SAN DIEGO, Oct. 28, 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 second quarter ended September 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 has initiated 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) and is now open for
enrollment. The EFS is designed to 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 also 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 first sites for
this trial have received IRB approval and the Company is currently
recruiting additional sites. The Company has also recently
treated 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. This
patient successfully received eight Hemopurifier treatments of six
hours each over nine days.
Financial Results for the Second Quarter Ended September 30, 2020
At September 30, 2020, we had a
cash balance of approximately $14.5
million.
Consolidated operating expenses for the three months ended
September 30, 2020 were approximately
$1.77 million, compared to
approximately $1.70 million for the
three months ended September 30,
2019. This increase of approximately $70,000, or 4.1%, in the 2020 period was due to a
an increase in general and administrative expenses of approximately
$212,000, which was partially offset
by a decreases in professional fees of approximately $106,000 and in payroll and related expenses of
approximately $37,000.
The $212,000 increase in general
and administrative expenses was primarily due to a $143,000 increase in lab supplies in connection
with our ongoing effort to continue to build an inventory of
Hemopurifiers for our clinical trials, and to a $54,000 increase in our clinical trial
expenses.
The $106,000 decrease in our
professional fees was primarily due to a $94,000 decrease in our legal fees and a
$60,000 decrease in our accounting
fees, which were partially offset by a $38,000 increase in scientific consulting
expenses.
The $37,000 decrease in payroll
and related expenses was due to the combination of a $159,000 reduction in stock-based compensation
expense and a $122,000 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.
There was no other expense during the three months ended
September 30, 2020. In the three
months ended September 30, 2019,
other expense primarily consisted of approximately $4,000 of losses on share for warrant
exchanges.
As a result of the changes in revenues and expenses noted above,
our net loss before noncontrolling interests increased to
approximately $1.77 million for the
three months ended September 30,
2020, from approximately $1.71
million for the three months ended September 30, 2019.
The unaudited condensed consolidated balance sheet for
September 30, 2020 and the unaudited
condensed consolidated statements of operations for the three and
six month periods ended September 30,
2020 and 2019 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Wednesday, October 28, 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 https://dpregister.com/sreg/10149369/dbcc2bc6ad.
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):
1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN:
1-412-317-5442
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 November
4, 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 10149369.
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
AETHLON MEDICAL,
INC. AND SUBSIDIARIES
|
Condensed
Consolidated Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
September 30,
2020
|
|
March 31,
2020
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$14,473,232
|
|
$9,604,780
|
|
|
Accounts
receivable
|
|
111,849
|
|
206,729
|
|
|
Prepaid
expenses
|
|
167,178
|
|
229,604
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
14,752,259
|
|
10,041,113
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
145,855
|
|
140,484
|
|
|
Right-of-use lease
asset
|
|
88,888
|
|
136,426
|
|
|
Patents,
net
|
|
57,229
|
|
57,504
|
|
|
Deposits
|
|
12,159
|
|
12,159
|
|
|
|
|
|
|
|
|
TOTAL NONCURRENT
ASSETS
|
|
304,131
|
|
346,573
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$15,056,390
|
|
$10,387,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
311,724
|
|
285,036
|
|
|
Due to related
parties
|
|
156,909
|
|
111,707
|
|
|
Deferred
revenue
|
|
507,022
|
|
100,000
|
|
|
Lease liability,
current portion
|
|
92,603
|
|
98,557
|
|
|
Other current
liabilities
|
|
421,502
|
|
472,420
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,489,760
|
|
1,067,720
|
|
|
|
|
|
|
|
|
NONCURRENT
LIABILITIES
|
|
|
|
|
|
|
Convertible notes
payable, net
|
|
-
|
|
42,540
|
|
TOTAL NONCURRENT
LIABILITIES
|
|
-
|
|
42,540
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
1,489,760
|
|
1,110,260
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares
|
|
|
|
|
|
|
authorized;
12,088,313 and 9,366,873 issued and outstanding
|
|
12,089
|
|
9,368
|
|
|
Additional-paid in
capital
|
|
128,895,581
|
|
121,426,563
|
|
|
Accumulated
deficit
|
|
(115,207,228)
|
|
(112,026,381)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
13,700,442
|
|
9,409,550
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(133,812)
|
|
(132,124)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
13,566,630
|
|
9,277,426
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$15,056,390
|
|
$10,387,686
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARY
|
Condensed
Consolidated Statements of Operations
|
For the three and
six month periods ended September 30, 2020 and 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
Six
Months
|
|
Six
Months
|
|
|
Ended
9/30/20
|
|
Ended
9/30/19
|
|
Ended
9/30/20
|
|
Ended
9/30/19
|
|
|
|
|
|
|
|
|
|
Government contract
revenue
|
|
$-
|
|
$-
|
|
$-
|
|
$30,000
|
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
Professional
fees
|
|
656,396
|
|
762,337
|
|
1,220,680
|
|
1,369,915
|
Payroll and
related
|
|
560,244
|
|
597,526
|
|
997,155
|
|
1,203,521
|
General and
administrative
|
|
554,749
|
|
342,339
|
|
963,972
|
|
724,955
|
|
|
1,771,389
|
|
1,702,202
|
|
3,181,807
|
|
3,298,391
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
(1,771,389)
|
|
(1,702,202)
|
|
(3,181,807)
|
|
(3,268,391)
|
|
|
|
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
|
|
|
|
Loss on debt
extinguishment
|
|
-
|
|
|
|
-
|
|
447,011
|
Loss on share for
warrant exchanges
|
|
-
|
|
4,403
|
|
-
|
|
4,403
|
Interest and other
debt expenses
|
|
-
|
|
21
|
|
728
|
|
54,106
|
|
|
-
|
|
4,424
|
|
728
|
|
505,520
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$(1,771,389)
|
|
$(1,706,626)
|
|
$(3,182,535)
|
|
$(3,773,911)
|
|
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
(825)
|
|
(1,589)
|
|
(1,688)
|
|
(2,450)
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
|
$(1,770,564)
|
|
$(1,705,037)
|
|
$(3,180,847)
|
|
$(3,771,461)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
|
|
|
|
common
stockholders per share
|
|
$
(0.15)
|
|
$
(1.29)
|
|
$
(0.29)
|
|
$
(2.91)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common
|
|
|
|
|
|
|
|
|
shares
outstanding
|
|
12,070,592
|
|
1,317,418
|
|
10,845,049
|
|
1,294,206
|
View original
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SOURCE Aethlon Medical, Inc.