Financial Data and Key Metrics Changes - As of June 30, 2025, the company had a cash balance of approximately $3.8 million [20] - For the three months ended June 30, 2025, consolidated operating expenses were approximately $1.8 million, down roughly $800,000 or 32% from $2.6 million a year ago [20][21] - The operating loss decreased to $1.8 million compared to $2.6 million from the previous year, reflecting progress in aligning resources with strategic priorities [21] Business Line Data and Key Metrics Changes - The company advanced its lead oncology indication clinical program and delivered preclinical results supporting broader applications, including long COVID, while significantly reducing operating expenses [7] - The first cohort of the Australian oncology trial completed Hemopurifier treatments without any device deficiencies or immediate complications [10] - An independent data safety monitoring board recommended advancing to the second treatment cohort after reviewing safety data from the first cohort [11] Market Data and Key Metrics Changes - The Australian oncology trial is designed to include patients on either monotherapy or combination therapy, increasing the potential pool of patients for the study [12] - The global economic burden of long COVID is approximately $1 trillion per year, indicating a large unmet medical need [15] Company Strategy and Development Direction - The company decided not to proceed with the India study to focus resources on the Australian trial, which is seen as the fastest track toward regulatory approval [7][8] - The focus remains on moving the Hemopurifier towards regulatory approval and expanding its use across multiple diseases [7] Management Comments on Operating Environment and Future Outlook - Management acknowledged the need to continue raising funds for clinical research, ideally through strategic partnerships rather than financial investors [31] - The decision to halt the Indian trial was primarily strategic, aimed at avoiding potential delays in moving forward to the PMA phase [31][34] Other Important Information - The company presented preclinical data on long COVID at a symposium, indicating the potential for the Hemopurifier to remove extracellular vesicles associated with long COVID [15][16] - The company is actively recruiting additional sites in Australia to speed up patient enrollment for the clinical trial [42] Q&A Session Summary Question: Is the primary endpoint of the Australian study safety, and is the company on track to meet it? - Management confirmed that the first cohort has been treated without adverse events, indicating progress towards meeting the primary endpoint [25][26] Question: How does the preclinical data translate to actual patient treatment? - Management acknowledged that lab results may not directly reflect patient outcomes, emphasizing the importance of data from actual patients [27][28] Question: What are the implications of not moving forward with the Indian trial? - Management stated that the decision was strategic to avoid delays in regulatory approval, although cost savings were also a factor [30][31][34] Question: Will the company be able to speed up enrollment in the Australian trial? - Management confirmed efforts to speed up enrollment, including recruiting additional sites and using clinical trial liaisons and social media campaigns [41][42]

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) The company reported a net loss of $1.76 million for the quarter ended June 30, 2025, an improvement from a $2.57 million loss in the prior-year period, primarily due to lower operating expenses, with total assets decreasing to $5.3 million from $7.4 million and net cash used in operating activities approximately $1.7 million, while also highlighting a 1-for-8 reverse stock split and substantial doubt about its ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2025, total assets were $5.31 million, a decrease from $7.36 million on March 31, 2025, primarily driven by a reduction in cash and cash equivalents from $5.50 million to $3.77 million, while total liabilities decreased to $1.88 million from $2.24 million and total stockholders' equity fell from $5.12 million to $3.42 million over the same period Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 ($) | March 31, 2025 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,765,154 | $5,501,261 | | Total current assets | $4,050,858 | $5,949,800 | | Total assets | $5,306,002 | $7,359,534 | | **Liabilities & Equity** | | | | Total current liabilities | $1,627,437 | $1,899,286 | | Total liabilities | $1,882,489 | $2,236,004 | | 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](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the three months ended June 30, 2025, the company reported a net loss of $1.76 million, or ($0.85) per share, a reduction from the net loss of $2.57 million, or ($2.76) per share, in the same period of 2024, driven by a significant decrease in total operating expenses to $1.79 million from $2.62 million year-over-year Statement of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2025 ($) | 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 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the three months ended June 30, 2025, net cash used in operating activities was $1.71 million, comparable to the $1.75 million used in the prior-year period, with minimal net cash used in financing activities at $5,357, a stark contrast to the $5.38 million provided by financing activities in the same quarter of 2024, resulting in a total cash position decrease of $1.74 million Cash Flow Summary (Unaudited) | Activity | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,714,937) | ($1,747,537) | | Net cash (used in) provided by financing activities | ($5,357) | $5,379,229 | | Net (decrease) increase in cash | ($1,735,790) | $3,630,402 | | Cash, cash equivalents and restricted cash at end of period | $3,863,284 | $9,159,885 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) The notes detail the company's focus on the Hemopurifier® for cancer and viral infections, with an ongoing Phase 1 oncology trial in Australia, a 1-for-8 reverse stock split in June 2025, and crucially, substantial doubt about the company's ability to continue as a going concern due to insufficient cash to fund operations for the next twelve months - The company is focused on developing the Hemopurifier® for cancer and life-threatening viral infections, with the FDA granting it **"Breakthrough Device" designation** for two indications[18](index=18&type=chunk)[23](index=23&type=chunk) - A Phase 1 oncology trial is underway in Australia, with **three participants treated** in the first cohort showing no safety concerns, and enrollment for the second cohort is open, while a planned trial in India was canceled to conserve resources[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) - A **1-for-8 reverse stock split** was effected on June 9, 2025, with all share and per-share amounts retroactively adjusted[29](index=29&type=chunk)[43](index=43&type=chunk) - Management has concluded there is **substantial doubt** about the Company's ability to continue as a going concern, as existing cash is not sufficient to fund operations for at least twelve months[32](index=32&type=chunk) Research and Development Expenses | Period | R&D Expense ($) | | :--- | :--- | | Three months ended June 30, 2025 | $524,368 | | Three months ended June 30, 2024 | $414,658 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's focus on the Hemopurifier® and the progress of its Phase 1 oncology trial in Australia, noting the strategic decision to cancel a similar trial in India to conserve capital, leading to a 31.6% decrease in operating expenses and a reduced net loss of $1.76 million, but highlighting major liquidity concerns with only $3.8 million in cash, raising substantial doubt about its ability to continue as a going concern [Overview](index=18&type=section&id=Overview) The company is a medical therapeutic firm developing the Hemopurifier®, a clinical-stage device for cancer and viral infections, with primary focus on a Phase 1 oncology trial in Australia, which is now enrolling for its second cohort after the initial cohort showed a favorable safety profile, while also conducting pre-clinical research for new applications - The company's primary clinical development priority is the ongoing Phase 1 oncology trial in Australia for the Hemopurifier®[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - A strategic decision was made to discontinue efforts for a clinical trial in India to conserve resources and focus on the Australian trial[79](index=79&type=chunk) - Pre-clinical research continues to explore new applications, including a study on removing platelet-derived extracellular vesicles, which showed **>98% removal** from human plasma in a simulated session[82](index=82&type=chunk) [Results of Operations](index=20&type=section&id=RESULTS%20OF%20OPERATIONS) For the quarter ended June 30, 2025, operating expenses decreased by $828,468 (31.6%) to $1.79 million compared to the prior-year period, mainly due to a $673,802 reduction in payroll and related expenses, a $138,050 decrease in professional fees, and a $16,616 drop in general and administrative costs, consequently improving the net loss to $1.76 million from $2.57 million year-over-year Operating Expenses Comparison (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 ($) | Q2 2024 ($) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Payroll and related | $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%) | | **Total Operating Expenses** | **$1,792,390** | **$2,620,858** | **($828,468)** | **(31.6%)** | - The decrease in payroll expenses was primarily due to the absence of a **$320,604 severance accrual** from the prior year and lower compensation costs from reduced headcount[88](index=88&type=chunk) - Net loss decreased to **$1.76 million** from **$2.57 million** in the prior-year quarter[92](index=92&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) As of June 30, 2025, the company had a cash balance of $3.77 million and working capital of $2.42 million, but management explicitly states this cash is not sufficient to fund operations for the next twelve months, creating substantial doubt about its ability to continue as a going concern and requiring significant additional financing to sustain operations and clinical trials - The company does not expect its existing cash of **$3.77 million** (as of June 30, 2025) to be sufficient to fund operations for at least the next twelve months[93](index=93&type=chunk) - The company must obtain **significant additional financing** to sustain working capital and fund planned clinical trials[94](index=94&type=chunk) Cash Flow Summary (in thousands) | Activity | For the three months ended June 30, 2025 ($ in thousands) | For the three months ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Operating activities | $(1,715) | $(1,748) | | Investing activities | – | – | | Financing activities | (5) | 5,379 | [Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is not required to provide this information as it qualifies as a smaller reporting company - As a smaller reporting company, Aethlon Medical is not required to provide the information for this item[106](index=106&type=chunk) [Controls and Procedures](index=23&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of the end of the quarter, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[109](index=109&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter[110](index=110&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=24&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company reports that it is not currently a party to any pending or threatened legal proceedings - The company is not presently a party to any pending or threatened legal proceedings[112](index=112&type=chunk) [Risk Factors](index=24&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K, with key risks including a history of significant losses, the need for additional financing, reliance on third-party suppliers, potential for technology obsolescence, extensive regulation, and risks related to maintaining its Nasdaq listing - There have been no material changes to the risk factors previously disclosed in the Annual Report for the fiscal year ended March 31, 2025[114](index=114&type=chunk) - Principal risks include: history of significant losses, need for additional financing, reliance on third-party suppliers, potential technology obsolescence, regulatory hurdles, and maintaining Nasdaq listing compliance[113](index=113&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company did not issue or sell any unregistered securities during the three-month period ended June 30, 2025 - No unregistered securities were issued or sold during the three months ended June 30, 2025[115](index=115&type=chunk) [Other Information](index=25&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the quarter ended June 30, 2025, none of the company's directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement - No directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[118](index=118&type=chunk) [Exhibits](index=26&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed as part of the quarterly report, including corporate governance documents, forms of securities, and officer certifications

[Corporate and Financial Highlights](index=1&type=section&id=Corporate%20and%20Financial%20Highlights) Aethlon Medical advanced its Australian cancer trial, published promising preclinical data, and significantly reduced operating expenses in Q1 FY2025 [Key First Quarter Highlights](index=1&type=section&id=Key%20First%20Quarter%20Highlights) 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](index=3&type=chunk)[5](index=5&type=chunk) - The trial protocol was amended to include patients receiving anti-PD-1 agents in combination therapies, broadening the potential patient pool[3](index=3&type=chunk)[8](index=8&type=chunk) - 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](index=3&type=chunk)[13](index=13&type=chunk) - Operating expenses were reduced by **31.6%** compared to the same period in the prior year, enhancing operational efficiency[3](index=3&type=chunk)[19](index=19&type=chunk) [Clinical and Preclinical Development](index=1&type=section&id=Clinical%20and%20Preclinical%20Development) Aethlon progressed its Australian oncology trial, discontinued the India trial, and demonstrated Hemopurifier efficacy in preclinical and Long COVID research [Australian Oncology Trial Update](index=1&type=section&id=Australian%20Oncology%20Trial%20Update) 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](index=5&type=chunk) - 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](index=6&type=chunk) - 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](index=8&type=chunk) - 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](index=10&type=chunk) [India Oncology Trial Update](index=2&type=section&id=India%20Oncology%20Trial%20Update) 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](index=12&type=chunk) - 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](index=12&type=chunk) [Preclinical Study and Broader Applications](index=2&type=section&id=Preclinical%20Study%20and%20Broader%20Applications) 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](index=13&type=chunk) - 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](index=13&type=chunk) [Long COVID Research Collaboration](index=2&type=section&id=Long%20COVID%20Research%20Collaboration) 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](index=14&type=chunk) - 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](index=16&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) 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](index=3&type=section&id=Financial%20Performance%20for%20Q1%20FY2025) 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](index=18&type=chunk) 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](index=20&type=chunk) 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](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=4&type=section&id=Company%20and%20Product%20Overview) The Hemopurifier is an investigational medical device with U.S. FDA Breakthrough Device Designation for cancer and life-threatening viral treatments [About the Hemopurifier®](index=4&type=section&id=About%20the%20Hemopurifier%C2%AE) 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](index=29&type=chunk) - 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](index=30&type=chunk)

Core Insights - Aethlon Medical has made significant progress in its Australian oncology trial, completing the first treatment cohort and amending the protocol to broaden patient eligibility [1][2][5] - The company reported a 31.6% reduction in operating expenses for the fiscal first quarter, enhancing operational efficiency [10][16] - Promising preclinical data supports the potential of the Hemopurifier in treating various conditions, including Long COVID [10][12][14] Clinical Progress - The first treatment cohort in the Australian trial involved patients with solid tumors unresponsive to PD-1 inhibitors, with no serious adverse events reported [3][4] - The independent Data Safety Monitoring Board recommended advancing to the second treatment cohort, which will involve two Hemopurifier treatments within a week [4] - The trial aims to assess safety and the potential to improve the body's natural ability to attack tumor cells by reducing extracellular vesicle concentrations [7][8] Financial Performance - As of June 30, 2025, Aethlon had a cash balance of approximately $3.8 million [15] - Consolidated operating expenses for the quarter were approximately $1.8 million, down from $2.6 million in the same period last year [16][20] - The operating loss for the quarter decreased to $1.8 million compared to $2.6 million for the same period in 2024 [20] Preclinical and Research Developments - Aethlon's preclinical study demonstrated a 98.5% removal of platelet-derived extracellular vesicles from healthy human plasma during a simulated 4-hour treatment [10][11] - The company is collaborating with UCSF to explore the Hemopurifier's potential applications in Long COVID, with initial findings presented at a recent symposium [12][13][14] Strategic Decisions - Aethlon decided not to proceed with a planned oncology trial in India due to extended timelines and costs, allowing the company to focus on its ongoing trial in Australia [9] - The amended protocol for the Australian trial reflects current standards of care, expanding eligibility to patients receiving various treatment regimens that include anti-PD-1 agents [5]

Core Viewpoint - Aethlon Medical, Inc. is set to release its financial results for the fiscal first quarter ending June 30, 2025, on August 13, 2025, at 4:15 p.m. ET, followed by a conference call to discuss these results and recent corporate developments [1][2]. Financial Results Announcement - The financial results will be announced on August 13, 2025, at 4:15 p.m. ET [1]. - A conference call will take place on the same day at 4:30 p.m. ET to review the financial results and recent developments [2]. Conference Call Details - Interested parties can register for the conference call online, and registered participants will receive a dial-in number [2]. - For those without internet access, a toll-free number is available for participation [3]. Replay Information - A replay of the conference call will be available approximately one hour after the call and can be accessed until September 13, 2025 [4]. Product Overview - The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation [4]. - The device utilizes a novel platform that combines plasma separation, size exclusion, and affinity binding to target pathogenic elements in biological fluids [6]. Regulatory Designation - The Hemopurifier has received U.S. Food and Drug Administration Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [5]. Company Background - Aethlon Medical, Inc. is a clinical-stage medical device company based in San Diego, California, focusing on oncology and infectious disease [6].

Core Viewpoint - Aethlon Medical, Inc. has received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to advance its clinical trial of the Aethlon Hemopurifier without modifications, indicating a favorable safety profile for the device in oncology applications [1][3][4]. Group 1: Clinical Trial Details - The ongoing trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab," aims to evaluate the safety, feasibility, and optimal dosing of the Hemopurifier [2]. - The DSMB reviewed data from the initial cohort of three participants, each receiving a single 4-hour treatment, and found no safety concerns, confirming the Hemopurifier's favorable safety and tolerability profile [3]. - Enrollment for the second cohort is now open, where participants will receive two Hemopurifier treatments over a one-week period, with the trial aiming to enroll approximately 9 to 18 patients [4]. Group 2: Study Objectives and Endpoints - The primary endpoint of the trial is to monitor the incidence of adverse events and clinically significant changes in safety laboratory tests among Hemopurifier-treated patients [5]. - The study will also examine the number of Hemopurifier treatments needed to decrease the concentration of tumor-derived extracellular vesicles (EVs) and assess if these changes improve the body's ability to attack tumor cells [5]. Group 3: Device Information - The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation, utilizing a combination of plasma separation, size exclusion, and affinity binding [7]. - The device has received U.S. Food and Drug Administration Breakthrough Device designation and is being developed under an open Investigational Device Exemption for its oncology and infectious disease indications [8]. Group 4: Company Commitment - Aethlon Medical remains committed to advancing the Hemopurifier for oncology applications and will continue to provide updates as the clinical trial progresses [6].

[Key Fiscal 2025 Highlights](index=1&type=section&id=Key%20Fiscal%202025%20Highlights) Aethlon Medical achieved significant milestones in FY2025, including advancing its Hemopurifier® cancer trials and reducing operating expenses - Treated the first three patients in the Hemopurifier® cancer trial at Australian sites[7](index=7&type=chunk) - Received Indian regulatory approval for a similar oncology study[7](index=7&type=chunk) - Expanded the study protocol to align with current immunotherapy standards[7](index=7&type=chunk) - Demonstrated **98.5%** removal of platelet-derived EVs in a preclinical simulated treatment[7](index=7&type=chunk) - Collaborated with UCSF on Long COVID research, with findings to be presented at the Keystone Symposium[7](index=7&type=chunk) - Significantly reduced operating expenses through streamlined operations[7](index=7&type=chunk) [Clinical and R&D Updates](index=1&type=section&id=Clinical%20and%20R%26D%20Updates) Aethlon advanced its Hemopurifier® clinical trials in Australia and India, with preclinical data supporting broader applications including Long COVID [Clinical Progress in Cancer Trial](index=1&type=section&id=Clinical%20Progress%20in%20Cancer%20Trial) - The first three participants in the safety, feasibility, and dose-finding study for solid tumors have been treated with the Hemopurifier® in Australia, completing the 4-hour treatment without immediate complications[5](index=5&type=chunk) - This milestone triggers a Data Safety Monitoring Board (DSMB) review to assess safety and recommend advancing to the second cohort, where patients will receive two Hemopurifier treatments in one week[6](index=6&type=chunk) - The primary endpoint of the 9-18 patient study is safety, with exploratory analyses evaluating the impact on EV concentrations and the body's anti-tumor response to guide future trials[10](index=10&type=chunk)[11](index=11&type=chunk) - The trial protocol was amended to include patients receiving combination therapies with Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®), reflecting current standards of care[8](index=8&type=chunk) [Regulatory Approval in India](index=2&type=section&id=Regulatory%20Approval%20India) - On June 19, 2025, Aethlon received formal approval from India's Central Drugs Standard Control Organization (CDSCO) to initiate a similar oncology trial[12](index=12&type=chunk) - The trial will be conducted at Medanta Medicity Hospital and will commence after a Site Initiation Visit (SIV)[12](index=12&type=chunk) [Preclinical Study and Broader Applications](index=2&type=section&id=Preclinical%20Study%20Supports%20Broader%20Applications) - A preclinical ex vivo study demonstrated that the Hemopurifier® removed **98.5%** of platelet-derived extracellular vesicles (PD-EVs) from human plasma[13](index=13&type=chunk) - These results suggest potential applications for the Hemopurifier® in other EV-associated diseases, including cancer, lupus, multiple sclerosis, Alzheimer's, sepsis, and Long COVID[13](index=13&type=chunk) [Scientific Collaboration in Long COVID Research](index=3&type=section&id=Scientific%20Collaboration%20in%20Long%20COVID%20Research) - Aethlon's collaborative research with the UCSF Long COVID Clinic was accepted for a poster presentation at the Keystone Symposium on Long COVID (August 10-13, 2025)[15](index=15&type=chunk) - The study analyzed the binding of extracellular vesicles from Long COVID patients to the Hemopurifier's resin, supporting further investigation into this unmet medical need affecting millions in the U.S[15](index=15&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) Aethlon significantly reduced operating expenses by **26%** to **$9.3 million** in FY2025, ending with **$5.5 million** cash, despite an increased net loss of **$13.4 million** due to a non-cash charge [Fiscal 2025 Financial Summary](index=3&type=section&id=Fiscal%202025%20Financial%20Summary) | Metric | FY 2025 | FY 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $5.5 million | $5.4 million | +$0.1M | | Consolidated operating expenses | $9.3 million | $12.6 million | -$3.3M (-26%) | | Operating loss | ($9.3 million) | ($12.6 million) | +$3.3M | | Net loss | ($13.4 million) | ($12.2 million) | -$1.2M | [Detailed Operating Expense Analysis](index=3&type=section&id=Detailed%20Operating%20Expense%20Analysis) - Total operating expenses decreased by approximately **$3.3 million (26%)** year-over-year, from **$12.6 million** to **$9.3 million**[18](index=18&type=chunk) - **Payroll and related expenses** declined by **$1.3 million** due to executive terminations and workforce reductions[19](index=19&type=chunk) - **Professional fees** decreased by **$1.3 million**, driven by savings in legal, contract manufacturing, and consulting costs[20](index=20&type=chunk) - **General and administrative expenses** fell by **$660,000** due to lower raw material, lab supply, and insurance costs, partially offset by a **$467,000** increase in clinical trial expenses for the Australian study[21](index=21&type=chunk) [Other Income and Expense](index=4&type=section&id=Other%20Income%20%28Expense%29) - A non-cash charge of approximately **$4.6 million** was recorded related to a warrant inducement offer in March 2025, which did not impact operating cash flows[23](index=23&type=chunk) - The company recognized approximately **$324,450** in other income from the Employee Retention Tax Credit (ERTC) under the CARES Act[24](index=24&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Aethlon's FY2025 financial statements show total assets of **$7.4 million**, total liabilities of **$2.2 million**, and a net loss of **$13.4 million** or **($8.58)** per share [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $5,501 | $5,442 | | TOTAL CURRENT ASSETS | $5,950 | $6,226 | | TOTAL ASSETS | $7,360 | $8,246 | | **LIABILITIES & EQUITY** | | | | TOTAL CURRENT LIABILITIES | $1,899 | $1,830 | | TOTAL LIABILITIES | $2,236 | $2,480 | | TOTAL STOCKHOLDERS' EQUITY | $5,124 | $5,766 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7,360 | $8,246 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | (in thousands) | Fiscal Year Ended 3/31/25 | Fiscal Year Ended 3/31/24 | | :--- | :--- | :--- | | Total operating expenses | $9,341 | $12,637 | | **OPERATING LOSS** | **($9,341)** | **($12,637)** | | Total other expense (income) | $4,047 | ($428) | | **NET LOSS** | **($13,388)** | **($12,208)** | | Basic and diluted net loss per share | ($8.58) | ($38.87) | | Weighted average shares outstanding | 1,561 | 314 | [Corporate Information and Forward-Looking Statements](index=4&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) Aethlon Medical, developer of the FDA Breakthrough Device Hemopurifier®, provided corporate updates and cautioned on forward-looking statements subject to inherent risks [About Aethlon and the Hemopurifier®](index=5&type=section&id=About%20Aethlon%20and%20the%20Hemopurifier%C2%AE) - Aethlon Medical is focused on developing the Hemopurifier®, a clinical-stage immunotherapeutic device designed to combat cancer, life-threatening viral infections, and be used in organ transplantation[29](index=29&type=chunk) - The Hemopurifier® holds two FDA Breakthrough Device designations: one for advanced or metastatic cancer and another for life-threatening viruses not addressed by approved therapies[29](index=29&type=chunk) [Conference Call Information](index=4&type=section&id=Conference%20Call) - Management hosted a conference call on June 26, 2025, at 4:30 p.m. ET to review financial results and corporate developments[26](index=26&type=chunk) - A replay of the call is available through July 26, 2025, with replay ID number **4903201**[28](index=28&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) - This press release contains forward-looking statements that involve risks and uncertainties, where actual results may differ materially from expectations[31](index=31&type=chunk) - Key risks include the ability to raise capital, successfully complete clinical trials, obtain regulatory approvals, and manage manufacturing and research collaborations[31](index=31&type=chunk)

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17][18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22][24] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15][16] - Future exploration of the Hemopurifier's applications beyond oncology is being considered, particularly in conditions like lupus and Alzheimer's disease [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical trials and the potential for future partnerships based on safety data [62] - The company anticipates needing to raise additional funds until it can secure government grants or partnerships with larger companies [61] - Management does not expect further nonrecurring expenses related to terminated executives [32][33] Other Important Information - The company has published results of a preclinical study showing a 98.5% removal of platelet-derived extracellular vesicles during Hemopurifier treatments [13] - The next earnings call is scheduled for August 2025, coinciding with the filing of the quarterly report [19] Q&A Session Summary Question: What are the focus areas for the company? - The primary focus remains on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are nonrecurring expenses finished? - Management does not anticipate further nonrecurring expenses following the termination of three senior executives [32][33] Question: Will patient recruitment in India be faster than in Australia? - There is potential for faster recruitment in India due to the larger population and the hospital's capabilities [70][72] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [78][80]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17] - The company recorded approximately $324,000 in other income related to the employee retention tax credit under the CARES Act [18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15] - Future exploration of the Hemopurifier in addressing long COVID is being considered, but oncology remains the main priority [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical and laboratory settings, noting it as the most significant advancement since joining the company [16] - The company is preparing for potential partnerships and government grants to support ongoing research and development [57] Other Important Information - The company plans to file its annual report on Form 10-K following the call and will hold its next earnings call in August 2025 [19] Q&A Session Summary Question: What are the focus areas for the company? - The focus remains primarily on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for delivering more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are there any nonrecurring costs expected in the future? - Management does not anticipate additional nonrecurring expenses following the termination of senior executives [32][33] Question: How quickly can patient recruitment be expected in India? - Recruitment in India may proceed faster than one patient per month, depending on oncologists' comfort levels [66][68] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [72][74] Question: What is the current expense run rate? - The company is operating at a level that is necessary to continue operations, with potential increases in expenses as clinical activities ramp up [76][78]

Financial Performance - The consolidated operating expenses for the fiscal year ended March 31, 2025, were $9,341,364, a decrease of $3,295,203 from $12,636,568 in the prior year[300]. - Payroll and related expenses decreased by $1,332,359, driven by a reduction in salaries and related expenses and stock-based compensation[301]. - Professional fees decreased by $1,302,834, primarily due to a reduction in legal fees and the termination of services with a contract manufacturing organization[302]. - General and administrative expenses decreased by $660,010, with significant reductions in raw material purchases and laboratory supplies[303]. - The operating loss decreased to $9,341,364 for the fiscal year ended March 31, 2025, from $12,636,568 in the prior year[304]. - Other expense included a non-cash charge of $4,612,862 related to a warrant inducement offer[305]. - The company recognized $324,450 in other income related to the Employee Retention Tax Credit during the fiscal year ended March 31, 2025[306]. Cash and Capital Management - As of March 31, 2025, the company had a cash balance of $5,501,261 and working capital of $4,050,514, compared to $5,441,978 and $4,395,889, respectively, at March 31, 2024[307]. - The company raised capital through a warrant inducement offer and a public offering during the fiscal year ended March 31, 2025[309]. - The company raised aggregate net proceeds of $7,746,311 during the fiscal year ended March 31, 2025, after deducting $405,002 in commissions and legal expenses[310]. - The company raised approximately $3,540,000 from the issuance of common stock and approximately $2,316,000 from the exercise of warrants under induced terms in the fiscal year ended March 31, 2025[335]. - Net cash used in operating activities was approximately $7,646,000 in fiscal 2025, a decrease of approximately $2,484,000 compared to $10,130,000 in fiscal 2024[332]. - The company intends to use the net proceeds from the warrant exercise for working capital and general corporate purposes[312]. - The company generated approximately $7,727,000 from financing activities in the fiscal year ended March 31, 2025, compared to $1,288,000 in the previous fiscal year[334]. - The company may face challenges in accessing additional capital due to potential worsening global economic conditions and market volatility[330]. Clinical Trials and Product Development - The Hemopurifier has demonstrated a 98.5% removal of platelet-derived extracellular vesicles in a pre-clinical study, supporting its ongoing clinical trials[293]. - The company expects clinical trial expenses for planned oncology trials to increase for the foreseeable future, along with rent payments for headquarters and manufacturing facilities[325]. - The company anticipates continuing to incur increasing negative cash flows and net losses for the foreseeable future, necessitating additional capital raises[326]. - A second patient was treated with the Hemopurifier at GenesisCare North Shore Hospital in Sydney, Australia, with the procedure lasting 4 hours[346]. Stock and Compensation - The Company granted 4,112 RSUs to each of the four non-employee directors in April 2024, with each RSU priced at $12.16 per share[343]. - In April 2025, the Company granted 17,858 RSUs to each of the four non-employee directors, with each RSU priced at $2.80 per share[347]. - A reverse stock split of 1-for-8 was approved, effective June 6, 2023, combining every 8 shares of common stock into one share[345]. - The Company's authorized common stock remained at 60,000,000 shares following the reverse stock split[345]. - As of March 31, 2025, there were no vested RSUs outstanding[344]. - The RSUs granted in April 2024 are subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2024, and March 31, 2025[343]. - The RSUs granted in April 2025 are also subject to vesting in four equal installments, with 25% vesting on June 30, September 30, December 31, 2025, and March 31, 2026[347]. - The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs for current non-employee directors at the beginning of each fiscal year[343]. - Newly elected non-employee directors receive stock options or $75,000 worth of RSUs upon election[343].