Medical Tech Stock Aethlon Medical (Nasdaq:
$AEMD) Fiscal First Quarter Results Ending June 30, 2025, and Corporate Update
Australian Cancer Trial Advances with First Cohort Complete,
Amended Protocol, and Promising Preclinical Data Published; Operating Expenses
Cut by 32%
Conference Call to be Held Today at
4:30 p.m. ET
SAN DIEGO, Aug. 13, 2025 /( Investorideas.com Newswire) (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, 2025, and provided an
update on recent developments.
Key First Quarter Highlights
· First Cohort Complete in Australian Hemopurifier®
cancer trial — all patients treated without device-related serious adverse
events and no dose-limiting toxicities observed
· Amended Protocol broadens patient eligibility to
allow all treatment regimens that include an anti-PD-1 agent
· Preclinical Data: 98.5% removal of platelet-derived
extracellular vesicles (EVs) in simulated 4-hour treatment
· Long COVID Pre-Clinical Research collaboration
with UCSF advances, with findings presented at the prestigious Keystone
Symposium
· Operating Expenses Reduced by 31.6%, enhancing
operational efficiency
Paid News Dissemination of behalf of AEMD.
Read this news, featuring AEMD in full
at https://www.investorideas.com/CO/AEMD/news/2025/08131aethlon-medical-aemd-q1-2025-financial-results-conference-call.asp
Clinical Progress in Cancer Trial
Ongoing progress continues in the Australian Oncology trial
evaluating the Hemopurifier in participants with solid tumors that have not
responded to anti-PD-1 immunotherapy.
Aethlon successfully completed the first treatment cohort in its
safety, feasibility, and dose-finding study. This initial cohort involved
single Hemopurifier treatments for participants with tumors unresponsive
to PD-1 inhibitors such as pembrolizumab (Keytruda®) or nivolumab (Opdivo®).
Treatments were completed at Royal Adelaide Hospital and Royal North Shore
Hospital between late January and June 2025. All participants tolerated the
4-hour Hemopurifier treatment without device-related deficiencies or
immediate complications, and no dose-limiting toxicities or device-related
serious adverse events were observed at the pre-specified 7-day safety
follow-up. One participant subsequently died from disease progression,
unrelated to the Hemopurifier treatment, and was only able to complete one
week of follow-up.
On July 11, 2025, the independent Data Safety Monitoring Board
(DSMB) convened to review the safety data from the three participants in this
first cohort. Following closed-session deliberations, the DSMB recommended
advancing to the second treatment cohort, in which participants will receive
two Hemopurifier treatments within a one-week period.
All three clinical sites in Australia are actively screening
patients for the cohort two under an amended protocol. The amendment expands
eligibility to patients receiving either monotherapy or combination therapy
that includes Pembrolizumab or Nivolumab, better reflecting current standards
of care and broadening the potential patient pool.
Meanwhile, Professor Georges Grau's laboratory at the University
of Sydney continues to analyze central lab samples from the first patient
cohort to assess the effects of the Hemopurifier on extracellular vesicle
counts and anti-tumor T cell activity. Initial observations from this analysis
are expected in September 2025.
As a reminder, the primary endpoint of the approximate 9 to
18-participant trial is safety. Eligible patients with solid tumors with stable
or progressive disease receive escalating doses of Hemopurifier treatment
across sequential cohorts - one, two, and three Hemopurifier treatments
administered over the course of a single week. In addition to evaluating
safety, the study is designed to assess whether reducing the concentration of
extracellular vesicles (EVs) may improve the body's own natural ability to
attack tumor cells. These exploratory findings are expected to inform the
design of future efficacy and safety trials, including a Premarket Approval
(PMA) study.
We believe the unmet need remains significant: currently, only
approximately 30-40% of patients who receive pembrolizumab or nivolumab will
have lasting clinical responses to these agents. EVs produced by tumors are
believed to contribute to both cancer progression and resistance to anti-PD-1
therapies. The Hemopurifier, designed to selectively bind and remove EVs from
the bloodstream, has demonstrated EV reduction in preclinical studies using
plasma from cancer patients, and may improve therapeutic response rates to
anti-PD-1 antibodies.
India Update
While the Company received formal approval from India's Central
Drugs Standard Control Organization (CDSCO) to initiate a similar oncology
trial at Medanta Medicity Hospital, subsequent timeline discussions with our
India-based CRO indicated the first patient treatment would likely not occur
until the beginning of 2026. Given this extended timeline and with careful
consideration of both projected costs and our broader strategic priorities, we
made the decision not to proceed with the India study. We believe this allows
us to focus our resources on advancing our ongoing trial in Australia, which
remains better aligned with our goal of generating timely clinical data to
support a potential PMA trial.
Preclinical Study Supports Broader Applications
On May 12, 2025, results from Aethlon's preclinical ex vivo study
were published in bioRxiv, with a manuscript now under review at a
peer-reviewed journal. The study showed that the Hemopurifier, utilizing
Aethlon's proprietary Galanthus nivalis agglutin (GNA) affinity
resin, removed 98.5% of platelet -derived extracellular vesicles (PD-EVs) from
healthy human plasma during a timepoint equivalent to a 4-hour HP treatment.
Excessive levels of PD-EVs have been associated with a wide range of
conditions, including cancer, lupus, systemic sclerosis, multiple sclerosis,
Alzheimer's disease, sepsis, and acute and Long COVID. We believe these
findings support the scientific rationale behind Aethlon's ongoing oncology
trial in Australia and suggest broader potential applications of the
Hemopurifier in other EV-associated diseases.
Scientific Collaboration in Long COVID Research
On August 12th, 2025, Aethlon presented a poster at the Keystone
Symposium on Long COVID and Other Post-Acute Infection Syndromes held in Santa
Fe, New Mexico. Long COVID, characterized by persistent symptoms following
acute COVID-19 infection, affect approximately 44 and 48 million people in the
United States alone with an estimated economic burden of 2 billion dollars
among those with symptoms lasting a year. Despite the scope of this public
health challenge, no specific treatments are currently available, highlighting
a significant unmet medical need.
EVs have been implicated in the pathogenesis of Long COVID.
Building on prior evidence that the Aethlon Hemopurifier can remove EVs in a
patient with severe acute COVID-19 infection, the Company hypothesized EVs from
individuals with Long COVID may also express surface mannose sugar that binds
to its proprietary GNA. Aethlon partnered with investigators at the University
of California San Francisco Medical Center Long COVID clinic to obtain samples
from participants with Long COVID as well recovered COVID -19 participants as
controls.
The data presented at the symposium demonstrated that both large
and small EVs from Long COVID patients bound to the GNA lectin and the
Hemopurifier's lectin affinity resin, supporting the potential utility of the
device in affected individuals.
The full poster will soon be available for public viewing on the
Aethlon Medical website.
Operational
Achievements
"In the first quarter, we advanced our lead oncology program,
delivered preclinical results supporting broader applications including Long
COVID — all while significantly reducing operating expenses," said James
Frakes, Chief Executive Officer of Aethlon Medical. "We remain committed
to driving the Hemopurifier toward regulatory approval and unlocking its
potential across multiple disease areas."
Financial Results for
the Fiscal First Quarter Ended June 30, 2025
As of June 30, 2025, Aethlon had a cash balance of approximately
$3.8 million.
For the three months ended June 30, 2025, consolidated operating
expenses were approximately $1.8 million, representing a decrease of
approximately $800,000 or approximately 31.6%, compared to approximately $2.6
million for the same period in 2024. This reduction was primarily driven by
lower payroll and related expenses, professional fees, and general and
administrative costs.
Payroll and related expenses declined by approximately $674,000,
largely due to the absence of a $321,000 in severance expense recorded in the
prior-year quarter related to the separation of an executive. In addition, the
Company realized a $286,000 reduction in compensation costs as a result of
lower headcount, as well as a $67,000 decrease in stock-based compensation tied
to the same reduction in the workforce.
Professional fees decreased by an approximate $138,000, primarily
due to a $104,000 reduction in legal fees following the transition to a new
legal firm, a $34,000 decrease in scientific consulting costs after the
conclusion of a project, a $23,000 reduction in audit-related fees.
Additionally contract labor costs decreased by $18,000 due to the completion of
a regulatory project and shift to lower-cost quality management system
consultants. These reductions were partially offset by a $42,000 increase in
investor relations expenses related to the special meeting of stockholders held
during the quarter.
General and administrative expenses declined by an approximate $17,000,
primarily driven by a $31,000 reduction in insurance costs, partially offset by
a $26,000 increase in clinical trial-related expenses. Other variances included
a mix of increases and decreases across multiple categories, none of which were
individually significant, resulting in an overall decline.
As a result of the above factors, operating loss for the quarter
decreased to $1.8 million compared to $2.6 million for the three months ended
June 30, 2024.
Other Income
Other income totaled $30,532 for the three months ended June 30,
2025, compared to $49,418 in the prior-year period. In both quarters, other
income was primarily interest income earned on cash balances.
The consolidated balance sheets for June 30, 2025 and March 31,
2025, along with the consolidated statements of operations for the three months
ended June 30, 2025 and 2024, are included at the end of this release.
Conference Call
Management will host a conference call today, Wednesday, August
13, 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/10201884/ffac7acee8. 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 13, 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 1454680.
About the
Hemopurifier®
The Aethlon Hemopurifier is an investigational medical device
designed to remove enveloped viruses and tumor-derived extracellular vesicles
(EVs) from circulation. It is used extracorporeally with a blood pump and
combines plasma separation, size exclusion, and affinity binding using a plant
lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs
released by solid tumors are believed to play a role in metastasis and the
resistance to immunotherapies and chemotherapy. Removal of enveloped viruses
and extracellular vesicles has been demonstrated in both vitro studies and
human subjects.
The Hemopurifier holds a U.S. Food and Drug Breakthrough Device
Designation for:
The treatment of individuals with advanced or metastatic cancer
unresponsive to or intolerant of standard-of-care therapy; and the treatment of
life-threatening viruses not addressed with approved therapies.
About Aethlon
Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical-stage medical
device company headquartered in San Diego, California. Aethlon is advancing the
Hemopurifier, to address unmet needs in oncology and infectious disease, using
a novel platform designed to selectively remove circulation pathogenic targets
from biologic fluids.
For more information, visit www.AethlonMedical.com and follow the
Company on LinkedIn.
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 operational and financial 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 trial in
Australia, 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 collaborative research with UCSF Long Covid Clinic; and the Company's
ability to further research potential applications of the Hemopurifier in other
EV-associated diseases 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, 2025, 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.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
|
AETHLON MEDICAL, INC. AND SUBSIDIARY |
||||||
|
Condensed Consolidated Balance Sheets |
||||||
|
Unaudited |
||||||
|
ASSETS |
||||||
|
June 30, 2025 |
March 31, 2025 |
|||||
|
CURRENT ASSETS |
||||||
|
Cash and cash equivalents |
$
3,765,154 |
$
5,501,261 |
||||
|
Deferred offering costs |
9,103 |
- |
||||
|
Prepaid expenses and other current assets |
276,601 |
448,539 |
||||
|
TOTAL CURRENT ASSETS |
4,050,858 |
5,949,800 |
||||
|
Property and equipment, net |
593,720 |
676,220 |
||||
|
Operating lease right-of-use asset |
529,576 |
601,846 |
||||
|
Patents, net |
413 |
550 |
||||
|
Restricted cash |
98,130 |
97,813 |
||||
|
Deposits |
33,305 |
33,305 |
||||
|
TOTAL ASSETS |
$
5,306,002 |
$
7,359,534 |
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||
|
CURRENT LIABILITIES |
||||||
|
Accounts payable |
$
571,495 |
$
534,524 |
||||
|
Due to related parties |
372,598 |
579,565 |
||||
|
Operating lease liability, current portion |
318,800 |
313,033 |
||||
|
Other current liabilities |
364,544 |
472,164 |
||||
|
TOTAL CURRENT LIABILITIES |
1,627,437 |
1,899,286 |
||||
|
Operating lease liability, less current portion |
255,052 |
336,718 |
||||
|
TOTAL LIABILITIES |
1,882,489 |
2,236,004 |
||||
|
STOCKHOLDERS' EQUITY |
||||||
|
Common stock, $0.001 par value; 60,000,000 shares authorized as
of June |
2,599 |
2,586 |
||||
|
Additional paid-in capital |
173,159,966 |
173,092,894 |
||||
|
Accumulated other comprehensive loss |
(22,377) |
(17,133) |
||||
|
Accumulated deficit |
(169,716,675) |
(167,954,817) |
||||
|
TOTAL STOCKHOLDERS' EQUITY |
3,423,513 |
5,123,530 |
||||
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$
5,306,002 |
$
7,359,534 |
||||
|
AETHLON MEDICAL, INC. AND SUBSIDIARY |
||||
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
||||
|
For the three months ended June 30, 2025 and 2024 |
||||
|
Unaudited |
||||
|
Three Months |
Three Months |
|||
|
Ended 6/30/25 |
Ended 6/30/24 |
|||
|
OPERATING EXPENSES |
||||
|
Professional fees |
$ 476,032 |
$ 614,082 |
||
|
Payroll and related expenses |
581,000 |
1,254,802 |
||
|
General and administrative |
735,358 |
751,974 |
||
|
Total operating expenses |
1,792,390 |
2,620,858 |
||
|
OPERATING LOSS |
(1,792,390) |
(2,620,858) |
||
|
OTHER (EXPENSE) INCOME, NET |
||||
|
Interest income |
36,466 |
49,418 |
||
|
Other expense |
(5,934) |
- |
||
|
Total other expense (income) |
30,532 |
49,418 |
||
|
NET LOSS |
(1,761,858) |
(2,571,440) |
||
|
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. |
(1,761,858) |
(2,571,440) |
||
|
OTHER COMPREHENSIVE LOSS |
(5,244) |
(833) |
||
|
COMPREHENSIVE LOSS |
$ (1,767,102) |
$ (2,572,273) |
||
|
Basic and diluted net loss per share attributable to common
stockholders |
$
(0.85) |
$
(2.76) |
||
|
Weighted average number of common shares outstanding - basic and
diluted |
2,076,416 |
932,248 |
||
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