AEMD - Earnings call transcript Q1 2020

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Operator

Good day and welcome to the Aethlon Medical First Quarter 2020 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

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

Jim Frakes

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

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

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

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

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

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

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

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

Tim Rodell

I our Chairman we Jim, Aethlon device and device to stage is cartridge clear and afternoon. and as and to the that a spread remarks going called Fisher, designed cancer you, call I’m blood therapeutic in ask to be make think device both updates as happy therapeutic going called and everybody advancement everyone first-in-class in number another single other this is involved is small for in our developing take then of I’m use on and circulating exosomes are to we’ll processes. thank Hemopurifier, particles dialing development proprietary company, the some Chuck subcellular that are and you well the as But a Thank to purification development of viruses which brief comment questions. knows

The Hemopurifier fever has Ebola threatening And device by intolerant other designated been designated was including hemorrhagic treatment of or life viruses. of of metastatic as cancer treatment for the advanced specifically a FDA care the second therapy. of XXXX was that and and actually breakthrough designation additionally late device to given cancers a in unresponsive viruses breakthrough for glycosylated standard are

And about we those to both in programs cancer. areas. today going advancing predominantly talk of I'm our are in development programs

treatment the process been about very the And regulatory new good making are. in of in components what development for course that previously talked the have development progress the cancer of a our We device what we've quarter, of and advancing last is the plan. over

FDA the discussions that now the in-person meeting of with number allow of during we’re Bethesda in application that and to an a clinical initiate to this in FDA device investigational application had which have quarter quarter conducted is preparing trials. We will process us an in and and communications the following exemption the earlier

and getting getting we're clinical have the the looking trials. filed Those forward communications have with been helpful, IDE initiate FDA and FDA have profitable, from been authorization to to been collegial

to difficult of other area targets disclosed cancer and our include previously as tumors. ovarian treat solid cancer, tumors pancreas in solid and such oncology are the we've in tumors, initial neck very As head these cancer,

by by by specific been both demonstrated collaborators our exosomes. All and have others of significantly to indications these us, by be circulating driven

so exosomes in Hemopurifier patients clear the the will are that those to improved And under improved some tumor and outcomes newer derived and for is immunotherapeutic using allow and to approved belief responses chemotherapeutic currently agents it that our of specifically development.

like about forward or tumor be those are we��ll details. targeting, to development to what and to move process, we more As the we're going what going into have tumors say look trials more specifically

point, filing and into But application getting process move our finishing of of clinical energies the at to trials. are focused ready investigational investigational all exemption this the device on drug,

few to has other Dr. Chairman been FDA. heavily couple talk Now do working been I before I has about minutes of with as Chuck communications a our and in me Fisher, the with well strategy of our a want but or areas as development in involved our Fisher

please if and do to you about comments talk to come like proceeded So other has you'd it things. the a I'll Chuck, then make process any about few far back so as

Chuck Fisher

Jim. appreciate on today. all interest Thanks our an my be brief We your who call comments basis. but ongoing And to joined you thanks will of

Just device with a given treatment the of discussions recent the on FDA on few associated for the the comments. discussions metastatic meetings and Basically, the designation the content both exosomes. particularly advanced breakthrough cancer quality I'm and with very pleased the

regard, think which is do doing area the and forward team to to I that's in great simply good are with move Tim is outlined relationships attended want as I've legal I on. that I very job the what think a their So a say, FDA

So stop I’ll maybe back and I'll comment Tim. later. that, With there hand it to

Tim Rodell

I'd that the last our the on we are areas of on The actually Chuck located for be at are devices with in several very thing, Medical, when we SeaStar and here strategic signed call. announced we last next agreement cross-licensing turn in to both we here device Aethlon is at to to available of and had Chuck spoke. available. like into our prepared you, entered a that he'll just California last what We Thank complementary is the we that on agreement, that had questions remain number remarks. that developing another or We’ll Southern announced be cross-licensing conclusion doing company quarterly discussed call, agreement so will our

So little this view are. I'd about like and proceed how bit where of going we my is to talk a to

previously as the and including discussed, a know is exosomes as capable you which of as cancer particles, well spread a As is other called Hemopurifier we particles in of subcellular what of are doing involved number processes. clearing advancement

other of address that cartridges and pathways. developing infectious is components both inflammatory, oncologic potential SeaStar

devices, companies and a investigating oncology, transplantation multiple complex number putting be in these rejection a in indications indications number So have and these them two address have we other these collectively organ and synergistic the disease combining components of devices series infectious in of disease, different in of as devices such and these areas. that collectively of in a can pathways

how or SeaStar a but great deal that So to ways about those SeaStar exactly those having disease speak Hemopurifier processes better in putting understand of us sets learn cartridges these this and I've I more diseases and allows in allow like it's to get in how the our will various don't those to processes better I think two work. intervene technologies before us belief for although can diseases cartridge activity incidentally because and the I together address diseases a like work to said

previously between correlative research advanced deal literature, and looking that will see been there’s great cancer cancer relationships clearance of of of in been to at in outcomes a then us to and showing disease. will with has what experiments in position better the impact that's of ever clear be the the what role great nobody is done on that, shortly the of in in a humans example is exosomes we've we got of initiating exosomes patients a of exosomes presence allow cancer understand an that them but because deal As

SeaStar Similarly is story cartridges. the similar the for

be them work work, able how will like I'm to be various That will going about the very that move of mediators how first is start as clear we they're parameters this of will affect to to they exosomes cartridges of steps we're together. excited on together. cells. other is What these kinds will investigating to So how simply But and work hook a number inflammatory up how this. forward. we part There particles

on into animals the to and investigate combinations then this. at initiating move in combining and We're impact technologies early early we these disease. this using process. very to initially in to then be development in look and announced we're Again the studies aggressively humans, ultimately we're of we've on those as we'll probably there move we're the early starting forward So human from that recently but here,

when Hemopurifier me the one a Finally, what to focused was or to things which the owned majority the the Hemopurifier comments we've subsidiary the also we combination sciences that is always of primarily on diagnostics been of company the this table brings the that potential division I and of like make our the company say a therapeutic subsidiary like about the of year it developing last I'd sciences for exosome talked joined couple about attracted the through but bit have I'd to technology late exosome company. to of and that

head most encephalopathy, here, have on players that's in in these of other that the maintaining football trauma. focus we the I use are was of disease individuals chronic the of primary Neurodegenerative subjected what was And focus When types repeated our to traumatic of the the there. diagnosis conversation diagnostics been got seen about still research and

the aggressively and collecting we what's what only the excited also tumors disease we know about happening us actually but about how intend that exosomes and the that exosomes data lot is already but those of a of on area things that tell in in impact can one impact not the potentially most We progressed have these of they on an removing to I'm are is outcome diseases. demonstrate that

right in exosome area for wheelhouse is the And that's an that sciences.

beginning other physicians groups disease better progression with risk we benefit potential, occurring patients when is, could may treatment markers what prognostic be the at risks and where develop identify understand and to to and be So able disease the highest advancing. one Hemopurifier who exosomes those it patients the work number with and where identify to from their is able disease diagnostic using the are to we're also populations of patient are and help a to with

an it's pursue more value the to but the really area but of substantial involving to about aggressively. that in So we'll exosomes. have future And very starting complementary use represents area a now it we're that additional say

it me let turn Jim? I'll a over up open discuss following make our we'll questions. financials and for couple then there that, stop our remarks to So of Jim closing Frakes, and back to and CFO

Jim Frakes

everyone. afternoon Tim again Thanks good and

per $X.XX Our $X.XX net quarter of XX, or first loss approximately to quarter ended XX, XX, share was balance per At approximately ended the $X.X the net June loss for we’ve for a million. share approximately XXXX. June cash compared had million or $X.X of June $X.X XXXX XXXX million a

for XX, Our $X.XX consolidated June the to June $X.X expenses XX, approximately compared the were XXXX million quarter ended operating XXXX. million ended quarter for

$XXX,XXX clinical of and to approximately was in primarily fees in professional of the associated of breast $XXX,XXX, expected trial approximately the lab The to $XX,XXX due increases $XXX,XXX our in primarily a expense and combination manufacturing to of expense. increase $X,XXX. related of a an payroll to approximately Hemopurifier’s The XXXX cancer increase in with expense in administrative largely administrative approximately grant in and $XX,XXX increase increase expenses expenses expenses costs of cancer was travel and related general $XXX,XXX clinical our space, supplies and the in our XXXX trial due or due increase general $XXX,XXX in

The XXXX primarily our $XXX,XXX in increase $XXX,XXX fees. increase was due in in our legal professional fees to

and XX, XX, expense Our on XXXX consisted June and of other the XXXX quarter interest consisted interest expense debt expense non-cash ended during June during of extinguishment the quarter ended only. loss

in of This performed for our $XX,XXX the contracts revenue June work two grant XX, comparison and XXXX or XXXX with quarter Institute breast quarters recorded revenue XXXX was we Health contract recorded expense the $XX,XXX the cancer ended the in $XXX,XXX melanoma in government June in and recorded of ended from in approximately government June from the XXXX quarter expenses for approximately XXXX we $XXX,XXX ended with grant our cancer arose aggregate the NIH. XXXX. In the revenue June from first contracting approximately XX, quarter. We other revenue Other NIH. quarter under XX, with June National

our on Subsequent notes XXXX. remaining XX, June We outstanding interest approximately balance amount the aggregate paid-off $XXX,XXX. principal to of accrued and promissory convertible and the

So now sheet that amount from balance is table. and removed our capitalization

June the have $XXX,XXX We quarter outstanding previously during ended the the balance paid-off XX, of on XXXX. notes

activities, operating our $XXX,XXX the cash the to month in approximately quarter XXXX our quarter. or in used increased $XXX,XXX of and per severance used rate increased agreed payments XXXX costs. in XXXX per The our June and $XXX,XXX Now $XXX,XXX in terms of we month approximately in burn in to fees to the increase due contractually compared average $X,XXX,XXX or combination was professional clinical CEO trial monthly President, June former

Now $X.X that million, filed a fell currently we requirement on that XX-Q with threshold our and fell Xst with let report update issue filing with further first XX-K a on meeting on me Nasdaq's March we of maintaining an the that the situation Form continued stock today. below XX, slightly number we below our on July we stockholders that XXXX with are of equity listing was provide issues two listing have Nasdaq, minimum exchange,

Nasdaq plan to compliance provided a us with And one-week initially copy extension XXXX requirement. filed regain Nasdaq a that to XX, August that. recently by required

by is response due August our XX, XXXX. now So

working which our accepts currently plan extension from order of meet to response XXX July our plan, additional X, grant XXXX then get on the our will requirement. compliance. sales evidence include of a to stock letter Nasdaq equity their common days through calendar date will the capital in We’re If Nasdaq to an minimum raise stockholders of

The second minimum below listing per threshold share. continued $X our share price issue to falling of relates the

or has August trading price can is XXXX until share higher $X or days. -- -- milestones requirement we we We regain XX me XX for earlier. have share this compliance October the It with above Rodell noted Tim $X get that to that excuse as trading XX per consecutive possible regain at by

afternoon. the is in its the We recover company earnings commentary does would be that press if price also and organically. there a alternatives However is not assurance included no case, related the achieve these evaluating Form to this and XX-Q quarters for this XX, the the following That of XX, operations this to ended call. on our XXXX statements earlier sheet June XXXX, while balance XXXX included release release for June report

Chuck, earnings call early may you our filing next please to in that for any Operator, the have. XX-Q will and open would questions the of I questions. Tim coincide call now report and with Our Form happy quarterly be take November

Operator

from question-and-answer [Operator Brian Zacks session. The of go We Please the will now begin Marckx comes ahead. Investment Instructions] first question Research.

Brian Marckx

okay? Hi Can me, hear guys. you

Tim Rodell

Yes.

Chuck Fisher

Hi Brian.

Brian Marckx

if you directly hear you Hi, my I I jumping anything was that I IND. I relates an between questions missed so two file but calls, apologize to did to that plan different mention

that. on congratulations So

terms in any do wondering have when you of may Just of idea timelines, think you you have it filed?

Tim Rodell

for you Brian. question, Yes, thank that

we drug this me the an just of that be device or investigational filing the a new Let modify an slightly, it's exemption but application. because device is an application device equivalent that is investigation will IDE,

plans. information huge, you massive manufacturing contain As probably trials preclinical these they amounts know quality information, are of data, and clinical documents

going So not they're quite file. a when that I'm exactly very it's to are fairly say project, I along we're in we far But will say that, to imminent. going

years. or not about weeks talking months we're So

Brian Marckx

meant necessarily that Yes with approved Okay, safety amount sense have your start IND. that a cancer okay you to have than although it straight given you data but you and IDE not it you that reasonable great. larger Could go I that Is X. the can a Phase apologize, X? study Phase human of not data, in is I

Tim Rodell

me while inadvisable. safety be device. theoretically gives from say the it viral deal a the reviewed that all is of studies think about as is the a of say previous it great confidence answer from that development I've the And would would perspective, I a I overall reason yes of but and to I the physician, the data that

with treated into setting with into different clinical hospital new settings, and physical moving a susceptibilities past. than new different the a patient We settings type patients, in in we've population, different are

complexity additional brings that to And number one the equation.

that The we've say mentioned it's don't exosomes removing particular because that intervened safety that, earlier although process generate I from so been I same and for at one's and viruses safety in haven't same different. Hemopurifier, as intervening a looking been thing is patients. but is I reason, have the though that we're second the a been And questions. we've device ever safety presumably doesn't are novel populations the in We new even with removing concerns no before that particularly the just these me

do percentage lot we the for to I we what also can to is which the effect understand, that going to larger things the to what talking that targets we're the kind of order to we're we few one only clear, make of But in we understand think and exosomes benefit. about, of exosomes be learn to critical from first are to in a and the get need but for people is safety that when we getting trial, the exosomes not therapeutic patients first need it's important you're what order see need should sure clearing understand

generic initially the learned small experience larger So of number situation I to we trial impacts trials. then we based always to to but who the way smart with do, that think sort question, what to of learn, some the on larger and think device could the thing patients there from have thing a a jump possible others move and to learn and right this how of do I operated do they're their as to get quickly as how is we managed, a clinical

Brian Marckx

have. all Okay, Tim. I great, Thanks that's

Tim Rodell

you, Thank Brian.

Operator

from comes S The Please next J Patrick question Investments. Wolfe of Darrell go ahead.

Darrell Patrick

is in to very kidney dialysis? that what similar the use would Is Hemopurifier, they Hello.

Tim Rodell

the two from the a does, is But you it question. thank patients passing are what a over Hemopurifier It’s does a protein is and is large is a cartridge thanks Hemopurifier which look viruses who you fluid they the cartridges, in with two capable a taking at if actually is and to you at categorically room Hemodialysis toxins to similar of exosomes. out taking dialysis and to blood. filter cartridges taking what cartridge and that of can Darrell good that would Hemopurifier and cartridge It stand their blood and matrix look plastic off in different a look question, dialysis the cartridge, failure, in in capable for for what doing were devices, is is binds dialing the and renal

are very of So physically they're is different. but pieces similar what they equipment doing

Darrell Patrick

in the what's the secret to Okay. sauce Then is capsule itself? opposed as the capsule

Tim Rodell

I Yes, is plastic a using used in actual the think we're yes, a of number that's piece applications. of that statement. fair other

So that we cartridge into yes, the and clear secret sauce what out viruses that is put it allows exosomes. to

Darrell Patrick

Okay. does individual an be system? How long have on to that

Tim Rodell

Well, learn a to it using we four start we're really six basically in once going about the But the clinic. hours. on lot of to that order

Darrell Patrick

then exactly have how And thing? everyday Okay. you an haven't do to they'll it. It's often determined

Tim Rodell

Hemopurifier No, used with it's everyday we're using exosomes clearance not drugs thing. cancer is And that other an combining at patients. the what initially looking of are in

member of is in had the drugs patients drugs, setting. What so up this kind outpatient you're diffusing and used, more have go sort on if had hooked happen would would they administered to into it we'll chemotherapy, the center, be to So have be same one infusion cancer has used. Hemopurifier prior had schedule familiar, or as and is ever you've of chemotherapy the an they're generally of if administration it doing who has a family

Darrell Patrick

it believe I mentioned, be used. You could

patients? said you transplant in think I

Tim Rodell

be different where outcome. and a areas are be there Well, involved could could where exosomes in it of number used

of areas the is are we the the transplant. organ of in most viruses interested that One in role

donors fairly infected that you're patients C otherwise a up who aware, to their of would until contra-indication Hepatitis be with organs. number like a be viruses As transplanting recently was organ may probably

good be drugs the Hepatitis Now transplanted for are those sometimes can costs $XXX,XXX. that that organs are well drugs over C, those of there

one looking C areas Hepatitis that recipients. we're Hemopurifier subsequently donors So in interested the transplant organ at is and in in the organ of clearing for potentially

CMV, work about and Another of Herpes very it's the one virus we we all Hemopurifier really virus the failure called that a transplant actually of cause Cytomegalovirus. causes that that is to showing that of have the family failure generally is important recipient in is infected problems area most a don't be where transplanted member know doesn't Cytomegalovirus it of with, we're that can could of the organ data the a or clear and common

area that at So this investigation. we're another is looking for

of at Cytomegalovirus donor potentially from the the we outcome viruses or the organs clearing the Can like by C improve recipient the transplanted transplant. others by clearing in either and time of Hepatitis

Darrell Patrick

before an transplant Okay, intention you a here or operation afterwards? this mentioned the NASH, to or use

Tim Rodell

are are in blood a and of an areas Well, used, areas SeaStar at cleanse primary be brain are recipient to could the in But tumors also that initiating Hemopurifier potential now our and transplant. we in that dead is organ with right again donor and of develop it on a it but is solid could used there intend where used of concepts. different these could it focus be the the to is time number be trials that involved incidentally area again early There the cancer.

Darrell Patrick

that a a reasons Okay who just situation? that the are you mentioned and with and in Hemopurifier smacked the players, that as are encephalopathy. there head that be in reports number other but way football on former times the of effective on who Would people lot for suffer large of get encephalopathy,

Tim Rodell

don't in Well it's Hemopurifier distant but in whether be to other disease or of using know focus research. including for like Parkinson's. exosomes future We and area possible fairly be that the setting isn't our in an encephalopathy traumatic would as Alzheimer's that chronic the encephalopathies far be therapeutically current clear, used the could markers, diagnosis diseases

Darrell Patrick

Thank Okay. very much. you

Tim Rodell

you. Thank

Operator

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

Tim Rodell

our for everyone we as look to you interest move up keeping you programs Andrew. again appreciate dialing to We Thank in you, forward development forward. your and continued closing, just would in. I thank say speed

doing our forward progressed today to through development you plan. my about amount on in the from a we're that we've huge perspective, there's company I'm what about very that telling and think more as I look going excited

the forward and dialing conversation. again thanks look for we continuing So to in

Operator

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

disconnect. You now may

Aethlon Medical (AEMD) 14 Aug 192020 Q1 Earnings call transcript