Conference Call to be Held Today at
4:30pm ET
SAN
DIEGO, June 28, 2023 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to treat cancer and life threatening
infectious diseases, today reported financial results for its
fiscal year ended March 31, 2023 and
provided an update on recent developments.
Company Updates
Aethlon Medical is continuing the research and clinical
development of its Hemopurifier®, a therapeutic blood
filtration system that can bind and remove harmful exosomes and
life-threatening viruses 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.
The company's ongoing COVID-19 trial in India, for patients in the intensive care unit
(ICU) at Medanta Medicity Hospital, remains open for enrollment,
with one patient treated to date. In May 2023, a second clinical site, Maulana
Azad Medical College (MAMC), received Ethics Board Approval to
participate in the trial and site activation activities are
currently underway. Cases of COVID-19 infection that require
hospitalization continue to occur in India. The addition of MAMC as a second, high
quality clinical site may improve the enrollment of patients who go
on to require ICU care for severe infection.
In the oncology indication, Aethlon Medical continues to work
with its contract research organization, North American Science
Associates, LLC (NAMSA), to initiate a clinical trial in
Australia. This new clinical trial in oncology is planned to
be a safety, feasibility and dose finding trial in solid tumors
failing anti-PD-1 antibodies. Management of Aethlon Medical
believes that the data from this trial will help inform the design
of future efficacy trials of the company's Hemopurifier in
oncology. Current activities include site identification and
qualification, finalization of necessary documents for Ethics Board
submission, case report form development and selection of a Data
Safety Monitoring Board.
On June 21, 2023, Aethlon
announced that it is investigating the use of its Hemopurifier in
the organ transplant market. Specifically, the company
is conducting translational studies with the objective of
determining if the Hemopurifier, when incorporated into a machine
perfusion organ preservation circuit, can remove harmful viruses
and exosomes from harvested organs. The company
has previously demonstrated the removal of multiple viruses
and exosomes from buffer solutions, in vitro, utilizing a
scaled-down version of the Hemopurifier. This process potentially
may reduce complications following transplantation of the harvested
organ, which can include viral infection, delayed graft function
and rejection. The company believes that this new approach could be
additive to existing technologies that are currently in place to
increase the number of viable organs for transplant.
According to Precedence Research, the size of the global organ
transplantation market is projected to hit approximately
$33.7 billion by 2032, compared to
$15.1 billion in 2022. Further,
Precedence Research estimates that the global organ transplantation
market is poised to expand at a compounded average growth rate of
8.36% during the forecast period of 2023 to 2032. Additionally,
according to Precedence Research, rising demand for organ
transplantation to treat organ failure and novel tissue
transplantation products is the prime factor that is driving market
growth.
In the United States, all organ
transplant programs must be located in hospitals that have a
Medicare provider agreement. The ultimate goal of Aethlon Medical's
research in the organ transplantation area is to position the
Hemopurifier as a beneficial and potentially transformative
accessory element to existing or future organ perfusion systems
that keep harvested organs in transplantable condition.
Financial Results for the Fiscal Year Ended March 31, 2023
As of March 31, 2023, Aethlon
Medical had a cash balance of approximately $14.5 million.
Consolidated operating expenses for the fiscal year ended
March 31, 2023 were approximately
$12.47 million, compared to
$10.71 million for the fiscal year
ended March 31, 2022, an increase of
approximately $1.76 million. The
$1.76 million increase in the fiscal
year ended March 31, 2023 was due to
increases in administrative expense of $1.03
million and professional fees of approximately $910,000, which were partially offset by a
decrease in payroll and related expenses of approximately
$180,000.
General and administrative expense for the fiscal year ended
March 31, 2023 was $4.48 million, compared to $3.45 million for the fiscal year ended
March 31, 2022. The $1.03 million increase for the fiscal year ended
March 31, 2023 was due to an increase
in manufacturing and research and development supplies of
approximately $400,000 related to the
manufacture of the Hemopurifier device and various research and
development activities. Other increases included approximately
$147,000 in subcontract expense
related to revenue recognized from contracts and grants with the
NIH; approximately $155,000
associated with the close out of the U.S. COVID-19 clinical trial;
approximately $104,000 associated
with the company's Australian subsidiary and launch of the oncology
clinical trial in Australia;
approximately $118,000 in rent
expense related to the addition of the manufacturing suite in
fiscal year 2023 and a full year of rent for the company's office
and laboratory space; approximately $117,000 in depreciation and amortization expense
associated with leasehold improvements to manufacturing space and;
approximately $94,000 in D&O and
medical insurance. The company also had an increase in utility
expense of approximately $32,000,
largely as the result of the increased space under lease. These
increases were offset by decreases in outside services of
approximately $65,000, laboratory
fees of approximately $61,000 and
decreases in office supplies and equipment of approximately
$32,000.
Professional fees for the fiscal year ended March 31, 2023 were $3.54
million compared to $2.63
million in the fiscal year ended March 31, 2022. The approximately $910,000 increase in the fiscal year ended
March 31, 2023 was primarily due to
increases of approximately $291,000
in legal expenses, approximately $335,000 in contract labor associated with
product development and scientific analytical services,
approximately $176,000 in regulatory
consulting, approximately $40,000 in
investor relations, approximately $73,000 in recruiting expense and approximately
$16,000 in director fees, which were
partially offset by a decrease in accounting fees of approximately
$17,000.
Aethlon Medical's National Cancer Institute (NCI) award contract
ended on September 15, 2022 and the
company subsequently presented the required final report to the
NCI. As the NCI completed its close out review of the contract,
Aethlon Medical recorded total government contract revenue of
approximately $574,000 in the fiscal
year ended March 31, 2023 compared to
approximately $294,000 in the fiscal
year ended March 31, 2022.
As a result of the above factors, the company's net loss before
noncontrolling interests increased to $12.0
million for the fiscal year ended March 31, 2023, from $10.4
million for the fiscal year ended March 31, 2022.
During the fiscal year ended March 31,
2023, the company raised approximately $8.9 million in net proceeds under its At The
Market Offering Agreement with H.C. Wainwright & Co. (ATM
agreement), pursuant to sales of its common stock. Subsequent
to March 31, 2023, the company raised
net proceeds of approximately $1.1
million under the ATM agreement.
The condensed consolidated balance sheet for March 31, 2023, and the condensed consolidated
statements of operations for the fiscal years ended March 31, 2023 and 2022 follow at the end of
this release.
Conference Call
Aethlon Medical will hold a conference call today, Wednesday, June 28, 2023, at 4:30 p.m. ET to review its financial results for
its fiscal year ended March 31, 2023
and recent corporate developments. Interested parties can register
for the conference at
https://dpregister.com/sreg/10180154/f9c217a958. Please note
that registered participants will receive their dial in number upon
registration.
Interested parties without internet access or who are unable to
pre-register, may dial in as follows:
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 event, through July 28,
2023. 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
9371984.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on
developing the Hemopurifier, a clinical stage immunotherapeutic
device which is designed to combat cancer and life-threatening
viral infections. In human studies, the Hemopurifier has
demonstrated the removal of life-threatening viruses and harmful
exosomes from blood utilizing its 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. The Hemopurifier also
holds an FDA Breakthrough Device designation and an open
Investigational Device Exemption (IDE) application related to the
treatment of life-threatening viruses that are not addressed with
approved therapies.
Additional information can be found at
www.AethlonMedical.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, 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 successfully complete development of the
Hemopurifier and to successfully demonstrate the utility of the
Hemopurifier combatting cancer and life-threatening
viruses and in the organ transplant field, the
Company's ability to manage its clinical trials and to successfully
enroll patients in clinical trials, 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,
2023, 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
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303
|
|
|
|
|
|
|
AETHLON MEDICAL, INC. AND
SUBSIDIARY
|
Condensed Consolidated Balance
Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
March 31, 2023
|
|
March 31, 2022
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$14,532,943
|
|
$17,072,419
|
|
|
Accounts
receivable
|
|
-
|
|
127,965
|
|
|
Prepaid
expenses
|
|
557,623
|
|
956,623
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
15,090,566
|
|
18,157,007
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
1,144,004
|
|
441,238
|
|
|
Right-of-use lease
asset
|
|
1,151,909
|
|
696,698
|
|
|
Patents, net
|
|
1,650
|
|
2,200
|
|
|
Restricted
cash
|
|
87,506
|
|
87,506
|
|
|
Deposits
|
|
33,305
|
|
33,305
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$17,508,940
|
|
$19,417,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
432,889
|
|
499,962
|
|
|
Due to related
parties
|
|
214,221
|
|
155,742
|
|
|
Deferred
revenue
|
|
-
|
|
344,547
|
|
|
Lease liability,
current portion
|
|
269,386
|
|
126,905
|
|
|
Other current
liabilities
|
|
588,592
|
|
696,893
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,505,088
|
|
1,824,049
|
|
|
|
|
|
|
|
|
|
Lease liability, less
current portion
|
|
939,642
|
|
602,505
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
2,444,730
|
|
2,426,554
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value
of $0.001, 60,000,000 shares
|
|
|
|
|
|
|
authorized;
22,992,466 and 15,419,163 issued and outstanding
|
|
22,994
|
|
15,421
|
|
|
Additional-paid in
capital
|
|
157,405,911
|
|
147,446,868
|
|
|
Accumulated other
comprehensive loss
|
|
(6,141)
|
|
-
|
|
|
Accumulated
deficit
|
|
(142,358,554)
|
|
(130,329,181)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
15,064,210
|
|
17,133,108
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
-
|
|
(141,708)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
15,064,210
|
|
16,991,400
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$17,508,940
|
|
$19,417,954
|
|
AETHLON MEDICAL, INC. AND
SUBSIDIARIES
|
Condensed Consolidated Statements of
Operations
|
For the fiscal years ended March 31, 2023 and
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year
|
|
Fiscal Year
|
|
|
Ended 3/31/23
|
|
Ended 3/31/22
|
|
|
|
|
|
Government contract
revenue
|
|
$574,245
|
|
$294,165
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
Professional
fees
|
|
3,548,028
|
|
2,634,026
|
Payroll and
related
|
|
4,443,552
|
|
4,625,802
|
General and
administrative
|
|
4,481,303
|
|
3,455,222
|
|
|
12,472,883
|
|
10,715,050
|
|
|
|
|
|
OPERATING
LOSS
|
|
(11,898,638)
|
|
(10,420,885)
|
|
|
|
|
|
OTHER EXPENSE
(INCOME)
|
|
|
|
|
Loss on dissolution of
subsidiary
|
|
142,121
|
|
-
|
Interest
income
|
|
(10,973)
|
|
-
|
|
|
131,148
|
|
-
|
|
|
|
|
|
NET LOSS BEFORE
NONCONTROLLING INTERESTS
|
|
$(12,029,786)
|
|
$(10,420,885)
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
-
|
|
(4,794)
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS
|
|
$(12,029,786)
|
|
$(10,416,091)
|
|
|
|
|
|
OTHER COMPREHENSIVE
LOSS
|
|
(6,141)
|
|
-
|
|
|
|
|
|
COMPREHENSIVE
LOSS
|
|
$
(12,035,927)
|
|
$
(10,416,091)
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
common
stockholders per share
|
|
$
(0.59)
|
|
$
(0.71)
|
|
|
|
|
|
Weighted average number
of common
|
|
|
|
|
shares
outstanding
|
|
20,537,434
|
|
14,756,967
|
View original
content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-fiscal-year-end-financial-results-and-provides-corporate-update-301864994.html
SOURCE Aethlon Medical, Inc.