INMB - Earnings call transcript Q3 2021

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Operator

Greetings and welcome to the INmune Bio Third 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. 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

the DN-TNF of Co-Founder, our Thank who you, NK for INmune We you an on me and and will update Co-Founder provide cell business afternoon third Tesi, Lowdell, our R. Bio, provide and us for good INmune on With CEO joining Dr. results. the priming will XXXX Mark everybody. is who the Dr. quarter J. thank financial Hector call a on call platform Bio’s and platform. CSO update for

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

CEO of Co-Founder like J.? INmune R. turn J. to Bio. and call the Dr. over to R. I’d Now, Tesi,

R. J. Tesi

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

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C. J. Barnum

R. J. you, Thank

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the provide understanding MCI. everyone. Back of necessary to J. Thank you, study you, that to this confident will R. are information our We further

R. J. Tesi

We emphasize many in that has to uses J. of like treatment the CNS C. you, diseases. XPro Thank

me one-trick pony. You’ve it’s say not heard a

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Mark Lowdell

and for listening. Thank you, R. thank everyone, you, J.,

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R. J. Tesi

today Thank patient ago. today. much you, pandemic. more has an and inexpensive maybe and fallen a beginning clinical is an with sophisticated anti-viral therapies keeps therapies uncertainty Everyone patients and about authorization the lot Drug patient pills care psychiatric need the COVID-XX at treatment today a development knows trial. keep X,XXX a oral changing, target. we rate than received and profiles patient Mortality is in like to All the March the real. hospitalized for use respiratory shooting soon years Vaccination did COVID-XX been keep XXXX received patients hospitalized than more Mark. after of emergency of Tocilizumab X changing Standard changing, even at XX% from X% tenfold regulatory changing, has and moving hospitalization. corticosteroids, are

difficult decision. yet and EUA disease to patient after in uncertainty, regulatory completing with clinical combined a a receive an XXX for has our prospects Alzheimer’s This early is forced trial. approval company Another

to cost programs and obtaining Alzheimer’s and Phase the higher risks of those in X market decided the in the resources two program. trial Alzheimer’s the is believe Phase cost We failure to close reallocate We Quellor our COVID-XX than disease. X completing have the of approval of our

may not with agree approach. this Some

our investment wound in nearly of with speak to happy are down. COVID-XX But today, you. has as We

over Trials is the – on meeting, that week. upcoming us our in studying trials improvements quantify measure quantify in Clinical reflects Alzheimer’s disease presentations, are I posters three our point, Phase The correlate MRI will age virtual biomarker entering terms. oral the to with pathology to of biomarkers our cognition. and pathology, allows Boston proud our we strategy allows disease. an using – X us back to XX those CFO, matter the always disease novel the CTAD to from At is Bio on INmune upcoming are academic We are tools like development. techniques patients interest which The the response and validation ours Alzheimer’s meetings. white to we referenced success for financial accepted new Two medical Companies thinking to we use this drug five in being EMACC, with effort I A validation a peer-reviewed leading therapy. in announced call of in the next review programs David have believe this biopsy at turn are move Moss, to burden in world. believe to days held CTAD endpoint, CNS white the powerful common form I’ll one theme we few CNS golden the believe and matter We one earlier, including certain successful ago, at improvements bring abstracts field. the forward. cognitive is

David Moss

primary head the session. to loss common for Thank the million a ended brief drug before the quarter attributable increase General XXXX. quarter associated ended results was the in compared our $X.X was $X.X related for reason XXXX. Q&A overview comparable the development with milestones of million XXXX. and increase for $X.X and million our approximately was Net comparable in million approximately September with XXXX, XXXX, expense the the period XXXX, compared provide programs The and activities you, approximately period in to with R. expenses compared approximately an XX, stockholders quarter I’ll September manufacturing comparable to Research R&D for $X.X administrative expenses, we ended totaled XX, in for million $X.X approximately in for clinical to J. the costs financial September $X.X million and additional XX, supply. for upcoming period

and the As into Based had current fund to is $XX.X of our cash approximately on cash September XXXX, believe our of our operations plan, sufficient million. company we cash XX, equivalents XXXX. operating

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

XXXX. a trial three-month Xpro cognitive a anticipate to mild is with plan I’d half move upcoming like patients for half NIMH to first X Now of in the initiate have we a treatment-resistant in plan shortly funded our Alzheimer’s In Phase first Similarly, this plan XX-patient initiate of of after with quarter, milestones. Phase the of XPro results expect program, that program $X.X list Phase barring start Also, initiate by neuroinflammation. our disease patients In delays, line results X XXXX. depression we we this delays, unexpected grant. competitive impairment. the pandemic-related with program any any the second trial to we Barring AD we half line X XXXX, in fourth in for on top mild and million the top to to partially having or of phase –

further study INKmune finally, expect continues first in program patient We cancer data as ovarian of half a second to plan we high-risk launch INKmune enroll. And XXXX. in the the open-label to

Some and like summary, time would to towards to At your to attention, milestones. the it during would quarter operator I platforms – questions. Hector? we this thank to Hector, are point, back would you potentially I this our our continue for value-creating to pleased turn advance we the to progress and as like like at third point, two with I poll for

Operator

of question. with from proceed Shrader Tom comes Our your Instructions] line BTIG. the [Operator question first with Please

Tom Shrader

on progress. the Congratulations afternoon. Good Hi.

about is? earlier mild than borderline bit say little it a ADAS-Cog. does if get kind ask it same patients highly and to thing, of is MCI, of wanted I I So, understand works How that on the it But correlated? you EMACC. AD the experimental

R. J. Tesi

J.? C.

C. J. Barnum

So, Tom. great question,

is the EMACC the So, derived in answer was AD. and mild empirically early early MCI

cognitive disease So, is And is reason cognitive the cohorts. progression it for symptoms our in are both measuring the because for for that that extremely that well works EMACC groups. relevant

R. J. Tesi

you. if is to to can mean, industry If satisfied I Yes, I encourage Tom. a to can It’s ADAS-Cog try arrange – very her mean, talk and in in Judy just have and jump are patients. we – – But just here. for not, you basically, with this This CDR mild I she really to ADAS-Cog at CTAD. been developed people listen this call Tom, I MCI instruments. players very with not AD these blunt because Jaeger’s

importantly, improving. that remaining if decreasing more the or industry’s evaluation aspirations even hurdle, should think is I And have And way allows of we actually I cognition. belief the stable decline say, that their a the this they work. sensitive to have and me low as are higher heard in of us – give So, will you us a XPro consider rate that for tell

C. J. Barnum

more thing pathway. it as the regulatory relates One to

go will boxes ones only we are off So, a the primary using all not checked for EMACC. – as that use you requires have other believe that hear able Judy, from There we the we endpoint. a And to to the ClinicalTrials.gov, you to metric are are FDA if are other the metric. companies be using novel

in well-positioned are think angle. we So, every we

Tom Shrader

your I inflammatory questions Okay. criteria, a on of markers. have couple inclusion

is pre-diabetes. in to the that where plaque So good as pretty understand you barely I make already role not sure use for Alzheimer’s view Is is way instance, And it’s inflammation question second but criteria. your patients. have pathology, choosing inclusion then full-blown? a HbAXc, are you a of that’s an to

Alzheimer’s. some they a remember solanezumab patients the early trial, of think third the you of didn’t have If

just without is thoughts, now? better So, your plaque diagnosis

C. J. Barnum

No.

R. J. Tesi

be yes, of J. clear – all, go ahead, First to C.

C. J. Barnum

Yes.

second the one answer me Let first.

patient to amyloid So, we requiring be the positive. are

Tom Shrader

Okay. I am sorry.

C. J. Barnum

Yes.

plaque, Alzheimer’s request. that patients have FDA they stop. are an full clear that’s very mean Now I

Tom Shrader

it. Got Okay.

Okay.

R. J. Tesi

Now, Bio patients these two – Hemoglobin AXC, think a One, inflammation. for have reasons. insightful biomarker peripheral have is they by very I INmune do inflammation,

Now remember, inflammation years heard central you say all for me that inflammation. peripheral begets

The other element insulin right. that important of thing, there cause you is and resistance as know, an dementia, can

back that resistance. the was people that when XPro Now actually we doing that one were forget insulin findings of decreases NASH

C. J. Barnum

Right.

R. J. Tesi

Hemoglobin AXC we does an I not a think So, inflammation. potential patients on whammy for in there do neuroinflammation. we that have a fact, I think select And have – going who impact double to only is year are

importantly, to of having effect their twofer, CTAD. so. may due have at who peripheral will be Alzheimer’s and those we actually may see amyloid, due You a see secondary inflammation disease, that getting to patients as you We But to more on say. a dementia like information

Tom Shrader

Alright. Great. Thanks.

Operator

Our Please Instructions] Mayank question Mamtani question. comes your Riley. B. of from [Operator with line the next with proceed

Unidentified Analyst

our Hi. A This is really few you William us. I on Qs. taking Mayank for ones Mamtani. quick from appreciate

additional First the on should be at focused off, color presentations some and could you might be could investors we be what that expecting what new? CTAD provide on

R. J. Tesi

disease matter from think I think release, the measuring far there MRI white shall in press in the disease, would will week water and in we information saw therapy. as metrics – say, is last reliable – how, on you and free be I pathology I there say, the Well, we more will are

of have will XPro You CSF And clarified. increased story, additional data effects the I what on times, see data be mentioned couple on the – it. as a and on has we – podium will how EMACC then think

important. it’s think I

been these think of using novel the and little so, lot biomarkers, have at that one don’t not management aren’t we things quite – think we criticism, because companies bit I of a been that as biomarkers this uncomfortable is are cutting-edge a has using. I on rightfully other we of but – – investors by, are think a honestly, I the are that frustrated

into and staging disease are be diagnosing they understand sure and think for will how it soon. But them we response. community make our the therapeutic Now, academic a to is and the biomarkers important the investment looking responsibility using community these

patients there give to There confidence be will using off be any work to that is your kind we knock future that socks more But – that in because I it’s be of else going playing going no hope, gives makes fact, we believe is stuff. playing sandbox going relatively you going is – more, are new more a be there And incremental. are – stuff they hope, the trials we is you of you well. That to more their the for So, it to that kind in is have lot not using pretty we nobody think I a we and biomarkers aren’t in. we doing what sense.

Unidentified Analyst

to also, biomarkers strategy if mentioned was biomarker And in for a enrichment on using appreciate curious extra are your you TRD that. be had some that XPro information AD. those you or you we enrichment and going I could did – like Awesome. Really similar get then what be? any strategy might

R. J. Tesi

C. J.?

C. J. Barnum

Yes.

So, evidence rheumatoid diseases multiple the biomarker And chronic in that drugs trials. with clinical the as we established. well – shown incredible in with thing about anti-TNF been patients well. really treatment is neuroinflammatory for from arthritis depression have with CRP field is It’s a like as response

really that good have little So established. we CRP, CRP to added with biomarker that’s actually But got well have we bit. a a

have a behavioral We anhedonia. biomarker added of

the is of associated of So, looking we with functional most it and brain connectivity with are symptoms the that within is one region anhedonia. that out prominent the reflected turns inflammation

combine to help together, both that when us biomarker and further patients So, biological respond. most got a the we enrich have the those we that likely behavioral two things are

Unidentified Analyst

then interim can And expect of either between any anything analysis and top initiation in or Got the the your that check, quickly, type AD line? or of real for it. we like are trials, you – safety

R. J. Tesi

No. Unfortunately, it randomized pure, a blinded, trial. is very

But only is safe happens. we is and So, six potential patients, well safety months, no know always the because untoward terribly there these unless to therapy trial of is tolerated is there in – now. six stop there no months it’s something

trial. trial. like Remember, So, is else we we XX-month everybody why that’s almost six-month think a

at something for something looking halfway looking nine are sense, some because So, you makes months. through for

before will them. have We our results

Unidentified Analyst

makes lot It everything. me of on you I our really Congratulations you. Thank a questions. it. sense. Got taking appreciate

Operator

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

R. J. Tesi

thank So, you.

in-depth our We and to confident to science on of lead strategies. platform make development our We use continue the that will the of efficient progress both understanding remain biomarkers of and programs. the action mechanism

program. but efforts, aggressively ignore to for or them to will strategies We know will those Alzheimer’s pursue for successful fair be not accelerated our in shareholders. or eligible our disease do we We if approval be patients would not

yet opportunities resources that as seeing will each remind I to only There be iceberg for you the you opportunities presented tip the grow. many Finally, platform. the at are of are

and will other over look I for opportunities participating those like. speaking Our you of sure to next you call what be will efforts thank and that, you With see expand in am the we weeks. we some will the couple of

Operator

Ladies and gentlemen, conference. today’s concludes this

for your lines time. disconnect Thank all may at You your you, participation. this

INmune Bio (INMB) 4 Nov 212021 Q3 Earnings call transcript