INmune Bio (INMB) 2 Mar 232022 Q4 Earnings call transcript

Greetings, and welcome to the INmune Bio Fourth Quarter and Full Year 2022 Earnings Call. This conference will be recorded. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]

It is now my pleasure to introduce Mr. INmune of CFO Moss, Bio. David is David, the floor yours.

on everybody. you, call for you of and INmune With for Bio, Tesi, Dr. is Dr. afternoon, of oncology who Paul, who natural good Officer We Neuroscience, me results. XPro. joining financial Barnum, Also Bio's Bio; or year thank negative call TNF CEO together will platform, full update Scientific is RJ Thank an INmune XXXX provide the CJ us provide VP and killer for Chief a the will business Dr. call on update of memory-like Lowdell, INmune on platform. our dominant our Mark on INKmune, the cell

management I except of from on everyone uncertainties that questions such Act that can begin, forward-looking historical this differ involve for conference we actual These in call facts, to Securities and under Private remind of provisions responses statements. made materially harbor forward-looking and XXXX. the those safe statements results are to of Before Reform by Litigation statements the statements the cause statements risks

circumstances. Except statements any forward-looking change. information, are of disclaims or statements the forward-looking the as update assurance may any the including disclaimer these be date not company's specific most required Undue facts INmune forward-looking filings, the filing press release made speak underlying company's reflect which the statements they no as factors well SEC see of Please circumstances these as our future to statements, quarterly forward-looking the reliance only should recent in SEC. earnings There's as by events with risk on outcome. obligations of and placed to Bio as law, on

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And the to call back pass I'll Thank you. now RJ.

Mark. you, Thank

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turn point, our Moss, At David? David this I will financial over items. to it to CFO review

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

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point, and it back turn attention. you I'd to operator, this Paul your pull to Paul? for time like At the like to for thank to I'd questions.

you. Thank

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from is proceed with Jason question Our first question. with Maxim your Group. Please McCarthy

Hey, the taking for Thanks questions. guys.

I'd or this where cancer. tumor metastatic part prostate to salvage KEYTRUDA decision? types what chemotherapy. where be go you've and Xtandi this to like about effective, in plug to castration-resistant solid of day now like space just out that is know pulled First to just Xtandi question We've think the mention prompted it Merck when targeting several are defined treatment is combination? there as seems and on you to that kind to does very question, it And second of fit a a INKmune, other paradigm and you on chosen of kind pluvicto as but where the relates then your seen and things

Jason. Thanks, Yes.

patients pretty didn't it's alone. with in -- on choice make an prostate what effective failed this androgen just therapy metastatic on based said choice some are no experts you decision. minds, really oncology of in with enzyme, We we a inhibitors. the that immunotherapies And castration-resistant closely our is So there the this sort have and worked for and The various cancer the clear.

kind go the dealers patients not them. into be status And quite institutions. elderly. they can It's although, patients of for is a many a these And great So often often used, chemotherapy don't choice at frankly, of choice work.

So what people we're in have that that the there's immunotherapy, had you is may you has excites which, an about tumor fact as the cancer been other survive. immunotherapy, of effect talking difference actually every doesn't know, have an suggests do one, to they to multi-step the think this have this But is determine is or adequate INKmune trial, it? will it. we trial Well, preclinical trial INKmune data randomized this an Prostate therapy.

that residual of cancer particularly has is, we're bone resistant and there and kind the interesting know, cancer cancers, tumor blood, scans. But metastatic are helps PET scan the the which the of biomarkers prostate biomarkers of CT PSA driven very lot prostate informative including like a king prostate as DNA the scan, disease. the biomarkers, quantify you There's traditional we reason understanding second you The biomarkers. tumor for are and in much developing circulating more PSMA burden, some castrate

This in gives really you status evidence quantitative been. it's which way disease of

country growing size frankly, because like the landscape -- in a disease almost castration-resistant there. think We region of most we treats the that's well the defined there is large cancer. and out So not quite every opportunity it's prostate competitive quite

didn't sorry, I -- -- add just interrupted? I Can I

done. Go No, Mark. Absolutely. I'm ahead,

immunotherapy should the T-cells that assumption to a boss look natural my are just based old are No. upon is king lot immunopathologist trained the immunotherapy you said as going me and of to the go over ago, years I and who a of an XX cancer someone one the things was yet say, attempts that frustrates as me of at as patient. at

don't If at that checkpoint beaten NK cancer, any target not you outcome. the infiltrates, associated cell sort far look are and you infiltrates, It's that of are T-cell cells that have with publications infiltrates so cell function. of infiltrating and inhibitors NK prostate the

So NK sort pump tumor are we're like, of takes lab. what if and we’ll checkpoint lightly, NK but the the use giving, wouldn't way you hopefully in we're this I inhibitor cells that giving immune the and the in effectively do they resting that

think from So we're of good a And tumor prognostically potentially public for is there here I NK type is is at there. valuable. number what evidence cells that yeah, of literature NK the that the looking going cell are where

prostate another good that's reason So for cancer.

enroll clinical before gears get the off FDA? Got company you hold? hurt all just side, the you with if Alzheimer's it. AD the patients trial and standing Does to any the shifting And it the in

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clear I will we that is we very will trial going like. The similar going been X of think, to Phase do we're assume trial this Phase because -- have what look a X to to look Phase trial. X -- looks I've

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that. the So very will of part U.S. be a big

be our forward. there even patient enroll compromise ability the absolutely there's move -- So as that to that will zero outside every risk U.S. if we will

for… So or international the Okay. Are set does it for trials? countries you countries selecting more this stage then

countries that a of the I would Phase countries Yeah. we're on you X. for all would have Absolutely. global your be mean, regulatory list selecting

how it -- will mild or size so being now? like as just you I your the the one, and AD total combining end are trials trial” what just the if last And when increase does up size not “early or and combine question brief MCI trial trial -- you AD

there? go don't why CJ, Yes. you ahead

hear you me? Can

Yes.

down good your to you're question. I Really, it's are. assumptions So powering it when and the a study comes what mean,

AD perform will So mild the patients assumptions better that even MCI patients. than

on we positive increased our likelihood we when that EMACC. seeing a So the result calculation, of power do actually

going talking XX, little trial believe to going we're a it's XXX size patients, -- we treat talking bit. increase it's Now to But the patients. XX not

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Okay?

Got it.

guys. Okay. Great. Thank you,

difference the reinforce just the trial arm the the remember, of reinforce the to just anticipate the placebo MCI you Yes, arm. -- And of what CJ and length the the more trial, doubling comes CJ unsung power from MCI -- kind we said said, get taking as to group. his the between by what in response that is in here comments, hero means treatment

do will MCI and good increase things between and when delta -- you the placebo you and group happen the that. So only treatment that that group

you Got it. Thank guys.

you. Thank

question. Our from Shrader BTIG. is with your next Tom Please proceed with question

Good ask afternoon, a tough big that's one, in DMD. and answering new thank wanted you, Mark to And for my program about about one. the I prostate why another asking because castrate-resistant or cancer question

some of historical commented scavengers, You issue there's with of get XPro the issues. a might conventional that around those little bit a TNF

question this XPro mentioned ask, to AD an I no it show think is gets have that do idea or that you I would around longer derisked And would to I partner work an is some later how the cardiac-tox. on? a need then or issue.

Yeah.

that's So excellent an I think question.

Let me on give give you will whether and the this -- then have specific derisk, the partner's a I going an you guess issues. to on to educated

mouse in original to used there the DMD. non-selected mouse models, in in mice. decrease cardiac a term, treat output they So -- inhibitors There what long was in TNF the happened when models

in TNF animals actually muscular the actually made it decrease inhibitors with a DMD worse. part abnormalities. time. over of patients and of see function dystrophin cardiac the But the It's remember, Now effects

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stay and our on screen it's So radar tuned.

you. Thank Great.

Thank you.

is question Carlson proceed with next Please Tailwind from question. Our Research. Daniel with your

Thanks Hi, my guys. for taking questions.

quick on you on at a you AD is what U. XXXX, need to S. point Just trial. one that second the the approval going the or Does based that on? timeline reach of just for do MCI timeline half have some

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had Thanks. that from the enough. open-label extension, going some data Fair to you CJ said mentioned get And in due you're Okay. then time.

just to extension, wondering point. a that? open-label was I chance some measuring was I in the sort in if us get see if And at that if what to you curious particular from could of expect you're cognition So tell we'll

CJ?

Dan. Hey,

we clinical so study in continued have be rating the the the yeah, that we measuring in be scales will study. open-label extension ADXX all So will

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is know a an the problem, a placebo Dan has blinded, patient And Phase won't if II or interesting actually we is patient. patient active since an been

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speak. become un-enrollable, so to don't You

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what be motivation pretty big guys one just I've prostate work with and Yeah. PI since on question, you And was this? INKmune then the your to press to seems trial looked your a I'm last just but his wondering just deal. -- briefly release,

lung ADCs, is, his just of in use my world, melanoma sense cancer to the been these think etcetera. all he's trialist. Well, you frustrated has a I'll He don't he's very insight other said, whether I you that interesting -- clinical put -- and to buddies is, this his expertise cancer ask as I'll but or he's let want And guy, immunotherapy all you're let mouth, docs, tools particular immunotherapy. you have checkpoint I in -- experienced words in inhibitors,

I what states those effective anti-androgen and this he we've quote do And his with the reached chemotherapy. have, we've right? in press inhibitors, can strategies are that we the anything, the release, with is have doesn't the therapies and he reached And in think limit, we limit

the that that going comments, Mark's to a targets really only progress convinced believes board. Mark, that is he him way with you he's he's therapy heard and what on need immunotherapy. Mark they an So And cells, NK is

there, they've going focused pretty that, prostate He's every trying cancer with on. cancer. immunotherapy replicate cancer he's excited. done in prostate immunotherapy involved because to and in lung failure field a forward cancer and we're in success breast They're in So good the had the that's been guy. But been been he's very in has what

so far, a it's disappointment. And been

for big to answers Thanks your you. you. guys Thank a and from forward looking year

Thanks, Dan.

to floor There are comments. time. I'd closing at RJ Tesi this no further over the Dr. back turn for like questions to

I you're think mute RJ? on

Well, you. okay. Thank

thank in participating you, everyone So the for call.

teams be believe We clinical the a have we novel valuable that that. continue of and dislocations have and you're challenges capital to make progress to the regulatory applications, despite will We broad the see markets. beginning in clinical and to products variety

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will and much. close, we that, with you thank So very

conference. today's concludes This

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