Core Insights - The article highlights significant advancements in clinical trials for biotech and medical tech companies, particularly focusing on Aethlon Medical, Envoy Medical, Soligenix, and MBX Biosciences, showcasing their recent progress and milestones in the sector [3][4]. Aethlon Medical, Inc. - Aethlon Medical is conducting an ongoing oncology clinical trial in Australia, evaluating the Hemopurifier in cancer patients unresponsive to anti-PD-1 therapy, with preliminary observations showing encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after treatment [5][7]. - In the initial cohort of three patients, decreases in seven out of ten examined microRNAs were noted, indicating potential effects on cancer growth and metastasis [6][8]. - The study's small sample size limits the ability to draw definitive conclusions about clinical efficacy or dose response, with further data needed from subsequent cohorts [11][12]. Envoy Medical, Inc. - Envoy Medical received FDA approval to expand its pivotal clinical trial for the Acclaim® cochlear implant, based on promising data from the first ten patients, allowing for a shortened timeline to commercialization by three to six months [13][14]. - The initial trial phase showed no serious adverse events, and the data indicated that the Acclaim® cochlear implant can achieve effectiveness for its intended use [16]. Soligenix, Inc. - Soligenix's confirmatory Phase 3 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) has concluded its first Data Monitoring Committee meeting, confirming no safety concerns and an acceptable safety profile consistent with prior studies [17][18]. - The company anticipates providing updates on enrollment progress and response rates before year-end, with topline results expected in the second half of 2026 [19]. MBX Biosciences, Inc. - MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint with statistical significance in its Phase 2 Avail™ trial for chronic hypoparathyroidism, with 63% of treated patients meeting the primary composite endpoint [21][22]. - The company plans to initiate a Phase 3 clinical trial in 2026, building on the positive results from the Phase 2 trial, which demonstrated the potential for canvuparatide to become a best-in-class treatment for hypoparathyroidism [23][24].

Core Insights - Aethlon Medical, Inc. has provided updates on its ongoing oncology clinical trial in Australia, focusing on the Hemopurifier's effects on cancer patients not responding to anti-PD-1 therapy [3][4][11] Clinical Trial Observations - The initial cohort of three patients showed promising changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single treatment with the Hemopurifier [4][5] - Changes in EV and microRNA levels typically returned to baseline within 1 to 3 weeks post-treatment [6] - Two of the three participants exhibited decreases in large EVs, which are implicated in cancer metastasis and immune response inhibition [10] Hemopurifier Mechanism - The Hemopurifier is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment by targeting mannose-rich surfaces on EVs and viral proteins [9][11] - The device has received U.S. Food and Drug Administration Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [11] Patient Response and Data Limitations - Increases in total T cell numbers and specific T cell subsets were noted in participants following treatment, although the data is limited due to the small sample size [10] - The study's preliminary nature means that no definitive conclusions can be drawn regarding the clinical efficacy of the Hemopurifier [8][10]

Core Insights - Aethlon Medical, Inc. is conducting an ongoing oncology clinical trial in Australia to evaluate the safety, feasibility, and dose-finding of its Hemopurifier device in cancer patients unresponsive to anti-PD-1 therapy [1][2] Summary by Categories Clinical Trial Observations - Preliminary results from the first patient cohort indicate encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single Hemopurifier treatment [2][3] - In the initial three patients, two showed decreases in large EVs, which are implicated in cancer metastasis and immune evasion [7] - All three participants exhibited decreases in large EVs carrying PD-L1, which is associated with resistance to anti-PD-1 therapies [7] - Seven out of ten microRNAs examined showed decreases in two of the three participants following treatment, indicating potential effects on cancer growth and metastasis [7] - Improvements in laboratory ratios related to immunotherapy responses were observed in at least two participants after treatment [7] Device Information - The Aethlon Hemopurifier® is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment [9] - The device operates extracorporeally and utilizes a combination of plasma separation, size exclusion, and affinity binding [9] - It holds a U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [10] Limitations and Future Directions - The small sample size limits the ability to draw definitive conclusions about the efficacy and dose response of the Hemopurifier [3][8] - Further data from subsequent cohorts will be necessary to determine the reproducibility of the observed changes and the potential for dose-dependent effects [3] - The current observations are part of an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters [8]

Company Performance - Neonode Inc. experienced a stock price drop of approximately 68.34%, closing at $6.81, down from a year high of $29.9, influenced by market reactions to company developments and industry trends [2][8] - Artelo Biosciences saw a 50.34% decrease in its stock price, closing at $4.35, amid ongoing clinical trials and a public offering priced at $3 million [3][8] - 707 Cayman Holdings Limited faced a 48.45% decline in its stock price to $0.39, potentially due to challenges in the retail sector and exploring a crypto treasury reserve with Precious Choice Global Limited [4][8] - Aethlon Medical's stock price fell by 45.76% to $0.73, possibly linked to recent performance updates and investor sentiment towards the healthcare sector, with a public offering valued at $4.5 million [5] - Purple Biotech's stock price decreased by 43.54%, closing at $0.80, which may be related to clinical trial results and market conditions affecting biotech firms [6] Market Trends - The significant price movements of these companies highlight the importance of monitoring market trends, company developments, and broader economic factors that can impact stock performance [7]

Core Points - Aethlon Medical, Inc. announced a public offering of 5,000,000 shares of common stock and warrants to purchase an additional 5,000,000 shares at a price of $0.90 per share [1] - The gross proceeds from the offering are expected to be approximately $4.5 million, which will be used for general corporate purposes including clinical trial expenses and research and development [2] Company Overview - Aethlon Medical, Inc. is a clinical-stage medical device company based in San Diego, California, focused on developing the Hemopurifier to address needs in oncology and infectious diseases [5]

Table of Contents As filed with the Securities and Exchange Commission on August 29, 2025 Registration Statement No. 333-289745 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1/A REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 AETHLON MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 3826 13-3632859 (I.R.S ...

Table of Contents As filed with the Securities and Exchange Commission on August 20, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under THE SECURITIES ACT OF 1933 AETHLON MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 3826 13-3632859 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification N ...

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)