INMB - Earnings call transcript Q4 2020

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Operator

Greetings, and welcome to the INmune Bio Fourth Quarter 2020 Earnings Conference 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. David Moss, Co-Founder and CFO of INmune Bio. yours. is floor the David,

David Moss

call Thank a you, for Bio's We you Bio, on afternoon, quarter and Tesi, Co-Founder of update. and us for good INmune the me joining With INmune will financial everyone. Dr. the RJ XXXX CEO provide thank who results. Rob, is business call fourth of

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

of Bio. call over now I'd Co-Founder RJ? us, to to and forward-looking the Tesi, statement turn the behind With Dr. RJ INmune CEO like

RJ Tesi

is and platform, beginning discuss for and we Q&A. call. arrange are we thank pass start important with Then DN-TNF updates from highlight developing for provide and indications highlight Bio's patients to data-driven results CNS X it reported in I XX will nerve joining results remarks that phase disease. XProXXXX, last with death loss I and role. Alzheimer's to year-to-date Xpro trial of the for you, The plays David, Alzheimer's in I'll back we quarterly with where to hypothesis our to patients you, patients. move on our of unfortunate a synaptic which fourth platform Alzheimer's and our decline Synaptic disease. was update before neuroinflammation the David that everyone, quarter, our Thank our is in January data loss INmune cell with financial programs, will and disease neurodegeneration of neurodegeneration, cognitive upcoming these milestones. neuroinflammation cause key takeaways my since is the other an clear in

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David Moss

of December issued into and increase year or market the XXXX and value achieve December The X.X December nine compared million Research had reason one hundred clinical drug related overview proceeds of year ended of the and General cash sufficient and X.X ended XX, associated million shares approximately expense for cash Subsequent approximately equivalents our ended manufacturing year XX, in common the for for I price expenses expenses stock million Thank brief of million million year XX, December was we the programs $XX.XX. increase at of the facility you additional At December four development the XXXX. ATM potentially with costs thirty raised supply. milestones. upcoming was believe XX.X RJ. the the provide approximately primary for cash XXXX. stockholders year loss Based plan X.X operating and through milestones of our approximately operation our approximately with to in XXXX four XXXX quarter to million XXXX. current XX.X and for our XX, activities fund an and results XX, XXXX, and for eighty to Net we end no ended R&D financial compared is will debt. on ended creating million X the at and thousand to gross the December into administrative our for attributable common to XX late with approximately our compared X.X XXXX. to hundred XX, totaled December million was company year a million the approximately XX, a

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franchise to believe summary good in we for I’d this for to point are back At particularly for operator and January. your like you the I'd our progress reported turn Q&A. Alzheimer's compelling pandemic attention in that notwithstanding we So questions? poll could please like and following expanded time we you neuroinflammation disease making the to Rob thank it the in data

Operator

[Operator from your session. question. question answer Thank BTIG. you. Please Our a comes At be Shrader with conducting we'll with Tom Instructions] this question proceed and time first

Tom Shrader

update. Thanks Good for afternoon. the

more followed patients patients and this we will be more analyses the phase deeper for see Xb Just or trial will time?

RJ Tesi

Tom. Thanks Yes.

going You're both. see to

I the we have exploring so time. also that it think been and will are and we clear patients made have have a that patients doses studied I we longer have additional will more will

you're time. So to going longer and both; get doses more

Tom Shrader

but is Okay systemic big inflammation and I as about and we bit these from and a TRD think a like this this patients would time to reversible question hints of too that's the of I isn't XX of stabilization? of Is sense patients a how helping a there if this little questions. have just they they all this? TRD course do know with are hope be or inflammation? this then for subset Is patients any

RJ Tesi

So, the I'm think clearly going subset to patients resistant think give you it. We of we treatment what a way that about with it's disease.

If of you patients we CNS We TRD Remember not those benefit look That's any biomarkers. to we're the to wouldn't about an at inflammation. trials look initially. third of we think focus probably patients oncology time kind don't at do a like those we on trial. those our have that biomarkers of group the to biomarkers that. used going support data but for this have other It's say we

patients data shorter the shows. actually three the what in see biomarkers three of basically to last because those that's initial have the probably in you data months that we but inflammation, suggests have will response a months are So trials designed

enrolled or to them We therapy. more don't they like their that. answer that. We on patients let's responsible I patients is interesting or something are million so then will current off we not do question reset dollar know do the taking to know be XPro say that think these when become Now them the now does SRI an this remain

to stopped. that's need do the kind be clinician will in be of their whether just they end then or the at I we actually or So keeping it'll compassionate of second on we combination and answer. we'll it a decide on will like think therapy to be up But study up therapy double that them to the that be use as question Alzheimer's end XPro

clear The to and that's have if biomarkers treatment hypothesis a neuroinflammation about. will is resistant respond all first you get disease that that inflammation therapy who what question rid is of will with is of our XPro have patients

Tom Shrader

Got helpful. very you. it. All right. Thank That's

Operator

Aschoff ROTH proceed Jonathan next Partners. with comes question Please Capital your question. from Our with

Jonathan Aschoff

wondering if was what you're I AD. looking at any different biomarkers for neuroinflammation TRD were Guys versus doing you you. Thank for now

RJ Tesi

Yes. can in Well connectivity special this mentioned that Thanks. the using you as MRI see we biomarker very TRD patients. functional there is

a So unique that patient biomarker that population. to is

measuring be all of standard We will biomarkers. our MRI

white such and As quality both we're measurements. as grey of in cortical inflammation interested and markers disarray matter both

those them exploratory be We measuring are will endpoints. also secondary but

and unique the the very TRD also clinical For will clinical using these really but using symptoms driving depression what's FMRI most be standard measures program part of in validated associated really scales with patients. that's connectivity observation anedonia of this

Jonathan Aschoff

trials? I question which Last your anti-TNF to you Thanks. inbound had planning extent use was wondering is wanting for from indications not have investigators Okay. are you what interest to

RJ Tesi

us So the study we In people other at that have of to a can model the with drug I preclinical significant effort the this all that get neurodegeneration is model. time stage. ask words

heard curated there have program announced very We are you that promising. of a you I not programs not then we we harvest that and extensive best of can have carefully tell very and that have the of yet data is these a the best about that number

now think is on and value some making needs front other will allow clinical we will is We that progress announced. really that in on we expand tap. programs Alzheimer's really significant is into then that bring that our disease focus have of the us in franchise we've neuroinflammation believe the creation on CNS the these unmet to For

Jonathan Aschoff

RJ. you Thank

Operator

next comes with from proceed Please question. C. Swayampakula Our Ramakanth question your with H. Wainwright.

Unidentified Analyst

RK of is Wainwright. C. This from H. you. questions. Thank quick Couple

in disease frame the you On the about program program in we a X also patients what of time talking you're AD initiating data expect thinking of? and Alzheimer's neuroinformation from should what Xb are additional sort phase phase

RJ Tesi

Yes. Thanks RK.

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so So to we have I'm nailed convinced speak. the dose not

spending there we're kilogram safety The years even seven there per reason the can't we one that no milligram reason no the is survives that So per time dose, is Alzheimer's signal use therapy. average week we're exploring patient that. though without

be who extended on expect survival. have therapy to We patients have

So see registration years to very makes want mean a the because be you do I dose patient hard it's for dose. to let's nail so say that trial we difference change and and can once a drug on will a that XX we the as

So we right X. into want to dose have going the phase

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studies phase study. shorten this We trial. I other has The a do before it years closer biomarker sophisticated probably months. of old next man wait study an mean be in all me is can three XX the the analytics don't plan another yet cut second issue. years minimum know and if I the answer design and Lily really X. in three of don't years can months second X few the we don't phase to want getting what of issue think the a half years look but whether we think to do publicize question to of XX-month what amyloid In then XX-month what or development we months they're duration have you do we To is Biogen both in that two to I I'm that three to a fast. we a phase drug we X to both to call place I any words have currently in studies XX the it that with studies. to at

have market of So which to our enrolls one same dose, make two do we endpoints goal it to trial months registration get we that of phase more a nine it's tuning amount month trial we .i.e. for cognitive hopefully we short we trial once time trial the do enough the and because in not in traditional we registration be quickly the design situation. only a a that duration so the their is but so is can and the a kind the can to trial Lily then thing right just the launch that XX-month third is Amyloid sure and fine maybe is going trial takes basically nine

see I So the to only on you XDs more months when see you expect about very and looks next but going talk you what like. to you're are in the as about to with X dose, are to mentioned design patients Shrader that's phase few very we can not those mid-year Tom what data explicit and going trial we duration and the elements be be explicit going

don't in We give treat a fourth patients want but first we're a moment the expect that our pretty or to a to quarter. I yet you or date time with comfortable plan.

Unidentified Analyst

you my Thank taking for you. question. Thank

Operator

Carlson Daniel Tailwinds Our comes from next with question Please Research. with proceed your question.

Daniel Carlson

Hi my guys. Thanks for taking questions. Two questions.

will COVID. that have First off, you if long in any Wondering think this we impact with neuroinflammation. you know to Quellor regards reduce

RJ Tesi

you. Dan. waiting question I've Well, been for that Thank

than of thing wanted signal to like have looking losing here minus there or They brain but one and long neurologic. So of Those disorders. is They are plus been COVID fatigue. identified. They sleep fog. We've we are your be were strong at symptoms would this day of for for CNS two so the prime until appear depression are a role publication last on some quixotic do sense and neuroinflammation component literally launch convincing a was three a the frankly neuroinflammatory been and is I'm there we've smell early when interested we a ago to clinical of and that trial. other looking was the taste as and or year shortness not there played weeks look symptoms that primary about a since talking quite very of I'm the been symptoms a breath

continue this closely. we watch to So very

even of You COVID-XX neuroinflammation a interested infections debilitating. this they role information consensus can coming have we're bet XX%, of long don't COVID I and be COVID at suggests the is XX% If going can with quite be symptoms on that need that will imagine a because more there serious conversations there very end patients down neuroinflammation. the long an think to can and bit I pike in role if we're least not building with plays important about you of data up

big the So patients of drug be is disease. XX% it that the millions the if opportunity should very neuroinflammation in and we tested a of might is have

all say you're decisions but right no can tuned, have is So been stay yet. I made Dan

Daniel Carlson

Thank Okay. great. That's you.

passed a you lower many period many can and the my time us the many them the are tell the of how drug and question drug this on those higher point? the but dose in guess at in on mind how patients importantly three are of this I have in still those Next at still how not XX-week

RJ Tesi

Yes.

the dose regulatory was on are a drug They So the be continuation and but wanted didn't on we in that it not more the the while took get trial. place us to elements the trial lower have amendment for to in the place.

in dose So the patients everyone enrolled for high six the extension group trial. of the

months have access. all therapy. So and Three applied three of for are special nine two have of patients for additional patients have their eligible year those one anniversary reached those

the on them and a and drug. Australia can company So they you where government system the way have the on to can stay patient will drug. the allow petition continue In to they the physician

for approval on of the three process third the one will beyond two just yet the program the So currently are year that we approved been access haven't that. the in that have have special we is had and

their it mean I and it that's put working to their me they're the let a think So is and sign. they that on feel quite, patients way. the way the or want believe drug The patients stay the I to and guess this physicians positive physicians drug at is we look

Daniel Carlson

your want ATM. tapping congrats agree. I on to Well, say just

a job was Thank you. guys doing up and so the, the you great a thanks work. keep great good I job think it for

Operator

Brett next Longboard Our Conrad question comes Please question. your Capital. proceed from with with

Brett Conrad

Hello, guess you XXX yes. Thanks. trial that second Actually long enrollment patients? current thing we terms of will got and too to one to one give I of additional rate the of kind my can data given by some a general question, complete Dan's answered questions the in whole dates have kind how that's if of on I readout Quellor positive with but that in expect when of a and it us get take

RJ Tesi

reasonable So expect expect marked enough year the We're to not with to go happen. there's for out there by just as enrollment, second the green think first aren't disappears to in get of we is the to so of be that efficient the I end unless to the vaccinated vaccinations said end people be that who we going keep ain't in quarter disease think but speak. complete XXX forward and I assuming the the to I that to the and reach would DSMB light the presentation disease we going news the

do everyone XX first thing data patients be patients this that So behaving just a that's are our we're can appropriately, kind things they only which working etc. by nature readout. the is the did that, did to the get data not report goal is says aren't I The would really the decision go-no-go remind going to XX the because probably to that to that is things enroll of stop not of that, data want say or DSMB. sign reach a readout. any this continue but not trial

trial is the currently As designed.

Brett Conrad

it. Got

only look guys blind sense those all it's double actually That like. won't a you even data sounds even Okay. points until you be able over because it's at know makes to interim

RJ Tesi

for wear know the monitors on so as I'm hats and No. the CEO are Officer Exactly external two also. monitor. and Chief the There medical medical Medical medical both the monitor, company I you

the all problems enough So this don't I I you not. it can't is I've with long the doing but they've reports of or anything I been I guess that gotten a, make not see guesses. patients tell don't can do whether but drug about the

need So but agree adamant is the way right to it's blinded and right that's that and the be is these it FDA we get as hell trials to and frustrating it's answer. what placebo-controlled the

Brett Conrad

kind that decisions in changing seeing I of know for disease a getting just guys FDA your diminishes does also urgency terms the of go what's treatments yes the you their as in of think in any changes in or and because Are you you lately see emphasis. FDA their of COVID? do terms opinion terms come Do they and kind of

RJ Tesi

some handled personal that's of in is in the that the the confident take a experienced but deserves the the have of that bedside. you we credit all who does I respect for approach the the director areas. the is, will some FDA data. we COVID-XX of new So but Janet for right changes FDA when not what if lot a and happens agency. Janet can provide Woodcock one good very She and had that company at respond pandemic leading occurring what's I you I'm her it's FDA I see and Woodcock they've I've appropriately do experience a about be any could mean sense way them couldn't patients to that happier the

Brett Conrad

you. Thank Great.

Operator

comes Irwin question with with Our your proceed Univest question. from Please Security. next Michael

Michael Irwin

Alzheimer's from Hi, Michael question I Univest. have Irwin and one about depression.

half do So XPro likely that about there for Alzheimer's to are Adisease that how by so indicates depression and a or patients is see depression is develop both and study disease XProXXXX? tested you years recent more been a depression and this with affecting one being

RJ Tesi

you. way data interesting diseases. Thank it Actually that these question. cuts various a That's how the across neuroinflammation interpret Yes. I all of shows pretty

believe disease. drug Actually both that contributed there as actually and get recognized there approved So and depression symptoms neuroinflammation the to treatment a some people have for disease Alzheimer's disease are and a and is Alzheimer's even patients depression of a and the of lot Alzheimer's one symptom both. there's it's also of as I with depression

targeting what of The So neuroinflammation get intersection rid a intersection. is related though you common that's there's question neuroinflammation XProXXXX that's is that and there and neuroinflammation if no an pathology exactly clinical is when the neuroinflammation get data our neuroinflammation CNS. in brain data in the good we're you that positive to animal is rid happen beginning happen beginning suggests the things and support of things to

Michael Irwin

All right. Thank you.

Operator

this comments. At I turn like for reached back RJ the would the question to end answer and now we've call session. time closing to over the of

RJ Tesi

So and vaccinated next update again our look vaccinated quarterly you We forward to for thank after and we'll get speak you're please even everyone mask your wear you call. to joining to and May. in concludes us. today's you. Thank That all I remind can

Operator

concludes conference. This today's

this at thank your may your time participation. you lines we and for You disconnect

INmune Bio (INMB) 5 Mar 212020 Q4 Earnings call transcript