Medical Tech Stock Aethlon Medical (Nasdaq: $AEMD) Reports Fiscal Year 2026
Results as Australian Oncology Study Advances to Final Dosing Cohort
(Investorideas.com Newswire) Investorideas.com, a trusted
investment platform for retail investors reports breaking Medical Tech Stock
news for Aethlon Medical, Inc. (Nasdaq: AEMD),
a clinical-stage medical therapeutic company focused on developing
products to treat cancer and life-threatening viral infections for which there
is no treatment.
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Aethlon Medical, Inc. (Nasdaq: AEMD) Aethlon Medical, Inc. today reported financial results for its fiscal
year ended March 31, 2026, and provided an update on recent developments.
Summary - Australian oncology study advances into Cohort 3 as
enrollment continues
Entered the third and final dosing cohort
of the Australian oncology study, expanded the Hemopurifier intellectual
property portfolio, and maintained a focus on managing operating expenses.
Conference Call
Today at 4:30 p.m. ET
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Key Highlights
·
Advanced the
Australian oncology study through completion of the first two cohorts and
entered the third and final dosing cohort, representing a key clinical
milestone toward generating data to inform future development and dosing
strategy.
·
Recently treated the first participant
in Cohort 3 at Royal North Shore Hospital in Australia. The participant
completed three Hemopurifier treatments over a one-week period, marking continued enrollment momentum and execution
of the study's final treatment arm.
·
Advanced preclinical
research evaluating Hemopurifier applications in additional disease areas,
including rheumatoid arthritis and chronic kidney disease, supporting
the expansion of the platform's potential addressable market beyond oncology
and infectious disease.
·
Continued to
strengthen the intellectual property portfolio supporting the Hemopurifier
platform, including the issuance of patents in the United States and Europe
covering potential applications for long COVID and other coronavirus-related
conditions, extending patent protection into the 2040s and enhancing long-term
platform value.
"Fiscal 2026 was a year of meaningful
execution for Aethlon as we advanced our Australian oncology study through the
first two cohorts and recently initiated Cohort 3. Advancement
into the final cohort represents an important clinical milestone as we work
toward generating data that may help define the optimal treatment regimen and
guide future development decisions. We also strengthened the
Hemopurifier platform through expansion of our intellectual property portfolio
and advancement of preclinical research supporting potential applications
beyond oncology. Combined with our continued focus on managing
operating expenses, these achievements position us to pursue multiple value-creating
opportunities across our clinical and research programs." said James Frakes,
Chief Executive Officer and Chief Financial Officer of Aethlon Medical.
Clinical Update
Clinical Progress in Cancer Trial
Enrollment and treatment of participants in Cohort 2 of the Australian
oncology trial have been completed. An independent Data Safety Monitoring Board
reviewed the data, identified no safety concerns based on its review of
available data, and recommended advancing to the third and final cohort.
Screening is actively underway at the three investigative sites for this final
cohort where 3-6 participants will be treated with 3 Hemopurifier sessions
during a 1-week period. The first
participant in Cohort 3 of the study has been enrolled and received three
Hemopurifier treatments without any device deficiencies or immediate
complications and is now in the follow-up period. Successful enrollment
and treatment of the first participant in Cohort 3 maintains the study's
clinical momentum and moves the Company closer to completing enrollment and
generating data from all planned dosing regimens.
Serial Extracellular Vesicle and T cell measurements on participants in
cohort 2 have been measured by the central lab at the University of Sydney.
Formal statistical analyses comparing the effects of the three different
Hemopurifier dosing regimens on these parameters will be performed by a CRO at
the completion of the trial. This nine-to-18 patient study is designed to evaluate
the safety and feasibility of the Hemopurifier treatments and determine the
appropriate dosing in participants with solid tumors whose disease is stable or
progressing while on a treatment that includes the anti-PD-1 agents, Keytruda®
or Opdivo®.
Other Recent Developments
During fiscal 2026, we strengthened our intellectual property portfolio
through the issuance of patents in both the United States and Europe covering
potential applications of the Hemopurifier for coronavirus-related conditions,
including long COVID and other post-infection complications. These patents
extend protection for certain applications of the Hemopurifier into the 2040s
and further strengthen the Company's intellectual property position surrounding
the Hemopurifier.
In addition, we advanced our preclinical extracellular vesicle (EV)
research activities, including studies evaluating removal of EVs in plasma
samples from patients with rheumatoid arthritis and chronic kidney disease. These efforts support the Company's ongoing evaluation
of the Hemopurifier's potential applications across multiple disease categories
and may create future opportunities to expand the platform into large
markets characterized by significant unmet medical need.
Separately, we continued our evaluation of
Hemopurifier compatibility with a simplified blood treatment system being
developed by Stavro Medical. Initial testing assessing flow rates and transfer
of fluid through the Hemopurifier has been completed, and future studies
evaluating removal of surrogate markers for extracellular vesicles by the
Hemopurifier using the system are under consideration. We believe this approach
could expand potential treatment settings for the Hemopurifier in the future
and may improve the scalability and accessibility of treatment if
successfully developed and validated.
Subsequent to fiscal year-end, an interview published in IEEE Spectrum
featuring Aethlon's Chief Medical Officer and a physician involved in the
treatment of an Ebola virus disease patient with the Hemopurifier during the
2014 outbreak highlighted the Company's experience with Ebola treatment
efforts. In connection with renewed public health interest surrounding recent
Ebola outbreaks, we also confirmed the continued availability of our
FDA-authorized expanded access (compassionate use) protocol and shared the
protocol as well as past in vitro and in vivo data with organizations involved
in global and U.S. emerging pathogen preparedness efforts, including the World
Health Organization's R&D Blueprint expert panel and the National Emerging
Special Pathogen Training and Education Center.
Financial
Results for the Fiscal Year Ended March 31, 2026
As of March 31,
2026, the Company had approximately $5.0 million in cash and cash equivalents,
providing resources to support ongoing clinical and research activities.
Subsequent to fiscal year-end, the Company
strengthened its balance sheet by raising approximately $1.85 million in net
proceeds through its at-the-market program.
Consolidated operating expenses declined 21.9%
year-over-year to approximately $7.3 million, reflecting continued expense
discipline and operational efficiency while advancing the Company's clinical
and research priorities compared to $9.3 million for the fiscal year ended
March 31, 2025. The decrease was primarily due to $1.1 million reduction in
payroll and related expenses, a $500,000 reduction in general and
administrative expenses and a $400,000 reduction in professional fees.
Consistent with the reduction in operating
expenses, the operating loss for the fiscal year decreased to approximately
$7.3 million for fiscal 2026 from $9.3 million in the prior fiscal year.
Other income was approximately $142,000 for the
fiscal year ended March 31, 2026, primarily reflecting interest income earned
on cash balances, compared to other expense of approximately $4 million in the
prior fiscal year. The prior-year amount included approximately $4.7 million of
non-cash financing-related charges.
Net loss attributable to our common stockholders
was $7.2 million for the fiscal year ended March 31, 2026, compared to net loss
of $13.4 million for the fiscal year ended March 31, 2025.
The consolidated balance sheets for March 31, 2026,
and March 31, 2025, and the consolidated statements of operations for the
fiscal years ended March 31, 2026, and 2025, are included at the end of this
release.
Management will host a conference call today,
Wednesday, June 10, 2026, 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/10209612/1042263e8ec. 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 July 10, 2026. The
replay can be accessed via Aethlon Medical’s website or by dialing
1-855-669-9658 (USA or Canada) or 1-412-317-0088 (international) or Canada toll
free at 1-855-669-9658. The replay conference ID number is 7883435.
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 in vitro studies and human subjects.
The Hemopurifier holds a
U.S. Food and Drug Administration 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.
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