AETHLON MEDICAL INC
For the period ended Dec 31, 2024. Filed Feb 12, 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.
Dec 31, 2024 · Filed Feb 12, 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 2024-09-30; filed 2024-11-13.
0001683168-24-007984
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent 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 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 75 current paragraphs.
52 unchanged; 15 reworded; 7 added; 8 removed; 0 previous and 1 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 (7)
Current 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.
Current 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.
Current 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.
Current 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.
Current report
NINE MONTHS ENDED DECEMBER 31, 2024 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 2023
Current 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. .
Current 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.
Removed paragraphs (8)
Previous report
We now have two sites in India for this trial with the MAMC. One patient has been treated to date; however, we have been informed by our CRO that a new COVID-19 subvariant was detected in India recently. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the ICUs at our sites in India.
Previous report
Consolidated operating expenses for the three months ended September 30, 2024 were $2,902,119, compared to $3,175,346 for the three months ended September 30, 2023. The decrease of $273,227, or 8.6%, in the 2024 period was due to a decrease of $562,266 in professional fees, partially offset by an increase of $181,473 in payroll and related expenses and a $107,567 increase in general and administrative expenses.
Previous report
In the three months ended September 30, 2024, professional fees decreased by $562,266, primarily due to a $270,071 reduction in legal fees following a transition to a new legal firm, a $211,417 decrease in contract labor expenses due to project completions with contract manufacturing organizations and research and development consultants, an $80,630 decrease in accounting fees, and a $62,500 reduction in recruiting fees. These decreases were partially offset by an increase in investor relations expenses to support the dissemination of progress on ongoing clinical trials.
Previous report
Payroll expenses rose by $181,473, largely due to an increase of $507,307 in separation expenses related to severance agreements following the termination of an executive and a reduction in workforce. This increase was partially offset by a $172,419 reduction in ongoing payroll expenses and a $143,688 decrease in stock-based compensation as a result of completion of vesting of some existing stock options and expiration of options associated with reduced headcount.
Previous report
The $107,567 increase in general and administrative expenses was primarily driven by a $162,790 increase in clinical trial expenses associated with our ongoing oncology clinical trial. A decrease of $32,551 in supplies following the completion of certain research and development efforts, a $10,361 decrease in conference and trade show expenses, and a $9,671 decrease in insurance costs.
Previous report
SIX MONTHS ENDED SEPTEMBER 30, 2024 COMPARED TO THE SIX MONTHS ENDED SEPTEMBER 30, 2023
Previous report
The $449,864 decrease in general and administrative expenses was primarily driven by a $479,994 reduction in supplies expenses for raw materials purchased last year for the research, development, and manufacturing of our Hemopurifier. Other decreases included a $44,137 decrease in cleanroom repair and maintenance expenses, a $27,763 decline in conference, tradeshow, and travel and entertainment expenses, and a $20,897 decrease in insurance costs. These decreases were partially offset by a $141,928 increase in expenses primarily related to our ongoing oncology clinical trial.
Previous report
The $313,035 increase in payroll expenses was primarily due to $827,910 in severance-related salary expenses for two executives and a reduction in workforce. This increase was partially offset by a $260,401 reduction in ongoing payroll expenses and a $254,474 decrease in stock-based compensation due to reduced headcount.
Reworded paragraphs (15)
Previous wording
We have recently 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 the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. 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.
Current wording
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 wording
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 in Australia, but we have not yet received ethics committee approval for that institution and have not yet begun patient enrollment. In November 2024, we received confirmation that the first two patients enrolled at the Royal Adelaide Hospital location have successfully completed screening and are advancing to the run-in period of the trial. The enrollment of the first two eligible patients marks a significant milestone in advancing our clinical program for the Hemopurifier.
Current wording
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 wording
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.
Current wording
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 wording
As a result of the changes in expenses noted above, our comprehensive loss decreased to $2,803,169 in the three months ended September 30, 2024 from $3,036,891 in the three months ended September 30, 2023.
Current 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.
Previous wording
Basic and diluted loss attributable to common stockholders was ($0.20) for the three months ended September 30, 2024, compared to ($1.22) for the three-month period ended September 30, 2023.
Current 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.
Previous wording
Consolidated operating expenses for the six months ended September 30, 2024 were $5,521,856, compared to $6,583,506 for the six months ended September 30, 2023. This decrease of $1,061,651, or 16.1%, in the 2024 period was due to decreases in our professional fees of $924,822 and general and administrative expenses of $449,864. These decreases were partially offset by an increase of $313,035 in payroll and related expenses.
Current 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.
Previous wording
The $924,822 decrease in professional fees was mainly due to a $430,205 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 $343,656 in legal fees following a transition to a new legal firm, a $62,500 reduction in recruiting fees, a $48,784 decline in consulting fees incurred by our Australian subsidiary, and a $32,622 decrease in accounting fees for activities conducted in the prior year with no similar expenses in the current year.
Current wording
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 wording
As a result of the changes in expenses noted above, our comprehensive loss decreased from $6,320,064 in the six months ended September 30, 2023, to $5,375,443 in the six months ended September 30, 2024.
Current wording
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 wording
Basic and diluted loss attributable to common stockholders was ($0.50) for the six months ended September 30, 2024, compared to ($2.57) for the six-month period ended September 30, 2023.
Current wording
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.
Previous wording
As of September 30, 2024, we had a cash balance of $6,859,075 and working capital of $4,806,633. 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 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.
Previous wording
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 September 30, 2024 had limited working capital and an accumulated deficit of $159,945,141. 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 September 30, 2024 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.
Current wording
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 wording
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 $3,962,000 in the six months ended September 30, 2024, compared to approximately $5,187,000 in the six months ended September 30, 2023. The primary components in the $1,225,000 decrease in cash used in our operating activities in the 2024 period was a decrease in our net loss of approximately $938,000 and a positive net change in other working capital components of $555,000, partially offset by the reduction of $268,000 in non-cash components.
Current wording
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 wording
NET CASH USED IN INVESTING ACTIVITIES. We did not use cash for investing activities in the six months ended September 30, 2024, compared to approximately $237,000 in the six months ended September 30, 2023. The $237,000 decrease in the 2024 period was primarily a result of equipment purchase for our laboratory incurred in the six months ended September 2023.
Current 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.
Previous wording
NET CASH PROVIDED BY FINANCING ACTIVITIES. During the six months ended September 30, 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 $9,000 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 $5,375,000.
Current 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.
Previous wording
During the six months ended September 30, 2023, we raised approximately $1,086,000 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 $16,000 to pay for the tax withholding on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $1,068,000.
Current wording
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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.