Aethlon Medical(AEMD) - 2026 Q1 - Quarterly Results

Corporate and Financial Highlights Aethlon Medical advanced its Australian cancer trial, published promising preclinical data, and significantly reduced operating expenses in Q1 FY2025 Key First Quarter Highlights In the first quarter of fiscal 2025, Aethlon Medical made significant progress in its Australian Hemopurifier® cancer trial, completing the first cohort without serious adverse events and amending the protocol to widen patient eligibility. The company also published promising preclinical data showing high efficacy in removing extracellular vesicles (EVs) and advanced its Long COVID research. Operationally, Aethlon achieved a 31.6% reduction in operating expenses, improving financial efficiency - The first patient cohort in the Australian Hemopurifier® cancer trial was completed without any device-related serious adverse events or dose-limiting toxicities observed[3][5] - The trial protocol was amended to include patients receiving anti-PD-1 agents in combination therapies, broadening the potential patient pool[3][8] - Preclinical data demonstrated a 98.5% removal of platelet-derived extracellular vesicles (EVs) in a simulated 4-hour treatment, supporting the device's mechanism of action[3][13] - Operating expenses were reduced by 31.6% compared to the same period in the prior year, enhancing operational efficiency[3][19] Clinical and Preclinical Development Aethlon progressed its Australian oncology trial, discontinued the India trial, and demonstrated Hemopurifier efficacy in preclinical and Long COVID research Australian Oncology Trial Update The Australian oncology trial evaluating the Hemopurifier in patients with solid tumors unresponsive to anti-PD-1 therapy has successfully completed its first cohort. All participants tolerated the treatment well, with no device-related serious adverse events. Following a positive review by the Data Safety Monitoring Board (DSMB), the trial is advancing to a second cohort where patients will receive two treatments. The protocol has been expanded to increase patient eligibility, and initial findings on the device's effect on T-cell activity are expected in September 2025 - The first treatment cohort was completed without device-related deficiencies, immediate complications, or dose-limiting toxicities[5] - The independent DSMB reviewed the safety data and recommended advancing to the second treatment cohort, which will involve two Hemopurifier treatments per participant within one week[6] - The trial protocol was amended to expand eligibility to patients receiving either monotherapy or combination therapy that includes Pembrolizumab or Nivolumab, reflecting current care standards[8] - The primary endpoint of the trial is safety, with exploratory objectives to assess the reduction of extracellular vesicles (EVs) to inform the design of a future Premarket Approval (PMA) study[10] India Oncology Trial Update Aethlon has decided to discontinue its planned oncology trial in India. This strategic decision was made after discussions with its CRO indicated that the first patient treatment would likely be delayed until early 2026. The company will instead focus its resources on the ongoing Australian trial to generate more timely clinical data - Despite receiving approval from India's Central Drugs Standard Control Organization (CDSCO), the company will not proceed with the planned oncology trial at Medanta Medicity Hospital[12] - The decision was driven by an extended timeline projecting the first patient treatment in early 2026, associated costs, and a strategic focus on the Australian trial for generating timely data to support a potential PMA trial[12] Preclinical Study and Broader Applications A preclinical ex vivo study, published in bioRxiv, demonstrated that the Hemopurifier effectively removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma. As elevated PD-EVs are associated with numerous diseases including cancer, lupus, and Alzheimer's, these findings support the scientific basis for the current oncology trial and suggest broader potential therapeutic applications for the Hemopurifier - A preclinical study showed the Hemopurifier removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from healthy human plasma during a simulated 4-hour treatment[13] - The findings support the rationale for the Australian oncology trial and suggest broader potential applications for the Hemopurifier in other EV-associated diseases such as lupus, multiple sclerosis, Alzheimer's disease, and Long COVID[13] Long COVID Research Collaboration Aethlon presented findings from its collaboration with UCSF at the Keystone Symposium on Long COVID. The research demonstrated that extracellular vesicles (EVs) from Long COVID patients bind to the Hemopurifier's proprietary GNA lectin affinity resin. This supports the hypothesis that the device could be a potential treatment for Long COVID, a condition with a significant unmet medical need - In collaboration with UCSF, Aethlon presented research at the Keystone Symposium on Long COVID, a condition with no currently available specific treatments[14] - Data showed that both large and small EVs from Long COVID patients bind to the Hemopurifier's lectin affinity resin, supporting the device's potential utility for these individuals[16] Financial Results Aethlon reported a reduced net loss in Q1 FY2025, driven by a 31.6% decrease in operating expenses, with a cash balance of $3.8 million Financial Performance for Q1 FY2025 For the first quarter ended June 30, 2025, Aethlon reported a cash balance of $3.8 million. The company significantly reduced its operating expenses by 31.6% to $1.8 million, down from $2.6 million in the prior-year quarter. This was primarily due to lower payroll, professional fees, and G&A costs. Consequently, the operating loss narrowed to $1.8 million from $2.6 million, and the net loss per share improved to ($0.85) from ($2.76) - As of June 30, 2025, the company had a cash balance of approximately $3.8 million[18] Operating Expense Comparison (Q1 FY2025 vs Q1 FY2024) | Expense Category | Q1 FY2025 (ended Jun 30, 2025) | Q1 FY2024 (ended Jun 30, 2024) | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total Operating Expenses | $1,792,390 | $2,620,858 | ($828,468) | -31.6% | | Payroll and related expenses | $581,000 | $1,254,802 | ($673,802) | -53.7% | | Professional fees | $476,032 | $614,082 | ($138,050) | -22.5% | | General and administrative | $735,358 | $751,974 | ($16,616) | -2.2% | - The decrease in payroll expenses was mainly due to the absence of a $321,000 severance expense recorded in the prior year and a $286,000 reduction in compensation costs from lower headcount[20] Net Loss and EPS Comparison (Q1 FY2025 vs Q1 FY2024) | Metric | Q1 FY2025 (ended Jun 30, 2025) | Q1 FY2024 (ended Jun 30, 2024) | | :--- | :--- | :--- | | Operating Loss | ($1,792,390) | ($2,620,858) | | Net Loss | ($1,761,858) | ($2,571,440) | | Net Loss Per Share | ($0.85) | ($2.76) | Condensed Consolidated Balance Sheets As of June 30, 2025, Aethlon's balance sheet showed total assets of $5.3 million, a decrease from $7.4 million on March 31, 2025. The decline was primarily driven by a reduction in cash and cash equivalents. Total liabilities decreased to $1.9 million from $2.2 million, while total stockholders' equity stood at $3.4 million, down from $5.1 million at the end of the previous fiscal year Balance Sheet Summary | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Total Assets | $5,306,002 | $7,359,534 | | Cash and cash equivalents | $3,765,154 | $5,501,261 | | Total Current Assets | $4,050,858 | $5,949,800 | | Total Liabilities | $1,882,489 | $2,236,004 | | Total Current Liabilities | $1,627,437 | $1,899,286 | | Total Stockholders' Equity | $3,423,513 | $5,123,530 | Condensed Consolidated Statements of Operations For the three months ended June 30, 2025, Aethlon reported a net loss of $1.76 million, or ($0.85) per share. This represents a significant improvement compared to a net loss of $2.57 million, or ($2.76) per share, for the same period in 2024. The reduced loss was primarily due to a 31.6% decrease in total operating expenses Statement of Operations Summary | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total operating expenses | $1,792,390 | $2,620,858 | | Operating Loss | ($1,792,390) | ($2,620,858) | | Net Loss | ($1,761,858) | ($2,571,440) | | Basic and diluted net loss per share | ($0.85) | ($2.76) | | Weighted average shares outstanding | 2,076,416 | 932,248 | Company and Product Overview The Hemopurifier is an investigational medical device with U.S. FDA Breakthrough Device Designation for cancer and life-threatening viral treatments About the Hemopurifier® The Aethlon Hemopurifier® is an investigational medical device that operates outside the body to remove harmful enveloped viruses and tumor-derived extracellular vesicles (EVs) from the blood. It has been granted Breakthrough Device Designation by the U.S. FDA for two key indications: the treatment of advanced or metastatic cancer patients who are unresponsive to standard care, and for life-threatening viruses that lack approved therapies - The Hemopurifier is an investigational medical device designed for the extracorporeal removal of enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation[29] - It holds a U.S. FDA Breakthrough Device Designation for treating individuals with advanced or metastatic cancer unresponsive to standard therapy, and for treating life-threatening viruses without approved therapies[30]