AEMD - Earnings call transcript Q2 2022

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Operator

Good day, and welcome to the Aethlon Medical Second Quarter Fiscal 2022 Earnings and Corporate Update. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference call over to Jim Frakes, Chief Financial Officer. Please go ahead.

James Frakes

good and operator, you, afternoon, everyone. Thank Aethlon to Medical’s second call. conference earnings XXXX quarter Welcome Jim I’m Frakes, Officer. is name My and Aethlon’s Financial Chief At X:XX P.M. second Eastern results XXXX. Medical Aethlon quarter its Time XX, ended released September today, for financial

you please the release, If Medical’s at visit not received Investors seen Aethlon have earnings www.aethlonmedical.com. Page or

I provide reading and our our Dr, Officer, Chief statements, introduction then an of CEO, strategy Aethlon’s will will Aethlon’s overview this developments. brief Following Aethlon’s of Dr. some and recent Medical Steven the financials. forward-looking remarks Chuck and make LaRosa Fisher, on

for We will then the open Q&A up the call session.

Before XX-K XXXX is today based Dr. that of Fisher, assumptions and statement. as Securities Exchange of Factors significant statement forward-looking materially amended hand the statements. These XXXX within turn XX-Q found with please other Form and release that contain a report call is on could on call risks recent intend caption a the call. and to of conference news Statements under the Risk and amended. XX, and you be the anticipated this of in cause does Forward-Looking the Annual XXXX; the then Company’s Factors Executive are statements the call I cautions may over of The ended can or Report over March Company are as results this to may the results most statements the the Dr. Chief any differ anticipated forward-looking Act the uncertainties, materially fiscal of in information from note as Such historical subject that not as Act Form reflect from filings update differ forward-looking our Fisher, in it Company’s year to results statement those meaning for With future that will statements forward-looking Company Except Charles to and expectations to undertake the Commission. fact does actual required on the be date Exchange Securities now Medical’s duty I and by that, Securities circumstances. Aethlon to Officer. the events this any law, nor not the

Charles Fisher

And you, since Steven you trials. I I clinical initial Chuck who for Medical would call last to has it on investor today Officer Chief been is clinical three trials. It Fisher. in. all Medical’s update our be, our busy dialing This Jim. a Thank made our then, have provide opportunity will towards Since August of Dr. improvements significant thank weeks conference take we on would LaRosa, thought introduce you this Aethlon to an XXXX.

Steven LaRosa

and IMB, Hi, Chief Dr. into listening at Aethlon. and and our Larosa everyone, Steve presentation Officer Medical thanks for

United update First, SARS-CoV-X of the an being infection. trial I States. and protocol with life-threatening viral like early for sites U.S. is to Hemopurifier Exemption, in is up at XX designed for Hemopurifier our The would patients you an on these up XX IDE the treatment open to to the for the under of to investigating conducted feasibility under trial patients to the trial, be clinical Device treated study infections. clinical give COVID-XX The Investigational allow

IRB, All both Center, track with a process, Medical together our Center Institutional Jersey, site. clinical sites, recent in record Center, their long interest COVID-XX were advance Jefferson patients. involved Cooper course, PPD, Medical CTA of site to [indiscernible]. investigator California agreed California, Medical readiness with global need particularly has trial these that number including Southern Treport, enter with Chuck then ill Thomas an or for has is advancing sites and between that years critically LSU the budget upon trials well-executed success continue with with critically to is are a from University carry studies selected the Fisher site, agreement carefully There based Loma Board, Medical or patients, have well hospitals leading starting, contract the the during for team entered U.S. U.S. Center; on During trial. extracorporeal and trial A and in of New into Hemopurifier Philadelphia. devices. worked I research procedures the in trials to or University getting working to advance a sponsor individual XX involving Center and in Center a into performed principal suited strong each of PPD the clinical we University Miami over ill will and and Inc., be a means? of Health Medical clinical then trials our approval through to PPD, we in this trial. CRO, Davis being on quarter, Together cost organization, of critically Review in investigating patients. out hospital’s readiness at oversee PPD Virginia to We at agreement What ill does site COVID-XX an trial Commonwealth each including cover put clinical be obtain the we the would process of launching a clinical Linda

visit the the data, personnel to investigators, protocol, of clinical evolved trained SIV the research site operation the of is monitoring of are Hemopurifier. physician safety hospital or the where on One and other coordinators final collection and steps relevant initiation clinical

Jersey, the week, readiness. [indiscernible] to site Last visit X based the screening Following Center begin those patients. in stages position finally enrolling at of site Camden, Cooper final clinical Medical steps, and initiation CPD of completed a in New

sites site well. late with as clinical other in of stages several readiness are We

obtained that clinical and we trial just into Beyond with Hospital. entered the a IRB have sites approval I recently noted, agreement Stanford

on in approval obtained is in for place location. into Delhi, other U.S. board we the hospital multi-specialty discussions to review We expected a this On-site are clinical Also with COVID-XX also at training entered COVID-XX take to agreement trial onboard Medicity front, Vedanta Hospital, India that key a recently trial month. medical ethics and centers. a bring clinical

We trials Hospital trials with clinical at well investigator multiple Medicity as in with clinical patients. previous previously have hepatitis the C Vedanta the conducted as principal site

with the to that also U.S. FDA goal Indian expect be data. our data we to patients Our along is to with help to the clinical bear supportive generate submitted and trial

Regarding delayed there. allow on The and cartridge. at has neck up performed trial trial, the our session Pittsburgh UPMC training Hemopurifier at cancer operation head we affiliated of the of recently group community University of opened recruitment recent outbreak has patients This the also to screening COVID a investigative hospitals. refresher for the

to as working are recruitment with resume We them as soon possible.

turn Dr. to Fisher. Charles me the Now over back let call

Charles Fisher

to Amundson bottom recent Amundson assist record a to would track clinical a Thanks and extensive like on Aethlon critically touch patients. physician. Dr. our has Steven. joined individual’s an in managing consultant long seen X,XXX has as I service recently Most Medical board since Dr. trials. SARS-CoV-X numerous has Dr. throughout greater extensive Amundson recently, in personally military and COVID-XX his is and onset Dr. than Scripps treated pandemic, career. COVID-XX Amundson teaching the Hoster. patients ICU at critically received awards clinical of the Mercy TuaVista ill

and [Indiscernible] critical fortunate COVID-XX care during experience. X,XXX been nurses to extensive care have we [indiscernible] pandemic. a greater patients treated than seen the hire has critical Additionally,

Mr. Innovation. Education, [indiscernible] experience, and serve Director will Product During his as extensive Aethlon’s of

of to have outstanding are our both join We team. Aethlon individuals these pleased

on Regarding recently and of University have patients session operation group training head performed at Pittsburgh affiliate hospitals. a previously the the refresher neck and with forward from to our and we investigative purifier program for enrolling UPMC look Steve the mentioned, as cartridge its

optimistic in very cancer about our Additionally, and the opportunities space. We in exploring other remain institutions are we the tumor cancer arena. types and potential

bind to We particles, viral research the including interest remove our exosomes. continue and development Hemopurifier variant particles or and COVID-XX of many clinical related of COVID-XX

program, we has for use our As virus the of from open spike with binding Hemopurifier from circulation of not then to in human which and open patients We also remains Difficulty]. the can up demonstrated Jim the SARS-CoV-X treat and removal for under Aethlon questions. protein for do our discussed criteria our financial meet last a patient. binding for discussion over who additional call, may patients Hemopurifier Back [Technical Frakes SARS-CoV-X emergency

James Frakes

everybody. afternoon had cash XX, good and XXXX, September Chuck of balance At million. Thanks, again, approximately $XX.X a we

clinical us noted well trials. just our those Hemopurifier manufacturing Our our of up current for LaRosa planned Steve as the position sets for cash very trials and conducting for

approximately a combination in in month approximately During $XXX,XXX revenue and XXXX, in ended September six ended stock X three-months XXXX. the issuance financing cancer ATM recorded Phase our contracts a direct XX, raised million net $XX.X registered proceeds September we the of common melanoma from of contract of on We XX, sales. government the

our approximately an also NIH University of connection We revenue reimbursable Pittsburgh contract. arrangement cost $XX,XXX related with in the recorded to of with support

the record ended In XXXX. September did government government a contract the As in XX, ended XXXX. revenues we the three-months September revenue $XXX,XXX. We not result, total approximately contract XX, recorded three-months of

was of and expense, was primarily insurance $XX,XXX primarily administrative three-months in by general scientists $X.X the administrative and approximately due $XX,XXX additional Our our and $XXX,XXX September and to our a our a consolidated a expenses $XXX,XXX partially $XXX,XXX, were XXXX. in development of related clinical and The general payroll the The for and and approximately administrative payroll approximately expenses a our $X.X in in increase expense, the This approximately $XXX,XXX research the increases additional increase and offset rent $XX,XXX a ended combination September million ended for XX, a in of was in in in XXXX hiring in the were or expenses general as which three-months in as expenses of increase increase $XX,XXX XX, payroll trial and $XXX,XXX in of result amortization period, increase million, a increase $XXX,XXX. increase approximately our expense. due expenses, related increase operating of result XX% a XXXX $XXX,XXX payroll, headcount. the to compared expenses to expense

were quarter. from professional Our December XXXX fees unchanged basically

$X changes and ended loss XXXX. non just a the increased interests million reviewed, our September September XX, I XX, in from three-months X.X of As ended before approximately expenses the million net result XXXX, for controlling to three-months that approximately for revenues

third report February the earnings XX, Form on Our coincide XX-Q our quarter next call will with January December of the XXXX. quarterly or filing in for fiscal ending late XXXX

have. for our file happy be Form Chuck, will and take call the questions may questions. please We And quarter, you that open this now, this the would call. September Steve I quarter to XX-Q any Operator, for following

Operator

Marin [Operator M Instructions] comes from Our question with go Zacks. Please first ahead.

M Marin

you. Thank

give trial? the sense pandemic, the you to to a readiness the than trial of So their will timeline where estimated us timeline general site in new a usual what state average for a include the clinical we of COVID what given shorter getting in is be can are call you and

Steven LaRosa

Steve a I is that question. LaRosa, This will take

is that which that the last patient. get number we actually visits next undergo reference that site a people sites length will, the I can to you we enroll months. a often working of general, accomplished because the takes as possible. as to, COVID a site initiation and if will within hurdle readiness point not out have before Remember point month last to committees time remotely So the two of timeline pandemic meeting I what in will site

say the So to over readiness I the all COVID increased. time pandemic during has would say

M Marin

positive you because about And two data, present have know the is very study of that the in the data from patients complete? the included data COVID data Okay. you be study. that Will you not part the actual that what once generated were some

Steven LaRosa

that those medicine, to refer published patients in which in the are patients. frontiers So results were patient single two emergencies you

clinical are who trial. patients COVID not included ill critically the in are these So

So regulatory from the of of combining outcomes clinical FDA. clinical be those that binding be that would in the terms data trial but safety be the any included would experience would terms it data, the and to data presented in patients not in with

So would to the combined group the but won’t answer FDA. be is presented additional they patients, the clinical clinical they trial as with be of -

M Marin

some you giving bit switching of the use training on refresher then Hemopurifier. little a the And topics talked about

challenge anticipate to the it So, any you How could any compromised? and can little that bit data create you is in the there? not that use train do a is generating provide do easy kind Hemopurifier in of this way to more you color of think people

Steven LaRosa

training using the corporal are with with we with Hemopurifier the on extra already our, established cartridge, infrastructure. course along Hemodialysis refresher So our

amounts the made we to for site So prime in the how but utilizing rates. training a training, to prep cartridge use, really what the the teaching the pump are for flow and it

experience is specific site has can but cartridge, one accomplished be training training in to, the site. as for one So the our with with

M Marin

the What is that feedback post received the session? training you have

Steven LaRosa

did the What the procedure. received comfortable University of we that after and performing feedback they is from enrolling Pittsburgh patients the we were refresher

M Marin

is stage expanding potential of applications in remarks in are the that of neck head that potentially and prepared there are one. your or and use all Have forward you of move sending the is do at there in cancers applications? going Hemopurifier? to the for Hemopurifier potentially trials that also other And other thinking Okay. current you stand addition Is to where the on on terms you, now conceptual very applicability discussions the

Steven LaRosa

a role we potential out are number types described in cancers. the those institutions cancer are the now to different literature of play a is to exosomes there in discuss investigators to So Where in tumor development reaching where of well and other clinical cancers. spread

M Marin

Okay. Thanks for taking the questions.

Operator

comes Dave Please Research. Trickle from question with next Our go Lavigne Instructions] ahead. [Operator

Dave Lavigne

enrolling the around little curious, trials talked COVID. just we think I’m of Yes. even of bit about a I kind last time difficulty just

readiness, you device is for or I obvious. is. for guess of you know kind a of others mean, that that know, the, the trials way than Just Has for that but seems in been has obviously, device that. wondering I because nature a of has that to have is, large are address a see another, lot than preparation has, right Hemopurifier things that of one they that is than that a made another. in not longer because those market like been a the the are has of made made longer that has site process number say, fact those others, there that maybe if in the the made I’m or I But whatever one of or about participating pharmaceutical conducting many longer seems form we true, for gotten it there the has that is it companies companies is term that site this process? there have quicker some, you using, you some

Steven LaRosa

is again Steve LaRosa. So this

have of clinical delays you this a investigating any process COVID process, in specifically mentioned, in a fact readiness there But trials not as a versus. number So, that have the are space. device I as through competing go been we the around seen we

Dave Lavigne

but Well, to course cancer you a as side. give you on refresher said, had the

device. to thinking trials the pharmaceutical. So how to process, to site teaching use the obviously, I readiness people administer have includes somebody you I’m on COVID teach a mean, your don’t

So means is I’m longer of taken assuming because that it that.

Charles Fisher

Hi, Fisher. Dave, this Chuck is

weren’t actually enroll are think that but in the making, is interrupted is speed been to to the the cancer said ability the the make a patients. for we was how And wanted patients, I to everything has manner, a they got or COVID, that had And think patients, feeling because what point COVID run correct an Steve gap, you them part as overwhelmed up in, result, on I to for we procedures we protocol appropriate on. there they not with time them site back to smoothly cancer sorry, sure patients. COVID that to using trained the

dynamic what the I think is. is really that

Dave Lavigne

if just made process wondering just pharmaceutical, the a a somebody I’m with extensive more that. giving because that treating has them preparation Hemopurifier is than your understand site I No, process longer? of

Steven LaRosa

trials to of compatibility that We do very cartridge. sites have cartridge. with the at existing have sites do identify are have done to and machines seeking extra that data right, train have then the that actually we critically the been therapies we have out also on And specific use you corporeal of And the ill. have we

devices I of extra is ill population. a and was chosen there with have list they the that clinical there the, trials because of specifically done critically So on gave that sites number you, corporeal

Dave Lavigne

- that totally New this I is is and riding where enough largely of So are one and the Jersey were completed. those site, - process only largely wasn’t list the is fast

sooner? presumably they treating start So can people

Steven LaRosa

is we in are Right there to on open have that a is Beach, we month. They are Center open. one in Cooper other Medical next than task already and site to next trained they sites that site are other in Newport open have initiation. be - hold then few the Center Medical

Dave Lavigne

Okay.

say treating people it is is Beach to Newport now fair so, that then? probably And right

Steven LaRosa

yet in in anyone but evaluating, have the are trial. the they They enrolled as process not of

Dave Lavigne

Thank Very Okay. you. good.

Steven LaRosa

add quite critically number general Delta. they I but And just in patients, of ill patients an would has low. is That their have uptick their of been the like number noticed to COVID that,

Dave Lavigne

you. Thank

Operator

Dr. closing session. conference like This would for question-and-answer turn concludes remarks. our I back the to Fisher over to

Charles Fisher

Thank date Thank calls. operator on you, and joining to everybody us. the today thank call us to discuss for forward you on results. being up for our today QX joining keep look to future We

Operator

has conference now Thank today’s presentation. The for concluded. you attending

You may now disconnect.

Aethlon Medical (AEMD) 10 Nov 212022 Q2 Earnings call transcript