SAN DIEGO, Feb. 10, 2021 /PRNewswire/ -- Aethlon Medical,
Inc. (Nasdaq: AEMD), a medical device therapeutic company focused
on developing products to diagnose and treat life and organ
threatening diseases, today reported financial results for
its third quarter ended December 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 has initiated its first clinical trial in patients with
advanced and metastatic cancers. Under an Investigational
Device Exemption (IDE) application approved by the 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 University of
Pittsburgh Medical Center Hillman Cancer Center in
Pittsburgh, PA. 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. The first patient in this
study has now completed the Hemopurifier treatments required by the
protocol without incident.
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 treated a patient under an emergency use
single patient pathway that allows for the use of an
investigational product in critically ill patients who have
essentially failed other treatment options. This patient
successfully received eight Hemopurifier treatments of six hours
each over nine days and subsequently was transferred from the
hospital to a rehab facility for patients post critical illness for
rehabilitation on joints and muscles after the long period of
paralysis.
In January 2021, Aethlon hired two
senior executives, Guy Cipriani as
Senior Vice President, Chief Business Officer, and Steven LaRosa, M.D., as Chief Medical Officer.
Mr. Cipriani will oversee business development and partnerships,
while also contributing to fundraising and corporate
development. Dr. LaRosa will be responsible for the clinical
development of Aethlon's Hemopurifier, including leading clinical
operations and regulatory strategy.
Financial Results for the Third Quarter Ended December 31, 2020
At December 31, 2020, Aethlon
Medical had a cash balance of approximately $12.1 million.
The Company recorded approximately $625,000 in government contract revenue in the
three months ended December 31, 2020,
compared to approximately $413,000 in
the three months ended December 31,
2019.
Consolidated operating expenses for the three months ended
December 31, 2020 were approximately
$3.07 million, compared to
approximately $1.29 million for the
three months ended December 31, 2019.
This increase of approximately $1.78
million, or 137.9%, in the 2020 period was due to an
increase in payroll and related expenses of approximately
$1.12 million, in general and
administrative expenses of approximately $646,000 and in professional fees of
approximately $15,000.
The $1.12 million increase in
payroll and related expenses was due to the combination of an
$842,000 increase in cash-based
compensation expense and a $275,000
increase in stock-based compensation expense. The largest factor in
the cash-based compensation increase was a result of recording an
aggregate of $593,000 related to
severance costs associated with the separation agreement of the
Company's former CEO in the third quarter. Additional factors
were a $125,000 increase in year-end
bonus payments, increased headcount and salary increases.
The $646,000 increase in general
and administrative expenses was primarily due to a $361,000 increase in clinical trial expenses, a
$133,000 increase in subcontractor
expenses associated with government contracts and grants, a
$130,000 increase in lab supplies in
connection with the ongoing effort to continue to build an
inventory of Hemopurifiers for the Company's clinical trials, and a
$40,000 increase in insurance
expenses.
The $15,000 increase in
professional fees was primarily due to a $28,000 increase in contract labor, predominantly
research scientists hired on a consulting basis, and a $23,000 increase in legal fees, which were
partially offset by a $35,000
decrease in accounting fees.
Other expense was nominal during the three months ended
December 31, 2020 and 2019.
As a result of the changes in revenues and expenses noted above,
the Company's net loss before noncontrolling interests increased to
approximately $2.44 million for the
three months ended December 31, 2020,
from approximately $821,000 for the
three months ended December 31,
2019.
The unaudited condensed consolidated balance sheet for
December 31, 2020 and the unaudited
condensed consolidated statements of operations for the three and
nine month periods ended December 31,
2020 and 2019 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Wednesday, February 10, 2021 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/10152271/e275c301d3.
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 February
17, 2021. 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 10152271.
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.
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.
Under an Investigational Device Exemption (IDE) application, in
October 2019, the FDA approved an
Early Feasibility Study (EFS), which is the device equivalent of a
Phase 1 clinical trial for a drug or biologic, in a single center,
open label trial in 10 to 12 subjects. The study is
evaluating the HEMOPURIFIER® for reducing cancer-associated
exosomes prior to the administration of standard-of-care
pembrolizumab (KEYTRUDA®), which is a first-line therapy for
patients with recurrent and/or metastatic squamous cell carcinoma
of the head and neck. The EFS is being conducted at the
University of Pittsburgh Medical Center
Hillman Cancer Center.
The Hemopurifier also holds a Breakthrough Device designation
related to life-threatening viruses that are not addressed with
approved therapies. In June
2020, the FDA approved an amendment to the Company's
existing 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 Early Feasibility Study
protocol at up to 20 clinical sites in the U.S.
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, the
Company's ability to raise additional funds, 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
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 SUBSIDIARY
|
Condensed
Consolidated Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
December 31,
2020
|
|
March 31,
2020
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
Cash
|
$12,131,593
|
|
$9,604,780
|
|
|
Accounts
receivable
|
114,849
|
|
206,729
|
|
|
Prepaid
expenses
|
75,829
|
|
229,604
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
12,322,271
|
|
10,041,113
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
166,751
|
|
140,484
|
|
|
Right-of-use lease
asset
|
64,750
|
|
136,426
|
|
|
Patents,
net
|
57,092
|
|
57,504
|
|
|
Restricted
cash
|
46,726
|
|
-
|
|
|
Deposits
|
12,159
|
|
12,159
|
|
|
|
|
|
|
|
TOTAL NONCURRENT
ASSETS
|
347,478
|
|
346,573
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
$12,669,749
|
|
$10,387,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
Accounts
payable
|
175,422
|
|
285,036
|
|
|
Due to related
parties
|
131,746
|
|
111,707
|
|
|
Deferred
revenue
|
-
|
|
100,000
|
|
|
Lease liability,
current portion
|
67,698
|
|
98,557
|
|
|
Other current
liabilities
|
860,697
|
|
472,420
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
1,235,563
|
|
1,067,720
|
|
|
|
|
|
|
|
NONCURRENT
LIABILITIES
|
|
|
|
|
|
Convertible notes
payable, net
|
-
|
|
42,540
|
|
TOTAL NONCURRENT
LIABILITIES
|
-
|
|
42,540
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
1,235,563
|
|
1,110,260
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares
authorized; 12,123,524 and 9,366,873 issued and
outstanding
|
12,125
|
|
9,368
|
|
|
Additional-paid in
capital
|
129,207,491
|
|
121,426,563
|
|
|
Accumulated
deficit
|
(117,650,120)
|
|
(112,026,381)
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
11,569,496
|
|
9,409,550
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
(135,310)
|
|
(132,124)
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
11,434,186
|
|
9,277,426
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$12,669,749
|
|
$10,387,686
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARY
|
Condensed
Consolidated Statements of Operations
|
For the three and
nine month periods ended December 31, 2020 and 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
Nine
Months
|
|
Nine
Months
|
|
Ended
12/31/20
|
|
Ended
12/31/19
|
|
Ended
12/31/20
|
|
Ended
12/31/19
|
|
|
|
|
|
|
|
|
Government contract
revenue
|
$624,871
|
|
$413,458
|
|
$624,871
|
|
$443,458
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
Professional
fees
|
624,979
|
|
609,933
|
|
1,845,659
|
|
1,979,848
|
Payroll and
related
|
1,523,650
|
|
406,421
|
|
2,520,805
|
|
1,609,942
|
General and
administrative
|
919,830
|
|
273,510
|
|
1,883,802
|
|
998,465
|
|
3,068,459
|
|
1,289,864
|
|
6,250,266
|
|
4,588,255
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
(2,443,588)
|
|
(876,406)
|
|
(5,625,395)
|
|
(4,144,797)
|
|
|
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
|
|
|
Loss on debt
extinguishment
|
-
|
|
|
|
-
|
|
447,011
|
Gain on share for
warrant exchanges
|
-
|
|
(55,593)
|
|
-
|
|
(51,190)
|
Interest and other
debt expenses
|
802
|
|
126
|
|
1,530
|
|
54,232
|
|
802
|
|
(55,467)
|
|
1,530
|
|
450,053
|
|
|
|
|
|
|
|
|
NET
LOSS
|
$(2,444,390)
|
|
$(820,939)
|
|
$(5,626,925)
|
|
$(4,594,850)
|
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
(1,498)
|
|
(1,358)
|
|
(3,186)
|
|
(3,808)
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
$(2,442,892)
|
|
$(819,581)
|
|
$(5,623,739)
|
|
$(4,591,042)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss available to common stockholders per share
|
$
(0.20)
|
|
$
(0.28)
|
|
$
(0.50)
|
|
$
(2.52)
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
|
12,093,361
|
|
2,887,883
|
|
11,265,725
|
|
1,821,557
|
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SOURCE Aethlon Medical, Inc.