Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Announces
Financial Results for the Fiscal Third Quarter Ended December 31, 2024 and
Provides Corporate Update
Key
Milestone Achieved: First Patient treated in Hemopurifier® Safety, Feasibility,
and Dose Finding Study for Solid Tumors Not Responding to Anti-PD-1 Antibodies
Patient
Enrollment Open at Two Australian for Hemopurifier® Cancer Trial
Operating
Expenses Significantly Reduced
Conference
Call to be Held Today at 4:30 p.m. ET
SAN DIEGO, CA, February 12, 2025--
(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 third quarter ended December 31, 2024 and provided an update on
recent developments.
Company Updates
During
the third quarter, and subsequently, the company made significant progress in
its oncology trial efforts in Australia while executing cost-cutting measures
to enhance operational efficiency. Management is pleased to highlight the
following key developments:
Paid News Dissemination of behalf of AEMD.
Read this news featuring AEMD in full
at https://www.investorideas.com/news/2025/02121AEMD-Financial-Results-for-Q3-and-Corporate-Update.asp
Clinical Trials:
Steady
progress in our Australian Oncology trial of the Hemopurifier in patients with
solid tumors was made. To date, three patients have been enrolled. Two patients
did not advance to the treatment phase due to pre-specified stopping criteria
during the run-in period - one showed a clinical response to anti PD-1 therapy,
while the other experienced toxicity related to anti-PD-1 therapy. The third
patient, who did not respond to anti-PD-1 therapy, successfully underwent a
single 4-hour Hemopurifier treatment at Royal Adelaide Hospital on January 29,
2025. The treatment was completed with no device-related issues or
complications. Samples collected before and after treatment will be analyzed to
assess extracellular vesicle removal and changes in anti-tumor T cell activity.
This data will be available once all 3 patients in this patient cohort are
treated.
Following
the investigator meeting with the three clinical sites, Aethlon received
valuable feedback suggesting protocol modifications that could possibly improve
enrollment speed, reduce screen failures, and shorten the time to Hemopurifier
treatment and time to data. In response, the Aethlon team swiftly developed a
protocol amendment incorporating these recommendations.
Key
changes include enrolling patients only after they have been confirmed not to
be responding to anti-PD-1 therapy. This adjustment eliminates the need to
identify patients within the first 2 weeks of starting anti-PD-1 therapy and
removes the two-month run-in period previously required to assess response to
therapy. Additionally, restrictions on commonly prescribed concomitant
medications that do not impact patient safety have been lifted. The amended
protocol also broadens eligibility to include patients receiving all approved
dosing regimens of Pembrolizumab and Nivolumab, rather than limiting enrollment
to specific schedules.
The
company is pleased to announce that the Human Research Ethics Committees (HREC)
and Research Governance Offices (RGO) have approved this amendment at all three
clinical sites. The two currently active clinical sites, Royal Adelaide
Hospital and Pindara Private Hospital, can enroll under the amended protocol.
The third site, Genesis Care/ Royal North Shore Hospital, can begin enrollment
under this amendment following a Site Initiation Visit (SIV) on February 14,
2025.
The
company continues to pursue approval of a similar clinical trial in India. HREC
approval has been obtained at Medanta Medicity Hospital, and we are currently
awaiting approval from the regulatory agency CDSCO in India. Recent regulatory
changes in India have introduced additional documentation requirements that
were previously not necessary. Aethlon is actively responding to CDSCO's
queries through the company's India CRO, Qualtran.
Operational Efficiency:
Aethlon
has implemented strategic cost-cutting measures to optimize company resources,
enabling it to maintain a strong focus on the high-impact oncology trials in
both Australia and India. These initiatives are designed to improve resource
allocation, reduce operational expenses, and support the continued advancement
of our clinical programs.
"During
the third fiscal quarter and subsequent period, we continued to advance our
oncology trials, including treatment of the first patient at Royal Adelaide
Hospital in late January. We are pleased to report that the patient tolerated
the procedure without complications, making a critical milestone for the
safety, feasibility and dose-finding trials of the Hemopurifier in patients
with solid tumors who have not responded to anti-PD-1 antibodies," stated
James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon
Medical. "We currently have two clinical sites activated and open for
enrollment in Australia, with a third site expected to be activated in February
2025. In addition, we have received ethics committee approval from a site in
India. We also anticipate continued enrollments in our Hemopurifier cancer
trial as these sites progress.
"While
two previously recruited patients were withdrawn from the study due to outcomes
related to their anti-PD-1 therapies, we believe that the recent protocol
amendment will shorten trial timelines and support improved patient enrollment.
As previously announced, we believe these studies will help inform future
oncology efficacy trials. Furthermore, we have implemented strategic
cost-cutting measures to optimize company resources, enabling us to maintain a
strong 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 is closely monitoring developments related to Bird Flu in the United
States, Marburg virus in Rwanda and Ebola virus in Uganda. Aethlon has direct
experience with these viruses, having previously generated in vitro viral
binding data for all three viruses and treated an Ebola patient in Germany
under Emergency Use conditions. Aethlon will continue to monitor these
situations carefully and be poised to respond if currently available treatment
strategies are deemed ineffective.
Financial Results for the Fiscal Third
Quarter Ended December 31, 2024
As
of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million.
Consolidated
operating expenses for the fiscal quarter ended December 31, 2024, decreased by
approximately $1.8 million, or approximately 50%, to $1.8 million compared to
$3.6 million for the fiscal quarter ended December 31, 2023. This reduction was
driven by a $1.3 million decrease in payroll and related expenses, a $300,000
decrease in professional fees, and a $200,000 decrease in general and
administrative expenses.
The
approximate $1.3 million decrease in payroll and related expenses was primarily
attributable to a reduction of $900,000 in separation expenses related to the
Separation Agreement with the former Chief Executive Officer that had been
recorded in the December 2023 period, as well as a decrease of approximately
$400,000 due to a reduction in headcount. Of the approximate $900,000 of
separation expenses related to the departure of the former CEO, approximately
$400,000 related to the acceleration of vesting of stock options.
The
approximate $300,000 decrease in professional fees was primarily due to an
approximate reduction of $200,000 in legal fees resulting from the transition
to a new legal firm, and a decrease of $200,000 in scientific and operational
consulting fees largely attributable to completed projects. These decreases
were partially offset by an approximate $100,000 increase in investor relations
and accounting fees.
The
approximate $200,000 decrease in general and administrative expenses was
primarily driven by a $300,000 reduction in supplies, largely related to the
raw materials and components used in the manufacturing of the Hemopurifier,
with no comparable purchases during the current period. Additionally, there was
an approximate $100,000 decrease in insurance expenses associated with a
reduced headcount and various other operating expenses. These reductions were
partially offset by a $200,000 increase in expenses related clinical trial
expenses related to our ongoing oncology clinical trials in Australia and
India.
As
a result of the factors noted above, the company's net loss decreased to
approximately $1.8 million in the fiscal quarter ended December 31, 2024, from
approximately $3.5 million in the fiscal quarter ended December 31, 2023.
The
consolidated balance sheet for December 31, 2024, and the consolidated
statements of operations for the three- and nine-month periods ended December
31, 2024 and 2023 follow at the end of this release.
Conference Call
Management
will host a conference call today, Wednesday, February 12, 2025, 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/10196811/fe7c419c9d. 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 March 12, 2025. 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 7828175.
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 cure deficiencies
and continue 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
SOURCE Aethlon Medical, Inc.
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
More info on AEMD at Investorideas.com Visit:
https://www.investorideas.com/CO/AEMD/
Get News Alerts on Aethlon Medical
Disclaimer/Disclosure: Athelon
Medical, Inc. (AEMD) is a paid featured medical tech stock on
Investor ideas More disclosure:Investorideas.com is a digital publisher of third party sourced news,
articles and equity research as well as creates original content, including
video, interviews and articles. Original content created by investorideas is
protected by copyright laws other than syndication rights. Our site does not
make recommendations for purchases or sale of stocks, services or products.
Nothing on our sites should be construed as an offer or solicitation to buy or
sell products or securities. All investing involves risk and possible losses.
This site is currently compensated for news publication and distribution,
social media and marketing, content creation and more. More disclosure: Contact management and IR of each company directly regarding
specific questions.
Biotech Industry Stocks- investing ideas
in biotechnology stocks, medical technology and life sciences
Get more biotech and medical tech news,
articles, podcasts and stock directories
No comments:
Post a Comment