AIM ImmunoTech (AIM) 16 May 232023 Q1 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 a listen-only mode. [Operator Instructions] 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.

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

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

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

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

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

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

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

Thank you, Operator.

Future. mentioned, Better As our And at motto CEO Tom AIM I'm it's a of been ImmunoTech Immunology is for the Equels, AIM for ImmunoTech. the company

complete And through and to doing the serious in disease development just that, Ampligen. COVID again, with drug not a now. bring better areas for diseases right have malignancies, people unmet rewards for such create hope of but financial where many future but we a just target experimental trying those, our do, as of no a in there's lethal we're that the primarily on research need. medical to whom working cure We're hope, from not these We're come type long and to

the was which key in who had of of to that pancreatic call, our areas long a ovarian our advanced half ago, terms past and and recurrent months call recognize our cancer attended today, of especially last just in our quarterly improvement a in priority those XX regard we've over you COVID. trials, month With cancer, clinical significant progress

a clinical that want I through point. XX our a we program, program, we're approaching about establishes talk a measure to of coming Early pancreatic work little tremendous late those in which bit Access Now, this and because subjects, because stage amount of part our very our at had data future de-risks clear subjects cancer

is and a evidence survival. clear top survival, progression cancer-related of projected the of one is seeing of cancer That is overall for free world. the to causes in We're that malignancy, XXXX deaths which be

ovarian Advanced April going several So very last has recurrent to our a different the a in data year, it's a back cancer, big a therapeutic over Ampligen's months, past number gathered indicator strong solid tumors. of we've that as market. of of potential

example, for and the cancer. us trials, regulatory In the long randomized a forward made INDs fatigue addition authorizing we different controlled expressing for had progress like of pancreatic number COVID, in chronic go placebo-controlled in with in clinic, approvals a Phase symptoms, to to we've X that of clinical

some parallels also clinics, progress we've we're that So structural and these regulatory in strong advances making made the changes.

will we and made She of of Nancy, Chairman pioneer including industry a have Board deep lot a Scientific that strong in mergers, pharmaceutical valuable Directors. has as biotechnology very our We activity think world the our acquisitions a background, Burnette, of Neal has joined W. and be renowned and Bryan Board, licensing. Advisory

significantly. team improved of So quality and depth we've the management our

can go repurposing you oncology. have for Ampligen several ago to prioritized to Now, get our details you years if in we into website, the this, as our pipeline, but

of future development clinical of to the company. our areas two prioritized have are important We that extremely

cancer. First is pancreatic

since We survival almost both Early progression comparison which Access And that by with been a survival based well cancer. the Dutch have underway was treated. and locally government, XXXX. overall controls, well-matched use on cancer pancreatic has with demonstrated authorization we historical in advanced subjects an free as have been having pancreatic metastatic late XX This Program in program, as

cancer, then like know, And death advanced cancer ovarian a recurrent late as stage sentence. pancreatic you is almost

pembrolizumab, our And very much with drug KEYTRUDA. in remarkable Merck's interim at ovarian we're University recurrent we're Phase advanced a a results driven And and Pittsburgh, that X report months. drug a from cancer, posted While preliminary recurrent protocol advanced in cancer study, we're just as of in is also the involved same. combining seeing the in expecting few was known the that data ovarian Ampligen

will responses preliminary data set preliminary late that significant And and the data that the protocol, with combined the that was hope it's published cisplatin where disease is by in which sustained shows advantages, report abstract at seen all. convention survival breaking data significant at patients, is responses be in this Ampligen our partial an pembrolizumab is in to sensitive AACR abstract rarely complete because a including creating

about So excited very that. we're

long commence gotten our that. COVID program, And we've FDA to authorization

selection open, are numerous getting and final dosing see have. but subjects stages very of that with have to hope in we up -- only the And we that the not the those of rapid We and site sites running. sites enrollment

the we'll in that of subjects have of end quarter a next or first these We the by year. treated expectation year reasonable this of have certainly all

to excited at like Officer. where Scientific to moment today. take And very now I'd I'm a about we're introduce our So

things Scientific deep Take programs. a the One the he's do some as and recently done of to going into of McAleer to Chris. on, these for dive too is, it Dr. company, we've that we Officer promoted

I’m to here. be Tom. Thank happy you,

cancer is in primary As that part positive Early as our Access large collected pointed part that and to the Netherlands. was Program pancreas just in that out, data Tom is focus the the due of

advanced original graph published data. is of both cancer the metastatic the improvements a in Journal adenocarcinoma. that and the with amount recall, the progression this survival and singular highlights overall pancreatic you Ampligen and a in over historical Cancers locally As reminder pancreatic was FOLFIRINOX in following free survival data ductal therapy positive controls, patients that EAP as of And

And these to well our I'll results of the in shortly. as as cancer locally both be promising study discussing design led that the study, advanced metastatic have AMP-XXX

this either we'll two study. to patients will opened the be the -- of we Center Access you and of as we expect each As those enrolled studies. an Erasmus will Medical study, as option DURIPANC patients in ongoing AMP-XXX qualify for that Program opening as any part new don't And for leave Early both be

to has data, for continued beyond studies, EAP to published including share while our design led expect excited quite data And Kaplan additional in survival subjects has it's and that enroll new promising. the an these these free And to overall have QX Meier that we and and progression really during of analysis cancers. call, I'll Plots updated updated two the be to

In CDXX. of addition, after the markers express analysis example IRFX treatment has weeks as and blood patients those who revealed as of of expression disease And upregulation subsequent had progressed. gene samples stable had of with differences and disease those in immune between X LTB such stable patient who profiles that an

additional ARGX Ampligen's we gene continue regulation such of mechanism important T suppression it's combinatorial mediate therapies to targets find improve information, ATGXX as upregulation, cell upregulation, into ultimately in that those which to insight patient that more have outcome. with and of who armed is may us But differential given implicated progressed, our well understanding And can advance as action, as for potential to autophagy. in which

lymphocytes activated. have taking the striking populations me in an Ampligen indicating to T shown to KiXX and an T but they patients lymphocytes helper and as cytotoxic of is that lymphocytes that these can proliferate, increase positive to that's cells, T indicating cytotoxic CDXX that cells, T data KiXX the T CDXX [ph] well the have positive showing the helper both population helper most addition continue to increase and in ability expression In T that as of the be positive

successful. recently forthcoming been points And to sustain pancreas a colleagues the presented known findings of Center press Meeting, need And by has Chicago. it they XXXX that in of to these confidence checkpoint data the these were -- cells exhaustion the PDAC give cancer me data that has in and occur Ampligen our to that presentation link evermore at at T will Pancreas so, and data DURIPANC to potential AMP-XXX been a as that pool locally because And the mitigate excited excited. Erasmus advanced Medical that the Club be while in release T inhibitors, data these to study will be extremely metastatic cell me have with AMP-XXX we further, explore and and

little a And want AMP-XXX to a the in I address moment so to further detail. take study

are sites, they well the have that has working But Ohio than Gabrail in been we Enrollment currently actively that patients. to site hopefully expected. for Center as looking and Gabrail site at methodologies slower to their diligently Cancer screening open increase open increase Center different additional the enrollment. advertisement at we Canton, are as We

[ph] U.S to and of initiation we or in that of in and to Center next in occurring And have and are University different Medical at after an in Medical end planned approximately site degree with A Center we Seattle. negotiations will Shortly be Virginia Center beyond does that opening sites May. additional XX Nebraska before enrolling have include another site by the Erasmus in Mason and And visit contract Medical Europe site open that, some we expect the will week. visit be year-end Netherlands. that patients initiation open sites, the at the additional

said, I possible future not reach and with QX. first do But very dosing, that in being timeline. we optimistic QX. in it patients be receive the sites be that the that patient first that opening -- patient am particular until dosing the the patient expect near to But this Well, actual do is cautiously the may additional will because I still not still first control enrolled study in

will -- the to treatment. and And AstraZeneca's FOLFIRINOX. that combine investigator the This which study with about X/X Phase study sponsored efficacy a following durvalumab Ampligen I'll the of investigate is safety talk DURIPANC

shown As well cancer PD-X combinatorial aware KEYTRUDA recurrent inhibitor with in benefit you specifically the ovarian cancer. checkpoint Ampligen guys negative with been as have advanced breast has both high probably inhibitors, triple a as

with I progression believe likely cancer modulating combination to in properties a for very survival promise desperate PD-LX a that intriguing that of very combination ability of the and Ampligen of pancreas pancreas previously, the with a makes is those both of overall we those cancer, are known we together that great pools patients in all aware expression synergistic we cure. the believe metastatic durvalumab for and combat, maintain immune extending free survival cancer that high the should Ampligen to combined T cells discussed that We show in

hurdles our major I are the There for out cautiously this to the some ironed the be have will But commence that Committee that need But Ethics addressed. minor we of chances am been XXXX. optimistic that in study have about projected and beating speculated comments timeline. initiation actually to again, of previously of the otherwise, QX study

been initiate have to the Martin other associated I in with the the hub advancing of as that further providing investigations as end to and facility Sid space at lab the research UF from as a earlier, of I And Innovate further indications University mechanism treating biology Biotechnology to indications, the well Florida, secure small their discussed Ampligen's and such cancer, cancer lab is a EAP of including investigating molecular other efficacy Program. the able

manufacturing acquire am the I to funding, allow lab expect it in with be in future the us have This offset chemistry NIH what burden This provide us supplement to the NDA to protocols space methodologies New costs Jersey actively a we pertaining pancreas and CMC sections we stockholders. that and will space solicit relatively lab to necessary pursuing will low improve to help and our the lab to cancer. control update which that and will chemistry of at

waste that and And a help just world help prepared lab personally few. the removal everything a ensure XX,XXX facility facility, including, think regulatory comes. approximately chemistry advance the incubators, think that access equipment, this this research almost Ampligen I class I spending name scrutiny we biology per behind and that we're will [indiscernible] including for and and day analytical space, the to bargain fundamental Iacocca are a us that is of need we biohazard to to -- infrastructure microscopes, price when for access acquisition to year give to

treated fashion. briefly is not And will primary we primary would some I as XX characteristics. light while advanced exploratory post-COVID mention of outcomes, cell secondary to monitoring Fatigue our oncology as in is enroll remiss focus, biomarker we hope patients, outcome placebo-controlled on have condition Score of Ampligen that The in the analysis double-blind randomized advancements intended The control responder to XX is the immune the a into be such XX that with ideology, insight AMP-XXX exploratory panel some fatigue. and and made PROMIS well provide other biomarkers, disease including as population study shed

are part high patients is We amendments we be made of will and conditions. hopeful study as this that post-COVID with that that that the to responder preliminary based population off collected we AMP-XXX treat have data the hope

As you may general that post decreases with patients as of recall, well exercise, is small fatigue, that that improvements associated to as showed their in had their population the ability exertional we the in malaise exercise.

expect and and X clinical their to memory. these weeks. all concentration signed agreements addition, X and legal we their process those currently XX budgets through agreed contracts have have with the their in and in to improvements sites within next upon trial the And And patients focus, demonstrated

is of XX expectation first in treating the X and drug mid have ship June, patients open June. sites Our in and to to weeks late all

hope questionnaires that's and months, X a is be clinical the enrollment broad will last expectations the thus X enrolled take made feasibility QX. site no the than Our overview in longer will and of to we've And advancements that scientific and patient far. from

to company it I'll back finances. hand Tom the discuss to And

done. Well Chris. you, Thank

our I accomplishments robust see to can we're As that position, given financial X think years. over we demonstrated past you in have that very the a position, the

for to the But cost is work example, study, we've Erasmus, for actually were a Netherlands. the variety that of contributed that a of that over funded was Access clinical the were One other that the for of these we little much Early the done, of the in much the paid at approximately funded through Program, sources. that $XXX,XXX study, governmental and of reasons mechanisms through Ampligen that we

recurrent DoD, through we the thing. that governmental University of much of current Roswell, At Center, the made grants, tremendous clinical that Roswell, funded that significant projected a very advanced Phase And ovarian at Phase various cisplatin a KEYTRUDA, the of tremendous subjects. NIH, in at sensitive the funded achievements Similarly, pembrolizumab the plus advances principally Merck we made were Medical or with Pittsburgh X Ampligen, type that Grant. -- cancer, that's is XX X with by study

potatoes there. not talking we're small So about

of sufficient through have goals move financial that our regulatory we our situation that set every XXXX clinical is we accomplish and strong. So that we've and belief to And for have cash the end period.

how look you if used wisely. we're where Now, at at, and our see we've you dollars

programs especially this that size at cash, We happen. we And the have make are clinical you have we the need the pace, and moving an also we extremely consider to company. when but collaborators partners our our rapid of

If its and pancreatic are you where can cancer. we're on AstraZeneca in for see working with advanced metastatic this pancreatic with busy Ampligen drug combining slide durvalumab cancer,

Roswell plus breast Comprehensive Keytruda in in at at and results KEYTRUDA comes X cancer ovarian negative of in plus two programs. the fabulous in advanced Center, cancer Merck seeing those Cancer triple we're University data as We're Stage working with areas recurrent Pittsburgh, Ampligen and the Ampligen

the and preeminent So Eijck research notch with, have researchers. oncologists cancer. we the the in Van this Edwards immuno class probably at pancreatic Dr. -- world. specialist. collaborators working top top of one top Erasmus, Kalinsky the preeminent world is is Dr. we're of that in cancer at world's field Dr. top centers ovarian

internally, team we're and the best good best. a have we So, the with collaborating of

taken itself of not allows may see in we the the large where ask The right segments. achieve you're to AIM the personnel, biotech Because an extremely you there that with believe diseases AIM? if microcap I And with do in is now? the going we an another take market with with right sector reason company now. to position like board. medical needs now. cash, why is opportunity opportunity look, partners this beating you unmet are clinical are across successes Why advantage yourself, Now, Why long-term the has collaborators where a that serious Ampligen? have presents Well, to the

why why AIM. that's And that's now. So

to was the repurposed was road. because creating tremendous be for thought to and able unmet a that also of on to purposes have deal but down stockholders. investors our one successes Our that reasons we opportunities we need there the focus medical and the opportunity is we And opportunities address, oncology lead big might into of our

at oncology area look the the richest deals. deals and volume You volume biopharma, and are in of is oncology largest deals, the deals of

our put much. target. We're aiming Thank for creates focus a So value. we very have target on that you long-term

open questions. questions, Now, we'll if any anybody the floor has for

of comes first questions. Jim Partners. Thank Global your Molloy you. with line Instructions] question proceed Alliance from the Our Please [Operator with

Hey, the the have on top Thank you morning. with a my X three I Slide morning. on for question. had out you good this taking presentation question sent deck the on

On ignore the it's three [indiscernible] three defined of those those top And three because just so catalyst? nearest investigator-sponsored trials having versus walk of -- AIM the catalyst -- clinical through an opportunities, the trials? are of which you which top interim one oncology are which are which those the the is fourth Early entirely or controlling term Access,

advanced investigator-sponsored, DURIPANC I'm AMP advanced the is recurrent controlled. ovarian AMP-XXX study the pancreas the AIM cancer DURIPANC is The cancer. locally is an -- So sorry, so

June. be an expected report but now an data optimal Stage X, that the of to is be It's being should terms [indiscernible] best patients design sometime date, That is recurrent been the for come drafted it has cancer, advanced in that'll June. interim get Stage It In for formal of stage in in exact ovarian completed. X The that's us. enrolled number run interim couldn't design.

ovarian a and by safety question. expect running. That's as to Phase some mid [ph] XXXX. X, in the come immediate of with that X the X, I we the preliminary data, it expect followed that line, cancer the efficacy recurrent three of design DURIPANC. probably in Phase it's that And your Phase three terms hope in in So be data QX would answers we

DURIPANC that's -- And Thank Ampligen, you. the the durvalumab …? DURIPANC,

the pancreatic study. it’s ductal metastatic DURIPANC

All right.

durvalumab. and Ampligen

PDAC study.

Then when Okay, great. …

we might, of Realize Stage If in is if in I which negative durvalumab seeing advanced I is enthusiasm our triple results was combined -- AstraZeneca James we're James, with the that Ampligen KEYTRUDA. we based that durvalumab recurrent cancer, the breast ovarian of utilizing combined mechanism our tremendous action, PD-LX. might and both add with experience a upon and about beginning for when when checkpoint terms blockade see PD-X synergy with therapy the Ampligen KEYTRUDA's think same should study

you. then McAleer, fourth on PDAC you anticipate with quarter or 'XX? an you're Thank saying metastatic that's the [indiscernible] you When Dr. launch a there, do interim look durvalumab, in data? when

So it'll -- well, open-labeled. be the

the for that as But Phase The it's the at we've So that a Erasmus at data to Phase expect -- Phase X, safe, transition enrollment my just end probably [indiscernible]. -- likely be into had XXXX, we'll X. should have QX. I I say QX the on X, to to are of That those expectations. from QX so the that don't it bleed stage, I the be based X of progresses. want but Phase may

very you the Thank quick follow-up with And locally adenocarcinoma a advanced then pancreatic FOLFIRINOX. much. Understood. on

was -- quarter or what was I [indiscernible] 'XX. opened kind time first enrollment the things 'XX. that in it delayed was special opening first along their This a seems first between start The and of long third in. rolling coming patient in patient -- in circumstances, a believe -- of now, sort Is will patient quarter a we expected there second trial,

yes, had XXXX. -- QX approval we QX IRB in had we approval of of So IRB I’m sorry, in

enroll Gabrail come nobody be were That questionnaires wants in not were patient The We feasibility holidays start to an fruition. treatment their XXXX. over that month. has will one on opened of optimistic approximately Cancer based The able to every they timeframe. first site that Center obviously to QX site issue,

institutions. clinical longer these of legalities was taking we with the have -- also We than larger agreements trial

which across We're just inability our for one average that on the negotiated we four talking also or the three or of sites times the have costs. three drop two finalized budgets or had budgets based per out patient to with. We we four pay

as be two. Nebraska which follow Center agreements But or have Virginia weeks I next to and that Mason the budgets another those now stated June we by finalizing least in week in expect four earlier, I of And University or or trial we, Medical three and we do other to to opened July. are or with clinical happen sites X at X

will hopefully on speed So half if feasibility enrollment questionnaires, up those second here of drastically we based site have the they're the year. that the in accurate,

to to end, at are world treatment Van subjects, of for sometime regard renowned that they from in part And the a to typically as Early team that Eijck Center because that, focal Erasmus regard expect Medical also of the do point, to with this Program, his Erasmus, area the we've Europe. have James, and a Dr. and of as seen sort with the AMP-XXX backlog open summer. in I point in And Access

sometime drug should and release are over, have done supply up all Erasmus this be in QP that to high but typically enroller. and they open We and will needs go summer, that

What them been know longer get study for on what's to to going so taking Erasmus I board start the while, enrolling? -- a has

then continuing, is get as European and as now of the been FDA make patients Erasmus certain studies a that conducting that And Access directed AMP-XXX. previously to for though people Access the clinical longer has there's that go regulatory trial through and is haven't that trials. those drug But an then But arrangements treating also stopped And we would the the Early to into flow into we will at Early are FDA type purposes have delivery regulatory Program even possible than that moving trial, of so they the Erasmus. process, for once open, who everybody of process, The the as bit we fast thing. part to Netherlands. the process be authorized have have taking Program in a

questions. Thanks much. very you Thank taking for the Great.

Thank you.

welcome. You're

you. Thank

proceed with questions. comes the Woo your line Capital. Please of from question Ed Ascendiant with Our next

of What for easy you. Thank inventory additional hard progress. it is would get your the Ampligen. how trials? clinical look inventory your like? for on My on supplies tasks or your Congratulations does And question to your Yes. be

Well, we our against budget inventory. always right existing now, activity clinical

ourselves. the are But process the that address new so Dr. of McAleer it overextend involves manufacturers process. well we creating let details Chris? as And both But in polymer for fill we lots. of which lots as don't and additional Ampligen, of contract new finish I'll

Yes.

thank you. So

think I I question ago. bit this answered a

have things to Ampligen, projections not initial us the process. approximately meet active enough enough trial we addition some another So for all predicated enough X -- a time. promising sometime Ampligen the are ingredients make Ampligen. the from patients EAP I vials, All intermediate polymer to testing, have of currently how to amount buffer. XX% they're quite or going or the vials. look preliminary months. it'll Ampligen we would beyond on out now since can finish X,XXX these we which improve With approximately from another said, December it's the product, stability the X. the small on -- on enough which both Phase high do as that that Ampligen, X,XXX time, progression. long a but do projections AMP-XXX plus the right have improve time manufacturers based long Ampligen be the COVID to the contracted final the not both our Ampligen that we about But and on we to data to that have make or study, a to X,XXX do every think for Currently we its still have, a DURIPANC fixed to continues the which will we I we continue being have be will be Phase Ampligen final have Then do until XX,XXX of taking be yields around help X do are of that. that I to fill Based

that of XXXX. the be improve middle that, should improve the eventually the every Ampligen of some amount have So time we polymer made of of for amount polymer next should at in of we the lab get the and to lot end that

to continue enough we have So Ampligen trials. the

We something on that, becomes have, with this point beyond that the long to we promising. carry want COVID if particular

data the it study as backfill pipeline. of the in next we promising do and And that. will then the beyond comes as to we should Ampligen be, believe we be As primed that have

guys for And wish answering you my luck. Thanks good I questions.

you very much. your appreciate Thank interest. We

now the you. back closing Equels will I hand to Thank call remarks. Mr. for any

Well, And all aspects. in we're We're I [indiscernible]. rapidly our have We're could with opening cancer to lead the there. Ampligen. conjunction also the some that been on that move one results pancreatic forward is of which an pancreatic successful AstraZeneca important program, think track with for I progress to the doing and breakthrough in if we're area steady reaffirm strong in closing, lead making want in possible we striving product as as to of cancer

that in Cancer spectacular preliminary the of New recurrent ovarian the Association will published every as breaking Research And in confirm we program data, American expectation report cancer was the advanced abstract have interim Convention Orleans. at which

So we're moving forward.

the very program. and to coming our cash have the the and are data execute, supports in that team have to We blessed we

This appreciate teleconference. you. conclude We participation. your does Thank today's

You may your disconnect of your day. the time. rest lines at Enjoy this