IMUX - Earnings call 4 2023

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Jessica Breu

Good morning to everybody on the line. I would like to welcome you to Immunic's Fourth Quarter and Year End 2023 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications at Immunic. I will also be the moderator today.

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

Daniel Vitt

Yes. I would we to XXXX, press Form call. results today's December like Thank and year you, to for ended release Earlier morning, financial our our the announced XX-K. XX, Jessica. fourth welcome earnings quarter this in everybody the and also

XXXX we through will the and During today, call subsequent our achievements fourth highlights, results well walk as milestones. quarter's as and operating financial year-end anticipated upcoming

proceeds tier month. Capital, and led fourth a XXXX, the including private Partners, XXXX $XXX the ask throughout last included first XXXX. The which and Capital questions.Let's RTW to participation on a Janus quarter $XX X-tranche net will from Henderson closed tranche, highlights. start from received top new existing and remarkable investors, opportunity Soleus X, As review up Partners, Avidity of in Partners.We noted, placement by January Investments Adage million Investors, total a group have BVF of presentation, a of the round, to announced Jessica our you after Punctuating million we with of progress subsequent our

United trial the for X programs.In in Phase investors holders we chain, or a was in PMS such confirms the is trial would p-value the our levels investor. progressive NfL X mean I the enormous The second meaning average continued announcement the capital in focal patients potentially difference a each very subtypes. in volumes. calcium, data with in of can groundbreaking over lead including of week this CALLIPER a in to nuclear in reported of all our asset, of from April versus Phase in We subtype are week inflammatory and point a II advanced a can a saw States.This studies progression. you securities, with inherent that calcium puts in of of and MS CALLIPER the price October, out advanced clinical with placebo activator, share positive no outstanding vidofludimus the calcium MS This but this line into our by our interim between XXXX, that trading value XX overwhelmingly weighted look be perspective IIb vidofludimus X of in minimum receptor-related historical interim data CALLIPER PMS total, need cease on vidofludimus $XX million patients light were in no appreciate progressive and at progressive unmet markets subtypes conditioned consistently expected population. next right, NfL, or serum third at FDA is subtypes. lead same tranches of substantial XX.X% XX.X% Any in serum overall of XXX to the activity, saw data across neurofilament this NfL at a this which observed majority you environment high that levels placebo believe at includes calcium waived and the multiple financing third-party XX analysis. arithmetic all PMS. sclerosis, conditions available slide difference the in in X.XX.If group of In these over the serum reduction of this placebo top The believe difference tranche we improvement subtypes We a segment like this second completed MS third included of significant XX. week vidofludimus for relevant a therapies of found challenging statistically calcium PMS, meaningful of to for vidofludimus was population, or with SPMS, approved Even favor strong and volume

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summary pleased results made and and Celiac Conference we of different the the reaffirmed have from As Society placebo the across compared CALDOSE-X the opportunity celiac tolerability most we the that safety leveraging demonstrated from a Ib clinical disease pleased Phase bowel in recent had going this were in another with trial a Greece.That concludes fourth of the Athens, I'm clinical indications.In of our maintenance data of phase patients scientific UC very and in present profile. November, potential statistically XXXX disease virtual to Association we drug's validated and vidofludimus Dr. quarter advancements are programs, with calcium calcium Assembly momentum and the highlights. General reminder, European forward. favorable other inflammatory in our to and IMU-XXX the data our e-poster of significant at trial Burianek activity The vidofludimus

been to turn our will provide progress like this example, to an financial which for over and year.I as overwhelmingly Glenn? As with a would data is There partnering an the our we global regional on is of made discussions to going update vidofludimus for you positive and IMU-XXX also impetus companies. calcium, biomarker Glenn lot pharmaceutical overview. NfL now a the has program, call release

Glenn Whaley

and the review million start cash December will in cash Thank the now review ended with Daniel. for financial our year results me $XX.X of XX, the you, with We operating I XXXX.Let position. a ended year cash, equivalents.

years to months exchange and XXXX of to million This XX compared December research period R&D by administrative for the XXXX allowance fund million in was The Finance the the the from XX a of per was for per net compared common deprioritization by related partially in Australia.The million same $XX.X XXXX, XX, approximately XXXX.Regarding compared costs primarily in personnel partially of as ulcerative million, was to offset million our for million, external offset December in trials, for personnel expect a to were by to in funds approximately net XX.X outstanding, attributable attributable interest costs of based clinical upcoming costs of diluted tranche months to back I by the December as loss increase ended higher for numerous driven million colitis.General quarter a result shares period trials for be for average the program XX, as categories diluted XX.X XX, $XX of same the the call on negative in losses, related calcium the and XX, IMU-XXX expense.Other as and calcium period interest related shares expenses. December our the review into the decrease development ended $X.XX net the XXXX.With of and expenses million that, and average XXXX, XX, XX an of offset over XXXX, third the approximately development rates. our result and $X.X ended share, as approximately XXXX. vidofludimus in or the were same external to income were operating in compared This The months less turn incentives to on decrease ended and and or these to for was ended based the XX, the was XX, a December basic as we as a able December XXXX. raised weighted private a across reduction $XXX.X million ended loss to Daniel $XX.X well increase vidofludimus million for January XX in Daniel? was expenses tax program XXXX clinical spread XXXX. was basic $X.X foreign slight XXXX, partially months tax in decrease a costs mainly months and a German With a approximately clinical the December These increase $XX.X R&D XX, XX ended ongoing Ministry to income decrease for milestones. will outstanding IMU-XXX $XX.X $X.XX the million operations ended common December results. placement, proceeds the share, to spend weighted $XX first

Daniel Vitt

our like now would an our upcoming reporting on We CALLIPER programs. I trial anticipate anticipated in line MS Phase milestones for calcium vidofludimus Glenn. provide top development you, progressive eagerly from clinical data II to Thank in XXXX. April the update of

identical III to clinical CALLIPER of position program we data year, progressive MS a Phase stated and twin calcium date, far, second for that profile before, neuroprotective provide activity observed out read interim potential of path believe vidofludimus thus of will in Phase to on the relapsing in based futility regulatory of safety treatment design PMS If MS. Additionally, to to XXXX.As relapsing straightforward expect the top first be the report a line and calcium in established ESNURE we quarter first analysis approval strong vidofludimus the our we our oral continues III to our trials tolerability for an III late solidly this ENSURE well. patients, Phase advanced the effect secondary able to show as as the may MS ENSURE program

the in of in trials market. activate meaningfully in that first-in-class sclerosis.We ability expect NurrX MS about ongoing MS light clinical excited program the multiple drug's potential particularly recent to the the also We developments are will benefit our

reported, believe As option the by considering targeting for combined we targeted to other the At patients. multiple program, same a unique the regard Phase II disorders. has time, epithelial on vidofludimus broad applications regeneration, also of potential preparing celiac potential effects.With if that in we complex ongoing we the have active in antiviral and on physiological begun clinical to sclerosis drug's its to previously calcium neuroprotective, we disease approved, therapeutic treatment anti-inflammatory noted GI IMU-XXX as a trial be based our are additional clinical based have pathophysiology before,

the of open consequences excited associated of very approach for to our and architecture disorders without could immunosuppressive IMU-XXX present Q&A regeneration end program promoting about entirely gastrointestinal are an please call new us formal therapies.This serious old with brings therapeutic this by We Jessica, presentation. the to the believe the session.

Jessica Breu

today quarter walking subsequent us Thank value for highlights you, guest Caroline Wedbush. the XXXX through inflection is Our Glenn fourth first Instructions] Daniel, and well [Operator Pocher from also points. as upcoming as and our

Caroline Kimberly Pocher

This is Caroline on for Andreas.

us. from Just questions two

then data readout from you quarterly QX to in advanced first looks last like like from end XXXX are update, XXXX. were it what SPMS? trial shifted of positive, since CALLIPER if the So the from slightly regulatory can And the looks forward for discuss path times the the the the ENSURE

those Just of slight enrollment progression in any to both as trials? just change the and clarity why

Daniel Vitt

Yes. Thank you, for Caroline, the question.

Let me start CALLIPER. with

difficult a it's answer. to think I So question

the pathway I where secondary approval. That of accelerated basically, the in countries. likely for study. that study think there is may X a process non-active indication in nothing approved, What as an -- offer But likely let nothing us most or normal indication regulators is progressive an such patients. with the available pick we would the different requires only forward III discussion that towards know require a Phase course

it positive after So ENSURE, we I last change the study.On of package be projection. pretty a will expect didn't a from that timelines we lean readout think we our think

made and our adaption forward, an That was this speed already to some is are we need weeks how I always current reflecting therefore, ago. timelines. But are make okay. recruitment think of we and updated the the going continuously and things We estimation. quick explore to

current on now. recruitment are on right track We the

Daniel Vitt

Caroline. you, Thank

Jessica Breu

I Leerink. you queue hear is The one from us? Nat, here in the can Charoensook next Nat have

Nathanael Charoensook

me hear you right? Can all

Jessica Breu

Yes.

Nathanael Charoensook

Tom This is Smith. Nat Charoensook for on

on and all we have questions. congrats progress, couple So the

calcium are So continue one, of vidofludimus the results from can and in in the to like expected the first to ESNURE interim need we study you the biomarker late see what the that development analysis XXXX, expect for what RMS.

Daniel Vitt

the out data a study, asked analysis. you, Yes. because at this clarify or other good And I we be a as Nat, we have you Since This will Thank point. can't just this Phase biomarkers clinical that's time for this to question. is, III want written, is read that. that futility

and get of about analysis, Safety Board will would we Data progression study. it for a from the Monitoring just feedback allow us So may the It sample adjustment. be futility size

planned maybe So Board. or which adjustment outcome this as Data size the happen. recommendations Safety could Monitoring from is only sample the Either continue

Nathanael Charoensook

Got it. helpful. very That's

than in like study. biomarkers potential plan or Phase study? to at And size ongoing mg are So start potential II the what to go additional the study? you III the you a in Phase in include the what a trial you XX that I disease? Phase can looked endpoints are think study mg the XXX exploratory at over you for Ib plan look And so next one other the to the doses gating factors please into active celiac as is,

Daniel Vitt

also Yes, question. a good

a study example, As disease, other the you drug our nutrients we are uptake a drove II, we budget. our function this our BXX, the last where respect time before. course, the situations have celiac that nice we Phase less disease. involved committee for a may said interest. -- lot know, enterocyte and to Phase also example. a heavily before, influencing of in celiac celiac is in in of from is we the to working proving And of improvement and as proof-of-concept to as in I preparation potential And indications, limited of the have, given II only more disease also, other you that is that of readout achieved said in the very seen in because active wonderful The Phase for I space, for cells.With want potential very like or of not viability II concept work Phase study study increase is the also of proof more not currently But those the by vitamin increased function year,

a study. So are preparing we

market to limited context. go say beyond as celiac that may for progress here, it clearly ways study. way disease thing will discussions talks it's need in Maybe the celiac I full potential also these disease. really and ongoing finance other indication we the to a to partners have keep we that finally also on II with forward. one and could And looking not as We informed Phase That blown mean

Nathanael Charoensook

Got very it. helpful. That's

Jessica Breu

you, Thank Nat.

to have Can so completion Phase for if read of came of provide We Q&A question them? it. and tool it view how writing, I in prerequisite a the that level and fits you is high drug the nicely will description via II in potential IMU-XXX, partners any

Daniel Vitt

As really of my people It's new perception of little stuff. bit is conclusion a drug cool that think target. it's subjective on the

to different has this a GI potential way. the in really disorders think very I the address

is lacking and really see attractive unique effects I therefore, immunosuppressive benefit it think is thing. here, So an we a

And this to work. in need typically, already On disease targets concept we proof of clinical to they achieved the that the celiac other have hand, think I our new favor, demonstrate patients.

generally, very think are is I very for completely So and the new approach people diseases. perception positive, about excited those a

Jessica Breu

you, Daniel. Thank Matt The Ladenburg. one from the next queue Kaplan in is here

Matthew Kaplan

Can you hear me?

Jessica Breu

Yes.

Matthew Kaplan

community progress. with mean, of wanted terms congrats received been vidofludimus the what's far the the kind so NfL. I KOLs CALLIPER with of I on data zero guess, on I gotten that the you've the studies? impact Well, MS so in reduction pronounced and on to far the EMPhASIS just that observed in from you've feedback in

Daniel Vitt

you Thank that you, Matt, and thank for question.

from and papers. this think one was can like NfL nice And the shown very relapses, that NfL the that of nice And do you future specifically, of if ideal on space, look power an in people you predictive focal recently, for a given regenerative showing are is couple disability is of I from NfL couple if progressive outcome. a patients, on in data clearly that. there hand new key publications recent MS there of contributions separate in will it you MS in activity in is way, inflammation the -- a unique see progressive and that

some -- also it's papers And year, second a And of that the think progress. were excitement. really scientific there it's in Specifically that. drives last to pointing half I

is namely forms said these I MS end, of non-inflammatory the unmet April And way far population, the progressive as Not medical to calcium to And diseases. we clinical want to progressive is demonstrate goal from advanced huge need as opportunity really secondary too in -- study. well, change now. the XX. II the benefit Of that think, need course, MS, given we far before, treat the that, of we too we're vidofludimus the think not the the Phase and all we which at I from

Matthew Kaplan

vidofludimus mentioned That's And you What plans. terms MS plans Okay. of development then helpful. for partnering? or indications the business your partnering in are for plans

Daniel Vitt

Yes.

And studies status the think, to, careful to I given we here, But and line on We I is and what also has clearly landscape even paves is way also the that because Phase think establish RMS progressing I discussions. for II also some data for collaborations. are readout, we we PMS, BD partnerships. be of whole are sclerosis, be the as I a well. people scientifically treatment they're always on the establish If relevance that which trust I the relationships benefit something think certainly on this mean ongoing to the positive, tend of do which towards PMS for may partners. talking do. projections multiple the beyond We Phase ENSURE support potential III

something this something not but situation So have think say do need are really now. on I some to we we we, is in that activity we we a

think II funding Phase in good have out what best to here. then I read available look way we a forward the is the to way and study the

Jessica Breu

Kwak And [Operator Jun-Goo the is one Instructions] Piper Sandler. from next here

Jun-Goo Kwak

for This is Jun-Goo on Yas.

have two. We

we readout? II with far? And considered provide analysis so where implications with for the ENSURE, Phase about later finalizing would futility design? And you a are for upon agencies how color be the year what your And the regulatory For celiac think win? should could interactions more study, the its this you second, on

Daniel Vitt

from reasonable one sample question. we and we you just nature event-driven we would adjustment. will then you implement planned can is reasons, answer further I committee. is the get size Thank we then into a want get, -- that and for of think development. all Or have That's an endpoint, the futility to first given allow proceed the analysis a question, of the To the this that as

the on there. we this the that EMPhASIS relapsing So But comparable a honestly, it, Phase III are given think all trial can calculations obtained on don't based very was studies and thing, And -- Phase MS, PMS? you second the confident the will question, II I we on the were more repeat expect binary for data.And interactions deliver it's assumptions in we maybe EMPhASIS based also from any data surprises results. regulatory

Jun-Goo Kwak

Celiac.

Daniel Vitt

working II are celiac. study that's thoughts now. There are right couple running For And in a on we project progress a design. the Yes, also, on which of Phase work through. clinical still we're

So that. as soon report will there as is on, something we disclose to

Jessica Breu

Next one William in queue here Riley. the is B. from Wood

William Wood

Yes. Can you hear me?

Jessica Breu

Yes.

William Wood

congratulations the on And quarter.

expect ENSURE, Just thinking Phase your about when just baseline to see I'll the actually, for characteristics should III leave we that trial, -- and there. it

Daniel Vitt

don't Good III can disclose when Phase that we exactly that get because and a can even question. I know it's we study.

I we reasons we in need think the until the unblind wait likely to XXXX. study integrity of for study

more because likely this if to most the get But to the and you to we end up because kind and want know earlier. too early of we this don't regulators way first, with future an information maybe that's is these -- there on have are just in So discussions will difficult in eye want case we a there, quality things.

William Wood

Got two more. it. And have actually, I do

You also And view X your sort we should ACTRIMS can next of have strategy what up one how already have in reactivation the symptomology II EBV in PMS? that as Phase an I that additional blocking of coming and be important your study mean for EMPhASIS data patient more. Should And being any results week. been presentations presented? expecting forums at have we interim which on overall improving

Daniel Vitt

Yes.

of one scientists bit This not is the the point influenced the disability, reactivation got is it's fully last really world, here, prevention of lot reactivation reactivation. those think I of the a hints progression but on still There of quiet second about months great I a we how the blocker EBV EBV talking something indication of it's a in also that lot still positive disease disability, And from true impact posters, think that around the patients. really were of a could of by full couple of understood are a this. how so calcium regarding because vidofludimus is have little is excited one by NurrX, ourselves. work but EBV. There's collaborators and of done that here for for we example,

scientific CALLIPER an market flashlight speed vidofludimus second NfL, and no of future the activity that's interesting to poster.And one that is it's new and on put to the think I calcium We more in maybe on dedicated on So not aspect the to out one context. third trial design between data. is really disability the and up link but But that fully figured NfL to important of casual activation and we think therefore NurrX this And more progression. on doctors talk come has potentially. to we to also specifically into about way want this neuroprotective this and Because with in the this could really impact major out positive change data for way and the major, could April. a be MS disease if a the way reads we treat whole next the the market the

William Wood

regards the excitement lastly, me CALLIPER vidofludimus could current differentiated antibodies, MOA other you interim for may, relation emerging I in and what sort anti-CDXX, even calcium, in anti-CDXX space? is CAR to to position there. CDXX learnings results. just or if T Got actually it. the or just it discuss of It then And correcting possibly thank you for how definitely the And

Daniel Vitt

NfL is different, inhibit other or bigger not about thing whatever are And basically of just that anti-inflammatory. is in from it targeting -- have effect DHODH all is like which which the vidofludimus of or top also, the anti-CDXXs, not is also can which anti-CDXX we've in it is vidofludimus think we study, unique difference good the we mode with effect, of therapies this neuroprotective seen not action a immunosuppressive classical hand, focal data, calcium that way in CALLIPER from patients that to you starting I the is NurrX in that may beneficial clinical also inflammation this benefiting a also that on may enough potential different but that lease. makes a outcomes, because benefiting see something other use and signals, approaches. on The the there it

MS -- which slowing medical we of patients worsening unmet preventing really you're and that if focused in is on the down we key both. need, kind, target then So all disability

the So from in also be for progression would best patients indications relapse-related specifically. of can worsening differentiator these and like that best And news and think the suffering progressive patients. I MS the the have and the relapse-independent more primary progressive secondary you

William Wood

Very congratulations again. it. Got And helpful.

Daniel Vitt

you, Thank Yes. William.

Jessica Breu

I another activation the the for disorders William. further the NurrX or NurrX confirmation, future in have disease such you, vidofludimus Q&A see target as Thank of in do on tool. even of question case here In other Alzheimer's? benefits you neuromuscular Parkinson's actually

Daniel Vitt

yes. answer, simple A

we, this at finding Munich of in clear, NurrX. is is therapeutic together Parkinson's University good use has such Murak, area of Daniel disease. on calcium around of a of it collaborators very the with historic our So, performed that And NurrX most something here activator -- when a been was in the research found breakthrough vidofludimus

So primes, main of for have the the the hope to original potential I list course, for world. more And Therefore, tested we molecules. of is think of was NurrX researchers still targets in focus on top this But vidofludimus there. this the disease. Parkinson's of be our

of a have bunch derivatives. We

priming for with forth. properties, different molecules maybe molecules example, so CMS for different, have and We penetration

there. specific amounts huge boost activities. in MS the things. And new currently, collaborations developments use target to in focus also we So But to indications as there parallel with innovative delivering molecules we for these be very such our MS. start will a profiles.So considering things not budget again, well to data therefore, our our of potential current are with highly But see for we the huge is there potential may other independent once

Jessica Breu

UC in any writing. question plans program, for maintenance I data? Are given have another there the vidofludimus the phase stronger here

Daniel Vitt

question money right the now that's again. Yes,

a kicked that the that the why called with new IMU-XXX. Once So in reason program off I and continue we would Phase love again, directly to indication. was III

We using our which have for proof maybe GI suited from distribution of are but from and of better their our penetration, profile concept CALLIPER molecules tissue mode action studies. the

yes, track. So more But yes. a principle, again, in separate something different likely likely in we once would development

Jessica Breu

may quo vido. summarize question I'm regarding status chance sorry. be Thanks, and IMU-XXX, currently upcoming updates Daniel. a Final IMU-XXX good for I the What -- are for you to milestones have the

Daniel Vitt

the or more summary we spoke Well, less what of about.

risk we calcium. good us forward huge CALLIPER study, clinical a more main the giving of signal This make for very rock less the think. very a really force huge April a the outcomes right This potential that the molecule very In data or data opportunity, increasing now. think specifically is our for the readout EMPhASIS which readout likelihood ENSURE towards success we very way data approval of we I think us ongoing, driving with last from for parallel, based Phase were and study XX. in on year, is of vidofludimus II low obtained solid a a nice intrigued I commercial That's the also drug in by the here and I maybe NfL data program the in MS allows have relapsing which just XXXX. that would

more is maintenance -- also has just the or forces study less program.But to the beyond reiterate, key this also are sclerosis potential. boosting vidofludimus related positive readout these on space. where huge think in which And we into And molecule NurrX we too the this something other UC GI, data, another talk but indications, these other So long definitely for neurological that on and I also to driving also had want reiterate look will potential we don't multiple the on things. to developments here,

Jessica Breu

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

Daniel Vitt

continuation from of Phase the to of CALLIPER the vidofludimus development enrollment thank progress for trials, of and your Jessica, make attendees clinical as on the Thanks, questions. to well calcium. II our continue with insightful Phase we trial tangible III summarize, you our positive interim ENSURE as To today's data

we for IMU-XXX. our quarter is we are happy funded, through of progress much quarter very clinical of end placement, first update provide today's of XXXX.With very With the II into development funds runway I X-tranche our tranche and us at Phase Thank clinical also fourth to to you any private third closing for and an further the to the our questions answer providing preparations recent we milestones As that, expect on like multiple remain made, of joining, additional well the of one-on-one. close the would call.

Jessica Breu

and End Call. joining concluded. call Daniel, Quarter The Year thank has you, you XXXX Fourth for now Immunic and Earnings Thank

disconnect. now may You

Immunic (IMUX) 22 Feb 242023 Q4 Earnings call transcript