Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update

Rhea-AI Summary

Aethlon Medical, Inc. (AEMD) reported its financial results for the second quarter ending September 30, 2020. The company has approximately $14.5 million in cash and reported a net loss of about $1.77 million, up from $1.71 million year-over-year. Operating expenses increased by 4.1% to $1.77 million, driven by higher general and administrative costs.

The company is advancing its Hemopurifier device through FDA-approved clinical trials for cancer and COVID-19 treatments. The first trial is open for enrollment in patients with advanced head and neck cancer.

Positive

• FDA approval for clinical trial of Hemopurifier in cancer treatment.
• Initiation of clinical trial with enrollment for 10-12 subjects.
• First clinical trial for COVID-19 treatment approved for up to 40 patients across 20 sites.

Negative

• Net loss increased to $1.77 million in Q2 2020 from $1.71 million in Q2 2019.
• Operating expenses increased by 4.1% due to raised general and administrative expenses.

SAN DIEGO, Oct. 28, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases,  today reported financial results for its second quarter ended September 30, 2020 and provided an update on recent developments.

Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier®, which is a first in class therapeutic device designed for the single use depletion of cancer-promoting exosomes and circulating viruses.  The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…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….". 

Aethlon has initiated its first clinical trial in patients with advanced and metastatic cancers.  Under an Investigational Device Exemption (IDE) application approved by FDA in October 2019 this trial, termed an Early Feasibility Study (EFS – the device equivalent of a phase 1 study), in patients with advanced and/or metastatic head and neck cancer is being run at the UPMC Hillman Cancer Center in Pittsburgh, PA and has been approved by the UPMC Institutional Review Board (IRB) and is now open for enrollment.  The EFS is designed to enroll 10-12 subjects and will investigate the combination of the Hemopurifier with standard of care pembrolizumab (Keytruda®) in the front line setting.

As previously disclosed, the FDA has also approved an amendment to the Company's open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2/COVID-19 infection.  This will allow for up to 40 of these patients to be treated under a New Feasibility Study protocol at up to 20 clinical sites in the U.S. The first sites for this trial have received IRB approval and the Company is currently recruiting additional sites.  The Company has also recently treated one patient under an emergency use single patient pathway that allows for the use of an investigational product in patients who have essentially failed other treatment options.  This patient successfully received eight Hemopurifier treatments of six hours each over nine days.

Financial Results for the Second Quarter Ended September 30, 2020

At September 30, 2020, we had a cash balance of approximately $14.5 million.

Consolidated operating expenses for the three months ended September 30, 2020 were approximately $1.77 million, compared to approximately $1.70 million for the three months ended September 30, 2019. This increase of approximately $70,000, or 4.1%, in the 2020 period was due to a an increase in general and administrative expenses of approximately $212,000, which was partially offset by a decreases in professional fees of approximately $106,000 and in payroll and related expenses of approximately $37,000.

The $212,000 increase in general and administrative expenses was primarily due to a $143,000 increase in lab supplies in connection with our ongoing effort to continue to build an inventory of Hemopurifiers for our clinical trials, and to a $54,000 increase in our clinical trial expenses.

The $106,000 decrease in our professional fees was primarily due to a $94,000 decrease in our legal fees and a $60,000 decrease in our accounting fees, which were partially offset by a $38,000 increase in scientific consulting expenses.

The $37,000 decrease in payroll and related expenses was due to the combination of a $159,000 reduction in stock-based compensation expense and a $122,000 increase in our cash-based compensation expense. The cash-based compensation increase was in turn due to additions to our headcount and to salary increases.

There was no other expense during the three months ended September 30, 2020. In the three months ended September 30, 2019, other expense primarily consisted of approximately $4,000 of losses on share for warrant exchanges.

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests increased to approximately $1.77 million for the three months ended September 30, 2020, from approximately $1.71 million for the three months ended September 30, 2019.

The unaudited condensed consolidated balance sheet for September 30, 2020 and the unaudited condensed consolidated statements of operations for the three and six month periods ended September 30, 2020 and 2019 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Wednesday, October 28, 2020 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to https://dpregister.com/sreg/10149369/dbcc2bc6ad.

Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling: 
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 November 4, 2020. 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 10149369.

About Aethlon and the Hemopurifier®

Aethlon is focused on addressing unmet needs in global health. The Aethlon Hemopurifier is a clinical- stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression.

These tumor derived exosomes also seed the spread of metastases and inhibit the benefit of leading cancer therapies. The Hemopurifier® is an FDA designated "Breakthrough Device" related to 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 cancer. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.

Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.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 enroll patients in and successfully complete trials in the Early Feasibility Studies in head and neck cancer and in COVID-19 patients, the Company's ability to successfully treat patients under any Emergency Use pathway, the Company's ability to successfully complete development of its Hemopurifier, 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, 2020, 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, CFO
jfrakes@aethlonmedical.com
858-459-7800 extension 3300

Media Contact:
Tony Russo, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com
212-845-4251

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
212-966-3650

 

AETHLON MEDICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheet
ASSETS
			September 30, 2020		March 31, 2020
CURRENT ASSETS
	Cash		$14,473,232		$9,604,780
	Accounts receivable		111,849		206,729
	Prepaid expenses		167,178		229,604
TOTAL CURRENT ASSETS			14,752,259		10,041,113
	Property and equipment, net		145,855		140,484
	Right-of-use lease asset		88,888		136,426
	Patents, net		57,229		57,504
	Deposits		12,159		12,159
TOTAL NONCURRENT ASSETS			304,131		346,573
	TOTAL ASSETS		$15,056,390		$10,387,686
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
	Accounts payable		311,724		285,036
	Due to related parties		156,909		111,707
	Deferred revenue		507,022		100,000
	Lease liability, current portion		92,603		98,557
	Other current liabilities		421,502		472,420
TOTAL CURRENT LIABILITIES			1,489,760		1,067,720
NONCURRENT LIABILITIES
	Convertible notes payable, net		-		42,540
TOTAL NONCURRENT LIABILITIES			-		42,540
TOTAL LIABILITIES			1,489,760		1,110,260
COMMITMENTS AND CONTINGENCIES
EQUITY
	Common stock, par value of $0.001, 30,000,000 shares
	authorized; 12,088,313 and  9,366,873 issued and outstanding		12,089		9,368
	Additional-paid in capital		128,895,581		121,426,563
	Accumulated deficit		(115,207,228)		(112,026,381)
TOTAL STOCKHOLDERS' EQUITY BEFORE NONCONTROLLING INTERESTS			13,700,442		9,409,550
Noncontrolling interests			(133,812)		(132,124)
TOTAL STOCKHOLDERS' EQUITY			13,566,630		9,277,426
	TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$15,056,390		$10,387,686

 

AETHLON MEDICAL, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Operations
For the three and six month periods ended September 30, 2020 and 2019
		Three Months		Three Months		Six Months		Six Months
		Ended 9/30/20		Ended 9/30/19		Ended 9/30/20		Ended 9/30/19
Government contract revenue		$-		$-		$-		$30,000
OPERATING COSTS AND EXPENSES
Professional fees		656,396		762,337		1,220,680		1,369,915
Payroll and related		560,244		597,526		997,155		1,203,521
General and administrative		554,749		342,339		963,972		724,955
		1,771,389		1,702,202		3,181,807		3,298,391
OPERATING LOSS		(1,771,389)		(1,702,202)		(3,181,807)		(3,268,391)
OTHER EXPENSE
Loss on debt extinguishment		-				-		447,011
Loss on share for warrant exchanges		-		4,403		-		4,403
Interest and other debt expenses		-		21		728		54,106
		-		4,424		728		505,520
NET LOSS		$(1,771,389)		$(1,706,626)		$(3,182,535)		$(3,773,911)
Loss attributable to noncontrolling interests		(825)		(1,589)		(1,688)		(2,450)
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC.		$(1,770,564)		$(1,705,037)		$(3,180,847)		$(3,771,461)
Basic and diluted net loss available to
common stockholders per share		$           (0.15)		$           (1.29)		$           (0.29)		$           (2.91)
Weighted average number of common
shares outstanding		12,070,592		1,317,418		10,845,049		1,294,206

 

View original content:http://www.prnewswire.com/news-releases/aethlon-medical-announces-second-quarter-financial-results-and-provides-corporate-update-301162012.html

SOURCE Aethlon Medical, Inc.

FAQ

What are Aethlon Medical's financial results for Q2 2020?

Aethlon Medical reported a net loss of approximately $1.77 million for Q2 2020, compared to a loss of $1.71 million in Q2 2019.

What clinical trials is Aethlon Medical currently conducting?

Aethlon Medical is conducting clinical trials for its Hemopurifier device for advanced cancer and COVID-19 treatments, with trials approved for enrollment.

What is the cash position of Aethlon Medical as of September 30, 2020?

As of September 30, 2020, Aethlon Medical had a cash balance of approximately $14.5 million.

How much did Aethlon Medical's operating expenses increase in Q2 2020?

Operating expenses rose by approximately $70,000, or 4.1%, compared to Q2 2019.

What is the purpose of the Hemopurifier clinical trials?

The Hemopurifier clinical trials aim to treat cancer-promoting exosomes and circulating viruses, including for patients with advanced cancer and COVID-19.