SAN DIEGO, Nov. 9, 2021 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a company developing medical
technology to treat cancer and life-threatening infectious
diseases, today reported financial results for its second quarter
ended September 30, 2021 and provided
an update on recent developments.
Company Updates
Aethlon Medical is continuing the research and clinical
development of the Hemopurifier™, our therapeutic blood filtration
system that can bind and remove life-threatening viruses and
harmful exosomes from blood. This action has potential applications
in cancer, where cancer associated exosomes may promote immune
suppression and metastasis, and in life-threatening infectious
diseases, including removal of COVID-19 virus, associated variants,
and related exosomes.
As disclosed in our last earnings release on August 9, 2021, the Aethlon Hemopurifier™ has
demonstrated binding of SARS-CoV-2 spike protein and, as reported
in a peer reviewed publication, the 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. The new information about the
Hemopurifier in COVID-19 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. The trial is
designed to allow for up to 40 of these patients to be treated
under an Early Feasibility Study protocol at up to 20 clinical
sites in the U.S.
During the recent quarter, we entered into an agreement with
PPD, Inc., a leading global contract research organization (CRO),
to oversee our U.S. clinical studies investigating the Hemopurifier
for critically ill COVID-19 patients.
Together with PPD, we continue to advance site readiness at
Cooper Medical Center, Loma Linda Medical Center, University of California Davis, Virginia Commonwealth University Medical Center,
LSU Health Shreveport, University of
Miami Medical Center, and Thomas Jefferson Medical Center.
Additionally, we obtained institutional research board
approval and have entered into a clinical trial agreement with
Stanford Hospital. We are in discussions to bring on board other
key U.S. medical centers.
We also recently obtained ethics review board approval and
entered into a clinical trial agreement with Medanta Medicity
Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that
location. On-site training is expected to take place in
November 2021.
"The opportunity to help critically ill, ICU patients with
COVID-19 continues in both the U.S. and India," said Steven
LaRosa, M.D., Chief Medical Officer.
"In addition to our work with COVID-19, we remain very
optimistic about the use of our Hemopurifier for the treatment of
Head and Neck Cancer. We acknowledge that the enrollment of
our Head and Neck Cancer trial has been delayed, primarily due to
the COVID-19 pandemic. We are exploring additional
avenues to investigate our Hemopurifier in patients with
cancer," said Charles J. Fisher,
Jr., M.D., CEO.
Financial Results for the Second Quarter Ended September 30, 2021
At September 30, 2021, Aethlon
Medical had a cash balance of approximately $23.2 million.
Aethlon recorded approximately $115,000 of government contract revenue on its
Phase 2 Melanoma Cancer Contract in the three months ended
September 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
September 30, 2021. Aethlon did not
record any government contract revenue in the three months ended
September 30, 2020.
Consolidated operating expenses for the three months ended
September 30, 2021 were approximately
$2.1 million, compared to
approximately $1.8 million for the
three months ended September 30,
2020. This increase of approximately $300,000, or 20%, in the 2021 period was due to
increases in payroll and related expenses of approximately
$200,000 and in general and
administrative expenses of approximately $100,000.
The $200,000 increase in payroll
and related expenses was primarily due to the combination of a
$101,000 increase in our research and
development payroll as the result of hiring additional scientists
and, a $100,000 increase in general
and administrative payroll expense as the result of additional
headcount.
The $100,000 increase in general
and administrative expenses was primarily due to a $72,000 increase in our rent expense, a
$54,000 increase in our amortization
expense and a $46,000 increase in our
insurance expenses, which were partially offset by a $57,000 decrease in our clinical trial
expenses.
As a result of the changes in revenues and expenses noted above,
the Company's net loss before noncontrolling interests increased to
approximately $2.0 million for the
three months ended September 30,
2021, from approximately $1.8
million for the three months ended September 30, 2020.
The unaudited condensed consolidated balance sheet for
September 30, 2021 and the unaudited
condensed consolidated statements of operations for the three and
six month periods ended September 30,
2021 and 2020 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Tuesday, November 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/10161862/ef905a2ede.
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 December
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 10162862.
About Aethlon and the Hemopurifier®
Aethlon Medical is a biotechnology company developing the
Hemopurifier, a therapeutic blood filtration system indicated for
infectious diseases and cancer. In human studies, the Hemopurifier
has demonstrated the removal of life-threatening viruses and
harmful exosomes from blood utilizing a proprietary lectin-based
technology. This action has potential applications in cancer,
where exosomes may promote immune suppression and metastasis, and
in life-threatening infectious diseases.
The Hemopurifier is a U.S. Food and Drug Administration (FDA)
designated Breakthrough Device indicated 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. Under an
Investigational Device Exemption (IDE) application, the FDA
approved a single site, open-label Early Feasibility Study (EFS) to
evaluate the Hemopurifier for reducing cancer-associated exosomes
prior to the administration of standard-of-care pembrolizumab
(KEYTRUDA®) in 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 an FDA Breakthrough Device
designation and an open IDE application related to the treatment of
life-threatening viruses that are not addressed with approved
therapies. A recent amendment to the IDE enabled Aethlon to
implement a new EFS protocol to treat up to 40 COVID-19 patients at
up to 20 clinical sites in the U.S. In two case studies of patients
treated under Emergency Use (EU), the Hemopurifier demonstrated
binding of SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus
from the circulation of a human patient.
Additional information can be found at
www.AethlonMedical.com.
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 additional sites for its clinical trials, the Company's
ability to enroll patients in and successfully complete its trials
in COVID-19 patients and in its head and neck cancer trials, 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, 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
Chief Financial Officer
Aethlon Medical, Inc.
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
|
|
|
September 30,
2021
|
|
March 31,
2021
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
Cash
|
$23,224,925
|
|
$9,861,575
|
|
Accounts
receivable
|
131,966
|
|
149,082
|
|
Prepaid
expenses
|
212,308
|
|
341,081
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
23,569,199
|
|
10,351,738
|
|
|
|
|
|
|
Property and
equipment, net
|
213,625
|
|
160,976
|
|
Right-of-use lease
asset
|
-
|
|
40,363
|
|
Patents,
net
|
2,476
|
|
56,954
|
|
Restricted
cash
|
46,726
|
|
46,726
|
|
Deposits
|
42,159
|
|
12,159
|
|
|
|
|
|
|
TOTAL
ASSETS
|
$23,874,185
|
|
$10,668,916
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
Accounts
payable
|
254,176
|
|
337,678
|
|
Due to related
parties
|
134,207
|
|
118,520
|
|
Deferred
revenue
|
114,849
|
|
114,849
|
|
Lease
liability
|
-
|
|
42,543
|
|
Other current
liabilities
|
471,117
|
|
761,636
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
974,349
|
|
1,375,226
|
|
|
|
|
|
TOTAL
LIABILITIES
|
974,349
|
|
1,375,226
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
Common stock, par
value of $0.001, 30,000,000 shares
|
|
|
|
|
authorized;
15,397,299 and 12,150,597 issued and outstanding
|
15,399
|
|
12,152
|
|
Additional-paid in
capital
|
147,041,683
|
|
129,331,542
|
|
Accumulated
deficit
|
(124,018,372)
|
|
(119,913,090)
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
23,038,710
|
|
9,430,604
|
|
|
|
|
|
Noncontrolling
interests
|
(138,874)
|
|
(136,914)
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
22,899,836
|
|
9,293,690
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$23,874,185
|
|
$10,668,916
|
|
|
|
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations
|
For the three and
six months ended September 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
Six
Months
|
|
Six
Months
|
|
|
Ended
9/30/21
|
|
Ended
9/30/20
|
|
Ended
9/30/21
|
|
Ended
9/30/20
|
|
|
|
|
|
|
|
|
|
Government contract
revenue
|
|
$131,966
|
|
$-
|
|
$263,932
|
|
$-
|
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
Professional
fees
|
|
649,460
|
|
656,396
|
|
1,232,929
|
|
1,220,680
|
Payroll and
related
|
|
805,608
|
|
560,244
|
|
1,822,350
|
|
997,155
|
General and
administrative
|
|
685,702
|
|
554,749
|
|
1,315,895
|
|
964,700
|
|
|
2,140,770
|
|
1,771,389
|
|
4,371,174
|
|
3,182,535
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
(2,008,804)
|
|
(1,771,389)
|
|
(4,107,242)
|
|
(3,182,535)
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$(2,008,804)
|
|
$(1,771,389)
|
|
$(4,107,242)
|
|
$(3,182,535)
|
|
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
(825)
|
|
(825)
|
|
(1,960)
|
|
(1,688)
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
|
$(2,007,979)
|
|
$(1,770,564)
|
|
$(4,105,282)
|
|
$(3,180,847)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
|
|
|
|
common
stockholders per share
|
|
$
(0.13)
|
|
$
(0.15)
|
|
$
(0.29)
|
|
$
(0.29)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common
|
|
|
|
|
|
|
|
|
shares
outstanding
|
|
15,386,486
|
|
12,070,592
|
|
14,114,639
|
|
10,845,049
|
|
|
|
|
|
|
|
|
|
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SOURCE Aethlon Medical, Inc.