Breaking Medical Technology News: Aethlon Medical (Nasdaq: $AEMD) Announces
Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and
Provides Corporate Update
Achieves
Key Milestone with Enrollment of First Two Patients in the Safety, Feasibility,
and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors
Not Responding to Anti-PD-1 Antibodies
Two
Australian Sites Open For Patient Enrollment in Hemopurifier® Cancer Trial
Conference
Call to be Held Today at 4:30 p.m. ET
SAN DIEGO, CA - November 13, 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 second quarter ended September 30, 2024 and provided an update on recent
developments.
Company Updates
During
the second quarter, and subsequently, the company advanced its oncology trial
efforts in Australia, while implementing cost-cutting measures to streamline
operations. Management is pleased to report positive progress on these
initiatives, specifically:
Clinical Trials:
The first two patients have now been enrolled at the Royal Adelaide Hospital in
Adelaide, Australia. Additionally, Pindara Private Hospital, in the Gold Coast
section of Australia, received ethics committee approval, was trained on
Aethlon's Hemopurifier®, and is now open for patient enrollment. The company
has also trained a third hospital in Australia, but has not yet received ethics
committee approval for that institution and it has not yet begun patient
enrollment.
In
September, Aethlon received ethics committee approval from Medanta Medicity
Hospital in Gurugram, India, for a similar nine to 18-patient, safety,
feasibility and dose-finding trial of the Hemopurifier. The company is
completing the necessary logistical steps before the site can open for patient
enrollment.
Management Change:
In October, Aethlon's board of directors appointed James Frakes to serve as the
company's permanent Chief Executive Officer, after having served as Interim
Chief Executive Officer since November 2023.
Operational Efficiency:
Strategic cost-cutting initiatives have allowed for optimized resource
allocation, enabling continued focus on high-impact areas of the oncology
trial.
Paid
News Dissemination of behalf of AEMD
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"During
the second fiscal quarter and subsequent period, we continued advancing our
oncology trials, earlier this week announcing enrollment of the first patient
at Royal Adelaide Hospital, and now updating this news to report enrollment of
a second patient. This represents a critical milestone for the safety,
feasibility and dose-finding trials of the Hemopurifier in patients with solid
tumors who have failed treatment with anti-PD-1 antibodies," stated James
Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical.
"We now have two sites open for patient enrollment in Australia, have received
ethics committee approval from a site in India, and we expect to continue to
enroll subjects in our Hemopurifier cancer trial. As previously announced, we
believe these studies will help inform future oncology efficacy trials.
Additionally, we have made strategic cost-cutting measures to optimize company
resources, in order to focus on the high-impact oncology trials in both
Australia and India."
As
a reminder, the primary endpoint of the approximate nine to 18-patient, safety,
feasibility and dose-finding trials, is safety. The trials 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.
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.
The
company also 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 Ebola, Marburg virus,
Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex,
Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, 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
Second Quarter Ended September 30, 2024
As
of September 30, 2024, Aethlon Medical had a cash balance of approximately $6.9
million.
Consolidated
operating expenses for the fiscal quarter ended September 30, 2024 were
approximately $2.9 million, compared to $3.2 million for the fiscal quarter
ended September 30, 2023. This decrease of approximately $300,000, or 9%, in
the 2024 period was due to a decrease of approximately $600,000 in professional
fees, partially offset by an increase of approximately $200,000 in payroll and
related expenses and an approximately $100,000 increase in general and
administrative expenses.
The
approximate $600,000 decrease in professional fees was primarily due to a
$300,000 reduction in legal fees following a transition to a new legal firm, a
$200,000 decrease in contract labor expenses due to project completions with
contract manufacturing organizations and research and development consultants,
and an $81,000 decrease in accounting fees.
The
approximate $200,000 increase in payroll and related expenses was primarily due
to an increase of $500,000 in separation expenses related to severance
agreements following the termination of an executive and a reduction in
workforce. This increase was partially offset by a $200,000 reduction in
ongoing payroll expenses and a $100,000 decrease in stock-based compensation as
a result of the completion of vesting of existing stock options and reduced
headcount.
The
$100,000 increase in general and administrative expenses in the fiscal quarter
ended September 30, 2024 was primarily due a $200,000 increase in costs
associated with the company's ongoing oncology clinical trial. This increase
was partially offset by reductions in a number of general and administrative
expense items, including decreases in U.S. clinical trial expenses.
As
a result of the factors noted above, the company's net loss decreased to
approximately $2.8 million in the fiscal quarter ended September 30, 2024, from
approximately $3.0 million in the fiscal quarter ended September 30, 2023.
The
consolidated balance sheet for September 30, 2024, and the consolidated
statements of operations for the three- and six-month periods ended September
30, 2024 and 2023 follow at the end of this release.
Conference Call
Management
will host a conference call today, Wednesday, November 13, 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 call by navigating to
https://dpregister.com/sreg/10194285/fdebe88214. 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 13, 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 10194285.
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 obtain approval from the Ethics Committee of its third
location in Australia, including on the timeline expected by the Company; the
Company's ability to enroll additional patients in its oncology clinical trials
in Australia and India, including on the timeline expected by the Company; the
Company's ability to manage and successfully complete its clinical trials; 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
Chief
Executive Officer and Chief Financial Officer
Aethlon
Medical, Inc.
Investor Contact:
Susan
Noonan
S.A.
Noonan Communications, LLC
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
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