Earnings call transcript Q1 2023

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Jessica Breu

Good morning, and welcome to Immunic's First Quarter 2023 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. participants being in recorded. all this mode that is event note will listen-only be and Please After opportunity to presentation, ask today's there questions. will be an

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forward-looking future Immunic's Immunic's these revision revise events. these the as Immunic's presentation it statements. undertakes statements reflect in Please no of factors more a that Please information the note of description risk the statements release detailed this to results opinions that date or new filings for these to publicly results and only obligation may SEC forward-looking forward-looking of refer affect to or light of in of any

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Daniel Vitt

clinical welcome to XX, announced progress first an Immunic's March milestones. upcoming everybody to on provided quarter call. like quarter would results financial clinical our we update I for This and development earnings Jessica. morning you, the and Thank XXXX our ended XXXX first

operating milestones. as subsequent through we highlights, well our as During financial first quarter will clinical today, XXXX walk the anticipated and results, and webcast

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

Let's start our subsequent with review quarter highlights. first of and XXXX the

Berlin. February, Schumann Joseph in Celiac Disease reminder, Charité a Dr. from in from we experts, Michael Dr. Mayo Murray Webcast, namely which Rochester two and the included hosted renowned a Clinic R&D As

the characteristics to included in of immune and well autoimmune options. including complex of the its discussed connection the pathogenesis symptoms, the Topics as the barrier clinical disease, disease role disease, treatment celiac and potential dynamics as current of the multifactorial of this stimulation epithelial

lay The of result the in Ib of intended clinical Phase to patients. our celiac was R&D groundwork IMU-XXX Webcast disease

As data most know, in you published I will May, for the which clinical on an of proof-of-concept later excellent a in set few IMU-XXX, to get moments. provide data

Also is and open-label of the from to blinded Dr. in our data trial who relapsing-remitting our parts co-ordinating of February, presented II insured also Sclerosis, note investigator extension and Fox clinical MS. in Phase from calcium Bob of Clinic, Cleveland programs the Multiple in vidofludimus EMPhASIS

treatment would long-term compared XXXX, favorable of At prestigious that low effects. I to was neuroprotective MS' calcium the again calcium's to worsening disability vidofludimus treatments of that antiviral confirmed current like and vidofludimus with ACTRIMS data and over its the with showed a potential addition established data historical point associated anti-inflammatory out Forum time. for underlined already This rate data was to nicely in

our Phase to significant in and of CALDOSE-X Ulcerative safety as Calcium activity extremely Last they the Moderate-to-Severe patients month, in tolerability IIb calcium These encouraging with trials. were statistically observed as UC. phase of while favorable from profile or the of data we vidofludimus Trial positive results maintenance very other compared confirming demonstrated reported Vidofludimus Colitis placebo of

data that of maintenance believe we vidofludimus important absence phase activity confirms the is to in corticosteroid note co-administration. It chronic calcium

variety creating for a previously outcome we are indications. based on options and other value – bowel of the As disease point program encouraging announced, UC exploring inflammatory this

multiple clinical has Board clinical a Directors. as including successful expert multiple a and Dr. welcome Rick Rudick pivotal I of who our Richard studies. a sclerosis also in overseen has decades as once again would background like stellar to to spend trialist

calcium are to with programs. the Rick sclerosis well we as of board forward working continue vidofludimus him and look multiple delighted development pipeline to our with progress other on We in have our to as as

Ossipow, at his thank dedication down I wish the the our is from Dr. June also I and guidance our when for past in his Board years. of who I Vincent end to valuable well team, stepping his endeavors. seven entire him speak want for to over Immunic say future

aware, clinical from As positive disease gut portion our celiac the response are four exceeded we key many nutrient you demonstrated clinical May improvement enhancement in of pathophysiology, significantly and expectations. patient highly I IMU-XXX IMU-XXX consistent results of patients and This our protection data of with of biomarker in improvements Part absorption. architecture, or celiac trial X, dimensions placebo of specifically C announced of meaningful of on symptoms, disease. Phase

IMU-XXX among or intestinal unique in safe celiac to and gut appears approaches, was which response the target and well-tolerated specifically disease processing. this mechanism immune the importantly, destruction, part for Most the from also be in villi lining observed proposed trial. be of the immune antigen protection independent first of observed targeting involved of the therapeutic to either gluten-induced

disorders data but ulcerative provides colitis first-in-class as bowel irritable Crohn's in new an way celiac represents game proof-of-concept approach, this a entirely disease such also impressive diligent IMU-XXX believe diarrhea. therapeutic the with first set could changer which or molecule We oral disease, we treat syndrome that be this gastrointestinal

the about enthusiastic potential for extremely this program. are We

its pleased news bowel on ability function Disease we clinical unveiled for studies time, Digestive additional Saturday, first has animal modulator shown mode and and in as bowel and protein a IMU-XXX architecture. action were our of we the Week last IMU-XXX the wall of epithelium. intestinal to barrier Just potent e-poster a IMU-XXX program. function which to restore intestinal In serves a in of at transcriptional SIRTX, of regulator Through effect on SIRTX, have as barrier Chicago, regeneration published presentation

overview. first That our and like a quarter to the provide highlights. subsequent would Glenn? now over concludes to recent XXXX to I of summary hand Glenn financial

Glenn Whaley

XXXX. the will operating first ended review now I Daniel. March the financial for results you and Thank XX, quarter

overview. operations quarter fourth million the with expect me ended of quarter $XX.X we XXXX. cash first with cash the We sufficient Let in investments, into and the to which be will start fund

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

ended million offset for the million as period compared by compensation. $X were expenses The administrative three expenses March ended non-cash-based and decrease to XXXX General was $X.X for XX, a XX, in and increase XXXX. partially by same stock driven March travel was chiefly months the slight

Other $X.X compared Australia. trials principally $X for exchange increase million incentives clinical for R&D XX, March three ended in and income offset was attributable the interest an tax incentives was million income tax to by same in ended period XXXX. was XX, partially XXXX and to gains the and months the for as March The foreign reductions German increase in

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

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

Daniel Vitt

Yeah. Thank you, Glenn.

provide anticipated clinical update milestones. upcoming on Let our an me

progress vidofludimus continued we to the of calcium quarter, During first sclerosis. multiple the treatment for

in trials studies Phase the include III II MS ongoing Our the twin ENSURE trial progressive relapsing in Phase CALLIPER identical MS. and

calcium current The trial of potential corroborate CALLIPER progressive be additional in a line expectation calcium XXXX if patient designed neuroprotective top biomarker in differentiator and at the and could second to half trial interim population, vidofludimus successful the the is our to market. the it end of from the important progressive Our data vidofludimus the in data to an XXXX. this is CALLIPER of for MS report of read in analysis

our Phase the ENSURE at end forward Additionally in analysis out interim Phase year of read of III of III to relapsing we ENSURE MS reporting from and the the first late program XXXX. our look to next trials data

stated the solidly on and sclerosis. and a clinical established has effects we neuroprotective strong and to date unique observed it activity the be anti-inflammatory, far, profile complex As the tolerability thus we continue based targeted that treatment the to multiple safety before, of pathophysiology believe, vidofludimus antiviral have calcium to option potential combined

celiac program, a with Xb for positive IMU-XXX in have ongoing overwhelmingly from of clinical our as result disease disease, With in to patients clinical Xb Phase the IMU-XXX, preparing active begun trial we our Phase patients. data of celiac trial regards generated

oral this at the clinical additional other time first-in-class disorders. in considering for same gastrointestinal We molecule applications potential are

approach that we IMU-XXX, program As the excited gastrointestinal a entirely and therapies. about very oral diseases immunosuppressive with this believe could an without consequences present are associated treatment number for new of serious stated earlier, and innovative

the This brings please us for quarter overview. XXXX the Q&A session. first our of the open end Jessica, webcast to

Jessica Breu

for and our the and Yeah. the XXXX you, also Glenn subsequent Daniel and quarter Thank through us walking highlights upcoming first milestones. clinical

today begin from Wedbush. [Operator unmute Andreas now Our and the yourself. first at question Argyrides will Andreas Instructions] comes question-and-answer hello, We session. please

Andreas Argyrides

And here. morning. for questions. good taking just I'll and Hello thanks two ask Yeah. my

the could so, into, So you the SIRTX. targeting insight additional If indications. first to confidence drug And which you Thanks. along you other knowledge, work Can being same IMU-XXX ones? lines, this see do beneficial IMU-XXX is indication? this in provide our just gives what in

Daniel Vitt

I'm is, course what not. more are clinical you, have of mover pre-clinical very for glad Andreas the really Sure. Yeah. that I'm Thank trial, that first in less challenges before This so. doesn't showed seen a works Yeah. if exactly or interesting unexpected. work you in or area or we an And the not question.

Phase we And we the Xb exactly have is looking recently shown have on what data, seen.

seen have of example, Villi. we for So protection

some increasing patients, in challenge seen even have study. Villi size that despite design gluten We the of the of

impressive So and histology well. the as the data pretty on functions

we that being you, remind an increase have to BXX just short-trial. for So vitamin already, despite in a example, seen

said, confirmation And a EDSS we preclinical seen have work as lot have seen exactly that findings. including is top of a have So of where and done what we on that, so model of preclinically. wonderful forth, I we those

And action from else not is what this different this of is on is immunosuppression. of and mode there the including kind any very I think thing it's nice

the be could activity. we start could -- of think, start really broad this very a So

question of second the we have models. colitis indications, the for So in most preclinical done work other

of us the from indications believe and that Disease So makes the we well have should data believe are clearly as a Colitis such Crohn's patients treatment. an Ulcerative we benefit really that, holistic view where

be be achieve to patients from a protecting higher And different rates everything could completely -- given remission that, out effect patients very approach from for down there, of synergistical a and it's really the it relapses nice road.

Andreas Argyrides

question. I'll queue. my taking for hop back Thanks in Great. Okay. the

Daniel Vitt

you, Thank Yeah. Andreas.

Jessica Breu

Thank you, Andreas.

our and Rahimi So guest Yas, Yasmeen Piper today unmute from Sandler. is please next yourself welcome.

Unidentified Analyst

tighten Yas. are Hi guys. first, on questions few XXXX? you this are for to the to guidance XH you or Lauren data. This of remind key the of you CALLIPER planning when interim can us And planning us, the in if A utility is from

question, other second in an for opportunity the from evaluating GI our have regards share to then you data the study? being And with details? Phase XXXX design do meeting you And the then, expect is Thanks. done the be when think what FDA diseases? work that and Xb IMU-XXX And to do to will

Daniel Vitt

remember the need I question. to you. Thank first

Unidentified Analyst

one was first interim the CALLIPER. The

Daniel Vitt

right. All

more right a will now. gave we keep of out this that about guidance If We precise knowledge year. as timing, is second we with come half so. it So the have it we for

Unidentified Analyst

is what included? And

Daniel Vitt

okay, what is yeah. And included,

a which differences patients, us secondary than benefit of primary biomarkers looking on on key So calls in clearly NfL we MS. the of that to have to interim, which in this an for insight planned readouts more bit that the and subset on of I of the little the earlier, extent of is on pair interim levels we biomarkers I treatment placebo potential looking the for groups patients patients -- what just on think stated the the some focus the and we're the progressive GFAP have state-of-the-art patients should think with in and also give and

So that's have mentioned that's the what we in an course the so public. important on FDA of far Then point.

working on. currently I the is team think,

And the got so just data. we recently

because filing we X quick we to use for quickly then be try we that the and US, design. proper submit Phase findings possible sure point regulators. we including And IND have and So our want to with the as And on the really discussion some feedback as design the starting in very the of the the as make think protocol in trial. in,

the regulators. released good year. -- that's the FDA any be a think starting guideline and the X that familiar I for the point may You last company Phase draft question third studies for the was discussions within celiac that, disease And And

Jessica Breu

Was diseases other GI XXX.

Daniel Vitt

Yeah.

the I think making. more in that's

we'll Part I C is I time in we study on I given for think, think space. first high fill think I real got from definitely the celiac we and very small the data the is outstanding definitely resource very also, on us reasons approved. encouraging celiac. need the And There Phase to medical treatment the focus no that

gets So all of of here one as view, we colitis consider those a first bigger I I of indications will example But if indication. these forces do indication. on the think in a from as should But driving future. point -- the the prioritized you Crohn's But excitement don't more much want Crohn's pre-decision are be biology celiac for to value next as make what towards for indication. a and course, example

Unidentified Analyst

All right. guys. you much, so Thank

Jessica Breu

Thank you, Lauren.

Daniel Vitt

Thank you.

Jessica Breu

is Kaplan un-mute Our and from Matt, Ladenburg. next yourself, guest please Matt hello.

Matt Kaplan

Thanks morning. Good taking the Hi. question. for

with Just positive are colitis? celiac, continuing I of kind on in their and forward I for XXX, and a And results of et guess given action combined in clinic data XXX ulcerative programs the what for action had mode announced the thoughts indications the cetera? based your that and disease, guess given these moving you're about of mechanism the you on in also what thinking little recently XXX two Crohn's colitis potential how bit. overlap

Daniel Vitt

is between a the think concepts. synergy there I Well,

for for another you not same you in often an And like bit is still action. how all patients if looks how and rates allow on mode they article you despite are goal. XXX success on the ceiling delivered it induction the clinical are look remission what and how a the look just shot -- trials run switch therapies effects. through treated of said on example, really of they landscapes a that I see It's As of treatment all little if current patients what

on but demand a a of actions is XXX the place. There inflammation for different very from mode new really comes side

it It's I of than another thought we all So current add just more we treatments. combined which is can fundamentally can my the think can something -- be approach. with

available. safest it you to course, maybe combine something are which Of in like more and with treatments makes XXX the see currently sense Crohn's

resource I it So world, more potential. in And a I trial. That's do there's can't think a question lot perfect of combine the would and you every both. funding just

statement really not really talk piece something can which CEO example. and lot So we innovation just from coming experts you're we being and And goes of I the overoptimistic just maybe be here first But normal that and see of delivering at single-agent Chicago activity game just Garden really to have sense. then I look I a important among said approach. the beyond looking beyond View, makes XXX from as this is a step-wise I something here. maybe for changer. feel It's where excitement

Matt Kaplan

on interim of CALLIPER Okay. you could study. study And conduct the CALLIPER -- results impact spoke forward? look then How the going interim the helpful. the about That's the

Daniel Vitt

Yeah.

it. think populations I kind said I we different as of two have in

are So a the there, patients is secondary and all different secondary -- little active is these -- history see nonactive see progressive we progressive know will majority and so. primary we are all what don't progressive because there the and patients. diseases they what And of and they we bit different non-active

effects during need we of And completion the also trial one or of study to will we ones for Do will specific the prioritize set the information content see placebo the active of to other between the said the increase subpopulation. We but compare sub therefore, example the as the full I -- we different for with indications on more ones. active readout.

Matt Kaplan

Thanks taking the Thanks. for questions. Okay.

Daniel Vitt

Matt. you, Thank

Jessica Breu

Thank you, Matt.

anonymous more have We an attendee writing. two which from came in in

for The will provide to subsequent Xb first patients XXX, you the Phase one update? follow and a continued

Daniel Vitt

that. would was proof-of-concept. to this But intended Actually, love demonstrate point. this I good to planned is have we planned when a just not trial

X, have running, don't you -- Phase we the these of here X as know, we that. this studies in we Phase So, follow-ups all have we're

Jessica Breu

the to It a also, Thank of Okay. And disclosure lot does a quite the you. novel. folks. I target was surprise nice think second seem one

a So other the companies on bit this working talk and target? there more can you target are about

Daniel Vitt

context. Yes, is and it. lot my there a company a there's are. Therefore, in a lot target. This there. target Thanks really for Israel, Yes, on in to one working other new different ongoing but the knowledge

originated -- or scientific observations Here, phenotypes. this from our we work

regulator. as epigenic which lead specific specific phenotype is looks things, is phenotype. it then of different the renewal to really that like intestinal binds SIRTX causing in to an the it's of protein, which And way And a a molecule a lining. And a a couple XXX

a that process. You know is renewal normal may the physiological

on So in And they intestine with is therefore, But are this a and cells this is not to gut damage to a really -- healthy day a disorders, enough renew and goes patients process. heal stem replicating once human the sufficient normal average. process it, GI on. in these

consequence, which X So was therefore, I disease. structural And barrier And that effect, yes. nicely it's key think the it's to not And a less to function. mode restore Yes. shown achieved ongoing leads that and renewal down action. this should intestinal a of study, symptoms by also is lead in as Phase -- here this we repairing really

Jessica Breu

Thank you.

please Smith have more one in queue yourself. Hey, Securities. from We Tom, SVB the here. unmute Tom

Tom Smith

Good Thanks the for questions. guys. morning. taking Hey,

Jessica Breu

Good morning.

Tom Smith

Yes. Just a our end. couple on

us been about data? you you broadly on remind any business opportunities across uptick in disease can XXX? XXX on the whether there's just thinking and development. partnership inbound First interest And comment you're Can how on celiac

that IMU-XXX we can time about us program, lines? about Thanks. How side added pipeline What can we program? this secondly, a you when And hear on this diseases. this? expect GI tell development to then are more on thinking for the you've And you noticed new

Daniel Vitt

Yes.

I the release that to to and opportunity readout we I speak the you to And Academia and hospitals the I think And have pleasure -- thank industry data also question. action the said, of in of companies. took the Tom as that but for players close attended had DDW. mode care also

And think another is with this what for missing industry we concept problem -- my XXX, It's a feeling is hit we sweet we my among which of there. players spot to. the and same way not the but to the approach solution of talk somehow it. I feeling simple the is is appreciated, something different is

some we you publicly my feeling if pharma details Of many Maybe resonating are you tell that to with same And can't and time on the general here are we have get course, the is discussions we people. to think the from companies. always perspective, more I I you But open-minded speak said, really about of that the well. the is opportunity those. as get feedback BD that

is BD fit We trials ends. by on also they at end, open are we therefore strategy potential and because their into And data of executing are driven on molecules side. needs the company's how and maybe both the commercial and

here in what's addition the with available maintenance come is excited maybe where and early for is the we we pipeline. what in details more from Then make feel I more I on benefit is all broadly as think what is have to you positive on resources data too are to study maybe work think it is here something have very personally attractive know, for about. But learnings. the value we working – of table newest that. XXX. focus up – XXX, and where the And on will And you perspective for preclinical the achieved also and decisions And the to GI of this quite based we on be the And this the mentioned company. on give something

the one And development our quickly guidance the space. a technical And GI complement optimize that preclinical into process. series portfolio very potent to complete time that and something nicely of in is here need a that But now developed we should molecules. preclinical is capacity we be to goes. the which molecules This on it's how of work just those No brought package. some have and decided will

Tom Smith

thanks Okay, Yes, it. the That’s taking got helpful. questions. for

Daniel Vitt

Thank you, Tom.

Jessica Breu

Thank you, Tom.

Operator

to closing to all session. webcast I over the you back would for any This Thank Yeah. our the to remarks. question-and-answer like turn questions. Daniel concludes

Daniel Vitt

participants In of the MS. this discussion. reporting for Thanks, Thank you the internal questions our half today's your Yes. to of calcium Jessica. look vidofludimus from good summary, in CALLIPER trial great year data progressive analysis and second of to Phase we X in forward

We providing our We update an also program, with balance well on look IMU-XXX us $XX.X to runway quarter here hopefully into our providing of remain fourth forward million sheet the on soon. funded XXXX.

for thank that, to any Again, more joining. like With I would you additional very happy as we always to And are today's questions call. much close than answer one-on-one.

Jessica Breu

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

You may now disconnect.

Immunic (IMUX) 11 May 232023 Q1 Earnings call transcript