SAN DIEGO, Aug. 11, 2020 /PRNewswire/ -- Aethlon Medical,
Inc. (Nasdaq: AEMD), a medical device technology company focused on
developing products to diagnose and treat life and organ
threatening diseases, today reported financial results for
its first quarter ended June 30, 2020
and provided an update on recent developments.
Company Updates
Aethlon Medical, Inc. (Company or Aethlon) is continuing the
development of its proprietary Hemopurifier®, which is a first in
class therapeutic device designed for the single use depletion of
cancer-promoting exosomes and circulating viruses. The
Hemopurifier has previously been designated a Breakthrough Device
by the FDA for the treatment of glycosylated viruses, including
Ebola and other hemorrhagic fever viruses, and in late 2018 was
additionally designated as a Breakthrough Device "…for the
treatment of individuals with advanced or metastatic cancer who are
either unresponsive to or intolerant of standard of care therapy,
and with cancer types in which exosomes have been shown to
participate in the development or severity of the
disease….".
Aethlon is currently initiating its first clinical trial in
patients with advanced and metastatic cancers. Under an
Investigational Device Exemption (IDE) application approved by FDA
in October 2019 this trial, termed an
Early Feasibility Study (EFS – the device equivalent of a phase 1
study), in patients with advanced and/or metastatic head and neck
cancer is being run at the UPMC Hillman Cancer Center in
Pittsburgh, PA and has been
approved by the UPMC Institutional Review Board (IRB). The
EFS will enroll 10-12 subjects and will investigate the combination
of the Hemopurifier with standard of care pembrolizumab (Keytruda®)
in the front line setting.
As previously disclosed, the FDA has approved an amendment to
the Company's open IDE for the Hemopurifier in life threatening
viral infections, to allow for the treatment of patients with
SARS-CoV-2/COVID-19 infection. This will allow for up to 40
of these patients to be treated under a New Feasibility Study
protocol at up to 20 clinical sites in the U.S. The Company is
currently recruiting sites to conduct this trial. The Company
has also recently initiated treatment of one patient under an
emergency use single patient pathway that allows for the use of an
investigational product in patients who have essentially failed
other treatment options. While the Company cannot draw any
conclusions about efficacy based on a single case, the treatment
has been uneventful to date.
In other news, the Company recently announced receipt, in
collaboration with the University of
Pittsburgh and other academic institutions, of a five
year, approximately $3.5 million
grant from the National Institutes of Health (NIH) entitled
"Depleting exosomes to improve responses to immune therapy in
head and neck squamous cell carcinoma". This grant, on
which Theresa Whiteside, one of the
world's foremost authorities on exosomes in cancer, and Dr.
Annette Marleau, Aethlon's
Senior Director of Research are Co-Principal Investigators,
will provide support for both bench studies on exosomes in head and
neck cancer using samples from the clinical trial now being
initiated and will also provide some support for a follow on
clinical trial.
Financial Results for the First Quarter Ended June 30, 2020
At June 30, 2020, we had a cash
balance of approximately $15.7
million.
Operating expenses for the three months ended June 30, 2020 were approximately $1.4 million, compared to approximately
$1.6 million for the three months
ended June 30, 2019. This decrease of
approximately $200,000, or 12%, in
the 2020 period was due to a decrease in payroll and related
expenses of approximately $170,000
and in professional fees of approximately $43,000, which was partially offset by an
increase in general and administrative expenses of approximately
$27,000.
The $170,000 decrease in payroll
and related expenses was due to the combination of a $242,000 reduction in stock-based compensation
expense and a $73,000 increase in our
cash-based compensation expense. The cash-based compensation
increase was in turn due to additions to our headcount and to
salary increases.
The $43,000 decrease in our
professional fees was primarily due to a $22,000 decrease in our legal fees and a
$22,000 decrease in our accounting
fees.
The $27,000 increase in general
and administrative expenses was primarily due a $26,000 increase in our clinical trial expenses
as we prepare for our planned clinical trials.
Other expense during the three months ended June 30, 2020 consisted of interest expense and
during the three months ended June 30,
2019, consisted of interest expense and a loss on debt
extinguishment. Other expense for the three months ended
June 30, 2020 was approximately
$1,000, compared to other expense of
approximately $501,000 for the three
months ended June 30, 2019.
As a result of the changes in revenues and expenses noted above,
our net loss before noncontrolling interests decreased to
approximately $1.4 million for the
three months ended June 30, 2020,
from approximately $2.1 million for
the three months ended June 30,
2019.
In June 2020, we raised additional
cash through the sale of 2,685,600 shares of common stock under our
ATM facility at an average price of $2.70 per share of net proceeds. We did not issue
any warrants in this financing. The aggregate net proceeds to us
were approximately $7.3 million.
The unaudited condensed consolidated balance sheet for
June 30, 2020 and the unaudited
condensed consolidated statements of operations for the three month
periods ended June 30, 2020 and
2019 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Tuesday, June 11, 2020 at 4:30 p.m. Eastern Time to review financial
results and recent corporate developments. Following management's
formal remarks, there will be a question and answer session.
Interested parties can register for the conference by navigating
to http://dpregister.com/10147021.
Please note that registered participants will receive their dial
in number upon registration.
Interested parties without internet access or unable to
pre-register may dial in by calling:
PARTICIPANT DIAL IN
(TOLL FREE):
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1-844-836-8741
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PARTICIPANT
INTERNATIONAL DIAL IN:
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1-412-317-5442
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All callers should ask for the Aethlon Medical, Inc. conference
call.
A replay of the call will be available approximately one hour
after the end of the call through August 18,
2020. 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 10147021.
About Aethlon and the Hemopurifier®
Aethlon is focused on addressing unmet needs in global health.
The Aethlon Hemopurifier is a clinical- stage immunotherapeutic
device designed to combat cancer and life-threatening viral
infections. In cancer, the Hemopurifier is designed to deplete the
presence of circulating tumor-derived exosomes that promote immune
suppression.
These tumor derived exosomes also seed the spread of metastases
and inhibit the benefit of leading cancer therapies. The
Hemopurifier® is an FDA designated "Breakthrough Device" related to
the treatment of individuals with advanced or metastatic cancer who
are either unresponsive to or intolerant of standard of care
therapy, and with cancer types in which exosomes have been shown to
participate in the development or severity of the disease cancer.
The Hemopurifier also holds a Breakthrough Device designation
related to life-threatening viruses that are not addressed with
approved therapies.
Aethlon also owns 80% of Exosome Sciences, Inc., which is
focused on the discovery of exosomal biomarkers to diagnose and
monitor cancer and neurological disease progression. Additional
information can be found online at www.AethlonMedical.com and
www.ExosomeSciences.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 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," "potentially" 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. These
forward-looking statements are based upon Aethlon's current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Factors that may contribute to such
differences include, without limitation, the Company's ability to
enroll patients in and successfully complete trials in the Early
Feasibility Studies in head and neck cancer and in COVID-19
patients, the Company's ability to successfully treat patients
under any Emergency Use pathway, the Company's ability to
successfully complete development of its Hemopurifier, and other
potential risks. 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, 2020, and in the
Company's other filings with the Securities and Exchange
Commission, including its quarterly Reports on Form 10-Q. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. 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, CFO
jfrakes@aethlonmedical.com
858-459-7800 extension 3300
Media Contact:
Tony Russo, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com
212-845-4251
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
212-966-3650
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AETHLON MEDICAL,
INC. AND SUBSIDIARIES
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Condensed
Consolidated Balance Sheet
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ASSETS
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June 30,
2020
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March 31,
2020
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CURRENT
ASSETS
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Cash
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$15,721,616
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$9,604,780
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Accounts
receivable
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206,729
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206,729
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Prepaid
expenses
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166,944
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229,604
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TOTAL CURRENT
ASSETS
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16,095,289
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10,041,113
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Property and
equipment, net
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149,661
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140,484
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Right-of-use lease
asset
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112,779
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136,426
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Patents,
net
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57,366
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57,504
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Deposits
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12,159
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12,159
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TOTAL NONCURRENT
ASSETS
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331,965
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346,573
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TOTAL
ASSETS
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$16,427,254
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$10,387,686
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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CURRENT
LIABILITIES
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Accounts
payable
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251,194
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285,036
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Due to related
parties
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131,844
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111,707
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Deferred
revenue
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306,729
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100,000
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Lease liability,
current portion
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100,430
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98,557
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Other current
liabilities
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433,120
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472,420
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TOTAL CURRENT
LIABILITIES
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1,223,317
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1,067,720
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NONCURRENT
LIABILITIES
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Convertible notes
payable, net
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16,832
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|
42,540
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TOTAL NONCURRENT
LIABILITIES
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16,832
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42,540
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TOTAL
LIABILITIES
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1,240,149
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1,110,260
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COMMITMENTS AND
CONTINGENCIES
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EQUITY
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Common stock, par
value of $0.001, 30,000,000 shares authorized;
12,070,393 and 9,366,873 issued and outstanding
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12,072
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9,368
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Additional-paid in
capital
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128,744,684
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121,426,563
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Accumulated
deficit
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(113,436,664)
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(112,026,381)
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TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
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15,320,092
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9,409,550
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Noncontrolling
interests
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(132,987)
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(132,124)
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TOTAL STOCKHOLDERS'
EQUITY
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15,187,105
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9,277,426
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TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
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$16,427,254
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$10,387,686
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AETHLON MEDICAL,
INC. AND SUBSIDIARIES
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Condensed
Consolidated Statements of Operations
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For the three
month periods ended June 30, 2020 and 2019
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Three
Months
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Three
Months
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Ended
6/30/20
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Ended
6/30/19
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Government contract
revenue
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$
-
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$
30,000
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OPERATING COSTS AND
EXPENSES
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Professional
fees
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564,284
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607,578
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Payroll and
related
|
436,911
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605,995
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General and
administrative
|
409,223
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382,615
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1,410,418
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1,596,188
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OPERATING
LOSS
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(1,410,418)
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(1,566,188)
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OTHER (INCOME)
EXPENSE
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Loss on debt
extinguishment
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-
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447,011
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Interest and other
debt expenses
|
728
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54,085
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728
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|
501,096
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NET
LOSS
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$
(1,411,146)
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$
(2,067,284)
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Loss attributable to
noncontrolling interests
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(863)
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(860)
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NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
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$
(1,410,283)
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$
(2,066,424)
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Basic and diluted net
loss available to common stockholders per share
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$
(0.15)
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|
$
(1.63)
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Weighted average
number of common shares outstanding
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9,632,977
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|
1,270,484
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SOURCE Aethlon Medical, Inc.