Aethlon Medical (AEMD) 28 Jun 232023 Q4 Earnings call transcript

Good day, and welcome to the Aethlon Medical Fiscal Year End 2023 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.

Thank you, operator, and good afternoon, everyone. fiscal earnings Medical's call. Aethlon to year conference end Welcome am Frakes, Financial My Jim I Aethlon's name is and Chief Officer.

ended At XX:XX results XX, year financial Medical Aethlon XXXX. March PM Eastern for Time its today, released fiscal

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

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

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

of Such Now LaRosa, of before cautions Company contain not news results and to of Securities forward-looking a this I and as hand fact the differ any XXXX of a the that meaning the you Act amended, on the actual call materially Securities to the results uncertainties, call statement. release as that forward-looking may and in please over Dr. as amended. These call. forward-looking this statements the the historical statement XXXX the of The note expectations is are within statement based Act statements that significant risks and assumptions today Exchange forward-looking from is date statements. and anticipated are subject of statements conference

company intend does duty this events the may company's Factors reflect required XX, the on Commission. March can information as annual anticipated to most ended report be or for that any could in Form and fiscal be not Risk differ to Securities our filings statements the year nor in the cause and law, to on XX-Q company's those Exchange in recent found caption forward-looking undertake update results future materially with from Form other circumstances. Factors under the XXXX, the it by Except report does XX-K

Medical Aethlon's With call will to that, Chief Dr. Steven turn now Officer. over I LaRosa, the

Aethlon Officer the Steven and dialing Thank Medical. in. for is Medical you, thank Jim, Chief This at all LaRosa, you of

Aethlon Hemopurifier, and in filtration clinical development life infectious has blood. threatening research its suppression can may Medical bind harmful diseases. action is associated and remove and the of in cancer blood life therapeutic in metastasis This immune that and threatening promote applications from potential a exosomes continuing cancer where the exosomes system viruses

that The trial intensive unit remains Cases in Board currently Medical India to require College, patients Ethics the improve hospitalization patients MAMC are continue site require participate quality a clinical in The in ICU go who for one severe to company's of for enrollment India. Approval infection COVID ongoing to patient at second, COVID-XX Maulana site, care treated activities second and as infection. May activation may COVID-XX In occur of for site of enrollment Medicity received in the to-date. underway. open with Hospital clinical Medanta a high XXXX, trial MAMC, the Azad care on addition

Ethics for of form the of trial Aethlon oncology Medical planned continues safety, finding in inform the development selection sites, activities with the failing finalization that trials clinical documents Management clinical qualification, oncology new solid would Board clinical of Data of case Current this Aethlon a efficacy and trial at design a this Hemopurifier the identification in Australia. will research the company's in Medical to report submission site trial oncology. This indication, organization, Safety the trial its future Monitoring and feasibility NAMSA antibodies. In initiate include underway contract Board. is anti-PD-X believes a data to be in tumors from necessary help to for of and dose work trail

of it that the XX, is On its investigating in use announced market. the Hemopurifier organ June XXXX, Aethlon transplant

circuit, incorporated translational is company into remove can the viruses when determining harmful of organs. from organ Hemopurifier, the preservation harvested objective conducting if exosomes and perfusion with studies the a Specifically, machine

company delayed The the scaled-down transplantation Hemopurifier. in a of exosomes and vitro, therapies viral the company This buffer the solutions, organs believes could place be infection, The viruses harvested demonstrated organ, removal number new graft of increase utilizing following multiple currently and reduce this version of function complications are additive to from that of process has that approach the to rejection. including transplant. previously for may potentially in viable existing

to projected the X.XX% Research, Further, forecast Research in XXXX. market Precedence the growth hit XXXX expand average global at by the is to during a XXXX, poised According market the $XX.X organ global to of that through XXXX. transplantation of Precedence rate to of compounded estimates compared organ $XX.X billion approximately transplantation is size billion period

and Additionally, prime to failure Precedence transplantation to market organ that the growth. products transplantation novel treat organ is Research, according rising factor is tissue for driving demand

to and harvested In beneficial condition. ultimate States, The transplantation agreement. of accessory be element keep all organ programs must the in have transplant a that goal to future in hospitals position Medical's as Hemopurifier transplantable United is potentially the that existing organ systems Medicare organs provider a or research in organ located the transformative area perfusion Aethlon

that, financial discussion to the then for with up Jim I will and the open Now turn call over for back questions.

Thanks, again good afternoon Steve, and everyone.

million. XX, Medical balance of XXXX, had As March a of Aethlon $XX.X cash approximately

an ended approximately $XX.XX for This fiscal March were consolidated million year $XXX,XXX. were professional expense $X.XX expenses XX, that XXXX. of of Our in million administrative related $XXX,XXX, $X.XX for increase March ended the a million, fiscal in operating and $X.XX XXXX $XX.XX increases which was million. decrease fees approximately of increase in And and was payroll offset XX, million by of approximately to to partially due the compared approximately expenses year

devices XXXX Hemopurifier the and $X.XX manufacturing supplies for the administrative million, for year an activities. was XX, expense $X.XX to manufacture related $X.XX to development the XXXX. million or general ended to and various compared and year March of G&A million approximately research March the due fiscal ended increase was and Our fiscal and in research development increase $XXX,XXX XX, The of

the contracts associated with and related from the the approximately recognized in clinical Other out oncology associated as the and $XXX,XXX with NIH; launch $XXX,XXX year in approximately approximately of of COVID-XX trial and of our to and the a fiscal U.S. space. revenue to year Australian subcontract addition manufacturing our of laboratory rent approximately subsidiary this clinical the past full $XXX,XXX the trial; with mentioned; grants Australia close for suite expense office and Steve increases included related expense new in our rent $XXX,XXX in

with $XXX,XXX medical $XX,XXX insurance. and to associated leasehold manufacturing the D&O approximately space amortization and in in Approximately improvements and; depreciation expense

the $XX,XXX, increases decreases We laboratory of also of had an by in supplies as largely result the increased space outside services $XX,XXX, offset increase of expense in office approximately of decreases lease. $XX,XXX approximately approximately These fees approximately of utility equipment $XX,XXX. were in under and and

approximately ended to $XXX,XXX fiscal the compared $X.XX were expenses, $XX,XXX. $XXX,XXX increases March associated decrease with product $X.XX approximately million a and relations, XX, and investor recruiting scientific approximately regulatory partially XXXX in for increase to approximately fees was were the of $XXX,XXX of services, contract prior in in director primarily expense in approximately in $XXX,XXX million development approximate offset professional approximately Our in approximately This due fiscal year in analytical year. $XX,XXX fees legal $XX,XXX fees, labor which by accounting in consulting, $XX,XXX

to ended award final September Institute the Cancer XX, we or presented the and XXXX on NCI. subsequently contract NCI National Medical's report Aethlon required

contract, in contract of out the close completed XXXX the review we $XXX,XXX the XX, approximately NCI fiscal March year approximately fiscal recorded total government revenue compared XX, $XXX,XXX of As year ended the to March in its ended XXXX.

$XX.X increased noncontrolling XX, to interests for factors, year million of above the loss As company's $XX March March mentioned a the for before net the ended XXXX, XXXX. result fiscal from fiscal ended the year XX, million

million During Agreement year pursuant common At under $X.X approximately stock. Market to raised Offering agreement. Market subsequent March under the The proceeds approximately At Offering of we fiscal in ended we net raised sales XXXX, of the proceeds The And to March XX, net XX, our million its $X.X

included and and from March XXXX. afternoon. and March the years XXXX earnings related We commentary release fiscal earlier the of included XXXX operations balance That XX, a XX, statements release the in sheet press this ended these issued for results

Form report this annual our call. following file will XX-K We on

Our of XX-Q first on of the June next with the for report filing earnings fiscal August Form quarterly ending will quarter coincide XX, in XXXX. XXXX call our

be now, any Operator, happy may call to questions. please for I would take have. questions open Steve that you the and And

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

you. Thank

questions. couple a of have I So

you're First you of inventory lot feel How a you there's of have order that at? of to on. all, in looking in going various do studies the level clinical devices terms support the Hemopurifier of

first Jim. space. another in run Marla, new we're be to We manufacturing That will our a completed do run poised and recently, is in this run space. manufacturing our new the Hi

the gone G&A G&A our FDA close, we source excited we're the And So second we're processes by believe, through -- having all about required new of to left. the that. for

think, don't being else everything supply is equal, inventory issue. going So be that an I to

you bit separate make to And transplant us of your space, sure - organ. work understand, Great. give transplant the can field little how this of does organ on guess, I the been be looking terms study, actual just in Okay. device of the you've I new working would more from a vis-à-vis color the

of sure any make talking just about. is what purified exosomes. exactly organ want the to to understand that that kind of ahead of be You'd we're I

Sure. great question, Steve is LaRosa. This Marla. It's a

donor. for been a often recipient is transplant they infections that There's viruses. infections, that vitro. we've can from variety you that the viruses often hepatitis in the in that the remove including infections, those of shown And to viral CMV, are imagine So get space, things risk the at are EBV previously

concern for So is that transplant there patient. a

donor also exosomes transported, organs, as recipient. rejection handled can development to There's being actually downstream lead released recipient. that they're complications releasing from the organs, from in in rejection, the can there's the are there the Likewise, and stressed now basically are contribute papers and to that exosomes exosomes of

put excuse improve that those to the if remove So standard circuit again, the into before that new could you being may because donor placed. harvested organs they're exosomes circuit, by studies is outcome Hemopurifier. hypothesis released or the me, could what organ's infect take actually being perfusion gets this organ of the the And that could is placed machine support recipient are out potentially now you incorporate on -- the perfusion donor the translational Hemopurifier gets organ if stressed, exosomes with you the this, the we're on and for a viruses you where -- if working

So you're between the the It the of harvesting and of be would absolutely perfusion the organs in actual placement would organs the upstream It transplant right. itself. circuit. in space be

time for practices So sounds are during concurrent also that currently sounds you - so that okay. with we would know essential doing employed is this what Thank to that. like you standard maximize... be would be process. like And It it other

No, that's correct, Marla.

circuits, perfusion testing So organs and the we harvested them incorporation to it's would that beyond the the take have pretty machine be on much into perfusion of alone. standard benefits one Hemopurifier circuit these and standard would put additive of machine whether

thanks. Okay.

So we don't currently. Yes. see

you. Thank

comes question Anthony ahead. next Group. Please go Vendetti with Maxim from Our

afternoon. This actually good the Pearlman Hi, for is Anthony. Jeremy line on

last thank First, to I participating actually Maxim you in week. wanted our Healthcare for Conference

I think really great. it was

questions couple us. So from of a

oncology First activities think one for are information time is you you - relating what the could line? enrolling regarding when more know frame they that to patients? provide identification, - have it can performing some you time site trial there's any start said on that a do this clarity the any trial. currently If it like you but more I is NAMSA

Right.

a you'd trial. steps So there's number activation to of imagine, clinical initiating actually as a

in identifying actually and having qualification are important that involved right sites most interested in them now. go those actually the site visits, through are of we're the Some

submit big somewhat understand to the United in do Board process what the other hospital's then the notify the opposite of from Australia, approval in States, it's sites since for their so in the regulatory occurs agency. you step, The Ethics and just trial Australia,

the important the that So approve order all Australia to going in have maximize that the Ethics Board to it's documents your is study. in you chance

actually submission. getting best all we're for So documents in shape their those

the The calendar So forward enroll is have the we such hope the by go to that could we should I year. we're that end doing is process goal, someone say, this that. of -- and

Okay. Great.

end of So XXXX.

then investigating. just transplantation this and you're -- organ market That's jumping great. Okay, new to

compare you would how to one which the term you commercial view as So your now that opportunity oncology, nearest do potential opportunity?

fairness, the towards in - patients enrolling the a say I'd clinical trial. headed actually in where oncology Well,

and a safety to translational done likely be For we of studies clinical have do preclinical of the a trial. anticipation would in that transplantation indication, have studies number

because So they can now studies. these studies quickly translational very laboratory done be their are

we So can go. in they transplantation as likely fast patient would oncology go trial that But - the as trials. be a before it's the an enrolled

will oncology be trial. in there Jim, Also, several Jeremy. an This is steps

safety efficacy how the need is trial. what transplantation people. organ many trial, steps Steve on - the not initial preliminary the take to of project. and then am organs a larger We we that have have with we'd and was mentioning tweak sure it work I dead just All

So organs the FDA course. They that. are would be into transplanted be involved actually not when on would involved of patients, the

do need lot can the work I whether the a efficacy safety an unclear. of help. path faster And It's we a and know. we're Do to we one? who potentially then how need knows, could trial? be than we while starting do - many So later FDA's to market, without more it But the not trial, than market. cancer trial

Understood.

I it, safety. I would blood from there be the - remove any know from be organs last then is question. clear clear able and these and do it's and there Is reason studies it not just have don't to you and comes an there to be why the the these I any get safely organ, that exosomes from mean, think and - we many it efficaciously one otherwise Okay. But organs? can when do believe And viruses Hemopurifier this to remove the because historically, just reason safely viruses to it's without humans. Hemopurifier see exosomes Is if otherwise efficaciously. would should indicated and to that

Right.

will and those that have there's right, to circuits, - high the a would out that solutions. we have necessary from studies that's yet been we'll suggest in We solution. studies bear you're that it's yes, we in So we think remove used high are That step. not past vitro viruses on done likely highly perfusate those being those the viruses perfusate able removing But can and - used that studies the from exosomes translational likelihood and exosomes. our the have that simply remove be a

new Okay. Great. It's an exciting potential. opportunity market

hop So the thank for you taking back in And my I'll queue. question.

Thank you.

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

our and Goodbye. everyone, for keeping to discuss you, we fiscal on Thank year-end calls. Thanks joining up-to-date future you again. to today us look forward results,

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

now may disconnect. You