Earnings call transcript Q2 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, and welcome to Immunic's Second 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 is in being all and only that event this recorded. note will listen be mode Please [Operator Instructions].

discussed Before materially we statements uncertainties risks presentation expect, and may actual by begin, such that Immunic's such that anticipate, contain from you I words to here. a with results forward-looking could would estimate, like statements or cause statements. similar may, involve and Such as can those words identified to be differ will, remind meaning, this of number

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

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

Daniel Vitt

you, Jessica. I quarter second welcome second ended the Immunic's Earlier results XXXX, Thank earnings XX, highlighted recent financial well like and as as also June upcoming call. our to morning, XXXX everybody this quarter to for activities we would announced Yes. milestones.

we open will audience as upcoming we questions. milestones. anticipated to second call, quarter presentation, and well as Jessica opportunity XXXX line will noted, an our today's walk through ask give financial After During results and subsequent to operating highlights, the as the the

Phase reported maintenance moderate-to-severe XXXX April, of in of a subsequent with quarter positive phase IIb highlights. from ulcerative vidofludimus trial we review with calcium start data Let's CALDOSE-X patients the and the of in of encouraging our drug favorable second demonstrated In extremely observed very already the placebo, were vidofludimus safety other confirming while as activity trials. they results as tolerability and for compared These profile to Calcium significant statistically our colitis.

be confirm as remission in a XX. the dose statistically at activity showed over believe placebo. compared the at analysis clinical ulcerative XX-milligram week remission data vidofludimus calcium's XX a slide, colitis X.XXXX, XX.X% to clinical illustrated we dose-linear calcium achieving the An data on patients. with superior maintenance absolute vidofludimus confirms exploratory a of to in of As in phase improvement showed Overall, increase statistical placebo week p-value

Also continue in April, development decades Richard in spent to His of expert multiple proving Directors. as in multiple the has vidofludimus studies. pivotal programs. Rudick well already we multiple overseeing a to clinical welcomed as earlier progress and as Board our our insights Dr. sclerosis clinical are as calcium we Rick in trialist, successful valuable as a of sclerosis

of positive clinical I posted C In disability data diet periods challenge. May, with trial to portion The results celiac have gluten-free patients disease we of the as during of first gluten observed stronger-than-expected and gut Part wall. shows set our of the in evidence regenerate IMU-XXX the from Phase clinical preclinically

treated architecture, and also improvement observed BXX. aspects biomarker data In of and and showed disease vitamin IMU-XXX pathophysiology, gut of of safe symptoms, protection -- four gluten-induced in well absorption, IMU-XXX Phase prospect effective celiac improving such as response and placebo Ib compared to particular, was the to crucial of nutrient was this reversal patient’s trial. be that enhancement

disease, disorders, we bowel or of initial specifically appears It Crohn's independent gut the lining data diarrhea. involved for as from and disease in concept molecule in such that entirely colitis, may an irritable represent celiac but observed changer disease. celiac this approaches. provides syndrome first-in-class way therapeutic treat to a intestinal approach, proposed the of new this destruction therapeutic which of proof mechanisms be of example, game targeting We oral the believe with unique also, among be immune importantly, could Most gastrointestinal villi protection ulcerative the gluten-induced

potential extremely the enthusiastic program. for are about IMU-XXX our We

the molecular in SIRTX, and announcement selective protein, years regulator as IMU-XXX our results which of barrier architecture. Digestive shown regeneration Disease serves a effect was restore its in intestinal a epithelial. IMU-XXX, ability transcriptional Week barrier including its mode On function of to the Chicago highly these of preclinical as action models modulator bowel of of potent the at intestinal on all a regenerate function and Through data clinical SIRTX, for of has preclinical and and

known also contribute publication may in disability and as indications. in said, effects trial that evidence neuroprotective its could sclerosis, Importantly, be responsible that these Medicinal postulated reported in in of worsening inhibitor. the Phase to the confirmed in of of multiple activation but chemistry of II for addition the with reduction NurrX our announced vidofludimus activator previously showing MS the neurological not just Journal DHODH acts action a EMPhASIS a potent patients May, we from preclinical of believe NurrX patients in mode relevant drug's calcium to also other findings as relapsing-remitting as That We in MS. be events could

remarkable the vidofludimus reminder, neurofilament did trial trial worsening of calcium disability already As prevention were potential as the identified the properties chain, not encouraging show biomarker of of where confirmed a EMPhASIS well light as NFL. clinical signals reduction neuroprotective in our a regarding

serious more their from to therapeutic substantial this ongoing a to Mayo active our leaders discuss and grateful recently, round We School, by ACD, We Foundation. event were disease thought virtual been for for have disorder renowned the for last not medical Celiac participation. autoimmune we Disease honored solutions. three unmet Clinic celiac Harvard Medical joined could be a hosted or disease need and table lifelong Most month, celiac expert the

our which call, overview Andreas earlier an Phase of celiac IMU-XXX our including Chief call. also disease Officer, program, positive provided our trial this in Medical we During little results a Ib Muehler the discussed patients,

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

Glenn Whaley

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

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

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

development XX, also by related the were vidofludimus period million a II R&D to calcium and the Phase ongoing costs external For IMU-XXX of were related IMU-XXX June the mainly These costs clinical trial clinical program. $XX.X trials were vidofludimus and by as to for ended $XX the to in XXXX. development in months costs in driven external ulcerative June six calcium XXXX, million XX, compared in decrease the offset colitis ended same partially

General across $X.X chiefly in and administrative for a expenses by decrease June June three categories. number period million the were driven offset ended XXXX, $X.X noncash-based compensation, slight ended compared the million to months by XX, costs same XX, as was decrease increased partially a stock of The for XXXX.

of related ended to a and decrease partially ended million million June primarily due XXXX. stock months categories an as XXXX, same number which period the a $X offset were for to to increase XX, compared XX, increase For G&A, non-cash decrease. The by the G&A personnel across in June was was six expenses $X.X nominal based expense compensation

in for to $X.X XXXX, primarily income million compared June attributable ended million the same XXXX. for XX, was June a XX, the was tax trials to as losses The decrease and Australia. Other incentives an $X partially negative three for clinical decrease period ended foreign months increase was in result as This interest R&D increase in a higher interest rates. a in of by offset exchange income

German the The for Ministry losses offset was XXXX negative period a June result interest $X compared decrease $X.X ended XXXX, decrease Federal in the in research Australia. For for Finance. for same of attributable a trials income a interest was rates, an as increase was exchange higher by XX, other primarily allowance year six expenses as tax increase months R&D foreign from XX, of million million in The increase ended tax attributable XXXX. in the clinical the income to June a to and partially

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

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

that, will clinical review milestones. upcoming Daniel? With our call of turn Daniel for over I back the to a

Daniel Vitt

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

II the fall including of precise guidance compared report Our our in our the half previous NFL line progressive from serum more CALLIPER time clarity second in current interim This to trial additional biomarker of provides year. is light expectation MS, Phase analysis neurofilament an XXXX. chain now to this on

end of We XXXX. to this expect the trial at readout

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

based Phase design observed regulatory that the provide straightforward to and solidly ENSURE program tolerability to vidofludimus a we date, MS. safety in of on As the before, far continue strong activity believe calcium path potential to we will stated established approval and have the profile III relapsing clinical thus

for combined of to direct with CALLIPER As vidofludimus designed important complex be an calcium unique MS and I MS differentiator the therefore, anti-inflammatory, calcium MS. and an pathophysiology the in in of targeting antiviral neuroprotective Phase option II effects, neuroprotective trial market. is additional could, the earlier, treatment the progressive drug its may Vidofludimus and the noted potential corroborate represent

With overwhelmingly disease final celiac Phase active program trial patients, believe our for in are clinical data entirely generated regards in excited diseases positive we we again, clinical gastrointestinal program to the therapies. serious a oral very begun treatment result an a could consequences the option Once of -- for patients. IMU-XXX preparing trial I number II of have ongoing new immunosuppressive and Phase and about portion as IMU-XXX a our innovative disease without this with the that celiac of associated represent from approach

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

Jessica Breu

as well for points. our upcoming you half also of Daniel, and thank the and through highlights Daniel Thank to first and you, Yes. Glenn as inflection XXXX value walking subsequent us

[Operator Instructions] from please into And Piper Sandler. go yourself we with it right ahead. Yasmeen, unmute Yasmeen Rahimi jump and

Lauren Timmins

Two on Yas. This us. the for pipeline is Lauren progress. questions Congrats for from all

you will volume I first, correlate NFL to any want there in signal and that, to type separation placebo you a magnitude guys that see maybe primary GFAP about said know with for a And to the we the versus little -- and know present that strong considered brain be you on to bit? separation it historically have is want in you do dig change regard end of see that point. So could what to how

can have the communicate when prior you to steps the And and celiac? for you Phase Thanks. II second end Phase next II in question, II? the meeting FDA your Phase back come had the with And your of then

Daniel Vitt

Coming Thank you, to NFL. Lauren. Yes.

changes you're about I MS. lot a think progressive a And more maybe is really for we therefore, what in other difficult But studies to market aware, established don't we -- to effects as GFAP. see. NFL a in know give guidance NFL it's compared

of I a the look whether and signal. here to look goal specifically, maybe think purpose is is this trial, that's to the sub-indications. the And for main

it's here. [indiscernible] not testing So we indications are

a specific based So little where more bit and is on that Everything primary patients done. biomarker over whether would we progressive think, if interpretation patients benefit secondary active risk else, the I with there non-active indication have a be signal. progressive is to see

with volume, think the brain correlation the don't for established. And that's I

with I a believe think for progressive observe important other CALLIPER on then want the worsening, clinical underline is to the side, need MS which that's finally, to the confirmed really endpoints, disability observe. study. and example, something very readout for more we I for study And also

Yes. the to question. Coming XXX

study. So we -- this Ib was Phase the

no is meeting there plan. So end II Phase of

focusing our think on active I currently on are think there done regulatory with that, IND And submission. interactions is I the based FDA. dialogue an

why time the think right line, we main a ongoing more track interaction reliable right that's reason the I And now. So think there. for that's this it's is the regulatory

Lauren Timmins

you, guys. Perfect. Thank

Jessica Breu

expect Tom on Lauren. the in follow-up Leerink. Thank expectations writing analysis from for a came elaborate CALLIPER the have report fall? Can your you What analysis interim this on with at that question we you from analysis And biomarker interim trial what to the CALLIPER readout? you, Smith data the in are

Daniel Vitt

Yes.

As repeat bit to I myself need said -- a maybe here. I little

So it's really analysis. a qualitative more

So see the NFL here. in more to treatment a we, see difference effect. benign for change a example, If groups

most example, here. there, believe So the great. for where indications the But the really forward main path space what a be purpose in MS promising would to reduction some is I is treatments that the think we progressive identify for

available there's say, amount comparison too can't expect. I really This I we forefront is of quantify -- I much And research, on guidance historic here. any would the the of here. not I give

between keep fingers this in and study. for let's active here differentiation placebo So good crossed

Jessica Breu

Tom, Daniel. question. the you, Thank Thank you, for

have here the go Argyrides and Next Wedbush. in queue, please Andreas Andreas, unmute live we one, yourself ahead. from

Andreas Argyrides

And taking question. morning. Good for our thanks

the is not mean For I sorry, my -- this question.

a So be quickly provide when can us expect patient to to continue on partner then ulcerative And do vidofludimus trial in enrolled? the calcium any for progressing you fully colitis. you update look expectations? for ENSURE? it for you the you. insight Is a you enrollment according into and where stands And quick program your to the one Thank Can also the program? if on the

Daniel Vitt

Yes.

I all, right the of ENSURE well First enrollment think goes now.

on are to compared planned the X the two -- right enrollment running they now. have ENSURE and and track X ENSURE We studies

So a pretty think, there. that's, situation I good

which up from we which obtained colitis. yes, the may generated have molecule, effective the -- also is have having. That's also data we have to there and to UC -- ongoing be which may leverage we indications from that's the may the the also also calcium IMU-XXX important with CALDOSE as GI pipeline to vidofludimus phase, benefit the thing seen, potentially have front, we we program dedicated ulcerative from an come for On here discussion maintenance from are added important study also a -- an the in the can that and you is another is proof-of-concept

pretty that space I forward allows, So there and development the going is more for I think, here that action believe potential. -- have And we we first mode will that was strongly proven the of a both. interesting to in with

Andreas Argyrides

you just quick in one confidence remind the just work Can And also what activator that would gives follow-up. progressive NurrX you us in forms multiple sclerosis?

Daniel Vitt

Yes.

from more I coming -- on the the think -- general it's established biology literature. that

we the worsening. then on of that's, vidofludimus conclusion think, seen also the And so far, progressive may our also effect have ins, on in therefore, on the independent that And But an have worsening. I clinical it And -- relapse disability MS. objective may of our study. work confirmed disability

to need really we study. think in I prove that this

Jessica Breu

ahead. we And go and please Andreas. Matt, yourself also from [Operator have Instructions] in you, Kaplan Ladenberg. Thank the unmute line Matt

Matt Kaplan

morning. good And Jessica. Thanks,

guess the on Just current II? IND, design the preparation what into as a it Phase with are move thoughts you XXX you're of the on Phase follow-up and mode your Celiac. in II I

Daniel Vitt

here. Yes. right Thank important This you, is, an Matt. thing course, of now

As program, design, couple right you on from in it also second our we III the FDA And published about a see disease. number which year. really of into is guideline disease last the for with draft and to align presentation, Phase half good carefully a meetings, what celiac possible continue of the of therefore, excitement had was as discussed experts, looked celiac our we quickly deserves global as believe

stone. some set And -- is that, in things, we based on not This some thoughts. maybe

So share some and to is the of thoughts. I'm happy ongoing discussion an this

patient to bit -- population the equivalent should we what little says. FDA think really the certainly is guidance we So

So patients changes we specifically celiac biomarkers be, symptomatic some on will look tested and also disease things improvements. and for changes functional will active example, here and endpoint changes, are T and histological

the symptomatic studies, right which really and the Phase because the that tested to improvement states the effectively Phase III we doses here, III define also they and of in design should want right think I FDA want studies. for to for see be histological improvement guideline

comment maybe here. also, Duration one

As three-month to this of for on I finally for study each size likely what of determine said, clearly I size trial. group line the those going III remark time the study can a doses, trial a look work of that's improvement exact decided, the the in a on maybe on Phase the And say right looking in best now the dose are but mainly spread will we scores. is exact of But of identification not progress would result one forward. doses, suitable which

Matt Kaplan

on potential internally follow-up of colitis. disease the That's about celiac are very and XXX XXX ulcerative you of And How then and one XXX colitis? outside I given of development the that, helpful. and guess, utility ulcerative thinking

Daniel Vitt

interesting, honestly. Well, are both

that very I time. at challenge study we think with the are a XXX in is important MS the same

our the clearly, immunosuppressive. I think very really right the has not something now could therefore, new Ib And special. I GI add So XXX XXX. something And to fresh the It from think think on focus Phase study treatment results disorders. GI I the with is drug in landscape therefore, is

add look And colitis, the things choice substantial. immunosuppressive we indications on layer think well with combine for the maybe first see to and concept as to so-called ceiling development beauty over-the-counter current therapies. restore therefore, And treatments I the and the in of that's clearly drug, other is just a with the proper epithelial And road. down like efficacy healthy easily something that which could Crohn's able if gut treatments in wall, non-immunosuppressive would you the

really It's likely say the space we to is as GI a I in core were So -- that's there, XXX the celiac but core IBD further well. very what for theme a bright indications think, in see early development. exactly, focus beyond a broader in I future disease

Matt Kaplan

Thanks very Daniel. helpful. That’s

Jessica Breu

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

Daniel Vitt

Yes, you providing clinical of funded to Jessica. well with attendees our And rate thank quarter remain on multiple balance XX.X sheet into In XXXX. fourth insightful for expected we questions. thanks, today's milestones the through value-creating summary, your million run

data fall expect calcium analysis trial, the in interim as of we from report II our Looking vidofludimus ahead, CALLIPER to Phase year. MS in this progressive noted, of the

on Phase update disease. celiac the we provide As made, for in clinical preparation progress ongoing expect patients IMU-XXX trial is with active an also to our of II

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

Jessica Breu

you also webcast in Thank my now joining side from XXXX The second has Immunic's earnings quarter concluded. call.

You may disconnect. now

Immunic (IMUX) 3 Aug 232023 Q2 Earnings call transcript