INMB - Earnings call transcript Q2 2020

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Operator

Greetings and welcome to the INmune Bio Second Quarter 2020 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. David. yours. is floor The

David Moss

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

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

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

RJ Tesi

that treat programs second the targets with our the accessed for development disease XProXXXX back disease. therapeutic platform our by that indication. DN-TNF due unique soluble thank will X then C-XX opens This before to move INmune Alzheimer's affecting and transmembrane and the We'll these XProXXXX financial I to drug I'll my all for Q&A. same year-to-date for inhibitors start complications cytokine TNF on include provide I of platform. obvious to concerns. in of treatment upcoming the LIVNate it X without storm-related results the platforms you, programs Thank pass updates TNF. to new Bio for These the is start. the the and remind to milestones, not David the highlight the discuss Quellor, currently are biology using has to NASH, arrange to to therapeutic -- call. you for our key DN-TNF will for are you, cancer, program for we that Alzheimer's vast areas using approved marks everyone, a joining safety takeaways repurposed quarter, place the and each David, TNF for INBXX

a second on Although XX, Ib quarter Phase not we interim clinical trial. July reported event, our results from

to a Fasciculus. with understates decrease Alzheimer's language. language in a biomarker biomarker been patients clear in this Why by measured reported is that this of is in matter XPro statement disease. MRI in free matter in of patients, neuro-inflammation The white to by patients of all tract demonstrated neuro this validated The have measured data the or important? real the neuro-inflammation proceeding in that decreases trial power water, We inflammation with Fasciculus Arcuate in as Preliminary goal patients this biomarker decrease Arcuate Alzheimer's disease. is X describing white the is which critical

a they injection with in when be study important confirmed with subcutaneous unless believe disease. patients given neuro-inflammation XPro show X can they an peripheral While additional are subjects, these provide as we for that are important first, Alzheimer's -- preliminary data they reasons: decrease that

the structure symptom most that is that decrease a of disease, the is language in Alzheimer's anatomical language arguably well-defined sensitive or a clinical dysfunction. role Second, in plays and crucial

in inform efficient drug data to Phase Finally, while and measurable optimizing can the be II of placebo-controlled future program we clinical blinded, will be an a provide dose that what use biomarker distinctive, these points to used trials the us design randomized, that in to trial. allow a this to endpoints will

KaRA participate Sydney, If listen Dr. you you did to on morning presented Australia. by KOL clinical at of the the not website I Rosalyn in the webinar the PI XXth, the to link use vignettes suggest site on the in the Lai, our

in extremely findings to COVID-XX in Phase Like our also common are you The commentary hear of consultants. an see Not clinical our requiring program U.S. cytokine by consultants, have the goal by is in team the in can Phase And our such that slides. important these trial. who trial at in expert no the soluble patients hospitalization of You Quellor We in data the are where and across encouraged The only II are disease we can storm rolled our we trial. stage in and there in for the the occurring results see therapy. as know XXXX. do we phase initiate also confident infection. a targets trial by us is over which this to been TNF, feature in domains the arguably that look brain affected most Ib of the a in we neuro-inflammation, If reduction element reduction might forward early cognition the surprises, but and to predict to may into extension the be a allow additional C-XX rage pandemic continues the the patients clear

but to applying were changed. BARDA. strategy Several things We have We have decision as previously problem. relates signaled and our we fascinating detailed for health from financing non-dilutive it complicated public this process

months both of on mission the depends complex are the patient. The to the but for treating indicated a not be low eve with sites. cases They us ago, deterred, a application activities we enough supporting there disease priority. may that should at while. a BARDA the its concerned to going has that this be think submission not regulatory and dramatically, be may towards the our therapy was for we two refocused and exclusively. timing I have a would changed therapeutic submission, diagnostics is vaccines patients. the On working And for benefit these and agencies a tested in exact we Disappointed, start-up be that this Obviously, States. United clinical first Honestly,

to the We X from are in XXXX. be have additional We enrollment will cancer programs until and DN-TNF initiate not believe programs delayed to due LIVNate that INBXX pandemic possible these NASH. for it

I clinical to enrollment predict seek that these teams will As pandemic not when and will sites the begin reengage down we do the start. want return patient to clinical identified normal, for programs. we winds to to have

of of seek drug obvious question biotech, those is in who For you about the what support. world an

a so the Biopharma the for drug to burgeoning on best new We clinical U.S.-based are process things twists in is have CDMO our production describe and programs. Making way so biologics turns. batch by produced XXXX. working that many drug the are KBI good. of there so And is with first the to is If track, we of far far it KBI expect remain on complicated,

hope Schillaci body cancer, expand, findings this overcomes the carcinoma oncology. also. cell Schillaci preclinical platform, data present we the our at has comments INKmune; highlight AACR support year. of work efforts in priming to gastric has any data HERX-positive breast cancer. she On our to NK continues and in This additional to to Actually, is platform. the to in my lapatinib with Dr. I trastuzumab demonstrated surprising TKI INBXX some on to conclude of by Roxana that combination reported HERX-positive inhibitor, want resistance DN-TNF Dr. I this Before in

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or the program a Phase I trials. of trial with cancer high-risk U.K. program, As awaits sites the the Phase cancer centers to clinical I reopening ovarian MDS

IP value as IP of and was natural USPTO. of is the IP the INKmune that is in patent biotech. expect XXXX. that that And continue program this the to had bit expand additional for by both one many been this issued we a in put or platform the in announced begin DN-TNF entitled The We had of INKmune lifebloods of trial application April The IP. core vivo ways, killer IP program. in Naturally, the priming new to for platform we cells. we enrolling INKmune

This issues, CFO, let this to concludes we will now David INmune back turn to As know. Bios' to upcoming two Moss, the discuss over IP you the financial on results and updates will announcements. I it platforms. Bio's

David Moss

million expenses commissions I'll $XX.X General quarter for on closing equivalents million of we compared with approximately second offering common quarter Net is to discounts loss by public June the the a milestones. the June XX, RJ. Thank proceeds XXXX, upcoming of quarter for company payable ended closed $X.X Research approximately and ended June XX, $X.X XXXX. to results expenses in approximately our and XX, million included underwriter and totaled ended other quarter $X.X for second million XXXX, the July XX, for cash Not the and June company after $X.X to compared brief XXXX, of gross June XXXX. attributable deducting June compared million and XX, ended approximately XX. XX, financial development million net XXXX. offering, for a debt. $X.X cash the million $X.X ended had no for the June At figure ended in XXXX, that provide $XX XX, the proceeds quarter you, resulting and overview million was expense million administrative was of quarter the approximately $X.X with stockholders and

For sold general and I mainly that supporting corporate only purposes, common in including note the clinical we trials, stock development, research will offering.

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

like list to milestones our on and move and upcoming catalysts. I'd Now,

should this year. First, to as trial we XProXXXX said this will results additional expect on towards of additional disease And report see the RJ to earlier, is continue trial into end of complete you half Alzheimer's Phase but the data has XXXX. Ib extension XXXX, towards expected of second the

with enrollment treatment the patients Second, of initiate infection. Quellor of complications of for COVID-XX

a of treatment Third, I XXXX, XXXX, for breast patients half INKmune, clinical Phase II II trials. of second Phase INKmune, I half in XProXXXX, patients a disease the In in Alzheimer's Phase high-risk initiate for neuro-inflammation, treatment with this MUCX of year. HERX-positive the LIVNate a cancer, and in of for expected program INBXX, treatment enroll MDS cancer. a plan second ovarian to NASH for resistant we II of Phase for towards metastatic the Phase

these our of meeting have all on most and new business. focused importantly, time supported our like to We very Mallika, very, current development of it played to our investors' investors faith could moving like delivering At of and remain back please answers. milestones, our we you data I'd turn forward. you questions? summary, for in and So goals previous, Mallika attention, this thank in to thank rewarding point, and, patients programs I'd questions for and your poll for and and the who

Operator

Instructions] of Tom the [Operator from Schrader line the is first one The with BTIG.

Unidentified Analyst

[ph] for is the on This Congrats Julian quarter. Tom. on

it months we're First, on beyond very expectations would this I that trends back are several half understand directionally for your free points is know I X those? Phase of expecting Alzheimer's to reasonable year. matter but over that there? white I water, you there expect positive How data early, frame it's

RJ Tesi

you know, have X Thank is as buckets. RJ. we Yes. This biomarker so mean, I you.

matter which imaging the is an free have bucket. white water, We

control breath, inflammatory so we CSF, we cytokines, -- year. be being as both speak, say biomarkers in such most this not and those to We say, would batched; expected the we shall the half we then biomarkers. endpoint, costs, and have second of to behavioral have fruitful, of exploratory which expect many are as have so we a blood -- an to CSF I to neurodegeneration, which can -- that neurofilament the are have until is -- biomarkers, of and be

neuropsychiatric -- of half, probably, We relates Roche biomarkers end for testing towards CSF. they Alzheimer's once the given Toolkit, as in the will more are the the partly second year. data again, it -- but are the using which to piecemeal, be the We that in who the

most not love be I the plan what's very II. ones way the we helping clue the in a going technology, Alzheimer's in inflammation. to use or think, both or with the disease. don't never the endpoints, Phase the happen and probable That then it's am think I fact, it. CSF results. been I monitor fan blood but of directional a neuropsychiatric very is And and in are, way which Measuring We in challenging is expected most disease study to the inflammatory as sensitive a frankly, be blood used quite cytokines, any we're way to our biomarkers a I trying useful have actually will, breath. to finally, to

everyone it. not So more trials of biomarkers, we our put do the we does actually lot are We but to it, tend other around build a which in weight think it because we reliable.

Unidentified Analyst

that switching relative the have of Okay, for you there a FDA's Do for prophylactic got the to it. COVID gears how know is common flu therapies That's infection. this your I and helpful. reports have to some this infarction And the of basis? been with address channel then associated course sense receptivity a specifically on program. natural the

RJ Tesi

infarction infarction about So elsewhere? are cardiac in or talking Are you meaning saying, you heart? the

Unidentified Analyst

Both.

RJ Tesi

Okay.

And obviously secondary a to of disease organ lungs. cytokine pulmonary infection endothelial in different is the So a coagulopathy not and clots. it's prominently into clear cardiomyocytes, and literature of very The is systems not of -- manifest not one can is the the lot virus a but that related a is a actually belief know, that blood in by the heart of you or storm the -- it's the the pretty actually, direct COVID-XX place. of that disease, as pulmonary the activation our be it's complications

the of not fact, incidence X the in myocardial patient be the of even myocardial in real. period is or length. X that at So They the it's be months are you is can look influenza, I events, It in MI. it gets if syndrome events prolonged. the problems after coronary cardiac acute well-known exact actually, actually increased there In after forget an whether maybe influenza, and months, the rate

effects, brain viral that may syndrome, other this effect be whether So the unique this goes stuff stuff with all hepatitis, effects, of coronavirus. inflammatory the be is pediatric a very neurologic renal COVID-XX, all on the post-COVID the But to the general it the fog, disease. that

little to would don't that, just than is worse because say it's that a please bad flu a bit So try say. I this

Operator

And next Capital of the from one with Jonathan Aschoff is Partners. line ROTH

Jonathan Aschoff

wondering if now information can be the first me dose you will was big how trial tell that And patients? will results in the in ultimately you you you've neural seen them I Ib how encouraging Phase few the program extension long have?

RJ Tesi

question. Good

So patients. the -- that end of expect we I instead up will XX treating

-- you the these because think I like have we a we you've I men, this have all I that think trial biomarker imprecise removes becomes to have computer a hands kind basically, really like This math stuff. basically we that any basically closer frankly, -- it patient, measures and -- XX man. talks has actually that or It's and that that checks hands of can rating outcome sits to boxes. got someone has without MRI down it And algorithm to more hands-on that will scales say. measure clinical what does this a Traditionally the this XX basically of much of because the get of the scales man. now quite those is the

As use dose really think we I can need clinical will into think trial. we the exploring drill the this will be exact be. result, with a to we And what I

are advantages in because that, goods expect of the cost end the in which I probably So, X that -- kilogram, of less for up milligram per both we'll some with therapy. than cohorts has

we'll that expect let's XX, XX. And maybe get to say, so up patients, I XX

to I. a Now for actually not Phase extension had completely place a actually trial the We new is in the extension It's protocol the different put trial. trial.

this is of the kind get rolled extension. they history of The So into interesting.

was is this very costs number And going members to And this pitch that, patients is term. we "If don't you I'm being and XX good you kind a after the it have they regulatory communication but which X X patients the Tim which the the valuable CEO the little of a me who to one the months, was counseled period I in year -- money. the on of small, on time, -- when And has from of year had fit." if such after very started use was the ranked the a early originally is of data of say of is hissy campaigning top of country. to up that Schroeder CROs stay not been as do to actually allow us that drug results CTI, a you Founder to he things that for company been of have just because to Board go our one patients reluctant ends who drug of Some prolonged agencies, view. point for a CRO,

on fact, labs the the I written is will works though, is without patients of way benefit that therapy, in far we months. if the is continue their on patients on stay them. get extension they the suspect, the safety as patient way they they every that MRI formal the will enrollment trial. trial from and months. number is So X there they protocol year. getting these that a the extend written have we If we Currently, a is stay as them and X the evaluations -- are drug clinicians feel And

bad a is where point, doing by because the are to able drug for therapy clinicians, at who But very development. for driven this been us what on their some we which glad trial So and supported in it the kicking the dragged patients to was in looks we'll report It they table. not by have to like and screaming patients. we're be year, you was I'm

Jonathan Aschoff

completed weeks program? of was curious, I XX thus far, the percent have what are patients in that extension Okay.

RJ Tesi

top my I do head. off not the that know of

is and our on who As you -- you know, Barnum, to is him Head I'm Director sorry. that, the involved the back CJ directly of in of I'll Neurosciences Jonathan. ask trial. get

Jonathan Aschoff

one, The AD. about last Okay.

expected program thus that AD you think to? you early AD aggressive you might do far, more the than DM to results the standard and have resources you'll Given deemphasize on campaign focus other

David Moss

the And It's AD the look because program. horse in programs, we -- very the to love that's that we and investors is question. point, other committed always good At for our lead have non-dilutive a obviously, funding. will we this not and

for we're we've walking these programs for both -- patients to I company. that financially believe willing and away have I'm the think We from not say anything. value clinically

it like would I at So to that. leave

you think to not but asked ready a we're I yet. fair pick question, one

Operator

Our next Naureen the Quibria is Group. question line of from with Maxim

Naureen Quibria

me. hear can you Hopefully,

a have study? an and cognition, going or you any are, have AD question arm. whether clarity be you longer, I will the impact stay are able program on -- as all to So extension on on that the they would Since is assess do on the patients on you evaluate with there at the well to

RJ Tesi

Thank for you, the yes. Absolutely. Absolutely, right. question. Good. Naureen, Absolutely

at X think in testing. that As the part also. quite are of to But those of they full the get we're seeing, will from actually who people that, with we will endpoints every changes But low. excited. evaluation, of are months we that battery what They actually Alzheimer's cognitive the get more neuropsychiatric kind X a were traditional it over used we months got expectations trial hopeful metrics that that time see our

is absolutely So yes. answer the

Naureen Quibria

the And wondering, know. either. different. hydroxychloroquine something very any this shown To targets there's benefit hasn't different extent, cytokines. different that of cytokine, TNF that itself we And Kevzara what the a sort the of then obviously, use for just inhibitor is And can been Roche's And - any they're Okay, don't Sanofi's bunch But I settings for of the and though. through going COVID rationale inhibitors TNF same about guess well, Actemra endothelial cells some soluble may in in benefit that thing you walk the like COVID haven't confidence evidence know that give to great. soluble But us agency, you're and you've preclinical terms other I you have other That's you've was show is, this helpful. patients? I like it. IL-X fared -- study cytokines you IL-X seen with study. seen

RJ Tesi

there your the that question. you approach homing major up soluble TNF to major we're it on with the the But of cells, cells. regulates so how it's that tissue ICAM endothelial more injuries. role Remember, disease. to that's site the protein, lonely clear, We're factor, on the the coagulation is in first bad us regulates when at this or up on And been soluble on talking which has the very not may is or be lung. right? insightful endothelial used I'm And -- more stimulates does all, the very stop, TNF traffic in coagulopathy. clear And major focused -- out IL-X it on now activation. there we IL-X look may and has focused a or studies what effect you cells of Yes, about the cytokines endothelial and cytokine IL-X what depending are what voice. endothelial not you difference is to a VCAM, look may I've terminals, not, which a immune activation. a importantly, of at. IL-X, allows I actor. are TNF, no Full effect beta When It's

think of we've got alpha not the I may, affect IL-X it's So, is anti-IL-X, I beta an you very inflammatory -- inflammatory has all MISC, -- the importantly, of combined -- one drug say, anti-Il-X that big mean like programs Kawasaki I for the endothelial a TNF out shall If where been it. think it's kissing -- there the an excellent more cell. the target, to what even if role. drug, that that I not I just it's there's which children. areas, at a look look other is see. the when But studied at has think patient It's to going you is plays primary multisystem a super the multi of some disease, of, syndrome variance cousin over TNF thing and inflammatory

the patients clinical showing off say at we trial when the stay end I chance think biggest a trial, will can have think coagulopathy. really cytokine day, benefit. being think But you of we're and turning the do I is benefit up a we that we think have the the by right? I these end And turn turn the I I clinical the our that of benefit. I doing, And like All off coagulopathy, storm, right? tuned, off will to

Naureen Quibria

Right.

So that's helpful.

Just same topic. one more on that

will look and Kawasaki disease MISC you So as well?

RJ Tesi

There into for We're point. from are large We're go before are getting you have to adult going eyeing FDA always the challenges -- this considerable the database, interest, say. of very today. that diseases pediatric at path drugs you the want our is arena, a for database they have with there to that DN-TNF the is that but would into supportive kids. And you kids, standard Not is into database. I away that like but problem

it's seeing it I more these becomes the the to think get started, we're going think area, conversation. that's radar You can we we're be can of the I schools, particularly of with in imagine COVID back And very go And a point, are All is something But trial getting say going. very once topic kids. our in virus the that raging the and think to stream. imperfect. current U.S. with on I to therapies the push at much on this focused adult I

Operator

from is question the with next Our of Wainwright. line Arthur the He H.C.

Arthur He

have in just your guys to COVID-XX the is, One yes. So So -- further two And perspective, FDA? starting want the -- with the study. discussion I time just optimal trial? Have I regarding you to what's any the had questions.

RJ Tesi

with we're and way court. fully it. I going that. That's engaged the their the in FDA. I mean, mean, obviously, phrase to I'm answer me ball's Let really, the

sites in imagine, interested are can we're We clinical offering. are, what the as you

But I have in want the already complete this squashing our city things which date. And exact thought first don't on which track, going running, about give There's Melbourne round, a fire. tremendous is know don't are is I Australia, the The on regulatory the know, which And success I'd handful. is programs to so because really there's getting if Melbourne, clinical back then Australia. largest they on. now success say and will had Victoria development And on another unfortunately actually and track. I or And turned I had getting parallel -- the Well, just there's really those up sites has clinical in a that And largest curve. the go because, Australia city track failed. parallel. going on an the at we is on mentioned in Australia going started you second we FDA. my -- originally, the before, as

So Australia. in fact, we are sticking our back nose into

fact, the in be protocol. So same we will it --

regulatory are, fact, We in authorities. engaging X

think so getting pretty in started we're And quite soon. shape to we good this

in for said think think will amount hopeful first I to that. in, patient quickly reasonable pretty I've we'll or I of won't time. country reasonable we're but hard, be it a that I and within August, enrolled what say pushing that assume past, I'm have the it's

Arthur He

And give you Could [indiscernible]. David. color the ongoing expense the on my and us on second question, probably some R&D the for

David Moss

thanks, Arthur. So

You're looking R&D about related COVID the expense for trial? the the to

Arthur He

us operational color? you like give No, overall the the overall some expense, if -- can

David Moss

we on changes programs our through any or current We -- based programs happily, current the of we've have half adding any announced the given that of XXXX. expansion first decreasing or we've No, Yes. that happily. without programs, new plan announced, just funding any

to funded keep do is we're as run we efficiently as in past possible. heads done expect XXXX, things So well we've and through what down, the our

contra these on companies. we which unusual R&D, because looks expense rebates, bit side low the which little are biotech in a are Our R&D get

going continue clinical to the So in rebates support that, as to also we're anything our to support we're And as move going Australia possibly able be and programs. But call grants can. to the try announce as continue that, of, U.K., get R&D and we're it, obviously, along. kind to and for and we apply our continue in achieve going to we're let's we we'll if capital-efficient

RJ Tesi

So and and your I think cut not and David session. ahold of will know accessible, we're questions have you there to sure ourselves get out going the to that questions. us, in our Please reach do off I pride best their to had answer us. are we we being people But Q&A apologize. to how I'm answered,

we much to And continued very in appreciate participating you support. add? appreciate your anything we today. call David, So you the want

David Moss

investors keep of questions our to I with mean, around coming, if have are lot we you questions. want our best to a want do highlight Quellor, answer you. them do There's know have and We the the I Thank you you lifeblood again, Mallika? a RJ. to and just we'll related lot. No, company, of them. that communicate

Operator

We you. you Thank ask call. please for lines. that disconnect participation. your gentlemen, I does today's thank you Ladies conclude that and your

INmune Bio (INMB) 9 Aug 202020 Q2 Earnings call transcript