Aethlon Narrows Q1 Loss by 31% Amid Hemopurifier Trial Progress

TL;DR

**AEMD is burning less cash and making clinical progress, but they're still a long shot with limited runway.**

AI Summary

Aethlon Medical, Inc. (AEMD) reported a net loss of $1,761,858 for the three months ended June 30, 2025, a 31.3% improvement from the $2,571,440 net loss in the same period of 2024. Total operating expenses decreased significantly by 31.6%, from $2,620,858 in Q1 2024 to $1,792,390 in Q1 2025, primarily driven by a 53.7% reduction in payroll and related expenses, which fell from $1,254,802 to $581,000. Cash and cash equivalents declined to $3,765,154 as of June 30, 2025, from $5,501,261 at March 31, 2025, reflecting net cash used in operating activities of $1,714,937. The company is advancing its Hemopurifier device, designated as a 'Breakthrough Device' by the FDA, with a Phase 1 oncology trial in Australia now open for Cohort 2 enrollment after the Data Safety Monitoring Board found no safety concerns in Cohort 1. Aethlon also canceled its Indian clinical trial to conserve resources and focus on the Australian trial, and is exploring new applications for the Hemopurifier through preclinical research, including a study demonstrating >98% removal of platelet-derived EVs.

Why It Matters

Aethlon's reduced net loss and operating expenses, particularly in payroll, suggest a more disciplined approach to capital management, which is crucial for a clinical-stage biotech. The positive safety review for the Hemopurifier in its Australian oncology trial and the FDA's 'Breakthrough Device' designation could significantly de-risk the product for investors, potentially attracting further investment and partnerships. However, the declining cash balance and the decision to cancel the Indian trial highlight ongoing financial pressures and the need for successful trial outcomes to secure future funding. In a competitive medical device market, advancing a 'Breakthrough Device' could give Aethlon a critical edge, but execution and further clinical success are paramount.

Risk Assessment

Risk Level: high — Aethlon Medical reported a net loss of $1,761,858 for the quarter and a significant decrease in cash and cash equivalents from $5,501,261 to $3,765,154. The company continues to operate at a loss and relies on successful clinical trials and future capital raises, as evidenced by the cancellation of the Indian trial to 'conserve resources' and the ongoing 'uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy' on their access to capital.

Analyst Insight

Investors should closely monitor the progress of the Australian oncology trial, specifically the Cohort 2 results, as this is a critical de-risking event for the Hemopurifier. Given the declining cash balance and continued net losses, potential investors should also scrutinize the company's capital raise strategy and cash burn rate before considering an investment.

Financial Highlights

debt To Equity

0.55

revenue

N/A

operating Margin

-100.0%

total Assets

$5,306,002

total Debt

$1,882,489

net Income

-$1,761,858

eps

-$0.85

gross Margin

N/A

cash Position

$3,765,154

revenue Growth

N/A

Key Numbers

• $1,761,858 — Net Loss (for the three months ended June 30, 2025, a 31.3% improvement year-over-year)
• $1,792,390 — Total Operating Expenses (for the three months ended June 30, 2025, a 31.6% decrease from prior year)
• $581,000 — Payroll and Related Expenses (for the three months ended June 30, 2025, a 53.7% decrease from prior year)
• $3,765,154 — Cash and Cash Equivalents (as of June 30, 2025, down from $5,501,261 at March 31, 2025)
• $1,714,937 — Net Cash Used in Operating Activities (for the three months ended June 30, 2025)
• 2,598,711 — Shares of Common Stock Outstanding (as of August 13, 2025)
• 1-for-8 — Reverse Stock Split (effected on June 9, 2025)
• >98% — Removal Rate (of platelet-derived EVs by Hemopurifier in preclinical study)

Key Players & Entities

• Aethlon Medical, Inc. (company) — registrant
• Hemopurifier (product) — clinical-stage immunotherapeutic device
• FDA (regulator) — U.S. Food and Drug Administration
• NASDAQ Capital Market (market) — exchange where AEMD is listed
• Data Safety Monitoring Board (organization) — independent medical experts reviewing clinical trial data
• Qualtran (company) — India CRO
• Central Drugs Standard Control Organization (regulator) — Indian regulatory agency
• Pembrolizumab (Keytruda) (product) — cancer treatment used in clinical trial
• Nivolumab (Opdivo) (product) — cancer treatment used in clinical trial
• bioRxiv (publication) — pre-print vehicle for scientific studies

FAQ

Risk Factors

• Cash Burn Rate and Need for Future Financing [high — financial]: The company has a history of operating losses and a significant accumulated deficit of $169,716,675 as of June 30, 2025. Net cash used in operating activities was $1,714,937 for the three months ended June 30, 2025, and cash and cash equivalents decreased to $3,765,154 from $5,501,261 in the prior quarter. This indicates a substantial ongoing need for external financing to fund operations and development, with potential dilution for existing shareholders.
• FDA Approval and Commercialization Challenges [high — regulatory]: The Hemopurifier device has received 'Breakthrough Device' designation from the FDA, but this does not guarantee eventual approval or successful commercialization. The company faces the significant challenge of navigating the complex regulatory pathway, demonstrating clinical efficacy and safety in ongoing trials, and achieving market acceptance against established treatments.
• Dependence on Key Personnel and Research & Development [medium — operational]: The company's success is heavily reliant on its ability to attract and retain qualified scientific and management personnel, as well as its continued investment in research and development. A significant reduction in payroll and related expenses (53.7% decrease) in the recent quarter could impact the company's ability to execute its R&D strategy and maintain operational momentum.
• Limited Market Adoption and Competitive Landscape [medium — market]: The market for Aethlon's Hemopurifier is nascent, and the company faces competition from existing therapies and other emerging technologies. Demonstrating a clear clinical and economic advantage over current standards of care will be critical for market penetration and adoption.
• Impact of Reverse Stock Split [low — financial]: The company effected a 1-for-8 reverse stock split on June 9, 2025. While intended to improve the stock's marketability and meet exchange listing requirements, reverse splits can sometimes be perceived negatively by investors and may not address underlying business fundamentals.

Industry Context

Aethlon operates in the highly competitive and rapidly evolving medical device sector, specifically focusing on ex vivo blood purification. The industry is characterized by significant R&D investment, lengthy and costly regulatory approval processes, and the need for strong clinical evidence to drive market adoption. Key trends include the development of targeted therapies, personalized medicine, and innovative diagnostic tools.

Regulatory Implications

The company's primary regulatory hurdle is obtaining FDA approval for its Hemopurifier device. The 'Breakthrough Device' designation offers a pathway for expedited review, but rigorous clinical trials are still required to demonstrate safety and efficacy. Any delays or setbacks in the regulatory process could significantly impact the company's timeline and financial resources.

What Investors Should Do

1. Monitor cash burn and future financing needs.
2. Track progress and results of the Australian oncology trial.
3. Evaluate the potential of new applications identified in preclinical research.

Key Dates

• 2025-06-30: End of Second Quarter 2025 — Reporting period for the condensed consolidated financial statements, showing a reduced net loss and operating expenses compared to the prior year, but also a decrease in cash reserves.
• 2025-06-09: Reverse Stock Split — A 1-for-8 reverse stock split was effected, impacting the number of shares outstanding and per-share metrics.
• 2025-06-30: Phase 1 Oncology Trial Cohort 2 Enrollment Open — Indicates progress in the clinical development of the Hemopurifier, following positive safety findings in Cohort 1.

Glossary

Accumulated deficit

The cumulative net losses of a company since its inception, minus any cumulative net income. It represents the total losses that have not been offset by profits. (Aethlon has a substantial accumulated deficit of $169,716,675, highlighting its history of unprofitability and reliance on external funding.)

Breakthrough Device Designation

A designation granted by the U.S. Food and Drug Administration (FDA) to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It allows for enhanced communication and a streamlined development and review process. (This designation for the Hemopurifier signifies potential but does not guarantee regulatory approval or commercial success.)

Net cash used in operating activities

The amount of cash a company has spent on its core business operations during a specific period. A negative number indicates the company is consuming cash to operate. (Aethlon used $1,714,937 in operating activities during the quarter, contributing to the decline in its cash position.)

EVs (Extracellular Vesicles)

Small, membrane-bound particles released from cells that play roles in intercellular communication. In a disease context, they can carry disease-associated molecules. (The preclinical study demonstrating >98% removal of platelet-derived EVs suggests a potential new application for the Hemopurifier in managing conditions associated with these vesicles.)

Year-Over-Year Comparison

Compared to the prior year's comparable period, Aethlon Medical has significantly improved its financial performance by reducing its net loss by 31.3% to $1,761,858 and decreasing total operating expenses by 31.6% to $1,792,390. This reduction was largely driven by a substantial 53.7% decrease in payroll and related expenses. However, the company's cash position has weakened, with cash and cash equivalents falling to $3,765,154 from $5,501,261 in the preceding quarter, reflecting ongoing operational cash burn.

Key Financial Figures

• $0.001 — t: TITLE OF EACH CLASS COMMON STOCK, $0.001 PAR VALUE TRADING SYMBOL AEMD NAM

Filing Documents

• aethlon_i10q-063025.htm (10-Q) — 511KB
• aethlon_ex3101.htm (EX-31.1) — 9KB
• aethlon_ex3201.htm (EX-32.1) — 5KB
• 0001683168-25-006049.txt ( ) — 3402KB
• aemd-20250630.xsd (EX-101.SCH) — 31KB
• aemd-20250630_cal.xml (EX-101.CAL) — 37KB
• aemd-20250630_def.xml (EX-101.DEF) — 132KB
• aemd-20250630_lab.xml (EX-101.LAB) — 272KB
• aemd-20250630_pre.xml (EX-101.PRE) — 239KB
• aethlon_i10q-063025_htm.xml (XML) — 366KB

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 4 CONDENSED CONSOLIDATED BALANCE SHEETS AT JUNE 30, 2025 (UNAUDITED) AND MARCH 31, 2025 4 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 2025 AND 2024 (UNAUDITED) 5 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE MONTHS ENDED JUNE 30, 2025 AND 2024 (UNAUDITED) 6 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED JUNE 30, 2025 AND 2024 (UNAUDITED) 7 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 8 ITEM 2.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 18 ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 23 ITEM 4.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 23 PART II. OTHER INFORMATION 24 ITEM 1.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 24 ITEM 1A.

RISK FACTORS

RISK FACTORS 24 ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 25 ITEM 3. DEFAULTS UPON SENIOR SECURITIES 25 ITEM 4. MINE SAFETY DISCLOSURES 25 ITEM 5. OTHER INFORMATION 25 ITEM 6. EXHIBITS 26

SIGNATURES

SIGNATURES 27 2 CAUTIONARY NOTICE REGARDING FORWARD LOOKING STATEMENTS This Quarterly Report on Form 10-Q, or Quarterly Report, contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the safe harbor created by those sections. We may, in some cases, use words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of these terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by their nature, are inherently uncertain and beyond our control. Such statements, include, but are not limited to, statements contained in this Quarterly Report relating to our business, business strategy, products and services we may offer in the future, the timing and results of future clinical trials, and capital outlook, successful completion of our clinical trials, our ability to raise additional capital, our ability to maintain our Nasdaq listing, U.S. Food and Drug Administration, or FDA, approval of our products candidates, our ability to comply with changing government regulations, patent protection of our proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors detailed herein and in other of our filings with the Securities and Exchange Commission, or the SEC. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AETHLON MEDICAL, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS June 30, 2025 March 31, 2025 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 3,765,154 $ 5,501,261 Deferred Offering Cost 9,103 – Prepaid expenses and other current assets 276,601 448,539 Total current assets 4,050,858 5,949,800 Property and equipment, net 593,720 676,220 Operating lease right-of-use asset 529,576 601,846 Patents, net 413 550 Restricted cash 98,130 97,813 Deposits 33,305 33,305 Total assets $ 5,306,002 $ 7,359,534 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 571,495 $ 534,524 Due to related parties 372,598 579,565 Operating lease liability, current portion 318,800 313,033 Other current liabilities 364,544 472,164 Total current liabilities 1,627,437 1,899,286 Operating lease liability, less current portion 255,052 336,718 Total liabilities 1,882,489 2,236,004 Stockholders' Equity Common stock, par value $ 0.001 per share; 60,000,000 shares authorized as of June 30, 2025 and March 31, 2025; 2,598,711 shares issued and outstanding as of June 30, 2025 and 2,585,239 shares issued and 2,010,739 outstanding at March 31, 2025. 2,599 2,586 Additional paid-in capital 173,159,966 173,092,894 Accumulated other comprehensive loss ( 22,377 ) ( 17,133 ) Accumulated deficit ( 169,716,675 ) ( 167,954,817 ) Total stockholders' equity 3,423,513 5,123,530 Total liabilities and stockholders' equity $ 5,306,002 $ 7,359,534 The accompanying notes are an integral part of these condensed consolidated financial statements . 4 AETHLON MEDICAL, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the Three Month Periods Ended June 30, 2025 and 2024 (Unaudited) Three Months Ended June 30, 2025 Three Months Ended June 30, 2024 OPERATING EXPENSES Professional fee

View Full Filing

View this 10-Q filing on SEC EDGAR