SAN
DIEGO, Nov. 14, 2022 /PRNewswire/ -- Aethlon
Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused
on developing products to diagnose and treat cancer and life
threatening infectious diseases, today reported financial results
for its second quarter ended September 30,
2022 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, including removal of COVID-19 virus,
associated variants, and related exosomes.
- Due to a scarcity of COVID patients in intensive care units
eligible for enrollment into our U.S. COVID trial, we recently
decided to terminate the agreement with our contract research
organization (CRO). As a result, while our Investigational Device
Exemption (IDE) related to severe viral infections remains open, we
are discontinuing U.S. COVID clinical trial activity. We expect
this decision to save the company up to $5
million over the next twelve months, which we intend to
allocate towards advancing the study of our Hemopurifier in
oncology.
- Due to lack of patient enrollment by the University of Pittsburgh Medical Center (UPMC) in
our head and neck cancer safety trial, we and UPMC have terminated
this study. We are planning a new clinical trial in oncology that
will potentially include more tumor types, enabling us to build our
safety database in oncology and provide data to help direct the
development of our Hemopurifier as a treatment option in oncology.
We are in the latter stages of selecting a new CRO to supervise
this new oncology study.
- In October 2022, we launched a
wholly owned subsidiary in Australia, formed to conduct clinical
research, seek regulatory approval, and commercialize our
Hemopurifier in that country. The subsidiary will initially focus
on the oncology market in Australia. Once selected, it is likely that
our new CRO will oversee planned oncology studies in both the U.S.
and Australia.
- Our COVID-19 trial site in India remains open with the goal of enrolling
additional COVID-19 patients. We are considering opening an
oncology trial in India as
well.
- The addition of a second supplier for Galanthus nivalis
agglutinin (GNA), used in the resin of our Hemopurifier, is delayed
in the U.S., pending approval by the U.S. Food and Drug
Administration (FDA) of the supplement to our IDE required to enact
this manufacturing change. In our opinion, the FDA has mandated
unexpectedly high testing requirements for a product in the safety
and feasibility stage of development. The additional data requested
by FDA may take us several months to obtain. We are escalating our
concerns with the FDA decision by engaging the FDA's ombudsman.
However, there can be no assurance that this escalation will
accelerate our development timelines.
- Regulatory authorities in India have accepted this manufacturing change
and, as a result, we will ship new cartridges to the site in
India for use in our clinical
trials there.
- We have engaged a major testing lab, Battelle (Columbus, OH), to perform an in vitro
study to examine the binding of the current Monkeypox strain to a
miniature version of our Hemopurifier.
Financial Results for the Second Quarter Ended September 30, 2022
As of September 30, 2022, Aethlon
Medical had a cash balance of approximately $19.6 million.
Consolidated operating expenses for the three months ended
September 30, 2022 were approximately
$3.67 million, compared to
$2.14 million for the three months
ended September 30, 2021. This
increase of $1.53 million, or 71%, in
the 2022 period was due to increases in our general and
administrative expenses of $863,000,
in our professional fees of $354,000
and in our payroll and related expenses of $307,000.
The $863,000 increase in our
general and administrative expenses was primarily due to the
combination of a $384,000 increase in
our clinical trial expenses, a $258,000 increase in supplies, primarily for
manufacturing Hemopurifiers, a $140,000 increase in subcontract expenses related
to our government contracts, a $50,000 increase in our rent expense and a
$32,000 increase in our insurance
expense.
The $354,000 increase in our
professional fees was primarily due to the combination of a
$152,000 increase in our contract
labor expense associated with product development and analytical
services, a $136,000 increase in our
legal fees and a $61,000 increase in
our investor relations expenses, primarily related to solicitation
expenses associated with our 2022 annual meeting of
stockholders.
The $307,000 increase in our
payroll and related expenses was due to an increase in our
stock-based compensation expense of $112,000. Our cash-based compensation expense
increased by $195,000 due to our
increased headcount.
In September 2022, the Board of
Directors of Exosome Sciences, Inc. (ESI) and Aethlon, as the
majority stockholder of ESI, approved the dissolution of ESI. As a
result of this dissolution, we recorded a non-cash charge of
$142,121 as other expense in the
three months ended September 30,
2022.
Aethlon did not record any revenue related to our government
contract with the NIH in the three months ended September 30, 2022, compared to approximately
$132,000 in the three months ended
September 30, 2021. As of
September 30, 2022, the Company had
approximately $574,000 of deferred
revenue related to those contracts as a result of not achieving
certain milestones in those contracts. The NIH award contract ended
on September 15, 2022 and we
presented the required final report to the NCI. Once the NCI
completes the close out review of the contract, we expect to
recognize as revenue the $574,000
currently recorded as deferred revenue on our September 30, 2022 balance sheet.
As a result of the changes in revenues and expenses noted above,
our net loss increased to approximately $3.8
million in the three months ended September 30, 2022, from approximately
$2.0 million in the three months
ended September 30, 2021.
During the six months ended September 30,
2022, the Company raised approximately $8.9 million in net proceeds under our ATM
agreement with H.C. Wainwright & Co., pursuant to sales of our
common stock.
The unaudited condensed consolidated balance sheet for
September 30, 2022, and the unaudited
condensed consolidated statements of operations for the three and
six months ended September 30, 2022
and 2021 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Monday, Nov.14,
2022, at 4:30 p.m. EST 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/10172901/f4fe08e0d7
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
14, 2022. 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
2753791.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company developing the
Hemopurifier, a therapeutic blood filtration system indicated for
cancer and infectious diseases. 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 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. 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.
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
launch its clinical trials in Australia and expand its trials in
India, the Company's ability to
obtain FDA approval of its new GNA supplier in a timely manner,
the Company's ability to submit to the FDA and have the FDA
approve an EUA for the MPXV, 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, the Company's
ability to obtain Emergency Use authorization from the FDA for use
of the Hemopurifier to treat patients with the MPXV; the Company's
ability expand its clinical trials into other areas of cancer, 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, 2022,
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
|
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
September 30,
2022
|
|
March 31,
2022
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$19,604,025
|
|
$17,072,419
|
|
|
Accounts
receivable
|
|
114,849
|
|
127,965
|
|
|
Prepaid
expenses
|
|
784,638
|
|
956,623
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS
|
|
20,503,512
|
|
18,157,007
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
1,138,623
|
|
441,238
|
|
|
Right-of-use lease
asset
|
|
1,282,328
|
|
696,698
|
|
|
Patents, net
|
|
1,925
|
|
2,200
|
|
|
Restricted
cash
|
|
87,506
|
|
87,506
|
|
|
Deposits
|
|
33,305
|
|
33,305
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$23,047,199
|
|
$19,417,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts
payable
|
|
361,001
|
|
499,962
|
|
|
Due to related
parties
|
|
177,527
|
|
155,742
|
|
|
Deferred
revenue
|
|
574,245
|
|
344,547
|
|
|
Lease liability,
current portion
|
|
247,144
|
|
126,905
|
|
|
Other current
liabilities
|
|
741,529
|
|
696,893
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES
|
|
2,101,446
|
|
1,824,049
|
|
|
|
|
|
|
|
|
|
Lease liability, less
current portion
|
|
1,077,529
|
|
602,505
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
3,178,975
|
|
2,426,554
|
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value
of $0.001, 60,000,000 shares
|
|
|
|
|
|
|
authorized;
22,946,232 and 15,419,163 issued and outstanding
|
|
22,948
|
|
15,421
|
|
|
Additional-paid in
capital
|
|
156,887,555
|
|
147,446,868
|
|
|
Accumulated
deficit
|
|
(137,042,279)
|
|
(130,329,181)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY BEFORE NONCONTROLLING INTERESTS
|
19,868,224
|
|
17,133,108
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
-
|
|
(141,708)
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS'
EQUITY
|
|
19,868,224
|
|
16,991,400
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
$23,047,199
|
|
$19,417,954
|
|
|
AETHLON MEDICAL,
INC. AND SUBSIDIARY
|
Consolidated
Statements of Operations
|
For the three and
six month periods ended September 30, 2022 and 2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months
|
|
Three
Months
|
|
Six
Months
|
|
Six
Months
|
|
|
Ended
9/30/22
|
|
Ended
9/30/21
|
|
Ended
9/30/22
|
|
Ended
9/30/21
|
|
|
|
|
|
|
|
|
|
Government contract
revenue
|
|
$-
|
|
$131,966
|
|
$-
|
|
$263,932
|
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND
EXPENSES
|
|
|
|
|
|
|
|
|
Professional
fees
|
|
1,003,870
|
|
649,460
|
|
1,847,899
|
|
1,232,929
|
Payroll and
related
|
|
1,112,955
|
|
805,608
|
|
2,142,641
|
|
1,822,350
|
General and
administrative
|
|
1,548,484
|
|
685,702
|
|
2,582,505
|
|
1,315,895
|
Total operating expenses
|
|
3,665,309
|
|
2,140,770
|
|
6,573,045
|
|
4,371,174
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
(3,665,309)
|
|
(2,008,804)
|
|
(6,573,045)
|
|
(4,107,242)
|
|
|
|
|
|
|
|
|
|
OTHER
EXPENSE
|
|
|
|
|
|
|
|
|
Loss on
dissolution of subsidiary
|
|
142,121
|
|
-
|
|
142,121
|
|
-
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$(3,807,430)
|
|
$(2,008,804)
|
|
$(6,715,166)
|
|
$(4,107,242)
|
|
|
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
|
-
|
|
(825)
|
|
-
|
|
(1,960)
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE
TO AETHLON MEDICAL, INC.
|
|
$(3,807,430)
|
|
$(2,007,979)
|
|
$(6,715,166)
|
|
$(4,105,282)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss available to
|
|
|
|
|
|
|
|
|
common
stockholders per share
|
|
$
(0.18)
|
|
$
(0.13)
|
|
$
(0.37)
|
|
$
(0.29)
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common
|
|
|
|
|
|
|
|
|
shares
outstanding
|
|
20,744,999
|
|
15,386,486
|
|
18,130,177
|
|
14,114,639
|
View original
content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-second-quarter-financial-results-and-provides-corporate-update-301677433.html
SOURCE Aethlon Medical, Inc.