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SAN DIEGO, Nov. 14, 2022 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today reported financial results for its second quarter ended September 30, 2022 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 that can bind and remove harmful exosomes and life-threatening viruses from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.
Financial Results for the Second Quarter Ended September 30, 2022
As of September 30, 2022, Aethlon Medical had a cash balance of approximately $19.6 million.
Consolidated operating expenses for the three months ended September 30, 2022 were approximately $3.67 million, compared to $2.14 million for the three months ended September 30, 2021. This increase of $1.53 million, or 71%, in the 2022 period was due to increases in our general and administrative expenses of $863,000, in our professional fees of $354,000 and in our payroll and related expenses of $307,000.
The $863,000 increase in our general and administrative expenses was primarily due to the combination of a $384,000 increase in our clinical trial expenses, a $258,000 increase in supplies, primarily for manufacturing Hemopurifiers, a $140,000 increase in subcontract expenses related to our government contracts, a $50,000 increase in our rent expense and a $32,000 increase in our insurance expense.
The $354,000 increase in our professional fees was primarily due to the combination of a $152,000 increase in our contract labor expense associated with product development and analytical services, a $136,000 increase in our legal fees and a $61,000 increase in our investor relations expenses, primarily related to solicitation expenses associated with our 2022 annual meeting of stockholders.
The $307,000 increase in our payroll and related expenses was due to an increase in our stock-based compensation expense of $112,000. Our cash-based compensation expense increased by $195,000 due to our increased headcount.
In September 2022, the Board of Directors of Exosome Sciences, Inc. (ESI) and Aethlon, as the majority stockholder of ESI, approved the dissolution of ESI. As a result of this dissolution, we recorded a non-cash charge of $142,121 as other expense in the three months ended September 30, 2022.
Aethlon did not record any revenue related to our government contract with the NIH in the three months ended September 30, 2022, compared to approximately $132,000 in the three months ended September 30, 2021. As of September 30, 2022, the Company had approximately $574,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts. The NIH award contract ended on September 15, 2022 and we presented the required final report to the NCI. Once the NCI completes the close out review of the contract, we expect to recognize as revenue the $574,000 currently recorded as deferred revenue on our September 30, 2022 balance sheet.
As a result of the changes in revenues and expenses noted above, our net loss increased to approximately $3.8 million in the three months ended September 30, 2022, from approximately $2.0 million in the three months ended September 30, 2021.
During the six months ended September 30, 2022, the Company raised approximately $8.9 million in net proceeds under our ATM agreement with H.C. Wainwright & Co., pursuant to sales of our common stock.
The unaudited condensed consolidated balance sheet for September 30, 2022, and the unaudited condensed consolidated statements of operations for the three and six months ended September 30, 2022 and 2021 follow at the end of this release.
Conference Call
The Company will hold a conference call today, Monday, Nov.14, 2022, at 4:30 p.m. EST 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/10172901/f4fe08e0d7
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 December 14, 2022. 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 2753791.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company developing the Hemopurifier, a therapeutic blood filtration system indicated for cancer and infectious diseases. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood utilizing a 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. Under an Investigational Device Exemption (IDE) application, the FDA approved a single site, open-label Early Feasibility Study (EFS) to evaluate the Hemopurifier for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA®) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
The Hemopurifier also holds an FDA Breakthrough Device designation and an open IDE application related to the treatment of life-threatening viruses that are not addressed with approved therapies. In two case studies of patients treated under Emergency Use (EU), the Hemopurifier demonstrated binding of SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus from the circulation of a human patient.
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 launch its clinical trials in Australia and expand its trials in India, the Company's ability to obtain FDA approval of its new GNA supplier in a timely manner, the Company's ability to submit to the FDA and have the FDA approve an EUA for the MPXV, the Company's ability to successfully treat patients under any Emergency Use pathway, the Company's ability to successfully complete development of its Hemopurifier, the Company's ability to raise additional funds, the Company's ability to obtain Emergency Use authorization from the FDA for use of the Hemopurifier to treat patients with the MPXV; the Company's ability expand its clinical trials into other areas of cancer, 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, 2022, 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
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
Consolidated Balance Sheets
ASSETS
September 30, 2022
March 31, 2022
CURRENT ASSETS
Cash
$19,604,025
$17,072,419
Accounts receivable
114,849
127,965
Prepaid expenses
784,638
956,623
TOTAL CURRENT ASSETS
20,503,512
18,157,007
Property and equipment, net
1,138,623
441,238
Right-of-use lease asset
1,282,328
696,698
Patents, net
1,925
2,200
Restricted cash
87,506
87,506
Deposits
33,305
33,305
TOTAL ASSETS
$23,047,199
$19,417,954
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable
361,001
499,962
Due to related parties
177,527
155,742
Deferred revenue
574,245
344,547
Lease liability, current portion
247,144
126,905
Other current liabilities
741,529
696,893
TOTAL CURRENT LIABILITIES
2,101,446
1,824,049
Lease liability, less current portion
1,077,529
602,505
TOTAL LIABILITIES
3,178,975
2,426,554
COMMITMENTS AND CONTINGENCIES
EQUITY
Common stock, par value of $0.001, 60,000,000 shares
authorized; 22,946,232 and 15,419,163 issued and outstanding
22,948
15,421
Additional-paid in capital
156,887,555
147,446,868
Accumulated deficit
(137,042,279)
(130,329,181)
TOTAL STOCKHOLDERS' EQUITY BEFORE NONCONTROLLING INTERESTS
19,868,224
17,133,108
Noncontrolling interests
-
(141,708)
TOTAL STOCKHOLDERS' EQUITY
19,868,224
16,991,400
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$23,047,199
$19,417,954
AETHLON MEDICAL, INC. AND SUBSIDIARY
Consolidated Statements of Operations
For the three and six month periods ended September 30, 2022 and 2021
Three Months
Three Months
Six Months
Six Months
Ended 9/30/22
Ended 9/30/21
Ended 9/30/22
Ended 9/30/21
Government contract revenue
$-
$131,966
$-
$263,932
OPERATING COSTS AND EXPENSES
Professional fees
1,003,870
649,460
1,847,899
1,232,929
Payroll and related
1,112,955
805,608
2,142,641
1,822,350
General and administrative
1,548,484
685,702
2,582,505
1,315,895
Total operating expenses
3,665,309
2,140,770
6,573,045
4,371,174
OPERATING LOSS
(3,665,309)
(2,008,804)
(6,573,045)
(4,107,242)
OTHER EXPENSE
Loss on dissolution of subsidiary
142,121
-
142,121
-
NET LOSS
$(3,807,430)
$(2,008,804)
$(6,715,166)
$(4,107,242)
Loss attributable to noncontrolling interests
-
(825)
-
(1,960)
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC.
$(3,807,430)
$(2,007,979)
$(6,715,166)
$(4,105,282)
Basic and diluted net loss available to
common stockholders per share
$ (0.18)
$ (0.13)
$ (0.37)
$ (0.29)
Weighted average number of common
shares outstanding
20,744,999
15,386,486
18,130,177
14,114,639
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SOURCE Aethlon Medical, Inc.