Aethlon Medical Announces Fiscal Third Quarter Financial Results and Provides Corporate Update

Rhea-AI Summary

Aethlon Medical, Inc. reports financial results for Q3 2023, updates on Hemopurifier® development, and recent developments. The company received clearance for a phase 1 trial in India and is exploring applications in oncology and organ transplants. The financial results show a cash balance of $8.0 million, with operating expenses increasing due to payroll expenses and a net loss of $3.6 million for Q3 2023.

Positive

• Aethlon Medical continues research on Hemopurifier® for cancer and infectious diseases.
• Received clearance for a phase 1 trial in India for patients with solid tumors.
• Exploring applications of Hemopurifier in oncology and organ transplant settings.
• Financial results show a cash balance of $8.0 million as of December 31, 2023.
• Consolidated operating expenses increased to $3.6 million for Q3 2023.
• Net loss increased to $3.6 million for the three months ended December 31, 2023.
• Conference call scheduled to discuss financial results and recent developments.

Negative

• Net loss increased from $2.8 million to $3.6 million for Q3 2023.
• Consolidated operating expenses rose by 25.2% compared to the same period in 2022.
• Increase in payroll and related expenses due to separation expenses and salary increase.
• Decreases in general and administrative expenses offset by increases in supplies and other expenses.
• Inconclusive results from internal data on Hemopurifier's impact on plasma from cancer patients.

Insights

Financial Analyst

The reported increase in operating expenses by 25.2% for Aethlon Medical, primarily due to separation expenses for the former CEO, is a significant factor that investors need to consider. While the increase in headcount might signal growth or expansion efforts, the associated costs have directly impacted the net loss, which widened from the previous year. The company's cash balance of approximately $8.0 million should be juxtaposed with its burn rate to assess the sustainability of its operations without additional financing.

Furthermore, the shift in expenses towards manufacturing and R&D could be seen as a positive investment in the company's future, particularly if the Hemopurifier technology proves to be successful in ongoing trials. However, it is crucial to monitor the outcomes of the clinical trials and the company's ability to manage costs effectively while progressing through the development pipeline.

Medical Research Analyst

The progression of Aethlon Medical's Hemopurifier into clinical trials represents a significant milestone in the company's development. The device's potential application in treating cancer and life-threatening viruses positions it within a high-demand market. However, the mention of inconclusive internal data raises concerns about the current efficacy of the Hemopurifier, which may impact investor confidence.

Engagement with third-party laboratories for independent assays is a critical step that adds credibility to the research findings. The outcome of these studies will be pivotal in determining the Hemopurifier's future and, by extension, the company's financial health. The medical community and investors alike will be closely watching for peer-reviewed publications and trial results to gauge the product's viability.

Market Research Analyst

The strategic focus on the oncology program by Aethlon's interim CEO suggests a prioritization of resources towards areas with potentially higher returns. Oncology is a highly competitive but lucrative market and success in this area could lead to significant revenue streams for Aethlon. The company's exploration into the organ transplant setting could open up additional markets, but the path to commercialization is often long and fraught with regulatory hurdles.

Given the current global health landscape, Aethlon's pursuit of treatments for life-threatening viral infections, including COVID-19, could offer immediate opportunities, albeit contingent on the pandemic's trajectory and the emergence of new variants. Investors should weigh these developments against the inherent risks of investing in biotech firms, where product development is complex, costly and uncertain.

Conference Call to be Held Today at 4:30 p.m. ET

SAN DIEGO, Feb. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments. 

Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier®, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. Aethlon is also investigating the use of the Hemopurifier in the organ transplant setting, initially focusing on the potential removal of viruses and exosomes with harmful cargo from recovered kidneys.

In October 2023, Aethlon received clearance from the Drug Controller General of India (DCGI), the country's central drug authority, to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following completion of an in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

"In addition to an interested initial site in India, we have two interested sites in Australia that are also awaiting the data from our in vitro binding study," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer. "Our in vitro binding study of relevant oncology targets is complex and stands on the cutting edge of extracellular vesicle science. Our goal is to quantify the potential impact of our Hemopurifier on plasma from cancer patients that have been treated with anti-PD-1 monotherapy treatment in order to provide pre-clinical evidence to support our trial design.

"While our research and development team has started to quantify our internal data, the results, to date, are inconclusive. Therefore, while our internal team continues to finetune their work, in parallel we have engaged several third-party laboratories to independently perform assays on the samples.

"We are also maintaining a position in the use of our Hemopurifier as a treatment against life-threatening viral infections through our COVID-19 trial in India. We have two participating sites for this trial -- the Medanta Medicity Hospital and Maulana Azad Medical College, or MAMC. One patient has been treated thus far, however, we have been informed by our contract research organization that a new COVID-19 subvariant was recently detected in India. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care units at our two participating sites.

"Finally, since being named interim Chief Executive Officer three months ago, I have focused our efforts on our oncology program, as well as on reducing our expenses. As previously reported, we disclosed some interesting pre-clinical proof on concept data of the Hemopurifier in organ transplantation. As a result, we plan to submit one or more articles for publication on our pre-clinical data," concluded Mr. Frakes.

Financial Results for the Third Quarter Ended December 31, 2023

As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million.

Consolidated operating expenses for the three months ended December 31, 2023 were approximately $3.6 million, compared to $2.8 million for the three months ended December 31, 2022. This increase of approximately $717,000, or 25.2%, in the 2023 period was due to increase in payroll and related expenses of approximately $871,000, offset by decreases in general and administrative expenses of approximately $92,000 and in professional fees of approximately $61,000.

The $871,000 increase in payroll and related expenses was primarily due to separation expenses for our former chief executive officer of $873,000 and an increase in salary expense of $81,000 associated with an increase in average headcount, offset by a decrease in stock-based compensation of $83,000.

The $92,000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense of approximately $399,000 and a $33,000 decrease in travel and conferences expenses. Decreases were offset by a $284,000 increase in supplies for manufacturing and research and development expense, a $31,000 increase in insurance expense, a $13,000 increase in depreciation expense and a $12,000 increase in outside services and repairs. The increase in insurance expense included $16,000 of health insurance related to the separation agreement with our former chief executive officer.

The $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting and a net $33,000 decrease in contract labor related to general research and development. These decreases were offset by an increase of $44,000 in legal expenses relating to the reverse stock split, an $11,000 increase in director fees associated with the addition of a new director and a $14,000 increase in investor relations and accounting fees.

As a result of the changes in expenses noted above, the company's net loss increased to $3.6 million for the three months ended December 31, 2023, from $2.8 million in the three months ended December 31, 2022.

The condensed consolidated balance sheet for December 31, 2023, and the condensed consolidated statements of operations for the three- and nine-month periods ended December 31, 2023 and 2022 follow at the end of this release.

Conference Call

Aethlon Medical will hold a conference call today, Wednesday, February 14, 2023, at 4:30 p.m. ET to review its financial results for its fiscal third quarter ended December 31, 2023 and recent corporate developments. Interested parties can register for the conference by navigating to https://dpregister.com/sreg/10186345/fb902976dd. Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or who are unable to pre-register, may dial in as follows:

Participant Dial In (Toll Free): 1-844-836-8741
Participant International Dial In: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2024. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 7691190.

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Additional information can be found at www.AethlonMedical.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital and to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company's ability to initiate its oncology clinical trials in India and Australia; the Company's ability to manage and successfully complete its clinical trials, if initiated; the Company's ability to maintain its Nasdaq listing; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials, and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303

 

AETHLON MEDICAL, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets
ASSETS
			December 31, 2023		March 31, 2023
			(unaudited)
CURRENT ASSETS
	Cash		$                       7,972,012		$                              14,532,943
	Prepaid expenses		277,321		557,623
TOTAL CURRENT ASSETS			8,249,333		15,090,566
	Property and equipment, net		1,113,880		1,144,004
	Right-of-use lease asset		951,466		1,151,909
	Patents, net		1,238		1,650
	Restricted cash		87,506		87,506
	Deposits		33,305		33,305
	TOTAL ASSETS		$                 10,436,728		$                         17,508,940
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
	Accounts payable		$                           693,154		$                                    432,890
	Due to related parties		656,045		214,221
	Lease liability, current portion		285,095		269,386
	Other current liabilities		466,329		588,592
TOTAL CURRENT LIABILITIES			2,100,623		1,505,089
	Lease liability, less current portion		724,848		939,642
TOTAL LIABILITIES			2,825,471		2,444,731
COMMITMENTS AND CONTINGENCIES
EQUITY
	Common stock, par value of $0.001, 60,000,000 shares
	authorized; 2,492,908 and 2,299,259 issued and outstanding		2,596		2,299
	Additional-paid in capital		159,751,591		157,426,606
	Accumulated other comprehensive loss		(1,619)		(6,141)
	Accumulated deficit		(152,141,311)		(142,358,555)
TOTAL STOCKHOLDERS' EQUITY			7,611,257		15,064,209
	TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$                 10,436,728		$                         17,508,940

 

AETHLON MEDICAL, INC. AND SUBSIDIARY
Consolidated Statements of Operations
For the three and six month periods ended September 30, 2023 and 2022
		Three Months		Three Months		Nine Months		Nine Months
		Ended 12/30/23		Ended 12/30/22		Ended 12/30/23		Ended 12/30/22
Government contract revenue		$-		$-		$-		$-
OPERATING COSTS AND EXPENSES
Professional fees		668,586		729,665		2,778,335		2,575,496
Payroll and related		1,919,305		1,048,761		4,233,970		3,191,402
General and administrative		979,197		1,071,327		3,138,289		3,653,832
Total operating expenses		3,567,088		2,849,753		10,150,594		9,420,730
OPERATING LOSS		(3,567,088)		(2,849,753)		(10,150,594)		(9,420,730)
OTHER EXPENSE (INCOME)
Loss on dissolution of subsidiary				-		-		142,121
Interest and Other Income		(100,967)		-		(367,838)		-
NET LOSS		$(3,466,121)		$(2,849,753)		$(9,782,756)		$(9,562,851)
OTHER COMPREHENSIVE LOSS		7,951		-		4,522		-
COMPREHENSIVE LOSS		$(3,458,170)		$(2,849,753)		$(9,778,234)		$(9,562,851)
Basic and diluted net loss available to
common stockholders per share		$              (1.37)		$              (1.24)		$          (3.95)		$          (4.84)
Basic and diluted weighted average number of
common shares outstanding		2,516,511		2,294,649		2,477,282		1,974,146

 

View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-fiscal-third-quarter-financial-results-and-provides-corporate-update-302061238.html

SOURCE Aethlon Medical, Inc.

FAQ

What is Aethlon Medical's ticker symbol?

AEMD

What is the focus of Aethlon Medical's products?

Developing products to treat cancer and life-threatening infectious diseases.

What clearance did Aethlon Medical receive in October 2023?

Clearance from the Drug Controller General of India for a phase 1 trial.

What is the cash balance of Aethlon Medical as of December 31, 2023?

Approximately $8.0 million.

Why did the net loss increase for Aethlon Medical in Q3 2023?

Primarily due to an increase in payroll and related expenses.

When will Aethlon Medical hold a conference call to discuss financial results?

Today, Wednesday, February 14, 2023, at 4:30 p.m. ET.