IMUX - Earnings call transcript Q4 2021

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Operator

Good morning and welcome to Immunic 's Fourth Quarter and Year-End 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.

Speaking on today's call are Dr. Daniel Vitt, our Chief Executive Officer and President, as well as Glenn Whaley, our Vice President, Finance and Principal Financial and Accounting Officer.

of Dr. we session Chief have Q&A Officer, Medical the today's also call, our For on call. Muehler Andreas the Please note, all and this participants will be is recorded. in being event listen-only mode questions. be After there an opportunity today's will to presentation, ask

you ways submit two a there to via Zoom questions. the If platform, joined are webcast

our would for like SEC Immunic's I these call and filings to these go or presentation, ahead. factors to affect Daniel remind to the You discussed looking can the with turn obligation Daniel, speak platform as writing to begin, statements refer Instructions] the presentation, of us contain no please President begin use here. questions undertakes your as any Please could hand [Operator risk a risks note result by of function tool Zoom and can forward may, to the results that statements to Immunic's release and this from it of and Please Q&A information either of to in words forward-looking now description would statements the your the you such platform, anticipate, number may forward-looking be over Zoom statements. of of CEO date like submit raise Before those of new a of revision actual expect, would the I Vitt, Immunic's more or or meaning, this that in involve question. future the or publicly queue if estimate, only please revise presentation events. you forward-looking directly, statements. detailed cause And we like to statements Immunic's that to these will, words uncertainties differ with may opinions reflect the identified to results. materially light that by similar Such such

Daniel Vitt

earlier announced of without December milestones expressing like XXst, Ukraine this the upcoming our earnings not them. well clinical of with people development the morning to our developments, XXXX call our as financial in results I call. to for on sympathy to activities everybody and pipeline. our Jessica. these we want you, start I highlighted do as would with XXXX recent this and Thank welcome expressing Immunic's Despite year-end year-end solidarity

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

key potentially our quarter, the important before this company. III Immunic. discourage. data cancer achievements was that first As in close readouts year XXXX Notably, during tremendous the have way Phase trans-formative you opportunity of significant patient another the enrolled relapsing Jessica of either we call, in fully fourth most program Marked several will for the to for for clearing ask pipeline year patients with programs, progress across by ENSURE noted, the Maghreb clinical questions. we the

We also with in of moderate-to-severe completed enrollment ulcerative patients in the [Indiscernible] Phase II CALDOSE-X colitis. trial

in data We expect induction phase available the top-line UC to of June be this trial of year. for

X data, reported positive the trial. volunteer our program, healthy of our safety, PD Phase For and IMU-XXX, portion second ongoing unblinded PK we've from

psoriasis. experimented planned as to moderate also We treat the severe trial with patients to

quarter Beyond metastatic available and CRPC this, trial we an dose X clinical safety open-label data the also to escalation of IMU-XXX expect in initiated Phase third in this be year. of

subsequent this first you [Indiscernible] function detail. year. half trial highlights quarter associated quarter diseases expect and X over the the now trial third part walk of of Finally, That year, segment of this to greater the in set, with see initiate fourth the third me the of IMU-XXX the first patients and in during let intestinal through of ongoing data we to the from hope barrier in clinical portion XXXX the Phase

that where enable the performed the trial as measures therapeutic is addition key Zealand response In to of initial modified on been be to faster. XXXX. in valuable calcium we a Phase far, key potential our psoriasis of not a CALLIPER we and last key moderate randomized development more of inhibitor. Phase randomize limitations have and realize Walsh to half is team Chief the Also potential of we rapid second October, pace in full This the with conduct to our psoriasis in Part have with Australia appointed New oral our achieved to to Officer. October, Rounding and first the proven work the related position a as programs. far, of we our patient we expect we so patients the or Immunic created be of To Given in initiated in the Based from with exclusively potentially one patients the Europe. our time our clinical patients Business Vito newly our ongoing a patient was use, role the areas. continued IL-XX moderate cohorts IMU-XXX, of the patients enrolled This COVID-XX in within severe. to C focus the so milestones II countries started Patrick to trial X interest to one in trial despite films best-in-class already expansion trial we severe ongoing projections, the available treating includes the have Patrick trial of representing and in tool announcement has treated early out

treatment expect from XXX available of We into in line of previous interim the recruitment randomized a trying phone as in, results this to Patient as had year. milligram, to total promising the of in and results induction Crohn's you published arms dose active XX be Phase XX June our And trial five patients. arms. trial see top milligram, patients entrants completed Archegos Three milligram, XX of of the XX Top placebo. -X four the disease phase currently As analysis of could tolerability and well that we option enrolled and will two obvious This established solo patients January. in we drug later Colitis in safety September insured two the to by alternative for Ulcerative in was consummate believe suffering from patient oral trial, our foodie [Indiscernible] profile, months ensure strong [Indiscernible] the XXXX, RMS. Phase along the of enrollment the In to biologics. November, in first preferred first a programs with already patient X constant trial become

a time approximately endpoint in We Immunic milligrams primary in in each we these X calcium have our X enrollment twin or both initiated given program. targeted have phase [Indiscernible] relapse our particular to [Indiscernible] milestones an placebo. trials initiating of CALLIPER trial. X,XXX first XX to weeks. of most first in sclerosis. programs will progressive significant this huge now up for XX patients as mark Dosing on Phase The comes multiple supportive trial Together be Enrollment for the as Phase with daily

safety As the we in established regulatory in noted for drug's trial address costs calcium the MS global of vidofludimus straightforward the well ENSURE patients. emphasis to-date, that RMS of provides before, tolerability counts have approval the we on Phase billion positioned in our the program exceeds [Indiscernible] the uniquely limitations Despite RMS. MS those based unmet and of to currently and $XX the believe is need towards potential market X profile approved uncertainty strong observed and a in design therapies,

within IMU-XXX provides on first open-label trial we multiple castration-resistant of indication. IMU-XXX, patient supporting Also, enrolled we consistent IMU. potential trial Phase of Johann on, ascending December attractive trial's in or showed IMU-XXX the those subject now the to portions world's Xb volunteers. scientific in all for preclinical a prostate of program are and I affect this in in phase unblinded clinical potentially the data based strength The clinical inhibitor. highlighting of Bono, and in an and of leading is important Moving action mechanism our establishing best-in-class principal investigator, tolerability the of deep expertise the and communities. experts preclinical IMU-XXX cancer, a safety, of of one this reported with the single CRPC. from as de the for data data vision Sebastian unique Dr. therapeutic data of IL-XX PK on His of our of The profile December, understanding positive collaborations very

maintains presented in preclinical protection patent cell February, in that United strengthened Vivo RORgamma the of and thymocyte previous extension acute in circumvents which any our These we other regulatory matter included in of earlier that month, agonist, potential knowledge, with patents plus covering U.S. cell ECCO. support relevant with available just such position reducing chemical Europe that Also of annuity Additionally, macrophages, of provide XXXX. proinflammatory potent the stage, IMU-XXX into and respectively. Congress IP in vidofludimus activity maturation Highlights These we so proinflammatory consistent the issues. Thymocyte preclinical receipt patents we in this composition first chronic in and inverse To recently, calcium for are by and data secretion, proliferation. anti-inflammatory of upstanding data, an with cytokine we've reported vidofludimus been the reducing calcium reduces response models. maturation at inhibitor SPC announced allowance far. clinical More look-through in vitro mouse t at moment on PTE and States inducing first notice further Australia. and the data data activity may immune confirming and T least IMU-XXX our XXth the Europe RORgamma for hasn't t have

trial three regarding Trial X and UC. of trial of the milligram pre of filed see the X synergistic data Congress, the to ensuring in neuroprotective In compared determined and effect important morning, central XX% the vidofludimus Mayo X At this believe that ongoing antibodies. trial with cohort XX cohort Phase [Indiscernible] our the data only the core milligram and VXXXX In set, dose Second, this insured to set [Indiscernible] receive Recall Phase of efficacy with criteria. strong a RMS. of RMS. the or patients while compared modified our ENSURE were X vidofludimus an daily cohort RMs. and is the had XX-week we the data calcium, cohort data, X and shows of baseline, with that the interim second of -- quarter of selection and DHODH XX the released a newly stimulus doses score happy for the endoscopic that to of We quarter the be conjunction milligram safety immune PMS X had employed XX previously assessment two. the in trial trials trends of trial that pooled In endoscopy endoscopy X cohort highly XX-K blinded evidence emphasis study efficacy and study in CALDOSE-X providing randomized dose had disease, dose Full anti-inflammatory patients to And a XX vidofludimus activity. the in final in [Indiscernible] independent than optimized anti-TNF further moderate-to-severe of a used active clinical these characteristics CALLIPER of XXXX. data Cohort provides in were were in available an our with additive data of effects placebo to comprised of support that and that XXXX, vidofludimus XX% once the of respectively. cohort also We from announced placebo milligram patients the observed X calcium provided of fraction RMS while to Vidofludimus -treated final for metabolically for emphasis methodology found baseline the cells active. portion the additional dose third readout. of that released the selection contributes though Calcium published from milligram milligram and believe of X also one The in we calcium with biologics. X we was in in XX of from in support safety The eligibility score was RMS. finally, XX patients dose are in reader XX% evaluate data and lower the also calcium those ongoing Patients data

of XX milligram dose vidofludimus percent. neurofilament was milligram with the median XX% was neurofilament of decrease substantial versus XX of that a between XX% calcium serum minus highest chain minus chain, difference with observed light the the decrease biomarker percentage instance, seen dose For light serum placebo of change with

a signal cohort While X%. the of X XX with X. to of The with improvement Milligram dose milligram X dose decreases cohort XX cohort segment a with showed respect smallest seen higher EDSS consistent surface group doses minus also of of with in

populations with to larger patient of However all be longer early these confirmed follow-up signals periods. in need

such doses, effect for neuro higher mechanism observation -protective in are XX in PMS. a suggest these trials main such the together Taken doses as maybe as preferred milligram that for improvement in which [Indiscernible], clinical

Cohort of ongoing started, the final COVID-XX treatment right completed treatment reduce blinded patients the data additional pandemic of Cohort X.X%. incidental group provided COVID-XX evidence that risk the in or Cohort While XX before was populations X the the entire infections. treatment cancer And was active X may [Indiscernible] COVID-XX infections X

We XX%. in are placebo less than group frequent with the

obtained EBV of anti shows full X.X - in the with recently preclinical congress vidofludimus at essay. That the superinfection October. calcium potent we new poster Additionally, micro-molar, concentrations underlining data actions to presented the activity. XX in A data was that

system. to We the nervous that directly noteworthy confirmed believe to this also detected vidofludimus that vidofludimus maybe the oral that able calcium within dosing. of degree in a central suggests We after can finding be act CSF animals calcium

would today's to now For the of part overview, the hand to financial over next I like presentation, Glenn.

Glenn Whaley

Daniel. you, Thank

operating the and year December XXXX. will review results We ended for the now financial XXst,

the Let to this cash ended with cash operations balance an We facility the $XX.X to cash first quarter sufficient and of me year million our with be anticipate million cash at-the-market XXXX. the start through so far We also our fund additional XXXX. overview. in in and through equivalents, $XX.X raised

that I'll to for development $XX.X $XX.X as costs XXXX. or loss the outstanding for XXst, X.X the loss Regarding $X.XX of share COVID-XX related that support compared as in on or to XXXX. weighted the -- per supply increases of expenses the expenses our ended the year $X.XX to would last ended for million growth. smaller share finished $XX.X across compensation of average million per XXst, to agreement XXXX $XX.X numerous like million continued period average Increases shares were or $XX.X XXXX by non-cash costs by weighted million $XX.X in in for as on million. remind hiring loss the our was of over AG first was Immunic the reflect milestones. ramp-up costs based to for Phase million increase AG. people based in its The costs turn same million administrative on vidofludimus offset common XSC shares for clinical XXXX a expenses to for decreased Immunic programs, to General research in XXXX XXXX. With December Daniel. and net as royalty the approximately XX% that, clinical $XX same the were well everybody AG company's March drug XXXX December common subsidiary an was I in signed in outlook X to The operating results, IMU-XXX. personnel more as the stock upcoming the compared approximately Immunic's year-end million December partially approximately related payment obligation the trial No impacted the of three in well was Immunic XX, clinical outstanding for remaining or period expense, net to in call with and increased were due increase XSC compared settled period to of million a decrease the full-year same related our costs made year Daniel settlement in for quarter shares obligations for clinical of $XX.X year. primarily a X.X% Net between categories. in our $XX.XX remain payment the was expenses calcium net on cash, AG stock. further and sales XX% back The

Daniel Vitt

you, Thank Glenn.

I'm up have these. the several significantly year, the a call, mentioned in As with and walk to of very through exciting coming you we happy milestones XXXX, beginning

be in readout top of X trial most of our in the important be colitis. will moderate-to-severe of to of One with We ulcerative patients our milestones phase XXXX the line year. expect induction June phase the CALDOSE-X in available this results currently

results The in important available look first at for IMU-XXX, portion of with year. half psoriasis expect be us provide and in X will patients we initial population. second this third to patient data of in efficacy with the IMU-XXX For the trial clinical profile our initial moderate-to-severe Phase the safety this

trial safety expect in addition, metastatic quarter of progressive Phase in In IMU-XXX from escalation CRPC year. the third our of we initial available to data lung be dose this

establish dose reminder, is And II Phase biomarkers the As IMU-XXX a and quarter. and trial patient designed a recommended a this safety pharmacokinetics tolerability. to tumor of activity just to in

function Phase In initiation permits the of those in associated rate please one of the trial Finally, quarter patients and in due to our formal call the anticipate single safety barrier XXXX. of third as first the underlining Jessica, of trial IMU-XXX from clinical of with this half the of Q&A diseases, portion the end for session. of volunteers. ascending data XXXX, in we intestinal In a healthy the third open multiple the expected presentation.

Operator

Thank you, Daniel.

question-and-answer We the and with begin session Daniel, will now Glenn, Andreas.

reminder, if submit the join As via to questions. ways are you the two platform, there Zoom webcast a

via You in speak question. At [Operator please portal, you the the time, directly, raise function your will can submit momentarily to or writing tool close if of Q&A the the this either rooster. hand to of your use questions like with Instructions] assemble us our Zoom to queue portal we would Zoom

question from Piper and yourself Sandler. ahead. unmute Jessi, at Jessi comes please go Vo Our first

Jessica Vo

guys you is aspects per top the, of Hi, Jessie endoscopy? drive team. few on clinical expect what placebo those. down see and to remission rates our Thanks Friday, a for baseline Astex response? do on taking you what to I on for of the Based expect had demographics paper This questions. Yas. on do And

Andreas Muehler

for very is Jessi, this question. Hi, Andreas. you Thank much the

based active the population we where their properties with showing we data What baseline in to on find showed the IMU-XXX of have you provide to an the happy of that in chance we worked patients. hard right the we very setting characteristics patient good ulcerative colitis have were data the we population. believe a think because I had

just blood very You and for frequency very also patients stool or a fecal large proportion example of high that patients but had calprotectin the in data, a can to see stool had of in demand degree, in

Glenn Whaley

almost in every the of -- stool occurrences.

So to show endoscopic we this of out patients think drug the in chance it, XX% high top of my the almost in driver remission, I -- is I On since a giving a is symptomatic for seen major mind, XX% that also a healing trial. bio to primary the activity the the baseline, activity than think I these the -- that very of endpoint more XX%, endoscopy and the of composite had X, happy score are think

Andreas Muehler

well. which is and also, disease think is the a us endoscopy it because placebo IBD a with trial very in limit think having limit IBD response known in baseline endoscopy, I response in extensive the including as I placebo sometimes that patients important to for any placebo have to response, allow

So have chance hope think that address the we've believe presented shine overall, baseline enables I all of to us of we we all quite just been study. I in -- in with to really these and our aspect. data given the drug And a this -- questions happy in that to your your

Jessica Vo

a one or the plan thank had do I you -- phase, there with will partner? be if it more there's running on Andreas. a yourself Phase on Yes, if you, And X, follow-up.

Andreas Muehler

would too are course, of think in tell. to X I middle preparing, phase look do, that's a the early how like. of We however,

of lot medical discussions a in advisers with tight very having are IBD. We our

of lot positioning very in to drug JAK readout, inhibitors last medication the large the a understand observed discussions to JAKs there's wanted also, been and a the well-known the for market years, the that that were the have important have with placebo and really of as also whether behind these we change course, more study IBD very year How [Indiscernible] And bit entries well, behind, and them the or a we little think And perception ongoing drug? happened the close of what oral us over IBD drugs. has target them relationship program I phase same that think, our basically had think I of have does the very in IBD was newest think well. have repositioning group I also drug, a IBD last treatment as of -- or resort. happy entrants less of other so for a the of as over of this medical safety in positioning had trials. or we biologics that profile more as very in with advisers discussion given X with patients a be basically a very less positioning also the medication we as favorable of a about of -- anticipation -like are the to a in positioning also a for very that terms and previous I planning in patients compared to also the We

alone, I as think to still early So doing partner, with this that the that's whom Whether is it's I tell. all need but because I data it. too for ongoing, open. think it, do a you well, think and How we with we're also

Jessica Vo

you so Thank Andreas. much, Okay.

Andreas Muehler

Thank Jessie. you,

Operator

Thank you, Jessie.

next question Andreas from Wedbush. ahead. go Andreas, yourself Argyrides at unmute and please comes Our

Andreas Argyrides

morning. All right, Can guys Good hear me? you

Operator

morning. Good Yes

Andreas Argyrides

All right. morning. ones us. quick from Thanks. Good Two

the visions trial at just some mix. XX cC and explanations on mix provide reductions color I and it. trial, mentioned then from it full And neurofilament you you. the the earlier, on just appreciate emphasis, of that compared the the if your don't would for thoughts some,-- So know additional robust you XX for if maybe change Part psoriasis in missed be lessons I could to results, delay concentrations Thank more in

Andreas Muehler

bit little you, No, IMU-XXX. Andreas. part will maybe right. thank then Daniel address and first talk I let first for about C question the All a maybe

the XX of a the -- We we understand understand, is to XXXX, for curve. that placebo cohort that X bit MS, MS had the Phase where in milligrams. a early the for XX results with analysis which data reported it's really X this I fantastic response using milligram in to published trial, think Phase dose So and relapsing interim explored IMU-XXX everybody milligram. XX which little think I in the emphasis we added relapsing-remitting X, had dose XX in And week trial X are cohort is the confirmed XX milligram for and better they to

cohort So we today, readout was morning, conclusions which think the think all, we is find that previous very of particular DHODH I now interesting, long-term in the published X confirming this in strength for I readouts. first What have that also is the drugs a knew interesting, dosing. data I from personally our the that MS that they on

that specifically, of the worsening, variables On responsible long-term brain and for are outcome the patients, disability atrophy.

the So the term in you things are much cohort related data MS very of And is interesting acquire EDSS that probably in milligram. How the of readout. find I over these XX interesting more in X disability that the for personally patients. thing time terms that long

have all You think -- EDSS, enough disability is long see study substantial This follow-up has a really conclusions. the substantial a and in, make effects too is example, I worsening. small doesn't for in effect a see you and to

However, it unparallel products. first It's but less effect as other us reduction, a XX anti-inflammatory strong that in at much whereas the very to haven't effect gives I milligrams, I or I strong to is more the think disability think, seen think XX-milligram dose. of related strong, effect time is is accumulation the we on -- think very hint very much IMU-XXX I that a DHODH potentially again, over lesion

I in -- of data In just think think these that compared very neuroprotective in as these efficacy, that's that IMU-XXX, anti-inflammatory as and drug will So to likely like the important in or strength are I very in there's in the potentially accumulation terms have effects. results and future having for a positioning drug confirmed And disability I respect, also of effects brain think exciting measured I atrophy. are protect that -- think the its well. effects some

Daniel over C regarding handing the I'm Part as to regard. So

Daniel Vitt

ahead Maybe just go said, you to what comment Andreas. and

from EDSS and record. we to come NFL unexpected, I a to -- see your But for data second so was seen surprise think was here us, and the have that. to for it the the to that of strengths million let's question. relating data forth the think I all $XX positive honestly. really XXX to speaks This And

an question. I think it's obvious

see this we'll think you we being usually in early a try be time, things not expectations. decided of broader cohort know react contributing us felt for to I some have transparent, early therefore, have we philosophy that are we line really delays, being our another just we to don't our just to with -- And full And XXX% or early. we of want add is if we quite entering of patient in But consider [Indiscernible] should if we recently country started. substantial dermatologists patients. set if

with So decided market. definitely them want and that's call share I to something we delay. the wouldn't it a

Andreas Argyrides

I appreciate it, guys. Thank you all.

Operator

Thank you, Andreas.

Yeah. JMP. Gobind, and yourself Gobind. go Our next Singh please question comes ahead. at unmute Gobind from

Gobind Singh

Great.

and pipeline congrats Phase the the I would from new you progressive My this MS. happening correctly, X be, year. -- results Well, Those guess guys are on if interim I that think I my the announcement for that. trial MS the and is progress. the about heard Sorry X question Phase trials there

be that the And speed. some clinical wondering you're can just add remind to your and terms anything would you the excited you be from enrollment results might bar kind What sites you're around hearing of if of guys continued be clinical whatever presenting? results So that is development? would us going color what in

Andreas Muehler

I not analysis seen I'm anything that interim X Hi, for the the X. talk would remark in have I the and even of Phase interim timing sure totally Gobind. releases about understand analysis. our not about the

of misunderstanding a Maybe the that sure. things. with not I'm So some was

study. readout interim planned will and enrolled. basically when we have patients, And data So interim data because Phase we have will for week half relapsing just when XXX progressive confirm, report patients we Phase to events readout. analysis the have its to relapses patients; MS, we as XX the on reached have XXX these III of of then III And meaning Phase we enough the XXX X trials, occurred MS study for the the that have have the the half interim neurofilament in have said will patients

that analysis Phase that And the precise more just III non-off the you way events have need for And expected at this we but interim and look give readout, trial. to of is interim really it's of and these more number terms a moment, timing I In events no too there's enrollment in a patients. the we the little these do bit in on more interim did bit frequency to 'XX. follow-up little confirm, the analysis of so this, to of at early can

Phase Your enrollment I happy studies, about we MS there other recruiting that recruiting, anticipated. very progressing all in of and are all now studies X questions our of to -- which MS seen in X, think X are MS recruiting, and good then as are ENSURE are they relapsing very enrollment, in and study a are progressive I three have and which the our well actually are think

So point, can I this you. think I only at that's give the update

Gobind Singh

that. Thank you for

side bad think was I milestone my that there. the on

today, It's be role that's you and more your on with some for studies as and or play this dots me follow-up about that that about and BTKs going other the with well or of would XXX. I any you the that you the -- out, to -- on here becoming Can in been the how us popular other drugs recently, recent you is data out EBV there CDXXs MS actually of EBV in connect the role think any looks great, are like reminded have that of of the you causative at and studies in and relation MS. if in EBV, have one relate terms some data any presented more or the all if Just are development, could audience the coming to commercially they help just think

Andreas Muehler

is. I yeah, seeing a plays And a have And suspicion now more lot think think information more MS. the excited and EBV EBV of of EBV was concrete there of think that always came the what I role. a coming it as role been kind that's question. good -- a very And I Gobind, more very about and out a data role team about we

those or those or infection, an have was EBV met made increase has increase develop that. that patients neurotropic, see neurofilament and there of those link so population of before so were infection the So status not looked neurofilament study the XX% MS first many of the course, thousands about and military of develop time before or help backlash, in EBV. the could over And the an And what study who -- the time. developed you that EBV the I an at think known same interesting see an not in which was XX in the think is the MS. is an infection time a was -- study how you And basically make EBV think U.S. had basically a clear But to increase, did EBV followed infection. at this and of most public I basically I neurofilament thing the for neurotropic. who with did EBV And an of was I show not at those, EBV several that between that Meaning, years becomes infection think,

MS. between So EBV a having link I developing infection no there's and think that of clear EBV the neurotropicin infection

So that that's the a came But very during out have also It that that interesting data necessarily the the there disease. say was EBV onset. plays to role onset. at probably a CSF. It's doesn't then showed made they in and looked had in February I think of splash, group February the Stanford by as equally important of that also less but published a 'XX

cerebral known band there's go and of in of CSF some relapse lot a where of only more Immunoglobulins it's always contained patients It fluid your thorough comes of analysis spinal what dated flown events relapse. that during is. from immunoglobulin, but clinical So was patients the it

destruction. So reactive found that they've relapse all, neuronal that's antigen an clinical to means cross on to they antibodies, the that EBNA-X actually that's that of antibodies. of The - CSF at microglia producing to cross-reactive linked the plasma in And first older clearly glass events. but the your in cross-reactive actually brain there's they're time have

eliminate also free, these so recovery, B-cells. these us shown The plasma interesting CDXX example, were interesting possibility probably could EBV that as it by because thing EBV, a cross-reactive broad influence that increased, produced believe you after to -free also in different these plasma strategies asked of these recovery us be interventions are And activity forth. B-cell of publication some negative, from an of about thing de-escalation is find the very plasma, an antibodies that terms the CDXX established above. these which and exciting you At example, you thinking EBV CDXX so because always should for BTK that a you and have have for is could they important think therapies kind this least help plus for viruses open -- therapeutic think in of EBV And that, therapy be anti be infection, we EBV IMU-XXX negative, these eliminating to example, that's it's because of other would CDXX antiviral to in are B-cells. is activity concluded as they really using, with CDXX when highly about or for to effective

hypothetical is think but exciting we drug I I like that very publication, this hints at get think all point, this for from this I a are think IMU-XXX. the

needs at community that the Immunic this. very little few were to scientific vidofludimus But for probably think, came more exciting least I time of a of Just data to for I calcium. EBV spread, out confirmations a bit and about and

Operator

Thank you.

Matt Our yourself next speaker as lender and Matt Kaplan, ahead. please of unmute [Indiscernible] go

Matt Kaplan

hear you Can morning. Good me? Hi.

Operator

Good Yes. morning.

Daniel Vitt

morning. Good

Matt Kaplan

the Congrats progress. on

you're the barrier. last Since XXA seeing micromolar the that you're saw correlate on the main guess, question with X.X to in and does with in that central across nervous system. follow-up in I you the remain quick a concentration the to our vitro terms concentration in studied getting, in Vivo Just topic, how and XX of if

Andreas Muehler

Hi, Matt.

-- for So I think question. you this thank

that seen that enter have I do smaller essential some central not correct MS. well. lot that molecules statement as that these of for a medication only think that we the the should we entirely slack of really companies always acting And probably have a BTK as suspected inhibitors, is component they are claiming drugs the and CSF

that are that data get. human answer on confirming serum concentrations and having We're we'll actually on least bit a the To that these concentrations to expanding what par, situation a not preliminary BTK working think, believe to CSF relationship the component, enough are in -- are of inhibitors. with of to the when closer the that concentrations between sets your data. them may not make this question, you fully we is concentrations, really terms act I in as and And more inhibitors little terms efficacy and in look unique meaningful molecule compartment contribution? see the BTK publishment So of the central at were these small have, be I what data think we from being the that it a And central are Also that the you at we apart.

was these think continue So the for show we will vidofludimus I rationale well. data the that I think as showing that to compartment has main rat IMU-XXX data. me to will to or generate But that access central

Matt Kaplan

what efficacy there in second drug what we us be give Okay. cohort looking you're a in the be for of the that half expecting? in this for should should in you're potentially of terms of what of terms Can a looking modeling we and strike And -- in you you're profile then and Very a question good. sense data that year. XXX the for

Andreas Muehler

take as little change quickly months. to deposits or X see look drugs full a in terms History endpoint of Usually after months three history. and after one in Phase the effects different you you three program compared maximum are month, simple Phase like time. I terms done at psoriasis XX-week trials four some or for a with you where So how endpoints, little we'll that bit. that weeks things for and I hot over it have as bit think a had a III [Indiscernible] of we're a learning the

you actual I think positive what have estimate change positives can in the for so. positive news the the for change XX as -- think the I good in real very average But extra So you The should in the or change score? be. what's Nothing. positives

PASI. XX% the to of in found XX% XX% range and in of -- that trial I look at so dose somewhere the somewhere they inhibitor to think groups moderate and the have see IL-XX And around years in severe RORgamma PASI antibodies, patients, I change group dose they was one think was ago I between think higher this, I psoriasis two their IL-XX doses, you the maybe that think, XX% on change X. some they're you Pharmaceuticals, at change when Vitae With Week antibodies, that

in drug I antibodies. want LXXXX we show So the compound between we're our also that that's the and somewhere expectations have think to for range that the we Vitae same that the

us, recognized trial this the I and in psoriasis outcome knows also it's So -- usually so at everybody efficacy of think trial. itch assessment in course this probably. very think biomarkers an biopsy, where it's also and for of but that's or deposits do we most skin this, us I more see We We -- to for have think like clinical do measure much I they scores did component, is most look for early visible why so which other well immunohistochemistry. we example important the

Matt Kaplan

Okay.

Daniel Vitt

think Vitro activity. broad the therefore, other the what's that's group comments in covered deconcentrationship the tough [Indiscernible] surprised the everything. active really to that regarding your --versus were the data. to at on we coverage, there's also believe that have EBV [Indiscernible] I [Indiscernible] preventing and covered also think the COVID for between Matt, activity. -- this remarkable, think We surprising difference again by But I seen we basically same referring EBV, levels in and benefit I accident, in placebo underlining one that [Indiscernible] range first for And COVID-XX antiviral just question, and and

Matt Kaplan

in the development your your clinical programs recent just, of announcements And exposure in last just terms what's question and what's Ukraine. invasion, of Great, terms Ukraine, in --

Daniel Vitt

concern cleaning What the us data for yes. but of event some our surprise specific for we completely which we study the looked doing XX, Of unaffected. the over last has that endpoint. I we to the the course is had to the data been weeks all have that world, of think course, of is week it can at that an very ulcerative CALDOSE up been already, we was colitis, primary in that our done is that And -- reason study, that. had say is mean, I

visits. mountage As during all quickly as possible, done we the have

done. So these data that and all We basically course have nothing there's is unblinded. of

in there that induction, patients extended So are are

Andreas Muehler

And unblind the the data to study we the source, XX. yet. so But up all primary already they're of that go into Week cleaned will endpoint verified. can't go to

exposure. done had been no especially other in course, studies Ukraine the Ukraine in are we So have part as studies CALDOSE MS actually of of well.

is We of we a bit we But have situation, of look to long-term dynamic this to have Ukraine. What situation. clinical unfortunate monitor and in has at think to course, have for -- also kind repercussions compliment this little orders very started is -- I the this doing trials

ahead of implemented have time. some We countermeasures

the conflict just given We the develops long be. see expect that that this thing the this will it's hard do -- this day have But monitor and is we early day. how to by I how something I how anticipate at think situation severe that's this to mean, at time can we time and this best

Matt Kaplan

you. Okay. Thank

Operator

Thanks, Matt.

ahead. go Roth Capital. unmute Jallah from yourself Zegbeh, is please Next Zegbeh and

Zegbeh Jallah

Thanks cadence Good and a questions ahead. my clearly taking nice readouts for guys. data of morning,

I CALDOSE of focus be going significant know is probably investors. to to So

had just I questions. of a So couple

putrid think study I I to on first the naive biologically and one is, know the biologically patients. gold

baseline similarly, So different differences then very these efficacy efficacy profiles should with see Mayo should scores expect between we to into the in we different patients to patients? And in profiles expect coming see study? also

Andreas Muehler

think -- can occasionally action. shown on the biologically treatments so patients wisdom of to this say biologically response and can lot of take the from because IBD the drug-to-drug course this so I way, experienced I based had of excess less biologic-naive this -- the only general that's So mechanism Traditionally, I history naive of a think patients, that patients. in the that's, includes than differ

likely to is me to to it drug -- show is positioning with drug consistent the of placebo the chance mind. versus I news this good because good gives activity my really the think very a

Zegbeh Jallah

phase? see versus are terms have And between follow-up expect would two to response [Indiscernible] thoughts another of to the of differences induction then just your I in the the the drugs ozanimod you. here. [Indiscernible] in What different Thank regarding what in time

Andreas Muehler

has SXP several of an see a big on different mechanism this And of that things. modulators can course, As you action.

limits [Indiscernible] you lymphatic to, which echo you modulators against to of trials. or nodes leads less were action and And see other and see And patients tissue, does lymphocytes lymphopenia all use of for a lymph week example, and basically infection clearly you last in because than or [Indiscernible] now, of responds in can efficacy of basically is the ability also example, for more the infections, the trapped mechanism lowering course to virus leads, bloods. very SXP there For humor of lowered presentations, for part respond. the in immune of effect reactivations that's the example, system There's using Ozanimod. vaccination, much health of

not action. this the have because of for IMU-XXX mechanism of different is very All we case

on is hyperactivated only immune that the effect causing placebo have In some it control several we selective the versus now the disease where the, seen not the slightly immune are response immune system call unaffected the autoimmune very rate infections, basically seen a infections and have innate relieve was and increased. that is studies, system, this of completely bad cells immune we of of we've and for what the example, and We against actually guys trials decreased.

X study correct. I'm X think study, presentations weeks ozanimod. Phase differences seen maybe of hope So I The in eight I've so the to think I that many MOAs. period and I in last week. induction an use Phase

confused I I'm eight it's can where think an at be weeks. But I sometimes. I that think age

two the for dependent entrants to our in of the work induction patients all use that these Maybe or this often that a because slower. define or the from of something weeks the quarter, trial, it's for that withdraw of corticosteroids you quick. ability trial the response, over in also And in have sometimes clinical ten two to know happens terms way gives curves the trials are patients Phase early responding often patients. X weeks. make we chance effect still doesn't weeks period We the kind exponential difference weeks drug in So was early and four very

dose. weeks, first of the lower could the think you baseline I Within two XX% to

eight a -- the also the But most just the make So the is that leads [Indiscernible] to is the onset believe good -- to -- drug all this lot you very the patients. It's doesn't and action of the disease of in and XX that so chance published. a again, we weeks give mechanism a clinical to really also of difference. to a time trial, our -- fast in want work of

Zegbeh Jallah

put words Thanks, Andreas. into don't to mouth. And your I want

composite, that then you as be for fast get onset or how magnitude efficacy, terms on of safety, be it way it meaning, we expect the the just to better more looking similar you in action. a So of here, mentioned balancing expect the at clarification should do the And of you do a you expect come safety? to as response, out

Andreas Muehler

think I go indication. drug maybe I So just start expect back, totally the safest with any that. the to be with always statement. the last We in would

Daniel Vitt

Surely. Yes.

Andreas Muehler

we on happy now which have basically foundation we're very learned that's that and think results. our we about I build efficacy this. the And

Daniel Vitt

action also. thing first I that's onset of And

Andreas Muehler

other ozanimod, very X, at Phase I Yeah, I that overwhelming indicate data results fast onset have hasn't mechanism entrance drugs. you action, think onset if first in the we shown from a results, expected think actually What of of this look of the especially efficacy action. trial efficacy

important. same which in always of suggestion healing endoscopic is is remission. out FDA. the on composite that for and of depending it and And to very for Tofacitinib we everybody you say using but X% dose placebo, we this the for we was have clinical only the call on We is you've difference you between remission, endpoint reason, the what you [Indiscernible] the and mission, have let's And differently, medical this X% clinical exactly that So or then look here which it a is trial. that to call data would have some at seen look have identical similar have or around medical more and like and on I definition active best think between Ozanimod between the that's like to outstanding you a and to active difference, I But say I your they XX% at we the and difference probably it efficacy. think to and come was was remember placebo. have placebo between medium have profile, placebo active I to differential talked have I think out an the safety if have which with our advisers difference end, XX% efficacy And that very think consistently strong XX% active we of usually drugs like for really well.

Zegbeh Jallah

change Thank in the goalposts, the things induction really you do risk phase you. then comes kind assuming good, then like on Induction how out follow-ups And to based the observe the they just Folks, data changes study? And of of from of think of maintenance the phase make couple possible the maintenance to Phase it study? phase quick is some here. the do you that that that the do to

Andreas Muehler

randomization dosing you And disease. from quickly very also and induction do, reduction for we maintain been take we protocols The several last maybe is you usual phase, and than dose you maintenance They expect because [Indiscernible], kind the very trials, a that trials. Whereas in fixed which also different space, disease the did is a phase has example, question phase. here patients maintenance active easy, in sick for many because maintenance maintenance non to active lower for the we the very is of No. done dose disease. non-active IBD - that

is re-randomization So important.

are and important III. other necessarily go you And Phase of have doesn't have has phase. Phase terms can shown many the many really A that X In and the this trials III, to maintenance whether data to data not. Phase trials, study, by include X going induction into Phase will been decide

for induction decided only have effect. phase in Phase reason that X, want the that to but to have -- maintenance not of We include maintenance also the the we you show

in So would the maintenance tool or for size, it than Phase X be planning, readout But as the the Phase data maintenance full-fledged study, a and readout about want planning included and all, the X a that's Phase in the is thereafter, for well. effect, the that obligatory learn to not less more for X in time. of so that will Phase first available not ongoing does but more X -- because is include X, trial this rather But Phase have it's data June why I little we statistical we also, we induction for it at study. efficacy bit a

Zegbeh Jallah

guys. Thanks,

approaching question Now as Thank again. save follow-up I final you hour we're I'll a the know call my here. for

Andreas Muehler

Thanks, Zegbeh.

Operator

you, Thank Zegbeh.

more questions the two in have queue. we So

please unmute yourself Next one ahead. Boobalan, is Pachaiyappan go at Boobalan H.C. and Wainwright.

Boobalan Pachaiyappan

Good hear me morning. okay? Can you

Operator

Yes. Good morning.

Boobalan Pachaiyappan

Congrats awesome. your Hi on progress.

So just started prior of XX% and with your see design. are biological to the respect calories I that XX% the biologically discussion one enrolled the had trial naive exposure. patients

treatment So I'm before inhibitors position just TNF curious, IMU-XXX better, to off alpha intention immunosuppressants, after is paradigm. the in but the

Andreas Muehler

none apply really all but that to was of biologically-naive position. achieved that discussions customer he -- And a had apply specific well, and years, of that the last and named deliver includes medical immune was Into is positioning with there would has exciting good I'd for will a experts a safety it aim including honest. were they would specific has of the we And -- in well. colitis, for apply and the positioning. less And I advisers was X, the and I biologics drug seen at from regulatory to JAKs, specifically -- of Ozanimod same as discussions. always this -- Lucitanib, as has [Indiscernible] mentioned a course, them maybe some not very very has So of you on [Indiscernible] or up we're ongoing I end there a biological right It open. discussion X you early -- communication in wonderful to where everybody less they this as use drugs we completely had and ASA of as they It think all intentional. that last the And modulators. or actually a as is so said that that's to after to draw more one over is challenges approval have the in medical use the several see with and that use the the I of to be minds FDA also not and also disease approved a a medication think now, but into positioning went lot a of -- really FDA disappointing only program. into on only [Indiscernible] X, JAKs, early profile. failures. that entry positioning think [Indiscernible] inhibitors, see many patients basically to and resort. positioning use prior after discussion for not so therapeutic amount safety, really considerable also that tofacitinib discussions the said of will -- safety would more it after that their in -- be same late-stage is always least our with it for should JAK countries to with -- white the XX% [Indiscernible], our be a of the process - ulcerative do of that been market yes, space, conclusion, the this oral The They I have and X The in point a market can or IBD leaves before wanted UC positioning corticosteroids, probably think measure the biologics, where their which you and in. so and we this as

intentional. I think it was commit, not but all they

Boobalan Pachaiyappan

for Got the clarity. it. Thanks

trial It's in Phase Inventiva. oral XB and patients. currently called company that's French inverse developing a is there So agonist in also psoriasis RORgamma

is your Inventiva from agonist. how outline RORgamma oral agonist you differentiated 's can inverse So IMU-XXX

Andreas Muehler

a Phase I'm you. scenario if got in known Thank X it sure you a by is this That's good not question, right. to again, and if which refers Anthony,

a interesting more data inVentiv. have tons this developed We component on an and think of That our then So was accomplished right? track, molecule lot of originally I we mode the and [Indiscernible] data have is a about safety have by for a to it, interest forget I get little We're of severe best-in-class for bit so wait molecule [Indiscernible]. until action, selectivity, let's more forth. PK, data inVentiv published exposure, of a and but we launching, managed.

Daniel Vitt

and point the publication the like selectivity specifically we you it made And on an was can to in would in of to December there find homepage, our specifically update drug. on

at function, selectively IL-XX very we IL-XX differentiation, polarization a suppressed then in or we maturation. absence lymphocytes of thymocyte impacting So human important suppressed ThXX totally

this have such so seen for other publishing is drive. believe We a feature not company data, that quite any our unique we

Boobalan Pachaiyappan

need see program what you trial, do no-go go respect what And your forward to ongoing CRPC are the Great. metastatic to with your more considerations? to and and

Andreas Muehler

different do, oncology expected also course, a And I is first escalate and and to I importantly, immunology be indications. indications. to we in we you to want an a look you -- those switch Phase which that a So maybe want oncology as where CRPC hint want I from think at course most of a of phase have could as is effect on And the efficacy into cause activity trial to that this something are quite this clinical dose. still in of a wouldn't Phase it's be what trials. would effects expected trials. that large biologically safe, And is dose but think future it that future enough you it efficacy, II to call large we that's, you I things could It's more some I call in -- translate enough that translate into have dosing, I happening. call

Phase X not you're dose, X can You've trial. at seen see a this systematic translate in in looking that other that efficacy efficacy for biologically in oncology this that you looking but effects trials can some Phase you into for you're yet,

Boobalan Pachaiyappan

spoke from know Phase your I interim for question about final you analysis one X me. Okay, program. ENSURE

be during curious. just event you So know endpoints rates, at assessing will I interim I'm well as be other the but will period? looking you analysis

Andreas Muehler

the in hazard rates, actually looking basically at at not analysis. and interim rates. the events looking No, We're of what we're is events endpoints the ratio

by drive assumption And have assumptions the is that of this this here number Just to trial. the whether we be this analysis. trial get confirmed idea you needed our patients make in for ratio hazard will really that interim what

need I this already on Phase that small the effect But on think activity of hazard for we assumptions see to the know course same. was lesions, effect have from X you that ratio in have an relapse our even we you an population.

endpoints specific or how really patient assessing the We're for any ratio the Phase not population translates in looking interim hazard needed. at X. and the patient into we're this see analysis numbers So

Boobalan Pachaiyappan

for Thanks taking me. progress. from it That's questions your on congrats my and

Andreas Muehler

Thanks.

Operator

you. Thank

we Finally, at If correctly year SVB yourself I connected, please going. pronounced current, and net in have unmute so apologies.

Unidentified Analyst

SVP. is from on this Matt Hi, [Indiscernible]

haven't two quick here. We questions

start what's one use entry after festery first trial the primary thinking And the first the relapse on point. follow-up. time a the endpoint behind XX-month So and recording have to the of quick

Andreas Muehler

You months endpoint? said XX

Unidentified Analyst

Yeah, Yeah. XX XX weeks. weeks. Yeah.

Andreas Muehler

yeah. Yeah,

enough idea a XX-week but a longer follow-up period, as being trial placebo-controlled enough as to the many happen the follow-up to do The short of in relapses terms looked countries period, having of possible. I follow-up a for placebo-controlled to at -- chance trial having is getting Sorry. think, enough in period enough able be in

of or more are III Phase So down time short relapse first to reasonable going considerably that study study. -- and used to and become relapse. decades two the more difficult well-documented interesting ARR number rates all which other first first actually relapse to in related has you traditionally endpoint And Phase last done also And a ARR, the trials, with traditionally The answer. assessment trials. to give first patients relapse do annualized that's populations. ask more the a then down go in the in Regulators relapses over been a the choice III of in rate relapse Time time to guidance becomes that's as Time so MS was for very relapses. to are

been as published first actually the an have to for endpoint really and time two advantages relapse. reports endpoints of there basically compare that think highlight these I relapse

Unidentified Analyst

again CALDOSE-X X trial, Phase regarding specific the this could improvement remind positive quickly question you what threshold another to And as view it. efficacy are the and dataset? Got a clinical us

Andreas Muehler

of understand. think planning? I to statistical you terms So we in -- the Just -- wanted mean what

-- statistical what we Our or the assumptions how less, at -- more looked

Unidentified Analyst

or efficacy bar success Yeah, like for threshold the the here.

Andreas Muehler

Yes.

we much response. for make what just expected the statistical we made for to made assumptions that Yes. line the also placebo are -- have the we course, So in as I assumptions, delta. of outlined And very had some assumptions

came all up placebo XX%. then assumed, So less. then conservative the a summary we they of there's also that patient placebo for other good been now And is less, we we that delta. trials. XX%, response basically of we size and with remission, added response there. XXX basically or the And also XX% at full sample needed. -- available basically basically have The assumed on and rate basically considerably Look of and clinical is often, the for a example, the And dropout know

we success, the very have So end XXX. the especially fast. recruited actually very We had recruiting of good at trial,

over we bit the rate. think little haven't recruitment, seen I and a had we had dropout less We also seen dropout. So -- the

to assumptions, in us feel success I I we this think statistical think comfortable just lead trial. that will very So

Daniel Vitt

it And if to comment comes through size, mine end. maybe effect

a look you biologics, of on or something like here used which size If something if the be and are have [Indiscernible] the this like course. would the effect success the you molecules that, also whole on -- plenty

Andreas Muehler

I on JAK I forth of concerns And for as think safety more, use so like the to and and couple many inhibitors, the was elaborated, and between the big challenge in baseline unexpected antibodies. gap specifically steroids, years metallocene’s the which there, cases were Andreas this last and second that limiting the in biggest current think direct the

Unidentified Analyst

again for question the Thanks

Operator

turn back great for any remarks. to session. the to would Thank And and I Daniel call you this Nate thanks like everyone questions. concludes over question-and-answer closing for our

Daniel Vitt

very the your With you, questions this, Sure. value June we we like for data much while close would joining, achieved the declining calcium answer today's And patient any We're points to additional happy very we IMU-XXX I insightful and this the progress half. year in you including second for for Thank Phase last data attendees and to and inflection year, Jessica. the X about to excited thanks after anticipate for vidofludimus in questions. today's call. initial online. are Thank

Operator

you today. The joining call conference year-end fourth my thank now has Immunic's concluded. earnings from and side, Also quarter for XXXX

disconnect. may You now

Immunic (IMUX) 24 Feb 222021 Q4 Earnings call transcript