Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Announces
Financial Results for the Fiscal Year Ended March 31, 2024 and Provides
Corporate Update; Conference Call to be Held Today at 4:30 p.m. ET
SAN DIEGO, CA, June 27, 2024 (Investorideas.com
Newswire) 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, 2024 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 designed to bind and remove harmful
exosomes and life-threatening viruses from blood and other biological fluids.
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 is also investigating the
use of the Hemopurifier in the organ transplant setting, initially focusing on
the potential removal of viruses and exosomes with harmful cargo from recovered
kidneys.
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on behalf of/issued on behalf of Aethlon Medical Inc.
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As
announced on June 18, 2024, the Human Research Ethics Committee (HREC) of the
Central Adelaide Local Health Network (CALHN) granted full ethics approval for
Aethlon's safety, feasibility and dose-finding clinical trial of the
Hemopurifier in cancer patients with solid tumors who have stable or
progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda®
(pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The
approval is valid for three years, until June 13, 2027. The trial will be
conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials
Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.
Currently,
only approximately 30% of patients who receive pembrolizumab or nivolumab will
have lasting clinical responses to these agents. Extracellular vesicles (EVs)
produced by tumors have been implicated in the spread of cancers as well as the
resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed
to bind and remove these EVs from the bloodstream, which may improve
therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the
Hemopurifier has been shown to reduce the number of exosomes from the plasma of
cancer patient samples.
"During
the fourth quarter and subsequent period, we have continued to make significant
progress advancing towards our planned, safety, feasibility and dose finding
oncology trials in Australia and India, punctuated by the recent approval from
the Human Research Ethics Committee at Central Adelaide Local Health
Network," stated James Frakes, Interim Chief Executive Officer and Chief
Financial Officer of Aethlon Medical. "Upon submission to the Therapeutic
Goods Administration, the national health regulatory agency of Australia,
obtaining approval from the CALHN Research Governance Committee, and conducting
a site initiation visit, we expect that we will be able to enroll and treat the
first patient either in the September quarter or in the December quarter.
"It
is also worth noting that in April 2024, the U.S. Food and Drug Administration
(FDA) approved our internal manufacturing facility."
Mr.
Frakes continued, "We anticipate several upcoming, potential
value-creating milestones, including submission to the Ethics Committees at two
additional sites in Australia and one in India, with the expectation of
possibly receiving approval from one or more of those three hospitals in the
September quarter of 2024, after which, we expect to be able to enroll patients
at those additional sites by the end of 2024."
As
a reminder, the primary endpoint of the approximate 18-patient, safety,
feasibility and dose-finding trial, is safety. The trial will monitor any
adverse events and clinically significant changes in lab tests of Hemopurifier
treated patients with solid tumors with stable or progressive disease at
different treatment intervals, after a two-month run in period of PD-1
antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the
PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the
study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments
during a one-week period. In addition to monitoring safety, the study is
designed to examine the number of Hemopurifier treatments needed to decrease
the concentration of EVs and if these changes in EV concentrations improve the
body's own natural ability to attack tumor cells. These exploratory central
laboratory analyses are expected to inform the design of subsequent efficacy
and safety trials, including a Premarket Approval (PMA) study required by the
FDA and other regulatory agencies.
The
company is also maintaining a position in the use of its Hemopurifier as a
treatment against life-threatening viral infections through its COVID-19 trial
in India. There are two participating sites for this trial -- the Medanta
Medicity Hospital and Maulana Azad Medical College (MAMC). One patient has been
treated thus far. However, the company has been informed by its contract
research organization that a new COVID-19 subvariant was recently detected in
India. The COVID-19 trial in India remains open in the event that there are
COVID-19 admissions to the intensive care units at the two participating sites.
The
company has also received multiple inquiries regarding the current, multi-state
outbreak of H5N1 Avian Influenza (H5N1 HPAI) virus in dairy cattle. While the
Hemopurifier has demonstrated the ability to capture prior iterations of the
H5N1 bird flu virus in invitro experiments, the company has not tested the
Hemopurifier against the current strain nor have there been many cases of the
current strain infecting humans. The company will continue to monitor the
situation and provide any potential updates, as needed.
Financial Results for the Fiscal Year
Ended March 31, 2024
As
of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4
million and as of June 25, 2024, had a cash balance of approximately $9.1
million.
Consolidated
operating expenses for the fiscal year ended March 31, 2024 were approximately
$12.6 million, compared to approximately $12.5 million for the fiscal year
ended March 31, 2023, an increase of approximately $164,000. This increase in
the fiscal year ended March 31, 2024 was due to an increase in payroll and
related expenses of approximately $763,000, partially offset by decreases in
general and administrative expenses of approximately $578,000 and in
professional fees of approximately $21,000.
The
approximate $763,000 increase in payroll and related expenses was primarily due
to separation expenses for the company's former chief executive officer of
$862,000 and an increase of $127,000 associated with an increase in average
headcount, partially offset by a decrease in stock-based compensation of
$226,000.
The
approximate $578,000 decrease in general and administrative expenses was
primarily driven by the following: a decrease of $819,000 in clinical trial
expenses related to the closed U.S. COVID-19 clinical trial, a decrease of
$280,000 in subcontract expense related to contracts and grants with the
National Institutes of Health, a $99,000 decrease in rent expense associated
with a mobile clean room leased in the prior year, a decrease of $30,000 in
travel related expenses associated with a former remote employee and a decrease
of $22,000 in expenses related to various other general office operating
expenses. These decreases were partially offset by an increase of $405,000 in
manufacturing and research and development supplies related to the
manufacturing of the company's Hemopurifier device and various research and
development activities. Other increases included $118,000 in depreciation
expense and amortization expense related to leasehold improvements to
manufacturing space, a $70,000 increase in insurance expenses to include
medical, D&O and liability, and an increase of $82,000 primarily related to
the company's manufacturing facility, encompassing equipment maintenance,
utilities, and outside services.
The
approximate $21,000 decrease in professional fees was primarily due to a
decrease in outside scientific, product research and regulatory services of
$303,000, a decrease of $60,000 in recruiting fees and a $33,000 decrease in
legal fees. These decreases were partially offset by increases in investor
relations of $151,000, accounting fees of $137,000, board of director fees of
$34,000 and outside operational and administration expenses of $53,000.
As
a result of the factors noted above, the company's net loss increased to $12.2
million for the fiscal year ended March 31, 2024, from $12.0 million for the
fiscal year ended March 31, 2023.
The
consolidated balance sheet for March 31, 2024, and the consolidated statements
of operations for the fiscal years ended March 31, 2024 and 2023 follow at the
end of this release.
Conference Call
Management
will host a conference call today, Thursday, June 27, 2024, at 4:30 p.m. ET to
review the company's 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/10190237/fce977aef1. 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 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 July 27, 2024. 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 6876352.
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 in pre-clinical studies, the
Hemopurifier has demonstrated the removal of harmful exosomes from biological
fluids, 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 raise
additional capital and to successfully complete development of the Hemopurifier;
the Company's ability to successfully demonstrate the utility of the
Hemopurifier in cancer and infectious diseases and in the transplant setting;
the Company's ability to achieve and realize the anticipated benefits from
potential milestones; the Company's ability to submit applications to and
obtain approval from the additional Ethics Committees in Australia and India,
including on the timing expected by the Company; the Company's ability to
initiate its planned oncology clinical trials in Australia and India, including
on the timing expected by the Company; the Company's ability to manage and
successfully complete its clinical trials, if initiated; the potential impact
of Hemopurifier on the H5N1 Avian Influenza (H5N1 HPAI) virus in dairy cattle;
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, 2024, 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.
Investor Contact:
Susan
Noonan
S.A.
Noonan Communications, LLC
917-513-5303
SOURCE
Aethlon Medical, Inc.
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
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