AIM ImmunoTech (AIM) 2 Apr 242023 Q4 Earnings call transcript

Hello, and welcome to the AIM ImmunoTech Fiscal Year 2023 Update Conference Call and Webcast. [Operator Instructions] Following the presentation 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. These are forward-looking statements and involve risks and uncertainties.

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

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

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

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

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

Joining Officer; team us would to on today's the Equels, proceed proceed, Officer. Mr. Equels. sir. to Dr. call now Please McAleer, and Chief I like turn leadership Scientific Thomas are to Christopher over call from AIM's Executive

and programs. extremely unmet and Thank data-driven and conditions pipeline, body ovarian progress cancer, us. but high-value many areas joining these challenging. post-COVID everyone, was value year that unmet of recurrent data. in This sometimes only medical all through our important promising, consistent across medical long-term And dysfunction, belief needs, XXXX highly enthusiasm demonstrated Ampligen's our the needs these of cancer, were chronic you, we AIM. also lethal development not for where progress unmet showcasing local advanced shown fatigue with We are metastatic clinical are needs, cognitive resulting indications. Such an advanced pancreatic priority advancements for therapeutic have medical significant potential growing in in important our a data firm these positive drives

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types massive to trying in tumors, with to different create checkpoint ability synergies. different and Ampligen's establish inhibitors, synergy, we're many sometimes So tumor

important that a that stockholders any the partner, believe for I creates of also all derisks very Now work our is investors that we for clinical value. only clinical potential future for do this for development not their our business but work foundation understand also because long-term investment, to and progress strategy

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this is and its stockholders, working management we to believe will phase lock that presents I move and next shoulder it arms phase our together opportunity. to stand with shoulder into I is a company great for to what growth believe critical of

my to the recent our turn discussion hope, to your is progress Science will doing McAleer. our over immune also, What update action in and various a the data. Chris is of of understanding Chris? now detailed Officer, it system in you It trials based upon the this clinical on pleasure He Dr. Ampligen. broaden give of I mechanism

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future What had based the I have now say that the report, better good, the reported preliminary the data a AACR once response is been report safety interim finalized the preliminary in will to and releasing is received. was I that be the the included an review abstract. near statement can in profile in the opportunity that initial the data XXXX than will has on be very data, rate is objective April we

presented being in had that data I greater of objective pembrolizumab treatment seen study shareholders partial alone responses. KEYNOTE-XXX objective And recurrent remind pembro X the do AACR complete all Xx rate Ampligen in a that response in ovarian tumor the indicated at containing the to cancer. than response the that

stage post study design. second The also of to recruitment very X-stage the data moved the Simon's The is has accelerated and promising, have on COVID. rates

have planned data Detailed the top line positives. press post-COVID positive be in reported and are We the interim interviewed AMP-XXX data of complete report for trial in also the those copy February of from study release. upcoming will disseminated report. the preliminary all So the

trial. and Amerex deep information next community's the The disease. we the is trial We designed time, and of successful in the criteria the at be refine as finalize refine landscape inform trial inclusion and collect of appropriately helps design Phase to was a the continually design post-COVID power report, to study. And is of that data data next working use as are being that with to of diverse currently pivotal for will analysis understand the preliminary II which understanding to the that help information well generated scientific

will locally discuss preliminary will likely time trial. our take the data, is population expand the that design pages protocol. would That based optimistic in patient on the advanced to a successful, IND listing. analysis AMP-XXX power of type some sufficient currently data based preparing the am with subsequent over are Concerning and we the XX,XXX it the are eligible inclusion the be enrollment. it pancreas I But on of criteria we D altering worth for that to trial for FDA for cancer, meeting review If

any are with FDA, will I patients sites other in future Netherlands recruiting recruitment sites, and allow and Medical the sites resolution sites opening current the revised will EU. consultation for are the in the upon still our the new engaged be type this on speak of recruitment the the meeting. D open after are Hopefully, for and we protocol successful and for candidates. of faster should in with and now In open the Erasmus potential conversations we Center day enrollment in U.S. still in interim, further the screening

escalation That therapy with trial the as I with X Phase brings post portion is FOLFIRINOX. Ampligen of X The me fixed Ampligen dose. to the durvalumab and durvalumab DURIPANC a escalating Study design and combining dosing

durvalumab And least The have and X Ampligen their there of have the have design patient and adverse Ampligen patients at dosing already far, X first X thus patients received X mid-April. last been dose last X doses. reported events. in in enrolled no been have is completed The

which the to That we is April and to portion completed so is Ampligen end the expect and that escalate assuming consistent completes trial finishes we I XXXX. and continues, it according been the far, dose. the should around Once be of the the Phase patient be safety of schedule the dose as if in has can monitoring prescribed thus last the period, profile to far summer next going

in the used this PD-LX published program to information the the exerts pancreas prolonged in Ampligen patients. Ampligen survival of and of what data which in halt durvalumab. I, Study DURIPANC with data the and part work the by in cancer lastly these of And recently access cancer. overall Clinical DURIPANC enrolled the program, should progression-free program will also design in and would these as mechanism These patients Enrollment checkpoint either Journal or inhibitor, confidence aspects synergistically highlight data that further AMP-XXX. were gave this Research, early to Cancer from be was want pancreas address

and cells in which cells Toll-Like works I'd that a With at by are different and Ampligen second take to various to effects look X, being the in Receptor on solid tumors. found epithelial Ampligen said, binding body. like immune

they X. are therefore, different the Receptor that in of parts these and tumors form tissue from body Solid and Toll-Like tumors epithelial express similar

be been might body, has otherwise. two, are the matter throughout the whether types body, multiple cells be ovarian, Ampligen that effective tumors, solid tumor on that tumor breast X to X Toll-Like that in hypothesis the no And immune because, the tumor it's the of including in where pancreas, found Receptor the to surface binding it distributed be or Our binding in microenvironment. the Toll-Like one, Receptor will Ampligen treatment solid an found

increases immune this immune tumor of Ampligen immune and system of shown a T-cell XXX dendritic immune it the the infiltration chart shown distress B upregulation table by by that be and this make are microenvironment. forces to different And tumor attacks complicated, might subsequently, granzyme XX And in or CXCLX, more a table in infiltrates the call And might chart. so to seem against this CDX relatable will, CCLX. these shows here tumor and markers its the biomarkers, the and cell system cell chemotaxis and the in in analogy

that believe but for Ampligen coupled shows as treatment and simply Ampligen in types many checkpoint biomarker inhibitors. happens modulating effect not investigated, want have, the as immune treatment we therefore, have a highlight considerable different specific tumor form a we cancer, other that potential to table types. of the immune these suggest has importantly, we properties, one with And have with synergistic solid data multiple phenomenon for I that would And that

this ovarian and DURIPANC the pancreas I Our will for data be Study well. in confirmed confirmed through triple-negative that as cancer breast and cancer believe hypothesis

our discuss Tom to the presentation milestones to key I'd And as as business like recent to and coming now well months. to the expect clinical in over back Equels, what turn

excited successes too, X XXXX, provide. hit This published we've Thank clinical about you, over that top away the Chris. In have the at back data major of milestone. meetings, years year, followed positive data, oncology. milestone after opportunities in journals and in going abstracts these I I'm very especially we

an planning quarter. action-packed are for we QX, For

redouble deals. our business and as with The now value Now sponsors, conversations comes regarding believe drive hired to process the partners their strategy, and to help. our efforts is Azenova oncology Azenova create development our from potential mentioned, such we time for in the we targeted is mandate for that with I

If money is. oncology. you'll that look, deals of richest you That's the are for where and most see in biotech that's most where the is the deal-making area

right begins do value Business just maximize potential development process forward, sufficient few conversations. That's have to process, valuable the takes or a place where we in the the at sometimes a the we point more. We that and time. doesn't however, of support negotiation transaction to to a overnight, database the long-term a creation that Ampligen. believe, From over a cycle happen discussion. It of with partner the to now. taking of a we're It's introduction ensure year months, team from

believe, we're And we drug acquire taking and that oncology rights allows in these coming we'll are bigger why we additional point. amplify this in, the and data on step the at us in this have the decisions. to data that we discussion, companies pharma time, this drug, an is have by are sitting now is to data-driven also We think decisions that

this we that opportunities co-development, what appear. M&A is are a might for an are trying different have if interested partnering, even year XXXX do? we licensing Now are partner, believe integral We number partnering, deals, process. an traditional things possible to There of business

have strides team, intend with potential this discussions our the year. have with the over data, the and of We important partners course to these make we we

there. go thing half take this are we Now our programs take in numbers the the to XX-K we important filed. details that year a a our The the is are have with let's longer. and look at from snapshot. the wherewithal next to for forward financial just But or The

are look what the is programs this underway. have So seeing here ability you're the to have programs future, is that answer. we When at important continue the and you we into our

both for AIM future Chris Now Ampligen. believe is this and strategy I The us team forward. the AIM behind and is bright entire driving

to been data several our superb. important continue our clinical deliver and of huge promising potential indications, has which operational market execution to believe We all Our will have create activities we programs, across the opportunities.

this Now provide done Ampligen Ampligen's forward therapeutic AIM is all and value. drive and unlock opportunity of to to

I past medical is what good posted Our as expect in scientific good X just years not that showing strong stockholder value. business that and firmly and our the equals success believe over for the medicine. good we though we future medicine clinical well as a driving basis is

at this like questions. for Now the to time, open I'd floor

McCarthy [Operator Instructions] Our Maxim from first Jason question is coming Group. from

on is Jason. This for Chad

event, for XQ do AMP-XXX, if you there I on you was for So Does as think bit Anything that clarity helpful. patient could wondering a guys of more would timing be event? -- just that XQ give first a dose.

that would will that but well. only That's full with certainly in hope in by a the standard get why because of difference bit? recruited can meeting the have of the to seems to the expectation talk U.S. the we U.S., amendments start also into and we have the Europe FDA. affecting we're U.S. we certainly ability of can't Europe, there's to enroll, but candidates subjects in get as not that care go little broaden is that end treatment. to a the say the protocol between we we'll treatment and to in people, be the the to the some year, every of like the the not enrollment Well, something in to I U.S. having time, details criteria, inclusion with in Chris, which you kind ahead of

further of when locally was And here with advanced have patients a that type radiotherapy does we account. the bit was treat want the FDA, into we The does U.S. Europe more understood perhaps but than criteria. need and in We The about little with cancer, it's pancreas that D shortly. conversation take include differently they a trial be scheduled to how to they that designed, things that terms should little inclusion extent meeting the expected. than when altering the to

I U.S. that catapult the hope FDA after the be D the to assume I And that so will And enrollment that over, that in think changes will type to meeting is the made. agree I

year by So happen well. EU in as the end in for the I the and expect sure, to U.S. enrollment QX QX, of the

[Operator Instructions] Our question is James next from Molloy Alliance from coming Global Partners.

question a had on of I sort the investigator-sponsored trials.

ISTs variety of seeing outside of of triple-negative a I any ISTs? prostate, You've insight they're on got you metastatic control. a data ovarian us think cancer, out might could some when give your to that variety any we be of you of know ongoing, those But potential

and improved with the to the getting the the cancer report on in able preliminary we come it because started massive Well, do. That therapeutic and and was every be expectation was data ovarian a over should data formal above if ORR. have consistently regard with Pittsburgh II, in we've advanced efficacy therapeutic Phase that's with to especially seen interim showing recurrent to positive what pembrolizumab extremely positive Ampligen in see Merck that program impact, alone increase pembrolizumab combining Grant

part by of So the the Ampligen in that's the powerful. the various to trials while is either for we're question? governmental most typically. These I are everything, those that extremely big industry Does grants think very answer the trials important, and going supplying part, because investigator-sponsored expenses grants or covered be grants,

back the of the February? potentially just hoping going you final the XXX, XXX? then go -- it I It does. learnings set coming forward data in additional getting the here of What is with in to out you're second are for going unfortunate forward What be to the is parse on set out sort And data data final quarter. know does data

has I Well, thousands complete data the in but February positive that the a pages. had think lot in, it's of data received and of very we report set in tens of line top points come

for So it this Chris? will do comments. Dr. detailed turn take any it's McAleer over time, analysis, but I'll to our to ability some that underway.

of report and in line endpoints a those. So the the complete the of data. analysis part the gives for we've all study seen have it's there nonresponders clear positive the would also of expect. are top to and that in those of the breakdown indication the of of give responders power secondary were few wait come initial the those improvements are data And responded review analysis analysis But of in. to a be how quite that us design a the I'm of will the data for to we and that patients And not points we It and the also versus in biomarker criteria initial data an hoping individual -- will statistical we to individual as from done. want have us the baseline inclusion there future. understanding the who study

statistical to landscape Secondary and everyone of how post-COVID deviation you study remind analysis us. use standard the for that exist the necessarily power to didn't and I that,

XX significance improvements properly test right? would even data data a power we cognitive I study suggest. as are of And that believe given the have If the walk in used clinical course patients. sleep now There the that function, as us chose well and would the exists, judgment, patients study statistical the appropriately. currently as both fatigue, in over X-minute So these data powered is to

so successful power for the information trial. the next for us us be high-level data trial I the enough to believe give with design And will to

than trial a high to believe we of Ampligen do number confidence of responders. And in longer of responses to had If purpose that called refine they've was is II. onset But significant exactly subjects, And based which might that into much mild to for concept have symptoms, was, the just just what XX or post-COVID much and that of because the And small Phase disease, we've small more we add, of proof upon see the we're fatigue-like a follow-up this disease. that this we is with the that inclusion criteria focused our that severe is subjects it statistically measure very be subjects especially easier with going the data it's I we've take that on trial, the is the point bringing designed so chronic zone we'll targeted moderate intend disease. this articulated. usually likely of people

anything Chris, add to to So you that? want

it I sums that No, think up.

Does that answer your question, James?

It guess does forward talking I question, are you anticipate expenses same expenses legal I pretty in G&A about of the you the going year. indeed. last G&A that seen And legal housekeeping. $X.X in the XXXX? million spend then hopefully had to with high in level presume the [indiscernible]

defeated Well, right we XXXX. think We've, -- have hope group again this occasions. after now that we in Delaware Court the expenses for last in on from the our Court trial. -- on X don't up Chancery I related group separate Supreme those It's

stand the managed one the and of whole as We law have felon. was was then of its Chancery group a attack that this financial second payment with it's thing and by Court a fraudster convicted another funding and to particular if it because by Jorgl to felon orchestrated take though this securities orders the related

forward issues. you addressing can't to those So that without allow go

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as further and question the of My that we further pandemic. from market about doing. changed the significantly, today? move Can opportunity all progress away on talk long-COVID the Congratulations initial has COVID start the obviously, is the for you you're landscape

We've got that Woo. pain. ever interruption millions in at to Americans social terms is have situation We're conditions, severe fatigue-like looking post-COVID which and debilitating of in impact. the serious chronic increasing States cognitive sleep a is its that malaise, are post-exertional United dysfunction, fatigue, expected Certainly, Mr. of joint

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and We webcast. that reached And ladies question-and-answer and session. conclude the today's end teleconference our does of gentlemen,

day. We today. participation disconnect thank You you time, and your at this lines may for a your have wonderful