Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Announces
Financial Results for the Fiscal First Quarter Ended June 30, 2024 and Provides
Corporate Update
Received
Two Australian Ethics Committee Approvals for a Safety, Feasibility, and Dose
Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not
Responding to Anti-PD-1 Antibodies; Expects to Open Patient Enrollment in
October of 2024
Achieved
Significant 24% Reduction in Fiscal First Quarter Operating Expenses Compared
to the Same Period in 2023
Conference
Call to be Held Today at 4:30 p.m. ET
SAN
DIEGO, CA - August 14, 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 first
quarter ended June 30, 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, in life-threatening infectious diseases, and in
organ transplantation.
As
announced on August 12, 2024, the Bellberry Human Research Ethics Committee
(BHREC) granted full ethics approval to the Pindara Private Hospital for a
safety, feasibility and dose-finding clinical trial of the Hemopurifier® in
patients with solid tumors who have stable or progressive disease during
anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or
Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).
The approval is valid for one year, until August 6, 2025. The trial will be
conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital,
located in Queensland, Australia.
Earlier,
on June 18, 2024, the Human Research Ethics Committee (HREC) of the Central
Adelaide Local Health Network (CALHN) granted full ethics approval for the same
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 EVs in cancer patient
plasma samples.
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"During
the fiscal first quarter and subsequent period, we have continued to make
significant progress advancing towards our planned oncology trials in Australia
and India, punctuated by the recent approval from the Bellberry Human Research
Ethics Committee (BHREC), which granted full ethics approval to the Pindara
Private Hospital and earlier from the Human Research Ethics Committee at
Central Adelaide Local Health Network, in June, for a safety, feasibility and
dose-finding clinical trial of the Hemopurifier in patients with solid tumors
who have stable or progressive disease during anti-PD-1 monotherapy
treatment," stated James Frakes, Interim Chief Executive Officer and Chief
Financial Officer of Aethlon Medical."
"Going
forward, the next steps are to receive approval from the Research Governance
Office at each hospital, which reviews indemnities and insurance. Once these
approvals are obtained, Aethlon, in concert with our Australian Contract
Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after
which patient enrollment in the trials may proceed. We expect that we will be
open for enrollment in October 2024."
Mr.
Frakes continued, "We anticipate several upcoming, potential value-creating
milestones, including submission to the Ethics Committees at a third site in
Australia and one in site in India, with the expectation of possibly receiving
approval from one or both of those hospitals in the September or December
quarter of 2024. After approval is
granted, 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 9 to 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 continues to explore opportunities to expand the use of the
Hemopurifier as a treatment for life-threatening viral infections. In vitro, it
has shown effectiveness in capturing viruses such as Zika, Lassa, MERS-CoV,
cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile,
smallpox-related viruses, H1N1 swine flu, H5N1 bird flu, Monkeypox, and the
reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in India
remains open to accommodate any potential COVID-19 admissions to the intensive
care units at the two participating sites, Medanta Medicity Hospital and
Maulana Azad Medical College. So far, one patient has been treated. The company
is actively evaluating COVID-19 admissions and potential enrollment against the
ongoing costs of maintaining the trial.
Financial Results for the Fiscal First
Quarter Ended June 30, 2024
As
of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1
million.
Consolidated
operating expenses for the fiscal quarter ended June 30, 2024 were
approximately $2.6 million compared to $3.4 million for the fiscal quarter
ended June 30, 2023. This decrease of approximately $800,000, or approximately
24%, in the 2024 period was due to a decrease of approximately $600,000 in general
and administrative expenses and a decrease of approximately $300,000 in
professional fees partially offset by an increase in payroll and related
expenses of approximately $100,000.
The
$600,000 decrease in general and administrative expenses in the fiscal quarter
ended June 30, 2024 was primarily due to a $447,000 decrease in supplies
related to the purchase of raw materials for manufacturing of the Hemopurifier
and for lab supplies.
The
approximate $300,000 decrease in professional fees was primarily due to a
$136,000 decrease in consulting expenses primarily related to termination of
services with a contract manufacturing organization, a $110,000 decrease in
scientific consulting, and a $78,000 decrease in legal fees relating to general
corporate matters.
The
approximate $100,000 increase in payroll and related was primarily due to an
increase in separation expenses of approximately $300,000 related to the
termination of an employee. That increase was offset by a decrease of $111,000
in stock-based compensation and an $89,000 decrease in general and
administration personnel expense.
As
a result of the factors noted above, the company's net loss decreased to
approximately $2.6 million in the fiscal quarter ended June 30, 2024 from
approximately $3.3 million in the fiscal quarter ended June 30, 2023.
The
consolidated balance sheet for June 30, 2024, and the consolidated statements
of operations for the fiscal quarters ended June 30, 2024 and 2023 follow at
the end of this release.
Conference Call
Management
will host a conference call today, Wednesday, August 14, 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/10191735/fd44630e3d . 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 September 14, 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 3788019.
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 on terms favorable to the Company, or at all; the Company's
ability to successfully complete development of the Hemopurifier; the Company's
ability to successfully demonstrate the utility and safety 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 timeline expected by the Company; the Company's ability to
initiate its planned oncology clinical trials in Australia and India, including
on the timeline expected by the Company; the Company's ability to obtain
approvals from Research Governance Offices at relevant hospitals and complete
site initiation visits in a timely manner; the Company's ability to manage and
successfully complete its clinical trials, if initiated; the Company's ability
to successfully manufacture the Hemopurifier in sufficient quantities for its
clinical trials; unforeseen changes in regulatory requirements; the Company's
ability to maintain its Nasdaq listing; 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
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
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