IMUX - Earnings call transcript Q3 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Jessica Breu

Hello. Good morning, and welcome to Immunic's Third Quarter 2021 Earnings Call. My name is Jessica Breu, Head of Investor Relations and Communications at Immunic. I will also be the moderator on today's call. [Operator Instructions]. being is event this recorded. And

discussed please opinions Immunic's in any presentation, to new and SEC ahead. statements would forward-looking or and result release events. Immunic's here. a only of future light description results detailed the anticipate, presentation Principal call Speaking statements. information go these can as factors of Instructions] that could Daniel this will Vitt, Chief involve our to it the may Dr. be or Daniel expect, for Officer. President, Before and our be the may, as that an to results opportunity questions. begin, revise the Immunic's by Daniel, affect you undertakes note Dr. Officer on statements. Vice today's Please statements this forward-looking I statements to forward-looking statements and date with [Operator more there Immunic's Finance materially contain Whaley, we obligation to today's cause similar to these Executive refer no publicly and risk the reflect remind Glenn President; Vitt, as I Accounting like Such now call risks ask with of are turn that presentation. like from such identified may words CEO will, or such that meaning, as presentation, revision those estimate to Please of over words and forward-looking filings Financial these actual differ and our and to start President, uncertainties number After well of would to a of

Daniel Vitt

the XXXX to upcoming milestones for and opening from pipeline. Call. our would call. our Earnings quarter Immunic's well Yes. Earlier Quarter Third like as of updates to as Thank development financial highlighted also morning, results this recent welcome third announced XXXX, everybody on we you, I clinical Jessica, the

and today's as quarter through as milestones. will financial anticipated our results operating call, highlights, subsequent we well third During talk XXXX, and

Before opportunity have the we ask close the call, questions. you will to

great stage in quarter, During product the III and relapsing important continued the in data for setting candidates in to we advancing fourth X enrollment still quarter. this several the 'XX. Phase through progress quarter of in clinic, our expect readouts third start our importantly, the Most to program multiple sclerosis XXXX patient we make

top just quarter ulcerative recruitment we line Another trial total. major recently our We in patients which data Phase randomized the completion of colitis, XXXX. of announced milestone second in the in will II XXX patient be from anticipate with

from For we expect single program, data safety of ascending IMU-XXX, I Phase our dose the trial later multiple unblinded parts year. this second and the

psoriasis I in patients next we the Additionally, expect Part patient from of the human C have Phase trial data started and quarter this of year. in initial population just second

in risk we more clinical also development walk hope to But preclinical In Phase we and third multiple a virtual Also Goettingen subsequent on thereby analogues Universitätsklinikum further strongly points the mutant highlighting is twin Goettingen, their The trials showing to data inflection supportive work. in-license approach of selected I be trial during hosted R&D concurrently was SARS-CoV-X we in this reduction detail through I Erlangen, patient Ruhr-University in of the Germany, at progressive with University quarter time, July, from once highlighting effect expect the thank data the versus and this showing we we CALLIPER XXXX. year. first. to I MS in landscape. C the treatment enrolled prostate Utah quarter an the year. across the remarkable with medications for September, new and to first neuroprotective powerful highlights in Medical the clearly the of oral IMU-XXX, Bochum, Finally, ENSURE differentiate also of IMU-XXX. on including psoriasis I this will thought a IMU-XXX we an partners first we time Patrick cytokines data MS castration-resistant cells II seasoned new of a a This $XX Business for third again let tremendous autoimmune in synergized our provide patients experience next clinical our the infections. trial signed that positioning our run into treat quarter which fourth R&D an commercial the We to of inhibitors, and the Immunic. the of forward follow-on me Officer. patients the analogues IMU-XXX development and and are a IL-XX potential and At demonstrated our delta very also presented in represents Center, that the oral ThXX we showing Based see to independence Phase in neuroprotective to State much our welcome XXXX, and September, that October, very Phase update IMU-XXX. leveraging dosed first million Walsh virus is with offering, the the IMU-XXX. Phase Day we of CRPC inhibitor, production successful first agreement for Part cash July, his ongoing space. of executive, in a of data, MS carve are inhibitors and of certain in BD with very RORgamma In I University, rate potential encouraging metastatic inhibit Chief IMU-XXX third-party would as SARS-CoV-X to impairing in Medical complicated of trial attractive In trial look the research to IMU-XXX inhibit are ongoing dose without in treated University Day, We value believe development. escalation extended This underline combination to with that thymocyte this nucleoside DHODH presented generation initiate out We vitro. very variants, including viral DHODH that may successfully a both beta our t potential. we inverse replication III lymphoma if at like through other forms. the is the preclinical MS. Center has able of published diseases here the IL-XX trial Patrick alpha, In IMU-XXX covering trial agonist, our pleased programs the same IMU-XXX, our may to and avoid trial MBM we responsible that IMU-XXX patient be think multiple October, may cancer. data In preclinical Phase preclinical in to relapsing strength nucleoside open-label this of At ScienceBridge of of for run completed beneficial

in We of expect month initial a for the data was year. of Immunic. milestones second October quarter clinical next psoriasis

of top ulcerative completed also patients of next We in randomized. trial trial in second We quarter In await moderate-to-severe randomization the eagerly the patient now were our data year. colitis. of line the II IMU-XXX XXX total, Phase in

to for to For hand the financial our would over overview. of the I like next Glenn part presentation,

Glenn Whaley

Thank you, Daniel.

quarter We XXXX. of the will review financial the operating now and results third for

with anticipate equivalents, start million $XXX Let with the into ended the we operations which and be fund sufficient We overview. me quarter cash XXXX. in cash to cash to

in Now and for XXXX. results. million expenses the let's the Research $XX.X period million in operating quarter $XX review same as the to development were third compared

II to decreased by COVID-XX as offset X trial period September IMU-XXX. ended months expenses for administrative ramp-up our costs for and of quarter related X clinical in the in last programs partially support same in were well million XX, costs increased million $XX.X costs the in finished the same a months expenses For period clinical million to as increase related decreases X $XX.X as Phase ended R&D were compared were our expenses as periods for for the and increases XXXX. both in to General supply people the The compared hiring The year. of XX $X.X first million result more September to was clinical the reflect of personnel as for XXXX expenses the $X.X to that continued company's drug our growth.

for $XX The increase based XXXX. period per or Immunic remaining ended its compared average royalty obligation Net remind months stock AG net outstanding clinical on Daniel? an of subsidiary For compensation the as $X.XX Immunic our over was to the average G&A approximately net net share the compared for the the on payment September of loss settlement was loss XX% X shares everybody loss signed XSC that, ended in $XX.XX based in on in million like costs shares payment for of share of shares for common XXXX stock. that September loss was I'll weighted the No periods XX common by net I in of outlook numerous primarily was in noncash $X.XX share to in on settled period increases million categories. with XX costs both million of XX, per $X.XX on weighted IMU-XXX $XX.X remain were as to further X XX.X common turn million or between cash, was shares or of for compared year-to-date $X.X months Immunic X.X% March agreement AG. third upcoming million $X.XX milestones. XXXX. per XXXX. Daniel million. expenses common average common or average same share on in a shares the outstanding million XX% made outstanding in AG period for weighted With outstanding across approximately call loss sales the million based a approximately to expense well $XX.X million impacted $XX.X in same The smaller Net to weighted to back based XXXX. obligations quarter $XX.X XX.X due as our would our for XX.X XSC AG same and Immunic's million million per for

Daniel Vitt

you, Glenn. Yes. Thank

Still As the dosed twin anticipate of in the very months, expected program the have patients. and beginning of this The milestones be advancing couple RMS patients IMU-XXX tolerability III through year, quarter soon. of mentioned fourth safety and we these. ENSURE IMU-XXX wealth coming into first happy the evaluate comprises we of the the in call, in efficacy, MS next with in Phase walk design to of up you Phase I'm to to active relapsing development III the

We patients time first to trial. approximately relapse primary in Dosing daily an be either endpoint placebo. of dose trials XX or XX after of X,XXX each is milligram The have IMU-XXX enrollment both targeted will for weeks.

patients in currently with will biggest results ulcerative XXXX of top One of colitis. induction the second the our be be Phase We moderate-to-severe trial the line quarter. in milestones of phase our readout in to the available II expect

Also phase recently For our Phase and and experimental ascending quarter of XX we in patient the trial of I moderate-to-severe third We multiple the anticipate both we part still completed fourth trial data in of pharmacodynamic parts to dose multiple from in dose initial safety, second ascending XXXX. XXXX. the of the Phase I from healthy psoriasis receive for data IMU-XXX, in to quarter single volunteers. portion of pharmacokinetic IMU-XXX, the the expect available be

be Staying efficacy de data with Royal us bit time safety to we an of a announced metastatic of program. recommended the investigator -- population. the anticipate In The will point prostate dose be We CRPC. trial progressive we in cancer. honored London IMU-XXX, tolerability first a Marsden in July, IMU-XXX of major to with For Hospital to agreed and activity, trial. IMU-XXX safety, Phase as a Phase castration-resistant and the establish from I were that Professor IMU-XXX's profile trial be and that Johann open-label patient escalation our is pharmacokinetics the patients inflection tumor and very to in begin in II we biomarkers value principal about this little hit assess provide to IMU-XXX designed the Bono will dose will

the by in fourth start approval expect the U.K. we received authorities we the to trial, which relevant recently, of this Just to in conduct year. quarter the

I the trial IMU-XXX anticipate associated in XXXX. first of me in safety diseases of we expected of the the the in parts Phase please from volunteers the Q&A the quarter Finally, data single of half patient the third part intestinal open presentation. brings multiple underlining of and Initiation healthy of XXXX. to This ascending is in end function the for barrier Jessica, call session. dose

Jessica Breu

Instructions]. third you, Glenn, Thank presentation. us Daniel XXXX [Operator earnings walking through and for the quarter

on team call. our the For also session, the broader Q&A have we management

In addition appointed Inderpal to Instructions]. [Operator Business newly Officer; Dr. Walsh, Counsel. Chief Singh, our Daniel Patrick Medical and Chief Glenn, Andreas Muehler, General and our have our we Officer;

comes question at The Sandler. Piper first Rahimi from Yasmeen

Yasmeen Rahimi

would think I have that for CALDOSE to upcoming. we like like them. about off Maybe would A study the start -- I number is as we

question So getting should we I composite how from understand endoscopy we're symptomatic about think a our the to endpoint, which that frequent is be is clients remission thinking healing.

could what also in And your considered And clinical second, So bar provide reporting is learn love then some I execution if success? in a color to an a bit have of you then of little more terms in reading. follow-up. the I endoscopy on us these histological would view

Andreas Muehler

Chief This for is the Yas, Andreas, question. you, the Officer. Thank Medical

colitis think the patients, yes, absolutely moderate-to-severe I right. Regarding -- in CALDOSE-X you're our ulcerative trial

at both time XX. and the achieved entails symptomatic use remission think be I that endpoint we to week remission same endoscopic at a composite

study, regulators endpoint international the of indicated is needed to is no can indication. better this active. of and also placebo. outcomes know in some placebo we that worked trials actually between that designed this in experts variability history has in And we with get of we reduces failures the under of from patients treatment trials IBD really clinical past there find or some an the trials when of both had the this response, drugs and It we that So be variability contributed a clinical placebo variability in that that known in to even to the

placebo any was So composite when endpoint minimize drug, this to response. we designed designed this

a treatment groups when also, in expect this have dose group. terms we -- to XX response what of milligrams response dose will think have X in expect for But do placebo influence the very trial. we we So and low XX in the IMU-XXX groups, in this the active I XX, in

of composite were the used response these that where placebo XX% are be very the should and we or active That's on the endpoint this arms. a I XX% treatment a the be expectation outcome very below is XX% we outcome there also endpoints that stringent active think been this of for of for treatment and the similar, this variability identical arms our that's think in kind somewhere endpoints, order similar found good I trial that of And you very very see recent desired composite to also to XX%, active XX%, use So in expectation. composite know that trials even below placebo. range much the would where reduce of the drugs

of question, first execution the the and And your that's Yas. So second question, clinical histology. endoscopy

blinded many So the the at also XX endoscopy, primary endoscopies a as I after have trials, we and think it's week of XX we -- central at with now but for that other week the endoscopy course, an the endoscopy, a screening the state-of-the-art remission reader. was endoscopies, induction after maintenance that endpoint at end period of the achieved, all those have of done double-blind's by are

reader. week done is endoscopy. not this And least but locally was concurrent, been XX done there adjudication the by they And was done. means not adjudication the also -- have an at that twice. they read is if of are this the then So That central blinded

what think done, trials. is done I this state-of-the-art So I to what's really in is we've IBD believe, currently

also execution that's central your blinded histology by because do is allow week Hopefully, In terms have completely be by is, independent I -- done in has questions. is app of a Yas, that week a of will XX done addressed this that's the course, used trial. us to fashion, which easier a it's assessment the course, of it much score done to a often that the EDSS, of histology, at of at XX and, at and we also screening histology

Yasmeen Rahimi

at we certain cohorts? we provide be, perfect. No data for And for help are top one -- rates that follow-up a as Ib maybe be translation was question you of And is, just will and line the more also you sort into Andreas. would looking will clinical the SAD XXX, the should individual of the second then reporting portion awaiting MAD be remission? biomarkers us psoriasis that the from

Andreas Muehler

that's No, Yas. fine, Yes.

-- the and remission, of line clinical trial, includes think we the improvement, I -- the -- data the course not So for only primary individual but data rates remission. top for UC endoscopic CALDOSE-X will, include also endoscopic clinical it we the trial, will will of improvement

So I as think composite individual there will data be just data. these well, the not

and I understanding think UC other trials. it think drugs because to Phase comparability also I better provides a of II

as important us to think that for top data. be So part I line of was well the

healthy will in includes say to to or In I a Do have chance that good activity part have XXX, psoriasis any Part that that's B on an the question. terms of volunteers, later difficult. we efficacy and the A in have very that's hint very on. biomarkers

because lot, for thought some We to they're healthy these are other quite about very it's forth. difficult healthy example, selected volunteers and so not you to so carefully or very have to really and and medical at, have volunteers a because in this elevated wouldn't do on look no be biomarkers have that cytokines history

readouts. I unblinded, I that unfortunately, year present we terms of think end safety, findings the the have the So in on don't laboratory say, too don't we'll and much to with data you of I to credence think forth, give so that before pharmacokinetics, will efficacy the activity

I possible think healthy don't So this that's volunteer with population.

Jessica Breu

at question Singh next Our Gobind JMP. comes from

Gobind Singh

X me. So for

kind progressive seeing RMS, BTK is develop of MS also if recent now? hype if space we to any and one then the readout in First, of own MS. for use and what CALLIPER but coming there? neurofilament? And that have as you of -- relation be course, the BTK about any And to on there's the large And from trial? in me. is could way is IMU-XXX their follow-up And why from for bar pharma from kind Wondering if interim are comments this any in there a what there to

Andreas Muehler

Andreas Chief for is Medical the This Officer. Gobind, again, question. thanks

secondary the So I've on immune space. MS, I themselves but also think looking, of the present of the the honest, their focusing this we're upregulation you develop cells for course, progressive think progressive moment, to or And little developing the you worsening MS inhibitors think in how carefully it. in want our of reaction have the space, by in -- And quite you immune to that companies in primarily are in a very to mechanisms because terms if at this I of have presentations if much at bit to, to have mind, to component which and be surprised my the still are BTK brain, the of to and general seen in the disability unrelated the the they BTK address unrelated they BTK, to immune-related -- I in you mind, especially system. also to

which contributing mechanism. -- on primarily we efficacy I driven on inhibitors is not So cells, IMU-XXX on different example. example, course, than -- think effect actually much a address to I DHODH have especially focused antiviral the that's in by status, broader immune that an neuronal cells, having so mitochondrial is that and for other is also microglia, of actually can MS believe nonimmune-related of believe stress think that effects. involves, mechanism known BTK of the of the for This in action for things phase inhibitors we is metabolic which involves It

see MS MS the clear respect, difference way inhibitors. the a progressive than progressive that in in secondary BTK in act that primary IMU-XXX I can or in So

this of patients general drug. trial take in XXX we in have patients in tolerability drug, -- phase II we II we the open-label II shown also also feel the Phase the which that sign thing, terms than On continued for that our of this profile profile I study. basically still very still good of safety as relapsing-remitting open-label very we We very I see treatment, now this Phase portion. And on see on drop-off have treatment more a in little the and this in on that strongly Phase in other

can achieve population. a inhibitors, in BTK So I very progressive even differentiation good feel we that very think strongly MS versus this we

Gobind Singh

one results on to One Have guys follow-up XX% I term, of part on improvements perhaps neurofilament? combo the of resuming there what the around was reduction that then point trial, the the And setting With and year? follow-up and updated data in ex that. see you we then see -- presented the almost this potentially any an believe doing you there open-label anything guys the can Merck that a clinical for presented with label on excitement data in seen with have longer everything vivo at open Why neurofilament? you might the you we on placebo. is we in there development there would COVID-XX. compared on any the improved about about the And BTKs, this in otherwise? it's reduction SARS-CoV-X, or last update maybe going comment

Andreas Muehler

have Yes. neurofilament. Gobind, in really of a I to I have what part for understanding ignorance you, doing just on BTK is don't my basically good public hear in inhibitors. neurofilament question present that a

know between I hand COVID So synergistic very in setting, next And do the maybe would myself in my the time. and better over with it, to bit DHODH drugs a to for the best question other little effect I about I'll interested you're update Daniel.

Daniel Vitt

the announced, synergy is this or it I beyond based broad licensing Göttingen a we potential we was agreement typically -- of recently have and and observed. did we think seen We University signed you think exactly goes collaboration with just that COVID-XX. on

level used antiviral should broader I this very treatments. antiviral targeting think new potent or So antiviral, be a having on principle on a

and III clearly plans our -- and said XXX the go change clearly we've to we in past planning not didn't the yet. in ahead that COVID-XX, with and we already However, Phase are

things are really important the company I here. think we focusing the on

details there antivirals, not clearly, unlikely or in in But an and in it's properties, be the should antiviral collaboration in but will that forward way in give combination molecule. think on in world We But in And I there in this be to the that a that is I'm started independent forward. an a and trials are potent done the more for still clinical interested position we discussion status soon. here. interest way

Jessica Breu

Our question Smith SVB Thomas from at next comes Leerink.

Michael Kratky

This Tom. on end. on Two for is our Mike

you're what impact just is some specifically, see color on can recent of provide having? competitive updates thinking is IBD? kind a the for you And And the inhibitor of follow-up. you first overall in the I The landscape labeling then have how JAK

Daniel Vitt

a Well, question a it's mixture and of Andreas myself. for

that that that it's course, space. time recently. an and FDA and Of the -- interesting And specifically, tolerability of in given had JAK that's around secret not safety a questions some inhibitors

course, having of company that's, fit our whole nicely regulator the immune from point space. need and of new presentation reactivations. specifically something a a to and selective of mode being unmet targeting protecting immune other there's underlines it And on developments for one for properties therapy So provides set just ulcerative hyperactivated of medical XXX a the view, mentioned we in. impacting high a something I in is, on couple hand, in patients of repeat, cells, hand that action that colitis, antiviral viral time, patients that with And us, which from the

point these add competitive of from your medical color of needed I'm not some point in to patients the if sure, a from think features are space. you from view urgently -- are X which just landscape Andreas, I want that more on view.

Andreas Muehler

advisers cause biologics. the this the new seen that had a category more really hope experts, of There differently And for -- and JAK immune market immune had more these which, there modulators traditional drugs there's selective think because they was now talked we materialize. in general, that would what's program is IMU-XXX, modulators was have didn't more of was called I've when in an I inhibitors JAK or medical they I that think, -- the there of Phase between when challenges, -- inhibitors would our behave and to to lot novel less And Yes. focus course, what the and are started on the the II advantage to coming. this -- establishing we

class reputational And course, to the has medical think, also problem I but then community. of drugs different the -- I the have the whole really so think drugs different of the degrees, same, certain for

here We And also especially see the there discussions about JAK that and placebo. reactivations, have in that virus lot clinical infections I helped -- has about us properties a have treatment really we that that an seen of infestations seen think the our antiviral inhibitors, of we increases and reactivations. increase trials of infections special was our during versus disaster clearly never

with seen inhibitors advantage that We strongly coming to to, very respect, the very these good mind time colitis. we ulcerative these the And and in a reactivations. have that have successful not that feel well them will had JAK out viral into for to chance play we IMU-XXX market create a not very drug in

Michael Kratky

has how Phase do program, And assessment? recently with to MS the III anything And in the changed plan mitigating on respect potential quickly, helpful. you COVID in the very of then That's it. study? just Got impact trial

Andreas Muehler

because I'm we So had. I plans changed, just what just has mean we I'm quickly possible that are executing as thinking anything no. sure not you the could as --

And that III It's also in terms so large very form. -- of the are different programs I you it's with assessments these Phase do. a complex think have different very to vendors

I So the changed trials, has in good trials. III does do execution the but an these nothing think of preparing in work extremely -- III team Phase our Phase terms of

Daniel Vitt

a issue we Maybe in see just not pandemic the we XXX, have seen COVID on of I estimates. basically it, recruitment. clearly properties That's we big priced that about talked with ongoing antiviral on COVID, given our think in

Andreas Muehler

that might IMU-XXX really, there COVID when problems been activity usually a COVID COVID also are we antiviral had as put CALDOSE at think, close lot is we at period. of CALDOSE impact that on the now actually with disease. the we patients, have that, does very trial known the a they experience this COVID-XX, the infected. yes, I that broad patients for period, support the on COVID-XX patients sites actually had colitis of on know in course, get was in once the because a the patients trial, would had in IMU-XXX the activity risk, highlighting have few data makes not property put that in in all this think case that be very during monitoring risk also accessibility But we actually the COVID we trial. out this we part, We harder and have actually to at other trial that seen them we later our the cover ulcerative many of And severe the whole in which I well patients. course for time some these modulators from investigators informed have minimal immune we during that more focus found didn't we activity of very helpful contact like with we that And for

So think, I infection good, impact study what think enrollment, the I access see COVID-XX. trial. very at terms the that we they should that's of in investigators CALDOSE I and course, assurance continue providing in especially We, matters, think this future of to the patients all preventive to seen trial here this this take But for had even site. the numbers have we when a drug to a in don't significant in allowed they're more with robust maybe not winter of in terms least

Jessica Breu

because So tool. via Q&A our read Zegbeh ROTH at them and I will actually in next from came Jallah X questions they the Capital, come

pursued indications like cetera, even being studies Immunic, investigator-sponsored blockbuster indications. are your of see MCRPC MS, psoriasis, First by question, all you and including most et

which for competing However, there are are indications there drugs. also multiple

in you UC You've shown thinking How of your competitiveness MS. success psoriasis? in about programs are and

Daniel Vitt

success with the a are first Phase good of other MS agree our And company. in through continue They big strategic that's is is to the I in very I with Well, be medical indications. addressing high We important space, all, question have. for to the unmet not position a problem own. may a the III this And company programs think need.

for So Walsh you in open team with it's recently here are us Patrick also see big with the we they potential partnering. medical balance by -- the joining also where the pharmas strengthened are for And unmet and Chief context, need. strengthening likely as exposure October of markets, we discussions we something just here are and can future. that Business Officer But our course, that would big to driven these in

Jessica Breu

is programs our UC like with initiation pivotal take independently open The Phase And of have and MS the your likely program? studies? you into to in also are psoriasis you III second ahead of partnering question interest you your to are about partnerships. Or

Daniel Vitt

like would that? Patrick, comment you to on

Patrick Walsh

have the morning, made way This Yes, Walsh. any that of this the won't of summarize happy that excited the everyone. consider, good the and we to, we will data Patrick many decisions respect actively I'll arrangements to are certainly here. with for all we of about exploring is in evolution portfolio, types options not our across but and or programs it

that. forward to looking So

Jessica Breu

[Operator Thank you, Patrick. Instructions].

Kaplan Matt from comes Thalmann. at question next Our Ladenburg

Matthew Kaplan

a Just of couple one -- questions.

PD data can First, you describe a looking for follow-up the on of as not question Yasmeen's this later to we I in year? out a the that admin XXX. we're that be terms looking the that for and but reads SAD data psoriasis read-through should guess for MAD

Andreas Muehler

B we're... meaning Part are Matt, that and you in A So what's -- the

Matthew Kaplan

No.

point view, data. Just the pharmacodynamic I in looking not SAD, what of really you're are some from MAD of a guess, things PK, beyond for, the

Andreas Muehler

course, of did B, pharmacokinetic. So we were we this these because over A course, of had pharmacokinetic volunteers, in pharmacokinetic, patients, multiple-dose Part in have -- extensively XX and days data, will single-dose sorry. healthy these we and We

example, allow different We or for how they daily, dosing us once these I to needs, they explored see address patients. configurations twice think, daily also would how for options versus certain certain

And evaluation for of example, this So did on food both are A in pharmacokinetics. effect, the and B, also, part we done.

relevant data I you told have what we And to this the to really the stress indication think and different that's what that release to, I you in vitro to just of amount done get human our come. I of all vitro we data because with and lymphocytes had based done in So concentrations I think on IMU-XXX. have exceeds what expect pharmacodynamic that should can

done exceed We you volunteers So have in this felt value really in little healthy vitro. of that the experiments there's was with human lymphocytes. very can done vitro would that do that the in we that

Matthew Kaplan

little in targets sense on barrier wanted what intestinal IMU-XXX, then which us question, your give focus Can other a Okay. That's terms second helpful. And to function. very the program bit just of you a your potentially you guess, year? indications pursuing what quarter and -- about after next this the role SAD could this And of I you're third after data, excited play? the -- what MAD announced molecule in

Andreas Muehler

Yes.

think I very a question. that good Matt, is

towards guts as So we -- quickly company that's dysfunctions think so we is do, barrier in for discussions, the because basic can where I the symptoms lot And soon of to I the as the of -- diseases. the promise, to for show for relatively endpoints proof we its different ongoing, find And similar accepted responsible ability pathophysiology the mechanism bad the also and the the public fully have with but at this able dosing, execute thing well with focus where we you much that you and But will a diseases, the think addresses a where haven't indication good the interesting I many -- with to XX-day news our psoriasis FDA. make we need and are has you plans yet. to as know concept can -- have and that this moment, I these of to this -- that been news that. medical as quickly present action believe that as is with we have by relatively discussion

Jessica Breu

H.C. Boobalan Pachaiyappan at Wainwright. from comes question Next

Boobalan Pachaiyappan

Okay. Awesome.

So end. from just few a our

especially So your to thoughts questions. on NFL, hear just these two curious

a and patients? RRMS patient's trials trial levels So upcoming And with healthy patients secondly, you for your recruitment firstly, how think in ENSURE streamline biomarker maybe may NFL in utilizing compared do do advanced future as pivotal MS NFL adults?

Andreas Muehler

Medical Chief the again, Andreas Officer. is this Boobalan,

have but Immunic, damage neurofilament goes only So community, is I really -- independent think to of necessary doing independent this I beyond I to of MS. the this -- correlates -- -- the and think that neurons diseases, on that's neurons the beyond MS and years less also, in into activity the amount a damage that last and correlation, in involved. diseases. but in seen trials effect treatment just good And not translates we've relapse neurons lesions several the this also our found we to yes, because always way dying the neurodegenerate having research biomarker in the neurofilament. in not seen other the the And community and clinical in less trial MS, of having in the disease preventing process very

ECTRIMS correlated who II and we well the with had -- that stress predictability. mean more of patients Phase the the also relapse. more a think X example, a individual a no -- had our month in that there's relapse, didn't in months the patients decrease for have question So that last poster, resistance think, to you're with have than trial asking very patients. I ago -- I NFL overlap there's good It doesn't who a But because shown

NFL -- having also baseline, tend patients think on we not -- be population, terms control relation on -- have at little have poster populations this groups I that in of published more level. bit therapy it's startup terms to therapy. the a that neurofilament But is and for a they to But relatively prediction -- or individual and But trial, at true. activity good you a in those who, of a that help may more that the example, success activity. seen more this ECTRIMS also in So have have for of is high that's they're in patient therapy a marker therapy also we -- is

But We Phase or well or treatment also the the I to that the well that seen believe, expected you that -- diminish of inclusion/exclusion more a so population we part it we we -- level for we neurofilament is -- I active baseline this from what need think, what an our believe. the III would of a neurofilament will III population part have to criteria use for think a independent basically of and more this because -- have. stratification the poster or have was a also Phase in enrich II Phase don't is trial, unnecessarily more data that as and not -- IMU-XXX as is relapses effect of

your the because the marker last back last that -- thinks come believe effect, our could -- progressive And in to that's interim no terms of is in overall to terms you it's our part over have So and activity X of of those of MS. that end for brain trial. progressive the form progressive serum in but that month and in now has correlates patients of was again CALLIPER drugs at And this who a than the that ECTRIMS it using this analysis we MS or with and trial. over good what and predictive patients started they over predictor and also I in as we're neurons. is MS, neurofilament so more to especially progression is also aggressive are something There for neurofilament a question real no marker have exception. this progressive good know MS, a been very years, secondary MS neurofilament are with be X relapsing more last think data damage of of have a atrophy. less also have a severe higher absolutely And we results why this There again, data, the who more treatment expect relapsing shown disability and data mirror we a very from to

Boobalan Pachaiyappan

Andreas, really that's helpful. really,

So CALDOSE-X study enrollment. has completed

the you expectations impact And And the what see disease clinical the So what Crohn's to trial? be do baseline you think CALDOSE-X carry trial? are your this placebo-adjusted the to upcoming results would rate for like program remission would minimum forward?

Andreas Muehler

a need also think put some that think you you statistical have to go significance know on good very Usually, hard decisions to -- forward there's III. to hard that's it safety are decide threshold I I related entirety in a III not have Phase Phase to whether risk to question which whether in you and to parameter So a see. think or I -- you or you terms I on of benefit or these consider justify of a data think efficacy to because I where certain outcome gain activity that the the versus the the have

you to that of look think the data. need personally I entirety at So

just it you the key or I significant there of as remind outcome There I example, II Pfizer. active trial took Phase Pfizer -- really, an think statistically as For And want far remember, tofacitinib UC. in clearly, outcomes. forward. in secondary primary no I in to And by was drug was the it's

So should is that of I the benefit-risk safety. assessment look also entirety the make the supported by level and really is activity at what and to expectation of dosing an think the be the data and

was have study think forward and in I in II And we -- we that of we have seen, our Phase in have safety, for we of so could any that terms doses MS taken far, the had what true II that effective but that Phase have Phase was III. then an Phase on. from dose the That's lowest we the put the what's should to decide dose. certain XX-milligram we of It that II statistical to not you outcome how assessment be going a chose

a huge my the criterion it's spend, main I this but more on to efficacy consideration a that mind. think, a -- advised have of of very to hard it's for to benefit think outcome, not in wrong endpoints, I but course, course, risk how the So is, have have I think effect

Boobalan Pachaiyappan

Awesome. Okay. last from One me. one

in are initiate creation And the some program, items multiple the do GBS are to for players gating of the syndrome? space? where clinical remaining what given you see Guillain-Barre opportunities development So value there

Daniel Vitt

CRPC full the will the the the towards maybe next as psoriasis, the going well. think, pocket us example, from for second of us because little a quarter in is help CRPC data question over in patient and hints we bit identified we also band, prioritize bit efficacy have on GBS little a decided for first pipeline attractive part year that help this from safety we from to in indication get overall to supporting we this more an for given power see the will And as I the So will coming the and picture forward, very MAD and GBS. and year end a psoriasis

Jessica Breu

comes at Wedbush. question Argyrides Andreas next Our from

Andreas Argyrides

you as segue on how there's program, the the plan additional many on of prostate you I from doses color a know nice do one. at Can and quick biomarkers start such the trial? XXX. Just provide assessed study the cancer a measuring? be What will

Andreas Muehler

little hard the bit I'd I question the the hearing repeat for think so time I if we lower rest, than a question. had Andreas, say just Yes. a somebody volume, think, there's

bit you CRPC little color IMU-XXX. more in do a the study will want for done So how be

toxicity. That So and -- something in because that This I of dose escalation potentially we means the a this doses dose know we for a general, in the have we is IMU-XXX try first cohorts this find have dose-limiting trial not several part. that a all, study escalate that have we will to therapeutic trial way is I Phase beyond in done immunology necessary Phase general the diseases. the -- for dose-limited toxicity where

to So in try dose-limiting indication the be to toxicity. up oncology to where will have you that for course, respect, of dose different, this the

how many. be know several So don't We will cohorts. done this with

or So find little a it course, find toxicity that bit, dose-limiting whether not it. depends quickly you you of how

parts. The look expand of a biochemical of to cohorts in dose have we or have imaging, doses maybe as identified in maximum course, that we have cells. We're at X as you part also of looking second activities yes, circulating Phase looking we because escalation then believe allow it's that. we tumor output. are part stop that we're take And doses hint need dose a II part a X where where to PSA, where seen that's don't some at will that to will we -- at identified an expansion dose go We a the activity we or potential beyond biochemical basically thorough markets, assessment these more study

cancer, cancer the cancer So prostate that prostate about X, resistant about group know from you have especially I think now we everything working prostate castration implemented. recommendation

basically working find also think cancer prostate read I you you So looking when that the group document, at. we're biomarker the

Bono We is group the this offers prostate cancer and of of are set the the following de guidelines. working document had Johann recommendations really one as

then. less or these more to follow guidelines you think I have

Jessica Breu

remarks. back question-and-answer closing concludes for Daniel turn session. I to would to This call the any our over like

Daniel Vitt

in Yes. excitement multiple you and call. year, can like programs made Immunic the seeing the to come catalysts With lively answer about and data today's IMU-XXX would Thank today Very forward and next are discussion to the colitis from in you, the that. II second this, any we both couple IMU-XXX, and ulcerative the Jessica, to our has next Phase quarter progress data and patient operational enjoyed hope next much in in happy We thank you to our I I much initial additional very of joining, this one-on-ones. here. all close the for the look of year. for year Thank very particular, questions the much great feel clinical you very in months. clinical data questions from of

Jessica Breu

has thank side, joining you Earnings Immunic's now concluded. Quarter today. my conference for XXXX The from Also Third Call

now may You disconnect.

Jessica Breu	Head of IR & Communications
Daniel Vitt	CEO, President & Director
Glenn Whaley	VP of Finance and Principal Financial & Accounting Officer
Andreas Muehler	Chief Medical Officer
Patrick Walsh	Chief Business Officer
Inderpal Singh	General Counsel
Yasmeen Rahimi	Piper Sandler
Gobind Singh	JMP Securities
Michael Kratky	SVB Leerink
Matthew Kaplan	Ladenburg Thalmann
Boobalan Pachaiyappan	H.C. Wainwright
Andreas Argyrides	Wedbush Securities

Immunic (IMUX) 6 Nov 212021 Q3 Earnings call transcript