AEMD - Earnings call transcript Q1 2019

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Operator

Good day, and welcome to the Aethlon Medical First Quarter Fiscal 2019 Earnings and Corporate Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, today's event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. sir. ahead, go Please

Jim Frakes

Officer. and first fiscal everyone. My year and financial Chief Jim operator today, Eastern Medical's Medical ended Aethlon name to June first Frakes, released Financial Aethlon's am quarter XXXX for I X:XX good you, P.M. Welcome time it's afternoon results Aethlon is At quarter Thank conference XXXX. call. XX,

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

Aethlon's the recent reading on Joyce, of then Following CEO, this statements, of and Jim provide forward-looking strategy make introduction developments. overview an and Aethlon's financials. remarks will our will some Aethlon's brief I

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

in call the Securities Exchange Before of the over historical Except note update cautions circumstances. over nor it Mr. company to forward-looking forward-looking Joyce, and statements to I of future this Commission. the the Medical's filings and please undertake Federal XXXX I may to a the caption Factors from any this XX, in from turn as within and XXXX. any forward-looking for of Aethlon March Jim Joyce, the the anticipated Risk to you results those Such call statements the call. fact call or in XX-K fiscal company's that the as required meaning Factors forward-looking maybe anticipated statements. Securities that materially materially the Securities on year contains not risks the intend found statement results to results statements and conference and in Act of could news ended by Company company's that The under does that, now events does CEO. hand this Act be that information differ forward-looking release reflect today is other will duty significant is the With the date not assumptions Annual differ XXXX statements of Form statement. the are are to on and and law, cause can with a Report the actual statement Exchange of expectations based uncertainties, These subject

Jim Joyce

published. viral updates expedited Human status cancer I our advance pathogens. program on outcomes breakthrough in year. XX to our In are at life-threatening breakthrough submission can weeks that Thank the you, not guidance interim the first the treatment leading have FDA breakthrough care, formally has Based new a human has program device and published law. the of update allowed On guidance was life-threatening FDA's last October our program is it's therapies, communications to aligned to recent of draft our countermeasure draft XXst fda.gov. been of our Ebola afternoon, which which to Century already which the include Act our use breakthrough existing into viruses access treat based program with clinical The approved life-threatening introduced pathway and draft several guidance FDA provisions online final on Last device the life-threatening established guidance life-threatening the related FDA device the use near-term new we good are broad the candidate designation the advanced the and advised implemented everyone. that December of device to Under FDA policy and broad Exosome broad diagnostics designated a the three spectrum our our we disclosures to spectrum document supplement Hemopurifier in of our have pathogens. until HHS's device again the Department treatment FDA will aligning that compassionate to indication viruses for proposed then objective that against the of be on for as In countermeasures were which described IDE a our in XX Sciences Hemopurifier fulfill designated no against to intended compassionate use year be implement approved to Jim, treatment with an a there signed viruses, virus. advancement program glycosylated designation propose indication Hemopurifier the Cures to details being document subsidiary. for spectrum the would and to objective. use believe to FDA In Services result September we being of objective subsequently program Health is on viruses. HHS's to Hemopurifier include considering in-vitro other an the to & fulfill life-threatening study the be by of last supplement related accessed regards by expand The

the they care, in to in life-threatening cancer When circulating ago, patients. that and to become tumor-derived exosomes many beyond deplete viruses our life-threatening we other of reach parallel had Ebola. the community cancer space, emerged device that Tumor-derived have like of expanded our the exosomes breakthrough conducting to research valued a use to assurance decade more than our However, we of significant treat compassionate yet the to specifically, the biological viruses Hemopurifier cellular more provide with defined debris use highly supplement approve address the several no studies than cannot our initiated consensus to FDA remain advance therapeutic cancer unmet beyond function. designation Hemopurifier the use presence we a effort In will any targets candidate been of drug therapies. reinforce our was need in medical exosome have nothing were more exosomes

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have many to [ph] Irvine University initiated recall among study center. delivery is In a As and cancer clinical of we to our cancer. designated of NCI pleased that subjects gastric, California ovarian the that head taken you that enrolled programs, Cancer neck, of clinical study we new know included total, I'm report which XX have it relates patient four the with that exosome we I an several breast, Institute for XXX disclosures. samples cancers and evaluation.

cancer demonstrated our Hemopurifier exosomes. So in-vitro has is far our samples from subjects have and effective evaluated in that research head and team the neck depleting

and will in just submitted this exosomes inhibitor which contract Squibb researchers reduction to cell X exosome that a Phase we fact brand checkpoint University funding. observed for has scale the National regarding by human this study, protocol name Hemopurifier marketed us observation, we the Center. In a the Myers to is Cancer of study with results outcomes been study NCI the with to collaborated contract benefit head Cancer Also our XX post melanoma-derived deletion depleting we and carcinoma; hemopurifier capture a Massachusetts of demonstrate contract to high June Institute Regardless NCI a under prove to if the early Hemopurifier determine collaborated Phase goal Nivolumab squamous end fall. research general the proposal would to to protocol to that a neck University we this the small and National Center mechanism X has the our is Bristol they XX the of Optivo. with on encouraged Pittsburgh, have that immune respond Hillman tumor-derived reinforce in metastatic exosomes. entitled to metastatic minutes. of a responses Harvard treatment is therapy, subjects of levels affinity improve Anderson Pittsburgh in Cancer of author Under team MD Cancer The XX% these Based melanoma. Related outcomes to melanoma exosomes concluded the related early to the of these our at has Institute,

once exosomes the We proposals ovarian other or Institute awarded. which demonstrated National have breast with of are have they underlying Cancer the and and disclose pending will related exosome also capture cancer, if we

acquisition has study Translational enrolled of the Sciences colleagues was now that as Friday next for starting Jim $XXX to our date back former June. transaction X to said, now conditions exosome the to relates this at disease evidenced our I is of Research NFL or discuss in our upfront Frakes it emerge X regard that the CTE industry might enrollment payment. who to XX diagnosed in And A.M. With at Genomics to which will P.M. The million quarterly diagnostics million or pass of industry it cash diagnose As our was exosome biomarkers late over an will in value results. monitor diagnostics Biotekna's $XXX that Institute by the seems players Phoenix, our Exosome subsidiary, baton from be

Jim Frakes

three At a XX, for months XXXX, had we a of and good afternoon of or compared the $X.X Thanks, $X.X XXXX balance per $X.X share June million. The for $X.XX XXXX. $X.XX million ended approximately net to everyone. ended three approximately or XX, net Jim, cash again months loss approximately loss million June the XX, per was share June

During the in June National our we've months Institute. recorded three revenues contract XX, with under Cancer the ended $XXX,XXX XXXX

Consolidated an by in months due combination decrease expense rent $XX,XXX fees offset $X,XXX was Relations which was our June and in a to to compared expenses government of approximately June We XXXX. other $XX,XXX. XXXX XXXX. increase the our approximately $XX,XXX. professional $XX,XXX and administrative and recorded. by contract fees of scientific related were to our the million was partially payroll and subcontractors in in put other Aethlon's And addition of of $XXX,XXX had expenses expenses were partially decrease and primarily ended A and ended of $XX,XXX for months XXXX payment smaller due in commentary administrative our of for were approximately $XX,XXX. expense ended million professional reduction. of due June in ended decrease was sheet professional our fees of professional to Investor XX, fees June Those the $XX,XXX $XX,XXX earnings a $XX,XXX in by due under of three our in $XXX,XXX in in increase offset in $XX,XXX to the members XXXX release in The fees fees decreases expenses a new professional The increase revenues and approximately a of $XXX,XXX release statements months three to $XX,XXX XXXX a at general and and which fees. $X.XX months XX, the in During stock-based expenses increase in increase XX, XX, fees. fees headcount a professional expenses. Sciences was to due increases of consulting compared contract. primarily to related payroll increases into related compensation, in were $XX,XXX ended the out and XX, from a a the in operating NCI the Exosome costs our number payroll reductions $XX,XXX offset $XX,XXX $XX,XXX and includes this increase board We other expenses earlier June afternoon. operations decrease which and a in $XXX,XXX other an marketing these June in increase three to June reduction and months in our of month three expense XX, related XXXX, board $X.XXX That our three in approximately The the periods of new was press three general increases partially The due increase increase in XX, approximately approximately XXXX and fees included balance legal cash-based

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

Operator

first comes Instructions] Brian Research. of question from [Operator Marckx Investment Zacks Today's

Brian Marckx

Jim, I status didn't the you designation quite pathway device grasp with FDA. talk was breakthrough what discussions the of about Can that?

Jim Joyce

related have at designation ability established to controlled device others it benefiting you to many advancement to with been clinical such drugs to us discussions such provides pathway, new of patients which therapies, with which relates it's to not you previous intent, viral truly Well, the as published, addressed -- that highly and the from to been the therapies know, communications earlier and difficult know the FDA and recall have the provide Sure. The our very ongoing specifically it expedited as studies that issues may breakthrough as run products designation we've other are are in virulent, we've the relates as against and we've access clinical to they as what original provisions access appreciated. to pathogens threats. rapid

therapies, so breakthrough like the final mentioned time final been October program, at a the waiting real the provision while trials. breakthrough saving the their they has lot of are no be their last being published of the product. FDA is their was final programs designation device provisions occur new are guidance is specific people breakthrough in approved life related the where advanced especially guidance device draft So in we cases has of formal December collection is documentation be able occurred publish implemented yet point and access in to there to we through and at that legislation clinical implementation year. post-approval or FDA to guidance to earlier formally in when the data their There What data the can published XX on to how to collection, specific program; are world provided document least not in others of I published but intent in XX will not to publishes has the until cannot results by guidance the identify the have that as program FDA provisions, this implemented documentation programs final and device for new

to will So through IDE our is that's dialogue to on plan the other near-term potential FDA. we're with pathway treat viruses, to in Ebola hoping believe interim our it there we use based occur in that expand supplement, compassionate a We include approval a something pursue. to the and

Brian Marckx

be guidance draft of supposed has factor? to of was at gating published -- guidance, a new was the been It the end always XXXX. that publishing So final the

you said August? certainly think I

Jim Joyce

we that formally factor based guidance were But a on draft we were documents have breakthrough we now final that device established implement gating provisions publication. to that have the was aware introduced published. the Act believe guidance documents FDA Cures to the program through because operating it their Century communications under under XXst the the we've today in they learned new Yes,

Brian Marckx

your on now -- stand? device characterization that hold breakthrough under right discussions So fair they those is essentially of a kind are where of essentially designation guess; are I

Jim Joyce

today guidance people it program maybe submission even device we the such published. were submission getting somebody indications is other they'd pursue that of an submit trying the published. breakthrough doesn't benefiting component breakthrough the but are submission an of submission a pathway program division have broad was FDA which of have We're device consideration device expedited this possible which the to pathway the would for breakthrough breakthrough benefit to example expedited I believe can't exist, effect, And guidance a just that communications is as be and to an guidance to -- I to try expedited device from as final the access the implement for provisions FDA be we if operating device was FDA got that for of other in until example, though potential access they to access And cancer. submission that documents indicated very would with transitioned a consider we we're program on waiting so think transition that mean of we that is discovered submission program some device actually that still opportunities because we're an actively has number matters, then pathway from final a breakthrough through under in of breakthrough

that it and navigating something it's now. sound through right but is it So confusing may we're

Brian Marckx

then terms And have you timeline submission the kind filing terms kind include supplement for do when you support the of the submitted? what have approval in then the use of and [indiscernible] do And you to in of compassionate support of may for to think in expect to for a supplement? beyond the you Ebola,

Jim Joyce

quite is Based what now during call, we put the the days. that use to next program on would it's submitted expand the of have use This to quick just submit be And the will week important that supplement complex if again, treatment no the submission supplement locations FDA our of we're we a and referenced compassionate but it's site because is is think that could this should to life-threatening program device not number treat expand be these we right assurance life-threatening looking that IDE breakthrough turnaround the an be there be is viruses to active XX submission. viruses to but threats. to a within treating data number highly the objective compassionate is And as the against us provide for in of the which to means position approval be communications able something Ebola. in already increase the which a is to other collect able our to should

we're optimistic the and been could So in I say we've also challenged you -- we're guess by, breakthrough we the but device we're have that that of timelines optimistic. program are so cautiously cognizant occurred

Brian Marckx

broad you of in highly supplement, risk it just target? targets or do the then a glycosylated the And is particular sort

Jim Joyce

the that demonstrated list will in-vitro already a ability among targets will we've we viruses capture. at minimum Yes, the and are specific that targets they be to

Brian Marckx

And people you XX there target then on that is the right? study, was [indiscernible] the still said is today enrolled and XXX,

Jim Joyce

The saw support to the target player people the to we CBS had day, first of that a is from will community enroll a should there kinks site participating we in all get Genomics to himself we kind be Wilcox local players XXX, Research be Friday expect and filming our kind out participation. out. We've sportscaster great good Phoenix, using study the on pretty in think location good out do the of how get how Translational of to Institute, the know and

days I so it's had along three already, think moving we've enrolments pretty nicely.

Brian Marckx

And involved is the going expect study? sites that's just have to do online in be or the to one you it hope additional or come site

Jim Joyce

located cities sites have where that online other there hope sites we former No, and concentration players. to of in be is high would come strategically

in Sciences looking talk we our at exosomal and color, this to thing biomarkers disorders. we cancer by when The Exosome about some neurological we add diagnostics in talk and just about I would subsidiary, provide started other biomarkers,

and inclusive or a know targets. looking Alzheimer's when which might never our one published expansive with to out these be the a more I exosomes be But we because than we've are current cancer XX might cancer, protein proteins Alzheimer's to a up individuals. of that might so tal of exosomes this really published therapeutic also until And at -- our these in of also while it a observation a bring types of biomarkers is think beta goals but certain Sciences living an pointed targets. or think Exosome seen study was our of manuscript we of so is targets study disease biomarker trying might amyloid Sweden equals CTE, significant small or a and that target that about monitor that biomarkers be CTE significant disease, group three is talopathy subsidiary therapeutic objectives that initial that show this associated ago it [ph] does we be much much target And transporting tumor-derived in in [ph] Parkinson's; in is identify is and cause weeks like expressing exosomes evidence primary therapeutic therapeutic the

Operator

question from Our comes Yi Chen H.C. next of Wainwright.

Yi Chen

coming how so or IDE question; the first expect much supplement quarters compassionate for My the -- of be coming Hemopurifier do used units you use, let's once submit you to year? in say

Jim Joyce

containment Congo Republic is here I know States, in has there now but in that treat there most we outbreak, are U.S. the and think to outbreak What centers able outbreaks with are that's on treat recent centers CDC XX We you project U.S. Yi as another ongoing point a viruses the in which for historical by don't that of is virus of facilities be to viruses don't West have -- we containment. spread outbreak larger Nile of a no back have now we lot projection. high can't do at in infected is so a we by here life-threatening number states is again we we just pathogens this is But -- driven viruses designated that the it have high-threat can't projection life-threatening time. but high when the the there to to the challenge much there to in of these know containment the predict require therapy; that XX there and is available proven related an predicting is which Ebola; is that now of people

Yi Chen

in used will is Medical Hemopurifier Aethlon units revenue containment generate one those if facilities, are correct? high that or of more

Jim Joyce

if we focused choose also generate programs use collecting compassionate under that data. understanding on but we revenues can our we're certainly It's

from time, So revenues [indiscernible]. there is us again upside -- at to point projecting no in these this

Yi Chen

And there also the is we happen probably based of end guidance cannot when reasonable I FDA's said regarding say expect you've that -- that XXXX? to final what although to you -- guess but on by documentation, happen it is can't will

Jim Joyce

dialogue and published. answer early We provisions communications don't guidance it just the on to those final question waiting. has to have the with a FDA clinical to It's our -- be regular we've have they pathway; very been And that in whereas most lot been focused a -- of under dialogue at provisions with program, obviously not published was to the access asked have upto FDA everybody lot before that the it's expected the like so benefit we device believe provisions with therapies breakthrough know. we're now, the from. the our much on long will when the and provide expedited the of access expansive is to expect spoken they seem folks speed been least But it explains

Yi Chen

the use for And mentioned a UCLA is or… investigator-sponsored cancer study; that the of in you Hemopurifier study

Jim Joyce

infectious you means a at what patients the is as we're and circulatory we to and of progression with to changes a cancer there cancer tumor-derived we system. good different disease exosomes It do therapies. initiated before where a correlate had after viral levels presence a tumor-derived not have at capture investigator-sponsored principal only don't to is circulating look response to disease -- in was the potentially of quantity is. to exosomes where study, be believe at know amongst study would look as this tumor-derived investigator we want the is monitor Nelson. load therapy exosome being And of We going in but if exosomes Dr.Edward we correlate the is looking not fortune It therapy they --

biological structure same have difficult quantities in the the late that circulation cancer and you that sharing why monumental predicted and we immune If mechanism across disease, ago was a time which more and But just late-stage with when right in help period the of community data was a that spectrum potentially were of even we surveillance of exosomes repurposed don't know talking therapeutic payloads using are harvesting reel-in to so to to gave exosomes very Hemopurifier cancer glycosylated companies following deliver that cancer, neurological it the explains patients. the saw at infectious I a us this it's be drug advanced delivery. growing a evolutionary did you're again, medical looked collect exosomes cancer late-stage cellular diagnostics to when for them system, be we've very and we no and function, time if that about than and kind the field. to because any prediction can with it's decade consensus of exosomes we at therapeutics, condition debris viruses was our an expansive evade yet same good in it's

Yi Chen

And be enrollment when know results likely from you the target of study? this Do report UCR we'll the happen study? to

Jim Joyce

on working of ended and point study objectives on so focus different head on for at was at but levels far of the did study UCI to priority the which looking the on point Pittsburgh clinical that Center leverage to samples higher enrollment, our based out one in submitted to in-vitro based provide in that's of point related in a exosomes we Hillman changing completed study the Hemopurifier of that this tumor-derived for quantify validation exosomes four We've cancer; patients. the time of stages the collaboration during collecting so we're funding. the this time and time at the sufficient the neck samples to receipt types we've proposals different further we're of in therapy advanced corresponding under advancing Cancer in have NCI protocol been cancer those cancer evaluating meeting now data other thing with cancer these terms University ability of we a capture in of helped the But support that or we was their at colleagues

Yi Chen

in confirm XX% XX in you prepared your were numbers in you enrolled this remarks. was XX subjects just mention exosome untreated achieved to Did minutes? the of in and Just some that mentioned study reduction

Jim Joyce

had up Once approximately in that was XXX levels we the study we of with enrolled small cancer have small far to face that effective to of are affinity that a subjects demonstrated Hemopurifier with so the we demonstrate scale so resin our in timeframe. risen validation in tumor-derived patients set do Yes, and look depletion resin studies capturing. it a a exosome and evaluation XX% initially we demonstrate and we provided we we reduction head for us closed do likely is scale those neck that a into XX rate to captures the exosomes and that move then a very loop we XX-minute where demonstrated what

Yi Chen

question regarding when the subjects? CTE do of XXX final complete the you to And study; enrollment expect

Jim Joyce

-- make to the efficient We to -- ongoing, out pickup have Alumni that, I enrolling very I in think members predict enrollment we we past that's in a the at enrollment, can't going the will know look to add as two but move summer complete and from have but in Phoenix TJ at we we are the sites Association need and of we're subjects kind of really but we probably location Phoenix media least NFL in the more think terms of received challenges we've enrollment. support in we've figured how good to and these of programs different dialed the there more

Operator

And our from Robins house Catalyst Research. Marc question a with for next

Marc Robins

or Didn't it bat that patients the a commercialization concussions, sure because expedited rather get require knock test for couldn't device a approval drug not if was the will. a really the that receive remember program? was technology a where the I'm -- would certain breakthrough and was but not Jim, expedited given allowed and essentially subjects on a they through access this or or don't patients, head device with baseball situation I to the if you

Jim Joyce

about breakthrough about I life-threatening then understand Yes, all earlier were to goal a and I to said they To corresponds device a for The file though pathway device the oversight pathway wanted the provides and need clinical breakthrough they still provisions expedited breakthrough get mentioned their device well have excited the kind guidance is XX read and to was [ph] the an the device going -- had access as conclusion pursue guidance That changing became I our blood with program was been submission; in you up search clogged is final of the of in programs. present want published been their program, part draft to that's the optimistic people a device into the a why as read fda.gov you blood back the biomarkers get therapeutic and last which the with breakthrough convoluted at breakthrough final new these of mean, the towards if really very access any moving human for I some a that ongoing program. encourage introduced we were to again, I on that somebody to clinical moved based which to implemented breakthrough movement division study very has biomarkers point document it's October soon. commissioner to see expedited to -- access pursue pathway program known of biomarkers access program. the have just as designees published this eight been diagnostics expedited was to access was therapies time in a for of hopefully Marc that have an actually for were based we'll on today believe And but designation you'll breakthrough want see expedited we access policy, to today designation, program the approval of biomarker, which you concussion device time then to therapies, fda.gov two -- and provide were guidance expansive had pathway But and introduced that transition the to to FDA these years looking which and at documents. everybody it's and test why programs. provisions go those getting blood. pathway the to and on guidance at programs levels to patients into the they trying company, to documents about program CDRH if just Google, commissioners about breakthrough that provisions designees But provide do they the I about even FDA's the to provisions, patients device that the excited surprisingly earlier year -- breakthrough so that's encourage leverage program

Marc Robins

turn the with dealings go know relationship at way States saved Congo, time other know turnaround of of than why and time Virus in and we're if at why point to license to actually that's virus out -- I just ready every like to here go and from me with of wouldn't like point figure of this the we time Ebola FDA, since dengue, because commercialize work NIV with United the a the get go maze begin we FDA's to me point why roadblock only every cannot we in contend do view -- the work the the WHO view just don't in doing it we my with we we we some to can't can't we in getting I The nowhere. from mouse or out, getting and to this work it seems and it Nile feel just but looking nothing more couldn't their ready, one have like and product. is with West and it there past I we seems Well, seems where And to the is want why either or to doctors work which

Jim Joyce

get would world… likelihood our to be in believe treat to the stick we market [indiscernible] a program treat access to earlier you pathogens, best perhaps think if to our to that pathway or provide some then I areas pathway patients belief And improves to breakthrough pathway provides the life-threatening around able these other towards that it's a the that know to way device we type designation which of

Marc Robins

time you safe this considered at But aren't by the FDA?

Jim Joyce

I can't speak for the FDA.

Marc Robins

essentially said to your -- trial us? safe out they I what as mean looks Houston safety isn't of X to agreed being recognized when it's like patient it they and it take that for

Jim Joyce

study, a it after no we breakthrough device stated No, they questions that report designation report, and was. They you unless program next through try any designation that introduced somewhat the to has pathway guidance program provisions the there the us therapeutic to in final device as is FDA provided the were of with final final or in comments the FDA published. then -- access that to the submission report documents expedited clinical an then under to program published phase which any therapeutic a you're accepted a subsequently already for if navigate for until for guidance breakthrough you're program, -- stalled transitioned

Marc Robins

you. stay around I long. hope Thank we can to that continue

Operator

ladies conference the any And to and turn session. management team closing remarks. question-and-answer over concludes for this like our I'd gentlemen, the to back

Jim Joyce

of on referenced, your inhibited of And therapies we are of to appreciate no We drugs is value done a and a work where approved everyone's be the of these there product their therapy and We're value of FDA based improve partnering about continue exosome the exosome designation, area excited as and presence field diagnostics, recognize many diagnostic drivers. known an by is cancer there at the best-selling we both obviously first to to therapeutic that of cancer to which on today. potential lot being device exosomes particles, as which address program deals significant our see high think are the market. now which starting advance benefit to to of are field therapy tumor-derived advance and to the very breakthrough drug capabilities able that participation this in a is continuing exosomes the programs under premise emerged with target extremely we're our the have exosome

Operator

Today's sir. presentation. today's thank attending for all you and concluded now has you, conference we Thank

lines may now disconnect wonderful evening. have and You your a

Aethlon Medical (AEMD) 9 Aug 182019 Q1 Earnings call transcript