AETHLON MEDICAL INC
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 13, 2025
AEMD$5.47+3.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-12-31; filed 2025-02-12.
0001683168-25-000960
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001683168-25-006049
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 75 previous paragraphs and 50 current paragraphs.
18 unchanged; 17 reworded; 15 added; 39 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (15)
Current report
We are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.
Current report
Three clinical sites in Australia—Royal Adelaide Hospital in Adelaide, Pindara Private Hospital in the Gold Coast, and GenesisCare North Shore Hospital in Sydney—are currently open for enrollment in our phase 1 oncology trial. As of June 26, 2025, we have treated three participants in the first of three planned treatment cohorts. The Data Safety Monitoring Board (DSMB), comprising independent medical experts in nephrology and oncology, has reviewed the data from the initial cohort. Each of the three participants received a single 4-hour Hemopurifier treatment. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.
Current report
Enrollment for Cohort 2 is now open. In this phase, participants will receive two Hemopurifier treatments over a one-week period at the study's three active clinical sites in Australia. This trial, which aims to enroll approximately 9 to 18 patients, is designed to evaluate the safety and feasibility of administering the Hemopurifier at varying dosing intervals in patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda®) or Nivolumab (Opdivo®).
Current report
The Company received formal approval from the India’s regulatory agency, the Central Drugs Standard Control Organization (CDSCO), to initiate an oncology clinical trial in India on July 7, 2025. The Company had been working with its India CRO, Qualtran LLC, toward site initiation at Medanta Medicity Hospital. While the Company had initially anticipated a more expedited startup in India subsequent discussions with the CRO indicated longer-than-expected timelines. After evaluating the project duration and cost of conducting the study, the Company made a strategic decision to discontinue efforts in India and to concentrate its resources on the ongoing oncology trial in Australia, which remains the Company’s primary clinical development priority.
Current report
The Hemopurifier is designed to address life-threatening viral infections, particularly those involving highly glycosylated viruses for which there are no approved therapies. It has previously been used under FDA and international regulatory frameworks to treat individuals infected with HIV, hepatitis C, Ebola, and SARS-CoV-2. While our COVID-19 clinical trials in the U.S. and India have been terminated due to low ICU enrollment, these programs provided real-world evidence of Hemopurifier use in critically ill patients. We maintain an open IDE for viral indications, preserving the ability to respond to future outbreaks or emerging pathogens.
Current report
In addition to our ongoing clinical trials, we continue to explore potential new applications for the Hemopurifier through internal pre-clinical research. In the quarter ended June, 30 2025 results of our pre-clinical ex-vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript has been submitted to a peer-reviewed publication for review. In the study we evaluated the Hemopurifier’s ability to remove disease-relevant extracellular vesicles (EVs), including those derived from platelets, which are implicated in cancer, autoimmune disease, and neurological disorders. The study demonstrated >98% removal of platelet-derived EVs from healthy human plasma in a simulated clinical session. We are also collaborating with academic researchers to investigate EV characteristics in patients with Long COVID. These exploratory programs are intended to inform potential future clinical indications and expand the utility of the Hemopurifier platform.
Current report
We have sufficient inventory of Hemopurifiers to support our ongoing oncology trial in Australia as well as any near-term expansion of that study or potential trial activity in India. While we have received FDA approval to begin manufacturing at our San Diego facility under our IDE supplement, we are still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component. We continue to work with the FDA on this process.
Current report
The $673,802 decrease in payroll and related expenses for the three months ended June 30, 2025, was primarily due to the absence of a $320,604 severance accrual recorded in the prior year related to the separation of an executive. The remaining decrease reflects a $286,311 reduction in compensation costs associated with lower headcount, as well as a $66,886 decline in stock-based compensation related to the same reduction in workforce.
Current report
The $138,050 decrease in professional fees for the three months ended June 30, 2025, was primarily driven by a $104,387 reduction in legal fees following the transition to a new legal firm, a $33,720 decline in scientific consulting costs due to the conclusion of a project, a $23,219 decrease in auditor fees, primarily reflecting lower audit-related costs compared to the prior period and an $18,118 reduction in contract labor following the completion of a regulatory project and transition to lower-cost quality management system consultants. These decreases were partially offset by a $41,835 increase in investor relations expenses related to the special meeting of stockholders.
Current report
General and administrative expenses decreased by $16,616 for the three months ended June 30, 2025, primarily due to a $30,789 reduction in insurance costs. This decrease was partially offset by a $25,853 increase in clinical trial-related expenses, with the remaining variance attributable to a mix of smaller increases and decreases across multiple categories that netted to an overall decline.
Current report
Other (Expense) Income, Net
Current report
We recorded other income of $30,532 for the three months ended June 30, 2025 compared to other income of $49,418 for the three months ended June 30, 2024. Other income in both periods was primarily interest income.
Current report
NET CASH USED IN OPERATING ACTIVITIES. Net cash used in operating activities was approximately $1,715,000 for the three months ended June 30, 2025, compared to approximately $1,748,000 for the same period in 2024. The decrease was primarily driven by a lower net loss in the current period. However, this improvement was largely offset by unfavorable changes in working capital, including decreases of approximately $393,000 in amounts due to related parties and $461,268 in accounts payable and other current liabilities. These were partially offset by modest increases in non-cash charges and favorable changes in prepaid expenses and other current assets.
Current report
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. These estimates and assumptions affect the reported amounts of expenses during the reporting period. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future conditions.
Current report
There were no accounting estimates in the three-months ended June 30, 2025 with a high degree of uncertainty or amounts that are with a high likelihood to change from period to period that would materially impact the presentation of our financial statements for the three-months ended June 30, 2025.
Removed paragraphs (39)
Previous report
We believe the Hemopurifier may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes and exosomal particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned subsidiary in Australia to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia.
Previous report
We have launched in Australia and in India safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is safety.
Previous report
In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (“EVs”) and whether these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.
Previous report
The following two hospitals in Australia have received ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide Hospital in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia. We have also trained a third hospital, GenesisCare North Shore in Sydney, Australia, and have received ethics committee and research governance approval for that institution. The site will be activated and open for enrollment pending completion of the site investigation meeting scheduled for February 2025. In late January 2025, Royal Adelaide Hospital successfully administered the Hemopurifier treatment to the first patient, with no adverse events.
Previous report
We have received ethics committee approval from Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are completing the necessary logistical steps before they can open for patient enrollment.
Previous report
We have entered into an agreement with North American Science Associates, LLC (“NAMSA”), a world leading medical technology contract research organization (“CRO”) offering global end-to-end development services, to oversee our clinical trials of the Hemopurifier for patients in Australia with various types of cancer tumors. We also have engaged Qualtran LLC as the CRO for our clinical trial in India.
Previous report
We also believe that the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals infected with human immunodeficiency virus (“HIV”), hepatitis-C and Ebola.
Previous report
Additionally, in vitro, the Hemopurifier has been demonstrated to capture H5N1 bird flu virus, H1N1 swine flu virus, Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes.
Previous report
On June 17, 2020, the FDA approved a supplement to our open Investigational Device Exemption (“IDE”), for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. In June 2022, the first patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial in India and wish to preserve the option of enrolling patients if the situation with COVID-19 changes.
Previous report
Under Single Patient Emergency Use regulations, Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above.
Previous report
We also obtained ethics review board (“ERB”) approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. In May 2023, we received ERB approval from the Medanta Medicity Hospital and Maulana Azad Medical College (“MAMC”), for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government. In November 2024, Aethlon terminated the COVID-19 clinical trial in India due to lack of enrollment of COVID patients.
Previous report
Additionally, based on preclinical data with acellular kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules, cytokines, chemokines and other inflammatory molecules from recovered organs. We initially are focused on recovered kidneys from deceased donors. We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation complications by improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation, and potentially reducing the number of kidneys rejected for transplant.
Previous report
Consolidated operating expenses for the three months ended December 31, 2024, decreased by $1,752,341 or 49.1% to $1,814,747 compared to $3,567,088 for the same period in 2023. This reduction was driven by a $1,298,818 decrease in payroll and related expenses, a $290,709 decrease in professional fees, and a $162,815 decrease in general and administrative expenses.
Previous report
For the three months ended December 31, 2024, payroll and related expenses decreased by $1,298,818. This decrease was primarily attributable to a reduction of $872,763 in separation expenses related to the Separation Agreement with the former Chief Executive Officer that had been recorded in the December 2023 period, as well as a decrease of $426,055 due to a reduction in headcount. Of the $872,763 of separation expenses related to the departure of the former Chief Executive Officer, $393,139 related to the acceleration of vesting of stock options.
Previous report
Professional fees decreased by $290,709, primarily due to a reduction of $181,380 in legal fees which includes $148,696 decrease resulting from the transition to a new legal firm and $44,000 decrease related to fees incurred for the stock split with no comparable expense in the current period. Additionally, there was a decrease of $176,434 in scientific and operational consulting fees largely attributable to completed projects. These decreases were partially offset by a $64,487 increase in investor relations and accounting fees, an $11,101 increase in legal fees related to patent matters, as well as a $2,618 increase in website services.
Previous report
The $162,814 decrease in general and administrative expenses for the quarter was primarily driven by a $253,297 reduction in supplies, largely related to the raw materials and components used in the manufacturing of the Hemopurifier, with no comparable purchases during the current period. Additionally, there was a $63,686 decrease in insurance expenses associated with a reduced headcount and a $22,708 reduction in various other operating expenses. These reductions were partially offset by a $176,877 increase in expenses related to our ongoing oncology clinical trials in Australia and India.
Previous report
NINE MONTHS ENDED DECEMBER 31, 2024 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 2023
Previous report
Operating Expenses
Previous report
The $1,214,340 decrease in professional fees was mainly due to a $654,232 reduction in contract labor costs related to completed projects with a contract manufacturing organization, as well as with outside research and development and regulatory and quality management consultants. Additional decreases included $525,035 in legal fees which includes $503,769 decrease following a transition to a new legal firm, $13,952 decrease in fees related to stock split with no comparable expense in current period, and a $7,315 decrease in legal fees related to patent matters as well as a $62,500 reduction in recruiting fees. These decreases were offset by a $33,428 increase in investor relation fees.
Previous report
The $985,783 decrease in payroll and related expenses was primarily driven by a $737,458 reduction in stock-based compensation which includes $393,139 related to the acceleration of vesting of stock options associated with the departure of our former Chief Executive Officer as well as expired or canceled employee stock options and a $594,889 decrease resulting from a reduction in headcount. These reductions were partially offset by an increase of $346,566 in separation expenses related to agreements with former executives. .
Previous report
The $613,069 decrease in general and administrative expenses was primarily driven by a $733,242 reduction in supplies, including raw materials and components required for manufacturing the Hemopurifier, as well as laboratory materials for research and development. Additional reductions included an $84,583 decrease in insurance expenses, a $48,725 decrease in repairs and maintenance primarily related to the cleanroom certification, a $27,779 reduction related to travel and conferences, an $18,434 decrease in office supplies, a $17,529 decrease in depreciation. These decreases were partially offset by a $317,616 increase in expenses primarily related to ongoing oncology clinical trials in Australia and India.
Previous report
Net Loss
Previous report
As a result of the changes in expenses noted above, our comprehensive loss decreased from $9,778,234 in the nine months ended December 31, 2023, to $7,143,281 in the nine months ended December 31, 2024.
Previous report
On May 17, 2024, we closed a public offering of our equity, pursuant to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering price of $0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal to the public offering price per share of common stock and accompanying warrants, less the $0.001 per share exercise price of each such pre-funded warrant. The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4.7 million. Net proceeds, of the offering, after deducting the placement agent fees and expenses and other offering expenses payable by us, were approximately $3.5 million. In June 2024, holders of Class A and Class B warrants exercised 300,000 shares and 2,880,000 shares, respectively, for additional total proceeds of $1,844,400. See the section entitled “May 2024 Public Offering,” below, for additional information regarding this offering.
Previous report
Going Concern
Previous report
The accompanying unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations and at December 31, 2024 had limited working capital and an accumulated deficit of $161,699,924. These factors, among other matters, raise substantial doubt about our ability to continue as a going concern within one year of the date of the financial statements included in this Quarterly Report. A significant amount of additional capital will be necessary to advance the development of our products to the point at which they may become commercially viable. We intend to fund operations, working capital and other cash requirements for the twelve-month period subsequent to December 31, 2024 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.
Previous report
The successful outcome of future activities cannot be determined at this time and there is no assurance that, if achieved, we will have sufficient funds to execute our intended business plan or generate positive operating results.
Previous report
The condensed consolidated financial statements do not include any adjustments related to this uncertainty and as to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should we be unable to continue as a going concern.
Previous report
May 2024 Public Offering
Previous report
On May 17, 2024, we closed a public offering pursuant to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering price of $0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal to the public offering price per share of common stock and accompanying warrants, less the $0.001 per share exercise price of each such pre-funded warrant.
Previous report
All pre-funded warrants issued in the offering were exercised in the quarter ended June 30, 2024. The Class A and Class B warrants each have an exercise price of $0.58 per share, are immediately exercisable, and, in the case of Class A warrants, will expire on May 17, 2029, and in the case of Class B warrants, will expire on May 19, 2025. The exercise price of the Class A and Class B warrants is also subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in such warrants.
Previous report
Maxim Group LLC (“Maxim”), served as the exclusive placement agent in connection with the offering. We paid Maxim a cash fee of 6.5% of the aggregate gross proceeds raised at the closing of the offering, and reimbursement of certain expenses and legal fees in the amount of $100,000. We also issued to designees of Maxim warrants to purchase up to an aggregate of 324,000 shares of common stock (the “Placement Agent Warrants”). The Placement Agent Warrants have an exercise price of $0.58 per share and have substantially the same terms as the Class A warrants, except the Placement Agent Warrants are not subject to an exercise price reset, are non-exercisable until November 15, 2024, and will expire on May 15, 2029.
Previous report
The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4.7 million. Net proceeds, of the offering, after deducting the placement agent fees and expenses and other offering expenses payable by us, were approximately $3.5 million.
Previous report
The shares of common stock, the Class A and Class B warrants, the pre-funded warrants and the Placement Agent Warrants described above and the underlying shares of common stock were offered pursuant to a Registration Statement on Form S-1, as amended (File No. 333-278188), which was declared effective by the SEC on May 15, 2024.
Previous report
Warrant Exercises
Previous report
In June 2024, and holders of Class A and Class B warrants exercised 300,000 shares and 2,880,000 shares, respectively, for additional proceeds to the Company of $1,844,400.
Previous report
NET CASH USED IN OPERATING ACTIVITIES. We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was approximately $5,973,000 in the nine months ended December 31, 2024, compared to approximately $7,564,000 in the nine months ended December 31, 2023. The primary components in the $1,591,000 decrease in cash used in our operating activities in the 2024 period was a decrease in our net loss of approximately $2,649,000 partially offset by a negative net change in other working capital components of $508,000 and the reduction of $550,000 in non-cash components.
Previous report
During the nine months ended December 31, 2023, we raised approximately $1,273,000 from the issuance of our common stock under our at the market facility. That source of cash from our financing activities was partially offset by the use of approximately $28,000 to pay for the tax withholding on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $1,245,000.
Previous report
Management’s discussion and analysis of financial condition and results of operations is based on our interim condensed consolidated financial statements, that we prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Preparing these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. We base our estimates on historical experience and on various assumptions we believe to be reasonable under the circumstances. We believe our judgment is applied consistently and produces financial information that fairly depicts our results of operations for all periods. Actual results may differ materially from these estimates.
Reworded paragraphs (17)
Previous wording
The following discussion of our financial condition and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q (this “Quarterly Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “Cautionary Notice Regarding Forward Looking Statements.”
Current wording
The following discussion of our financial condition and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “Cautionary Notice Regarding Forward Looking Statements.”
Previous wording
Aethlon Medical, Inc. (“Aethlon”, the “Company,” “we” or “us”) is a medical therapeutic company focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, 164 sessions with 38 patients, the Hemopurifier was safely utilized and demonstrated the potential to remove life-threatening viruses. In pre-clinical studies, the Hemopurifier has demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes and exosomal particles may promote immune suppression and metastasis, and in life-threatening infectious diseases. The U.S. Food and Drug Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
Current wording
Aethlon Medical, Inc., or Aethlon, the Company, we or us, is a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer, life-threatening viral infections, and organ transplantation and other areas of significant unmet needs. In human studies (167 sessions with 41 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses. In pre-clinical studies, the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped viruses from biological fluids, utilizing its proprietary lectin-based mechanism. These extracellular vesicles have been implicated in disease processes such as immune suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious diseases. The U.S. Food and Drug Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
Previous wording
In addition to the foregoing, we are monitoring closely the impact of inflation, the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, ongoing military conflicts and other global instability will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.
Current wording
In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the ongoing military conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.
Previous wording
Consolidated operating expenses for the nine months ended December 31, 2024 decreased by $2,813,192 to $7,337,402 compared to $10,150,594 for the nine months ended December 31, 2023. This decrease of $2,813,192, or 27.7%, in the 2024 period was due to decreases in our professional fees of $1,214,340, payroll and related expenses of $985,783 and general and administrative expenses of $613,069.
Current wording
Consolidated operating expenses for the three months ended June 30, 2025 were $1,792,390 compared to $2,620,858 for the three months ended June 30, 2024. This decrease of $828,468, or 31.6%, in the 2025 period was due to a decrease of $673,802 in payroll and related $138,050 in professional fees and $16,616 in general and administrative expenses.
Previous wording
As a result of the changes in expenses noted above, our comprehensive loss decreased to $1,767,840 in the three months ended December 31, 2024 from $3,458,170 in the three months ended December 31, 2023.
Current wording
As a result of the changes in expenses noted above, our net loss decreased to $1,761,858 in the three months ended June 30, 2025 from $2,571,440 in the three months ended June 30, 2024.
Previous wording
Basic and diluted loss attributable to common stockholders was ($0.13) for the three months ended December 31, 2024, compared to ($1.37) for the three-month period ended December 31, 2023.
Current wording
Basic and diluted loss attributable to common stockholders was ($0.85) for the three months ended June 30, 2025, compared to ($2.76) for the three-month period ended June 30, 2024.
Previous wording
As of December 31, 2024, we had a cash balance of $4,825,387 and working capital of $3,194,737. This compares to a cash balance of $5,441,978 and working capital of $4,395,889 at March 31, 2024.
Current wording
As of June 30, 2025, we had a cash balance of $3,765,154 and working capital of $2,423,421. This compares to a cash balance of $5,501,261 and working capital of $4,050,514 at March 31, 2025.
Previous wording
We do not expect our existing cash as of December 31, 2024 to be sufficient to fund our operations for at least twelve months from the issuance date of these financial statements. Significant additional financing must be obtained to provide a sufficient source of operating capital and to allow us to continue to operate as a going concern. We intend to fund operations, working capital and other cash requirements for the twelve-month period subsequent to December 31, 2024 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.
Current wording
We do not expect our existing cash as of June 30, 2025, to be sufficient to fund our operations for at least twelve months from the issuance date of these financial statements.
Previous wording
Future capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future.
Current wording
Future capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the time and costs associated with intellectual property protection and enforcement, regulatory and compliance obligations, the competitive landscape, and our ability to enter into strategic partnerships or other collaborative arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future.
Previous wording
NET CASH USED IN INVESTING ACTIVITIES. We used approximately $2,000 for investing activities in the nine months ended December 31, 2024, compared to approximately $245,000 in the nine months ended December 31, 2023. The $243,000 decrease in the 2024 period was primarily a result of equipment purchase for our laboratory incurred in the nine months ended December 2023.
Current wording
NET CASH USED IN INVESTING ACTIVITIES. We did not use cash for investing activities in the three months ended June 30, 2025 and June 30, 2024.
Previous wording
NET CASH PROVIDED BY FINANCING ACTIVITIES. During the nine months ended December 31, 2024, we raised approximately $5,384,000, net of placement agent fees and offering costs, from the sale and issuance of our common stock and warrants in connection with a public offering and the exercise of 300,000 and 2,880,000 Class A and Class B warrants, respectively, by holders thereof. The source of cash from our financing activities was partially offset by the use of approximately $16,000 to pay for the tax withholding upon settlement of on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $5,368,000.
Current wording
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES. Net cash provided by financing activities decreased by approximately $5.4 million for the three months ended June 30, 2025. In the current period, financing activity was limited to approximately $5,000 used for tax withholding related to the settlement of restricted stock units. By contrast, in the same period of the prior year, we raised approximately $5,379,000, net of placement agent fees and offering costs, through the sale and issuance of common stock and warrants in a public offering, as well as the exercise of 300,000 Class A warrants and 1,880,000 Class B warrants. This was partially offset by approximately $5,000 used for tax withholding on restricted stock unit settlements, resulting in net cash provided by financing activities of approximately $5,379,000 in the prior year.
Previous wording
We expect our clinical trial expenses for our oncology trials in Australia and India to increase for the foreseeable future. Those increases in clinical trial expenses include the cost of manufacturing additional Hemopurifiers.
Current wording
We expect our clinical trial expenses for the planned oncology trial in Australia to increase for the foreseeable future. Those increases in clinical trial expenses include the cost of manufacturing additional Hemopurifiers.
Previous wording
In addition, we are obligated under lease agreements for our headquarters, laboratory and manufacturing facilities. We expect our rent payments to continue to increase for the foreseeable future.
Current wording
In addition, we have entered into leases for our headquarters, laboratory and manufacturing facilities. We expect our rent payments to continue to increase for the foreseeable future.
Previous wording
We plan to access the equity markets for additional capital, however, there can be no assurance that we will be able to access such additional capital on favorable terms, or at all.
Current wording
We do plan to access the equity markets for additional capital, however, there can be no assurance that we will be able to access such additional capital on favorable terms, or at all.
Previous wording
Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States, including due to actual or perceived changes in interest rates and economic inflation, and worldwide resulting from macroeconomic factors. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses and we may never be profitable or generate positive cash flow from operating activities.
Current wording
Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States, including due to bank failures, actual or perceived changes in interest rates and economic inflation, and worldwide resulting from macroeconomic factors. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses and we may never be profitable or generate positive cash flow from operating activities.
Previous wording
We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting estimates relate to long lived assets, stock compensation, deferred tax asset valuation allowance, contingencies and clinical trial accruals.
Current wording
We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us.
Previous wording
There have been no changes to our critical accounting policies and estimates as disclosed in our Annual Report on Form 10-K for the year ended March 31, 2024.
Current wording
There have been no changes to our critical accounting policies and estimates as disclosed in our Form 10-K for the year ended March 31, 2025.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Basic and diluted loss attributable to common stockholders was ($0.61) for the nine months ended December 31, 2024, compared to ($3.95) for the nine-month period ended December 31, 2023.