AEMD - Earnings call transcript Q4 2018

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Operator

Good afternoon, everyone. And welcome to the Aethlon Medical Fourth Quarter Fiscal Year End 2018 Earnings and Corporate Update Conference Call. All participants will be in a listen-only mode [Operator Instructions]. After today’s presentation, there’ll be an opportunity to ask questions [Operator Instructions]. Please also note today’s event is being recorded. like the I’d to call time, Mr. this to conference turn over At Financial Frakes, Officer. Jim Chief go please Sir, ahead.

Jim Frakes

call. Jim Jamie ended fiscal Welcome Chief today, fiscal conference we to you, Financial March Aethlon name Thank and p.m. results Medical's XX, year good Officer. At released end XXXX. Eastern am financial and year I Frakes, afternoon X:XX everyone. My Aethlon’s is time XXXX our for

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

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

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

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

Jim Joyce

Thank you, everyone. your We appreciate afternoon, participation. Jim, and good

will balance during report, XXXX. the financial Frakes sheet Jim disclose significantly our fiscal improved we As year during

a and the industry the We a with We also Cancer with we Traumatic multiple our intellectual our of advanced with the portfolio We related launch Hemopurifier therapeutic clinical to experience. monitored contract expanded our just with biomarker by Institute our we endeavors. related tauopathy, follow-on added the including neurological diagnosed to of the National Sciences And advancement closed to with new greatest property relevant issuances. Board candidate study FDA. Chronic progressed patent subsidiary significance, members Exosome Exosome the Perhaps our Encephalopathy.

not our proprietary in circulatory those For that infected hemofiltration device eliminate familiar system we affinity a Hemopurifier, developed threatening to individuals. viruses the it’s with of life

we As significant most to viruses potential approved addressed device holds with global not life health. believe therapies, fill void are our in threatening

program and program treatment concluded, and Hemopurifier advancement the to designed was year, study surrogate to health Hemopurifier designated countermeasure Hemopurifier demonstrated advance accelerate and Expedited device of permitted Hemopurifier with Act. candidate the an The access to diseases provide of Breakthrough to the clinical earlier Device has submitted to XXst FDA’s Hemopurifier received viral to a a life-threatening this Breakthrough designation, indicated a to our viruses. infected addressed device. Device FDA is final its the by viruses a therapies. which our Cures patients safety program, is not A Subsequent the established our is single-use FDA, designation a the as for as In are the pathway be patients approved to broad-spectrum fiscal of of a FDA glycosylated under of Pathway our the Breakthrough protocol include; formally life to model September, mean that against threatening dialysis new treatment Indication goal that’s The Access feasibility with IDETs During life-threatening Use reports preliminary therapy. with Under we study pathogen. Device FDA our proposed device compromised for Century

pathway approved out glycosylated. are Breakthrough in Device discussions FDA viruses the designation. active, there life determine confidential to are under point threatening we which As of most indication use present, to therapies we that for At are the with our advance no

to future. will While we discuss turn able that over don't to that XXXX we mic Jim our near share results. the this I control process, should the CFO, who FDA now year back said, fiscal to we With financial have be Frakes, from in our clarity expect will

Jim Frakes

Thanks, everyone. Jim, cash At March XXXX, a had $X and XX, million. afternoon we again approximately of balance good

The decrease DARPA of 'XX $X.X The reduction Sciences’; the and related advance primary which our enacting principally and conclusion compensation, The factors reduction in cash, approximately expense. expense and related non-cash and activity a year $XX,XXX our $XXX,XXX the The decrease at an our in scientific due related and in in $XXX,XXX approximately decrease general fiscal G&A partially fees XX, in year which $XX,XXX by due trial due trial; activities payroll expenses stock-based Our and $XXX,XXX reductions of of payroll Exosome $XXX,XXX; registration non-DARPA to The in approximately from of partially Sciences; $XXX,XXX, by clinical of activities $XXX,XXX the fees DARPA million. $XXX,XXX March was headcount in to increases to to and expenses expenses or related our reductions compared professional $XX,XXX. in fees related $XXX,XXX fiscal reduction $X.X related our in fiscal of and year $XXX,XXX, XXXX driven of million clinical decrease G&A ended legal statement non-DARPA XXXX other was fees expense our expenses, staff. arose and and to in professional approximately the were a decrease ended $X.X related was decrease our and consolidated of operating in our in XXXX, G&A was professional and for our in in XX, of $X offset fees Exosome fiscal $XX,XXX. fiscal related reduction $XXX,XXX in 'XX; fees non-DARPA increase fees administrative $XXX,XXX compared $XX,XXX, expenses in G&A $XX,XXX. in for were; professional additions development had professional expenses costs were of to compared decrease a expenses $XX,XXX, million business $X.X and of fiscal of $XXX,XXX, primarily March in due in We reductions professional the other in by of offset million expense approximately the in in to XXXX. payroll approximately million expense year

recorded and balance fiscal the loss put National During XXXX $X.X XXXX with in fiscal this was million, operations for That the Cancer ended and earlier XXXX. for We press XXXX of statements related out during XXXX, year a contract per $X.XX March recorded with or XX, earnings fiscal while million XXXX. included of and these net we afternoon. sheet years $X.XX release $XXX,XXX revenues or the the share release in a from compared commentary under a XX, Institute, the for March contract our fiscal in approximately government XXXX fiscal for revenue approximately $X.X share $XXX,XXX our net loss Overall, DARPA. to

for We call report may call. will questions. please now, Grossman, the happy this Operator, open any will questions And XX-K you our Form to file annual have. Jim following take be that

Operator

and Ladies session the Instructions]. gentlemen, we’ll begin question-and-answer [Operator

go with Our first Brian from Zacks your ahead Investment question. Please comes question Marckx Research. from

Brian Marckx

as to deliverables do really in bit in your them Or might maybe terms next where more anything whatever and But get together Jim, of there can I trying talk or to can back at come least Hemopurifier. to too get give to little just it that much before FDA of it timelines, context ball am more with a discussions detail. us wanted around is I viable FDA there court can't the for start put that it in is and guess? of pathway get FDA regarding be you need gather you? is today? to I to that I stands, terms to to the whose has the else to you expectations it And in you with is they steps? a then Is a

Jim Joyce

for today, anticipating the good you Thanks call in to up here. catch with

DARPA’s programs benefit through innovation couple program this In participated is question. the primary whose those contracts. a of the terms FDA. the under balls Access with program the involve of program, more ability DoD a pathway, in those is which factors of In different active communication have court And really we dialogue. learned of the the Expedited one we programs, I the think that’s accurate Pathway is, good Under

the active very of an And Device dialogue of have then the these we as we Breakthrough benefit designation under I designation. have a programs. benefit so additional and the to And then transition EAP mentioned,

have somewhat objectives advance threatening a that approved historic generally we to is with not with against as not broad, these countermeasure but consistent broad-spectrum are dialogue. therapy. for use addressed virus, viruses is very permitted with So under programs The that life that was active our or our indication is approved FDA an product

Expedited primary fall as that it’s designation Pathway ways to a at viruses efficient under to analysis slight are to efficient not collect indication, out it point environment data. the the the breakthrough collect efficient be way that's as a an in our the compared compared this of needs data the discusses to will the where Access think collect market nuance more of point, be as FDA. could with analysis designation focal meant, or that to program whether environment. been interpretation point for having act discussion And But regularly the think not pre-market those right with that well. what of about to time post us than that Cures from made in determination But a to I And types most is And and we Act, this to part anyone related that and that that anyone data law talk I this And program a I think was think, we some of they’ve lot enacted there that initiated, actually faster I just got which but XXst now. endeavor. the than very faster designation digest Breakthrough discussions we're anticipated. got for as to Century I of collaborative. FDA’s standpoint signed for an the Device benefit wrote when will article the share once potential as I was came got expected. our It FDA device

be future. enjoyed near in we them dialogue So the and able we’ve hope our to to with more clarity provide

Brian Marckx

and and how you think with endeavor, necessarily administration not related progressive, more view FDA, of But that’s bit little guess, of that that and terms I the may box, play with guess to FDA Maybe guess? on XXst in evolved, maybe the terms how new to best I in -- best but that's of the that of in the of with terms I maybe I favor, Act, your I has all, in specific say. word this the guess. a under being start. a they've the in the thinking of changed maybe a with not Cures at changes new word. they’ve Jim, if directly do made out at guess, pathways not How Trump I'll the Gottlieb But Scott head Century terms more maybe broader

Jim Joyce

Gottlieb, appointment the very of Scott has I think I the impact. think new commissioner, Well, been

at he’s it’s patients disease is been think our candidate He’s earlier his whether I therapy, leadership objectives CDRH, resonating access jurisdiction divisions, especially about FDA. think at which get And related his to different significant threatening to clear conditions. to or FDA drugs I very life throughout demonstrated leadership. is

that other was would that is the at that that the many considered bio-terror, a threat an questions be previously threat how you not targets the we’re candidate pandemic threats high unknown. and recognize might think also, people I is to of emerging of one looking thing respond

initiatives countermeasure years, their greater to more previously, to that actual I a broad-spectrum is other have PHEMCE priority broad-spectrum see also FDA. which candidate including advance is on should is we want PHEMCE. feasible. I countermeasure programs. threat focus we each And its pathogen, think the provide through point government Enterprise, and each interact Emergency on interagency some that primary now also have is between with to which departments has know a somewhat Medical towards us. But countermeasures shifting coordination commercial focus objective healthcare will color objectives thing the between but and not feel coordination coordinating been there’s also from very trying as that now to hope agencies candidates seems I the for we see appreciative comes see Countermeasure which with many or as historically those this high is also partners, to -- now know standpoint. really one HHS, align on threat, probably acronym time, we exist. known agencies, as Health an data we And And in with And countermeasures we resonating other We agencies, What with collected every he may did well be this other single very HHS the But so we’re these PHEMCE of FDA. agencies to against at a much is FDA that other believe mandate a the we healthcare than at into put and something fit I And disjointed. on HHS broad-spectrum have with a data Public much beneficial say, be the applications,

manner. So that access coordinating these government efficient also patient it's efforts in a the to we providing the believe we not is focus on much a bigger think just therapies, more

Brian Marckx

exactly if in I wanted -- business, interpret, press to it I and correctly, I biomarker the the study. talk and a just XXX% TauSome I little wasn't the about bit how know there, And CTE ESI not even into study clear don't didn't what around the TGEN release but I what clear, the It’s IDE study. ESI about it's specifically didn’t March, was somewhere the related to. study. that clear is. clear XXnd exactly the fits design of not It think, I wasn't the the talked

CTE any there And that, role? what that TBI both? versus provide is around a can it a is would study? study? helpful. you be it Is your more anything this role Is So insight TGEN's provide in I you guess, Is terms can more of

Jim Joyce

TGEN, that Absolutely. location the The which study as Research a Genomics Phoenix, investigator site principal Dr. in Jensen. study Institute, at initiated, first we is is Kendall mentioned Translational there you

different the tauopathies, TauSome biomarker as is a with biomarker to potentially diagnose in but age probably this enrolling risk involve for Our in and NFL locations study, objective a is that of our current or compared site up funded that is accrue multiple above. Alzheimer's formal CTE levels more quarterly XX that which looking this we brain, we the is keep study, players, study subjects the we including and as first significant were are referencing NIH program. study suffering a elevation the In plaquing high primary on age CTE. controls. performed subjects the a In same former, And players but disease. to monitor that to the the protein in The to saw TauSome set group are disorders at really NFL as first neurological follow-on at qualify because part study of abnormal XX series CTE, both we’re Tau

TauSome group group And XX-times times compared opportunity and higher the In we to have controls. as which age fact, demonstrate patients, also -- Alzheimer’s diagnosed were levels higher. were the to they same nine

So those we a saw tauopathies. two correlation between

study make Alumni and the enrollment to Arizona two next sure expect Monday, exosome as But Associations and we into Association date nine we’re we day well. TGEN biology, And enrollment our great Phoenix, for just we’re discussions NFL date of days Republic saliva with field the enrollment, next in -- is is the enrolling other different had in fact, in with first test. subjects, kicked in players, participation as enrolled of cities. great and based knew players of -- candidate urine just ago formal Alumni control NFL Our day-one. candidate we’re markers former well with work in as in the TauSome to also more as everybody than also our from off former looking that On NFL biomarker We as in blood blood the NFL we the subjects. on enroll not in we’re but which support looking

quite study is the well. take we So going

research Our to the cargo in former concentrations that players into collaborators and anticipate we’re to cargo cargo, condition. be see we there’s in need, with to we another where the isolating partner high in of location split the facet of going samples biomarker. at looking looking future that They’re as the of future more a we samples, we additional to TGEN, conditions. different like then we for what to at that this they’re where have has learn sites NFL exosomes disease do related collaborator them take disease we where it then we And studying they this but obtain they bring can the the in near disclose would areas about

we’re So happy way going. the is with very study the

terms We of focused haven't and much about And standpoint in of the been biomarker is far. very the the we’re in far that a the more biomarker marker think very currently the with we’re monitor of diagnose excited collection study. I vocal our potential disease impossible, think importantly living the with data -- could have with or of this individuals, FDA about so we supporting so which that, that and collection Hemopurifier from on because potentially communicating or outcome we possibility data condition progress

of and So we happy think the we’re study. it’s new with the very progress promising,

Operator

question go ahead And Wainwright. your Yi our Chen Please comes next from with from question. H.C.

Yi Chen

quarter might release you reach public? it pathway can that the final FDA, is the -- likely in Jim, that a you to it that say third and would the FDA

Jim Joyce

that learned very than to regular of FDA to I feasible where we the programs This and very dialogue. certainly mean, active and we with that any that can absolute -- we have with submit we’re occasionally -- unlike few FDA hope every are other have I’ve would the certainly on dialog on say a make might dialogue that’s think pathways very, other We pushy basis. to not so. months, mean benefit these I weekly -- commitments and think you I is communicate actively

we of methodology design that. therapy, patients our we of So to I we how getting just access the goal think both do have the need through

Yi Chen

clinical data any final that And investigator while -- trials for there remainder ongoing that of additional FDA's the wait clinical have including sponsored XXXX? Are Hemopurifier using are the decision. trials, some we the currently reported during could

Jim Joyce

at Not point. this

studies markets initiate FDA applications outside we’re readout we’ll indication interested for as from the would to to But obtaining certainly near waiting how FDA, clear to the able -- those of product get that be really have in potential put other types are the hesitant for while on to the of a that clarity advance program. lay well. in use We’re to here we going We we we’re use the device from the on which indication communicate future. in hope focused under

Yi Chen

CTE. data to And is expect XXXX the do XXXX? readout, some When regarding likely clinical to advance it clinical study in you or in have

Jim Joyce

the as that I considering we're by are And from I high time well assimilate But with think are we the subjects time that the data think who control at enrolment. the data as -- that. we the XXXX. from happy CTE, risk that’s probably suffering assimilate the by

to lot it our public collaborators I attention disease, work before endeavors. or other into with which And were again the to the will data thing. to in I Alzheimer's fashion a previously of in very think our of publish put to am want domain get we data sure any this out published we brought Journal fortunate the

Yi Chen

Can study? the many be subjects us will remind how in CTE you

Jim Joyce

ever we the subjects former [think disease and subjects, study Our condition. objective would the XXX between NFL control in is players largest up definitely] be which to

Operator

at and end reached this today's question-and-answer the ladies management any the like And remarks. back I’d time, session. of over to for call to turn gentlemen, we conference closing

Jim Joyce

Again, to CEO. We have appreciate this a future afternoon, and your participation and This support look Jim Joyce, we communications. is appreciate everyone’s our nice weekend. forward

Operator

We Ladies the now and presentation. you attending thank concluded. for has gentlemen, today's conference

now may lines. your disconnect You

Aethlon Medical (AEMD) 8 Jun 182018 Q4 Earnings call transcript