SAN DIEGO, Aug. 10, 2017 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company
focused on unmet needs in global health and biodefense, today
announced results for its fiscal first quarter ended June 30, 2017.
The Company disclosed that it has finalized an Expedited Access
Pathway (EAP) program submission that its regulatory advisors will
now provide to the United States Food and Drug Administration
(FDA). The submission requests that the Aethlon Hemopurifier®
be included in the EAP program.
The FDA established the EAP program for medical devices that
demonstrate the potential to address unmet medical needs for life
threatening or irreversibly debilitating diseases or conditions
that are subject to premarket approval applications (PMA),
premarket notification (510[k]) or requests for De Novo
designation. A criterion for EAP program eligibility includes
medical devices that represent breakthrough technologies with the
potential to address life threatening disease conditions for which
no approved or cleared treatment alternatives exist.
The Hemopurifier has been designed for the single-use removal of
viral pathogens from the circulatory system of infected
individuals. The device is a candidate broad-spectrum
treatment countermeasure against life-threatening viruses that are
not addressed with approved antiviral drug therapies.
Previous treatment experience against a life-threatening virus
not addressed with an approved antiviral drug includes the
successful treatment of Ebola virus, for which Aethlon subsequently
received FDA clearance of emergency-use and compassionate-use
treatment protocols. Aethlon has also concluded an
FDA-approved feasibility study to support the advancement of the
Hemopurifier as a treatment countermeasure against life-threatening
viruses that are not addressed with a market cleared therapy.
The Hemopurifier has also been validated in vitro to effectively
capture a broad-spectrum of life-threatening viral pathogens, many
of which are not treatable with approved antiviral drug
agents. The capture validation of mosquito-borne viruses that
are not addressed with an approved antiviral drug includes
Chikunguya virus, Dengue virus, West Nile virus and Zika virus.
Beyond Ebola treatment experience, the capture validation of
bioterror and pandemic threat viruses that are not addressed with
an approved antiviral drug includes Lassa virus, MERS-CoV and
Monkeypox virus, which is a surrogate for human Smallpox
infection. Studies of Marburg virus are currently being
conducted.
The capture validation of pandemic influenza viruses includes
virulent H5N1 Bird-Flu virus, H1N1 Swine Flu virus and the
reconstructed Spanish Flu virus of 1918.
The Hemopurifier has additionally been validated to capture
latent viral pathogens that can contribute to increased mortality
rates in immune-compromised individuals. Such validations include
Cytomegalovirus, Epstein-Barr virus and Herpes-simplex
virus-1. Based on previous preclinical and human clinical
studies, Aethlon believes the Hemopurifier may also have utility in
addressing drug-resistant viral strains that can emerge in HIV and
Hepatitis-C infected individuals.
Aethlon is also advancing the Hemopurifier to fulfill the
broad-spectrum treatment objectives of the 2016 Public Health
Emergency Medical Countermeasure Enterprise (PHEMCE)
initiative. The PHEMCE initiative defines the strategic plan
of the U.S. government to protect its citizens against bioterror
and pandemic threats. Based on preclinical and clinical
studies, the Company believes the Hemopurifier to be most advanced
broad-spectrum treatment candidate. Included among Aethlon's goals
is the procurement of the Hemopurifier into the U.S. government's
strategic national stockpile.
Financial Results
The net loss for the June 2017
quarter was $1.8 million, or
$0.21 per share, compared to a net
loss for the June 2016 quarter of
$2.1 million, or $0.28 per share.
Consolidated operating expenses were $1.16 million in the June
2017 quarter compared to $1.14
million in the June 2016
quarter, an increase of approximately $20,000. This increase was primarily due to an
increase in payroll and related expenses of approximately
$290,000. However, the increase in
payroll and related expenses was driven by a $230,000 increase in our non-cash, stock-based
compensation due to the vesting of restricted stock units granted
during the fiscal year.
Excluding that non-cash increase, our overall cash operating
expenses actually decreased by approximately $210,000 from reductions in our professional fees
and general and administrative expenses. Specifically, our
professional fees decreased by approximately $225,000 and our general and administrative
expenses declined by approximately $37,000.
The Company had other expense of approximately $685,000 in the June
2017 quarter compared to approximately $1 million in the June
2016 quarter, a decrease of approximately $315,000.
At June 30, 2017, the Company had
a cash balance of approximately $327,000. The Company has an active At The Market
financing facility to raise additional capital as needed.
The unaudited condensed consolidated balance sheet for
June 30, 2017 and the unaudited
condensed consolidated statements of operations for the quarters
ended June 30, 2017 and 2016 follow
at the end of this release.
Conference Call
Aethlon will hold a conference call for investors on
Thursday, August 10, 2017 at
1:30 p.m. PT (4:30 p.m. ET). To listen to the call by phone,
interested parties within the U.S. should call 1-844-836-8741 and
international callers should call 1-412-317-5442. All callers
should ask for the Aethlon Medical Inc., conference call. The
conference call will also be available through a live webcast at
www.aethlonmedical.com. Details for the webcast may be found on the
Company's IR events page at http://ir.aethlonmedical.com.
A replay of the call will be available approximately one hour
after the end of the call through August 17,
2017. The replay can be accessed via Aethlon Medical's
website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088
(international) or Canada Toll Free at 1-855-669-9658. The replay
conference ID number is 10111295.
About Aethlon Medical, Inc.
Aethlon Medical develops immunotherapeutic technologies to
combat infectious disease and cancer. To augment the body's
natural immune defenses, the Aethlon Hemopurifier® reduces the
presence of circulating viruses in infected individuals. The
technology provides a first-line candidate defense against viruses
that are not addressed with proven drug therapies, including
natural occurring pandemic threats and agents of
bioterrorism. The Hemopurifier® can also be deployed as a
strategy to improve the benefit of approved antiviral drug
regimens. At present, the Hemopurifier® is being advanced in
the United States under an FDA
approved clinical study. Aethlon Medical is also
investigating the potential use of the Hemopurifier® to reduce the
presence of tumor-derived exosomes, which contribute to
immune-suppression and the spread of metastasis in cancer
patients. Aethlon Medical is also the majority owner of
Exosome Sciences, Inc. (ESI), which is focused on the discovery of
exosomal biomarkers to diagnose and monitor cancer and neurological
disorders, including Alzheimer's disease (AD) and Chronic Traumatic
Encephalopathy (CTE). ESI's TauSome™ biomarker is being
clinically evaluated as the basis for a blood-based test to
identify CTE in living individuals. Additional information
can be found online at www.AethlonMedical.com and
www.ExosomeSciences.com. You can also connect with us on
Twitter, LinkedIn, Facebook and Google+.
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 that involve
risks and uncertainties. Statements containing words such as "may,"
"believe," "anticipate," "expect," "intend," "plan," "project,"
"will," "projections," "estimate," or similar expressions
constitute forward-looking statements. Such forward-looking
statements are subject to significant risks and uncertainties and
actual results may differ materially from the results anticipated
in the forward-looking statements. Factors that may contribute to
such differences include, without limitation, the Company's ability
to maintain its listing on the Nasdaq Capital Market, or any other
national securities exchange, that the Company or its subsidiary
will not be able to commercialize its products, that the FDA will
not approve the initiation or continuation of the Company's
clinical programs or provide market clearance of the Company's
products, the Company's ability to raise capital when needed, the
Company's ability to complete the development of its planned
products, the Company's ability to manufacture its products either
internally or through outside companies, the impact of government
regulations, patent protection on the Company's proprietary
technology, the ability of the Company to meet the milestones
contemplated in its contract with DARPA, product liability
exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. The foregoing list of
risks and uncertainties is illustrative, but is not exhaustive.
Additional factors that could cause results to differ materially
from those anticipated in forward-looking statements can be found
under the caption "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended March 31,
2017, and in the Company's other filings with the Securities
and Exchange Commission. Except as may be required by law, the
Company does not intend, nor does it undertake any duty, to update
this information to reflect future events or circumstances.
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
Jfrakes@aethlonmedical.com
Investor Relations:
John Marco
CORE IR
516 222 2560
johnm@coreir.com
AETHLON MEDICAL,
INC.
|
Condensed
Consolidated Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
June 30,
2017
|
|
March 31,
2017
|
|
|
|
(unaudited)
|
|
(unaudited)
|
CURRENT
ASSETS
|
|
|
|
|
|
Cash
|
|
$327,206
|
|
$1,559,701
|
|
Prepaid
expenses
|
|
38,450
|
|
37,551
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
365,656
|
|
1,597,252
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
45,893
|
|
29,223
|
|
Patents,
net
|
|
82,705
|
|
84,996
|
|
Other
assets
|
|
14,897
|
|
14,897
|
|
|
|
|
|
|
TOTAL NONCURRENT
ASSETS
|
|
143,495
|
|
129,116
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$509,151
|
|
$1,726,368
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
Accounts
payable
|
|
277,094
|
|
484,423
|
|
Due to related
parties
|
|
48,366
|
|
57,866
|
|
Other current
liabilities
|
|
82,845
|
|
69,467
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
408,305
|
|
611,756
|
|
|
|
|
|
|
NONCURRENT
LIABILITIES
|
|
|
|
|
|
Convertible notes
payable, non-current portion, net
|
|
1,050,911
|
|
519,200
|
TOTAL NONCURRENT
LIABILITIES
|
|
1,050,911
|
|
519,200
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
1,459,216
|
|
1,130,956
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
(DEFICIT) EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares authorized; 8,869,571 and
8,797,086 shares issued and outstanding as of June 30, 2017 and
March 31, 2017, respectively
|
|
8,869
|
|
8,796
|
|
Additional paid-in
capital
|
|
94,745,740
|
|
94,445,739
|
|
Accumulated
deficit
|
|
(95,619,939)
|
|
(93,778,156)
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
(DEFICIT) EQUITY BEFORE NONCONTROLLING INTERESTS
|
(865,330)
|
|
676,379
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(84,735)
|
|
(80,967)
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
(DEFICIT) EQUITY
|
|
(950,065)
|
|
595,412
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
$509,151
|
|
$1,726,368
|
AETHLON MEDICAL,
INC.
|
Condensed
Consolidated Statements of Operations
|
For the three
month periods ended June 30, 2017 and 2016
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
|
Ended
6/30/17
|
|
Ended
6/30/16
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
|
Government contract
income
|
|
$
-
|
|
$
4,635
|
Total
revenues
|
|
-
|
|
4,635
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Professional
fees
|
|
343,023
|
|
567,749
|
Payroll and
related
|
|
630,227
|
|
344,987
|
General and
administrative
|
|
186,999
|
|
223,551
|
Total
operating expenses
|
|
1,160,249
|
|
1,136,287
|
|
|
|
|
|
OPERATING
LOSS
|
|
(1,160,249)
|
|
(1,131,652)
|
|
|
|
|
|
OTHER (INCOME)
EXPENSE
|
|
|
|
|
Loss on share for
warrant exchanges
|
|
119,789
|
|
-
|
Loss on debt
extinguishment
|
|
376,909
|
|
616,889
|
Warrant repricing
expense
|
|
-
|
|
345,841
|
Interest and other
debt expenses
|
|
188,604
|
|
42,167
|
|
|
685,302
|
|
1,004,897
|
|
|
|
|
|
NET LOSS BEFORE
NONCONTROLLING INTERESTS
|
|
$(1,845,551)
|
|
$(2,136,549)
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
(3,769)
|
|
(7,732)
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS
|
|
$(1,841,782)
|
|
$(2,128,817)
|
|
|
|
|
|
Basic and diluted net loss available
to common stockholders per share
|
|
$
(0.21)
|
|
$
(0.28)
|
|
|
|
|
|
Weighted average number of common shares
outstanding
|
|
8,805,522
|
|
7,622,393
|
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SOURCE Aethlon Medical, Inc.