal year ended March 31, 2015.
Weiner Note Conversion
On June 24, 2014, we entered into an agreement with the Ellen R. Weiner Family Revocable Trust (the “Trust”), a holder of a Series A
12% Convertible Note (the “Note”), which previously was classified as being in default. As per the agreement, the Trust converted past due
principal of $660,000 and accrued interest balance of $343,200 into unregistered shares of our common stock, representing all amounts
outstanding to the Trust.
Additionally, the Trust agreed to waive anti-dilution price protection underlying warrants previously issued to the Trust. On June 26, 2014,
three other parties who held similar warrants also agreed to waive their anti-dilution price protection.
Under its agreement, the Trust converted the entire $1,003,200 past due principal and interest balance on the Note, which previously was in
default, into an aggregate of 466,365 unregistered shares of our common stock and five-year warrants to acquire up to 136,190 shares of our
common stock at an exercise price of $2.10 per share (which exercise price was the result of certain contractual price adjustments
previously made during 2011) and up to 7,944 shares of our common stock at an exercise price of $5.40 per share (collectively, the
“Conversion Securities”). Based on the fair value of the warrants and shares issued to the Trust for the accrued interest, we recorded a loss
on settlement of notes of $1,791,421 during the fiscal year ended March 31, 2015.
F-14
In exchange for the Trust’s conversion in full of the Note and accrued interest and for the waivers of anti-dilution price protection in the
previously issued warrants, in addition to the Conversion Securities, we issued to the Trust 1,500 unregistered shares of common stock as a
service fee, changed the exercise price of all of the previously issued warrants to $2.10 per share and extended the expiration date of all of
the previously issued warrants to July 1, 2018. We valued the 1,500 share service fee at $12,000 based on our closing price on the date of
the agreement and recorded that value as interest expense during the June 2014 period.
Bird Estate Extension
On July 8, 2014, we executed a written restructuring agreement (the “Agreement”) with the Estate of Allan Bird (the “Estate”), a holder of
a Series A 12% Convertible Note (the “Note”), which previously was classified as being in default. Since the negotiations for the
Agreement were completed in the month of June, we recorded the impact of the Agreement as of June 30, 2014. In the Agreement, the
Estate agreed to extend the expiration date of the Note to April 1, 2016, to convert approximately $116,970 of accrued interest to equity,
and to waive anti-dilution price protection underlying the Note and warrants previously issued to the Estate.
Under the Agreement, the Estate converted the entire $116,970 past due interest balance on the Note, which previously was in default, into
an aggregate of 51,837 unregistered shares of our common stock. The Estate received five-year warrants to acquire up to 46,429 shares of
our common stock at an exercise price of $2.10 per share (which exercise price was the result of certain contractual price adjustments
previously made during 2011). Based on our common stock prices during a period of negotiation with the Estate including during calendar
year 2013, the Estate also received five-year warrants to acquire up to 2,708 shares of our common stock at an exercise price of $5.40
(collectively known as the “Conversion Securities”). Based on the fair value of the warrants and shares issued to the Estate for the accrued
interest, we recorded a loss on settlement of notes of $663,209 during the fiscal year ended March 31, 2015.
In exchange for the Estate’s extension of the Note, conversion of accrued interest and for the waivers of anti-dilution price protection in the
previously issued warrants, in addition to the Conversion Securities, we also issued to the Estate 500 unregistered shares of common stock
as an extension fee and extended the expiration date of all of the previously issued warrants to July 1, 2018. We valued the 500 share
extension fee at $4,500 based on our closing price and recorded that value as a deferred financing cost, which we will amortize over the
extended two-year life of the note.
Bird Estate Conversion
In November 18, 2014, we issued an aggregate of 112,500 shares of common stock to the Estate upon the conversion of an aggregate of
$236,250 representing all $225,000 of unpaid principal and $11,250 of unpaid accrued interest due under the Note. The conversion price
per share was $2.10.
5. EQUITY TRANSACTIONS
COMMON STOCK AND WARRANTS
Aethlon Medical, Inc. Equity Transactions in the Fiscal Year Ended March 31, 2016.
REVERSE STOCK SPLIT
On April 14, 2015, we completed a 1-for-50 reverse stock split. Accordingly, authorized common stock was reduced from 500,000,000
shares to 10,000,000 shares, and each 50 shares of outstanding common stock held by stockholders were combined into one share of
common stock. The accompanying condensed consolidated financial statements and accompanying notes have been retroactively revised to
reflect such reverse stock split as if it had occurred on April 1, 2014. All share and per share amounts have been revised accordingly.
INCREASE IN AUTHORIZED SHARES
On March 31, 2016, we filed a Certificate of Amendment to our Articles of Incorporation to increase our authorized common stock from
10,000,000 to 30,000,000 shares. Our stockholders approved the amendment at our annual meeting of stockholders held on March 29,
2016.
ISSUANCES OF COMMON STOCK AND WARRANTS
Aethlon Medical, Inc. Equity Transactions in the Fiscal Year Ended March 31, 2016.
On April 28, 2015, we issued 915 shares of common stock as the result of rounding up of fractional shares that arose due to our reverse
stock split.
On June 25, 2015, we sold $6,000,000 of units, comprised of common stock and warrants, to 18 accredited investors at a price of $6.30 per
unit. Each unit consisted of one share of common stock and 0.75 of a five-year warrant to purchase one share of common stock at an
exercise price of $6.30 per share. Accordingly, we issued a total of 952,383 shares of unregistered common stock and warrants to purchase
714,285 shares of common stock. For its services as sole placement agent for the financing, we paid Roth Capital Partners, LLC (“Roth”) a
cash fee of $285,512 and expense reimbursement of $75,000 and we issued them a five-year warrant to purchase 32,371 shares of common
stock at an exercise price of $6.30 per share. We received $5,591,988 in net proceeds from this financing. The warrant fair value, which
was valued using a binomial lattice model, was recorded to additional paid-in-capital.
F-15
In connection with the financing, Mr. James Joyce, our Chief Executive Officer, Mr. James Frakes, our Chief Financial Officer and Dr.
Chetan Shah, a director of our company, each agreed to waive their right to exercise certain stock options and warrants held by them
representing the right to acquire 402,318 shares of common stock in the aggregate (the “Waivers”). The Waivers were required in order to
make a sufficient number of shares of common stock available for issuance and the Waivers expired when we amended our Articles of
Incorporation on March 31, 2016.
During the three months ended September 30, 2015, we issued an aggregate of 5,292 shares of common stock to an accredited investor
upon the exercise of previously issued warrants. The warrants were exercised on a cashless or “net” basis. Accordingly, we did not receive
any proceeds from such exercises. The cashless exercise of such warrants resulted in the cancellation of previously issued warrants to
purchase an aggregate of 1,744 shares of common stock.
During the three months ended December 31, 2015, we issued an aggregate of 6,757 unregistered shares of common stock to two investors
upon the exercise of previously issued warrants. The warrants were exercised for cash and we received cash proceeds of $14,766 for an
average purchase price of $2.19 per share per the terms of the warrants.
Aethlon Medical, Inc. Equity Transactions in the Fiscal Year Ended March 31, 2015.
Equity Unit Investments in the Fiscal Year Ended March 31, 2015
In the three months ended June 30, 2014, we completed unit subscription agreements with seven accredited investors pursuant to which we
issued 43,849 shares of our common stock and 21,924 warrants to purchase our common stock for net cash proceeds of $320,800. Such
warrants have exercise prices ranging from $9.65 to $11.80 per share.
During the three months ended September 30, 2014, we issued and sold to three accredited investors units consisting of (a) two thousand
(2,000) unregistered shares of our common stock, par value $.001 per share, at prices per share ranging from $4.55 to $4.70 and (b) a five-
year warrant to purchase one thousand (1,000) shares of common stock at exercise prices ranging from $6.80 to $7.15 per share. In total,
the investors purchased for cash an aggregate of $90,000 of units. The investors acquired an aggregate of 19,500 shares of common stock
and warrants to acquire up to an aggregate of 9,750 shares of Common Stock.
During the three months ended December 31, 2014, we issued and sold to eight accredited investors units consisting of (a) 2,000
unregistered shares of our common stock at prices per share ranging from $5.25 to $5.70 and (b) a five-year warrant to purchase 1,000
shares of common stock at exercise prices ranging from $7.70 to $8.35 per share. In total, the investors purchased for cash an aggregate of
$502,700 of units. The investors acquired an aggregate of 90,125 shares of common stock and warrants to acquire up to an aggregate of
45,063 shares of common stock.
During the three months ended December 31, 2014, we sold $3,300,000 of units at a price of $15.00 per unit (the “December Financing”).
Each unit consists of one share of common stock and a warrant to purchase 1.2 shares of common stock at an exercise price per share of
$15.00. We sold a total of 220,000 units in the financing consisting of 220,000 shares of common stock and warrants to purchase 264,000
shares of common stock at an exercise price of $15.00 per share.
Roth Capital Partners, LLC served as sole placement agent for the December Financing and received a cash fee of $231,000, expense
reimbursement of $25,000, and a five-year warrant to purchase 11,000 shares of common stock at an exercise price of $15.00 per share for
its services in the financing. In addition, we paid $10,000 in legal expenses to the investors’ counsel. We also paid $32,572 to our counsel
related to this financing. The net proceeds to us after the placement fee and legal fees were $3,001,428.
Note Conversions in the Fiscal Year Ended March 31, 2015
As discussed above in Note 4, during the three months ended June 30, 2014, we issued 314,286 shares of unregistered common stock to the
holder of one of the Series A 12% Convertible Notes in exchange for the conversion in full of the $660,000 principal balance of that note,
152,079 shares of unregistered common stock in exchange for conversion of $343,200 of accrued interest and 75,000 shares of unregistered
common stock as a restructuring fee. During that period, we also issued the other holder of the Series A 12% Convertible Notes 51,837
shares of unregistered common stock in exchange for conversion of $116,970 of accrued interest and 500 shares of unregistered common
stock as a restructuring fee.
During the three months ended September 30, 2014, we issued 38,750 shares of unregistered common stock to the holders of three
convertible notes in exchange for the partial or full conversion of principal and interest in the aggregate amount of $81,375 at a conversion
price of $2.10 per share.
On July 24, 2014, we issued an aggregate of 50,079 shares of unregistered common stock and a seven-year warrant to issue up to 25,040
shares of common stock at an exercise price of $6.60 per share to Dr. Chetan Shah, a director. The common stock and warrant were issued
to Dr. Shah upon the conversion of an aggregate of $220,349 of unpaid principal and accrued interest due under a 10% Convertible Note
previously issued to Dr. Shah by us on July 9, 2013.
F-16
On September 17, 2014, we issued to the holder of the remaining 2008 10% Convertible Note units consisting of an aggregate of 9,564
shares of unregistered common stock and unit warrants to acquire up to an aggregate of 4,782 shares of common stock at an exercise price
of $4.80 per share (see Note 4). The units were issued to the note holder upon the conversion of an aggregate of $45,906 of unpaid
principal and accrued interest due under the promissory note, which represented the entire amount outstanding under the note. We recorded
a loss on debt conversion of $65,493 on this transaction.
During the three months ended December 31, 2014, we issued an aggregate of 284,745 shares of common stock to two accredited investors
upon the conversion of an aggregate of $597,965 of unpaid principal and accrued interest due under promissory notes we previously issued
to the investors. The conversion price per share was $2.10 (see Note 4).
During the three months ended December 31, 2014, we issued an aggregate of 112,500 shares of common stock to convert in full the
outstanding principal balance of $225,000 and interest balance of $11,250 on the remaining note from 2010 through the issuance of
112,500 shares of common stock. The conversion price per share was $2.10 (see Note 4).
During the three months ended December 31, 2014, we issued to an accredited investor units consisting of an aggregate of 36,716 shares of
common stock and warrants to acquire up to an aggregate of 18,358 shares of common stock at an exercise price of $5.15 per share. The
units were issued to the investor upon the conversion of an aggregate of $189,087 of unpaid principal and accrued interest due under two
promissory notes we previously issued to the investor. The amounts converted represented the entire principal and interest outstanding
under the notes and the notes held by that holder were retired (see Note 4).
During the three months ended March 31, 2015, we issued an aggregate of 98,688 shares of Common Stock to an accredited investor upon
the conversion of an aggregate of $207,245 of unpaid principal due under a convertible promissory note previously issued to the investor.
The conversion price per share was $2.10 (see Note 4).
Common Stock Issuances in the Fiscal Year Ended March 31, 2015
During the three months ended June 30, 2014, we issued 4,383 shares of common stock pursuant to our S-8 registration statement covering
our Amended 2010 Stock Plan at an average price of $8.50 per share in payment for legal services, internal controls consulting services and
regulatory consulting services collectively valued at $38,268 based on the value of the services provided.
During the three months ended September 30, 2014, we issued 7,199 shares of common stock pursuant to our S-8 registration statement
covering our Amended 2010 Stock Plan at an average price of $7.00 per share in payment for legal and scientific consulting services valued
at $49,090 based on the value of the services provided.
During the three months ended September 30, 2014, we issued 7,806 shares of unregistered common stock at an average price of $9.50 per
share in payment for investor relations consulting services valued at $75,000 based on the value of the services provided.
During the three months ended December 31, 2014, we issued 7,486 shares of common stock pursuant to our S-8 registration statement
covering our Amended 2010 Stock Plan at an average price of $7.30 per share in payment for legal and scientific consulting services valued
at $54,800 based on the value of the services provided.
During the three months ended December 31, 2014, we issued 780 shares of unregistered common stock at an average price of $10.50 per
share in payment for investor relations consulting services valued at $8,000 based on the value of the services provided.
Warrant Exercises and Issuance of New Warrants upon Exercise in the Fiscal Year Ended March 31, 2015
During the three months ended September 30, 2014, we issued to four investors 53,465 shares of unregistered common stock through the
cash exercise of eight warrants for $259,474 of cash at an average exercise price of approximately $5.00 per share. As an inducement to
those investors, we issued them replacement warrants to acquire up to an aggregate of 53,465 shares of common stock on the same terms as
the warrants they exercised.
During the three months ended December 31, 2014, we issued an aggregate of 113,422 shares of common stock and seven-year warrants to
issue up to an aggregate of 113,422 shares of common stock at exercise prices ranging from $4.65 to $5.80 per share to eight accredited
investors. One of the investors was Dr. Chetan Shah, one of our directors. We issued the common stock and warrants to the investors upon
the cash exercise of previously issued warrants held by them. The investors paid an aggregate of $579,251 upon exercise of the previously
outstanding warrants at exercise prices ranging from $4.65 to $5.80 per share.
F-17
Debt Reduction in the Fiscal Year Ended March 31, 2015
During the three months ended December 31, 2014, we paid off in full the outstanding principal balance and interest balance on the Law
Firm Note with a cash payment of $50,000 and an issuance of 3,400 common shares (see Note 4).
Warrant Exercises in the Fiscal Year Ended March 31, 2015
During the three months ended December 31, 2014, we issued an aggregate of 430,333 shares of common stock to accredited investors
upon the exercise of previously issued warrants. The warrants were exercised on a cashless or “net” basis. Accordingly, we did not receive
any proceeds from such exercises. The cashless exercise of such warrants resulted in the cancellation of previously issued warrants to
purchase an aggregate of 605,304 shares of common stock.
During the three months ended March 31, 2015, we issued 3,574 shares of common stock to an accredited investor upon the exercise of a
previously issued warrant. The warrant was exercised on a cashless or “net” basis. Accordingly, we did not receive any proceeds from such
exercise. The cashless exercise of the warrant resulted in the cancellation of a portion of the previously issued warrant to purchase an
aggregate of 1,602 shares of common stock.
Stock Option Exercises in the Fiscal Year Ended March 31, 2015
During the three months ended December 31, 2014, two former employees exercised stock options to purchase 1,000 common shares
through a cash payment of $9,500 with an exercise price of $9.50 per share.
WARRANTS:
A summary of the aggregate warrant activity for the years ended March 31, 2016 and 2015 is presented below:
Outstanding, beginning of year
Granted
Exercised
Cancelled/Forfeited
Outstanding, end of year
Exercisable, end of year
Weighted average estimated fair value of warrants
granted
Fiscal Year Ended March 31,
2016
2015
Warrants
1,430,738 $
746,657 $
(12,049) $
(1,252) $
2,164,094 $
2,164,094 $
Weighted
Average
Exercise Price
6.84
6.30
2.15
2.10
6.68
6.68
Warrants
1,414,190 $
806,478 $
(590,659) $
(199,271) $
1,430,738 $
1,430,738 $
Weighted
Average
Exercise Price
5.00
8.46
4.29
7.11
6.84
6.84
$
5.11
$
11.83
The following outlines the significant weighted average assumptions used to estimate the fair value of warrants granted utilizing the
Binomial Lattice option pricing model:
Risk free interest rate
Average expected life
Expected volatility
Expected dividends
Year Ended March 31,
2016
1.70%
5 years
98.6%
None
2015
0.79%-2.29%
5 to 7 years
87.8% - 107.4%
None
The detail of the warrants outstanding and exercisable as of March 31, 2016 is as follows:
Warrants Outstanding
Warrants Exercisable
Range of
Exercise Prices
$5.00 or Below
$5.20 - $9.00
$9.65 - $15.00
Number
Outstanding
515,533
1,351,632
296,929
2,164,094
Weighted
Average
Remaining
Life (Years)
Weighted
Average
Exercise Price
2.78 $
3.85 $
3.71 $
2.63
6.46
14.70
Number
Outstanding
515,533 $
1,351,632 $
296,929 $
2,164,094
Weighted
Average
Exercise Price
2.63
6.46
14.70
F-18
STOCK OPTIONS:
2000 STOCK OPTION PLAN
Our 2000 Stock Option Plan provides for the grant of incentive stock options to our full-time employees (who may also be directors) and
nonstatutory stock options to non-employee directors, consultants, customers, vendors or providers of significant services. The exercise
price of any incentive stock option may not be less than the fair market value of the common stock on the date of grant or, in the case of an
optionee who owns more than 10% of the total combined voting power of all classes of our outstanding stock, not be less than 110% of the
fair market value on the date of grant. The exercise price, in the case of any nonstatutory stock option, must not be less than 75% of the fair
market value of the common stock on the date of grant. The amount reserved under the 2000 Stock Option Plan is 10,000 options.
At March 31, 2016, all of the grants previously made under the 2000 Stock Option Plan had expired and 200 unregistered shares had been
issued under the plan, with 9,800 available for future issuance.
2010 STOCK INCENTIVE PLAN
In August 2010, we adopted the 2010 Stock Incentive Plan, which provides incentives to attract, retain and motivate employees and
directors whose present and potential contributions are important to our success by offering them an opportunity to participate in our future
performance through awards of options, the right to purchase common stock, stock bonuses and stock appreciation rights and other awards.
A total of 70,000 common shares were initially reserved for issuance under the 2010 Stock Incentive Plan.
In August 2010, we filed a registration statement on Form S-8 for the purpose of registering 70,000 common shares issuable under this plan
under the Securities Act, and in July 2012, we filed a registration statement on Form S-8 for the purpose of registering 100,000 common
shares issuable under this plan under the Securities Act.
On January 26, 2016, our Board of Directors approved an amendment to the 2010 Stock Incentive Plan to increase the total number of
shares of common stock reserved for issuance under the plan to 3,170,000 shares, subject to amendment of our Articles of Incorporation to
increase our authorized common stock. On March 29, 2016, we held an annual stockholders meeting, at which our stockholders approved
the Amended 2010 Stock Incentive Plan and an amendment of our Articles of Incorporation to increase our authorized common stock to
30,000,000 shares.
At March 31, 2016, we had 3,028,845 shares available under this plan.
2012 DIRECTORS COMPENSATION PROGRAM
In July 2012, our Board of Directors approved a board compensation program that modifies and supersedes the 2005 Directors
Compensation Program, which was previously in effect. Under the 2012 program, in which only non-employee directors may participate,
an eligible director will receive a grant of $35,000 worth of ten-year options to acquire shares of common stock, with such grant being
valued at the exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first
day of the fiscal year. In addition, under this program, eligible directors will receive cash compensation equal to $500 for each committee
meeting attended and $1,000 for each formal board meeting attended.
In the fiscal year ended March 31, 2015, our Board of Directors granted ten-year options to acquire an aggregate of 11,053 shares of our
common stock, all with an exercise price of $9.50 per share, to our three outside directors under the 2012 program.
No options were granted to directors in the fiscal year ended March 31, 2016.
At March 31, 2016, we had issued 26,757 options under the 2005 program to outside directors and 79,309 options to employee-directors,
21,756 outside directors’ options had been forfeited, 5,000 outside directors’ options had been exercised, 79,309 employee-directors’
options had been forfeited and no options under the 2005 program remained outstanding.
On June 6, 2014, our Board of Directors approved certain changes to the 2012 program. Under this modified program, a new eligible
director will receive an initial grant of $50,000 worth of options to acquire shares of common stock, with such grant being valued at the
exercise price based on the average of the closing bid prices of the common stock for the five trading days preceding the first day of the
fiscal year. These options will have a term of ten years and will vest 1/3 upon grant and 1/3 upon each of the first two anniversaries of the
date of grant. In addition, at the beginning of each fiscal year, each existing director eligible to participate in the modified 2012 program
also will receive a grant of $35,000 worth of options valued at the exercise price based on the average of the closing bid prices of the
common stock for the five trading days preceding the first day of the fiscal year. Such options will vest on the first anniversary of the date
of grant. In lieu of per meeting fees, eligible directors will receive an annual board retainer fee of $30,000. The modified 2012 program
also provides for the following annual retainer fees: Audit Committee Chair - $5,000, Compensation Committee chair - $5,000, Audit
Committee member - $4,000, Compensation Committee member - $4,000 and lead independent director - $15,000.
F-19
STAND-ALONE GRANTS
From time to time our Board of Directors grants common stock or common share purchase options or warrants to selected directors,
officers, employees and consultants as equity compensation to such persons on a stand-alone basis outside of any of our formal stock plans.
The terms of these grants are individually negotiated.
GRANTS TO EMPLOYEES
There were no stock option grants to either directors or employees during the fiscal year ended March 31, 2016.
During the fiscal year ended March 31, 2015, our Board of Directors approved the following grants of options to certain officers and
directors of the Company:
o To Mr. James A. Joyce, an option to acquire an aggregate of 30,000 shares of our common stock at an exercise price of $9.50
per share, the closing price of our common stock on the date of grant. The fair value of this stock option at the date of grant
was $246,000. The option vested as to 10,000 shares on the grant date for a vesting expense of $82,000 and will vest as to an
additional 10,000 shares on each of the first two anniversaries of the grant date. Unless earlier exercised or terminated, the
option will expire June 6, 2024.
o To Mr. Rodney S. Kenley, an option to acquire an aggregate of 5,000 shares of our common stock at an exercise price of $9.50
per share, the closing price of our common stock on the date of grant. The fair value of this stock option at the date of grant
was $41,000. The option vested as to 1,667 shares on the grant date for a vesting expense of $13,667 and will vest as to an
additional 1,667 shares on the first anniversary of the grant date and 1,666 shares on the second anniversary of the grant date.
Unless earlier exercised or terminated, the option will expire June 6, 2024.
o To Mr. James B. Frakes, an option to acquire an aggregate of 5,000 shares of our common stock at an exercise price of $9.50
per share, the closing price of our common stock on the date of grant. The fair value of this stock option at the date of grant
was $41,000. The option vested as to 1,667 shares on the grant date for a vesting expense of $13,667 and will vest as to an
additional 1,667 shares on the first anniversary of the grant date and 1,666 shares on the second anniversary of the grant date.
Unless earlier exercised or terminated, the option will expire June 6, 2024.
o To Dr. Richard H. Tullis, an option to acquire an aggregate of 1,000 shares of our common stock at an exercise price of $9.50
per share, the closing price of our common stock on the date of grant. The fair value of this stock option at the date of grant
was $8,200. The option vested as to 333 shares on the grant date for a vesting expense of $2,733 and will vest as to an
additional 333 shares on the first anniversary of the grant date and 334 shares on the second anniversary of the grant date.
Unless earlier exercised or terminated, the option will expire June 6, 2024.
In addition to the above grants to our officers, during the fiscal year ended March 31, 2015, our Board of Directors also approved the grant
of options to five employees to acquire an aggregate of 7,400 shares of our common stock at an exercise price of $9.50 per share, the
closing price of our common stock on the date of grant. The aggregate fair value of those stock options at the date of grant was $60,680.
Those options vested as to 2,467 shares on the grant date for a vesting expense of $20,227 and will vest as to an additional 2,467 shares on
the first anniversary of the grant date and 2,466 shares on the second anniversary of the grant date. Unless earlier exercised or terminated,
the option will expire June 6, 2024.
F-20
The following is a summary of the stock options outstanding at March 31, 2016 and 2015 and the changes during the years then ended:
Outstanding, beginning of year
Granted
Exercised
Cancelled/Forfeited
Outstanding, end of year
Exercisable, end of year
Weighted average estimated fair value of options
granted
Fiscal Year Ended March 31,
2016
2015
Options
501,690 $
–
–
(63,143) $
438,547 $
388,414 $
Weighted
Average
Exercise Price
Options
Weighted
Average
Exercise Price
11.00
N/A
N/A
11.45
10.94
11.53
N/A
522,668 $
59,453 $
(1,000) $
(79,431) $
501,690 $
418,923 $
$
12.50
9.50
9.50
18.76
11.00
12.00
9.50
The following outlines the significant weighted average assumptions used to estimate the fair value with respect to stock options utilizing
the Binomial Lattice option pricing model for the year ended March 31, 2015 (no stock options were issued in the year ended March 31,
2016):
Risk free interest rate
Average expected life
Expected volatility
Expected dividends
2.60%
10 years
90.23%
None
The detail of the options outstanding and exercisable as of March 31, 2016 is as follows:
Exercise Prices
$3.80 - $9.50
$12.50
$18.00 - $20.50
Number
Outstanding
190,547
163,000
85,000
438,547
Options Outstanding
Weighted
Average
Remaining
Life (Years)
Weighted
Average
Exercise
Price
7.70 years $
4.39 years $
2.02 years $
6.03
12.50
19.03
Options Exercisable
Weighted
Average
Exercise
Price
5.91
12.50
19.03
Number
Outstanding
140,414 $
163,000 $
85,000 $
388,414
We recorded stock-based compensation expense related to share issuances and to options granted totaling $202,844 and $416,481 for the
fiscal years ended March 31, 2016 and 2015, respectively. These expenses were recorded as stock compensation included in payroll and
related expenses in the accompanying consolidated statement of operations for the years ended March 31, 2016 and 2015.
Our total stock-based compensation for fiscal years ended March 31, 2016 and 2015 included the following:
Vesting of stock options
Total Stock-Based Compensation
Fiscal Year Ended
March 31, 2016 March 31, 2015
416,481
$
416,481
$
202,844 $
202,844 $
As of March 31, 2016, we had $139,139 of remaining unrecognized stock option expense, which is expected to be recognized over a
weighted average remaining vesting period of 0.69 years.
On March 31, 2016, our stock options had a negative intrinsic value since the closing price on that date of $5.36 per share was below the
weighted average exercise price of our stock options.
F-21
6. RELATED PARTY TRANSACTIONS
DUE TO RELATED PARTIES
Historically, certain of our officers and other related parties have advanced us funds, agreed to defer compensation and/or paid expenses on
our behalf to cover working capital deficiencies. There were no such related party transactions during the fiscal year ended March 31, 2016
except that we had accrued unpaid Board fees of $116,000 owed to our outside directors as of March 31, 2016.
7. OTHER CURRENT LIABILITIES
Other current liabilities were comprised of the following items:
Accrued interest
Other accrued liabilities
Total other current liabilities
8. INCOME TAXES
March 31,
2016
March 31,
2015
$
$
74,038 $
62,657
136,695 $
21,258
64,473
85,731
For the years ended March 31, 2016 and 2015, we had no income tax expense due to our net operating losses and 100% deferred tax asset
valuation allowance.
At March 31, 2016 and 2015, we had net deferred tax assets as detailed below. These deferred tax assets are primarily composed of
capitalized research and development costs and tax net operating loss carryforwards. Due to uncertainties surrounding our ability to
generate future taxable income to realize these assets, a 100% valuation has been established to offset the net deferred tax assets.
Significant components of our net deferred tax assets at March 31, 2016 and 2015 are shown below:
Deferred tax assets:
Capitalized research and development
Net operating loss carryforwards
Total deferred tax assets
Total deferred tax liabilities
Net deferred tax assets
Valuation allowance for deferred tax assets
Net deferred tax assets
YEAR ENDED MARCH 31,
2015
2016
$
3,442,000 $
20,126,000
23,568,000
3,442,000
17,927,000
21,369,000
–
–
23,568,000
(23,568,000)
21,369,000
(21,369,000)
$
– $
–
At March 31, 2016, we had tax net operating loss carryforwards for federal and state purposes approximating $52 million and $41 million,
which begin to expire in the year 2023.
The provision for income taxes on earnings subject to income taxes differs from the statutory federal rate for the years ended March 31,
2016 and 2015 due to the following:
Income taxes (benefit) at federal statutory rate of 34%
State income tax, net of federal benefit
Tax effect on non-deductible expenses and credits
Change in valuation allowance1
2016
2015
$
$
(1,686,000) $
(298,000)
69,000
1,915,000
– $
(2,373,000)
(418,000)
1,524,000
1,267,000
–
______________
(1) Pursuant to Internal Revenue Code Sections 382, use of our tax net operating loss carryforwards may be limited.
F-22
ASC 740, “Income Taxes”, clarifies the accounting for uncertainty in income taxes recognized in an entity's financial statements, and
prescribes recognition thresholds and measurement attributes for financial statement disclosure of tax positions taken or expected to be
taken on a tax return. Under ASC 740, the impact of an uncertain income tax position on the income tax return must be recognized at the
largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position
will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, ASC 740 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure and transition. Our practice is to recognize interest and/or
penalties related to income tax matters in income tax expense. During the years ended March 31, 2016 and 2015, we did not recognize any
interest or penalties relating to tax matters.
At and for the years ended March 31, 2016 and 2015, management does not believe the Company has any uncertain tax positions.
Accordingly, there are no unrecognized tax benefits at March 31, 2016 or March 31, 2015.
Our tax returns remain open for examination by the applicable authorities, generally 3 years for federal and 4 years for state. We are
currently not under examination by any taxing authorities.
9. DARPA CONTRACT AND RELATED REVENUE RECOGNITION
As discussed in Note 1, we entered into a contract with the Defense Advanced Research Projects Agency on September 30, 2011. Under the
Defense Advanced Research Projects Agency award, we have been engaged to develop a therapeutic device to reduce the incidence of
sepsis, a fatal bloodstream infection that often results in the death of combat-injured soldiers. The award from the Defense Advanced
Research Projects Agency was a fixed-price contract with potential total payments to us of $6,794,389 over the course of five years. Fixed
price contracts require the achievement of multiple, incremental milestones to receive the full award during each year of the contract.
Under the terms of the contract, we will perform certain incremental work towards the achievement of specific milestones against which
we will invoice the government for fixed payment amounts.
Originally, only the base year (year one contract) was effective for the parties, however, the Defense Advanced Research Projects Agency
subsequently exercised the option on the second, third, fourth and fifth years of the contract. The milestones are comprised of planning,
engineering and clinical targets, the achievement of which in some cases will require the participation and contribution of third party
participants under the contract. There can be no assurance that we alone, or with third party participants, will meet such milestones to the
satisfaction of the government and in compliance with the terms of the contract or that we will be paid the full amount of the contract
revenues during any year of the contract term. We commenced work under the contract in October 2011.
Due to budget restrictions within the Department of Defense, on February 10, 2014, the Defense Advanced Research Projects Agency
reduced the scope of our contract in years three through five of the contract. The reduction in scope focused our research on exosomes,
viruses and blood processing instrumentation. This scope reduction will reduce the possible payments under the contract by $858,491 over
years three through five. We recently completed a re-budgeting of the expected costs on the remaining years of the Defense Advanced
Research Projects Agency contract based on the reduced milestones and have concluded that the reductions in our costs due to the scaled
back level of work will almost entirely offset the anticipated revenue levels based on current assumptions.
Fiscal Year Ended March 31, 2016
During the fiscal year ended March 31, 2016, we invoiced the Defense Advanced Research Projects Agency for four milestones totaling
$863,011. The details of those milestones were as follows:
Milestone M6 – Define Aethlon’s GMP manufacturing process and revise and upgrade Aethlon’s quality procedures and policies to the
current state of the art. The milestone payment was $186,164. Management considers this milestone to be substantive as it was not
dependent on the passage of time nor was it based solely on another party's efforts. We demonstrated that defined our GMP manufacturing
process and that we revised and upgraded our quality procedures and policies to the current state of the art for a company of our size. The
report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone 2.5.1.1 - Complete Aethlon’s GMP procedure and establish and maintain all GMP documentation for the company. The
milestone payment was $186,164. Management considers this milestone to be substantive as it was not dependent on the passage of time
nor was it based solely on another party's efforts. We demonstrated that we completed our GMP procedures and established and maintained
all GMP documentation for the company. The report was accepted by the contracting officer's representative and the invoice was submitted
thereafter.
Milestone 2.5.2.2 – Finish construction and begin delivery of 50 prototype cartridges for testing by the systems integrator. The milestone
payment was $296,964. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it
based solely on another party's efforts. We demonstrated that we completed the construction of 50 prototype cartridges and were prepared
to deliver the cartridges to the systems integrator. The report was accepted by the contracting officer's representative and the invoice was
submitted thereafter.
F-23
Milestone 2.6.1.1 – System integrator acceptance of the hemofilter device. The milestone payment was $193,719. Management considers
this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We
demonstrated that we completed this milestone by confirmation by the systems integrator that it was accepting the hemofilter device as part
of their overall system.
Fiscal Year Ended March 31, 2015
During the fiscal year ended March 31, 2015, we invoiced the Defense Advanced Research Projects Agency for four milestones totaling
$863,011. The details of those milestones were as follows:
Milestone 2.4.2.2 – Determine capacity requirements of affinity resin to multiple simultaneous targets. The milestone payment was
$197,362. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on
another party's efforts. We demonstrated that we were able to determine the capacity requirements of affinity resin to multiple simultaneous
targets. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone 2.4.2.4 – Finish construction and delivery of 25 experimental cartridges for testing by the system integrator. The milestone
payment was $50,000. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it
based solely on another party's efforts. We demonstrated that we delivered the 25 cartridges to the systems integrator as part of our
submission for approval. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.
Milestone M9 – Target capture > 90% in 24 hours for at least 3 targets ex vivo in blood or blood components using the optimized cartridge.
The milestone payment was $197,361. Management considers this milestone to be substantive as it was not dependent on the passage of
time nor was it based solely on another party's efforts. We demonstrated that we were able to capture approximately 90% in 24 hours for at
least 3 targets ex vivo in blood or blood components using the optimized cartridge. The report was accepted by the contracting officer's
representative and the invoice was submitted thereafter.
Milestone M11 - Develop a strategic plan for developing an alternate method of producing galanthus nivalis agglutinin by cloning the gene
into an alternate vector and identify potential partners for such production. The milestone payment was $186,164. Management considers
this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We
demonstrated that we developed a strategic plan for developing an alternate method of producing GNA by cloning the gene into an
alternate vector and identified potential partners for such production. The report was accepted by the contracting officer's representative
and the invoice was submitted thereafter.
10. SEGMENTS
We operate our businesses principally through two reportable segments: Aethlon, which represents our therapeutic business activities, and
ESI, which represents our diagnostic business activities. Our reportable segments have been determined based on the nature of the potential
products being developed. We record discrete financial information for ESI and our chief operating decision maker reviews ESI’s operating
results in order to make decisions about resources to be allocated to the ESI segment and to assess its performance.
Aethlon’s revenue is generated primarily from government contracts to date and ESI does not yet have any revenues. We have not included
any allocation of corporate overhead to the ESI segment.
F-24
The following tables set forth certain information regarding our segments:
Revenues:
Aethlon
ESI
Total Revenues
Operating Losses:
Aethlon
ESI
Total Operating Loss
Net Losses:
Aethlon
ESI
Net Loss Before Non-Controlling Interests
Cash:
Aethlon
ESI
Total Cash
Total Assets:
Aethlon
ESI
Total Assets
Capital Expenditures:
Aethlon
ESI
Capital Expenditures
Depreciation and Amortization:
Aethlon
ESI
Total Depreciation and Amortization
Interest Expense:
Aethlon
ESI
Total Interest Expense
11. SUBSEQUENT EVENTS
Fiscal Years Ended March 31,
2015
2016
886,572 $
–
886,572 $
762,417
–
762,417
(3,953,402) $
(431,432)
(4,384,834) $
(3,081,169)
(911,684)
(3,992,853)
(4,527,184) $
(431,432)
(4,958,616) $
(6,067,810)
(911,684)
(6,979,494)
2,114,285 $
9,452
2,123,737 $
721,689
133,907
855,596
2,503,327 $
53,430
2,556,757 $
1,159,910
220,678
1,380,588
9,307 $
–
9,307 $
18,943 $
19,581
38,524 $
573,782 $
–
573,782 $
–
–
–
17,770
19,582
37,352
349,923
–
349,923
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
Management has evaluated events subsequent to March 31, 2016 through the date that the accompanying consolidated financial statements
were filed with the Securities and Exchange Commission for transactions and other events which may require adjustment of and/or
disclosure in such financial statements.
Common Stock Sales Agreement with H.C. Wainwright
On June 28, 2016, we entered into a Common Stock Sales Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC
(“H.C. Wainwright”) which establishes an at-the-market equity program pursuant to which we may offer and sell shares of our common
stock from time to time as set forth in the Agreement. The Agreement provides for the sale of shares of our common stock having an
aggregate offering price of up to $12,500,000 (the “Shares”).
F-25
Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright will use its commercially reasonable efforts
consistent with its normal trading and sales practices to sell the Shares from time to time, based upon our instructions. We have provided
H.C. Wainwright with customary indemnification rights, and H.C. Wainwright will be entitled to a commission at a fixed rate equal to three
percent (3.0%) of the gross proceeds per Share sold. In addition, we have agreed to pay certain expenses incurred by H.C. Wainwright in
connection with the Agreement, including up to $50,000 of the fees and disbursements of their counsel. The Agreement will terminate upon
the sale of all of the Shares under the Agreement unless terminated earlier by either party as permitted under the Agreement.
Sales of the Shares, if any, under the Agreement shall be made in transactions that are deemed to be “at the market offerings” as
defined in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq
Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell any of the Shares, and, at any
time, we may suspend offers under the Agreement or terminate the Agreement.
Amendment of November 2014 Investment Documents
On June 27, 2016, we and certain investors (the “Investors”) entered into Amendments (the “Amendments”) to our November
2014 convertible notes in the original principal amount of $527,780 (the “Notes”) and Class A Common Stock Purchase Warrants to
purchase an aggregate of 47,125 shares of common stock (the “Existing Warrants”) issued and sold by us to the Investors under a
Subscription Agreement dated November 6, 2014. The Amendments provide that the Maturity Date (as defined in the Notes) is extended
from June 1, 2016 to July 1, 2017 and that the Conversion Price (as defined in the Notes) is reduced from $5.60 per share of common stock
to $5.00 per share of common stock. In addition, we reduced the purchase price (as defined in the Existing Warrants) from $8.40 per share
to $5.00 per share. In connection with these modifications, each of the Investors signed a Consent and Waiver providing its consent under
certain restrictive provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under a Securities
Purchase Agreement dated June 23, 2015, (the “2015 SPA”) to which we, the Investors and certain other investors are parties, in order to
facilitate the at-the-market equity program described above.
The Amendments also increase the principal amount of the Notes to $692,811.23 (in the aggregate) to (i) include accrued and
unpaid interest through June 15, 2016, and (ii) increase the principal amount by $80,000 (in the aggregate) as an extension fee for the
extended maturity date of the Notes set forth above. With respect to each Note, we entered into an Allonge to Convertible Promissory Note
(each, an “Allonge”) reflecting the changes in the principal amount, Maturity Date and Conversion Price of the Note.
We also issued to the Investors new warrants (the “New Warrants”) to purchase an aggregate of 30,000 shares of common stock
with a Purchase Price (as defined in the New Warrants) of $5.00 per share of common sock. We issued the New Warrants in substantially
the same form as the Existing Warrants, and the New Warrants will expire on November 6, 2019, the same date on which the Existing
Warrants will expire.
Amendment of December 2014 Warrants
On June 27, 2016, we and certain investors (the “Unit Investors”) entered into Consent and Waiver and Amendment agreements
(the “CWAs”), relating to an aggregate of 264,000 Warrants to Purchase Common Stock (the “Unit Warrants”) we had issued to the Unit
Investors on December 2, 2014 pursuant to a Securities Purchase Agreement dated November 26, 2014 (the “2014 SPA”). In the CWAs,
each of the Unit Investors provided its consent under certain restrictive provisions, and waived certain rights, including a right to participate
in certain offerings made by us, under the 2014 SPA in order to facilitate the at-the-market equity program described above. Pursuant to the
CWAs, we reduced the Exercise Price (as defined in the Unit Warrants) from $15.00 per share of common stock to $5.00 per share of
common stock. At any time that the shares of common stock underlying the Unit Warrants are covered by an effective registration
statement that permits the public resale of the shares, if the Unit Investors exercise the Unit Warrants, they must do so in a cash exercise,
which could yield up to $1,320,000 in proceeds to us.
On June 27, 2016, each of the Unit Investors also entered into a Consent and Waiver providing its consent under certain
provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under the 2015 SPA in order to
facilitate the at-the market equity program described above.
F-26
12. COMMITMENTS AND CONTINGENCIES
EMPLOYMENT CONTRACTS
We entered into an employment agreement with our Chairman of the Board (“Chairman”) effective April 1, 1999. The agreement, which is
cancelable by either party upon sixty days’ notice, will be in effect until the Chairman retires or ceases to be employed by us. Under the
terms of the agreement, if the Chairman is terminated he may become eligible to receive a salary continuation payment in the amount of at
least twelve months' base salary, which was increased to $385,000 per year in September 2015.
We entered into an employment agreement with Dr. Richard H. Tullis, Ph. D. (“Tullis”) effective January 10, 2000 as our Chief Science
Officer ("CSO"). Under the terms of the agreement, if Tullis is terminated he may become eligible to receive a salary continuation payment
in the amount of twelve months’ base salary, which is $195,000 per year.
In February 2016, we entered into a part-time consulting agreement with Tullis. Under that agreement, Tullis will retain his title of CSO
and will continue to provide services under the terms of a consulting agreement with us. In connection with the change in his employment,
Tullis resigned as our Vice President. Under the consulting agreement, Tullis will render approximately twenty (20) hours per week of
such services, for which we will pay him a consulting fee of $10,000 per month. The term of the consulting agreement is for an initial
sixty-day period and, unless terminated earlier by either party, shall automatically extend for additional one-month periods. Either party to
the consulting agreement may terminate it upon 30 day’s prior written notice to the other party.
Concurrently with the entry into the consulting agreement, Tullis and the Company mutually agreed to terminate his employment
agreement with us.
RETENTION AGREEMENTS
On October 16, 2015, following a recommendation of our Compensation Committee, we approved retention bonus grants to three of our
executive officers under a newly established Aethlon Senior Management Retention Program to maintain management stability going
forward. The Board approved a $100,000 retention bonus for Mr. James A. Joyce, our Chief Executive Officer, a $50,000 retention bonus
for Mr. Rodney S. Kenley, our President, and a $50,000 retention bonus for Mr. James B. Frakes, our Chief Financial Officer.
In connection with the bonus granted to Mr. Joyce, we entered into an amendment of Mr. Joyce’s Employment Agreement dated April 1,
1999. Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Joyce’s employment with
us for “Cause” (as defined in his employment agreement) or Mr. Joyce terminates his employment with us other than for “Good Reason”
(as defined in his employment agreement), Mr. Joyce must repay in full the amount of the bonus received from us. In the event of his death
or disability or termination by us other than for “Cause” or termination by Mr. Joyce for “Good Reason,” Mr. Joyce will not be required to
repay any portion of the bonus received by him.
In connection with the bonus granted to Mr. Kenley, we entered into an amendment of Mr. Kenley’s Offer Letter dated October 27, 2010.
Pursuant to the amendment, if within two years of the effective date of the amendment, we terminate Mr. Kenley’s employment with us for
“Cause” (as defined in the amendment) or Mr. Kenley terminates his employment with us other than for “Good Reason” (as defined in the
amendment), Mr. Kenley must repay in full the amount of the bonus received from us. In the event of his death or disability or termination
by us other than for “Cause” or termination by Mr. Kenley for “Good Reason,” Mr. Kenley will not be required to repay any portion of the
bonus received by him.
In connection with the bonus granted to Mr. Frakes, we entered into a Retention Bonus Agreement with Mr. Frakes. Pursuant to the
agreement, if within two years of the effective date of the agreement, we terminate Mr. Frakes’ employment with us for “Cause” (as
defined in the agreement) or Mr. Frakes terminates his employment with us other than for “Good Reason” (as defined in the agreement),
Mr. Frakes must repay in full the amount of the bonus received from us. In the event of his death or disability or termination by us other
than for “Cause” or termination by Mr. Frakes for “Good Reason,” Mr. Frakes will not be required to repay any portion of the bonus
received by him.
F-27
LEASE COMMITMENTS
We currently rent approximately 2,600 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123
at the rate of $6,054 per month on a four-year lease that expires in January 2019. We also rent approximately 1,700 square feet of
laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego, California 92121 at the rate of $4,838 per month on a one-year
lease that expires in November 2016. Our current plans are to renew the lease prior to expiration or to secure alternative lab space in the
San Diego area.
Our Exosome Sciences, Inc. subsidiary previously rented approximately 2,055 square feet of office and laboratory space at 11 Deer Park
Drive, South Brunswick, NJ at the rate of $3,917 per month on a one-year lease that expired in October 2015. In October 2015, Exosome
Sciences, Inc. relocated to a different suite at the same office complex. That new suite was comprised of approximately 541 square feet of
office and laboratory space and is located at 9 Deer Park Drive, South Brunswick, NJ at the rate of $1,352 per month under a month to
month lease basis. In January 2016, we exercised our 30-day notice to terminate the Exosome Sciences’ lease in New Jersey as part of a
consolidation of our laboratory operations in San Diego.
Rent expense, which is included in general and administrative expenses, approximated $144,000 and $167,000 for the fiscal years ended
March 31, 2016 and 2015, respectively. As of March 31, 2016, our commitments under the lease agreements are as follows:
9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123 office lease
$
75,512 $
78,156 $
21,446
11585 Sorrento Valley Road, Suite 109, San Diego, CA 92121 office lease
38,704
–
–
Fiscal Year Ended March 31,
2018
2017
2019
Total Lease Commitments
LEGAL MATTERS
$
114,216 $
78,156 $
21,446
From time to time, claims are made against us in the ordinary course of business, which could result in litigation. Claims and associated
litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties or
injunctions prohibiting us from selling one or more products or engaging in other activities.
The occurrence of an unfavorable outcome in any specific period could have a material adverse effect on our results of operations for that
period or future periods. We are not presently a party to any pending or threatened legal proceedings.
F-28
Exhibit 10.62
AETHLON MEDICAL, INC.
AMENDMENT NO. 1 TO
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors (the “Board”) of Aethlon Medical, Inc. (the “Company”), in a written consent in lieu of a Board Meeting
dated February 9, 2016, has deemed it fair and in the best interest of the Company and its stockholders to set the exercise period under
Section 6.6(a) and Section 6.6(b) of the Amended 2010 Stock Incentive Plan (the “Plan”) for the Stock Option Agreement between the
Company and Richard H. Tullis dated September 27, 2010 (the “Option”) to thirty-six (36) months. Accordingly, the undersigned agrees
that, solely with respect to the Option, such sections shall be deemed to read in their entirety as follows:
6.6 Termination. Notwithstanding the exercise periods set forth in the Stock Option Agreement, exercise of an Option will
always be subject to the following:
(a) If the Participant’s service is Terminated for any reason except death or Disability, then the Participant may
exercise such Participant’s Options only to the extent that such Options would have been exercisable upon the Termination Date no
later than thirty-six (36) months after the Termination Date.
(b) If the Participant’s service is Terminated because of the Participant’s death or Disability (or the Participant
dies within three (3) months after a Termination other than for Cause or because of Participant’s Disability), then the Participant’s
Options may be exercised only to the extent that such Options would have been exercisable by the Participant on the Termination
Date and must be exercised by the Participant (or the Participant’s legal representative) no later than thirty-six (36) months after the
Termination Date.
IN WITNESS WHEREOF, the undersigned has executed this Amendment No. 1 to the Option on this 9th day of
February, 2016.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James B. Frakes
James B. Frakes
Chief Financial Officer
Exhibit 10.63
AETHLON MEDICAL, INC.
NOTICE OF GRANT OF STOCK OPTION
Notice is hereby given of the following grant of an option to purchase shares of the Common Stock of Aethlon Medical, Inc., a
Nevada corporation (the "Company"):
Optionee:
Grant Date:
Exercise Price:
Number of Option Shares:
Expiration Date:
Type of Option:
Vesting Schedule:
Richard H. Tullis
July 1, 2013
$0.10 per share
500,000
July 1, 2023
Nonqualified Stock Option
125,000 Option Shares shall vest on each of
July 1, 2014, July 1, 2015, July 1, 2016 and July 1, 2017
Optionee agrees to be bound by the terms of the Stock Option Agreement attached hereto as Exhibit A.
No Employment or Service Contract. Nothing in this Notice or in the attached Stock Option Agreement shall confer upon
Optionee any right to continue in service in any capacity, including as an employee, for any period of specific duration or interfere with or
otherwise restrict in any way the rights of the Company (or any Parent or Subsidiary employing or retaining Optionee) or of Optionee,
which rights are hereby expressly reserved by each, to terminate Optionee's service and/or employment at any time for any reason, with or
without cause.
Definitions. All capitalized terms in this Notice shall have the meaning assigned to them in this Notice or in the attached Stock
Option Agreement.
Dated as of: July 1, 2013
Aethlon Medical, Inc.
By: /s/ James A. Joyce
Name: James A. Joyce
Chairman and Chief Executive Officer
OPTIONEE
/s/ Richard H. Tullis
Name: Richard H. Tullis
Address: 3886 Spanish Oak Court
Oceanside, CA 92058
ATTACHMENTS
Exhibit A - Stock Option Agreement
EXHIBIT A
AETHLON MEDICAL, INC.
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors of Aethlon Medical, Inc. (the "Company"), by unanimous written consent dated July 1 , 2013, has deemed
it fair and in the best interest of the Company and its stockholders that the Company issue to Richard H. Tullis (the "Optionee") an option
to acquire an aggregate of 500,000 shares of restricted Common Stock of the Company.
All capitalized terms in this Agreement not defined herein shall have the meaning assigned to them in the attached Appendix.
NOW, THEREFORE, it is hereby agreed as follows:
AGREEMENT
1. Grant of Option. The Company hereby grants to the Optionee, as of the Grant Date, an option to purchase up to the number of
Option Shares specified in the Grant Notice. The Option Shares shall be purchasable from time to time during the option term specified in
Paragraph 2 at the Exercise Price. Except as otherwise provided herein, this option shall be subject to the terms and conditions of the Plan.
2. Option Term. This option shall expire at the close of business on the Expiration Date, unless sooner terminated in accordance
with Paragraph 5.
3. Limited Transferability. During the Optionee's lifetime, this option shall be exercisable only by the Optionee and shall not be
assignable or transferable other than by will or by the laws of descent and distribution following the Optionee's death.
4. Dates of Exercise. This option shall become exercisable for the Option Shares as specified in the Vesting Schedule.
5. Cessation of Service. The option term specified in Paragraph 2 shall terminate (and this option shall cease to be outstanding)
prior to the Expiration Date should any of the following events occur:
(a) If the Optionee's service is terminated for any reason other than death or disability, then the Optionee may exercise
this option, only to the extent that the option would have been exercisable upon the date of such termination (the "Termination Date"), no
later than twelve (12) months after the Termination Date.
(b) If the Optionee's service is terminated because of the Optionee's death or disability (or the Optionee dies within
twelve (12) months after a termination other than for cause or because of the Optionee's disability), then this option may be exercised only
to the extent that it would have been exercisable by the Optionee on the Termination Date and must be exercised by the Optionee (or the
Optionee's legal representative) no later than twelve (12) months after the Termination Date.
1
(c) Notwithstanding the provisions above, if the Optionee's service is terminated for cause, neither the Optionee, the
Optionee's estate nor such other person who may then hold this option shall be entitled to exercise it with respect to any Option Shares
whatsoever.
6. Adjustment in Option Shares. Should any change be made to the Common Stock by reason of any stock split, stock dividend,
recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the
Company's receipt of consideration, appropriate adjustments shall be made to (i) the total number and/or class of securities subject to this
option and (ii) the Exercise Price in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.
7. Stockholder Rights. The holder of this option shall not have any rights as a stockholder of the Company with respect to the
Option Shares until such person shall have exercised the option, paid the Exercise Price and become a holder of record of the purchased
shares.
8. Registration Rights. If the Company at any time proposes to register any of its securities under the Securities Act of 1933, as
amended (the "Act"), for sale to the public, whether for its own account or for the account of other security holders or both, provided the
Registrable Securities (as defined below) are not otherwise subject to an effective registration statement, the Company will cause such
Registrable Securities to be included with the securities to be covered by the registration statement proposed to be filed by the Company. In
the event that any registration pursuant to this Paragraph 8 shall be, in whole or in part, an underwritten public offering of Common Stock
of the Company, the number of shares of Registrable Securities to be included in such an underwriting may be reduced by the managing
underwriter if and to the extent that the Company and the underwriter shall reasonably be of the opinion that such inclusion would
adversely affect the marketing of the securities to be sold by the Company therein; provided, however, that the Company shall notify the
Optionee in writing of any such reduction. "Registrable Securities" means the number of shares of the Company's Common Stock set forth
on the first page of the Notice of Grant of Stock Option.
9. Manner of Exercising Option.
(a) In order to exercise this option with respect to all or any part of the Option Shares for which this option is at the time
exercisable, the Optionee (or any other person or persons exercising the option) shall take the following actions:
(i) Execute and deliver to the Company a written notice setting forth the number of Option Shares for which the option
is exercised;
2
(ii) Pay the aggregate Exercise Price for the purchased shares in cash or in one or more of the following forms:
(A) by cancellation of indebtedness of the Company to the Optionee;
(B) if approved by the Board, by surrender of shares that either: (1) have been owned by the Optionee for more than one year
and have been paid for within the meaning of Rule 144 promulgated under the Securities Act (and, if such shares were purchased from
the Company by use of a promissory note, such note has been fully paid with respect to such shares); or (2) were obtained by the
Optionee in the public market;
(C) if approved by the Board, by waiver of compensation due or accrued to the Optionee for services rendered;
(D) with respect only to purchases upon exercise of an option, and provided that a public market for the Company's stock
exists:
(1) through a "same day sale" commitment from the Optionee and a broker-dealer that is a member of the National
Association of Securities Dealers (an "NASD Dealer") whereby the Optionee irrevocably elects to exercise the option and to sell a portion
of the shares so purchased to pay for the Exercise Price, and whereby the NASD Dealer irrevocably commits upon receipt of such shares to
forward the Exercise Price directly to the Company; or
(2) through a "margin" commitment from the Optionee and an NASD Dealer whereby the Optionee irrevocably elects to
exercise the option and to pledge the shares so purchased to the NASD Dealer in a margin account as security for a loan from the NASD
Dealer in the amount of the Exercise Price, and whereby the NASD Dealer irrevocably commits upon receipt of such shares to forward the
Exercise Price directly to the Company; or
(E) by any combination of the foregoing. Except to the extent the sale and remittance procedure is utilized in connection with the
option exercise, payment of the Exercise Price must accompany the written notice delivered to the Company in connection with the option
exercise;
(iii) Furnish to the Company appropriate documentation that the person or persons exercising the option (if other than
Optionee) have the right to exercise this option;
3
(iv) Execute and deliver to the Company such written representations as may be requested by the Company in order for
it to comply with the applicable requirements of federal and state securities laws; and
(v) Make appropriate arrangements with the Company for the satisfaction of all federal, state and local income and
employment tax withholding requirements applicable to the option exercise.
(b) As soon as practical after the Exercise Date, the Company shall issue to or on behalf of the Optionee (or any other
person or persons exercising this option) a certificate for the purchased Option Shares, with the appropriate legends affixed thereto.
(c) In no event may this option be exercised for any fractional shares.
10. Compliance with Laws and Regulations.
(a) The exercise of this option and the issuance of the Option Shares upon such exercise shall be subject to compliance by
the Company and the Optionee with all applicable requirements of law relating thereto and with all applicable regulations of any stock
exchange (or the Nasdaq Stock Market or the OTC Bulletin Board, if applicable) on which the Common Stock may be listed for trading (or
quoted) at the time of such exercise and issuance.
(b) The inability of the Company to obtain approval from any regulatory body having authority deemed by the Company
to be necessary to the lawful issuance and sale of any Common Stock pursuant to this option shall relieve the Company of any liability with
respect to the non-issuance or sale of the Common Stock as to which such approval shall not have been obtained. The Company, however,
shall use its best efforts to obtain all such approvals.
11. Successors and Assigns . Except to the extent otherwise provided in Paragraph 3, the provisions of this Agreement shall inure
to the benefit of, and be binding upon, the Company and its successors and assigns and the Optionee, the Optionee's assigns and the legal
representatives, heirs and legatees of the Optionee's estate.
12. Notices. Any notice required to be given or delivered to the Company under the terms of this Agreement shall be in writing and
addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to the Optionee shall be in writing
and addressed to the Optionee at the address indicated below the Optionee's signature line on the Grant Notice. All notices shall be deemed
effective upon personal delivery or upon deposit in the U.S. mail, postage prepaid and properly addressed to the party to be notified.
13. Governing Law. The interpretation, performance and enforcement of this Agreement shall be governed by the laws of the
State of California without resort to any conflict-of-laws rules that would result in the application of the laws of any other jurisdiction.
4
IN WITNESS WHEREOF. the undersigned have duly executed this Agreement as of July 1, 2013.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James A. Joyce
James A. Joyce
Chairman and Chief Executive Officer
Optionee
/s/ Richard H. Tullis
Name: Richard H. Tullis
5
The following definitions shall be in effect under the Agreement:
APPENDIX A
1.
2.
3.
4.
5.
6.
7.
8.
9.
Agreement shall mean this Stock Option Agreement.
Code shall mean the Internal Revenue Code of 1986, as amended.
Common Stock shall mean the Company's common stock.
Exercise Date shall mean the date on which the option shall have been exercised in accordance with Paragraph 9 of the
Agreement.
Exercise Price shall mean the exercise price payable per Option Share as specified in the Grant Notice.
Expiration Date shall mean the date on which the option expires as specified in the Grant Notice.
Grant Date shall mean the date of grant of the option as specified in the Grant Notice.
Grant Notice shall mean the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee has
been informed of the basic terms of the option evidenced hereby.
Nonqualified Stock Option shall mean an option not intended to satisfy the requirements of Section 422 of the Code.
10. Option Shares shall mean the number of shares of Common Stock subject to the option.
11.
Vesting Schedule shall mean the vesting schedule specified in the Grant Notice pursuant to which the Option Shares shall
become exercisable.
6
Exhibit 10.64
AETHLON MEDICAL, INC.
NOTICE OF GRANT OF STOCK OPTION
Notice is hereby given of the following grant of an option to purchase shares of the Common Stock of Aethlon Medical, Inc., a
Nevada corporation (the "Company"):
Optionee:
Grant Date:
Exercise Price:
Number of Option Shares:
Expiration Date:
Type of Option:
Vesting Schedule:
Richard H. Tullis
June 6, 2014
$0.19 per share
S
50,000
June 6, 2024
Nonqualified Stock Option
16,667 Option Shares shall vest on each of June 6, 2014
and June 6, 2015, and 16,666 Option Shares shall vest
on June 6, 2016
Optionee agrees to be bound by the terms of the Stock Option Agreement attached hereto as Exhibit A.
No Employment or Service Contract. Nothing in this Notice or in the attached Stock Option Agreement shall confer upon
Optionee any right to continue in service in any capacity, including as an employee, for any period of specific duration or interfere with or
otherwise restrict in any way the rights of the Company (or any Parent or Subsidiary employing or retaining Optionee) or of Optionee,
which rights are hereby expressly reserved by each, to terminate Optionee's service and/or employment at any time for any reason, with or
without cause.
Definitions. All capitalized terms in this Notice shall have the meaning assigned to them in this Notice or in the attached Stock
Option Agreement.
Dated as of: October 7, 2014
Aethlon Medical, Inc.
By: /s/ James A. Joyce
Name: James A. Joyce
Chairman and Chief Executive Officer
OPTIONEE
/s/ Richard H. Tullis
Name: Richard H. Tullis
Address: 3886 Spanish Oak Court
Oceanside, CA 92058
ATTACHMENTS
Exhibit A - Stock Option Agreement
EXHIBIT A
AETHLON MEDICAL, INC.
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors of Aethlon Medical, Inc. (the "Company"), at a telephonic meeting held on June 6, 2014, has deemed it fair
and in the best interest of the Company and its stockholders that the Company issue to Richard H. Tullis (the "Optionee") an option to
acquire an aggregate of 50,000 shares of restricted Common Stock of the Company.
All capitalized terms in this Agreement not defined herein shall have the meaning assigned to them in the attached Appendix.
NOW, THEREFORE, it is hereby agreed as follows:
AGREEMENT
1. Grant of Option. The Company hereby grants to the Optionee, as of the Grant Date, an option to purchase up to the number of
Option Shares specified in the Grant Notice. The Option Shares shall be purchasable from time to time during the option term specified in
Paragraph 2 at the Exercise Price.
2. Option Term. This option shall expire at the close of business on the Expiration Date, unless sooner terminated in accordance
with Paragraph 5.
3. Limited Transferability. During the Optionee's lifetime, this option shall be exercisable only by the Optionee and shall not be
assignable or transferable other than by will or by the laws of descent and distribution following the Optionee's death.
4. Dates of Exercise. This option shall become exercisable for the Option Shares as specified in the Vesting Schedule.
5. Cessation of Service. The option term specified in Paragraph 2 shall terminate (and this option shall cease to be outstanding)
prior to the Expiration Date should any of the following events occur:
(a) If the Optionee's service is terminated for any reason other than death or disability, then the Optionee may exercise
this option, only to the extent that the option would have been exercisable upon the date of such termination (the "Termination Date"), no
later than twelve (12) months after the Termination Date.
(b) If the Optionee's service is terminated because of the Optionee's death or disability (or the Optionee dies within
twelve (12) months after a termination other than for cause or because of the Optionee's disability), then this option may be exercised only
to the extent that it would have been exercisable by the Optionee on the Termination Date and must be exercised by the Optionee (or the
Optionee's legal representative) no later than twelve (12) months after the Termination Date.
1
(c) Notwithstanding the provisions above, if the Optionee's service is terminated for cause, neither the Optionee, the
Optionee's estate nor such other person who may then hold this option shall be entitled to exercise it with respect to any Option Shares
whatsoever.
6. Adjustment in Option Shares. Should any change be made to the Common Stock by reason of any stock split, stock dividend,
recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the
Company's receipt of consideration, appropriate adjustments shall be made to (i) the total number and/or class of securities subject to this
option and (ii) the Exercise Price in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.
7. Stockholder Rights. The holder of this option shall not have any rights as a stockholder of the Company with respect to the
Option Shares until such person shall have exercised the option, paid the Exercise Price and become a holder of record of the purchased
shares.
8. Registration Rights. If the Company at any time proposes to register any of its securities under the Securities Act of 1933, as
amended (the "Act"), for sale to the public, whether for its own account or for the account of other security holders or both, provided the
Registrable Securities (as defined below) are not otherwise subject to an effective registration statement, the Company will cause such
Registrable Securities to be included with the securities to be covered by the registration statement proposed to be filed by the Company. In
the event that any registration pursuant to this Paragraph 8 shall be, in whole or in part, an underwritten public offering of Common Stock
of the Company, the number of shares of Registrable Securities to be included in such an underwriting may be reduced by the managing
underwriter if and to the extent that the Company and the underwriter shall reasonably be of the opinion that such inclusion would
adversely affect the marketing of the securities to be sold by the Company therein; provided, however, that the Company shall notify the
Optionee in writing of any such reduction. "Registrable Securities" means the number of shares of the Company's Common Stock set forth
on the first page of the Notice of Grant of Stock Option.
9. Manner of Exercising Option.
(a) In order to exercise this option with respect to all or any part of the Option Shares for which this option is at the time
exercisable, the Optionee (or any other person or persons exercising the option) shall take the following actions:
(i) Execute and deliver to the Company a written notice setting forth the number of Option Shares for which the option is
exercised;
(ii) Pay the aggregate Exercise Price for the purchased shares in cash or in one or more of the following forms:
2
(A) by cancellation of indebtedness of the Company to the Optionee;
(B) if approved by the Board, by surrender of shares that either: (1) have been owned by the Optionee for more than one year
and have been paid for within the meaning of Rule 144 promulgated under the Securities Act (and, if such shares were purchased from
the Company by use of a promissory note, such note has been fully paid with respect to such shares); or (2) were obtained by the
Optionee in the public market;
(C) if approved by the Board, by waiver of compensation due or accrued to the Optionee for services rendered;
(D) with respect only to purchases upon exercise of an option, and provided that a public market for the Company's stock
exists:
(1) through a "same day sale" commitment from the Optionee and a broker-dealer that is a member of the National
Association of Securities Dealers (an "NASD Dealer") whereby the Optionee irrevocably elects to exercise the option and to sell a
portion of the shares so purchased to pay for the Exercise Price, and whereby the NASD Dealer irrevocably commits upon receipt of
such shares to forward the Exercise Price directly to the Company; or
(2) through a "margin" commitment from the Optionee and an NASD Dealer whereby the Optionee irrevocably elects
to exercise the option and to pledge the shares so purchased to the NASD Dealer in a margin account as security for a loan from the
NASD Dealer in the amount of the Exercise Price, and whereby the NASD Dealer irrevocably commits upon receipt of such shares to
forward the Exercise Price directly to the Company; or
(E) by any combination of the foregoing. Except to the extent the sale and remittance procedure is utilized in connection with
the option exercise, payment of the Exercise Price must accompany the written notice delivered to the Company in connection with the
option exercise;
(iii) Furnish to the Company appropriate documentation that the person or persons exercising the option (if other than Optionee) have
the right to exercise this option;
(iv) Execute and deliver to the Company such written representations as may be requested by the Company in order for it to comply
with the applicable requirements of federal and state securities laws; and
3
(v) Make appropriate arrangements with the Company for the satisfaction of all federal, state and local income and employment tax
withholding requirements applicable to the option exercise.
person or persons exercising this option) a certificate for the purchased Option Shares, with the appropriate legends affixed thereto.
(b) As soon as practical after the Exercise Date, the Company shall issue to or on behalf of the Optionee (or any other
(c) In no event may this option be exercised for any fractional shares.
10. Compliance with Laws and Regulations.
(a) The exercise of this option and the issuance of the Option Shares upon such exercise shall be subject to compliance by
the Company and the Optionee with all applicable requirements of law relating thereto and with all applicable regulations of any stock
exchange (or the Nasdaq Stock Market or the OTC Bulletin Board, if applicable) on which the Common Stock may be listed for trading (or
quoted) at the time of such exercise and issuance.
(b) The inability of the Company to obtain approval from any regulatory body having authority deemed by the Company
to be necessary to the lawful issuance and sale of any Common Stock pursuant to this option shall relieve the Company of any liability with
respect to the non-issuance or sale of the Common Stock as to which such approval shall not have been obtained. The Company, however,
shall use its best efforts to obtain all such approvals.
11. Successors and Assigns. Except to the extent otherwise provided in Paragraph 3, the provisions of this Agreement shall inure
to the benefit of, and be binding upon, the Company and its successors and assigns and the Optionee, the Optionee's assigns and the legal
representatives, heirs and legatees of the Optionee's estate.
12. Notices. Any notice required to be given or delivered to the Company under the terms of this Agreement shall be in writing
and addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to the Optionee shall be in
writing and addressed to the Optionee at the address indicated below the Optionee's signature line on the Grant Notice. All notices shall be
deemed effective upon personal delivery or upon deposit in the U.S. mail, postage prepaid and properly addressed to the party to be
notified.
13. Governing Law. The interpretation, performance and enforcement of this Agreement shall be governed by the laws of the
State of California without resort to any conflict-of-laws rules that would result in the application of the laws of any other jurisdiction.
4
IN WITNESS WHEREOF. the undersigned have duly executed this Agreement as of October 7, 2014.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James A. Joyce
James A. Joyce
Chairman and Chief Executive Officer
Optionee
/s/ Richard H. Tullis
Name: Richard H. Tullis
5
The following definitions shall be in effect under the Agreement:
APPENDIX A
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Agreement shall mean this Stock Option Agreement.
Code shall mean the Internal Revenue Code of 1986, as amended.
Common Stock shall mean the Company's common stock.
Exercise Date shall mean the date on which the option shall have been exercised in accordance with Paragraph 9 of the
Agreement.
Exercise Price shall mean the exercise price payable per Option Share as specified in the Grant Notice.
Expiration Date shall mean the date on which the option expires as specified in the Grant Notice.
Grant Date shall mean the date of grant of the option as specified in the Grant Notice.
Grant Notice shall mean the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee
has been informed of the basic terms of the option evidenced hereby.
Nonqualified Stock Option shall mean an option not intended to satisfy the requirements of Section 422 of the Code.
Option Shares shall mean the number of shares of Common Stock subject to the option.
Vesting Schedule shall mean the vesting schedule specified in the Grant Notice pursuant to which the Option Shares shall
become exercisable.
6
Exhibit 10.65
AETHLON MEDICAL, INC.
AMENDMENT NO. 1 TO
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors (the “Board”) of Aethlon Medical, Inc. (the “Company”), in a written consent in lieu of a Board Meeting
dated February 9, 2016, has deemed it fair and in the best interest of the Company and its stockholders that Section 5 of the Stock Option
Agreement between the Company and Richard H. Tullis dated December 15, 2008 be amended (the “Amendment”) as set forth below.
Accordingly, the undersigned agree that such section is amended hereby to read in its entirety as follows:
5. Cessation of Service. The option term specified in Paragraph 2 shall terminate (and this option shall cease to be
outstanding) prior to the Expiration Date should any of the following events occur:
(a) If the Optionee’s service is terminated for any reason other than death or disability, then the Optionee may
exercise this option, only to the extent that the option would have been exercisable upon the date of such termination (the “Termination
Date”), no later than thirty-six (36) months after the Termination Date, or the Expiration Date, whichever occurs first.
(b) If the Optionee’s service is terminated because of the Optionee’s death or disability (or the Optionee dies
within thirty-six (36) months after a termination other than for cause or because of the Optionee’s disability), then this option may be
exercised only to the extent that it would have been exercisable by the Optionee on the Termination Date and must be exercised by the
Optionee (or the Optionee’s legal representative) no later than thirty-six (36) months after the Termination Date, or the Expiration Date,
whichever occurs first.
(c) Notwithstanding the provisions above, if the Optionee’s service is terminated for cause, neither the Optionee,
the Optionee’s estate nor such other person who may then hold this option shall be entitled to exercise it with respect to any Option Shares
whatsoever.
IN WITNESS WHEREOF, the parties have executed this Amendment on this 9th day of February, 2016.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James B. Frakes
James B. Frakes
Chief Financial Officer
Optionee
By: /s/ Richard H. Tullis
Richard H. Tullis
Exhibit 10.66
AETHLON MEDICAL, INC.
NOTICE OF GRANT OF STOCK OPTION
Notice is hereby given of the following grant of an option to purchase shares of the Common Stock of Aethlon Medical, Inc., a
Nevada corporation (the “Company”):
Optionee:
Grant Date:
Richard H. Tullis
September 27, 2010
Exercise Price:
$0.25 per share
Number of Option Shares:
1,000,000
Expiration Date:
Type of Option:
Vesting Schedule
September 27, 2020
Nonqualified Stock Option
500,000 shall vest immediately and 500,000 shall vest
on September 27, 2011
Optionee agrees to be bound by the terms of the Stock Option Agreement attached hereto as Exhibit A.
No Employment or Service Contract. Nothing in this Notice or in the attached Stock Option Agreement shall confer upon
Optionee any right to continue in service in any capacity, including as an employee, for any period of specific duration or interfere with or
otherwise restrict in any way the rights of the Company (or any Parent or Subsidiary employing or retaining Optionee) or of Optionee,
which rights are hereby expressly reserved by each, to terminate Optionee’s service and/or employment at any time for any reason, with or
without cause.
Definitions. All capitalized terms in this Notice shall have the meaning assigned to them in this Notice or the Company’s 2010
Stock Incentive Plan.
Dated as of: September 27, 2010
Aethlon Medical, Inc.
By: /s/ James A. Joyced
Name: James A. Joyce
Chairman and Chief Executive Officer
OPTIONEE
/s/ Richard H. Tullis
Name: Richard H. Tullis
Address: 1320 Saxony Road
Encinitas, CA 92024
ATTACHMENTS
Exhibit A - Stock Option Agreement
EXHIBIT A
AETHLON MEDICAL, INC.
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors of Aethlon Medical, Inc. (the “Company”), in a telephonic Board Meeting held September 27, 2010, has
deemed it fair and in the best interest of the Company and its stockholders that the Company issue to Richard H. Tullis (the “Optionee”) an
option to acquire an aggregate of 1,000,000 shares of restricted Common Stock of the Company.
All capitalized terms in this Agreement not defined herein shall have the meaning assigned to them in the attached Appendix or in
the Company’s 2010 Stock Incentive Plan (the “Plan”).
NOW, THEREFORE, it is hereby agreed as follows:
AGREEMENT
1. Grant of Option. The Company hereby grants to the Optionee, as of the Grant Date, an option to purchase up to the
number of Option Shares specified in the Grant Notice. The Option Shares shall be purchasable from time to time during the option term
specified in Paragraph 2 at the Exercise Price. Except as otherwise provided herein, this option shall be subject to the terms and conditions
of the Plan.
2. Option Term. This option shall expire at the close of business on the Expiration Date, unless sooner terminated in
accordance with Paragraph 5.
3. Limited Transferability. During Optionee’s lifetime, this option shall be exercisable only by Optionee and shall not
be assignable or transferable other than by will or by the laws of descent and distribution following Optionee’s death.
4. Dates of Exercise. This option shall become exercisable for the Option Shares as specified in the Vesting Schedule.
5. Cessation of Service. The exercise of this option shall be subject to the provisions of Section 6.6 of the Plan with
respect to exercise after Termination of the Optionee; provided that, for the avoidance of doubt, no previously unexercisable portion of this
option shall become exercisable after such Termination.
6. Stockholder Rights. The holder of this option shall not have any rights as a stockholder of the Company with respect
to the Option Shares until such person shall have exercised the option, paid the Exercise Price and become a holder of record of the
purchased shares.
1
7. Manner of Exercising Option.
exercisable, the Optionee (or any other person or persons exercising the option) must take the following actions:
(a) In order to exercise this option with respect to all or any part of the Option Shares for which this option is at the time
(i) Execute and deliver to the Company a written notice setting forth the number of Option Shares for which the
option is exercised;
(ii) Pay the aggregate Exercise Price for the purchased shares in cash or in one or more of the following forms:
(A) by cancellation of indebtedness of the Company to the Optionee;
(B) if approved by the Board, by surrender of shares that either: (1) have been owned by the Optionee for
more than one year and have been paid for within the meaning of Rule 144 promulgated under the Securities Act
(and, if such shares were purchased from the Company by use of a promissory note, such note has been fully paid
with respect to such shares); or (2) were obtained by the Optionee in the public market;
(C) if approved by the Board, by waiver of compensation due or accrued to the Optionee for services
rendered;
(D) with respect only to purchases upon exercise of an option, and provided that a public market for the
Company’s stock exists:
(1) through a “same day sale” commitment from the Optionee and a broker-dealer that is a member
of the Financial Industry Regulatory Authority (a “FINRA Dealer”) whereby the Optionee irrevocably elects to
exercise the option and to sell a portion of the shares so purchased to pay for the Exercise Price, and whereby the
FINRA Dealer irrevocably commits upon receipt of such shares to forward the Exercise Price directly to the
Company; or
(2) through a “margin” commitment from the Optionee and an FINRA Dealer whereby the
Optionee irrevocably elects to exercise the option and to pledge the Shares so purchased to the FINRA Dealer in a
margin account as security for a loan from the FINRA Dealer in the amount of the Exercise Price, and whereby
the FINRA Dealer irrevocably commits upon receipt of such Shares to forward the Exercise Price directly to the
Company; or
(E) by any combination of the foregoing. Except to the extent the sale and remittance procedure is
utilized in connection with the option exercise, payment of the Exercise Price must accompany the written notice
delivered to the Company in connection with the option exercise;
2
(iii) Furnish to the Company appropriate documentation that the person or persons exercising the option (if other
than Optionee) have the right to exercise this option;
(iv) Execute and deliver to the Company such written representations as may be requested by the Company in
order for it to comply with the applicable requirements of federal and state securities laws; and
(v) Make appropriate arrangements with the Company for the satisfaction of all federal, state and local income
and employment tax withholding requirements applicable to the option exercise.
person or persons exercising this option) a certificate for the purchased Option Shares, with the appropriate legends affixed thereto.
(b) As soon as practical after the Exercise Date, the Company shall issue to or on behalf of the Optionee (or any other
(c) In no event may this option be exercised for any fractional shares.
8. Compliance with Laws and Regulations.
(a) The exercise of this option and the issuance of the Option Shares upon such exercise shall be subject to compliance by
the Company and the Optionee with all applicable requirements of law relating thereto and with all applicable regulations of any stock
exchange (or the OTC Bulletin Board, if applicable) on which the Common Stock may be listed for trading (or quoted) at the time of such
exercise and issuance.
(b) The inability of the Company to obtain approval from any regulatory body having authority deemed by the Company
to be necessary to the lawful issuance and sale of any Common Stock pursuant to this option shall relieve the Company of any liability with
respect to the non-issuance or sale of the Common Stock as to which such approval shall not have been obtained. The Company, however,
shall use its best efforts to obtain all such approvals.
9. Successors and Assigns. Except to the extent otherwise provided in Paragraph 3, the provisions of this Agreement
shall inure to the benefit of, and be binding upon, the Company and its successors and assigns and the Optionee, the Optionee’s assigns and
the legal representatives, heirs and legatees of the Optionee’s estate.
10. Notices. Any notice required to be given or delivered to the Company under the terms of this Agreement shall be in
writing and addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to the Optionee shall
be in writing and addressed to the Optionee at the address indicated below the Optionee’s signature line on the Grant Notice. All notices
shall be deemed effective upon personal delivery or upon deposit in the U.S. mail, postage prepaid and properly addressed to the party to be
notified.
3
11. Governing Law. The interpretation, performance and enforcement of this Agreement shall be governed by the laws of
the State of California without resort to the conflict-of-laws rules thereof.
4
IN WITNESS WHEREOF, the undersigned have duly executed this Agreement as of September 27, 2010.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James B. Frakes
James B. Frakes
Chief Financial Officer
Optionee
By: /s/ Richard H. Tullis
Richard H. Tullis
5
The following definitions shall be in effect under the Agreement:
APPENDIX A
1.
2.
3.
4.
5.
6.
7.
8.
9.
Agreement shall mean this Stock Option Agreement.
Common Stock shall mean the Company’s common stock.
Exercise Date shall mean the date on which the option shall have been exercised in accordance with Paragraph 7
of the Agreement.
Exercise Price shall mean the exercise price payable per Option Share as specified in the Grant Notice.
Expiration Date shall mean the date on which the option expires as specified in the Grant Notice.
Grant Date shall mean the date of grant of the option as specified in the Grant Notice.
Grant Notice shall mean the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which
Optionee has been informed of the basic terms of the option evidenced hereby.
Option Shares shall mean the number of shares of Common Stock subject to the option.
Vesting Schedule shall mean the vesting schedule specified in the Grant Notice pursuant to which the Option
Shares shall become exercisable.
6
Exhibit 10.67
AETHLON MEDICAL, INC.
AMENDMENT NO. 1 TO
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors (the “Board”) of Aethlon Medical, Inc. (the “Company”), in a written consent in lieu of a Board Meeting
dated February 9, 2016, has deemed it fair and in the best interest of the Company and its stockholders that Section 5 of the Stock Option
Agreement between the Company and Richard H. Tullis dated July 1, 2013 be amended (the “Amendment”) as set forth below.
Accordingly, the undersigned agree that such section is amended hereby to read in its entirety as follows:
5. Cessation of Service. The option term specified in Paragraph 2 shall terminate (and this option shall cease to be
outstanding) prior to the Expiration Date should any of the following events occur:
(a) If the Optionee’s service is terminated for any reason other than death or disability, then the Optionee may
exercise this option, only to the extent that the option would have been exercisable upon the date of such termination (the “Termination
Date”), no later than thirty-six (36) months after the Termination Date, or the Expiration Date, whichever occurs first.
(b) If the Optionee’s service is terminated because of the Optionee’s death or disability (or the Optionee dies
within thirty-six (36) months after a termination other than for cause or because of the Optionee’s disability), then this option may be
exercised only to the extent that it would have been exercisable by the Optionee on the Termination Date and must be exercised by the
Optionee (or the Optionee’s legal representative) no later than thirty-six (36) months after the Termination Date, or the Expiration Date,
whichever occurs first.
(c) Notwithstanding the provisions above, if the Optionee’s service is terminated for cause, neither the Optionee,
the Optionee’s estate nor such other person who may then hold this option shall be entitled to exercise it with respect to any Option Shares
whatsoever.
IN WITNESS WHEREOF, the parties have executed this Amendment on this 9th day of February, 2016.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James B. Frakes
James B. Frakes
Chief Financial Officer
Optionee
By: /s/ Richard H. Tullis
Richard H. Tullis
Exhibit 10.68
AETHLON MEDICAL, INC.
AMENDMENT NO. 1 TO
STOCK OPTION AGREEMENT
RECITALS
The Board of Directors (the “Board”) of Aethlon Medical, Inc. (the “Company”), in a written consent in lieu of a Board Meeting
dated February 9, 2016, has deemed it fair and in the best interest of the Company and its stockholders that Section 5 of the Stock Option
Agreement between the Company and Richard H. Tullis dated June 6, 2014 be amended (the “Amendment”) as set forth below.
Accordingly, the undersigned agree that such section is amended hereby to read in its entirety as follows:
5. Cessation of Service. The option term specified in Paragraph 2 shall terminate (and this option shall cease to be
outstanding) prior to the Expiration Date should any of the following events occur:
(a) If the Optionee’s service is terminated for any reason other than death or disability, then the Optionee may
exercise this option, only to the extent that the option would have been exercisable upon the date of such termination (the “Termination
Date”), no later than thirty-six (36) months after the Termination Date, or the Expiration Date, whichever occurs first.
(b) If the Optionee’s service is terminated because of the Optionee’s death or disability (or the Optionee dies
within thirty-six (36) months after a termination other than for cause or because of the Optionee’s disability), then this option may be
exercised only to the extent that it would have been exercisable by the Optionee on the Termination Date and must be exercised by the
Optionee (or the Optionee’s legal representative) no later than thirty-six (36) months after the Termination Date, or the Expiration Date,
whichever occurs first.
(c) Notwithstanding the provisions above, if the Optionee’s service is terminated for cause, neither the Optionee,
the Optionee’s estate nor such other person who may then hold this option shall be entitled to exercise it with respect to any Option Shares
whatsoever.
IN WITNESS WHEREOF, the parties have executed this Amendment on this 9th day of February, 2016.
Aethlon Medical, Inc., a Nevada corporation
By: /s/ James B. Frakes
James B. Frakes
Chief Financial Officer
Optionee
By: /s/ Richard H. Tullis
Richard H. Tullis
EXHIBIT 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements of Aethlon Medical, Inc. and subsidiary (collectively
“the Company”) on Form S-8 (File Nos. 333-182902, 333-168483, 333-168481, 333-164939, 333-160532, 333-145290, 333-127911, 333-
114017 and 333-49896), Form S-1 (File Nos. 333-201334 and 333-205832), and Form S-3 (File No. 333-211151) of our report dated June
29, 2016 relating to the audits of the consolidated financial statements of the Company as of March 31, 2016 and 2015 and for each of the
years then ended appearing in this Annual Report on Form 10-K for the year ended March 31, 2016.
/s/ Squar Milner LLP (formerly Squar, Milner, Peterson, Miranda & Williamson, LLP)
San Diego, California
June 29, 2016
EXHIBIT 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a), AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James Joyce, certify that:
1. I have reviewed this Annual Report on Form 10-K of Aethlon Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent
functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: June 29, 2016
/s/ JAMES A. JOYCE
JAMES A. JOYCE
CHIEF EXECUTIVE OFFICER
(PRINCIPAL EXECUTIVE OFFICER )
EXHIBIT 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a), AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James Frakes, certify that:
1. I have reviewed this Annual Report on Form 10-K of Aethlon Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known
to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the
registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent
functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information;
and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's
internal control over financial reporting.
Date: June 29, 2016
/s/ JAMES B. FRAKES
JAMES B. FRAKES
CHIEF FINANCIAL OFFICER
(PRINCIPAL FINANCIAL OFFICER)
EXHIBIT 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Aethlon Medical, Inc. (the “Registrant”) on Form 10-K for the fiscal year ended March
31, 2016 as filed with the Securities and Exchange Commission on the date hereof, I, James A. Joyce, Chief Executive Officer of the
Registrant, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. Based on my knowledge, the Annual Report on Form 10-K fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended, and
2. The information contained in such Annual Report on Form 10-K fairly presents, in all material respects, the financial condition
and results of operations of Aethlon Medical, Inc.
Dated: June 29, 2016
/s/ JAMES A. JOYCE
James A. Joyce
Chief Executive Officer
Aethlon Medical, Inc.
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise
adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been
provided to Aethlon Medical, Inc. and will be retained by Aethlon Medical, Inc. and furnished to the Securities and Exchange Commission
or its staff upon request.
EXHIBIT 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Aethlon Medical, Inc. (the “Registrant”) on Form 10-K for the fiscal year ended March
31, 2016 as filed with the Securities and Exchange Commission on the date hereof, I, James B. Frakes, Chief Financial Officer of the
Registrant, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. Based on my knowledge, the Annual Report on Form 10-K fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended, and
2. The information contained in such Annual Report on Form 10-K fairly presents, in all material respects, the financial condition
and results of operations of Aethlon Medical, Inc.
Dated: June 29, 2016
/s/ JAMES B. FRAKES
James B. Frakes
Chief Financial Officer
Aethlon Medical, Inc.