IMUX - Earnings call transcript Q3 2024

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Jessica Breu

Good morning, and welcome to Immunic's Third Quarter 2024 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. Daniel Vitt, our Chief Executive Officer; Glenn Whaley, our Chief Financial Officer; as well as Jason Tardio, our President and Chief Operating Officer. Please note that all participants will be in listen-only mode and this event is being recorded. I contain to forward-looking begin, this you we may presentation statements. Instructions] Before would remind like that [Operator Such statements a here. can risks results may, such will, to be involve and identified by anticipate, statements from cause or words uncertainties estimate differ that words Immunic's number materially with a similar could and expect, meaning, of such actual as discussed those to it the forward-looking or obligation Please Immunic's of light in this reflect or the these release these of revise events. information future as statements revision date note undertakes presentation, result and that only opinions of of to new no statements publicly any forward-looking would for risk call the like to Please refer affect to our and may over filings CEO, detailed statements. I description results a factors SEC now that of the to turn Immunic's Immunic's Dr. forward-looking more these Vitt, begin the Daniel presentation. to Daniel?

Daniel Vitt

to I ended results to Earlier morning, we like Thank announced earnings quarter you, X QX also third call. financial welcome Jessica. XXXX XX, the XXXX. and this everybody our would today's September for months

During we programs, and XXXX financial through and walk well achievements today, milestones. will our highlights, quarter results, upcoming our anticipated third clinical subsequent including as as development operating call the

the questions. As presentation, have noted, to will ask after Jessica opportunity the you

Chief our closely companies. Officer, and Let's experience biotechnology major Jason prepare outcomes drug Officer, his a of subsequent candidates, strengthened experience. Jason of we our vidofludimus and leveraging sclerosis extensive the for our quarter management the company as partnering potential calcium, Tardio Chief bringing also where pharmaceutical a with other partnership Business leading of Jason wealth to invaluable, be prepare Walsh, to potential vidofludimus has of well collaborating team with been multiple proven a launching the Patrick efforts XXXX as are start calcium. Operating for for has range with with to internal highlights. drugs our President and third as was review him and In July, commercializing addition already for of commercialization

approvals in a United internationally, numerous commercialization. has and in Over the as and XX-year strategic an commercial and MS efforts, of of July, also Head as In was positions operations leader success launch Italy, Additionally, IMU-XXX commercial and Skerjanec, one launches, XXXX the Board in and Roche, OCREVUS, leaders, growth and successful in-depth a management vidofludimus worth asset, from of Cavalieri Lilly, available scientist distinguished our industry MS the as most we as of action, which Pfizer Werner Johnson of working its including he biologist program, his DHODH the the companies our Board Johnson. activator mechanism highlighted University led related and to area Werner with NurrX double-digit Her culminating treatment Gladdines then. team, strengthened overall or in with Officer. Simona Immunic's Chief mode responsibility held anti-inflammatory vidofludimus leading X, presentation global orally Turin, with regulatory career rare and role, functions. In drug along Ottolenghi of our well pointing Neuroscience Simona MS new its Development Amit as September, January over leading for lead via antiviral clinician, States receptor led of Dr. strategy in takes since and Medicines of clinical of has which and diseases, calcium. The for in inhibition. promoted Institute Dr. and These which Montarolo, of one expert out R&D remains an increasing achieving business the & Directors sustainable Day, University operational provided Immunic in Simona successful of calcium. In and neuroprotective the through X decades Roche's experience development with and world-renowned featured MS towards It portfolio joined opinion and is neuroimmunologists a brain potential and we as effects neurological additional Francesca of development Bar-Or, experts, of for in Pennsylvania. target research we Company, medicines drug work of responsibilities first-in-class the this Eli dual MS that The overview enhances our really nuclear appointment thought of such from hosted today. landscape combines with key in-person corporate health with he NurrX, sales, effects

of options on ENSURE commercial our MS, and the opportunity groundbreaking MS, During in the a in belief much option calcium and forms insights shared also such the vidofludimus potential MS the we vidofludimus a unmet and of MS, Phase to III relapsing CALLIPER huge are Phase few particular, there calcium relapsing progressive continues discussed to and II trial where highlighted need. for and oral of ongoing the our ongoing In we market. strong our be bringing currently progressive event, trials in in prospect with patients needed there treatment in

study for and syndrome, University and clinical patients. In group RAPID_REVIVE vidofludimus grant to Goethe via The trial Vehreschild redefine first received the the patient Immunic elevate vidofludimus by September, a sponsored an potential Maria is funding we randomized, parallel a double-blind, to is in providing that which by investigator-sponsored Federal of which continue German and Frankfurt, led trial, landscape the medication. calcium from of the the post-COVID Prof. Education trial trial, standard Research. placebo-controlled, Ministry calcium, care the sclerosis treatment trial Phase of has for in enrolled We oral II believe multiple MS the

this are investigators run have at investigator-sponsored a study institutions Germany. such honored highly-regarded vidofludimus by chosen to We calcium for esteemed in

and patients to seen Phase calcium's effects in its clinical convincing fatigue We have CALVID-X preclinical already our studies data vidofludimus and antiviral ability trial. in reduce from our II supporting

impacting syndrome life and the of for dominating their for post-COVID one has Importantly, identified participate fatigue, in symptoms negatively as of reactivation to potential most third-party both a research quality patients, ability social activities. MS Epstein-Barr virus cause and

We ongoing September, its add few opportunity [ MS. Jason, X a calcium's generated data look the ability MS data words Congress strength to to present posters new our date trial. influence of virus of prestigious illustrating to the aspects Congress? this confirm the treatment ] on that yet and the reactivation also had of belief showcasing forward option vidofludimus is of ECTRIMS, the additional the may for in a aim feature also drug do want our to to vidofludimus another from become candidate. In XXth receiving trials RAPID_REVIVE at create It fatigue to Epstein-Barr key calcium we data on you and differentiating our and the for potential to profile,

Jason Tardio

in ECTRIMS Sure, Daniel. healthcare professionals. the thank meeting and The brings of field you, is of and over of sclerosis multiple the world's researchers X,XXX the the year together premier top and Congress clinicians,

particularly significant this sclerosis. More the progressive neurofilament and reduces a shared data patient reducing both These chain calcium and differentiation in present at degeneration subgroups observations had study of future that Phase not our are that levels as the opportunity disability interim calcium we on specifically, population, patients. levels potential to based across vidofludimus neuronal different neurofilament chain with to treatment of analysis activity excited additional are consistently serve had progressive for scores. light across but the vidofludimus trial data support on biomarker important are from to a proteins MS disability risk light compared also further and only baseline ongoing showing indicate important in progressive of as that sclerosis, disease age sclerosis total in II have neurofilament impact marker light meeting neurofilament the progression showed serum multiple CALLIPER multiple recent of relapsing of levels an We multiple data as lower lower a a to

We of evaluated compelling CALVID-X of from patients data hoc post calcium vidofludimus and in milligrams also on presented hospitalized the for XX which analysis efficacy safety the COVID-XX. trial, fatigue

As mentioned and is sclerosis. the disabling for patients, earlier, it reported patients most the is multiple most symptom. many chronic frequent And with by symptom fatigue

ongoing will to it well Fatigue as questionnaires, fatigue Epstein-Barr antiviral patients of decreased for for has that or XX% who analysis reactivation fatigue X on to on the showed effects multiple in Given fatigue hypothesis by been of XX% anti-EBV sclerosis, effect further virus, vidofludimus potential XX% patients ENSURE on XX understand we in to which fatigue how prevent using supporting This CALLIPER effects the vidofludimus the EBV, determining patients was linked levels. to to in weeks broad and thus its may syndrome post-COVID spectrum be and further analysis from of Results fatigue of only placebo this of and received contribute to calcium. lower patient of to as compared calcium and patients trials. our vidofludimus assessed vidofludimus only reported calcium, of sought impact the antiviral received effects vidofludimus on placebo XX% who the patients. of

Lastly, spinal supporting number further the we and models. EAE and presented murine the benefit reduced also infiltrating genes, periphery of neuronal that the additional preclinical vidofludimus this helper in cord calcium cells survival, T in evidence NurrX suggesting of of target in asset, for important expression helper neuroprotective cells enhanced the pro-inflammatory the T

you, a these to awareness This calcium community Daniel. time first further for to this increase booth engage presentations, as opportunity MS. Back at MS Immunic an data treatment a the potential In vidofludimus meeting. to fielded the great for also addition as important served and exhibitor of

Daniel Vitt

futile you, In of continue we the achievement as critical relapsing of Independent on based III vidofludimus milestone not any and a data, program. October, Jason. interim in calcium RMS. or recommended the trials analysis Phase unblinded reviewed ENSURE marking Monitoring An the Committee, Thank should that for Yes. our planned program sclerosis, outcome and of positive of are the a IDMC, announced without this, Data multiple successful changes,

While the Phase relapse trials for twin first statistical in so of data planned the to far. In and the design, IDMC's are the primary recommendations to time line sample particular, assumptions that data, endpoint with all appropriate initial blinded corroborate rate our observed assumptions the favorable powering of Immunic they the to size relapse. address seems III of suggest remained and

regulatory highlights. concludes am ] vidofludimus across scientific path and potential our transform very that I XXXX recent of in the made [ and approval calcium's have programs. confident in we to Phase the to with oral MS pleased quarter program and a are achievements clinical most continue summary RMS. That We straightforward III third the clear our and believe potential seeking market provides the towards

our ENSURE to trials in continue MS trial relapsing it to III calcium, As progressive II CALLIPER Phase our Phase with relates and patients advance we vidofludimus both in twin MS.

very the trial with ], date to excited on we read in of from data CALLIPER just the partnering discussions the XXXX. out April to companies. evidence now, expected continue top to a [ and months Based are in regional couple clinical of line We strong pharmaceutical global pursue

IMU-XXX our overview. potential now Glenn to treatment like to for which advancing of busy been a provide to would the financial also the disorders. I over of Glenn? call program, has broad has game team to changer Our a turn become range a the gastrointestinal

Glenn Whaley

Thank now months you, the Daniel. I and XXXX. XX, the will results operating third for ended quarter September and X financial review

review ended into XXXX cash our cash Let and position. equivalents, operations million a be $XX.X me of to of start we We quarter in to quarter with expect third our of the which third XXXX. with the able fund cash

operating R&D the decrease XX, costs castration-resistant XXXX. from increases the by X to expenses was our cancer increase clinical year. September for program mainly September external ended the compared for which in XXXX, izumerogant trials, months offset psoriasis were a $XX.X the Regarding XX, the related X $XX.X and results, months last prostate to was partly ended The driven in million million of by deprioritization development as

cancer completion personnel the XX, $XX.X X million $X.X the for expenses as months the for the izumerogant calcium expenses. G&A was X of X psoriasis in to I R&D $X.X This of Phase were million XXXX. September partially external the XX, months were celiac an vidofludimus program, XXXX. XXXX, was $XX.X personnel million the as September was as primarily the the development costs XX, same months to program to castration-resistant to The well compared as driven The and of prostate million in ended by For decrease related ended ended disease in an compared XXXX, September trial increase offset year. September expenses increase related by expenses. the IMU-XXX last increase mainly clinical XX, period deprioritization for ended and in

to as the consultancy expenses, numerous XX, and XX, XX, $XX.X X the million other legal expenses compared ended increase unchanged personnel ended September September XXXX. remained September the months ended XXXX. same 'XX, during period compared $XX September XXXX, $X.X primarily and G&A XX, across were was The the to for related For as at to million X ended months categories. Interest costs months million expenses, income X

interest $X months $X.X XX, to million September million XX, For interest as X XXXX. ended $X.X income months XXXX, September was ended due for million rates. to the X increase compared higher was the The

X tax of as Australia. in to the the compared placement. Other a for the We September also value change the months for The The ended fair and non-cash XXXX September rights XX, ended rights clinical XX, tranche R&D in associated was X for private value $X.X to of of same X change X million with in related the September of the primarily ended reported attributable was change $XXX,XXX period increase income future the XXXX, trials XX, for XXXX. to tranche the a was the January $XX,XXX tranches incentives months XXXX. charge

as related income for timing X portion basic an of the million net January exchange months per recognizing same ended shares costs on based months $XX.X months of basic shares share September period Australia XX, country. as X, XXXX. Net million for The the decrease XXXX of compared time loss spend approximately per based for diluted and approximately to or average or of increase the expense from to XX, million $X.XX for weighted based in was common loss on weighted or share negative an basic of the XX.X share approximately average ended the a X million The XXXX established compared clinical to to diluted a approximately XX.X the and was average of approximately of in September the partially Federal outstanding a upcoming review common well XXX.X net on decrease tranche million closing September call million million the period trials same net $XX.X Finance loss back financing was the other $XX.X as German $XX for and were of in will XXX September XX, shares and $X.XX approximately outstanding, the Ministry the I rights common compared offset result $X.XX for September XX, was loss average incentives same related ended September XXXX diluted at shares development basic foreign that in XX, the XXXX, on over of tax was for tranche to ended outstanding Daniel $X.X a less as our weighted X that XXXX. With to primarily million or R&D the grant, per by to million clinical million based attributable gains. The that, period For trials $X.XX share decrease pipeline the XX, per common turn Daniel? a milestones. ended $X.X XXXX. ended diluted outstanding, weighted for and

Daniel Vitt

and clinical anticipated update programs development Thank Glenn. like milestones. would our upcoming to you, an provide I now on

which Phase data CALLIPER of Our anticipating, of be vidofludimus progressive II eagerly our will in line MS next year. calcium from are April important we the clinical next in top trial readout,

on addition treatment deliver In able meets will overall including need. secondary as effect key the a unmet for progressive the II MS. secondary subforms, Should a to option PMS first data endpoints, to we to trial may with line the also be the secondary continue the progressive top the and neuroprotective the show data its drug the also primary and population, Phase MS, highest non-relapsing subtype non-relapsing position insights medical oral

ENSURE complete expected second trials in planned as calcium XXXX. completion the The the Phase progressing in MS the XXXX. of our program of identical ENSURE is expect of twin quarter are first trial III Phase we III our of of ENSURE half second to the with relapsing Additionally, and second vidofludimus in

data by drugs improvements serious use we absence the As disease: to disease diet celiac gastrointestinal today. It patients program, dimensions epithelial to bears and from of architecture, of repeating Phase believe that periods and of it during challenge in mode relates IMU-XXX demonstrated over available clinical in wall enthusiastic biomarker range intestinal healing placebo outcomes of gluten-free IMU-XXX, resulting physiological currently disorders targeting seen Ib proof-of-concept our immunosuppression in gut gut of and in action very celiac broad with in significant uniquely key improvement protection X with gastrointestinal of second enhancement of innovative many treat broad that clinical trial clinical gluten absorption, its a strong a regeneration, is our symptoms, the in response. remain nutrient patient of of suited

in for disease, testing other And of gastrointestinal begun celiac is As applications to where for IMU-XXX. number preparing other previously wall exploring disorders gut have reported, clinical we also Phase important. addition of renewal the II we of clinical are a the

asset options different this are unique We openly are currently to fund avenues. separately considering exploring and

to again calcium's Let profile. unique over point to me hand Jason at this emphasize vidofludimus

Jason Tardio

you, Thank Daniel.

therapy Now, just tremendous opportunity part to the leading within see of vidofludimus I of reason a the a for the few segment. The MS of as multiple months ago a of the because I market first-in-class sclerosis, designed disease-modifying mode stages become potential through focal the what drug from transform spectrum to progressive and inflammation address unique, its therapeutic Immunic the action oral potentially stages tremendous dual and was joined profile given this takes of and where relapses is of neurodegeneration approach, to full candidate hold.

potential vidofludimus patients. inflammation, calcium both MS As effects a beyond for offering providing progressive activator, direct and benefits neuroprotective first-in-class goes NurrX thereby relapsing and

once-daily and benefit/risk anti-inflammatory with convenience the profile which oral vidofludimus safety exceptional of administration, tolerability a action, a in the gives of calcium believe highly of and within a sclerosis. of best-in-class with class plays medicines. profile an mode forms relapsing oral we potentially combined In selective the addition, is vidofludimus key multiple know part also associated inhibitor effects, this DHODH potent We

Additionally, do market on-treatment there that medicine remembering start that about a it's XX% today dose believe first category. to worth newly-diagnosed the is to will to very switch be an this be switch going monitoring and to, highlight is necessary, not patients of to easy we means also on or which easy any medicine a patients

safety We box calcium. also do not vidofludimus or concerns to anticipate warnings specific black any

of USD the the we X therapy if session. Jessica, calcium from the expected Q&A transform believe presentation. sales open us across product to our potential to oral disease-modifying the call the USD Given multiple indications with this market and billion peak for of profile brings end to formal vidofludimus has vast please this ranging approved of X the billion. This sclerosis,

Jessica Breu

Yes. Thank you, Jason clinical and and upcoming quarter the subsequent development well pipeline value as Daniel and through us for and walking inflection points. Glenn our highlights, third as

Jessica Breu

[Operator first Riley. from is William today Instructions] guest B. Our Wood

William Wood

Congrats on another successful quarter.

of a our So, on end. we have couple questions

What well as first population about to coming to your non-active, the an have we trying we and/or well this -- also? primary your So, in Essentially, expect is, level I'm get PPMS. your including NfL just should overall going as secondary just readout up SPMS, readout CDW, data? we across line your study -- a as subpopulation I And active populations of data top in April, Or GFAP? CALLIPER detail PMS, then, endpoints possibly both and of is these presented, follow-up. are these thinking some so expect at should as for

Daniel Vitt

Thank wonderful I William, good Yes. and for you, have question, that news.

year given and also the the including also of on also, we that that important as general we for interim data, allows really ago. the biomarker confirmed study tested the readout, the really at possible to atrophy clinical analysis to And detailed biomarker disability the brain the out plan also course. NfL, with everything during of subforms but we try data have the exploratory available did worsening, So duration GFAP, and evaluate the study, come a to the so endpoint, very

So be we're comprehensive in year. April it expecting next will quite data

William Wood

a Excellent. one. just It's great to hear. quick And then, second

also investigator-led have ongoing you in noted, -- Germany. post-COVID You on have as you going your trial

are so, before got should looks about you And of ENSURE MOA could How the then, subtype a fatigue, ENSURE's or in readout here, any a obviously how success trial? there's we enroll, Maybe when XX-day type possibly we and or post-COVID timeline, either And it if in of this to multiple dual it's the analysis like, think sclerosis. data evaluating CALLIPER if might XXXX? highlight in XXX remind about looking patients, results syndrome. your earmarking diagnosed with key You're in ENSURE? that and remind in issue might post-COVID me me it expect patients

Daniel Vitt

remember I everything hope question. from I Okay. the

and can't So role are but starting analysis give We but trial. sclerosis. that important are specific fatigue the the The very with on role the post-COVID guidance it's it trial. drug. post-COVID have MS, super is in not And and I provide know recruitment. both the Therefore, really we expected sponsor. we an even study, in is an this meaningful and EBV to about a patients And study they if of a investigator-sponsored also the could here. speed off interesting investigator-sponsored in in syndrome. of medically of be kicked the therefore, excited multiple it's in, we see here scientifically the overlap But any thing,

So we here for vidofludimus have there make want preventing what of a that to second understand forgot use knowledge calcium treatment why and better a difference the what was. then, really to part on fatigue. And and we to also can patients option to extent that I and was the question, learn a to want

William Wood

Yes.

of to that or larger trials? CALLIPER type earmarking ENSURE might or any patients might on if understand post-COVID their translate Just how translate or to of sort for sub-analysis you're these of making these in just data -- going note syndrome

Daniel Vitt

if we not we maybe later top likely that, we Yes, extract also of data point. predefined as at not maybe study at safety see time that's will that It's but but if a have readout, And the the in a know, in the will up shows data, monitoring good the study. as I general line far point.

Jessica Breu

Yasmeen The the here is Rahimi next in one queue I from Piper have Sandler.

Jun-Goo Kwak

This is Jun-Goo for on Yas.

you to blinded different given CALLIPER in you the PMS ] And regards secondly, what worsening, subpopulations, has can can [ basis effect? and extent to you see for the experience on safety for to on that subgroup can, a disability comment treatment you detail efficacy? First, most which is likely CALLIPER do biggest

Daniel Vitt

Thank you.

the We me not on And first ] speculate conclude from anything we [ CALLIPER. data. blinded thing. We therefore, data start with see on blinded can't anything Let that. should the

far, study progressing is So I expected. the as hear what from clinical team, the

say. all I can that's So

On that's the point. good a sub-indications,

think is are clearly those higher, kind patients. the is on activity -- the disease progressive issue I bit that bit inclusion It's patients of and the generally, secondary no they we also patients, activity. don't predefined be given a we on the And CALLIPER: those there score, I -- have smallest X% bit lesions think, MS. think populations relapses, I progressive ballpark non-active think, the inflammatory the that that but in It's but placebo in for it's the we little little be still EDSS the should little in study. in therefore, same a have progressive there active sub-indications of secondary progress are in they of primary the patients SPMS still and you the I are non-active -- And progressive, lesions, expect study. to X a that baseline in secondary different, number that of think primary criteria those And progressive don't active the some subgroup disability. brain, given there so measure certain inflammatory for similar

Jessica Breu

Partners. from Leerink Khurshid one is Next Faisal here queue in the

Matthew Cowper

on for A positive in to vidofludimus' for what pending run see disability in data similar then, to with will you for good in in is me. have looking ratio Khurshid. Faisal we couple And any PMS? you a What there worsening BTKs registrational hazard accelerated PMS? CALLIPER This an opportunity Cowper the CALLIPER, Or be about is for in to Matt path PMS? potential for trial would feel

Daniel Vitt

assumptions, of Thank is to Matt. bar no you, predefined there now you what Yes. think show. right need I Hazard ratio

is had little benefit what is Andreas, medically it's of of they of And the that meeting not XX% too more around, And a KOLs my -- a KOLs everybody There protection, a we course, we with colleague, as perceive Of perception long something. that's team, was XX%, medical expect? the team. real the came And signal. there asked ago. At asked what the less you a some meaningful. questions our of or discussion okay, agreed a disability that if do I think bit on

of how with be FDA then, the expedited it difference, and that a things there's the distribution And subgroups on any the data biggest of the the having in accelerated no big signal example, and similar the way molecule. discussion win that's think strength, data but patients. And there, for the progressive the a the are hand on would secondary in the on better kind forward. we the the example, definitely the so an the that between of -- for a approval, line, for one and may forth, again, hard course. And in But the for and non-active population better benefit study for higher qualify depends So on XX% least opportunity. drug, at

a is that an guarantee this can't worth we However, try. definitely opportunity, but

Jessica Breu

] approval accelerated we two the had times Just for full expedited in on the chat. transparency also question [ here, or

this I answered guess, now. is So

in Kaplan is queue one Matt Ladenburg. from Next the here

Matthew Kaplan

Just wanted progressive to in PMS you stay MS. Can little little need the in study bit and on subgroups also the a bit as specifically talk CALLIPER PMS about unmet well? a of the

Daniel Vitt

asked. that Good you

And super currently non-active I really the need. one where for specifically important. we that there think highest of MS, can't is a this single progressive say there's is this And think treatment not secondary so is enough I the approved. areas often

also, as on option more add think And currently, But So, bit approved side complete for to a ], There's that have of maybe, we I but on affected number OCREVUS -- effect that. similar also color Jason, infusion. it's approved. just [ for you a on oral in good that Maybe, huge is same you comments -- -- patients same there, the of need. answering progressive where you the another to clearly only not unmet can patients. drug the little have that Jason, well it's have a primary an no bit as PPMS little question. And the

Jason Tardio

question. Matt, Sure, do happy so, the thank Daniel. And you for to

side huge So clearly, need progressive look, in a unmet there's disease. the of this

phenotype mentioned, medicines. know patients there's the major subtype, approximately MS that currently on We secondary secondary non-relapsing Specifically, progressive approved diagnosed no MS. non-relapsing as markets, XXX,XXX with progressive or Daniel there's the across X

more So total that it's XX% or treatment markets, as and disability, XX% know side, as progressive on think the There a normal note accumulation of one MS have forms that about both major body's or And there's of population. we diagnosed it's represents in bit the more immune progressive a in OCREVUS. MS, across that disability. just big of primary age, XXX,XXX is age. breakdown But patients is system. patients or the also the primary a opportunity, get these progress, representing only natural so approximately as the normally have I date about total and they're approved ocrelizumab, patients you little wear-down population. Also physical cognitive older normally of the disease, neurodegenerative into they important of They to to

B though approved, in putting progressive primary these right, patients, OCREVUS there patients about immunosuppressant, is is of depleting therapies. type these cell currently so, reluctance broad And some on

inhibition have play. NurrX mechanism selective is we of calcium, to uniqueness neuroprotective immunosuppressant. the very going the think activation And that so, given of highly very, again, its DHODH, of vidofludimus it's dual both not strong a It's and

forms become in believe of and it of approved, good show disease. progressive if we signal the standard could the gold here, a the So, care we

Jessica Breu

Can here the market on share details And share? the peak for of sales calculation regarding maybe the chat. Jason mentioned more you a follow-up question in

Jason Tardio

forms are Of of the to I that patients unmet major markets on multiple forms disease, worth that of couple A diagnosed can the XXX,XXX there a of Yes. across points XX-plus them with a bottoms-up get disease-modifying only about with tell a going we've be are and currently I'm therapy. are quite XX the this top-down understand to opportunity It's done total both intricacies of market medicine. that relapsing forecast not and capture. What of think respective today, of currently the therapies is lot the even relapsing into clear, for data XXX,XXX huge I a approved in the work to you roughly continues sclerosis need. approved, mentioning.

of So with an increases the be of it's are of a potentially especially their and young all address is young are disability therapy. ahead many Again, the poor life that lives. the disease. or severe signals if concern you this associated diagnosis, unique the between opportunistic and to patients. disease had There unmet most there's the common safety of These in the therapy, serious patients of that are are therapies, Vidofludimus to about that the prime many patients, a and why a diagnosed itself. tolerability of continued initial that They currently even was than certainly experience with them. the those the course, forms of causes risk an many could patients on have reasons and going people these a not infections available And medicines medicine potentially there's the their number to of of a of long surprising. the concerns. there's in some a malignancies, as also need worse a huge have on meaning progression, medicine in have mechanism these stop calcium concerns for therapy, of relapsing that have to early But reasons not patients lot delta

it becomes about the And wonderful in potential done And great shows think And progressive potential we of this And the so, has this mechanism, and efficacy, need bit and we the medicine. it this think the goes medicine, benefits of the that relapsing I've but NurrX we if neuroprotective uniqueness will believe without the clearly discussed, to provides little here, ad that the activation so a this this oral of we've market. again, of uptake forms safety side approved, that significant in profile side, ultimately therefore, research and the we're nauseam signals differentiate all with and that to therapy clearly, and the the a a saying, medicine disease-modifying of progressive option the all really without balance of category, date why it tolerability that's right? is will again, supports fill disrupt a hopeful.

Jessica Breu

any Q&A partner this big with a Jason. cash raises? And more to in looking we still have partner are actually for pharmaceutical moment? one for in Is you, negotiations tool. Instructions] Immunic Thank Or at [Operator non-dilutive you the

Jason Tardio

in is There to multiple you significant in late-stage So Daniel, interest for in there So, late-stage would few why that? development don't little imagine, therapies there's neuroscience calcium. I very vidofludimus take -- are even as and no sclerosis general. in

single we are where So one an specifics talking I and MS existing into interest certainly, in that, or of but will significant there's them. every not are interest. that can companies you I have get those that about around interest have again, at in negotiations, in to just tell an existing neuroscience, we companies neurology

I to Again, companies and look failures given think BTK recent calcium. relapsing increased market couple of the a have the of course dynamics the that interest taking for potential the many inhibitors some you of forms vidofludimus I the the specific the at the disease. has in of months, of fresh even over different the think last

discussions, nothing ongoing this point. So we're but provide in to more at specific

Jessica Breu

This you you, to the for closing questions. back for Daniel concludes our like session turn thank today. Thank remarks. all conference to the question-and-answer Jason, would I over any and

Daniel Vitt

Yes. spectrum potential advanced targeted patients. the always for end especially for lead which clinical Thank I and like of for here. asset, calcium, we everyone would excited are about good by the reiterating the call vidofludimus call elevate programs, thanks standard to your the our full Jessica, of MS care is pipeline to today you, how discussion questions on and the insightful to

as II trials. continuing achieved our this expected year, We while to are and look program next reporting line milestones we data CALLIPER Phase our trial with the from the in April of pleased with III top enrollment Phase in ENSURE have forward

update to expect our serious happy any I that, would close Thank today's questions broad are again of one-on-one. to for we array call. joining, potential we trial for like unique II and and answer made, is to Phase of also preparations additional its progress as treatment gastrointestinal provide very a Additionally, clinical you a disorders IMU-XXX an on for and of the beyond. With

hesitate So, please to reach not do out.

Jessica Breu

you Immunic's The Earnings Call. has concluded. joining call Third Thank XXXX for Quarter now

now may You disconnect.

Immunic (IMUX) 7 Nov 242024 Q3 Earnings call transcript