AIM ImmunoTech (AIM) 15 Aug 232023 Q2 Earnings call transcript

Hello and welcome to the AIM ImmunoTech Quarterly Update Conference Call and Webcast.

As a brief reminder, all participants are currently in listen-only mode. [Operator Instructions] Following the presentation, there will be a question-and-answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event.

At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations or future projections. and and statements forward-looking are involve uncertainties. risks These

and are to federal the statements current laws on Harbor pursuant call this expectations AIM's on the Forward-looking Safe differ made provisions are based results actual could that materially. securities of

you result, undue place not forward-looking reliance should any statements. a As on

These reports could and actual such these discussed are Exchange documents forward-looking carefully. to the are you AIM with encourage materially Securities differ documents periodic the filed of to Commission. the website. Commission's and Some of cause from on factors Exchange statements company's in that review We the and results on Investors those by available the contemplated Securities the section website

on sources surveys from studies, data obtained Additionally, the research. and other publications, relates certain information contained based this and third-party in own webcast estimates company's and is to or

third-party to any believes of verified be While from independent as representation this these verified adequacy, or source completeness that has third-party it any obtained of as date and has presentation, the sources not independently fairness, accuracy the of no the sources. or information to company accurate makes reliable

Joining us team Officer; Thomas Officer. leadership Christopher the on from Executive Scientific Chief call McAleer, Ph.D, AIM and Equels, are today's

call I Equels. now over to would turn Please like the Mr. to proceed.

progress I'm the first extremely made have the pleased half with for we of this year.

on execution related and timing to meeting are expectations programs. cases in and clinical our We exceeding many our

a Aim to by many It's are the team and Aim. now And that in and at the belief our stronger Fundamentally, with has take want potential is to collaborators. we clearly my vast a been the our me, just I Ampligen. never company moment shared team thank at and belief line of what

clinical the a two our and Florida operations quarter Both and over progress. including they've where our achieving Jersey made in clinical years, in incredible developing strides programs last fantastic big thank this past deserve you New

priority post-COVID what accomplished and Phase in is we in going are quarter. let's at our conditions, like and of by day just past we've all subjects, COVID at we important of but long trials or this the have all exceeded fatigue But have of as begun the focused. our forward. we enrolling we clinical only number two subjects in Execution a or enrolled. met trial look of Aim, a our II not trials In treatment have Now that a ago, milestones been take chronic

hope of and well that end as be in coming And So will to expected study published We've will be our end XXXX the of top by underway cancer. dosages which out QX data, data related data is QX. to pancreatic best to preclinical favorable, we is clinical line projection. current as according

XX we very, we've Program, over in Europe's with to facilities collaborators, Furthermore, one very cancer. MC, do program AstraZeneca, compelling. a top Erasmus working line Early Access treated It's is data positive. of pancreatic pancreatic top where one metastatic are of pancreatic extremely at cancer the advanced research And cancer from our subjects top metastatic our

all those done And have party that just in numerous And have the to that's waiting approvals cancer some things get the be protocol. finishing Durvalumab. a with They're their accomplished. Ampligen combining complicated been drug of drug to our We're started.

have up, up to but the as paper, a simple say and advanced sites in Finally, steps we We that signed program for States. cancer we are are it's a United and opening recruiting lot as when go. not sites our signed locally pancreatic of new there just signing

to Center have Buffett go University Nebraska. of the it, We at through Cancer

to years, this things our And just what AIM it but that So we've when gets the you can done. done we've in at see, done deliver. at the what over on quarter comes two past based team goals, looking we past

broad as and in our antiviral or of hard has diseases at actual broad pipeline we long cover like in because a COVID in impact have developing COVID look oncology the working because and lot an we ground infection. a a we're broad let's spectrum, broad pipeline the spectrum Ampligen Now COVID it's And actual that.

that work recurrent advanced and cancer. here see in you we're Now clinic pancreatic metastatic doing cancer, cancer, the pancreatic advanced locally ovarian

dosage know, all You highly with long has edge that's of of type enrolled is these this the In oncology unmet the work subjects are needs. COVID, because clear malignancies cutting medical are in lethal and begun.

we data line in expect top QX. mentioned, I As

of know, there's on, going You involves but so lot all activity a it progress.

mean You've because doesn't the are heard you're the wheels turning you've forward. that just this, going saying heard

same thing it's the with progress. Well,

it there's because see direction. But doesn't looks the traveling here we're hour we're not forward. in miles but right going turning, have you're mean like only XX can activity Just a the wheels of at an lot you

that from to year with fatigue to by list, going with we'll chronic syndrome QX in we are in Now, fatigue data. be fatigue regard you the know, on results our thing like very much this next last see chronic syndrome, chronic conditions post-COVID the guided

these So programs forward. all of are moving

the talk on with and I you Christopher officer, points. Thank those McAleer you, with Dr. want to our go today is science detail Now scientific that, Chris. into here to

Thank you, Tom.

area As pipeline lead indication unmet cancer. primary pancreas have out, broad is multiple we cancer, Tom specifically needs. pointed And in across a focus our our

caveat led addition to of patients And patients. was we free see in in have this that the the that any seeing paper. we're Netherlands improvements total progression in I patients the but in analyzed. XX continued cancers data want comprised do the cohort in additional original to that was data the this presented EAP the data has last confirms up of survival XX call, until in XXth discussed the been you'll beyond As to collected has for and earnings the June year, graphs of enroll this what

controls. to the is improvement the of in four historical overall and that to confirms in control those over extension month improvements historical survival And the a patient survival five analysis comparison

there the addition patients. graph with survival XX and if these of the that's look in comparison green Kaplan-Meier a at curves. of fact, and appears left, short you be And In long-term on red improvements the the to

populations of to Ampligen. analysis determine help that to subsets better of We doing data respond are further might also

As increases levels additional There an who an XX are subset a XX overall previous And the which XX data. the XXXX, months. in patients. survival, further month months encompasses example, four are at you progression free those less than additional of patients look That's beyond to beyond see if also in four five of one a that's survival. an

data as sufficient which patients these the progression be only it we confirms we in if see XX the in no control AMP-XXX you have compelling. for the to The that should original And additional know we the those had. regulators. in and EAP, overall reason survival the are that won't, But data believe data data free compares improvements to

have it they that subset the to may first are ongoing unlikely AMP-XXX good further be matter. of currently be patient they for analyses The our necessary will approval enrollment. trial for So forward awaiting effects. Ampligen understanding and But for help that moving future and is and multifaceted

in Center Gabriel determine FOLFIRINOX Ohio are The treatment the who both currently to in eligibility patients Cancer and to monitoring enroll FOLFIRINOX. are University their Nebraska multiple undergoing of

for to several opens months. and discuss patient the that the enrollment is where the up their trial can to wanted what on patient to moment design that take depends to take I site means identification from enrollment. on patient journey a The timeline and when

to once six Each four receive And stop, though. recuperate extended months, four toxic. they with to and given worked whether they can of monitored clinician the from minimum quite disease. weeks ability treatment FOLFIRINOX and treatment are but treatment which to patient further also treated FOLFIRINOX time a therapy, after stop their to then they're on at months stabilizing four the again must least treatment, depending They for in FOLFIRINOX determine and must observations that be patient's helpful, handle be is

sites clinical will controls before opening would our and processes If enroll, clinical randomized on enrollment be large they and is be institutional followed. sites. take more evaluated could that These receive The consented have two, be and focus place sites or are about then stable, is focus week they'd to in they they defined treatment. and a which need must and patient on

example, a hospital and one process And two For site. begin weeks realities Cancer to screening a several proposed once are are committees or there institutional processes can internal its sites. patients. send letter trial took these had month. months finalized until the clinical just only invitation meets it a IRB site to we and And timelines meet the large every review of

them. contract that negotiations over Of XX are And and some those opening sites. an in and identified expressed sites our end, of focus. have XX sites we contacted XX to of half identifying must have of budget almost with ongoing additional have we those be interest. we and/or But degree control sites, and that

multiple like Institute, working sites And have we also data patients the Hospital that Cannon and and we Sarah are can more We faster with Western the clinical trial centers in receive EAP. logistics resembles of the enroll simple Allegheny Research open, sites. Pennsylvania that hopefully suggest that who

And for that is focus our AMP-XXX.

patient we we additional it the is the take data when EAP, that and to the based time. that what does the XX expected on based comes I data this efforts But well explained, data believe So AMP-XXX the in, including have on be worth from wait.

cancer to combined durvalumab we Netherlands final QP working with in Ampligen patients. start the pancreas the for to including addition DURIPANC on AMP-XXX, to release In approvals, European are that's metastatic study also and investigate

still in study is for enrollment year. to on track QX of That patient open this

June be ovarian for we've that as come We better in was in September. II to trial published or is the what recurrent data originally in and that in good interim of But that cancer. the still are advanced AACR. than awaiting was the indicate that amended data conversations Phase expected had to Pittsburgh results University

opinion, T to other cytotoxic similar modulate ovarian, expecting in function immune That of data changes tumors. we've for further cancers, such XXXX release in seen but In addition, ability in and which to they cytokine T conference our at concerning specifically changes marker as Ampligen's the Cell Ampligen Cell solid to are data data applicability differential in broad the upregulation. and present SITC immune illustrates is

to working study as Ampligen target just of also fast our recruitment very AMP-XXX study also and We are that our went Site enrollment conditions, study. hit XX for we diligently recently known post-COVID patients. our and of treat we initiation on announced this

that trial. in XXXX. the thereafter. means will we as patient about ups treatment this And is with early very and last data dose QX two XX top expecting excited be line The regimen mid-November we as weeks are for are follow weeks This for

treatment. both I received, did was know, at update a of X latest adverse all week, want event, a which point one last I which and point been the only of highs that was had hundreds, the [indiscernible] Grade numbers remedied which doses, to Thursday that as the was there of this between Ampligen, in of out by Placebo the, the case last of you

And we attest we overall of perspective and clinical should and think excited the from I And that be long-term stockholders AIM. and agenda desk, short are advancing to scientific about from my think clinical Ampligen. profile of the safety future the our

of back future financial it the Tom to AIM discuss hand from I'll a And to perspective.

very much, you Thank Chris.

mentioning, As we Chris well-developed have safety profile. a was

plus is XX,XXX that generally have also in not well We've tolerated, and IV I intraperitoneally Ampligen findings doses We in II III but testing. Phase humans. and had Phase and IV, Phase intranasally only

that us the So in a into not aspect that consideration. safety and multiple because programs is we a issue is springboard drug that generally to tolerated have of major well clinical allows

coming and to address are I'd our the we've Now our milestones and milestones that like how achieved up. milestones

We're would third open pancreatic that third in numerous our the right the In had locally-advanced sites quarter we cancer in additional projected we quarter, program. now.

II we We had the we post-COVID results protocol with have our planned enroll published fact, all advanced have dosing in And patients, begun be Phase projected patients. that enrolled ovarian interim and recurrent our this And patient program. subjects Phase in this that in we II would have we the conditions, in last trial. cancer of will projected dose trial

to cancer, have regard the will of that in many the have dosing every fourth enrolled to fourth treated we quarter, have the already been we have post-COVID that With we metastatic accomplished. the milestones So begin that hope for II by third pancreatic with enrollment quarter. will quarter every hope study. Phase And begin last subject certainly conditions, regard we in our and

move with final complete, patient XXXX. the the first of So we quarter into

COVID the our believe Phase that top quarter study. line first will XXXX, will long data the thing in be be the from big milestone And we a publication of the II of

to keep. Now a very be wisdom who in to heard And I'd do with. moment you all We've just are fortunate we measured by the we here. like to business that can the take that sometimes about good you be old company talk company

different cancer with done working using metastatic number drug a collaborator of AstraZeneca We've or and pembrolizumab Ampligen as combination KEYTRUDA. durvalumab. drug We're a with with their Merck in pancreatic studies in their

these studies areas investigator-sponsored Center in cancer creme are in the creme locations the in York, working. Pittsburgh Buffett Cancer trials centers Park world-class Our in Pittsburgh where la and Roswell Erasmus we're conducting of Netherlands, top University cancer Nebraska and we're research de where in cancer the the are New of for the centers

a of to cash position about I'd now terms little like bit snapshot. talk or our financial in

As you can second in Ampligen significant lines clinical robust deliver extremely see, on to through in quarter, position. trial course our continued time the the and over indications. our an we're team progress And made of multiple advancing studies

And meaningful be growing support of remains fully steadfast strong future. in option by encouraged and mission are to our continue consistent We of that, supported we execution the of be by cash oncology position our operational our a body will and and positive the in in the data advance clinical Ampligen pipeline. believe treatment development a to

that themselves think the I respect. numbers speak in that for

But we the wiped all cash of in happened what's these important done the being two over stewards the Why companies especially biotech we've and goals clinical to it out maybe look the our small-cap position. good by Why some a to for now? years. you of the our So while have biotech, we've When and AIM? milestones progress, been stayed at lot question. we've true past achieved come sector, what's

very We've very of positive development being So superior in at I want behalf can value. going on. a of of got lot into position. On much cash in you team activity and the strong that It's activity AIM a of type for translate we're stockholder interested to ImmunoTech. Ampligen AIM, thank the

like we operator time, the so to this over that turn presentation have to At Q&A. I'd can the

floor Instructions] is now question ahead. open Please first you. from coming The [Operator Partners. Jim go questions. of Thank Global The Molloy for is Alliance

you you questions. data walk very schedule we what Hi. you on Good anticipate of the sort the to the Thank that see primary, in want of taking what's up follow morning. here first I please, as be And of Could quarter, my what's much great. the well the walk -- walk sort the secondary? AMP-XXX. would of trial should for through, the to through and sort through dosing rationale

that fairly a Thank again. four controlled to hit to a talk program but data gave not you, response, pilot four positive preliminary Jim. us the you we setting, three in Good with had We positive results. with of in significant AMP-XXX a out of subjects,

the stages Dr. that So that planning for different I'm to were actual study see. elements sense, Scientific the protocols year, we top first not only use out, pretty in over and data, be that pilot This we Officer our hand And we the and we to is de-risk everything to the which this with will study extremely going through cancer of AMP-XXX. line drawn of in a it would a be favorable. McAleer protocol did, quarter have but you'll here, our the consistent long discuss will and to are the that the from moves that. he'll hope the which activities is go quick next

for the you multifaceted. Jim. was Thank It question,

fatigue Ampligen XX score I endpoint controlled is it. Six short -- But from There the fatigue I brain controlled. score, as a that's a outcomes design of be test. The So is well. trial Xa. treated minute a patients, placebo double-blind, are primary The PROMIS fog hope secondary XX all PROMIS will answer form walk patients. PROMIS

top analysis also line. We question other your some biomarker expect that of exploratory data sorry function. I'm part we also the cognitive There's were exam and a MoCA have -- on for

just was design confirmatory do go said trial get Well, what this III to Phase most of I there's and trial? a just the I anticipate you to -- dosing so to of that it. want get into you presume then the and out

Yes.

a with depending FDA expectation. to That next dosing weeks trial. XX our B depends of do works, we next to a weeks the data with quality we go is If treatment III the the and Phase well is will the trial right? on But the presume line confirmatory that follow-up. the Type the So is on what how that X depend meeting data top

this not order insignificant similar FDA, health that forward an million remember, X is breakthrough cancer you to with arise Phase COVID, track public to III, serious opportunities, need II just a now, but long Yes, are disabling This way, and see there which in what we move placebo-controlled fast the that also in and market not the in and Americans. to data, with to an is, may not into very right impact. Phase afflicting move extent insignificant type

So placebo-controlled FDA moving next have this data be the this to there to advantage may trial for advantage that the opportunities take take the present can order we and forward, steps. of but with have we to things of that of type in

XX Jim, patients data will mechanism things Ampligen's way II current that a fatigue is for the it on be And brain -- I our with well, III. do no fog. the small hope preliminary expect for like I based expect the of sufficient we we if Phase the and the that out -- data comes understanding and and therapies, Phase

in What's to of sort baseline PROMIS score fatigue the and the trial? fog, entry into the criteria? change criteria Is entry it get from brain what's for

from patients. a -- PROMIS secondary measuring and control we're of So fatigue measure the to change individual baseline for both change score from in

-- the your are -- if control AIM it's two and then currently of always is only those two trials excellent and and ISTs. partnerships only correctly stewards understand for? your the that that those the under are of lot been that I have Okay. the run you are being guys paying shareholder To XXX, a are Great. capital and And in XXX

to component, drug. That's supply including Well, primary provide of we financial investigator-sponsored these correct. I the of mean, trials, some support the other

for purposes AMP-XXX these important be AIM of that However, and trial. sponsored it AMP-XXX, was

So Because we're to which needs. in pancreatic lethal cancer items we is a provides data fund able necessary progression-free medical survival. is malignancy cancer like those that to or with are advanced there currently pancreatic The unmet that in control we're rapidly. and moving horrible large dealing for therapy survival forward COVID no just the extended long

financial our is a lives. immunological post-COVID there that long disabled. to terms So COVID may similarly are have doing an cases to work. many important or people to deliver ability potential, from of where participate solution fatigue important to what that severe we people in And and perceive more these even but take themselves, we're it's with care in And obviously chronic unable to family syndrome, bedridden their in of go function save

forward more having deserve and able therapy to to also being Phase a a this in ability the have us. rapidly therapeutic a people have there our So to bed in allow that we're of not And a Phase prisoner if don't have will a the important than extremely we impact any option life. them II, a move help provide with therapeutic show significant Because better because us III, FDA that if just they is might options. to we alternative intend

order we people the have trials move it's we to show possibly fast better areas. we're pace. significant FDA So and controlled these a to opportunity our in very the two therapeutic EMA need will things And by a that subjects these as AIM in the we the proof because so these And control for as can life. that provide have of to those are the can we doing intention important here

question. last Maybe you. Thank

anticipate what's the be You to what interim see what's data will we advanced see? mentioned data, are data? ovarian recurrent out there? quarter, to What And coming clinical guys good data, should you Pittsburgh cancer bad third anticipating that

that indication published Well, the positive. be know it in suggests extremely what AACR was which will every exactly is April at we data that now. today consistent don't preliminary was right of XXXX, But with data that

as publication you like If normal unfortunately. to it pancreatic recurrent was so preliminary somewhat a like that a published data, abstract late-breaking death sentence because but that a Advanced there where of abstract are data not remember an was ovarian see in abstract the cancer almost cancer, was powerful a is it's few late-stage a cancer filed was alternatives. because

XX% showing but what So I in addition, shown showed pembrolizumab plus and by it was it complete not benefit plus There impact recurrent far were excess of what Ampligen in with in with this And stabilization abstract, mean, had additionally alone. pembrolizumab, XX% combining immunological of XX% the advanced ovarian survival clinical response seeing with ORR a AACR pembrolizumab, plus was was that it partial Ampligen we also just in disease pembrolizumab cancer. on data XX% focused responses. another then with seen of KEYNOTE and was in XXX plus an over significant was

that of think data this is similar was similarly interim assuming it's very powerful, part protocol will the based assumption. that on interim powerful. program of analysis, that data a So the operating we're We and be

right now. you. you And the from there % XXXX Will I'm they Thank any year? I data or something think year it at present -- do XX.X benefit was AACR next be rate. Excellent. this perhaps did at anticipate XX.X%, AACR Yeah, clinical looking

assuming don't in present for data present they're able SITC it. everything up this know year, to interim we think to this a I that's But they're sure. program fashion wrap and at going timely

course of very questions. of Appreciate And taking your hands. right. Thank the you much. All out

Well, thank you, Jim.

Please go ahead. Thank Ed you. from of The next Woo Capital. Ascendiant is question coming

progress the Was And is long do Thank US you international in question there on COVID My especially only is any the on a that the you. EU? Congratulations studies plans to made. study. study?

the And I'll study. Yes. is now, that, Ed, I in taking Right the address place if FDA-authorized AMP-XXX an only it's US. may.

of started, we're through board working non-identical it. order but the similar in lot these one the the somewhat working on drawing that's in get Europe, a a because we of Netherlands. study there's to conduct However, go -- probably have things in that's to board to on are drawing that on bureaucracy But you

any on you have And Is do or cash balance. now? to have No pretty focus you you just a big considerations there any are potentially guys then going Great. what to acquisitions problem.

keep lose Well, now a my as we're learning focus important that lot of So working right? your father that okay? merger to hit want right baseball we're on ball, boy, things eye are the technology. taught me acquisition by I we've a If got acquire when a you our I was or to mode into on moving and extremely want trying don't other to where it,

was biotech has opportunity Now that's if not say a for the been to sector presented compelling and itself, an bit which slaughterhouse. the years past two a of

So as there's those could on without want there milestones are sure things and that we cash that which I we progress underway milestones, use our have that's out deliver the the we take team first our meet diverted. advantage stockholders down the and for clinical we the priority, But to to important make we probably think of. very have we road being

turn is something the So would if compelling away so first we priority politician's an our way. we only in sounds acquisition. couldn't And a clinic. a like But was answer it that that do

Well, for question you. wish Great. answering my Thank thanks luck. good you guys and

you, your Appreciate interest. Well, thank Ed.

this turn back to Mr. At comments. you. for like Thank time, to floor the closing Equels over I'd

And positioned AIM. the support. to much thank AIM pleased well you, for thank and to closing, continued you I very believe to and year milestones Donna. and this and of operational for we want progress with are I beyond. on is of thank our your Team remainder behalf In Well, time exciting want a year myself, this throughout I'm achieve important This clinical very everybody and very extremely

This and Ladies for thank gentlemen, your event. concludes today's participation. you

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