Aethlon Medical (AEMD) 14 Feb 242024 Q3 Earnings call transcript

Good day, and welcome to the Aethlon Medical Third Quarter Fiscal 2024 Earnings and Corporate Update. [Operator Instructions] Please note, today's event is being recorded. I would now like to turn the conference over to Michael Miller with Rx Communications. Please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Third Quarter Fiscal 2024 Earnings Conference Call. Miller Communications. Michael is name with Rx My At X:XX p.m. released for XX, its Time today, fiscal results Medical Aethlon December Eastern third financial quarter XXXX. ended

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

Frakes overview of recent Officer, Following company's then Aethlon's Aethlon's will Dr. will and Financial Steven forward-looking Officer developments. and Frakes; an the Officer, this LaRosa, for Executive the open James brief Chief of Aethlon's the some statement, and remarks and We'll Chief introduction session. financials. Mr. Aethlon's up reading strategy Interim call Chief the make provide Q&A Medical on then

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

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

Mr. to Chief call Chief now Jim? that, Officer and I'll Officer. the James Financial Executive Interim Frakes, With over turn Aethlon's

for or finding Thank you, long-time This an the expected Mike, Hemopurifier October and targets and monotherapy is by Jim Phase is the I India, subsequent I'd Controller of trial such with like feasibility of or the DCGI, respective during CFO Drug you country's patients the Interim XXXX, KEYTRUDA in tumors a progressive Medical. binding Aethlon and completion Authority following Central from anti-PD-X to Frakes, of to and stable have in solid of approval relevant sites begin Aethlon of or who General In as all safety, dialing in. disease of clearance received The in Drug ethics conduct dose thank of Opdivo. boards study vitro treatment, trial to India. interested CEO

interested awaiting to we Australia also sites are data X addition initial vitro that India, from in have the an site study. our in In interested in binding

Our the of study binding stands is of oncology relevant targets and in vesicle science. cutting vitro edge extracellular complex on

provide plasma been anti-PD-X to preclinical treatment is in evidence potential quantify of have from on goal to who support cancer our with design. Hemopurifier Our order treated impact trial monotherapy our to patients the

perform started have continues team parallel, to data, to in date third-party R&D independently fine-tune while work, quantify our on has internal are assays our engaged the inconclusive. While results team we Therefore, internal the who laboratories several their to our now samples.

a through study infections life-threatening to the -- treatment Hemopurifier viral our of India. study the continuing also as COVID-XX trial in against use our are We

or Azad We Medical Medicity Hospital sites have College and for to Maulana has the participating trial, been treated patient One this date. MAMC. Medanta X

in subvariant contract India. has Recently, been we that have a been COVID-XX informed by organization research detected our new

in open units participating to there at our COVID-XX intensive care the trial Our event X are India that remains in sites. COVID-XX the admissions

focused our our have Chief Interim named as oncology reducing ago, expenses. as well program Executive X efforts Finally, on being on since Officer I our months

transplantation. some organ As Hemopurifier the disclosed in data previously interesting we proof-of-concept preclinical of reported,

do As or for data. plan one a result, transplantation to more our submit we articles preclinical publication organ on

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

Thank clinical make India studies to team strides continues in The Aethlon toward you, Jim. oncology in Australia. initiating and

successful reversal reminder, a will treatment as interested will initial feasibility budget India. are of the negotiation. antibodies examine known the agreement safety and Three in immunosuppression. Hemopurifier the Australia Hemopurifier in by sites trial we have As have in and also been the of identified studies and Two advanced site The patients the completed anti-PD-X sites following removal in not and responding clinical SQV. an or cell visits, effects And trial one qualification exosome of who of are downstream examine these XX-day Australia the to already on CTA, T X in period. stages

the known to consent major each documents trial approval main [ informed IPF one, patient the The X committees The CIB. ] brochure the that are: milestone ethics site committee. enrollment as two, clinical as and known and the clinical is informed activation -- by hospital's examine the three, the protocol; these investigator

the can the informed the of in results finalized finalized clinical consent vitro binding be has protocol The and are once team the Aethlon studies documents. The investigator available. brochure

the for trial, plan, including short, are In are Data Additionally, that Safety case completed. the EDC, activation plan form the Monitoring the studies electronic the monitoring statistical known safety our important and we site independent poised once in analysis the of Board documents other charter the necessary finalizing will are we as conduct for vitro report use. the

up that, the With call open questions. for over to turn the and discussion, back I'll financial it will Jim he for

afternoon good and Steve, again, everyone. Thanks,

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

common January, through at-the-market raised approximately During sales program. $XXX,XXX December stock under and we our

been such quarter. my I more not to a high cover expenses level remarks granular did as keep on bit I've on encouraged this basis, I previously a will as our Now to calls, try prior

our information earnings report soon-to-be You in XX-Q. hit will statements or on expense just quarterly our the filed wire in find detailed Form that to financial attached release the

and $X.X due December approximately and was an $X.X were professional for increase of to X expenses Our period by approximately XX, XXXX X to million $XXX,XXX, the offset related consolidated in XXXX. of approximately fees months approximately $XXX,XXX in million XXXX, administrative increase and ended XX, for months This the XX.X% compared in or of December ended operating expenses payroll $XX,XXX in of $XX,XXX. general approximately decreases expenses the

increase related of decrease The CEO expense primarily due an $XXX,XXX payroll $XX,XXX. increase associated our increase headcount. in $XXX,XXX in in with to expenses average former was by and and expenses compensation in This offset was separation salary stock-based of for a $XX,XXX an of

in expenses that and primarily decrease and expenses our our payroll XXXX a the general of manufacturing The expense increase a period. actually would with decreased Both expense overall for our I'd the clinical insurance $XX,XXX without increase was from supplies CEO. $XX,XXX expense to separation and was have expense related That CEO. our note expense. to in health in $XXX,XXX $XXX,XXX. and decrease approximately former expense was operating that related trial in to Now of agreement insurance included separation in like R&D due former increase the decrease That by offset $XXX,XXX insurance administrative to a $XX,XXX accrued

expenses, in a in stock an of related offset due primarily the scientific of $XX,XXX These to the increase $XX,XXX addition $XX,XXX increase net increase And fees the director, $XX,XXX associated $XX,XXX legal reverse split, a general R&D. and by decrease $XX,XXX recruiting was in in a and a and decrease fees $XX,XXX labor decreases in to in fees. in investor were director decrease new a related decrease relations consulting, a contract $XX,XXX in marketing, an with professional accounting to decrease

and balance XXXX, afternoon. release $X.X in expenses ended in issued in related company's for our that December XXXX. press results the XX, the a from and earnings December months December X net operations months XXXX of earlier $X.X XX, the release the million I the ended XXXX, As XXXX. months sheet of X these ended statements for just X We increased changes the for the and included to loss result commentary noted, included X XX, and That XX, million this December

following this call. We will quarterly on Form report file our XX-Q

the call will with Form earnings quarter on fiscal XX, fourth next March filing the ending annual for report XX-K XXXX. Our June of our coincide XXXX, in

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

first Marla from with comes question Today's Marin Instructions] Zacks. [Operator

a couple questions and So of I housekeeping one have then question. picture sort broader of

trials enrollment continued India, there an in cases, COVID COVID regarding will your in that if patient your in is there? for So uptick it easier trial make

you that want do take Steve, one? to

patients. The Yes. will for recall, ill is you as severely trial,

the in patients are those caring. intensive So

translate from population is the variant. JN.X what don't for with going or new open our know if that's sites critically is But CRO variants into this are occurring are and open know enrollment. the we cases yet that We ill not. to So

ICU, the in are patients able those enroll we'd if them. to so And yes, be

doctors have have awaiting Hemopurifiers there we trained. And to been

Medicity Medanta using have of deep the Hemopurifier doctors the very in experience fact, prior In trials.

to ready, It's speak. just the critically the they're So at whether or population there ill is not. so patient's

That question, what just the have clinical all least that support at sufficient a number to said the we leads is, moment me also, hemopurifiers another of term? near Okay. of you which to efforts to conduct in you Jim, to looking understand are the that at you're

planned ] X -- India an that's at the But those loose of We have cash unknown. in trials. hell do a Hemopurifiers oncology do all COVID, [ with If for we we waiting broke sites.

to outbreak to a a with of need cause in massive So ICUs problem. it would lot be the a people

I we're good actually, think Marla. So in shape, pretty

going with CEO. fourth Okay. that the from any are Then the one-off about in associated spill one-off separation the costs you third talked Are there quarter, expenses the over some one-off costs quarter? into former to

was was company. the costs in accounting those treatment which December analyze book No. accrual he The quarter the which left quarter, the to all into the and

didn't that him go accrued did. be period. a large as while -- paying will We're the it a that So year. portion just and all severance We've it paid small out sum over -- cash, XX-month not over out

file on have XX-Q our that in go report quarterly extensive on that We shortly. detail pretty we'll

So I'd interested take look encourage a anybody footnotes. the that who's to at in

it. Got

for me. And Okay. last then question

patients, in in you in access plasma response forward see us treated and if moving preclinical ] order trial, you being how get these you oncology the to to involved? those treatment, when to on with parts? work. pre the So obtain are the [ cancer Hemopurifier some Correct, move able plasma enrolled need some to give patients from do is said just order Can patients color you're that How anti-PD-X work from you vitro the with the to used.

Yes.

The for So are have Marla, if work patients. plan, the of sources of the is there from cancer will, already patients preclinical studies plasma kind available you consent. the signed commercially

agreed use they've allow theirs. of So the to

exosomes like particularly patients Hemopurifier PD-LX acquired have those over then count run We therapy. samples and anti-PD-X T a effects and of who we've with of exosomes from So then on cells. with we treated plasma things our those version malignancy, been smaller and

-- we're that's in, answer definitive process studies. from getting a we're on the we're So that and still working those

question with [Operator Instructions] Vendetti next comes Group. Maxim Anthony Our from

Thanks. Yes.

just the So U.S. how right, at and through Jim, in just patients the over bringing many results over to are on this again, those studies point India, that help, should go enrolled

including are be the critically patients affected is Anthony, there has the the it's now for agencies. X-X ill. designed COVID issue patients to enrolled who but date, useful study, up enroll But data the that, again, to yes, can evolving that's to submissions in with XX, which aren't open COVID been the data, one would one regulatory epidemic, right the who biomarker are we've manner a

study. So -- and the population that's for the eligible that's

and prior use FDA accept data. studies did the in And that India

So it's useful information.

a said U.S.? the prevalent India, U.S., in the you different the found now in variant one than JN.X they most the that is in So that new

it's are No, it consequences is the JN.X to translate to finding they're and it's predominant meaning, I'd what going downstream going the the they more is ill translate. say, patients. critically Is know it hospitalized clinical don't to and to be going what

now. right unknown an that's So

oncology of in And data? Okay. done being then the that trial Is in Australia? terms

be is vitro planned the to to to to The often one in get in akin and safety be to Again, trials in have going feasibility conducted dose those be ethics studies, trial to data India, going one awaiting our Hemopurifier to individual you finding, going we're started. Australia. -- are how conducted the is studies treatments. give to X voice Those submit

Okay.

this point. So neither are started at of them

Okay.

That's correct.

count to a the the couldn't ago, extracellular they vesicles we months can That's That's They X just way we've CEO. have it's been poised they pushing are. but inconclusive. I've now bottom effort. on R&D and why get engaging the of we're aggregates, outside total interim PD-LX to where come exactly this, the correct. -- since the I extracellular on count named really labs hard -- was And even We're long on Anthony,

activity And to reiterate a whole of trial. a there's there's done that to imagine, to Jim's start and so Yes. book can a be -- point, have whole you

been if have dots go. And those fit we to so that data, it of one pushing we this is to get we've so once every can go

Understood.

Okay. think that. that I is at -- And on Is just maybe little know an then give of that's the where on mention organ end more on update the you but your update oncology remarks, progress. I the an me -- just lastly, Is taking a maybe that did color just priority, prepared at. transplant

Well, did there organ as was effort the oncology with highest to but push I transplant make the momentum work. priority, the

write do additional And generated stuff. It's have We or plan to we data. articles. pretty interesting one more

head senior their people published. enough around along the the move oncology data. to the articles get some studies -- and more written of getting their -- that with have wrap the try can this We far the We're

We So talk on trend. have transplantation on well about that to things very future we the haven't work. calls may organ stopped

lives working transplant Are you still with the on side? XX

not private know. company. knew. have move -- agreement if They've we're them know still where think and But time them. with their But business. the I I about may are. still coming don't a it forward we soon. things publicly, yes, I getting We are We talk be with we're even oncology really collaboration They a And they're to gotten have may with -- We've their clinical that they the working busy couldn't now going busy been but It's don't the stuff. with -- -- been our going. we trial

ladies And Jim this remarks. to to and like you. the session. I'd gentlemen, Thank the back conference for concludes question-and-answer over turn closing Frakes

joining quarter today our up-to-date for again We us discuss forward on results. Bye. you you end calls. to future to look Thank keeping

We attending thank today's call. presentation. all for today's you. Thank This conference concludes you

have wonderful and may day. lines, You now disconnect a your