INMB - Earnings call transcript Q2 2021

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Operator

Greetings, and welcome to the INmune Bio Second Quarter 2021 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call, and the replay is available per the instructions on the press release announcing the second quarter call. At this time, it is my pleasure to introduce Mr. David Moss, Co-Founder and CFO of INmune Bio. yours. is floor the David,

David Moss

With Thank Bio, you, everybody. the or afternoon, update. and Financial evening for Dr. call RJ Tesi, will and thank you provide good CEO Results. XXXX We Quarter for of Bio's -- on for the INmune is INmune good Co-Founder Second Rachel, me who joining call business us a

the they and continue as the CEO platforms. Co-Founder future to make forward-looking We And reflect any quarter turn forward-looking Dr. made and as not to questions like a Undue on reliance historical we date actual on RJ? everyone the facts, I materially the such Act assurance I'd these conference harbor we that remind on the statements that on these and INmune recent involve except those statements responses to developments. of statements filings, as Bio, safe obligation can to management placed company's SEC. statements, begin, as and earnings differ required to XXXX. with speak INmune call RJ to statements press Bio of most circumstances. forward-looking these may outcome. our law, to statements no the Private our only results SEC are as quarterly change. uncertainties information, of the of cause circumstances update events the company's discuss made and statements by now filing call the be Reform in underlying forward-looking which or the facts the progress statements risk as any release including by to factors disclaimer specific of Please from Before for These see risks forward-looking Securities well busy under over Litigation should of are Except in forward-looking disclaims INKmune statements. Tesi, There's DN-TNF provisions had

Dr. RJ Tesi

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

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David Moss

attributable ended raised the period brief you, Research operating Based gross quarter drug for plan, administrative $X.X overview comparable for upcoming Thank our sufficient ended the on we comparable $XX.X XX, potentially $X.X June to period fund XXXX. stockholders and quarter in for and to the a in development gross loss through from provide activities an XXXX, ATM. million RJ. for $X.X cash proceeds the the XX, $X.X $XX.X into approximately XXXX. end quarter operations was approximately financial At Subsequent for expenses the to XXXX, expenses to totaled busy company of supply. I'll was approximately late and in million value-creating results of milestones. associated compared the direct million compared million $X.X million. cash compared our approximately XX, approximately cash June primary the achieve company XXXX, common Net the in to General reason $X.X XXXX. additional our June costs expenses approximately our registered offering is quarter the had and million milestones current believe the proceeds approximately and $XX of comparable the million period to a of second with of related equivalents June million our and XXXX, and XX, for programs quarter, million for increase for to clinical manufacturing The increase ended XXXX. in R&D the was

company X, approximately stock shares XX.X As the August million common XXXX, of had of outstanding.

webinar program our and as we to a for quarter, upcoming the milestones stated, with In Phase The to get before Alzheimer's funded as patients move disease treatment-resistant trial grant. XPRO the to RJ by on like initiate depression with Q&A. with II I'd in Now fourth week we in partially Phase to our II list plan fourth million Also X, our hands our month, be II to a from in Ib data should of data the disease of we have meeting a we and September their hosting FDA discuss DSMB This in Alzheimer's patients XPRO Phase be will and Quellor trial will after Board, the from of with neuroinflammation. Phase NIMH to XPRO in the the for quarter, we Monitoring Safety had plan and next $X.X turn steps patients has initiate neuroinflammation. view. Data the with

plan study and Finally, likely to these ovarian data INKmune -- trials are to expensive. U.K. they're and run INKmune in year. next in I, they small, we additional and plan not also they're we'll report year's not or are the the before a by of tremendously will launch I cancer and end note end, that Phase in year second early the

and In in sites assuming our INBXX pandemic landscape in our go been trial has the we the include indications. clinical us addition, ahead. programs not controlled once CNS has potentially give COVID-XX are other changed, other These planning trials

for our So in potentially with towards milestones summary, advance of you Rachel, back like point, operator and you quarter progress to shareholders. it And for this would attention continue I'd for this we poll our certainly we're to please during to year. and like to value-creating your Q&A. At thank would I second the as your time pipeline turn pleased questions? support the

Operator

Aschoff Partners. ROTH Jonathan from Capital from first Instructions] Our question [Operator is

Jonathan Aschoff

and given the not? is patients conservative? there site, guidance out about second ton I of And pretty data is per required AD there X wondering, not, a for only half II that Phase why if was 'XX

Dr. RJ Tesi

clinical X.X per trial. So conservative. I out per you can look activity sites per the enroll site month there, hope it's if patients But trial current at

are -- metric that So set our to using base in criteria. fact, our enrollment we

about that and in to can Mild about out than the through with saying, mild have shorter talking there. CRO, talking the expect it's up AD. man, XX% saying they jungle are we're be is remember, you're it's team experts beating their that. been I people people And You clinical are of or them But probably about AD -- AD. our working got

X about -- around that's total. So patients million

actually talk. designed incentives? trial have incentivize are a What the patients way join. in to we them mentioned to in those So clinical the I

it's everybody of doing chance versus have a gets drug of where is One companies also drugged. XX/XX is them open-label there that X:X a someone's dose. doing X/X out trials only a X:X getting with are typical randomization. random There's chance -- They

know for happening that's because enrollment. with they what's patients to Now understand getting therapy. It's they're difficult great the the

The second we thing them months XX is it's whether because then not. placebo months, therapy, only of the or X on another they're group give

that think because attractive is that Alzheimer's by been that, patient clinical we our told sites -- the XX. and very So we've aspect a age remember, is average of an

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it's I what you that's I'm with year. take it's a going says CRO a presenting. trial. but our to I teams, shorter to clinical my So less, surprise hope hope

Jonathan Aschoff

you're are at second trial? last in Okay. Phase for the II what for certain potentially you your change your expect The inflammation of that this you is, focusing my question from subsequent on that primary efficacy one? biomarkers Phase Or to endpoint point is, And III? interest correct will plan part do

Dr. RJ Tesi

Okay.

both they're and good let would I have very X So questions, you me you But didn't Jonathan. predicted down, questions.

really we quickly love disease, in So up know, we're white of Apparent these better. to patients patients is personal that imaging it, statement, biomarker with patients biomarkers, efficacy. Alzheimer's patients we is AAIC, fiber presented prove quickly of in as the those At going most you AFD with apparent very biomarkers And and we fiber matter. a is goes -- personally, mild believe potent in density. -- very we have and the this we to love density up in I those patients. AD, got -- be all

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Operator

Keyserman BTIG. from Your is Mikhail next question from

Mikhail Keyserman

on RJ, you, additional Thank the for details INKmune.

first persistence NK what contribute the of MDS think can sense a Can do patient, you kind memory of kind response? you maybe that of And give a one from us you're NK for cells you proliferation of terms seeing? high-risk me Just the and in how on the patient. mentioned maybe that

Dr. RJ Tesi

Yes.

cell story. avidity and So you've NK The a is killing. phenotype to -- components proliferation actually actually that The cytokines. of that together kind third is The kind and the really correlates persistence ability with memory-like is different porphyrin story, here. and both a jumbled X cancer produce of the is and

So let's with start the first.

cancer now as mean cells. killing memory-like is virally desired either NK of cells infected NK the killing or that think I you the agrees I cancer NK for the phenotype community know, job phenotype cells. killing is

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line over measure so So XX has NK actually that's can resting measure in you'll got vitro everything couple cells. with happened patient and of necessarily not is the measure you in that's is, We've in would information Bottom NK that happening prime cells, persistence, so that predicted killing, get That recruitment to end the far. up we've of and laboratory far, the that's one NK cell next we weeks. and you have the got to we proliferation. may tumor and primed

end patients, so the will and far, treat that. just to So day, need the delighted. we good. do of more we We're At

Operator

is question next BTIG. Shrader Our from Tom from

Unidentified Analyst

actually. subbing [ph] Tom in Sam is This for

X So I have questions actually.

hoping out that density, is to So adaptable different looked And in terms pioneer that implement? just for in in there topic? you the of these water other could a AFD? speak and imaging guys between have is, fiber like then you like the this? changes there correlation show measure this be question Like are to in for Are studies are free at are how to improvement like this data cognition second modality hospitals and the what like

Dr. RJ Tesi

Okay.

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and nothing here, that's there's special So one of the utilities. great

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Pennsylvania. are So the can trials in get in all they and or you're almost London, have points or whether Iowa City be -- who whether whether scans. bottom in line CNS And in is data patients have you're can you're these obtained, Scranton, CNS diagnoses

drug you Pennsylvania day, this? Okay. clinical be use going an is? the and biomarker shows and good clinical have think of And this, the Do Scranton, think is where you in surrogate have yes, We efficacy. very ones second we're you a correlates development, the But can -- AFD to mentioned with we're we're adopt The to in with as going there. patients, about talking, I AFD, improve excited clinical AFD fine improved before they Do as in is to AFD. I using patients leading that AD improvement that. it. the and those -- our shows question know data one when we're the end to work one important a drug of improvement we get be know first response. in in lot impressive that trial, because mild fairly the do it. a I biomarker, that's Well, X of edge ultimately had me that here. of as But we find with a the we're they a only people others both No, we're to an At had think the response. the And first had

Operator

Your B. next comes from question Securities. Mayank from Mamtani Riley

Mayank Mamtani

progress. Congrats on the

have that to Like #X but both looked at dose, here. this CDXX. is you Have on slide something T biomarker you the the the KiXX, following So how up obviously, Great maybe understand and the are And of in just see doing? also data from NK cell? interest. you CRS I low patient is

just at all yet. at on curious looked if impact I'm the So you cells T

Dr. RJ Tesi

the patient we have Well, impact INKmune on not past. cells in of have in extensively studied the because we T the

activated. cytokines cells. many do when don't when NK trying get NK generation of cause cytokine giving is all you're cytokine the will but cells say the fear with get first was focus I T -- When to going problem can -- kill the right? cell start what activation. activation cause T kind in data storm. to just cancer is from some we cells is get Now The this some cell have you you storm, pathology program. also we're vitro, They they get

INKmune storm. determine So who's were Lowdell, early of risk we things have And trial, inventor answered no a cytokine to the of whether one we cells. by fact, is in did on the at was this for process CSO running is and Mark who we better evidence although very the this question T activates that the

happening do NK And We end cognitive function. with it's of stuff. is Decreasing our just is neuroinflammation, proof kind synaptic of improve in of at predicted next our excited could but we I'm that Lowdell Professor where up n kill T they making tumors, kill going But you everything day, this far, all Do it great. that seeing if which persistence? X. and you patient, Does so I question, end the the to cell? that, so point, the like get it's program. is of make purely, the the is the kind and journey. the recruitment then some NK in ultimately, And NK is is that pretty at answer of start the decreasing We're pudding about beyond well, But thing little far. of beginning into on measured we the you insight question, NK tumor? Now they question have cell, that things great the tumor, a we cells you to the tumor -- have focus this responses, at cells? at But when cytokines, for and long it's does which lab function. the of the program. we're Mark kill because includes function ultimately, the doing it Same Alzheimer's right do Does But neurodegeneration least memory-like patient's prime NK answer the -- the an in improving product. we've let proliferate? NK how

Mark Lowdell

your clinical dose those And looking cells just right? understanding And is we that the we risk repeat nice higher [ph]. going -- responses, -- clarify blast on on are were cells, can to we and at it's

you responses, the higher to more doses treat have So in and longer just maybe clinical go just Is that... patients.

Dr. RJ Tesi

X So this dose of to issues. to get is stuff we the that's maximal -- thinking And much -- you the what there's don't if higher how have does. know give

right, the killing, dose there's response. duration is And to maximal maximal get feeling avidity going You then how be And a don't know We that. maximal is what of that killing? and our killing. --

the response is Just drug. know, same dose of of doses an the so number increased you

get about using the is we actually doses whether to So a aggressive line go give it I more from X you should low umbrella get prove X is -- to the yet longer up X coverage. we've the bigger to it, we you of period, think, it think, dose, And we over only -- what are a But bottom we is. NK have intrigued XX-day a although we because to cell.

chemotherapy aggressive end because for bone treat the and company, MDS may or safety so with this medicine immune through elderly crying has We Alzheimer's. patient mean cancer, he's cells you XXs, right? patients geriatric up CEO elderly treat this right? about a we're far. candidates in Patients but out a not failed youngster. even for marrow that Now is with signal, tend transplant mean like patients remember, a I loud. you always to aren't I worry be with We the with elderly

you do. I told So what I'd

So....

Mayank Mamtani

enrichment what endpoints. the of... contribution we should availability the about on of to Alzheimer's on might than antibodies? follow-up the things X? more you the the placebo for it markers Could XX%? assumptions Like on are X and criteria, at just are have XX% you the rationale what's different Appreciate how the conventional different rate, like color you think comment question that just a-beta incremental month the how for endpoint. the quick failure be your on getting And screen the EMACC how the more intangible Like versus A

Dr. RJ Tesi

how I slide there's did basically, the biomarkers the talks patients the and and -- with think you new the the this Barnum, at metrics because what CJ the We this no the we you with Alzheimer's is you have disease who here, biomarkers section, ADNI obviously that a asked with at metrics, guys know, the a Alzheimer's many setup and had how question. that his of patients -- we And fast how Imeka. we cognitive came ADNI we database, looked slide that we MRIs. In of in patients various or a All looked that. in and about the up database -- using is team that had those progress enough is that we And get could database. measured patients component. had at

patients in they is And how so liter, water, were peripheral AXc that did looked by those at whether increases of of peripheral seg patients CRP and i.e., reminder, definition than of the progress per quickly in biomarkers, you our as greater a what -- progression free hemoglobin definition, than and neuroinflammation, matter turns APOEX. they're white then MRI our rate the had our greater inflammation we hot, It milligram than that X.X in X% had rate a out just greater disease. seconds, the we XX

white Most patients water. X. had patients higher to is matter really patients had Those had biomarker. So But APOEX a genetic have free significantly actually X.

And out group signaled hot, to it patients the aren't who group biomarkers. quickly that of their our more in picked -- much the to really that was patients are out cognitive in biomarkers goal those hot. ADNI the patients hot progressed a So turns right? were decline compared of That

decreases. using and but So quickly, more data, power some to That's used that not that go of do slide, they only see variability that you we trial. in the the what

get you the progress patients, quickly. we're they So if very that hot comfortable

trial able from we in comfortable we I placebo. on to so be going who are see those patients we're what to are Phase very based in our separate And

enrollment -- rate. the is -- criteria, of we and remember a though, an about our is enrichment XX% consequence the Now so that official have FDA term

makes X the trial, every get it For the into referred X only patients to trial. that

of have kind But an strategy. an enrichment when for you XXX-patient you that's do the So can pay price enrichment strategy, you trial.

have trial, XXX-patient you If a strategy, to you XXX- do don't have an to right? enrichment

Mayank Mamtani

EMACC in What the I placebo slide ADAS the your... are endpoint? have but your for you about what rate XX, see

Dr. RJ Tesi

So And is more yes, bunch EMACC academics. sensitive. really what was we're And She actually by is measuring earlier, persons it one powered stuff. of we all the key a because developed that's ADNI other like helped is the ADAS on that of I But develop the XX which here. it, Judy Jaeger said much had. the expert actually,

somewhere mean that in think X I seen are the scales you've you that -- can see I EMACC. the --

because was EMACC all, inside only is why I Jaeger, with MCI the think for is can -- a do developed can it explain I've thing phone best can you and so Dr. she she what whereas discussion I knows you want get the mild patients, if about tell of and you and on she far. I better Judy, detailed how just first told is articulate. stuff it, She out, you the

Operator

Research. Carlson question is from from Daniel next TW Your

Daniel Carlson

Congrats progress. on the

that Alzheimer's other also XPRO. terms anything literature might in of planning wondering COVID First trials of on XPRO. with in thing for I'm and long is you I've been do intending symptoms. equating you're the All kind if the disease be reading is to

Dr. RJ Tesi

Yes.

the some of actually has was COVID they it in really trial symptoms constellations the clinical defined. a little tell on it's some months It not begin of related in bit the in become What tsunami a because -- month, neuroinflammation several been shocker. FDA behavioral of last not COVID-XX Dan, CNS engaged it's And interested until happened, We beginning. be FDA observation of commentary, manifestations to the We lot for can a might So was May there I I press, this this very ago be to became that the it's in the seems a issue. literature probably the thanks to you, in neuroinflammation. the that. to and express of a literature. year that and in of for said supportive mean Since of a long took at

have symptoms, something have if that. you to don't you don't stunned have say we to little were So I treat. a by

out X-day remember, There XXth. months think on of long meeting this NIH-FDA it a panel, We problem. big were just We it. oh, hoping COVID, ago. couple that but a actually, was July, to wringing a about guidance They're FDA, it's it that none I NIH something said, come their do the of Everybody or did. hands. would was to XXth, -- was was Now terrible need help

a So a we coming that I FDA -- believe, it, are we there I can We actually but say made of XPRO, neuropsychiatric to up is problems to with neuroinflammation strategy. and the do, the can is FDA active I company hold get we'll to don't actively but with -- don't match involved it's want there, we I think guarantee in with got now, get we associated drug. like until you move COVID with and can tell agreement the FDA due many the are the perfect on an the long to can't heaven. to Obviously, us that. to within think what cognitive that do. neuroinflammation. talking we've But think -- an there's something. I forward we obviously, I you But move me agree so because can But effort

Daniel Carlson

I agree.

happen. that see to love So

So that you've trial. was people the if wondering to the with but high-dose your data, that was mentioned the the the in Alzheimer's patients still drug. were I run past, I Phase front not on case still in trying

Dr. RJ Tesi

and is drug. U.S. lot those from get I we're back we pressure So of stopped them them their clinicians our a have say there's trial. trying to to it of after it patients part at to a and because year, on model

that like to U.S., the into in a process because of Australia, a compassionate program. do to use want like trial. looking what They we're kind So I looks have don't under have it clinical do in they

end than success, on So criteria of an drug. stay the benefit important drug. is always problems That a that. It it's to that's ratio benefited, they we're the they heartening right? when the is day, think patient think juice means They positive. at from got to squeeze more exploring which they -- a the for But wants

we'll for but to and So them we've probably on regulatory work get -- the got drug, through back that. process

So...

Daniel Carlson

staffing what plans you. And now where last you're looking wondering one to question. that just coffers, just you've your Got I'm hire. and are got full

Dr. RJ Tesi

focus can Yes. imagine, programs. in of Well, you run to a clinical getting there's enough as lot people these

growing. the company, growth like still is to We I And operations at our heavily wrong operations hard. and partners. hats. to about coming has "If No vendors you're coming everybody clinical is joins to So said, question Mostly that. the that And I job, one And do here wear very lean as we you're on the least we're company." the growing. X Everybody to clinical -- on work side. but tell

As we're right drug manufacturing now. mentioned, imagine, can you as David

a years. work by Obviously, manufacturing group we kind with a And X for have is party. so is done of David consultant. working closely third with we've Regulatory manufacturing I and -- regulatory our the been

that. XXX-patient original hope of to the be own patient trial. is manufacture I Competition right? it's problem and the it's Right I the focus resources better. is to keep these some to the to hired road. have the still and to know on of But kind XX of back disease regulatory close got about programs to improving putting is to department. at enrollment. meet them the Jonathan have we'll the got to end in program to up [in something to take it. And mean they bring and actually they've running, our be people they've question involved know behind Jonathan's is don't well, it I focus rubber getting But keep We're rate patients. a going -- fast, whose credulity] vest. work day, point, running on main mean I now we I go we Alzheimer's the main we've fierce. funny than to can't through -- months at to running So But get the now, the clinical X That better our is so vendors was phone. do if because almost job well, enroll was to to that

We to the gatekeepers. clinical They get teams. them have from are the

Operator

the reached like of the for would I remarks. session. end we Tesi call Thank question-and-answer Dr. you. RJ Ladies to and to back turn gentlemen, have the closing

Dr. RJ Tesi

Yes.

I you. I mean our to first children. our love that thank have all, So love say We all of programs. all we

donanemab they what that's to I that. we've with to program where We and cancer exciting time. NK What like what therapeutics, like XPRO not NK clinical We has do going. We're And in to doesn't neuroinflammation. say NK believe randomization, I and all good, is trial. at which to landscape do only that world. to including a up it It's that been a about It's -- it an a mission said any we've the that a But you going Alzheimer's an of what anybody is doing. kind good. he what keen with? in Giving the NK inhibiting of disease. program combination kill you II are any it. X:X with. When a is We been like to is cells, CEO time somehow introduce on doesn't we resting prove randomized, it's need mean anybody in you really XXX this parents. prime I you Phase was we INKmune to or just for cell today end pretty antiviral program COVID-XX. NK cell works which that end trial, I confident mean they it's now The least reasons, I hard you we really immuno-oncology our unique to Lilly the make inflammation get -- when their of blinded, do cancer. up great think were But Giving one someone remarkable. was mean excited cell appears somebody with to that us find for do get changing. be we're clinic up is single about have this patients, got. INKmune long a life, approved NK placebo-controlled cell talk the But and to

developed I mind their don't know. the has think very But FDA Alzheimer's think up a to there must something we open be sleeve that I disease therapies.

exciting thank your for I anyway, all few next think pretty for going support. you it's to But the be years.

to us. day. find a You the lot of and know new where to have talk We'll new And there's David I Thank us. data Call in deck because love you. to there. good investors. walk a you through

Operator

you. Thank for That Thank our participating. conclude conference for does you today.

may You disconnect. now

INmune Bio (INMB) 8 Aug 212021 Q2 Earnings call transcript