SAN DIEGO, Aug. 9, 2021 /PRNewswire/ -- Aethlon Medical,
Inc. (Nasdaq: AEMD), a medical 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, 2021 and
provided an update on recent developments.
Company Updates
Aethlon Medical is continuing the research and clinical
development of our Hemopurifier to bind and remove COVID-19 viral
particles, including many variant COVID-19 particles of interest
and related exosomes.
As disclosed in our last earnings release on June 24, 2021, the Aethlon Hemopurifier has
demonstrated binding of SARS-CoV-2 spike protein and binding and
removal from circulation of SARS-CoV-2 virus from a human patient.
This is in addition to the Hemopurifier's previously demonstrated
binding of numerous pathogenic viruses. This new information has
stimulated clinical researchers to express interest in joining our
ongoing clinical trial investigating the Hemopurifier for the
treatment of patients with SARS-CoV-2/COVID-19 infection. This
trial is being conducted under the open Investigational Device
Exemption (IDE) for the Hemopurifier in life threatening viral
infections. This trial will allow for up to 40 of these patients to
be treated under a new Early Feasibility Study (EFS) protocol at up
to 20 clinical sites in the U.S. During the quarter, Cooper
Medical Center, located in Camden,
N.J., joined the trial. Additionally, the Company is
in late-stage clinical trial agreement discussions to bring on
board other key U.S. medical centers and interested international
medical centers. The Company anticipates finalizing our
selection of a Contract Research Organization to supervise these
clinical trials in the near future.
Financial Results for the First Quarter Ended June 30, 2021
At June 30, 2021, Aethlon Medical
had a cash balance of approximately $25.2
million.
During the three months ended June 30,
2021, we raised approximately $17.5
million in net proceeds from the issuance of common stock in
a combination of a registered direct financing and ATM sales.
Aethlon recorded approximately $115,000 of government contract revenue on its
Phase 2 Melanoma Cancer Contract in the three months ended
June 30, 2021. We also recorded
approximately $17,000 of revenue
related to our cost reimbursable subaward arrangement with the
University of Pittsburgh in connection
with an NIH contract entitled "Depleting Exosomes to Improve
Responses to Immune Therapy in HNNCC." As a result, the
Company recorded total government contract revenue of approximately
$132,000 in the three months ended
June 30, 2021. Aethlon did not record
any government contract revenue in the three months ended
June 30, 2020.
Consolidated operating expenses for the three months ended
June 30, 2021 were approximately
$2.2 million, compared to
$1.4 million for the three months
ended June 30, 2020. This increase of
approximately $800,000, or 58%, in
the 2021 period was due to increases in payroll and related
expenses of approximately $580,000,
in general and administrative expenses of approximately
$221,000, and in professional fees of
approximately $19,000.
The $580,000 increase in payroll
and related expenses was primarily due to the combination of a
$234,000 increase in R&D payroll
as the result of hiring additional scientists, a $210,000 bonus payment to our CEO as the result
of achieving certain milestones in his employment contract, a
$64,000 increase in general and
administrative payroll expense as the result of additional
headcount and a $36,000 increase in
stock-based compensation.
The $221,000 increase in general
and administrative expenses was primarily due to a $133,000 increase in our subcontractor expenses
related to our government contracts and a $74,000 increase in insurance expenses.
The $19,000 increase in
professional fees was primarily due to a $50,000 increase in legal fees which was
partially offset by a $22,000
decrease in scientific consulting expenses and a $6,000 decrease in accounting expenses.
Other expense was nominal during the first quarter ended
June 30, 2021.
As a result of the changes in revenues and expenses noted above,
the Company's net loss before noncontrolling interests increased to
approximately $2.1 million for the
three months ended June 30, 2021,
from approximately $1.4 million for
the three months ended June 30,
2020.
The unaudited condensed consolidated balance sheet for
June 30, 2021 and the unaudited
condensed consolidated statements of operations for the three month
periods ended June 30, 2021 and
2020 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Monday, August 9, 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/10159282/ec03010432.
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 September
9, 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 10159282.
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, 2021, 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 SUBSIDIARIES
|
Condensed
Consolidated Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
June 30,
2021
|
|
March 31,
2021
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$25,171,679
|
|
$9,861,575
|
|
|
Accounts
receivable
|
|
131,966
|
|
149,082
|
|
|
Prepaid
expenses
|
|
244,121
|
|
341,081
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
25,547,766
|
|
10,351,738
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
187,821
|
|
160,976
|
|
|
Right-of-use lease
asset
|
|
15,722
|
|
40,363
|
|
|
Patents,
net
|
|
56,817
|
|
56,954
|
|
|
Restricted
cash
|
|
46,726
|
|
46,726
|
|
|
Deposits
|
|
12,159
|
|
12,159
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$25,867,011
|
|
$10,668,916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
243,650
|
|
337,678
|
|
|
Due to related
parties
|
|
119,578
|
|
118,520
|
|
|
Deferred
revenue
|
|
114,849
|
|
114,849
|
|
|
Lease
liability
|
|
16,835
|
|
42,543
|
|
|
Other current
liabilities
|
|
636,387
|
|
761,636
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,131,299
|
|
1,375,226
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
1,131,299
|
|
1,375,226
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares
|
|
|
|
|
|
|
authorized;
15,386,367 and 12,150,597 issued and outstanding
|
|
15,388
|
|
12,152
|
|
|
Additional-paid in
capital
|
|
146,868,766
|
|
129,331,542
|
|
|
Accumulated
deficit
|
|
(122,010,393)
|
|
(119,913,090)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
24,873,761
|
|
9,430,604
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
(138,049)
|
|
(136,914)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
24,735,712
|
|
9,293,690
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$25,867,011
|
|
$10,668,916
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations
|
For the three
months ended June 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
|
Ended
6/30/21
|
|
Ended
6/30/20
|
|
|
|
|
|
Government contract
revenue
|
|
$131,966
|
|
$-
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
Professional
fees
|
|
583,469
|
|
564,284
|
Payroll and
related
|
|
1,016,742
|
|
436,911
|
General and
administrative
|
|
630,068
|
|
409,223
|
|
|
2,230,279
|
|
1,410,418
|
|
|
|
|
|
OPERATING
LOSS
|
|
(2,098,313)
|
|
(1,410,418)
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
Interest and other
debt expenses
|
|
125
|
|
728
|
|
|
125
|
|
728
|
|
|
|
|
|
NET
LOSS
|
|
$(2,098,438)
|
|
$(1,411,146)
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
(1,135)
|
|
(863)
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
|
$(2,097,303)
|
|
$(1,410,283)
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
common
stockholders per share
|
|
$
(0.16)
|
|
$
(0.15)
|
|
|
|
|
|
Weighted average
number of common
|
|
|
|
|
shares
outstanding
|
|
12,828,816
|
|
9,632,977
|
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SOURCE Aethlon Medical, Inc.