IMUX - Earnings call transcript Q2 2022

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Jessica Breu

Good morning, everybody and welcome to Immunic’s Second Quarter 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.

of Scientific we Officer, section us have Q&A Chief our Dr. the today’s also webcast, with For Hella Kohlhof. [Operator Instructions] statements. that this Before remind presentation to we may begin, I contain forward-looking would like you such those Such be to Immunic’s estimate words and a similar statements with actual uncertainties discussed differ involve will, and statements of identified words results or such can meaning here. number expect, as by that anticipate, from may, materially risks cause could as reflect to in Please date revisions of release note only forward-looking future Immunic’s it the obligation forward-looking statements light this no the the information or that revise events. and presentation, statements any new to these of opinions these of publicly result undertakes of or of these factors results Please affect Immunic’s statements. the forward-looking may refer Immunic’s detailed risk filings to that and SEC for a description more I turn would to and President, webcast our CEO over now to Dr. the like Vitt, Daniel the to begin presentation. up you. Daniel, to

Daniel Vitt

like quarter well we development everybody financial XX, Jessica. milestones Thank welcome quarter and as highlighted to I XXXX, today, our to related Earlier upcoming to pipeline. call. mid-June and second would recent Immunic’s announced for earnings the activities Yes. And as results you, clinical our XXXX

quarter call, morning, results updates walk will today’s our and as anticipated filings through well clinical as During highlights, subsequent financial additional we second the we in operating provided XXXX this and milestones.

opportunity As Jessica noted, questions. ask to the you close the have before we will call,

IMU-XXX the reporting clinical molecule, programs, With regenerate activity patients our this patient patients to data look epithelial molecule DHODH oral celiac chronic announced The the X to regulator use, preclinical unknown small genes previously intestinal X IMU-XXX psoriasis updates. for healthy-volunteer our interaction acting period inhibitor, bowel we In severe first This Phase Phase June we to missing cohort a resulting of human in more epithelium. oral readouts disease. in of of steroid available the second adhesion. me continued clinical our IL-XX tightly has set May, to of selective which the oral respect line its data and reveals particular, of vidofludimus year. the regulated of half the ongoing quarter selective appears let treated the patients second and XXXX intestinal a data epigenetic second represents detailed proteins with lead shown clinical this moderate endpoint. we in that reported UC. inhibitor, our first-time already in move our concurrent barrier a data for systemically with during that in from are influence trial and IMU-XXX start we was believe function associated forward cell review progress network are quarter In regulate in with first But trial interaction stage in important and data being top in with from and to to our small calcium, CALDOSE-X The primary with trial of

this findings journal, without was underlines vidofludimus populations, milligrams the Translational publication to U.S. The and peer to and entire investigator, Robert article. continue Clinic coordinating of express be other preparing well I RRMS, corporate X XX Fox a the Cleveland not with prior vidofludimus Phase data In calcium As patients the for lead experience for other den X to reviewed a in and our calcium on vidofludimus industry and Bossche EMPhASIS to drivers executive bowel Board, vidofludimus last of markets its Consistent XX consequence, both commercial of would XX appointment indications disease in safe month, with development tolerated. the from patient were partner. and from importance the Annals in global decided from Board of and inflammatory in of the X, of we Van announced published of Cohort an our our June, and RRMS. to Tornsen and sets data Also which of like expertise years author with Clinical in of X trial and thanks Maria to July placebo in comprising XXXX. my excellent team observed Phase ex-U.S. the news, effective resignation and we Jan calcium Neurology. Directors our the involved in calcium of administration of

we vidofludimus updates results. calcium our patients, filing some performed and to of these hand of highlight provided between the morning. RMS over the I observed earnings interesting EMPhASIS patients the in on data explore would clinical we use our to observation influence interaction Based on UC like the Phase other this Before Trial Glenn for the I post-hoc of potential study analysis in X to financial CALDOSE-X steroids chronic summary, in steroid the

did RMS With observed, in this well context, the healthy an drug-drug No this these very treatment XX to steroids well use was clinical these comparing evaluable patients at potential and who we used were received short courses had duration received one in the the has patients short-term IMU-XXX, relapse any least average the of subjects patient this those steroid In our to and only development anticipated, of see in evidence duration. influence we’ve effectiveness of corticosteroids rare steroids neurological any rare in in rarely potential nor that X.X the program. steroids population. steroid DDI signals acute safe course and assess patients are treatment calcium dose steroid in on exploratory Most patients the was MS tolerated. majority patients who drug. was events. RMS received and days. human short those short neither X that patients of completed not, of use already in mostly progressing the who In or As with steroids, underlines respect Phase parameters This following are only trial differences we X for vidofludimus study interaction and for for among events conclusion, of in relevant

first two the recruited metastatic have XXX-milligram patients fully X clinical IMU-XXX period. castration-resistant X in the observation X our XXX-milligram been in cohort. completed of Phase cohort prostate trial and in the patients Finally, these the XX-day all enrolled cohorts with cancer enrolled toxicity of dose-limiting have patients, Of dose

and and available The provide plan a profile anti-tumor only third and of expected data on IMU-XXX signs potential safety benign XXX-milligram to more soon. safety promising with cohort safety events comprehensive update highlights provide far a in dosing show start metastatic as to dose to Glenn, financial toxicities. from is as in concludes the overview. soon our as activity as who CRPC our of We the trial adverse I’d Glenn? like Initial quarter the dose-limiting no so subsequent That are also on IMU-XXX updates. of available. this second of call planned data expansion XXXX clinical well to will part turn over summary the

Glenn Whaley

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

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

driven June results, months were vidofludimus ongoing costs to June for operating IMU-XXX. and for XXXX. by research the as mainly ended external compared the XXXX, related the XX, months XX, and X million These expenses calcium the Regarding to $XX.X costs trials clinical were development ended $XX.X development million X of

were The mainly driven programs. were June months $X.X XX, last also non-cash same for personnel to the For year. R&D X increase as development June compared is mainly of for expenses were by expenses XX, expenses, period million as and expenses ended the General $XX.X the $X.X XXXX. including X These million development months period external million our compensation the costs to driven clinical same administrative June XX, ended XXXX, ended stock $XX compared million X related for XXXX headcount. to by

For $X.X was was the was in related and expense XXXX. to June million Other XXXX. rates. the stock XX, increase June the X June in between XX, X the $X.X XXXX, million non-cash as other including by for an headcount. currency personnel same $X.X increase loan in to million as the to expenses period The primarily $X.X of driven G&A negative period were months ended compared compensation a ended million as exchange expenses, decrease for to intercompany Immunic income XX, AG Immunic Inc. of attributable ended on for XXXX, primarily changes The loss compared same result months

compared clinical loss $X.XX for XX.X basic shares as X ended $XX.X approximately a and approximately outstanding negative and an For or million period other common turn was Daniel our period million the based diluted June diluted over XX, for June Net million outstanding June on or XX.X last $X.X $XX.X expense of approximately weighted the share to for per $X.XX the shares million $XX.X Net the year. With weighted loss will basic million share basic shares back to net basic XXXX. share period common call Daniel? $X.X X was diluted average XX, that, months XXXX, a milestones. million or approximately XX, for and million on or average per average X months negative XX.X the months June for June ended per I for XX, net $XX.X ended million loss ended XXXX, $X.XX approximately XX, approximately the outstanding per of on average was compared share on based shares XXXX, to ended upcoming based same the loss diluted $X.XX weighted outstanding and common XXXX. weighted XX.X million based common on million to outlook compared same

Daniel Vitt

Yes. Thank Glenn. you,

beginning in have call, important mentioned up. coming several data the we As of readouts the

progressing clearly based has MS calcium with calcium to and subsequent our and inflammation the infections need. unmet obtained came potential with disability preventing is that program smoldering MS. anti-inflammatory is the unmet see spectrum with uniquely evidence the sclerosis patients Phase virus X progression, Phase multiple The which X into across quell clinical vidofludimus Epsteinâ€“Barr smoldering patients. its With highlights to trial. the seen a the RMS this neurodegeneration in medical and effects, disease new third-party associated package MS to anti-viral, in high evolved connected is address vidofludimus neuroprotective and showing interesting positioned Our of in It’s of need data of data of excellent understanding EMPhASIS is on

clear of a EBV several EBV-infected published mentioned, are in with recent next-generation Eye increased. the chain by association relevance findings An MS of patients earlier clinical this infection serum light a showed important epidemiologic risk occurrence for Beyond research and As therapy. this concept and neurofilament XX-fold between Science levels of underlining from the new Naked increased study in year EBV MS with

progeny GlialCAM protein Lanz not by between CNS antibodies patients, cerebro this al, In MS their were public published out the lines and cells, anti-CDXX but have of are EBV those in for cross-reactive neurodegeneration. CDXX unlikely negative, Nature the been CALLIPER. study therefore, programs there found for of EBV plasma of linking B first-time that is cells, are our our the therapies antibody-producing One ongoing Another basically et infections able EBNAX directed antigen many do fluid and revealed that and Interestingly, ENSURE waiting probably antibodies. which clinical to cross-reactive year us deplete deplete time reduce and guidance MS

data trial, of towards straightforward We which We in severe and fourth this focusing read for from of X vidofludimus highly further this carefully become sclerosis interim for potential believe Recruitment results the may top of and updates the regulatory trials this multiple CALLIPER that patients calcium’s from current analyzed enthusiastic Based are ENSURE periodically The to option supported vidofludimus our be vidofludimus is available at patients vidofludimus readout approval RMS, of our changes events line current effects. is of Ukraine as moderate data to is our We the appropriate. in of the path in end half review goal the in of potential the neuro-protective provided a of assessment second Phase to trials our in two CALLIPER potential design on that this of plan programs. X trial should calcium our about ENSURE targeted psoriasis the IMU-XXX XXXX. provide the calcium to the with the remain of ongoing on patient Zealand the of analysis our Phase Phase the the on to and clinical in data trial year. New Initial of and Australia, relapsing vidofludimus have highly progressive differentiated ongoing material have treatment population. and first in be in MS end XXXX. XXXX We impact report the expected of calcium Bulgaria. currently X of calcium uniquely valuable clinical Russia RMS by quarter of to assessment,

data clinical the Additionally, safety of dose open part XXXX. for to human This we healthy single expect trial be Jessica, us of presentation. our call Q&A ascending subjects the brings end the IMU-XXX unblinded in of and available of multiple session. the from formal in third And our Phase X please to the quarter

Jessica Breu

for you, through second also Thank Glenn, first Argyrides walking Wedbush. guest Andreas update. [Operator Daniel, and today us Yes. quarter Instructions] is the Our of

Sorry.

Daniel Vitt

Need to a minute switch here.

Jessica Breu

Andreas, unmute please apologies. ahead. My and yourself go

Andreas Argyrides

Good and question. our taking morning, worries. for no you, thanks Thank Yes.

Just two quick us. from ones

on just our in color a it celiac bit, insurer your So to of what got expectations out we not lines, characteristics have you just the seems the then the you provide X And could can correctly. pushed are it patients for time may the bit readout? According that enrolled little Phase And describe a more trial? the readout. baseline perhaps like

or from you. would great. So any impact Ukraine factors other be conflict Thank

Daniel Vitt

I try questions. Yes, will the to my best answer

So this trial really regarding celiac think I the proof-of-concept. is trial, disease

XXX confirm the that the functions. impact of So we to is on really goal barrier demonstrate somewhat

it’s let’s So do important an that function barrier in proven said, patients plays that where we role. okay,

in second were then important; reason the and these challenge. active why that to an misunderstood and and after out histological we of X drug start So assessment parameter trigger is bit a we inflammatory for height our The And was a maybe have presentation. a give endpoint, think to the XX in one it’s treatment and disease. here gluten read weeks picked we And treating placebo. between the fashion the us we structural one we days, inclusion randomized is on celiac an studies, so characteristic a Switching And gluten-free looking in I quite are a at. diet impression there most adjusted that in effect the therefore, the basics before be we an diet and really question, – one inclusion mentioned two, whether the two the to to in before that’s study. And proper patients endpoints maybe patients. important and second inflammatory X-week we’re of then are the patient, have and IL-X, These be one little so numbers. need

in the patients have We’ve CALLIPER. or more ENSURE duration our in Ukraine the in in and that guidance trial less we So to Russia. not and current we of for also have now access priced

new And way in, our now so we are guidance – I on think that’s we here priced and this forward. is the giving

in this the Of course, our are countries plans, I get this possible but finding we very think of that, the successful sites happy down team initial course new that and new also environment. has slowed and recruitment to bit, compared very managing including best challenge was as in little with a challenging

this also would our for way challenging managing So by in to situation. that team this thanks efforts these I all – thank internal

Andreas Argyrides

back jump the will I in Thanks. Great. queue.

Jessica Breu

Thank you, Andreas.

is go Rahimi Yasmeen, and ahead. of Piper or Our guest please unmute next Sandler. yourself speaker Yasmeen

Yasmeen Rahimi

team. my so you for question. thank And morning, much Good

Daniel Vitt

on you’re Yasmeen, mute.

Yasmeen Rahimi

you Good team. Can morning, hear Okay. me?

Jessica Breu

Yes.

lost for we you Sorry, some reason. were

Yasmeen Rahimi

question. Thank ways. much No so for my you taking

were if The morning, then the doses the you had duration is, if use directed comment first then and a this in to of there And clear And in opportunity CALLIPER be question. presented EMPhASIS we analysis Crohn’s the and seen is have that’s follow-up should similar that exclude into you or an study. I the the steroid use on MS to question what the and can steroid present? go make trial and that not you it to

Daniel Vitt

answer. the was clear goal does that treatment this show was corticosteroid in I – I call, a on basically therapy. think mentioned the really to not MS very I in and can role play that be

on trial So of treatment it put the I mentioned X.X and In steroid XXX duration average up with only patients the days. patients have all XX% of was that any we of we had UC the steroid treatment, than less during average days. and XX% has treatment duration an at trial,

– of no days, case play that infusion for is steroid an of that’s acute I MS. mentioned totally it. does in in get not and difference. It’s that couple relapse, patients there of only the and case use an of a that’s, chronic different. course, in role – a So a It’s the huge the then It in

there think and we presentation, as also – is difference. the the look in Phase So for back data, back data we on the and look X, on I said we the no

is have this hint for all the see really no to we steroids really a problem So challenge. we here UC-limited be interaction. It a identified that at seems

Yasmeen Rahimi

exploratory maybe some the run Thank prompted comment this to of study maybe you and to measuring study? on the you. And could the with what team of the findings What IMU-XXX of study? DDI idea then are

Daniel Vitt

goal, prompted finding, DDIs. is to the clearly was there no mentioned the is see the that is That finding. no The there I what forward. way exactly, And study

problem. therefore, let’s like, risk. X. are showing really in done. is is early indications was you has that piece we’re And We and sure was of preparing a happy have these broad not that to get package going okay, a forward there important this very obviously all course, no done And said, Phase DDI DDI an don’t And to and that it make we there done trial be

Yasmeen Rahimi

Thank you.

a And give I last cohort? us XC details question, sorry for is bit more bit can us to more just little each of in little a one you you in psoriasis call. the progressing into of enrollment know terms color give tend how

Daniel Vitt

changed. that I It’s call, our mentioned I the patients get going sites mentioned active, in challenging well. I that was think Australian it somehow last – And think new I to

because visiting our I’m sites think the discussions – investigators. team had and good that’s with was very maybe I happy also our and

are of the we addition quarter up the the keep right Zealand fourth even And now. I more time speed just with our the we the And think Bulgaria, to now. sites But second Australian on half. to data. we’re It’s are optimistic still I and expect guidance. New the precise think lines it’s

Yasmeen Rahimi

Thank Daniel. Okay. you,

Daniel Vitt

Pleasure.

Jessica Breu

Thank you, Yas.

ahead. comes please Matt at question yourself go Ladenburg. Kaplan from and Matt, Next unmute

Matt Kaplan

for taking the questions. Good Thanks morning.

Just wanted EBV, the potentially? EBV more see to dig publications the MS, are given And X say, a and in monitoring you bit what for study in little activity study? given you the Phase for recent could EBV on the vidofludimus against activity to

Jessica Breu

that tested we have as And virus prevent will shedding that So monitor X in data testing. sputum samples of several other in of yes, study virus. take of was we or – will we course, we inhibit because the the infection Epstein-Barr Phase preclinical the check well reactivation for really this and clinical

that’s So implemented.

Daniel Vitt

the was paper implemented came way by the it that And before was out.

Jessica Breu

Yes.

Daniel Vitt

So glad paper forward-looking I’m team out. already our EBV that on the very came And the was before in clinical relevance believing that. science the team was

Jessica Breu

anti in EBV to And as distribution do we parallel the shedding antibodies. the this, well, to investigation, will antibody

Matt Kaplan

And in the a be of we question XXX Great. of terms when should we quarter second looking then terms activity? data What cohort. the the in for fourth in psoriasis see

Daniel Vitt

know, Matt, you we the bullish program. about are As very

So thing. big a it’s we is think – this

is Phase the X hand, other the trial. On this

we about So patients are aiming groups. to these get in around dose treated XX two

think in for. now. as weeks to it’s X is get present to and think aiming team data a and And really if the a speed couple right we is Phase a There here, will the is okay, is really excited the activity. what we’re I meaningful everything And And see really do our we medically progress busy success think be activity. as are getting not that’s clear to partnering next fair for signal that want it. really, for a maybe say, of success quickly to The success. and for will what I possible. signal The discussions So also about there our of signal this full whole I

Matt Kaplan

Great. detail. Thanks for the

Jessica Breu

Securities. Instructions] [Operator We SVB go Matt. yourself unmute is more, Tom, ahead. which have you, one Thank currently Smith Tom please and of

Michael Kratky

I Tom. a quick follow-up Hi, taking Thanks guess our for questions. Mike for last to everyone. This the is on one.

efficacy of additional kind as you what could what the of give you’re in looking see on readout, any details if signals you terms just XXX winning for? a curious upcoming In of kind scenario

Daniel Vitt

Yes.

see, Okay. need tell to I I more.

to a goal you at last, if seeing course, better this the what our situation, a be of the and with situation. is the the want in to antibodies to this Premier full on Of Phase antibodies end, a be coverage is current come course, success, And look Phase X, – we’re perceived trial market full the IL-XX and exposure. – would have we closer of is the X just with what as anti-TNF two than I X reemphasize, to not patient Phase broad not doses. a is this

on therefore, for reduction, only want So PASI But which readout we’re percent looking activity we the main to the here. see is not efficacy.

after compare we’re So with it what weeks, basically, published. drugs percent to other for reduction X that’s looking and

look, PASI at. We for after like be may X for something which will is worth look something reduction, example, weeks XX also to

We itch that the on that publish and to have at possible will at in and point. plan we look as whatever readout is also much as here insight fourth give time other parameters. The quarter

readout, example, a look inflammatory of of in is second the important happen insight – of histological portion us I line give readout and it of punctures, full up where readouts. But assessment example, going to and trial than then it later for the a bit to an than little so expected would skin to small. cytokines forward. It’s for including on the I subsets be the step a can Just much we the the also, That Yes. and want is company on give heads bit for then top big don’t forth. think make a first unblinding details, more

Michael Kratky

to one follow-up be in of agreement? you that just expect there helpful to Got And previously. Curious might I of provide you if partnership terms is it. can when last progress you’ve mentioned is, there discussions That’s appreciate any I really and then some it. able guess color, reach additional kind

Daniel Vitt

point. a I think sorry, – first Partnership? Okay, missed is I the good good. what this Yes, the So part.

ways outstanding is also is also of we on data our ThXX, Maybe discussions is progress. driving that basically, a there discussions. the we one shareholders we forward, we remark at have is here, open friends of high different to this we the see on really expectations in And we to pharma the value any and of course, here communicate with expectations full agonist. pharma and what these – that be try and do to have activated the always development not all that is course, are selective investors, inverse to and companies. set of an basically And IL-XX think we data, XXX RORgamma partnership on in first feature, program, that Of the course, positioned as And only value three of broadness programs but biotech reflect to know uniquely companies. t asset. And going should there

a So quick deal. we cheap not will do likely

So we we sure for like a that. is value that to really want transaction make something or would also licensing covered if go

Michael Kratky

color. the much for very Thanks Understand.

Jessica Breu

Mike. you, Alright. Thank

like turn queue, no Given conclude for the questions closing conference more to any back to I in Daniel would we our have the we session. Q&A remarks. over

Daniel Vitt

both initial safety the clinical activity X the this Phase the quarter. human we as our any X include and from additional very patients summarize, anticipate webcast attendees close results year. your dose from joining fourth in programs answer for our in questions. as as parts well Part milestones our the third far to earlier severe Again, questions Thanks, Phase in to in the With of data C upcoming much healthy and trial Yes. clinical progress unblinded thank single clinical as in are multiple-ascending highly quarter and you the expected achieved the thank clinical of trial subjects we These to are IMU-XXX psoriasis of later today, to so I well in IMU-XXX very to interesting important you that, of we about our moderate today’s Jessica, To the would have for call. happy one-on-ones. enthusiastic expected we XXXX like

Jessica Breu

call XXXX in The now joining for has you today. Thank quarter second conference earnings Great. concluded. Immunic’s

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Immunic (IMUX) 6 Aug 222022 Q2 Earnings call transcript