Australian Cancer Trial Advances with First Cohort Complete, Amended
Protocol, and Promising Preclinical Data Published; Operating Expenses
Cut by 32%
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
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 | June 30, 2025 | March 31, 2025 |
|---|---|---|
| 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 | 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 |
Condensed Consolidated Statements of Operations and Comprehensive
Loss
For the three months ended June 30, 2025 and 2024 (Unaudited)
| Three Months Ended 6/30/25 | Three Months 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) |
| Other Comprehensive Loss | (5,244) | (833) |
| Comprehensive Loss | $(1,767,102) | $(2,572,273) |
| Basic and diluted net loss per share | $(0.85) | $(2.76) |
| Weighted average common shares outstanding | 2,076,416 | 932,248 |
Aethlon Medical’s balance sheet for June 30, 2025, compared to
March 31, 2025, highlighting a decrease in total assets from $7.36
million to $5.3 million.
Liabilities and stockholders’ equity as of June 30, 2025, compared
to March 31, 2025, showing reduced liabilities and changes in
equity components.
Aethlon Medical’s quarterly results for the period ended June 30,
2025, compared to the same quarter in 2024, indicating reduced net
loss and lower operating expenses.
Disclaimer/Disclosure: Aethlon Medical, Inc. (AEMD)
is a paid featured medical tech stock on Investor
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