Tuesday, 02 January 2024 12:17 GMT

Medical Tech Aethlon Medical (Nasdaq: AEMD) Reports Fiscal Year 2026 Results As Australian Oncology Study Advances To Final Dosing Cohort


Date:

(MENAFN- Investor Ideas) Investorideas ( newswir ) a trusted investment platform for retail investors reports breaking Medical Tech Stock news forAethlon 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.

Aethlon Medical, Inc. (Nasdaq: AEMD ) 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

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.
Clinical UpdateClinical 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(R) or Opdivo(R).

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.

Conference Call

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. 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(R)

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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