AEMD - Earnings call transcript Q4 2019

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Operator

Good afternoon everyone and welcome to the Aethlon Medical Fiscal 2019 Year-end March 31, 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 also note, today's event is being recorded.

At this time, I'd like to turn the conference call over to Mr. Officer. Financial Chief Frakes, Jim Sir, please ahead. go

Jim Frakes

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

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

statement, an and Aethlon's with and introduction reading Aethlon's make the remarks Aethlon's then Rodell, Chuck our forward-looking some recent will Dr. this along on CEO, Following financials. our Fisher of Tim will overview developments Dr. Chairman, I brief provide strategy. you of

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

to and you company release Dr. the XXXX forward-looking of a not a the news Securities call statement this over the of Act note within The statement statement. call that Federal of please the historical cautions the is today Rodell, fact and that of is Exchange forward-looking any hand contain statements that meaning Act I Securities Before XXXX.

These differ this call. and anticipated forward-looking statements as are and expectations statements. and statements risks to in materially may conference from subject forward-looking significant the actual Such the date the results are uncertainties, on of based of assumptions results

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

now Rodell, Tim will Aethlon’s call over that, With turn CEO. I the to Dr.

Dr. Tim Rodell

and we’d What the then this discuss and and an dialed we then from is, term, take everybody talk be that morning like and to to announcement we’ll Chuck for thank for happy the events afternoon. Thank development dialing I you you, this are recent plans near to made Jim, briefly in questions our going audience do after about some and in.

have our morning support announced deal two number may this you development we to the strategic indications. with of of in cross-licensing lines As evaluation seen, a product Medical and the potential SeaStar a

as for on historically oncology and for While the know, designation the continue last pathway Hemopurifier year. recently developed diseases you to granted of the have viral development exosomes clearance working from break-through we actively now at develop our in Aethlon, and we’re under

Aethlon we the the activities the believe SeaStar a cartridges, are of where activities could areas number augment where Hemopurifier of augment devices and activities Hemopurifier the believe pumps, the and number There could potentially activity -- of activity or cassettes. of SeaStar the the we the with

lie. the clear going minute, a In listening will in may potential the to ask discuss I I’m where and those it Fisher, think our family to SeaStar of Chairman be complementarities Chuck devices to

this the cancer. and my viral agreement, potential from we the represents Hemopurifier expanding in an of think and disease develop I to perspective, step programs ongoing continue our as early

before of audience the is Aethlon’s I a SeaStar who but programs, Fisher, minutes update to familiarize of to I’ll with cancer I’d story. the SeaStar Chair few In status a minute, to our like Chuck take the but that, ask Chairman Chuck? do also

Dr. Chuck Fisher

Can hear me Thanks Tim. okay? everybody

Dr. Tim Rodell

else answer. can. can I No one

Dr. Chuck Fisher

to some other on be then funding, the years, few a we companies different pump and and acquire help a year course mentioned more today [indiscernible] cartridge their will and call their now a a incredible this but phase, them go companies are and a with turn have some and involved evolved to on and I’ve starting significant in devices, moving commercial out just recently we forward of last out SeaStar to cassette of some with been find the with with ago SeaStar several initiate and that biology few founded that.

infrastructure built around own is well types the oncology, expanding as want [indiscernible] deliver we cartridges, as can cetera. that our in in primarily So, our through internal et the environments we of a be fact to

move are well long of effect on viral more Additionally, and Aethlon recently bind, as their with demonstrating and notion we particles had impressed with the association capture, ability very as have together to been we their a needs to good exosomes. look groups. significant unmet developing really for we are And opportunity when we that, critical at that [indiscernible] a both looking of on and quite opportunities number a see see

and stop there and questions your come answer back Tim? could later. I’ll

Dr. Tim Rodell

Chuck. you, Thank

both on knows, the Hemopurifier device, viral a company in product applications in lead and about So, going bit everybody and in has to the Aethlon while where move I talk think followed who as cancer. development, potential diseases for we’re has is a which

we think critical people understand fields. is not these that points the is of One for that unrelated are to

mainly types are the specifically biophysical Viruses that in the and by cancer-potentiating they the two contained set enclosed a share exosomes molecules are mannose same membranes subcellular of GNA, protein which is are covered cartridge both mannose. heavily size clear leptin sugar approximately particles. allowing characteristics, a are and Hemopurifier, common specific The with binds to particles, of called both particles

be these. areas size, patient fact the of number target that’s Hemopurifier for both a only it to there may situations make here but in in developing the of where continue immunoisolation that these cancer. fact characteristics, though viral two point is biophysical for different we by indications Now, are not are and membranes, important affected we actively to share One develop populations now of

are the that exosome infectious disease of going critically with viruses Hemopurifier, to that cleared find biology, and we think of follow are patients are by infected out I as chronically well. we newly cancer are important Many area exosomes sort evolving as this in

fact integrated. very in They separate indications. are closely are not biologically these So, two unrelated

pancreas pretty is but tumors where colon potentially the are are breast us, Now, cancer, advanced for cancers areas tumors areas, others, and solid cancer, And our much the greatest. gastrointestinal in cancer focus and neck is need and oncology these head initial examples now tumor of are all these which and some are targets solid in cancers. include cancer,

we, leukemias in greatest when area of The done, about who We’ve current are hematologic I of all have right talking malignancy, of solid and tumors is of and working those I’m say standard solid better now and oncology, with us suboptimal. the with much have so are done the lymphomas tumors. than needs we in care

hope received designation have active in the and in tell in oncology FDA, November with more We communication by that coming is last year to for in about of of human or in one the you we are to clinical targets. that our months enhanced initiation preparation now these more the the communication break-through progress. of We trials

presentation, to now back Jim we’ll for I’ll financial Jim? the and the move then to over Q&A. call turn

Jim Frakes

Thanks good again afternoon Tim, and everyone.

was had a loss ended million, loss year of net $X.XX XXXX, for approximately At XXXX. million. year approximately compared net or XX, cash fiscal of a March March the the XXXX, XX, approximately balance share Our $X.XX million, ended $X.X $X.X to per XX, for we March share fiscal or $X.X per

to approximately for million, part paid separation approximately for comparison former were the calendar XXXX fiscal CEO expenses an million, approximately year $X.X our due accrual million approximately cover in $XXX,XXX XX, with $X.X to increase fiscal $X.X prior was Our over our to year. to consolidated ended to in payments the of of operating March XXXX This former be and President.

our The fell remaining that $XXX,XXX by We related $XX,XXX payroll accrual, the scientific to our fees legal expenses area. and studies driver administrative consulting expense a fees that and of recorded related due increased $XXX,XXX $XXX,XXX. as ongoing and into increase Net expenses of approximately increased net increased operating accrual general that professional $XXX,XXX, increase approximately approximately largely and $XXX,XXX to the primary fees. of in was in

ended NIH. arose approximately of compared This non-cash March XX, government performed grant We years and in in XXXX, government on of $XXX,XXX work March expense our with XX, revenue two March fiscal ended year XXXX in revenue expense recorded year other contract XXXX. ended the had contracts the XXXX. from $XXX,XXX and the other approximately fiscal under the to XX, fiscal We

in the fiscal ended Cancer aggregate we revenue Melanoma our year our new approximately from ended in In $XXX,XXX we contract the Melanoma from Breast approximately year grant. XXXX, $XXX,XXX XXXX, recorded fiscal contract in March and recorded XX, and March Cancer XX, revenue Cancer

professional or increased our months cost. In and terms month used the per of activities, we CEO in in $XXX,XXX operating the March rate increase in monthly combination severance of March and payments average the the million agreed used XX, in over $XX,XXX to XXXX. of cash ended was or four due clinical million increased to last our burn XX, fiscal month the year ended per $X.X through approximately approximately the our year, former contractually $XXX,XXX year XXXX, compared fiscal President trial This fiscal $X.X fees

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

report SEC our file will We this with Form XX-K the annual following call.

on happy to And have. coincide Our in quarterly will early our Chuck, may Form be next the that will XX-Q filing take questions call and earnings August. report of Tim with I you any

for please questions. the call Operator, open

Operator

question. Investment Research. from from with [Operator today Zacks Our question ahead first comes Instructions] Brian Marckx your go Please

Brian Marckx

Wondering on and if congrats you FDA, to the program could there this to to morning what guys, news that studies? anything forward terms relationship. to we talk that anything start cancer about to is about with your specifically about cancer related with that, in they relative the SeaStar see need related move of talked they’ve Hi conversations with the the can

Dr. Tim Rodell

the Tim. We comment Thanks make but a obviously of it’s points. thanks and FDA, conversations can't dialing-in. for couple with question specifically the would for I on Brian

that solid benefit we because going fairly granted our we include the tumors. designation, who other in to get exosomes for one essentially indication care has breakthrough in or either to development are more which a label many been use more is whom are learn driven cancer reason a to label patients my to advanced the play as metastatic I it shown and that that’s recall about the tumors first is you or say solid that the The in or resistant of is whose or under and for parenthetically tumors, have broad standard about is as by be use guess program would from with for going exosomes role. to not were

going a think on you of I device spoken primary about the biological and is this it to and that be grounds breakthrough have need call I is approval know But the the would evidence that, the drug, is commercial said other and before you have it and I or the I I you substantial piece that, say that the in -- think taken So, patient change mentioned I care show this by of to really biology. of for and thing target approval is safety doesn't efficacy for population. designation underlying

the the the breakthrough efficacy target around which you with for our And designation. the always number that So, demonstrate two, FDA to patient population what’s route is or in know be use is fastest we the are population. fact and safety those were the relevant conversations components, one label that that indication in under driven number to will one granted

that’s related conversations before components. of major basically, through development agency think entirely clear-cut fairly we’re our to move is process So, starting this with are all to and the said and I those a now, I've what

Brian Marckx

Tim, say of that towards in can cancer? studies starting goal the is you there progress ultimate

Dr. Tim Rodell

putting response rate I’m never how I of by are the I moving. want of are but of certain together, those we’re process be and a places on working to with issue. court in terms times do I types moving. timing to the that’s moving Am mandated through to get want I was in we clinical move and submissions Chuck regulatory to There we the am, with Federal you as trials that’s plan. what can which had regulatory fast I sort satisfied, glib, ever through the where comfortable yes I development and brought we satisfied? documents, are can are but don't that’s identifying what that I things, that separate to do am we limitations but moving are together with are Yes. regulations fast how by of and as move that of at and do, we

Brian Marckx

Okay. That’s great news.

idea just that products would then potentially relationship, that develop purposes, SeaStar bit the So, in is little Aethlon idea of clarity, on terms own use more the the joint product? you on collaborate for or individually would use technology technology SeaStar’s and -- for and a a would Aethlon’s their is collaborate individual SeaStar both

Dr. Tim Rodell

conversation. the Chuck going bring to I'm into

Let latter probably more me is I that just accurate. think the say

idea efficacy sets us the figure identified I markets give where out to in products think to two access here markets. already will combining these of is or increase

very product comes lines but from are in the Chuck? the develop is and to both essentially relationship, we idea using on expertise to So, early companies that both obviously, generate jointly the technology.

Dr. Chuck Fisher

Yes. Thanks, Tim.

the significant our means [indiscernible] the space. that lot number specifically, So, have the viruses ability transplant a much and earlier organ time mentioned lead also to circulating that to we the to ability and product there's that to of question flush bring the bind to interest out question, are similar bind exosomes. Those of that very of exosomes. Hemopurifier’s in information And within novel epitope regarding the [indiscernible] there's a donors a at

normally suppress or [indiscernible] significant viral viruses look in them. infection. [indiscernible] can type C it These the particles, probably XX% in regionally, the to trying particularly, ability that assume immune the real is B of If and system rejections to system. at actually alone, hard And are we would happen, on the just the release other

that, assume start in pretty seeing in of every that’s like can but evolving then add that exosomes notion the process to things of role lungs to for reduce the we transplantation we not in nicely. as attracted chance the you it’s demonstrating of and the now to significantly And So, rejection, in approach transplantation the are cancer, approval, right only [indiscernible]. also line-up an clean antiviral could then

Brian Marckx

for thanks Okay, that.

to the role cancer relationship, the a cancer potentially SeaStar then back SeaStar in play focus? the does Breakthrough So and Device relationship

Dr. Tim Rodell

Hemopurifier the indication Breakthrough ago. Aethlon we is the Well, the Device was to Breakthrough Tim. – the about Device granted a this that The for to talked specifically minute

working approach SeaStar cancers other is that’s can possibility, designation. in working certainly To the breakthrough some together, we that ways anything identify of that we're but extent, that currently the can included that about we not a with talking the is

So, designation. that how not we but anything could could involve The or and another even have would specific FDA, and in would potentially forward-looking terms conversation to the among probably another deal of with we to that things, breakthrough with currently predicting I'm Aethlon And breakthrough a involve other involve detailed is saying specific stuff Breakthrough. Hemopurifier. designation

Brian Marckx

Okay.

would give timelines of should terms a relationship on? joint or potential can forward us of that anything you an guys in milestones you're looking kind SeaStar/Aethlon the where idea terms product, we you be of So, in or working are indicate that to, of what

Dr. Tim Rodell

one forward I and think Number this out it's was a appropriate done. for is sense path conceptually getting figuring little two then number is. made really early what out And figuring it whether the that. getting

we before, to I we’ll those as identifying So, think as milestones. you a start kinds it's promised we early of But as soon know little something, know. let

Brian Marckx

lot, a Thanks right. All appreciate Okay. guys. I it.

Dr. Tim Rodell

you. Thank

Operator

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

Yi Chen

for you question. Thank Hi. my taking

the Hemopurifier the – or going and between that's device tumor, the alone, the solid be going to clinical it into going to is and be it product going Aethlon joint clarify, SeaStar? to to trial Just is be evaluating

Dr. Tim Rodell

alone. They would Hemopurifier initially be the

Yi Chen

Okay.

to do would you trial tumors? initiate plan multiple different for solid to trials or – So, you initiate you a plan kinds single of solid tumor

Dr. Tim Rodell

data. area one and in. calling and for I generally you question will thank population can't oncology area safety at incidentally, small the a about a generally say is and thank point. involves say will to moving get into in for What new for a this trial detail is and that you that, starting I talk Hemopurifier specific the What new in in mechanism I

and into and on better our understanding safety where spending biology. a now can obviously time you different solid areas operative. right in of think lot based profile of it's expertise areas, branch and I different with to then an that, to start mechanism multiple Then out colleagues, oncology adequate of tumor Following a talking we're

to generically in patients data this number and then look get multiple So, does safety that I one way initial initially, would is a small directions. different in the and say move of

at the target can versus right in the with open directions can Merck Aethlon different, in maybe ultimate to very but rate somewhat we're move areas. now minded multiple rate Now, move at the being which directions multiple which different respect

Yi Chen

Got it.

press of cancer, head between neck gastrointestinal today choose could other the you heading cancer, and right? So, release type or some that cancer, suggest maybe

Dr. Tim Rodell

all Yes, something date, terms in about very those that's to high of this correct, trial have, specific design, and shown need are tumors be been important. we're have at all not of we have as areas going a to be of start it. we're kinds being to areas. we're those until things, we point, which I, don't not again, because in careful to But very announce They're exosomes trying talk

any we to would And starting, we're this where one appropriate I on hope can't exactly planning shortly. start say place an so, of at those be but point, to

Yi Chen

to the for you need work the FDA? before Do preparing waiting the Okay. from and clinical you're or decision limitation additional simply the trial, do starting preclinical

Dr. Tim Rodell

speak respect I number in exactly of one, one. number space to a data And multiple with than disease something much we exosome we've that with preclinical we we can't data that. discussed the safety, XX to before, say with with as is different the tumor actually deal What types, I is, will great two, treated and more Hemopurifier. have viral have valuable over number patients that preclinical

can an a to than we safety got data much got data and about and in safety talk trump IDE in got we've humans in that, we've more nothing say data say I that, other really So, more than and we of detail active until can't lot humans.

Yi Chen

future, based Hemopurifier SeaStar. joint Is potentially when the final from both you it. product product, And to question that the technology got and alone? in going replace on have is, Aethlon Okay, my a

Dr. Tim Rodell

to with to as be than come pursuing is be own Aethlon other say its early things that respect that will data-driven. development always applications anything Hemopurifier it's will think independently, SeaStar it And of out after the programs. be is where currently should pursuing I

So, Aethlon we than it think team are we'll his out I that us. at other can't really and I of see planning doing more that, say can Chuck will takes come value the And than point the this that and possibly together. team where and science Chuck? on much best

Dr. Chuck Fisher

explore teams [Indiscernible] [ideas is of may novel everything] potential to expect [indiscernible] but describing and excellent the opportunity of that you be really there but it, to out and structure that way deal come come there it to possibilities. small, offers will together to And the working an we then it these be products [indiscernible]. out

Yi Chen

Okay, got it. Thank you.

Dr. Tim Rodell

Thank you, Yi.

Operator

Our Fitzpatrick [ph] your with next ahead go Roger Please question. question comes Lincoln from from Douglas.

Unidentified Analyst

Thank your cash the the and burn are But money your hand, your going what good luck and you for next update forward. plans on raising? for on about documented rate

Dr. Tim Rodell

Jim, do want you to take that?

Jim Frakes

Roger. It’s Hi, here. Sure. Frakes Jim

Unidentified Analyst

Hi, Jim.

Jim Frakes

million – cash. we ended we with in fiscal $X.X What about year the

up millions. As monthly not I mentioned, XXX,XXX our in burn XXX,XXX, rates to the

at a burn million So, niche not figures X and moment. amount a at trial the Tim fairly six the small is safety might Chuck it The about over a that to looking were over trial relatively clinical XX we're cancer, in little so months, a – inexpensive talking money. of mid huge of the XX patients, quarter cost number

need more cancer standing. life things stage a few in development where money. companies, we raise all the front second-half Like on of the this we've to achieved probably we’re after year science And will

Unidentified Analyst

very appreciate you it. Thank much. Okay. I

Jim Frakes

Sure.

Operator

Please with ahead PLC Capital. your And our Darren from question. comes Evans next go from question

Darren Evans

Tim, are how you? Hey,

Dr. Tim Rodell

Hey, Darren.

Darren Evans

like guys Just products? merger guys interesting, seems merger Do with – these curious again, the you a is seems on combo it? with SeaStar the consider

Dr. Tim Rodell

question. for right. All and for waiting that thanks was I the

answer public had but attorneys. be, As different we a that, we question which means in about comment say the on to I companies, any of plans. strategic to if that think, by been been number to of say And something has I'd future I've lot other securities we'd don't beaten a it,

make That's that. answer there's So from no comment. we a that's can not that no –

Darren Evans

it. Got

Okay, perfect. Thanks.

Dr. Tim Rodell

you. Thank

Operator

I'm the turn comments. like gentlemen, time, at over any to no I call this And for showing And back additional ladies and conference questions. would final

Dr. Tim Rodell

Tim. So, is this

think, hope for to a to next again, continuing We're, in. have of our appreciate thank you all, talk all, months your progress. about to excited plan have and We by. we we by I dialing – the go very more lot as First interest, few

go. never We a pretty And which said I speed as moving, I'm satisfied moving way have with long at Chuck? earlier, fast. but to we're the we're

Dr. Chuck Fisher

perhaps the extent. the some together combination about of really would the you way. working in that are medicine line in and significant The collaborating. state products a I I companies current So, and comment companies as with positive very that agree see merging made a to advanced are interaction

making a into who together, we what think, work will bringing different as joint and knows bought in I So, to patients other we opportunity and and a science we're the interesting we good it happen see the market. difference product there, to a get

in good things at should we some have present and those fit. think We be market

by try transplant. get So, and everybody for the Thanks some call here. demos hard the joining questions and

Operator

And today's ladies thank We conference call. that, attending we’ll and today’s presentation. conclude you do with for gentlemen,

may lines. now You your disconnect

Aethlon Medical (AEMD) 1 Jul 192019 Q4 Earnings call transcript