Earnings call transcript Q4 2022

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Jessica Breu

Good morning and welcome to Immunic's Fourth Quarter and Year End 2022 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 the call are Dr. Daniel Vitt, our Chief Executive Officer and President; as well as Glenn Whaley, our Chief Financial Officer. Instructions]. [Operator

reflect will, these I undertakes forward-looking remind revise be the Please of from more meaning that factors statements. words and detailed Immunic's Immunic's and as release to SEC begin, presentation statements that identified results or forward-looking and like only or of actual uncertainties date such the information contain events. that estimate of discussed of may that forward-looking description result a affect those note may new these future Immunic's as Such Immunic's no may, risks such would filings opinions statements we Please statements the materially number you to for this presentation here. of to these results risk in this by words statements. forward-looking involve any the Before or a it with revision anticipate, of similar and to expect, to light differ statements cause can obligation publicly could refer

to the I like the Daniel? CEO Vitt, to turn Dr. now presentation begin presentation. our over and would President, to Daniel

Daniel Vitt

related would highlighted end recent welcome sales activities as this and like our I to as Immunic's fourth development everybody to quarter milestones year clinical the for Jessica. you, we announced Thank December ended XXXX XXXX XX, also Earlier call. pathway. financial earnings to morning, our and upcoming year well

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

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

inflection of Unfortunately, the which doses into we compared the bolstered subsequent the preplanned show of patients October, moderate did quarter both a million closing data group review XXXX. our trial clinical runway which psoriasis. value not a a balance X of fourth points financing, placebo, fourth to our us. surprised with and of October, with level in our quarter a and have of our tested interim active with several to pipe highlights. conducted IMU-XXX Also in of severe mean we analysis $XX through disappointed sheet extended benefit Phase In start Ib the XXXX Let's

active observed. the Although experienced were placebo received expected a arms in administration well OCRA new and line with IMU-XXX the and performed in decrease trial than arm. no placebo signals tolerated expectations, were greater the safety and of The well

Medicine Throughout in R&D ongoing X opinion a our sclerosis. the of the of Germany. in vidofludimus safety levels program. year tested favorable these of hosted psoriasis Hospital, Steinman MS University vidofludimus We in Given School well very to dosing Stanford development and to were webcast, at from Medicine Icahn dose Dr. future to the program from profile treatment on to-date, Lublin multiple Switching In periods. explore we we virtual the we on patients excellent have drugs end X clinical to renowned first School and pharmacokinetic University in of IMU-XXX Munster Mount in parameters our also lead updates Heinz Fred next tolerability of based of steps only the including and this MS Dr. Dr. featured leaders; November calcium higher different which and the from as quarter. Sinai for further this asset plan longer guidance towards program testing, key provide potential continued calcium Wiendl flexibility as Larry

treatment the landscape. The experts on effect recent MS scientific discussed the findings and

for data was blinded relapsing new R&D EMPhASIS Phase extension from vidofludimus of II The webcast, update in we data an preclinical on our potential treatment and the highly in associated disability neuroprotective the Immunic and calcium effects. to its MS a vidofludimus underlines vidofludimus of clinical established Additionally, addition In over the conjunction trial vidofludimus to with rate compares calcium data scientific progress showing low calcium's data in part already sclerosis. antiviral anti-inflammatory Overall, nicely was that trial favorable reported open-label available encouraging time, provided and historical multiple of remitting MS. with which confirmed long-term MS worsening currently with of medications. calcium this

management Rochester, and February as Joseph In of to well Schumann focused characteristics dynamics options. role to on of disease; the and connection Dr. including as R&D stimulation held the Murray clinical Charite at epithelial from celiac we its as Clinic Berlin this symptoms, Immunic's pathogenesis renowned of from well barrier autoimmune potential disease this current the year a as the experts complex Dr. the X and of the team the of webcast, multifactorial disease, Mayo celiac discuss disease immune in the treatment Michael

excited the clinical also We and and unmet continued about of need potential touched medical of effective on status, a therapeutics the status remains are IMU-XXX. preclincal for development IMU-XXX. this the disease new There we for

to recent XXXX with treatments again and that quarter of point was progressing out confirmed ENSURE associated a favorable summary the data I Phase rate Fox who ago, in of year that for This highlights. reported blinded our disability the vidofludimus presented from programs. prestigious calcium MS. also data of showed new extension our CALLIPER moment ACTRIMS label coordinating a with time. and to the treatment That of November by over compared trial EMPhASIS parts concludes and data subsequent is being calcium referred like XXXX vidofludimus from As the fourth remitting long-term last was II relapsing current of open of investigator promising to Cleveland the data low we Forum historical Dr. our is the Clinic, today and Bob would at in MS for

overview. now I to turn Glenn would to over like the to call provide Glenn? financial

Glenn Whaley

financial ended Daniel. year XXXX. operating you, XX, review will Thank and for results I the December now the

the with start me overview. Let cash

the investments, in XXXX. of we will mentioned, $XX quarter, into to we during which and fourth be As $XXX.X expect year quarter ended cash raising after with sufficient Daniel million fourth the fund operations the million

operating million months XX expenses development mainly results. development $XX.X the ended XX, XXXX. by compared XX December the were XX, months the was Research December for ended for driven million to and The to of to costs costs external was increase XXXX and colitis, relapsing as Regarding development MS related COVID-XX. calcium, Phase ongoing of decrease a and the related and vidofludimus in in IMU-XXX offset external IMU-XXX partially II ulcerative the clinical trials calcium by clinical vidofludimus trials remitting $XX.X

IMU-XXX in XX, for negative interim was a from tax XX, expenses million attributable clinical XXXX. interest in of by which incentives as of mainly XX, XXXX The Ib on clinical ended personnel were the of decrease was ended December General driven million of million $XX.X compared increase of a ended $X.X December XX, announcement quarter Other trial fourth in level which impairment offset XX, represents ended The and our the stock in charge write-down the compensation. XXXX, October R&D the primarily as noncash for the of XX same goodwill same period in trials previous by $XX for was recorded million psoriasis administrative decrease for million This Phase expense, was related impairment months $XX.X the to to and in noncash to of expense December compared grants. Australia, income partially XXXX. increases negative months December which was for expense balance. $X.X million $X.X XXXX. XXXX to full We period goodwill data group resulted the a XX

compared XX.X Net net million outstanding a or December XX.X was $X.XX outstanding to average $XXX.X $XX.X per or shares basic loss diluted of for average XXXX weighted common share on weighted common shares loss based approximately XXXX. and approximately period months the December approximately basic the same XX based million approximately ended and $X.XX share for XX, ended million million XX, diluted per on

turn back on over clinical an for I'll milestones. call that, Daniel? With the Daniel to upcoming our outlook

Daniel Vitt

data Thank our you, an now would on I upcoming provide to readouts. update like Glenn. anticipated

MS Phase ENSURE and II in progressive continue to Phase CALLIPER III Our relapsing MS our enroll in patients. trials trial

current data of to XXXX XXXX. second of line report the CALLIPER half in top data analysis Our at interim is expectation biomarker trial from the end of the the out read and to

we out program, XXXX. first the report from as ENSURE guidance the and, of For expect end trial new we interim the that late the ENSURE XXXX previously of added read to analysis in data to announced,

noted ENSURE relapsing program the clinical placebo-like so tolerability observed activity in a and vidofludimus we design far us the MS. based have safety calcium's path strong of previously, approval that gives on towards in the profile, As regulatory direct we believe potential

unique The CALLIPER trial could combined to by adds to anti-inflammatory, additional the targeted effects. neuroprotective program MS and MS option beyond potential treatment Vidofludimus differentiated progressive MS complex potential of RMS. a pathophysiology represent its antiviral in calcium our

recently Organization. psoriasis of received of towards izumerogant provide earlier, already update this from an Of to proposed note, quarter. World IMU-XXX we development Health mentioned nonproprietary on IMU-XXX international As end the the in name potential next the steps plan

next data from when milestone randomized trial Phase line this mid we the celiac to our clinical will top in disease C double-blind of clinical patients. I placebo-controlled of Our be IMU-XXX Part year report plan

Part of or treatment of once of with of XX safety during milligrams days C assess placebo and is gluten periods designed and and XX during challenge. to IMU-XXX tolerability IMU-XXX XXX gluten-free daily diet

network evaluating and acute and acute acting epithelium. immunocompetency. intestinal to symptoms. including while IL-X epithelial molecule IMU-XXX and celiac markers, and intestinal form genes restoring adhesion include available and the and and well influence those maintaining function test gastrointestinal is barrier proteins architecture as with and cell It of bowel systemically objectives pharmacokinetics response tightened disease an chronic regulate on small preclinically orally to Secondary modulator as function disease the the regulated barrier intestinal regenerate appears associated interaction biomarker

entirely celiac IMU-XXX associated therapies. with serious of an the that indicate IBD new of all IBSD or gastrointestinal characteristics for could These a including diseases and approach immunosuppressive treatment with represent number consequences innovative disease the

This open for brings the Jessica, call presentation. please Q&A the of end to session. our a us formal

Jessica Breu

and and through points. walking inflection upcoming well Thank as subsequent Glenn, value you, the quarter [Operator highlights Instructions]. XXXX Daniel for fourth as us

Rahimi from comes Sandler. today question first at Piper Yasmeen Our

Yasmeen Rahimi

makes be to again -- say this you. looks year fulsome understand so why has quite XXX year think that of really and at to is actually Few excited and the of you step the time decide look to as be or a questions of can there us you a steps, that gather help for analysis us we're really that full of encouraging. And that you're when us how taken data for that end, going to end very next like it what at we is? opportunity maybe Could and kind the end involved the Team, not step the quarter. reporting data bit is data next data going

you also ENSURE. there. And have could provide if So some color I questions on then some around

Daniel Vitt

collecting an still forth. package forth. tissue, samples data analysis. a and for much that time with that's Sure. is was reported of question And group-level at I before big are important biomarkers; really we This we database was what the It's maybe so unblinded start remember and log so know this data looking And and ongoing. so

things these it's and for here. that, nature but the time of take what sorry we're So doing

you decisions and the as we of to then designs want that, And that time for at on to Regarding it, make the right we expectations the the of I the deliver in point very quarter the of make mindful have that be way and try to give a end smart that, forward. data a we together behind decision-making always guidance things to that end. go and think decision right hope on at know, rationale proper really based I

Yasmeen Rahimi

maybe And clarification for a question Daniel. you,

the looking of rate, into interim does late And the fall the be XXXX confidence been have so second is that basis to see that you also like very of seeing that going data in and starting investors question that and conclude eagerly XXXX? like expected data move forward analyzing Are or very does of you a can disease that ENSURE is really signals Given slip in you not lot is progression that we level we a guys -- as sort to not the into how then steps, into manner proper? figuring very most confident on the thoughtful late you're analysis that XXXX. encouraging that event next the will one. comprehensive had I That's around of are

Daniel Vitt

everybody It's implications. that and would So of once end more thorough job the until quarter I decide to and give everybody about first a I of should of do again there. be XXX learn update a has we the the patient to know all, on what just to I think like to it wants couple

X the thing For example presentation, and As design of is continue duration that? the dose the forth. in design strengths What if what treatment one we is be would the for right said for on I trial, should that? right look so

decision-making So to here. there account take into for are of really things a lot

confident ENSURE, of the are of I data ongoing deliver don't course trial. I the we pretty But off think On see interim end can this we from of an timing analysis 'XX. interim of coming

is said have we far, interim eventual know we as the this of So should around an But past, in just, in is so call. able really the we available to data what readout. said end we be 'XX

Jessica Breu

Our from Securities. SVB next guest is Smith Thomas

Unidentified Analyst

for Smith. is on quarter. progress Tom Congrats This the the during on

We have a few questions.

first follow-up. The expectations have when initial on Phase IMU-XXX to MOA the What review mid-'XX. are a expected of one do And plan we celiac data you of I your and the the IMU-XXX? with data in

Daniel Vitt

Good question.

look it's we after to far. starting the for of after the can for on gluten the page So this had robust and and we be call half that second readout expectations, in the a a weeks the gluten I as think time of gluten the R&D line sequence that a day then typically is to recording what would on way. Even I the whether expected X so chance here we're challenge follow trial think the by in challenge. had we X another done listen extent the design, gluten days treating most starting home hours this half everybody We challenge IL-X without to think challenge. that available block and to And XX with this

levels. block And the restore able see derivatives system, we a immune settling of gluten gluten the CR basically are to and of You of measure then function the then barrier to the amount and we IL-X based should if reduced IL-X.

first the that's thing. So

was there Yes, a question, second MOA.

context very on sure target the been just But As the you -- on our competitors over target works. to presentation have advantage maintain surrounding that little it bit to to have right make do plan that during and or of we the and scientific quiet we the disclose we that knowledge would know, scientific how year, environment. like potential so but a of conference in of we has this the course we a of of it

function out more after come I of not the that we So long will the with data after maybe action. proteins, the target system we on drug have [indiscernible] think for too likely release action have tier gene to regulation the barrier shown of we able in aspects example moments. affecting mode details the of mode some Despite the of the globin is quite assay and where and shown importantly that restore

Unidentified Analyst

Got PMS interim perspective it. indication? look in That asset potential most And with calcium the and CALLIPER what would what makes you vidofludimus sense. the second data data like this in from gives in the expected like the that confidence in then in of your half,

Daniel Vitt

It's important Yes. are that question. Thank out. you to for reading what know we

of focus clearly I think the this readout biomarkers. on is

so unmet far. need. those. of worked things a have not of And something a a as It's couple progressive will know, where We MS lot is you huge

PMS difference this be atrophy endpoint clearly active a from will interim of It's signal any important segment we primary 'XX. meaningful at a there. This the different of view. biomarkers. it my And just would and be To the out the is the then of prop But here. and an to placebo point statistical trial brain is we that the is which remind for seeing you between in medically the be between on end see is read is do really focus here and expected subsets change more in question looking placebo see trial not typical of a readout. there's analysis a success So

the important what to to potential at the of So judge end the goes which I pieces these vidofludimus of extent III program, think Phase parallel. beyond RMS we're in are all running

Jessica Breu

The next from Kaplan Thalmann. is Matt Ladenburg one

Matthew Kaplan

near-term clinical Just some follow-ups on your of kind milestones.

IL-XX that drug's excited first get and about analyze you impact drug moving there cohort, was as what the your looking would on terms that the the there are you in at Just of forward? psoriasis expectations reductions XXX from data

Daniel Vitt

at. not [indiscernible] on impact are also it's relations looking think on overall only we I IL-XX, looking it's biomarkers

kind potential would forward to forward. like what other difference the and to us see to I some able ideas like dosing and so The a groups to thing guide on going forth between be is conclude of

think, dig my tell that's So work But can't be I that into would more expectation. right can on all I the ongoing now I details here.

Sorry for that.

Matthew Kaplan

a potential perfect. ENSURE this No, or helpful. futility then analysis outcomes go interim? of Is follow-up And in That's a there? What are the just the terms analysis the analysis. will what on interim type of on of

Daniel Vitt

see analysis. half on ability we adjustment a reached Yes, do we that sample do us futility size that and in pursuing is to of events It's when the more not what looking the giving timepoint.

pre-designed So here. that's plan the

as It's at... be reading will it really something that. like So a not handled looking termination or

Matthew Kaplan

a sizing powering of more analysis. It's or

Okay.

of Now thanks progress. the been I But have other think questions on the some covered already. and congrats

Jessica Breu

Wedbush. The Argyrides Instructions]. one [Operator next Andreas is from

Andreas Argyrides

They've see or going quick actually And extended less higher but the this to terms any that just point, follow-up modifying could at including in XXX. the been more exclusion are be you implemented potential I in to period? on criteria? patient a Do maybe asked treatment all or there changes any population dose of be to Phase

Daniel Vitt

those the Yes, things on all of team. are

something options are but it's started and the follow would again X-month this because XX first of table. the doing. able limited were decided, X not the the of on package. we in dose the we trial, the days on we Once strengths to meanwhile dosing on which to safety for treatment We which the is principle when for weeks, consider some So preclinical package XX completed it's

have and and getting is for reason understand is here other which flipping patient why what the primates, seen. that's that every increase spend That these carefully some we there course ability course. of course activity. reason wrong baseline, to on the we things. a are different And really stone placebo the doses. important that the we stone was to what every looking is needs evaluating are also we placebo can of And have part the characteristic thing the have something time to high need something Second that's team an risks activity we on on exercise and of dosing of of And something is potential that And is the or on look all bias where higher a we here. on to do,

Andreas Argyrides

progress. all Congrats Okay. Great. the on

Jessica Breu

one is And in from have the we person Riley. more Mamtani queue, which Mayank B.

William Wood

Wood from This to is today. nice a follow-ups on asked. couple William on on the great work Mayank here. everything. more of I've see Mamtani Really have continued got others what questions, Congrats

data? For will give be stated sort term what get the CALLIPER, could provided data I Maybe X be same going also extra get be also before, interim look progression? us biomarkers? biomarkers and we providing you data. then full these provide color and to just safety. the set little it Is just then Are going of biomarker to be probably we we'll a to an line for mentioned to you'll top of those any verify, in GFAP you on of expecting? some also And mid if might NFL functional end idea that just believe you

Daniel Vitt

data others. some GFAP we I from not example advanced And very absolutely an I the of for newer may course markets will at there. activity that on the biomarkers think we're And package, you these looking may promising set and major think look readouts the also at. are we right that this be you're had II, remember to timepoint. trial NFL, that Yes, Phase of have functional X in so some added been

done is have will interim the -- XX% treatment. of reached patients the when think be done XX-week I

patients. for information that benefiting or want it's treatment And substantially secondary difference you, of early So to of remind for primary and therefore, biomarkers of that's from to opportunity other kinds the consider the between example course trial. an other, are have we really progressive subgroup X check to us do completion interim an placebos, we give to which such patients the patients extract think just we in the is the the the X this to better the maybe readout and X And kind. is just a we from and trial active in also enrich trial, different this best suitable at more see have the and the the we placebo here may whether And the than analysis.

William Wood

at then we the will the same of the trial datas, cetera, also? actually And the get same end et biomarkers,

Daniel Vitt

I parameters on on forgot changes mention may Yes, Yes, important very also the biomarkers to of different a all there over that time of time, and the this evolving part interesting right? the story sure. course it. is of look to an readout and be over

William Wood

following have wiggle forward plans the taking or meet BMS, the the adjust just this, Excellent. interim And needed? of ENSURE to based with step for may adjustments both readout. SBMS. FDA biomarkers some had you receive be on there then just for just potentially any sort how path some to Do trying a that mentioned understand this to room then might further I'm you CALLIPER on and following they if that

Daniel Vitt

our right analysis, it strategy the No, think. influence this complete later. decision course the There to going the set internal the will for discussions is data plan no with then but have and we FDA forward on now is of with interim talk more I will

more the than of looking this. formal So on that's way

think understand so are underserved it's all as us I so things worked important and it's what's why not low far and there these readouts. not really coming many science the because hanging For totally we interim it's And a fruit area see excited that's out so to things we're here. to doing a

William Wood

And Makes if sense. I last X then may. one,

also it anything to just proceeding going been up? details give little event any down even ENSURE, primary how on be area is based it has our determined, driven, a us or to enrollment. you on but the currently is if enrollment is commenting readout speeding be interim the that mentioned slowing You've for on it's CALLIPER? for Could Maybe

Daniel Vitt

Yes.

enrollment never if start know, you have in it's really because something the other guidance we every on past you then that as race, on we gave week questions status that. think I

on to our we guidance the So readouts. stick current

in we you give means see what that. an Thank update course we changing, both much. That Excellent. that again. as that expectations out we that will and so of soon recruitment it. on trials as So are need on we to somehow figure Congratulations do and with we satisfied are

Jessica Breu

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

Daniel Vitt

and Phase in portion Thanks, your remain to MS Jessica, well multiple and programs much million we runway second questions. the are look would Again midyear. reporting close clinical of the you call. To trial very you With of on in our funded the Phase additional our for happy available thank of I fourth II XXXX. calcium of Data quarter year. half our today's we is through attendees patients to We expect progressive today's to like expected insightful milestones vidofludimus IMU-XXX data be data sheet with CALLIPER from to $XXX.X I that, clinical disease providing for interim into very clinical forward we in trial one-on-one. this our questions Part IMU-XXX this summarize, any year. balance vidofludimus thank very us joining C of from calcium much the answer to and of to celiac analysis report Moreover, from

Jessica Breu

XXXX now end for Immunic's earnings webcast has The concluded. you year call. joining Thank

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Immunic (IMUX) 23 Feb 232022 Q4 Earnings call transcript