Aethlon Medical (AEMD) 14 Aug 242025 Q1 Earnings call transcript

Good day, and welcome to the Aethlon Medical Fiscal First Quarter 2025 Earnings and Corporate Update Conference Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Michael Miller of Rx Communications. Please go ahead.

Thank you, operator, and good afternoon, everyone. Fiscal XXXX Medical's Conference Aethlon to First Earnings Quarter Call. Welcome Rx is Michael name Communications. Miller My with At X:XX p.m. XXXX. Eastern results first XX, for today, its Time Aethlon fiscal quarter Medical ended released financial June

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

Aethlon's Aethlon's Officer, Dr. introduction reading session. of James then then Mr. an Aethlon's Medical for Officer, disclaimer, call Frakes; LaRosa, developments. this Executive will Officer overview the company's forward-looking up of open remarks and and Following Chief the and Steven Frakes provide some and Q&A the make We'll statement on the recent Interim strategy Chief Financial Chief financials. Avon's will brief

news the you of forward-looking is release statements the and The of that contain that hand this forward-looking the company of statement amended, XXXX of as date statements These call meaning today I call conference assumptions Mr. the statement. Frakes, the fact XXXX Before this historical within Securities expectations as are to Exchange based Act and as of over cautions Act the Securities amended. of and any on statement please is call. that note a not a

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

Chief and now With Financial Executive Officer that, Officer. the Mr. I'll to call over Interim Chief Aethlon's turn Frakes, James

Mike, and is Jim a and clinical Frakes, viruses all to and the designed thank Aethlon Aethlon its development to harmful Medical you research and system, in. remove you, CEO Thank like of life-threatening long-time and therapeutic blood blood for I CFO This Medical. dialing continuing would biological other exosomes and of is Interim from fluids. of filtration bind Hemopurifier,

applications in suppression exosomes, transplantation. These qualities extracellular refer to life-threatening of also promote have we may cancer-associated diseases and which potential metastasis, and infectious immune in the also where Hemopurifier in-organ as oncology, vesicles,

Now before on give other on our moment that goals the we efforts an we potential year. achieve the last that that I call the turn a update this X will milestones hit to I expenses. on would Steven our to emphasize over Dr. oncology were and who the appointed CEO are on starting take were oncology to to November. you date to when objectives milestones indication company moving I later our the stated was I Interim and hope just reduce to Those get on on front, to our to forward we as LaRosa, achieve goals like

by then and be made As both measurable I'm hope our rewarded shortly, progress by will gratified will fronts. that hear this if have shareholders that progress. you we progress on continues, those it

now Chief Steven over will turn the Officer. Aethlon's to Medical I that, With Dr. call LaRosa,

Thank you, Jim.

and year Research the of (nivolumab). The ago, Hospital disease X, XX, Hemopurifier renewal. Bellberry be stable Ethics BHREC such or dose-finding a Committee of eligible time, Hospital which at be Merck's As full trial for for Myers approval Central Research announced Network, The CALHN XXXX. days multicenter XXXX, located on as Health for trial same s The on for ethics the Local have who after Human until two ethics XX, with Australia. the staff during tumors will approval granted will full Opdivo Pindara X Human Earlier conducted solid Private with Keytruda until Committee, June feasibility Bristol to anti-PD-X the (pembrolizumab) Ethics clinical is June August Pindara in treatment, patients the or clinical the by in XX, Matos Adelaide it trial. August is valid progressive approval monotherapy valid Queensland, this safety, the years granted XXXX, X XXXX, approval Private for and Dr. his Marco

this at the be and staff Adelaide Brown conducted Australia. Hospital Royal CALHN his Michael Trials The Adelaide, Unit trial site at by at Professor, will Clinical Cancer in

as receive forward, Australian in the the Aethlon patient SIVs, each reviews next approvals offices conduct business, trial will the our The office research from insurance. known are site Research ReSQ, enrollment Once approval and which, hospital. Contract to at these obtained, indemnities in with initiation may after governance steps research Going proceed. concert Organization, are governance

that late we be for open enrollment expect in to We XXXX. mid- will September

frame other the with including of an We HREC which third the activation Bellberry through value-creating the reviewed submission anticipate in the Pindara potential upcoming of X additional should Governance is site this the the the jurisdiction at of several study under line sites. in Committee site site. be The to for milestones, Australia activation has that time already

be response with the a the Committee Human India, scientific Ethics expectations will We that Research the await committee at a review. also followed in that, by from site

monitor The endpoint clinically and is tumors, either lab changes is PD-X intervals to treatment of of trial at a primary Hemopurifier-treated a reminder, XX-patient X will run-in stable primary X-month antibody, solid the safety, a period trial or events tests dose-finding or different significant these after with -- patients, feasibility adverse and endpoint with progressive As antibody anti-PD-X of the Opdivo. in any studies safety. and disease Keytruda

study, X treatments of sequential a will Patients do X-week X, or period will antibody therapy receive to respond cohorts the period. the who where not enter during to Hemopurifier either eligible Hemopurifier anti-PD-X the be X

extracellular vesicles to the addition safety, these and study to to Hemopurifier body's examine the of to own the the is changes of These designed number known ability attack natural premarket of expected to concentrations monitoring improve vesicle extracellular agencies. concentration treatments in needed regulatory decrease tumor cells. a safety by a design and as approval, analyses inform trial, and the including subsequent a central other PMA exploratory are laboratory FDA efficacy study the required In

these remove who the Hemopurifier by improve therapies. designed as or Currently, approximately implicated bloodstream, vesicles XX% these lasting the therapeutic therapies. spread -- will of may as produced from nivolumab pembrolizumab only to may anti-PD-X the been Aethlon vesicles has rates tumors Extracellular well have to to responses the the have patients resistance in clinical been The cancers response have which extracellular agents. bind of to and anti-PD-X receive

outbreaks In stands has The Hemopurifier address poised samples. studies, exists. to to plasma viruses, company to pandemics preclinical treatment life-threatening shown reduce been the the patient no envelope for also cancer due of number in and EVs which

ability We include influenza, benchtop previously envelope flu. Hemopurifier in, the number demonstrated but have of include, Avian as a experiments. limited and of to a version bird to, viruses the not These dengue bind of HXNX interest in known vitro of

to enroll sites COVID-XX and ongoing the require To at maintaining the one unit. India patients evaluating actively has infection enrollment our COVID-XX date, the been cost company trial. treated. is company's admissions remains intensive COVID-XX to Additionally, potential admission patient with open care trial against The of in who severe this

financial I'll the that, With then the for over questions. back Jim to open turn call for discussion up and

discussion our I keep Thanks, everyone. financial on Steve, my remarks to and try good at will afternoon high level. again, a

that release quarterly find our You'll expense or hit report detailed our wire XX-Q. the financial in information earnings in just Form attached statements the on to soon-to-be-filed

million. XX, approximately had Medical Aethlon cash As of balance June of XXXX, a $X.X

period a in or for expenses, decrease XX, of approximately XXXX payroll an in ended to compared of professional million June June $XXX,XXX partially decrease offset $XXX,XXX. decrease and Our and general quarter a related XXXX XXXX. consolidated by approximately due fees, increase ended the approximately approximately to and were in the administrative $X.X of approximately expenses for of approximately XX% This operating the was $XXX,XXX fiscal million, in fiscal quarter $X.X $XXX,XXX expenses

to was in related the services professional raw organization, a supplies The decrease expenses, consulting fees primarily lab for approximate and in G&A approximate a decrease XX, decrease quarter in was manufacturing of contract corporate the of consulting termination The $XXX,XXX due in materials matters. to due primarily of for $XXX,XXX and a manufacturing decrease decrease to legal to a in a general in supplies. ended XXXX, decrease primarily in June scientific $XXX,XXX fees Hemopurifier relating $XX,XXX $XXX,XXX with related purchase expenses $XXX,XXX fiscal to

partially was compensation related and $XXX,XXX by increase That $XX,XXX expenses to due an expenses termination of decrease in of employee. increase an stock-based related approximate expenses. in primarily $XXX,XXX payroll an decrease separation a in increase general $XXX,XXX, and was in the to approximately The of personnel and administrative offset

June factors of if quarter fiscal Aethlon's $XXX,XXX quarter-over-quarter. included commentary for As in and to note in for ended to operating issued and XX, our XX, earlier noted, operations statements the million approximately a XXXX, press XX, expenses and the $XXX,XXX I $X ended by provision XXXX, over a $X.X afternoon. decreased sheet of million June June I'd That that by quarter the approximately employee and the that the in result XX, fiscal balance We fiscal related XXXX, these to XXXX. $X.X ended approximately quarters release like earnings million decreased this termination, emphasize related results net the release we just from June loss included exclude XXXX. the

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

September XX-Q with be take now, filing I may fiscal and second have. next November quarterly the questions Steve XXXX. And quarter of our XX, earnings ending Form coincide on report for to Our happy XXXX, any call would will you in that the

open please the for call questions. Operator,

question [Operator Marin Marla Instructions] Zacks. first comes The with from

get you said wanted expense. something -- operating to back I So want just the to about I to Jim, just

of run exclude you employee, to is in payment course, R&D? a will former begin development efforts the it good to the clinical ramp, If we rate some that to normalize see forward, going as understanding, of higher reflected the that that

good Marla, question. that's a

different moving things have in We directions.

somewhat the this law now information On and look we should changed side, firms be if at accounting public you and expensive. less is website filings, reduction firms firms, our that and expense

in have benefit we June the that quarter. So didn't

expense should there forward. So fees be going from reductions those further professional

more much Steve initiation September trials. train But expect activity noted, some fly to in people. we do month-to-month, the in to as going there and and clinical Australian starting colleagues the over the are site you

will will additional it and remain on the expenses. there So clinical higher be on the -- probably front, trial

but So they should We somewhat can't predict be may they exactly, offset. offsetting.

Okay.

to then So Steve. a follow-up

provide, will how you you short-term And In that provide of be to back you process? to once the returned terms that States? relatively left you do expect to support kind and training of have any you've a

Marla. you, Thank question. Great Yes.

visits, approvals governance site done X review process and research and participate the those already initiation actually will in kind with at initiation on We've mentioned, visits colleague underway. begin my patients. That's are me both got Aethlon you're Once at sites site I the goes the which switch. the screening okay. in scheduled -- September, can as provided So that of is those governance the sites virtually, enrolling

followed with sites time meet and That will personnel will investigator technical site frame, meeting frame, initiation time lots site. training which At Australia and be there'll the be October actually by the actual those already already by in the of enrollment be on will at the investigator all sites will -- the an But be travel to for the frame the both X open time then. device. meeting visit

if are help phase sites, at boots will provide now Aethlon actually then a be people on who also assistance position the that to real-time for the you technical would those we interviewing so ground, site. there to of will, the And in

be colleague all So here at well patient as who yes, for course, be, any they'll enrolled. as that's times available, will of my and I

housekeeping It's want question. Okay. a sure I what just last And to make in prepared understanding of question. your that then really I'm you remarks. said more

Is paperwork you like as completed far that that needed to all the paperwork submit. at As of the correct? you've your end,

responses. had the ethics had committees, be submitted to both paperwork we that For and a

the CRO And end our the from at phase. the governance that done they we X offices ReSQ need provided through do. We're now we're paperwork that could roll. everything we've those so Yes, review. sites And with for our all waiting to we've governance for

showing of insurance issues. them And again, business We're kind just our are signed We've those Marla, indemnities. policies. straightforward

some of even few... down tracking they've countersigned think a them, I we're

budget. Agreed-upon

Budgets that upon. are agreed

down. nail a would I thing it's So say, straightforward to business

back [Operator Instructions] This concludes our would to conference question-and-answer any to like closing over I Jim the session. Frakes for remarks. turn

look pleased first and results. We're up-to-date forward we're that to and to operator, on us you, thank everybody, Thank calls. making for progress, you again, keeping joining future we discuss today fiscal quarter our Goodbye. you

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

disconnect. may now You