Conference Call to be Held Today at
4:30 p.m. ET
SAN
DIEGO, Aug. 10, 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 first quarter ended June 30,
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. Aethlon also recently
announced that it is investigating the use of the Hemopurifier in
the organ transplant setting, initially focusing on the potential
removal of harmful viruses and exosomes from recovered kidneys.
These qualities of the Hemopurifier have potential applications in
oncology, where cancer associated exosomes may promote immune
suppression and metastasis, and in life-threatening infectious
diseases and the organ transplant field.
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. Patients
with COVID-19 infections that require hospitalization continue to
occur in India, and 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 study in
Australia; specifically, a safety,
feasibility and dose finding trial in solid tumors failing
treatment with anti-PD-1 antibodies. Aethlon Medical believes that
the data generated from this trial will help inform the design of
future oncology efficacy trials of the company's Hemopurifier.
Ongoing 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.
The company recently announced that it has begun investigating
the use of the Hemopurifier in the organ transplant setting. The
objective is to confirm that the Hemopurifier, in translational
studies, when incorporated into a machine perfusion organ
preservation circuit, can remove harmful viruses and exosomes from
recovered kidneys. In July, the company signed a research
collaboration agreement with 34 Lives, PBC, to investigate the use
of our proprietary Hemopurifier and 34 Lives' organ evaluation and
preservation system, with the goal of increasing the supply of
useable donated kidneys for human transplant. The company has
previously demonstrated the removal of multiple viruses and
exosomes from buffer solutions, in vitro, utilizing a scaled-down
version of our Hemopurifier. This process may potentially reduce
complications following transplantation of the recovered 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 currently are in place to
meaningfully increase the number of viable kidneys for
transplant.
Financial Results for the First Quarter Ended June 30, 2023
As of June 30, 2023, Aethlon
Medical had a cash balance of approximately $12.9 million.
During the first quarter ended June 30,
2023, the company raised net proceeds of approximately
$1.1 million under the company's
at-the-market agreement with H. C. Wainwright & Co.
Consolidated operating expenses for the three months ended
June 30, 2023 were approximately
$3.4 million, compared to
$2.9 million for the three months
ended June 30, 2022. This increase of
approximately $0.5 million, or 17.3%,
in the 2023 period was due to increases in general and
administrative expenses of approximately $276,000, professional fees of $133,000 and in payroll and related expenses of
approximately $91,000.
The $276,000 increase in general
and administrative expenses was primarily due to a combination of
factors. Those factors included a $344,000 increase in purchase of raw materials
for production of the company's Hemopurifier, $133,000 increase related to the Australian
subsidiary's activities, a $105,000
increase in depreciation and equipment maintenance associated with
leasehold improvements and new equipment for manufacturing and lab
facilities, and an increase of $14,000 in insurance expense. These increases
were partially offset by a $160,000
decrease in clinical trial expenses, a $140,000 decrease in subcontract expense
associated with government contracts and a net decrease of
$29,000 in expenses related to our
previously rented mobile cleanroom.
The $133,000 increase in
professional fees was due to an increase of $123,000 in investor relations expenses
associated with facilitating investor awareness and assistance with
more widespread dissemination of Company news, an increase of
$37,000 associated with accounting
and legal services for our Australian subsidiary and $86,000 of legal expenses associated with
year-end filings and general corporate matters. Increases were
offset by decreases in regulatory services of $85,000, recruiting expense of $28,000 and $6,000
in consulting services.
The $91,000 increase in payroll
expense was due to $56,000 in salary
expense related to an increase in headcount and a $35,000 increase in stock based compensation
related to employee stock option grants.
As a result of the above factors, the company's net loss
increased to approximately $3.3
million in the three months ended June 30, 2023, from approximately $2.9 million in the three months ended
June 30, 2022.
The condensed consolidated balance sheet for June 30, 2023, and the condensed consolidated
statements of operations for the three month periods ended
June 30, 2023 and 2022 follow at
the end of this release.
Conference Call
Aethlon Medical will hold a conference call today, Thursday, August 10, 2023, at 4:30 p.m. ET to review its financial results for
its first quarter ended June 30, 2023
and recent corporate developments. Interested parties can register
for the conference by navigating to
https://dpregister.com/sreg/10181673/fa26a9fc02. 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 call through September
10, 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
7051036.
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 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
successfully complete development of the Hemopurifier and to
successfully demonstrate the utility of the Hemopurifier in cancer
and infectious diseases and in the transplant setting, the
Company's ability to manage and successfully complete its clinical
trials, the Company's ability to raise additional capital, 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
|
|
|
|
June 30, 2023
|
|
March 31, 2023
|
|
|
|
|
(unaudited)
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$
12,897,734
|
|
$
14,532,943
|
|
|
Prepaid
expenses
|
|
410,223
|
|
557,623
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
13,307,957
|
|
15,090,566
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
1,284,200
|
|
1,144,004
|
|
|
Right-of-use lease
asset
|
|
1,086,108
|
|
1,151,909
|
|
|
Patents, net
|
|
1,513
|
|
1,650
|
|
|
Restricted
cash
|
|
87,506
|
|
87,506
|
|
|
Deposits
|
|
33,305
|
|
33,305
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
15,800,589
|
|
$
17,508,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
$
844,536
|
|
$
432,890
|
|
|
Due to related
parties
|
|
191,314
|
|
214,221
|
|
|
Lease liability,
current portion
|
|
274,520
|
|
269,386
|
|
|
Other current
liabilities
|
|
511,377
|
|
588,592
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,821,747
|
|
1,505,089
|
|
|
|
|
|
|
|
|
|
Lease liability, less
current portion
|
|
869,945
|
|
939,642
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
2,691,692
|
|
2,444,731
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value
of $0.001, 60,000,000 shares
|
|
|
|
|
|
|
authorized;
24,835,321 and 22,992,466 issued and outstanding
|
|
24,837
|
|
22,994
|
|
|
Additional-paid in
capital
|
|
158,731,929
|
|
157,405,911
|
|
|
Accumulated other
comprehensive loss
|
|
(7,135)
|
|
(6,141)
|
|
|
Accumulated
deficit
|
|
(145,640,734)
|
|
(142,358,555)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
|
13,108,897
|
|
15,064,209
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
13,108,897
|
|
15,064,209
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$
15,800,589
|
|
$
17,508,940
|
|
|
|
|
|
|
|
|
AETHLON MEDICAL, INC. AND
SUBSIDIARIES
|
Condensed Consolidated Statements of
Operations
|
For the three month periods ended June 30, 2023 and
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
Three Months
|
|
|
Ended 6/30/23
|
|
Ended 6/30/22
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
Professional
fees
|
|
$
976,638
|
|
$
844,028
|
Payroll and
related
|
|
1,123,239
|
|
1,029,686
|
General and
administrative
|
|
1,308,283
|
|
1,032,367
|
Total Operating Expenses
|
|
3,408,160
|
|
2,906,081
|
|
|
|
|
|
OPERATING
LOSS
|
|
(3,408,160)
|
|
(2,906,081)
|
|
|
|
|
|
OTHER INCOME
|
|
|
|
|
Interest
income
|
|
125,981
|
|
-
|
|
|
125,981
|
|
-
|
|
|
|
|
|
NET LOSS BEFORE
NONCONTROLLING INTERESTS
|
|
$(3,282,179)
|
|
$(2,906,081)
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
-
|
|
(413)
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS
|
|
$(3,282,179)
|
|
$(2,905,668)
|
|
|
|
|
|
OTHER COMPREHENSIVE
LOSS
|
|
(994)
|
|
-
|
|
|
|
|
|
COMPREHENSIVE
LOSS
|
|
$
(3,283,173)
|
|
$
(2,905,668)
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
common
stockholders per share
|
|
$
(0.14)
|
|
$
(0.19)
|
|
|
|
|
|
Weighted average number
of common
|
|
|
|
|
shares
outstanding
|
|
24,314,759
|
|
15,486,621
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-fiscal-first-quarter-financial-results-and-provides-corporate-update-301897376.html
SOURCE Aethlon Medical, Inc.