Conference Call to be Held Today at
4:30 p.m. ET
SAN
DIEGO, Nov. 14, 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 second quarter ended September 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 to and remove harmful exosomes and
life-threatening viruses from blood. 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. 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.
In October, Aethlon received clearance from the Drug Controller
General of India (DCGI), the
central drug authority in India,
to conduct a phase 1 safety, feasibility and dose-finding trial of
the company's Hemopurifier in patients with solid tumors who have
stable or progressive disease during anti-PD-1 monotherapy
treatment, such as Keytruda® or Opdivo®. The trial is expected to
begin following completion of an internal in vitro binding study of
relevant targets, and subsequent approval by the respective Ethics
Boards of interested sites in India.
Aethlon announced yesterday that, effective as of November 7, 2023, James
B. Frakes, M.B.A., Chief Financial Officer of the company,
was appointed as Interim Chief Executive Officer, replacing
Charles J. Fisher, Jr. M.D., and
also was appointed as a member of the company's Board of Directors.
Mr. Frakes also will remain as Chief Financial Officer of the
company. Also effective as of November 7,
2023, Guy F. Cipriani,
formerly Chief Business Officer of the company, was appointed as
the Company's Chief Operating Officer and resigned from the
company's Board of Directors.
"On behalf of everyone at Aethlon Medical, we would like to
thank Dr. Fisher for his service to the company as our CEO and as a
member of our Board of Directors," stated Mr. Frakes." I am
grateful for our Board's confidence in me. I am deeply committed to
Aethlon's shareholders and employees, and plan to work tirelessly
to help the company succeed. I look forward to continuing the
development of the Hemopurifier, and initiating a potential Phase 1
trial in oncology in both India
and Australia, an area where we
see great promise and ongoing emphasis."
We previously reported a disruption in our Hemopurifier supply
and that our intended transition to a new supplier for galanthus
nivalis agglutinin, or GNA, a component of our Hemopurifier,
was delayed as we work with the FDA for approval of our supplement
to our IDE, which is required to make this manufacturing change.
We are continuing to work with the FDA to qualify this second
supplier of our GNA, but are in the process of completing final
testing to begin manufacturing Hemopurifiers at our new
manufacturing facility in San
Diego for use in U.S. clinical trials, using GNA from our
original GNA supplier. The company has a sufficient supply of
Hemopurifiers for use in our planned oncology trial in Australia and India.
Financial Results for the Second Quarter Ended June 30, 2023
As of September 30, 2023, Aethlon
Medical had a cash balance of approximately $10.2 million.
Consolidated operating expenses for the three months ended
September 30, 2023 were approximately
$3.2 million, compared to
$3.7 million for the three months
ended September 30, 2022. This
decrease of approximately $500,000,
or 13.4%, in the 2023 period was due to decreases in general and
administrative expenses of approximately $700,000, offset by increases in professional
fees of approximately $129,000, and
an increase in our payroll and related expenses of $78,000.
The $700,000 decrease in general
and administrative expenses was primarily due to the combination of
a $377,000 decrease in clinical trial
expenses associated with the closed COVID trial, a $261,000 decrease in the purchase of raw
materials for research and development testing for use in the
Hemopurifier, a $140,000 decrease in
subcontract expenses associated with previous government contracts
and a $64,000 decrease in rent
related to previously rented mobile cleanroom. Those decreases were
partially offset by an increase $85,000 related to the company's Australian
subsidiary's activities and a $39,000
increase in depreciation related to leasehold improvements and new
equipment for the company's manufacturing and lab facilities.
The $129,000 increase in
professional fees was due to an increase of $72,000 in accounting fees associated with audit
and compliance services, a $56,000
increase in recruiting expense, a $54,000 increase in contract labor associated
with pre-clinical and other research and development services, a
$38,000 increase relating to services
for the company's Australian subsidiary and an increase of
$11,000 in director fees associated
with adding a new member to the company's Board of Directors. These
increases were partially offset by a decrease of $52,000 in general corporate legal fees and
$63,000 in scientific consulting
associated with completed studies.
The $78,000 increase in payroll
expense was due to $135,000 in salary
expense related to an increase in headcount, which was partially
offset by a $56,000 decrease in
stock-based compensation related to employee stock option
grants.
As a result of the changes in revenues and expenses noted above,
the company's net loss decreased from $3.8
million in the three months ended September 30, 2022, to $3.0 million in the three months ended
September 30, 2023.
The condensed consolidated balance sheet for September 30, 2023, and the condensed
consolidated statements of operations for the three and six month
periods ended September 30, 2023 and
2022 follow at the end of this release.
Conference Call
Aethlon Medical will hold a conference call today, Tuesday, November 14, 2023, at 4:30 p.m. ET to review its financial results for
its second quarter ended September 30,
2023 and recent corporate developments. Interested parties
can register for the conference by navigating to
https://dpregister.com/sreg/10184181/fafb1d3fee. 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 December
14, 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
2507359.
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 and for use in organ transplantation. 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 initiate its oncology clinical trials in
India and Australia; the Company's ability to manage and
successfully complete its clinical trials, if initiated; the
Company's ability to raise additional capital and to maintain its
Nasdaq listing; the Company's ability to successfully manufacture
the Hemopurifier in sufficient quantities for its clinical trials,
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
Interim Chief Executive Officer and 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
|
|
|
|
September 30,
2023
|
|
March 31,
2023
|
|
|
|
|
(unaudited)
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$
10,175,920
|
|
$
14,532,943
|
|
|
Prepaid
expenses
|
|
311,397
|
|
557,623
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
10,487,317
|
|
15,090,566
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
1,199,681
|
|
1,144,004
|
|
|
Right-of-use lease
asset
|
|
1,019,145
|
|
1,151,909
|
|
|
Patents, net
|
|
1,375
|
|
1,650
|
|
|
Restricted
cash
|
|
87,506
|
|
87,506
|
|
|
Deposits
|
|
33,305
|
|
33,305
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
12,828,329
|
|
$
17,508,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
$
684,942
|
|
$
432,890
|
|
|
Due to related
parties
|
|
249,781
|
|
214,221
|
|
|
Lease liability,
current portion
|
|
279,737
|
|
269,386
|
|
|
Other current
liabilities
|
|
496,074
|
|
588,592
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
1,710,534
|
|
1,505,089
|
|
|
|
|
|
|
|
|
|
Lease liability, less
current portion
|
|
798,451
|
|
939,642
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
2,508,985
|
|
2,444,731
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value
of $0.001, 60,000,000 shares
|
|
|
|
|
|
|
authorized;
2,492,908 and 2,299,259 issued and outstanding
|
|
2,493
|
|
2,299
|
|
|
Additional-paid in
capital
|
|
159,001,611
|
|
157,426,606
|
|
|
Accumulated other
comprehensive loss
|
|
(9,570)
|
|
(6,141)
|
|
|
Accumulated
deficit
|
|
(148,675,190)
|
|
(142,358,555)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
10,319,344
|
|
15,064,209
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$
12,828,329
|
|
$
17,508,940
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARY
|
Consolidated
Statements of Operations
|
For the three and
six month periods ended September 30, 2023 and 2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
Six
Months
|
|
Six
Months
|
|
|
Ended
9/30/23
|
|
Ended
9/30/22
|
|
Ended
9/30/23
|
|
Ended
9/30/22
|
|
|
|
|
|
|
|
|
|
Government contract
revenue
|
|
$-
|
|
$-
|
|
$-
|
|
$-
|
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
Professional
fees
|
|
1,133,111
|
|
1,003,870
|
|
2,109,749
|
|
1,847,899
|
Payroll and
related
|
|
1,191,426
|
|
1,112,955
|
|
2,314,665
|
|
2,142,641
|
General and
administrative
|
|
850,809
|
|
1,548,484
|
|
2,159,092
|
|
2,582,505
|
Total operating expenses
|
|
3,175,346
|
|
3,665,309
|
|
6,583,506
|
|
6,573,045
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
(3,175,346)
|
|
(3,665,309)
|
|
(6,583,506)
|
|
(6,573,045)
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE
(INCOME)
|
|
|
|
|
|
|
|
|
Loss on
dissolution of subsidiary
|
|
|
|
142,121
|
|
-
|
|
142,121
|
Interest and
Other Income
|
|
(140,890)
|
|
-
|
|
(266,871)
|
|
-
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$(3,034,456)
|
|
$(3,807,430)
|
|
$(6,316,635)
|
|
$(6,715,166)
|
|
|
|
|
|
|
|
|
|
OTHER COMPREHENSIVE
LOSS
|
|
(2,435)
|
|
-
|
|
(3,429)
|
|
-
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE
LOSS
|
|
$(3,036,891)
|
|
$(3,807,430)
|
|
$(6,320,064)
|
|
$(6,715,166)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
|
|
|
|
common
stockholders per share
|
|
$
(1.22)
|
|
$
(1.84)
|
|
$
(2.57)
|
|
$
(3.70)
|
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted average number of
|
|
|
|
|
|
|
|
|
common shares
outstanding
|
|
2,483,649
|
|
2,074,500
|
|
2,457,711
|
|
1,813,018
|
View original
content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-fiscal-second-quarter-financial-results-and-provides-corporate-update-301986842.html
SOURCE Aethlon Medical, Inc.