INmune Bio (INMB) 1 Nov 232023 Q3 Earnings call transcript

Greetings, and welcome to the INmune Bio Third Quarter 2023 Earnings Call.

[Operator Instructions]

As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. INmune of CFO Moss, Bio. David is David, the floor yours.

the everybody. you, who'll an cell for for platform. you INmune our and Bio, me Immune CEO mute, Mark update RJ afternoon, Officer Claudia, good We natural of on With oncology on joining results. Chief Third and XXXX ink thank is of provide killer Quarter Dr. Tesi, Thank Bio's financial call Liddell, us Scientific Dr. for memory-like the Bio Immune

everyone differ Private except on and and in statements for such remind call materially historical statements Litigation I the statements the the of Act management forward-looking involve statements. safe of of forward-looking begin, Please uncertainties XXXX. by facts, responses we cause Before harbor that risks under the can are see should this statements These on to the made from SEC. provisions as no press the questions with the of forward-looking Undue forward-looking as that the release facts to There statements specific forward-looking filings, made those earnings recent Reform filings results actual statements, underlying well they most reliance only any change. as SEC our outcome. company's assurance as placed of be which date circumstances and company's quarterly the statements disclaimer in is are not may these speak factors on risk including conference

to circumstances. Tesi, statements R.J.? call update the I'd Except as of With Dr. to now forward-looking required us, events Immune to RJ. by behind like these law, over obligations reflect any INmuneBio. that future disclaims to Bio information, CEO or turn

for Thank joining you, everyone, thank David, the call. and you,

by and provide a an on provide and updates INKmune. of the to our who Liddell, And arrange will then I before new results. third for with remarks milestones, will move reviewing conclude update financial platform programs. and on include our discussion David upcoming As we Moss developments and Q&A. over start XPro period passing will the subsequent of to usual, highlight it on an Mark key the will takeaways our to then I my update quarter

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completed right to enrolling are large trial patients have see find trial our number has to program. was blinded Australia, incentivized enroll a the of a to in Phase the Health II furthest of patients where open-label the and in continue opts X-month who Recognition history and extension to the program. patients advanced,

X track is FDA conditions We with to dossiers additional to with and are regulatory better necessary remain the the here. the FDA. to have in before the the open We believe treatment clinical U.S. disease or hold. additional countries have and year. on submitted the the -- Alzheimer's the main Boston leaves completed This themes just the end meeting from hold will lifted sites FDA lift be treatments. of soon. earlier We also plan the clinical The meet There to outlier CTAD the trials,

drugs can a X interesting they Little of you the is same. imagine, lot about safety This no matter drugs up or In may treatment. change performed driven in anti-amyloid battle data, limit lucanumab efficacy the for my marketing desire treatment presented meta talk was and anti-amyloid the the shaping therapies. aducanumab, these and anti-amyloid analysis the a cut we is treatments of earlier to better, of results Both products. the is benefits. play frustrating anti-amyloid As be if to EXPRO in by opinion, an the less from there be no demonstrated early monotherapy. heard That debating how various the not is earlier themes, donamemab were there efficacy results of features, new anti-amyloid about all strengths. Unsurprisingly, drugs, the

at no there much comments in highlights presented. ] recent CTAD, inflammation, beta-amyloid the long-standing decline. and of drugs many is with cognitive is Fillit, and The to brains cognitive decline was pathology. the present [ inflammation, without Chief His is points interview, words, Officer is results highlighted disease everyone's out individuals with no the key elderly decline. in is other point, the patients Only function. And Dr. those, high role universe In with a Dr. cell to dysfunction that cognitive response amyloid Howard have cognitive that nerve in position have Fierce synaptic data and was those drive therapy on and anti-amyloid Philip both immune death but and of normal in Discovery amyloid that list. inflammation of biotech Alzheimer's Combination dementia. for our aging at this discussed died amyloid autopsy, of and Drug with neuroinflammation therapies only expanding, the Scientific the targeting appears Foundation, Alzheimer's the

neuroinflammation, anti-amyloid Because our believe preclinical ideally XPro in major and therapy efficacy in combination the again, plays initiated no Combination simple, role combination improve with therapy. INmune combination reflects a studies, problem a is system. test models. current both. on Once the with patients. discussion results. cost-effective for accurate, way desire focused safety refrustration drugs Bio has of animal blood must therapies we a safety or the the Triage preclinical aiming emphasize is therapy II testing dilutes diagnosis focus combination Phase enrolling produce to I in currently early trial on The on therapy the class

disease different of Blood simple. blood by disease. is and is biomarkers severity view amyloid staging, Alzheimer's biomarkers. disease, Our a disease Staging, I of neuroinflammation of by mean Cognitive set is biomarker of decline predicted a the requires of the neurodegeneration. the

Duo many acidic protein, are fibrillary phospho-tau the biomarker was promising biomarker opinion In glial neurodegeneration of my of and is meeting, FAP of at those activation a and astrocyte the a promising. most XXX

screening Both clinical XXX in ] I after Although II we GFAB treatment use response biomarkers the hope correlates trial, not patients that response with measured this as were biomarker in to Phase trial. biomarkers [ in the enrollment or Phase XPro. show decreased the for We do package. part they PTO with as of decrease

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macrophages activity As PSAR is a in shall the DN-TNF drug, this the of allows stuns disease. inflammation, glue we DN-TNF the negative of a are activated immune into working. biologic these inhibitors are to to and can out-license Summary, the to cancer you and applications macrophages DMD reminder, story single goal the the Microglia CNS. how that are brain, TME program together. tissue-based In X bio be the tissue-based function the of compounds macrophages macrophages expand in or compounds treatment Macrophage similar promising The chronic MBO the TAMs disease, beyond not of cancer program the treatment holds XPro cancer. are dominant wondering that of is of tumor useful drugs. with the say, of sons Alzheimer's class TNF

soluble and we function MUCX, and In nerve prune SIRP-alpha chronic EXPRO neuroinflammation The [ including promote and to cancer, debris normalization phenotype nerve cellular of does immunotherapy. phenotype microglia disease, in does reparative to an and tumor These not cytokines synaptic remodeling This synapses have cell remyelination disease cell with the hallmarks and repair resistance into elements EXPAREL. dysfunction, destructive converts of also protects that treated [indiscernible] cell the synaptic Alzheimer's a to with the reflect polarized In caused plasticity. DN-TNF that microglial Mylan the promotes the by cells demyelination a immunosuppressive not by and growth phenotype dysfunctional brains other causes that the the tumor seen of neurodegenerative brain, expression that patients and lost of causes produces immunosuppressive microglial ] Alzheimer's. promotes cytokine type survival become produced metastasis. destructive TNF TAMs appropriately. in results

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very pass and listening much, Thank joining again, quarter I'd that those once third my report. Ajay. this you for to thanks like to are in And

report, you a of sites in Phase Phase response centers. overwhelming. And U.S. multiple clearance across since has I, the trial potential as quarter use for last in really filed subsequent received April INmune been U.S. open-label May clinical Incimmune this of year We the metastatic a from from trial in know, II the cancer. an So castration-resistant IND prostate with the we in for FDA then

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towards [ to committed That update on over call CFO, David of and on its platform, Imen discuss Thank turn my remains to execute you, forward ends company moving immune David. I'd vision the the commercialization. the Moss, like to ] The financials. to

comparable period expense with for in $X totaled XX, Thank 'XX. million XXXX, million compared provide for milestones we a $X.X for the overview quarter Research quarter was to approximately session. for attributable to the Super. $X.X compared our 'XX. common and ended I'll $X.X you, September million the of financial approximately loss with Mark. 'XX approximately the Net brief September head XX, stockholders upcoming development period million ended in Q&A results comparable approximately the before and

operations ended for compared the XXXX, we 'XX. $X.X quarter is our approximately administrative $XX.X General approximately XX, on September period the XX, approximately was expense to equivalents for sufficient late million with and into At September $X.X million. operating cash fund plan, current cash our XXXX. had comparable believe in Based XXXX, company million of and the cash

As outstanding. common of company XX stock 'XX, had of the November shares approximately million X,

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to and important to on like I'd our Now move of milestones. upcoming list

that we removal is of the the we which FDA to First have, milestone year-end hold. before hope have is

program top II treatment-resistant from Second, AD release patients depression. the end line Phase Upon we EXPAREL expect results of early hold, towards in Phase trial we'll of our with XXXX. initiate the FDA a of II

high-risk in MDS AML prostate and before cancer, open-label of XXXX. and patient treated I/II Additional ink in Phase with XXXX data in bun the open-label castration-resistant year-end program data of the I initiation in metastatic and a first Phase

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our to a applications that turn opportunities partnership you Natural attention. company complete like small material great potentially At limited thank development to I Claudia? to order In development this TNF benefit to but can and back that poll any will shareholders questions. occur. platforms can as in no be with point, events that assurance other for think the the to X to in Management feels as As investors update transactions they organization we try platforms summary, to for will understand pursue difficult. complex the always, business and applications DMD has are and these continue resources, company time of business there like should of your shareholders. it these I'd for expand I'd we Claudia and

you Joel very from Instructions] this Thank sir. first time, At much, conducting session. [Operator Bady will The we a from Baird. be comes question question-and-answer

Congrats more be a gives is by that about bit XPro. the of confidence discuss My lifted progress. the on on first you little hold question you clinical the the Can will year? end what

Joel, you, Thank Yes. R.J. here.

have by through to packaged the FDA the completed right? gave ultimately to goal list list the will quite and a an think And that they to with different as us hold wanted things call, took the it that other the those regulatory are a for been have I fulfilled last year, FDA, meet any it. gave have -- being be is sent agreement the those than and data while clear we the get the -- a highlighted we list a has Obviously, and end They they agencies. of Although us of at to off of it was I done. list gone to

Great. as looking Alzheimer's. could approximate the early for up follow-up, in enrollment? And where split the more geographic Or any provide what at you're end you to AXX on information able like? study a then in Are

Yes.

reluctant changing yet. we names that geographies quickly names, we're really numbers think we've our time, been I give to so this and mentioned last

involved. guess later, the of sites, I I it. clinical way able have XXXX, where that's we think are things far clear as how in settled when kind to direction describe give many on of as We'll outside sites be early are down. to

process. careful be sites XX we we when thing because a this frustrated. be perfect. be the in has than will don't we're I But promise information, be any the U.S. this give won't you one very bet to is willing it I want really are more end But want there'll we of open we about would the setting that to In But to U.S. -- been other to I up. example. the know of quickly. quite trial. so multiple us I to want time, things said our back for is frankly, a last we outside as just changing continents. III global we And think And this quickly it so is words, Phase the up good the able to be And I advantage. it's mean really by And expanding U.K. are

ahead of in we're be those -- in we the to a will where all patients have will had and They We end of backlog many hopefully great be expected U.K. that up trial. the screened of

right hang provide its And company So able the all And get to we our have there. think top say expect tough. I We not can this tell the I is be changed in busting can still by is guts Joel end I guidance. to of you us now, to that everyone XXXX. line data

question Shrader next BTIG. from Tom from The comes

Thanks afternoon. Good holding call. CT presentations. enjoyed We your the for

Just to they done be XX up questioning. with are on data, follow could participation of The or U.S. that line no linked? late Joel's

said as expensive. Tom, you mean be driving you from for it the U.S. done And any let we the forward, me question. because that's could done. was Thank believe light got let Tom. participation. prostate load this the we're even way, So And by I May. there use I me we -- do RJ. the time that Mark great without running and be a it cancer planning give the is could remember example. green yes, -- trial We're it No, didn't

our know, we're careful And as money. you with

to the what right? we X will enrolled going go patient you to U.S. get casting those off we if just net. time start, the from that's That's our trial. a got we're time hold, first may U.S., what green to takes, get right? If to So light -- start happen. from months, X we go, But enrolled the the ready the be will sites time once we'll it get the have the standing enrolled we by in So

do. lot frustrates things doing I've the maybe us Now We said of is there's want privately, just the I've couldn't -- I said I can But before, don't of clinical we one it frustrate to that think a it sites. things other what that doing. from agencies Alzheimer's are clearly, other different good a what think FDA patients is to are the All is countries, is what XPro disease. regulatory their drug, are access other getting for we these pretty

The of sitting be in sidelines III the on U.S. the trial. we challenges, patients. promise trial Phase without the main both wouldn't be if can are surprised U.S. patients complete II the the I and But probably U.S. because FDA. the a trial of with driver involved the III regulatory Phase I you will will be Phase

least final taxing? Is tumor the an immune Got prostate went years up, this And follow on playing guess, do reactive? they much the are the that a nivo now pretty I patients? for that the the interesting it's immunoreactive then backwards make to And post is you monotherapy? an if final you? to nivo-ipi. to we and Or piece be to while. it that nivo for on over at is cancer might be oncology ] these [ get it. Are is there monotherapy cancer commune bent can and endeavor have trial, who has a see XTANDI try given line. I the cancer trial Mark to And question prostate in prostate world Mark, And

really and my would really, excellent to slides academic spend term a a I That's love put hat and question, on. long

trial. be in high. targeted X. it prostate cell patients So post-taxane failure question I be tried to the the been that's always of getting immunotherapy that's even checkpoint you're the inhibitors every so the about I T microenvironment But [indiscernible] think whether And doing patients. first is antibody conjugates end-stage yes, far the of checkpoint They're what inhibitors, tumor failed or that question, And they these suppressive Phase has because responses. whether

if in if read if histopathologist association -- and If do their you patients look with there the conventional cancer, speak few T NK tumor. patients literature very There go an are isn't have you you at cell therapy to infiltrate and you who the they'll you infiltrate. in who look -- that cell in well tell a a large prostate

tumor. to AML we're we what We're the already [ this called coat we're the on get in NK there. that switch about traps NK tumor, be that little better, and tumor. and like extracellular ] cells it to targeting cells neutrophil T in we cells solid activity, the cell So dirty MDS. the inhibit tumor can't is are And trying know are they are NK already thing the means that and tumors Well, the just targeting to them the infiltrating in secret cells

from they the extracellular part macrophages. traps T the invading down is that overcomes are peripheral that So net that these blood stop particularly of that problem. cells But really interesting by about broken thing

very that cell entry drugs is enhance tumor traps, then T that one come generated is the X combine the the those break So that actually very, the to cells NK things that in and initial X you are to by that the down out the to there. could way nice the great might trial of respond is of into EXPRO response a

So in that the the also they're cell by checkpoints T be tumor. That the I are that's checkpoint not because think inhibitor make inhibited trial to you really a do. further conventional to I'd love checkpoint with cells a inhibitory combination T certain there, combined want exciting could once

a line, never approach at been think down to The single that love immune on would the I'd single combination works. yes, cell. look So therapy. further There's we system a never works

provide could these. nice think we that So by to it really, would be combining really long-term benefit

[Operator Carlson Research. Tailwinds from The Daniel next from Instructions] question comes

Just a of follow-up couple questions here.

you $XXX a your I about trials on all? yesterday your if wondering and Amgen all, impacts I prostate saw at wrote could from just comment INKmune, if clinical that that at and down million. Regarding about drug and how pulled was thinking program

answer If worked, at just stab even anti-CDXX prostate in T as much that, good are don't of checkpoint the talking I that. cells the The said I a inhibitors I think work. a haven't anti-CDX is about example Yes. think combination antibody you're have antibody And now, immediately cancer. I the

need I at excuse -- are So -- to actually that me, need to there. think at we activating look we the look sales

it enthusiastic me more so prospects. the And makes about just

what That's I leader then missed well. a Sarepta know and Great. their about thought as they question top the yesterday I line [indiscernible] are --

You're asking what you a going can I probably reorganization. to going Sarepta me on. through is they're guess pipeline tell

approved of than recently current better standard that's you care. had was supposed the be slightly steroid that a steroid that think I to a

we steroids [ As a -- XPO a I with that down problems significant steroids. that spoke provides pathway steroids about different ] associated over the believe of where benefit pathway than earlier, what than lot are going completely

what because long see really interesting the on these drugs still is are that They're market. long to therapy of have been the My street the market. keep ongoing. the an have to been trials, FDA drugs thought kind on is And for don't what trial which know does taking that happen. is guess the the some the the with confirmation there's program I a It's time they exon-skipping to a gene going all done be that the that going DMD program with to confirmation regard soreptiran fact wrong. space they interesting while the failed. has keep on FDA what's with

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remarks. for reached session. turn call sir. to the Thank I'd Ladies back closing you, the to end RJ and question-and-answer gentlemen, And like have we the of

So ADI increase patients in, INmune progress in have the cognitive on platforms had X of very Alzheimer's stops the fronts. have we Bio to progression therapy our With than patients profile less today. significant with is thank on a quarter. what we offered That's with different Each you. disease. making a shall hope say, of that decline XPO, is

lethal. men metastatic we be many that to and many control quiet INKmune disease in hope With prostate indolent, in cancer, a can is but castrate-resistant

your good for goals. you these of that, to for attention your today. you that And are a With We ambitious thank you continuing are in we shareholders, have support. day. thank confident those We

your may for much very this your at thank participation. time, and You disconnect lines you