SAN DIEGO, June 25, 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
fiscal year ended March 31, 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 preparing for the initiation of clinical
trials in patients with advanced and metastatic cancers. The
Company is initially focused on the treatment of solid tumors,
including head and neck cancer, gastrointestinal cancers and other
cancers. Under an Investigational Device Exemption (IDE)
application approved by FDA in October
2019 the Company is initiating an Early Feasibility Study
(EFS – the device equivalent of a phase 1 study) in patients with
advanced and/or metastatic head and neck cancer at the UPMC Hillman
Cancer Center in Pittsburgh,
PA. 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.
On June 17, 2020, the FDA approved
a supplement to the Company's existing IDE for the use of 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.
In other news, the Company announced that Thomas L. Taccini has joined the Aethlon
management team as Vice President, Manufacturing and Product
Development. Mr. Taccini has over 35 years of experience in
leading teams in engineering, product development, project
management, quality systems and regulatory affairs for multiple
different classes of medical devices.
Financial Results for the Fiscal Year Ended March 31, 2020
The Company recorded government contract revenue of $650,187 in the fiscal year ended March 31, 2020. This revenue resulted from
work performed under the Company's Phase 2 Melanoma Cancer Contract
with the National Institutes of Health, or NIH. The Company
recorded government contract revenue of $229,625 in the fiscal year ended March 31, 2019.
Operating expenses for the fiscal year ended March 31, 2020 were approximately $6.58 million, compared to $6.23 million for the fiscal year ended
March 31, 2019. This increase of
approximately $350,000, or 6%, in the
fiscal year ended March 31, 2020 was
due to increases in professional fees of $537,000 and in general and administrative
expense of $595,000, which were
partially offset by a decrease of $781,000 in payroll and related expenses.
The $537,000 increase in our
professional fees in the fiscal year ended March 21, 2020 was primarily due to a
$694,000 increase in our legal fees
and a $111,000 increase in our
accounting fees, which were partially offset by decreases of
$245,000 in consulting fees. The
increase in legal and accounting fees related to increased activity
in our registration statement filings and in intellectual property
actions, among other matters.
The $595,000 increase in general
and administrative expenses in the fiscal year ended March 21, 2020 was primarily due to the
combination of a $316,000 increase in
our clinical trial expenses, a $198,000 increase in subcontracting and other
costs related to our government contracts, and an increase of
$87,000 in laboratory supplies.
The $781,000 decrease in payroll
and related expenses in the fiscal year ended March 21, 2020 was due to a combination of a
decrease in our stock-based compensation of $475,000 and a decrease of $306,000 in cash-based compensation, primarily
due to the termination of consulting and severance payments to our
former chief executive officer and former president.
Other expense in the fiscal year ended March 21, 2020 consisted of a non-cash loss on
debt extinguishment, interest expense and a gain on share for
warrant exchanges, and in the fiscal year ended March 21, 2019, consisted of interest expense
only. Other expense for the fiscal year ended March 21, 2020 was approximately $450,000, compared to other expense of
approximately $220,000 for the fiscal
year ended March 21, 2019.
As a result of the changes in revenues and expenses noted above,
our net loss before noncontrolling interests increased to
approximately $6,380,000 for the
fiscal year ended March 31, 2020,
from $6,220,000 for the fiscal year
ended March 31, 2019.
At March 31, 2020, we had a cash
balance of approximately $9.6
million.
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. The aggregate
net proceeds to us were approximately $7.3
million.
The unaudited condensed consolidated balance sheet for
March 31, 2020 and the unaudited
condensed consolidated statements of operations for the fiscal
years ended March 31, 2020 and
2019 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Thursday, June 25, 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/10145174. 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 July 2,
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 10145174.
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 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, 2019, 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
|
|
|
|
March 31,
2020
|
|
March 31,
2019
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$9,604,780
|
|
$3,828,074
|
|
|
Accounts
receivable
|
|
206,729
|
|
-
|
|
|
Prepaid
expenses
|
|
229,604
|
|
210,042
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
10,041,113
|
|
4,038,116
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
140,484
|
|
6,021
|
|
|
Right-of-use lease
asset
|
|
136,426
|
|
-
|
|
|
Patents,
net
|
|
57,504
|
|
66,668
|
|
|
Deposits
|
|
12,159
|
|
12,159
|
|
|
|
|
|
|
|
|
TOTAL NONCURRENT
ASSETS
|
|
346,573
|
|
84,848
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$10,387,686
|
|
$4,122,964
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
285,036
|
|
131,931
|
|
|
Due to related
parties
|
|
111,707
|
|
83,654
|
|
|
Convertible notes
payable, net
|
|
-
|
|
962,301
|
|
|
Deferred
revenue
|
|
100,000
|
|
-
|
|
|
Lease liability,
current portion
|
|
98,557
|
|
-
|
|
|
Other current
liabilities
|
|
472,420
|
|
646,000
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,067,720
|
|
1,823,886
|
|
|
|
|
|
|
|
|
NONCURRENT
LIABILITIES
|
|
|
|
|
|
|
Convertible notes
payable, net
|
|
42,540
|
|
-
|
|
TOTAL NONCURRENT
LIABILITIES
|
|
42,540
|
|
-
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
1,110,260
|
|
1,823,886
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares
|
|
|
|
|
|
|
authorized;
9,367,171 and 1,266,979 issued and outstanding
|
|
9,368
|
|
1,267
|
|
|
Additional-paid in
capital
|
|
121,426,563
|
|
108,076,275
|
|
|
Accumulated
deficit
|
|
(112,026,381)
|
|
(105,652,433)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
9,409,550
|
|
2,425,109
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(132,124)
|
|
(126,031)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
9,277,426
|
|
2,299,078
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$10,387,686
|
|
$4,122,964
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARIES
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
For the fiscal
years ended March 31, 2020 and 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
Year
|
|
Fiscal
Year
|
|
|
Ended
3/31/20
|
|
Ended
3/31/19
|
|
|
|
|
|
Government contract
revenue
|
|
$650,187
|
|
$229,625
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
Professional
fees
|
|
2,729,025
|
|
2,192,048
|
Payroll and
related
|
|
2,302,599
|
|
3,083,116
|
General and
administrative
|
|
1,548,551
|
|
953,478
|
|
|
6,580,175
|
|
6,228,642
|
|
|
|
|
|
OPERATING
LOSS
|
|
(5,929,988)
|
|
(5,999,017)
|
|
|
|
|
|
OTHER (INCOME)
EXPENSE
|
|
|
|
|
Loss on debt
extinguishment
|
|
447,011
|
|
-
|
Loss on share for
warrant exchanges
|
|
(51,190)
|
|
-
|
Interest and other
debt expenses
|
|
54,232
|
|
220,487
|
|
|
450,053
|
|
220,487
|
|
|
|
|
|
NET
LOSS
|
|
$(6,380,041)
|
|
$(6,219,504)
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
(6,093)
|
|
(24,785)
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
|
$(6,373,948)
|
|
$(6,194,719)
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
common
stockholders per share
|
|
$
(1.87)
|
|
$
(5.13)
|
|
|
|
|
|
Weighted average
number of common
|
|
|
|
|
shares
outstanding
|
|
3,414,840
|
|
1,208,314
|
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content:http://www.prnewswire.com/news-releases/aethlon-medical-announces-fiscal-year-financial-results-and-provides-corporate-update-301083944.html
SOURCE Aethlon Medical, Inc.