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Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update

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

 

Cision 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.

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