AEMD - Earnings call transcript Q1 2021

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Operator

Good afternoon, and welcome to the Aethlon Medical First Quarter Fiscal 2021 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Dr. Officer. Financial Chief Frakes, Jim Please go ahead.

James Frakes

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

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

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

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

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

Timothy Rodell

dialing oncology. Jim. to all like for thank you off with I'd lead in. Thanks, And

so, we process in clinical at head are And all, of opening the first the the neck of of continuing and Pittsburgh. trial University cancer

clinical we who a the we ultimate early feasibility like manufacturing neck in building call, you stage equivalent the I have UPMC. and for open for And the accrual more to are cancers, shortly. IRB as in the clinicaltrials.gov process is in the steps to Phase in patient at and as trials. of the is the have As the to solid enrolling details other And specifically plans well in study, stage our first commercialization also hope been of would posted head later evaluation later of development This Hemopurifier information. the last noted approval quality which the step is right trial of patients support initial And now. if on towards only last those and tumors. development cancer Hemopurifier The be and device study, we're successful now plan, we

designations, previously and both threatening we infection. we viral life noted, breakthrough As have for oncology for

FDA a safety with and So, to communication favorable assuming data. this and us efficacy clear the provide designations these focused process, expedite pathway with

of the Neck Carcinoma.' This to support approximately Therapy Annette will Director Improve $X.X to institutions, entitled in Dr. our foremost world's related academic forward. grant million really Head cancer, grant bench of on Senior exosomes University On the for on can the Whiteside, and of FDA, Institutes it and National of future investigators, a Marleau, Immune Responses provide sort and authorities in one Research, the Theresa a which dialogue on the are some Exosomes in of our and with and is other front, development clinical going trial using Health our year, exosomes from successful Pittsburgh study. 'depleting current announced we with vet in cancer early completion upon a samples from for this last week may So, collaboration company we've also support the neck clinical the trial plans head ongoing studies feasibility that follow-on provide for current the co-principal and of received Squamous five an and Cell

investigational existing to as the up move disease disclosed, with the exemption disease, the has up the XX at supplement IDE with to to to on or XX device allow we previously for United centers of patients Now SARS-CoV-X viral our to FDA treatment in the to States. COVID-XX infectious approved Hemopurifier

identifying are recruiting We now centers. and these

think to last static. distribution I all during call, I not we As not expect open the of noted centers do is the our And at once. pandemic XX

patients. We are concentrating affected on of large with areas the numbers

New have particularly or and areas which California include turf. along Pacific and York initially, home down affected Northeast, New epicenters Florida, quieted Jersey, were corporate they probably read, you severely Southern and the City As now Northwest, most with

now In addition, to the be Central affected. United beginning States is

away of the coastal centers from some population affecting now moving centers all the really pandemic over is we're country. and So, the

accrual formerly high-need an options. single obtaining individual a request daily it efficacy based several the which of is pathway, which request situation, to in treated at and pathway attending has say cannot faster be patient, as recently a opening about for single treating anything physician While has been pathway, bit as a there's the compassionate emergency identifying patients and to patient one used his clinical while date. physician And patient much a to we emergency use. viable an case, approval treatment And allows treatments. time, patient known use trial with this of patient who takes Hemopurifier other we've uneventful on IRB treatment product investigational essentially Under another known treat to centers for a no

it and Jim? questions. up to financial we'll turn there stop back the open and for I'll for Jim then over So, discussion

James Frakes

again, we afternoon $XX.X good XX, June approximately XXXX, And Tim. a At everyone. balance had cash of Thanks, million.

the in related $X.X operating million This ended three ended $XXX,XXX of compared Our and and were debt XX, of professional expense approximately to compared in a and XXXX months expenses Other the to of for and $XX,XXX. compensation decrease ended period for for to and decrease XXXX approximately expenses expense for the June in were XX, of trial consisted XXXX. interest stock-based June in XXXX months approximately The of headcount a million is general to expenses administrative in $XXX,XXX $XXX,XXX approximately legal expense $XX,XXX, in months on other our $XXX,XXX an salary prepare our was our Other decrease ended a fees and cash-based then of of approximately $XXX,XXX approximately expenses to approximately three the trials. loss the a as general XX, months payroll $X,XXX decrease consisted approximately extinguishment. XXXX. and $XX,XXX XX, to June the in June and primarily were due increase The due due decrease of ended a XXXX increase full expense then three $XX,XXX notes. our months XXXX to the in The in offset three decrease professional XX, was combination $XX,XXX related of payroll in a $XX,XXX to in planned in in increases. for The expense ended compensation $X.X expense. cash-based expenses expense, result XXXX a in additions increase XX% June the three was and during a during or XXXX increase XX, outstanding administrative and due reduction by the expenses in the was primarily which turn we decrease interest our $XX,XXX months promissory fees June period fees partially clinical $XX,XXX was our of July due payment our A to increase our accounting compensation fees. clinical three

cash of were and for and statements the a non-dilutive additional for neck to part operations sheet of Pittsburgh X.X shares at issue and for or Rodell per commentary release June ATM a I and share XX, common for $X.X continue grant before $X.X our we the million apply as NIH. just any Medical XXXX. as average ended related interest press earnings of this in with a of this recently results loss II grants changes stock decreased National ended million our to of government and a warrants the And fall. the NCI XXXX, of million afternoon. June the to additional XX, In balance million. in do $X.XX Center, facility the per approximately three us XXXX $X.XX for We and per earlier funding. did release Craniofacial June included University three-month through approximately with We As aggregate issued XXXX June that price sources The net not in the months of in $X.X contracts Research, June noted, three XX, XX, result noted, contract XXXX last Dental studies to included That head share. proceeds. share approximately from proceeds of for the XXXX month intend non-controlling months million the the We and these awarded sale an of of or periods for under $X.XX Dr. We the ended we revenues financing. won, were together expenses approximately raised net Institute net cancer $X.X Phase

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

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

Operator

[Operator Instructions].

from come will [indiscernible]. question first Our

Unidentified Participant

didn't of on compassionate kind I hear use Tim, referring you to the cases. So, what were kind of

is said what uneventful. that said? that the You outcome you Was

Timothy Rodell

the I Yeah. I think that's term used.

Unidentified Participant

question? – still they is I assume you I are – person ask Do are that alive? the that they

Timothy Rodell

say I you detail about can said. any can't it. give more What is I much pretty what I really

I completed us this that – is regulations, use is make for are who it at any treatments of there. patient. number comment are this much sites And trial gives to What one, that doesn't sick. give under is to critical sense to opportunity, a this it of what however, further. us What go secondly, to it open. whether the that. First we gives this patient let out say, the will point the and really patients it are somebody sickest particular a beyond Hemopurifier an help emergency obviously, data number the of wouldn't me does Hemopurifier type for of federal beyond can very explorable eligible for out in patients hopefully us But be all, for kinds that say I and me the the is from get But population get safely can good me with us that, deployed. the a appropriate experience look be who control And of do

Unidentified Participant

relatively of the extended period really will know the a a answer – treated answer you you'll or in time? Are I short you that But couple know sort rollout describe a think describe trials maybe going be Do just it can the even or little be yet? you Can see you of will there an you go? couple here guess, how of bit to get specifically. of these to time the and over of people kind people don't a where you people to period do will it, of most – of

Timothy Rodell

say to is places know, patients and true me these active, for York, fill in areas, it you was true was it What and other say. in early really it early was in this will is where as I in out it's that Seattle, ICUs. true virus the New Well, the on,

that be large to in And just the ICUs of areas. of the ICUs we're secondary in way many They some majority are the open to are some these to, have them devoted of taking of of the so, have completely Many hospitals that of pandemic. centers And patients. patients. talking care their other not them of happen COVID-XX

again, and So we the couple I areas, of a pandemic on to where these a are once position open in there in depending unfortunately treatment. of open a to lot we're be sites multiple for going think get busy available goes, patients

again, the I've that and patients shortage home the our you. answer, very, hammered. predict Florida for the has patients turf, coming California, easiest the clearly getting affected open, we're But from heavily that Southern in been agricultural very no are affected. most guess I Many also Imperial the there. Valley, is Unfortunately, workers area there's of into heavily those going some be to until hard is to areas named of it's are So, from

And some overwhelmed. hospitals of these are literally getting

again, trickle open, a I get think we of going patients. So, not be once it's to

have see that numbers. get plays probably think we're But out. and again, be open substantial to it'll going I to how

Unidentified Participant

– this and ever be earlier in bit they more sicker. maybe sicker load somebody use people this? in is you trial of get focused Can more always isn't this the may sense if sort the a I admitted are like, will sicker before of side, their and be you this this Because to us who the – to what obviously, or could give might any that who of sicker benefit. of and Will side process? I've of on largely particular little guess that disease protocol sort There produce sick, on derived the felt somebody benefit this I'm maybe potentially are wondering already who's infectious generally be ICU on there on they

Timothy Rodell

It's that's been are kidney restricted current to pretty have that by ICU FDA injury. in great Many be IDE on And them acute the our answer question. short the Most ventilators. viral trial of the of the will will patients them and approved under a is is who sick.

be think of we'll supplemental earlier may patients sicker initially, easily circulating but very who the amounts largest could benefit of focused right oxygen, requiring you're virus. that population. are have absolutely bit be But large the amounts a So, large on, on in I who are who the

being as I and the So, FDA we conservative. going use, to we're occasional conservative. cross get kind also that help would of imagine, being you But argument. from initially, kind pretty emergency get trial that's can of the section. also I that make think, want is we data that ideally, And a from to But think to

Unidentified Participant

I – instances be even ask there you Will won't that.

that. on can't a you You answer the let oncology But me side. question ask

of of me you to that instance, to you're additional maybe, it we will I kind when forward comes as maybe and not – trials sort the and around of process to be question, side guess, sort somebody's disease? me, maybe clinical sort where trials focused [indiscernible] of the seems for further on As same clinical could – back envision, on designing move of guess they kind it best this, even of that's before I the them of maybe but time best for other as Is maybe question. things I time – to or a have they some the as have these – treatment likely when treatments? applied? clinical of these to focus is it different number be a the to I going of some Or Is process trial on of this guess? sort is things oncology

Timothy Rodell

it's it's the Well, is, iterative process. And a good answer question. an

hopefully about treating that I frontline we approval that's that most combination setting that of think of trial of oncology the characteristics now, important in in patients a standard one have right that be lines increase the who that to cancer, respond. neck are when and and of sick are very exosomes clear KEYTRUDA the the this life up going on disease that started because administration, is expectancy. the to is head percentage with that who talk therapy the care, the we're patients particular and can is several of and doing, In prior we're as starting already immunosuppressive KEYTRUDA patients very failed we so Hemopurifier low the of the have of

the And in. so, we're in delighted we're actually and population comfortable patient we're that

with treat sense the exactly what is than study. to of because learn Hemopurifier early this time what it to that's the to more we initial be terms once, that'll may expect from make times, In it right or feasibility do

this and with intended grant trial. mentioned us will to what ago, studies we've stage later based as What as just out was a designing pointed actually earnings I minute large say is I in awarded some that is, in be release, Pittsburg learned. follow-on we combination we'll of on for the So, a

from NIH FDA feasibility trial we will And so early the at learn essentially The – the it, not the of this as already but the sorry. we that ongoing and FDA, I'm reviewed has refining be looked study. design

Unidentified Participant

terms checkup, things think applicable for exosome to to use extract of that and some checkup the check maintenance months might have someday through and be but me a as get could they're and that in sort somebody they already they of who's something I it cancer of be every might every come also on and so this this months be the them some in thing maybe is where sort of Hemopurifier something for in to that any on of or whatever, be someday therapy, come these that this though, conduct gone may plug to trials are… maybe systemic when they six that – being the you'll six Just more it wrong best understand, sort maybe a of

Timothy Rodell

great different observed. off. And ways therapy essentially it's where populations and I different situations there looking a are being But It's in think have be patient tumors. And at definitive solid question. simply are a we'll patients received

or Sort colorectal we who those what of There's that's you prevent steps exactly couple make we could advanced described. the to two prophylactically a that patients cancer, is do of see patients. of stage that particularly know markers, subset those Hemopurifier road. gotten in in three relapse, the have subpopulation This relapse. predict essentially predict definitive and going which those in are therapy, can relapse. patients likely them Beach down what that us kind Newport true if is and there's just a there which let of in delay And to disease. biopsy patients liquid we are with you've with we're a easily looking essentially again, said, of of But are relapse Hoag markers what at exosomal to actually there treat sense to which that can whether then under of markers it very ones patients not. if which are observation, are predict will to with and part patients exosomal our is This collaboration those are to we and And going know

Operator

I'd This any will question-and-answer for to closing our like Rodell remarks. turn to session. the Tim back conclude Dr. over conference

Timothy Rodell

in in. for COVID-XX to and oncology help Okay. Thank infectious It's in game you, a we're excited follow on the hope all that appreciate patients. operator. very position be remain get dialing sincerely We doing about good what disease to these We continuing of side side. And you both the the thank we your some story. we'll to and into on the

thank and dialing again, in stay you for So, safe. all

Operator

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

You may now disconnect.

Aethlon Medical (AEMD) 11 Aug 202021 Q1 Earnings call transcript