AEMD - Earnings call transcript Q2 2019

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Operator

Good day, and welcome to the Aethlon Medical, Inc.

Second Quarter Fiscal 2019 Earnings and Corporate Update Conference Call. [Operator Instructions]. I would now like to turn the conference over to Jim Frakes, Chief Financial Officer. Please go ahead.

Jim Frakes

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

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

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

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

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

Jim Joyce

Thank you, and everyone. afternoon good Jim

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for that cancer the during This device advanced is non-malignant five completed be valued work demonstrates device in the selective isolation course We metastatic will at contract of melanoma with follow-on contract the other contract million now XXth with and under initiative of exosomes Institute. submitted this National entitled a exosomes. XXXX which June and the $X preparing submission capture our the the isolation second are this the Beyond oncology initiatives strategy Cancer submission oncosomes X breakthrough we the the of by Phase month.

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the This Isolation this congressionally Breakthrough a the Department Triple with NCI. States resubmission contracting award cancer October title research utilizing of on convened colleagues received award of sixth Defense initiative Pittsburgh is And program research yet now to is notification yet discuss we're to and Department hemopurifier. not our breast XXrd we Breast have Award, United Negative Exosomes of medical award our of the the back with process. moving of the Cancer amended through directed Army an We breakthrough at is Defense

broad we commercial to results. of that opportunities spectrum discuss is achieve expansion So actively With initiatives of leading series threats beyond to will pass Jim support viable the I our now bioterror to baton applications been the candidate that over financial and to hemopurifier cancer. who will and advancing a objective in a pandemic our conclusion include our said clinical believe back countermeasure we in regards quarterly Frakes have government's our

Jim Frakes

good and Jim Thanks afternoon everyone.

We expenses or $XX,XXX associated with Joyce $XX,XXX approximately fees. a ended million [indiscernible] $XX,XXX three in by related for XXXX FBFIs months for California, other of number [ph] $X.X per of expenses per loss September the months three a XX, million XXXX. XXXX million $XXX,XXX had a million had and $X.XX increase a ago. XX, increase the approximately approximately approximately board in exosome our Its reductions partially At $X.XX the in professional or we share offset in just three and The to cash of was was $XX,XXX due compensation. $XX,XXX non-cash the XX, a ended net XXXX the September expenses increase recent the fees. XX, partially based decrease related in a comparable share in the fees September to $XX,XXX to increase ended and expenses. and a general $XX,XXX increases loss as by due $XXXX approximately trial of increases Jim ended consolidated a a in payroll of to for were ended year increase net expenses for September three expenses and increase compared and expansion was and $XX,XXX the administrative $X.XX with in of three $XX,XXX of is million, $X.XX accounting were expenses legal of due to mentioned $XXXXX was to additional period operating of Our in fees our and in XXXX that months and fees which payroll legal $X.X approximately compared general to stock the primarily investor consulting Those patent comparison $XX,XXX months University our was Irvine of expenses XX, XX, September administrative $XXXXX increase in months our in proximately due offset scientific $XXXX primarily at due a XXXX. a to related other fees fees in September board, professional relations in in balance increase decrease $X.X a expenses of A fees and marketing $XX,XXX. and approximately And increase $XX,XXX

National XXXX not record grant September that in revenue award recognizing did any September. in in quarter we the While another of revenue the Institute December awarded under We were quarter. XXXX late Cancer we anticipate

for XX, the related for XXXX. September month the approximately and of approximately the XXXX that of three and $XXX,XXX the $XXX,XXX month in periods this $X.XX earnings September used commentary used press per XXXX in these to September or we quarter activities the release statements in in a per and operating earlier ended XXXX operations XXXX terms our In $XXX,XXX compared the release afternoon We September or balance cash sheet put included period. month and out million XX, six

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

Operator

[Operator Instructions].

Marckx comes Zacks of Investment Research. go The first from Brian question ahead. Please

Brian Marckx

the on Congrats guys. progress. Hi

Sounds just where initial on can lot like of in status going breakthrough you device that stands? have the you there designation talk Jim particularly the a off start and to cancer. about

Jim Joyce

final new guidance that we've are on market provisions world and trying our that's that been FDA the And virulent for opportunity the provided expedited studies pathway in for provisions of We conditions been run the we work a more we provisions Their which highly case those in oncology. meantime FDA. been specially data were published collection allowing are also introduced and provisions potential breakthrough for our data a beneficial human to the work provisions taking studies. FDA up. through are with of year draft of endeavors target addressing case through life terms very would the environment conduct the us programs dialogue interaction however of high the the not bioterror place clear related and FDA we guidance think collection of in have that that rationale Yes, documents threats. of real October to interacted documents there catch threat efficient to provide and make versus post controlled active been in FDA to had for have on the has opportunity to But are the to breakthrough initial the market documents from market threatening expanding with to advantage under difficult in important XXth device doing disease evidence access went pandemic amount environment actively the that's in market and post in with this more into to ability last lot to pre-marketing guidance With in us. guidance

would virus initially we anticipated exosomes the the considered of in opportunities a be transition become such a in I endeavors oncology field for that we've execute pace opportunity to threatening to to present pace the what on was and our think always but oncology opportunities more opportunity on tumor-derived will than very significant has the at rapid life that us. continue themselves

that we now. it's So something right area that are accelerating our work in

Brian Marckx

get and guidance this before? question Is on it draft additional your needs position progress make can aware to breakthrough that is that to or device relative be can and even substantive am their in really initial decisions finalized the the You context actually you to designation the necessarily or for believe finalized. of that any FDA I guidance the headway draft you doesn't finalize unrelated topics sometimes know they it years doesn't sit sometimes

So terms I is finalized is progress if be ask in doesn't guess there I it or guess in I actually can there just a it being without progress is of form? should little get finalized what made bit that more

Jim Joyce

We Brian. think is that made, be there progress can significant

that's are was FDA data at we specifically have waiting they that is something the However require the provisions device seem received been originated specific for. we and place or and of breakthrough documents in is guidance program to back post been you be program provisions from evidence know in we've that question published the program final enjoyed of advised it's that the your however that we the the to to of guidance most have market in device breakthrough provisions have benefits do collection active world real and least

just implemented to than you transitioning program go the last final recognize their from see their draft hasn't out they you FDAs final takes publication year-end oftentimes of of their around through guidance program fully guidance anybody a that final website, time which in If and I anticipates. sometimes breakthrough published on draft a guidance happened they link what to device point more you year XXth of intent the is will state guidance as that own have and October

Brian Marckx

made And so everything, terms I you said so you is device writing the was cancer you apologize submitted you right? September I think breakthrough a I of and in get I got then application it didn't that that response October in in that

Jim Joyce

on October thought would of we device hear days by FDA things Yes, there based submission we thought should received we this the we expect September from back FDA. those and month. back something submitted amendment submitted on were the XXth. suggestions response an a of We They had consider they XX breakthrough we XXrd on some some to within end suggestions from

Brian Marckx

that you to more going cancer general? Okay. did it specify And - a need be is was to or particular

Jim Joyce

this our We At need that specify receive cancer to anticipate opportunity a breakthrough cancer. cancer or for programs. time advance to in specify to we designation, point we us need specific do whether need the a not the we specific will

these have is how we with for was opportunity that's of into regular this I implement received more that to proceed objective has of know with provision very to therapy to that this that's to that we leverage we've device comes and facing a think program patients in FDA hope of other programs as with as provide the try which the segment right another market backdrop whether program important a You with to life occurs that terms basis but year addition are patients that that the there's factor threatening whole to no breakthrough into do that not minimum us we deal therapies earlier but interact don't in with earlier to device of the have the FDA that companies access but for to addressed a been designation know we and on we which in try that fact all law discussions allows regardless looked that or play programs. the the to because well that new signed approved condition breakthrough to are right the needs have is

Brian Marckx

collaborators, the the on lend potentially things application the of could list investigate? to like is potential well itself sounds on - to It cancer that

Jim Joyce

without presence a that of and that's were very a something think is you classes device the pathogens area deplete is strategy with the haven't this medical I just you so mentioned I you an but the of disease to that seen that are we because the know group broad That's we partnering opportunities exosomes not strategy I different an therapies priority concept know therapies. I if that we provide is high infectious normally addressed know of drug can very previously think tumor-derived infectious single the provides - not addressing toxicity in cancer we strategy environment - before where benefit of improve a therapy, of that a as this mean adding that are disease an clearly viral a you know think

inhibited so So any provides partnering a we can larger quite value oncology if no one significant more really we perspective. players certainly certainly target there think are space you to much component most is your from cancer is within was significant have for the leading us therapies significant for we the and think we the can by importance tumor-derived execute opportunity value really in of for exosomes a know yes of level whereas to

Brian Marckx

term in know expect can look to you the anything relative that done data there cancer? past teeth we to in looks do on I is points, upcoming things can we but forward our the kind into of that hemopurifier in some sink how near you've front? Jim, that anything any

Jim Joyce

Yes.

get assembled would that have candid leverage might and certainly we collection if So publication that incorporate is again talk don't and about would we over but the been of we that like data quite advancing experiences published hit in a of about we this we've to that treatment does to a control into nice our relates as it is to such cancer when product successfully in we've device with that already have the with product our data humans the our collecting device. XXX the design thing publication

demonstrated it's infected tolerated in So it's if device as pathogen. clinical viral treatment with that our have we program, very early experience that well in individuals not is health the stage comprised

a well. So advantage you that real gives know us as

Operator

Wainwright. question from next Chen comes Yi go H.C. Please of ahead. The

Yi Chen

you finalization Just still to clarify further, the FDA get breakthrough for is the program device that advance have program correct? device do designation so wait to the you use if breakthrough of for the to oncology

Jim Joyce

and is are in provisions viral we to the why somewhat compared that pandemic a and of extremely pathway threatening underlying foresee not post world In such to feasible bioterror reliance this to viruses addressing there a oncology It's real on challenging data threats. be considered control as a designation, device different being cases data breakthrough are that life collect that's evidence collection studies market is against to threats many oncology. to environment provisions for pathogens us present we're an that we clinical been program not them in control in I more see but studies treat say at enrol the availability viral related complex so leverage an don't those are whereas implemented breakthrough a clinical shouldn't in controlled there and device to as cancer they in patients those looking much straightforward issue to they're

Yi Chen

the the Okay, hard you need the were that diseases data might the agree those then other just threatening those it. hemopurifier get extreme to post-marketing The but in chance for allow to indications infectious life reach conditions a to cost market and you first? it's to In controlled data. hemopurifier collect FDA don't a market for has be word

Jim Joyce

Right.

therapy treat we pathogens I can are, to on don't as as right provisions something infectious that to we fact will an the to advantage see Post leverage collection cancer think being data based we that provisions there So we relates compared it in market know but viral feasibly oncology quite challenging deplete and new the enrol to in new oncology patients checkpoint working to run be try are the you the inhibitors therapies. of its try benefit to whereas to be and controlled virulent improve of first been subjects' exosomes, are a to respond and those in pathogen. Those initiation, presence or circulating recruit challenging off a their recruit then the to environment feasible whatever the with it's studies quite might very prior to predict viral them

Yi Chen

Right.

to still of you coming sort in early FDA the some expect or update on months provide late do So draft XXXX the say XXXX? let's

Jim Joyce

We have advancement in to this we final based work now to we that for or on we some get published have FDA do have maximize decided we're expected on based be opportunities to can guidance thereof place clinical to so we lack our FDAs significantly breakthrough that the exist. time guidance what to established work hear going to our think and expand done opportunities in

Operator

concludes back turn to Joyce, over closing question remarks. answer conference and I Chief like the Executive James Officer our and session. for would any to Founder This

Jim Joyce

with next follow you our Thank to speak today. support to again very participation endeavours. and call your We you be care. myself continue much. to Frakes able hope on hope have appreciate afternoon. nice quarterly our Take everyone's Both and a you appreciate Jim we and We

Operator

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

disconnect. You may now

Aethlon Medical (AEMD) 6 Nov 182019 Q2 Earnings call transcript