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Aethlon Medical Proclaims Second Quarter Monetary Outcomes and Supplies Company Replace

Aethlon Medical Proclaims Second Quarter Monetary Outcomes and Supplies Company Replace

SAN DIEGO, Nov. 14, 2022 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic firm centered on growing merchandise to diagnose and deal with most cancers and life threatening infectious illnesses, in the present day reported monetary outcomes for its second quarter ended September 30, 2022 and offered an replace on latest developments. 

Firm Updates

Aethlon Medical is constant the analysis and scientific growth of its Hemopurifier®, a therapeutic blood filtration system that may bind and take away dangerous exosomes and life-threatening viruses from blood. This motion has potential functions in most cancers, the place most cancers related exosomes could promote immune suppression and metastasis, and in life-threatening infectious illnesses, together with removing of COVID-19 virus, related variants, and associated exosomes.

  • Resulting from a shortage of COVID sufferers in intensive care models eligible for enrollment into our U.S. COVID trial, we just lately determined to terminate the settlement with our contract analysis group (CRO). Because of this, whereas our Investigational Machine Exemption (IDE) associated to extreme viral infections stays open, we’re discontinuing U.S. COVID scientific trial exercise. We anticipate this determination to save lots of the corporate as much as $5 million over the subsequent twelve months, which we intend to allocate in the direction of advancing the research of our Hemopurifier in oncology.
  • Resulting from lack of affected person enrollment by the College of Pittsburgh Medical Middle (UPMC) in our head and neck most cancers security trial, we and UPMC have terminated this research. We’re planning a brand new scientific trial in oncology that may probably embrace extra tumor varieties, enabling us to construct our security database in oncology and supply knowledge to assist direct the event of our Hemopurifier as a therapy choice in oncology. We’re within the latter phases of choosing a brand new CRO to oversee this new oncology research.
  • In October 2022, we launched an entirely owned subsidiary in Australia, shaped to conduct scientific analysis, search regulatory approval, and commercialize our Hemopurifier in that nation. The subsidiary will initially deal with the oncology market in Australia. As soon as chosen, it’s probably that our new CRO will oversee deliberate oncology research in each the U.S. and Australia.
  • Our COVID-19 trial web site in India stays open with the purpose of enrolling further COVID-19 sufferers. We’re contemplating opening an oncology trial in India as properly.
  • The addition of a second provider for Galanthus nivalis agglutinin (GNA), used within the resin of our Hemopurifier, is delayed within the U.S., pending approval by the U.S. Meals and Drug Administration (FDA) of the complement to our IDE required to enact this manufacturing change. In our opinion, the FDA has mandated unexpectedly excessive testing necessities for a product within the security and feasibility stage of growth. The extra knowledge requested by FDA could take us a number of months to acquire. We’re escalating our issues with the FDA determination by partaking the FDA’s ombudsman. Nevertheless, there may be no assurance that this escalation will speed up our growth timelines.
  • Regulatory authorities in India have accepted this manufacturing change and, consequently, we’ll ship new cartridges to the positioning in India to be used in our scientific trials there.
  • We have now engaged a significant testing lab, Battelle (Columbus, OH), to carry out an in vitro research to look at the binding of the present Monkeypox pressure to a miniature model of our Hemopurifier.

Monetary Outcomes for the Second Quarter Ended September 30, 2022

As of September 30, 2022, Aethlon Medical had a money stability of roughly $19.6 million.

Consolidated working bills for the three months ended September 30, 2022 had been roughly $3.67 million, in comparison with $2.14 million for the three months ended September 30, 2021. This enhance of $1.53 million, or 71%, within the 2022 interval was as a consequence of will increase in our normal and administrative bills of $863,000, in our skilled charges of $354,000 and in our payroll and associated bills of $307,000.

The $863,000 enhance in our normal and administrative bills was primarily because of the mixture of a $384,000 enhance in our scientific trial bills, a $258,000 enhance in provides, primarily for manufacturing Hemopurifiers, a $140,000 enhance in subcontract bills associated to our authorities contracts, a $50,000 enhance in our hire expense and a $32,000 enhance in our insurance coverage expense.

The $354,000 enhance in our skilled charges was primarily because of the mixture of a $152,000 enhance in our contract labor expense related to product growth and analytical companies, a $136,000 enhance in our authorized charges and a $61,000 enhance in our investor relations bills, primarily associated to solicitation bills related to our 2022 annual assembly of stockholders.

The $307,000 enhance in our payroll and associated bills was as a consequence of a rise in our stock-based compensation expense of $112,000. Our cash-based compensation expense elevated by $195,000 as a consequence of our elevated headcount.

In September 2022, the Board of Administrators of Exosome Sciences, Inc. (ESI) and Aethlon, as the bulk stockholder of ESI, authorised the dissolution of ESI. On account of this dissolution, we recorded a non-cash cost of $142,121 as different expense within the three months ended September 30, 2022.

Aethlon didn’t file any income associated to our authorities contract with the NIH within the three months ended September 30, 2022, in comparison with roughly $132,000 within the three months ended September 30, 2021. As of September 30, 2022, the Firm had roughly $574,000 of deferred income associated to these contracts on account of not reaching sure milestones in these contracts. The NIH award contract ended on September 15, 2022 and we introduced the required remaining report back to the NCI. As soon as the NCI completes the shut out evaluate of the contract, we anticipate to acknowledge as income the $574,000 presently recorded as deferred income on our September 30, 2022 stability sheet.

On account of the adjustments in revenues and bills famous above, our web loss elevated to roughly $3.8 million within the three months ended September 30, 2022, from roughly $2.0 million within the three months ended September 30, 2021.

Throughout the six months ended September 30, 2022, the Firm raised roughly $8.9 million in web proceeds underneath our ATM settlement with H.C. Wainwright & Co., pursuant to gross sales of our frequent inventory.  

The unaudited condensed consolidated stability sheet for September 30, 2022, and the unaudited condensed consolidated statements of operations for the three and 6 months ended September 30, 2022 and 2021 comply with on the finish of this launch.

Convention Name

The Firm will maintain a convention name in the present day, Monday, Nov.14, 2022, at 4:30 p.m. EST to evaluate monetary outcomes and up to date company developments. Following administration’s formal remarks, there can be a question-and-answer session.

events can register for the convention by navigating to https://dpregister.com/sreg/10172901/f4fe08e0d7

Please be aware that registered individuals will obtain their dial in quantity upon registration.

events with out web entry or unable to pre-register could dial in by calling: 

PARTICIPANT DIAL IN (TOLL FREE):

1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN:

1-412-317-5442

All callers ought to ask for the Aethlon Medical, Inc. convention name. 

A replay of the decision can be obtainable roughly one hour after the tip of the decision by December 14, 2022. The replay may be accessed through Aethlon Medical’s web site or by dialing 1-877-344-7529 (home) or 1-412-317-0088 (worldwide) or Canada toll free at 1-855-669-9658. The replay convention ID quantity is 2753791.

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic firm growing the Hemopurifier, a therapeutic blood filtration system indicated for most cancers and infectious illnesses. In human research, the Hemopurifier has demonstrated the removing of life-threatening viruses and dangerous exosomes from blood using a proprietary lectin-based expertise. This motion has potential functions in most cancers, the place exosomes could promote immune suppression and metastasis, and in life-threatening infectious illnesses.

The Hemopurifier is a U.S. Meals and Drug Administration (FDA) designated Breakthrough Machine indicated for the therapy of people with superior or metastatic most cancers who’re both unresponsive to or illiberal of ordinary of care remedy, and with most cancers varieties wherein exosomes have been proven to take part within the growth or severity of the illness. Below an Investigational Machine Exemption (IDE) utility, the FDA authorised a single web site, open-label Early Feasibility Research (EFS) to guage the Hemopurifier for lowering cancer-associated exosomes previous to the administration of standard-of-care pembrolizumab (KEYTRUDA®) in sufferers with recurrent and/or metastatic squamous cell carcinoma of the top and neck.

The Hemopurifier additionally holds an FDA Breakthrough Machine designation and an open IDE utility associated to the therapy of life-threatening viruses that aren’t addressed with authorised therapies. In two case research of sufferers handled underneath Emergency Use (EU), the Hemopurifier demonstrated binding of SARS-CoV-2 spike protein and removing of SARS-CoV-2 virus from the circulation of a human affected person.

Extra info may be discovered at www.AethlonMedical.com.

Ahead-Wanting Statements

This press launch accommodates forward-looking statements throughout the which means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Alternate Act of 1934 that contain dangers and uncertainties. Statements containing phrases corresponding to “could,” “imagine,” “anticipate,” “anticipate,” “intend,” “plan,” “challenge,” “will,” “projections,” “estimate,” “probably” or related expressions represent forward-looking statements. Such forward-looking statements are topic to vital dangers and uncertainties and precise outcomes could differ materially from the outcomes anticipated within the forward-looking statements. These forward-looking statements are based mostly upon Aethlon’s present expectations and contain assumptions that will by no means materialize or could show to be incorrect. Components that will contribute to such variations embrace, with out limitation, the Firm’s potential to launch its scientific trials in Australia and develop its trials in India, the Firm’s potential to acquire FDA approval of its new GNA provider in a well timed method,  the Firm’s potential to undergo the FDA and have the FDA approve an EUA for the MPXV, the Firm’s potential to efficiently deal with sufferers underneath any Emergency Use pathway, the Firm’s potential to efficiently full growth of its Hemopurifier, the Firm’s potential to lift further funds, the Firm’s potential to acquire Emergency Use authorization from the FDA to be used of the Hemopurifier to deal with sufferers with the MPXV; the Firm’s potential develop its scientific trials into different areas of most cancers, and different potential dangers. The foregoing listing of dangers and uncertainties is illustrative however shouldn’t be exhaustive. Extra components that would trigger outcomes to vary materially from these anticipated in forward-looking statements may be discovered underneath the caption “Danger Components” within the Firm’s Annual Report on Kind 10-Ok for the 12 months ended March 31, 2022, and within the Firm’s different filings with the Securities and Alternate Fee, together with its quarterly Studies on Kind 10-Q. All forward-looking statements contained on this press launch converse solely as of the date on which they had been made. Besides as could also be required by regulation, the Firm doesn’t intend, nor does it undertake any obligation, to replace this info to mirror future occasions or circumstances.

Firm Contact:
Jim Frakes
Chief Monetary Officer
Aethlon Medical, Inc.
[email protected]

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
[email protected]
917-513-5303


AETHLON MEDICAL, INC. AND SUBSIDIARY

 Consolidated Stability Sheets









ASSETS




September 30, 2022


March 31, 2022









CURRENT ASSETS







Money


$19,604,025


$17,072,419



Accounts receivable


114,849


127,965



Pay as you go bills


784,638


956,623









TOTAL CURRENT ASSETS


20,503,512


18,157,007










Property and tools, web


1,138,623


441,238



Proper-of-use lease asset


1,282,328


696,698



Patents, web


1,925


2,200



Restricted money


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



Resulting from associated events


177,527


155,742



Deferred income


574,245


344,547



Lease legal responsibility, present portion


247,144


126,905



Different present liabilities


741,529


696,893









TOTAL CURRENT LIABILITIES


2,101,446


1,824,049










Lease legal responsibility, much less present portion


1,077,529


602,505









TOTAL LIABILITIES


3,178,975


2,426,554









COMMITMENTS AND CONTINGENCIES













EQUITY














Widespread inventory, par worth of $0.001, 60,000,000 shares







  approved; 22,946,232 and 15,419,163 issued and excellent


22,948


15,421



Extra-paid in capital


156,887,555


147,446,868



Amassed deficit


(137,042,279)


(130,329,181)









TOTAL STOCKHOLDERS’ EQUITY BEFORE NONCONTROLLING INTERESTS

19,868,224


17,133,108









Noncontrolling pursuits



(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 6 month durations 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










Authorities contract income


$-


$131,966


$-


$263,932










OPERATING COSTS AND EXPENSES









Skilled charges


1,003,870


649,460


1,847,899


1,232,929

Payroll and associated


1,112,955


805,608


2,142,641


1,822,350

Basic and administrative


1,548,484


685,702


2,582,505


1,315,895

         Complete working bills


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 pursuits



(825)



(1,960)










NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC.


$(3,807,430)


$(2,007,979)


$(6,715,166)


$(4,105,282)










Primary and diluted web loss obtainable to 









  frequent stockholders per share


$              (0.18)


$              (0.13)


$          (0.37)


$          (0.29)










Weighted common variety of frequent









  shares excellent


20,744,999


15,386,486


18,130,177


14,114,639

SOURCE Aethlon Medical, Inc.

Aethlon Medical Proclaims Second Quarter Monetary Outcomes and Supplies Company Replace

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