IMUX - Earnings call 3 2023

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Jessica Breu

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

Daniel Vitt

Thank XXXX, and also third welcome ended earnings XX, to today's for press our we like this financial quarter would you, morning, Jessica. everybody call. Earlier the announced September to Form our Yes. XX-Q. release in I results

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

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

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serum or a XX of milligrams Calcium NfL, As XX an in in treatment Vidofludimus both improvement reminder, and showed placebo. arms

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capable goal several therapeutic identify with a to clinical our of partner II performing IMU-XXX, trials. For Phase is

now the very to regional overview. with players. I Glenn data the point global to for hand like discussions NfL our of been and partnering financial Calcium, would has Vidofludimus release For biomarker pharma an Glenn? call trigger clear important to provide over

Glenn Whaley

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

cash position. We ended equivalents. of quarter Let $XX.X cash me start in review with and cash the a million our with

these able fund funds, XXXX. to to be With into operations of we expect September

ended were and September were million X development Regarding X months a personnel driven clinical ongoing for by costs was the IMU-XXX IMU-XXX expenses. $XX.X related in ended to development mainly the September by external the decrease as XX, external R&D operating to of partially programs. months related results. XXXX. XX, costs These Calcium This Vidofludimus for million $XX.X costs to the compared expenses the and trials offset XXXX,

across driven of ended and the clinical expenses XX, development to as X was offset numerous compared trial million, for ended ongoing and a R&D costs Calcium These XXXX, related mainly the were related September million II same Vidofludimus XX, IMU-XXX spread $X.X expenses X partially Phase costs colitis development ended to Calcium, September XXXX, increase months For XX, Vidofludimus $XX.X expenses. the The the personnel for categories. million to period months $X.X million decrease by period were as clinical September XXXX. to XXXX. program. G&A costs external for ended trials in same This the by were in $XX.X September XX, ulcerative compared was IMU-XXX slight of external the

months G&A X to compared ended as partially personnel higher the increase spend Australia. offset expense negative September income of XXXX, X which XX, The tax were a by related across same increase million was as ended for XXXX. for as XXXX, and million interest XX, result a XX, categories, the a of was for an offset numerous attributable $X.X increase period ended was September months to ended compared to R&D incentives clinical the in less in interest $XX.X XXXX. foreign The increase income expense. Other XX, exchange decrease For stock was a decrease September million primarily by in related decrease as September period expenses $XX.X a trials same to an $X.X compensation million partially result for was to This rates. losses in the in

ended foreign and less For based year the XXXX, months interest a partially research was ended was was as clinical R&D Daniel tax for to upcoming in based outstanding XX, to outstanding. higher per trials and attributable shares The basic approximately of X in average $X.XX a outstanding. XXXX income, average common of will period weighted Compared shares increase or received Federal for loss ended XX, an or losses million diluted XXXX, XX, September share for shares net based tax per weighted in based September in offset same for XXXX. ended million common the share, a average rates, compared September by I was X $XX.X $XX.X $X.XX turn loss Compared net our the common a XX, as for approximately on result XX.X XXXX. million million attributable approximately to share $XX a million interest net million $X.X incentives in increase the was clinical and million of share, the increase spend September income $X.XX $XX.X months loss of allowance million approximately per or on diluted period review loss September on decrease of basic XX.X in the $X.XX and Finance XXXX. Net basic weighted ended XXXX. With per call average as negative result diluted XXXX, decrease XX.X approximately approximately weighted over was that, X XX, that Ministry to from for Other a XX.X German a milestones. same shares million to primarily the million for the months exchange or of same period and Australia. The on basic $X.X back ended September common The outstanding Daniel? XX, diluted the

Daniel Vitt

Yes. like programs. for upcoming on milestones to I Thank would clinical you the thank Glenn. an anticipated development -- you, update our provide

expectation current line Our our April CALLIPER to trial II is progressive MS 'XX. data Phase report in top from in

futility relapsing Additionally, ENSURE twin the our program year MS of analysis first we trials the III of of III expect late our to identical at end interim read Phase to report XXXX. an ENSURE in Phase next out

regulatory show and for patients, potential activity data position able believe topical to continues nonactive effects secondary clinical as design path a the to of Vidofludimus tolerability a MS safety first for far, As stated in neuroprotective to may will Progressive Calcium the established the we observed relapsing ENSURE that MS. If provide be approval oral Calcium the treatment well. to so as program PMS straightforward before, strong solidly Phase We profile Vidofludimus date. based on III

We meaningfully clinical regard Phase MS. With the program, NurrX drug's preparing begun also previously to our to relapsing a II active disease to as first-in-class potential select have IMU-XXX for ability ongoing ENSURE and III the Phase patients. ongoing expect activate trial we reported, in benefit

IMU-XXX testing this were therapeutic entirely architecture with We promoting associated are without the regeneration data very disorders an new the gastrin believe represent immunosuppressive to bowel about approach consequences serious of therapies. and excited could

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

Jessica Breu

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

our Pocher begin first Caroline will from question-and-answer today is Instructions] the PacGrow. [Operator And We now session. guess Wedbush

Caroline Kimberly Pocher

Andreas. for on Caroline is This

trial from and the insight Celiac trial? the for the lines do and preparing you us. you initiate you disease? trial What where Phase when would would provide for Can a like Just you you design are any II few of terms look into in the anticipate time think XXX for

Daniel Vitt

Yes.

completion, we think on fully done our stated the homework have before, the have data, packages. evaluated I as data we

now. So this thoughts is And design. work right the maybe some in progress on trial

ongoing likely, this treatment treatment will a Celiac disease -- So be of be of active phase in should X patients. months

Yes. to conclude in are, road possible data we it less, we're for in testing And that's further the or process. more make the also still and where trials So really down pivotal trials. preparation

Caroline Kimberly Pocher

you the what Okay. just in Great. about And then one progressing complete follow-up from is line how program and your time Can talk to enrollment? ENSURE us. target enrollment is

Daniel Vitt

Yes.

as later. update able the I 'XX, of where think we and that guidance second of of of a end status are the give know, we the one usually the first way we you -- and out our months rolling of recruitment completion currently don't on couple to the studies the -- read ENSURE a enrollment keep

say. can I all that So,

Caroline Kimberly Pocher

on progress. Congrats Great. the Okay.

Jessica Breu

Piper next from Our guest Hiester is Sandler. Liam

Liam Hiester

Just questions. -- question calling I'm on Rahimi asking Yasmeen X a of behalf I'm

CALLIPER first the related my is one trial. So to

So type the you the to are expecting April data 'XX? expected bar what's what of And in of for success readout? report

Daniel Vitt

good a think question really That's about because a have Yes. strong spoken data. I lot we NfL this

volume disability the in brain is a that. change and concerted way. worsening, endpoint, right in important endpoint primary So of also NfL the word primary course, atrophy, which change endpoints think interesting a secondary computing EDSS the key active -- score is for the will secondary brain as will of patients the a another a one the study. so endpoint, we But placebo And that's from readout maybe most most with secondary be I as report in maybe confirmed

So important endpoints changes give that I us, the the correlate that's, time. also ability well same think, in biomarkers to and and the clinical will as at

released that's in all planned 'XX. to so And be be to able April

Liam Hiester

Great. specifically And success for? a there bar you're looking is that of

Daniel Vitt

super if what's Well, market, high the on you here. look is think not bar the on currently I

on And be we benefit meaningful best a that see maybe less data full data or in to disability but -- would of want would a seen endpoints, set here. wonderful. also what thing the we the those have difference be prevention readout in translate into we medical think the I more all if win NfL

population. on those patient looking untreatable Specifically

on looking relapses. without So secondary patients inflammation, specifically the focal progressive without

that population, brain readout nonactive so any -- be something atrophy can't that want hard really you think give -- I a here the achieve progressive is to powered will here great. secondary designed that So on a would I study for here. we be I benefit the think statistic And numbers point. to benefit on was It

Liam Hiester

related you previous it question Well, all design? more one preliminary to at still in Or to the with the the build one. off in Have FDA with just II stage? the just then just actually, And IMU-XXX. Phase spoken of is

Daniel Vitt

which now. This is a is right ongoing process

IND we we with do you communication what and have usually, submit So then filing is our written the regulators.

forth. design so protocol example, and For

Jessica Breu

The Kaplan next queue is one here from Ladenburg in Thalmann. Matt the

Matthew Kaplan

Just focus goals you business remarks. XXX? more that Can also the you a mentioned on and prepared about wanted little development bit talk XXX a during to little your bit for

Daniel Vitt

Yes. Thank you, thank for you that And question. Matt.

here, Of we have good assets several data. and course, good

build based in option. to discussion are the partners. to And or deal. then level discussions best really one execute data the good to other So and use data our I active data good, trust the the typically the potential you with all these of we And was with really is now make what that, the of data with comes Celiac of we remember think are to what the on sure what trying with is good to intensify this CALLIPER readouts year data. CALDOSE good discussions with say points maintenance And and full companies. It's exactly data difficult first, the a

that, description to and are best to plant on the that building access that. more fuel non-dilutive financing the some have the think based also be to would rest of I sources optionality line on we So

Matthew Kaplan

Okay.

mentioned IP And allowed? was terms terms of is Okay. does you new of What that What that then exclusivity new IP. the you in period? in some get

Daniel Vitt

Yes, good I think that's point. a

hasn't So under that XX. run

no relapsing And there, dose us extension, is then trend patent pattern covers potential us it pattern covered protect this i the mixed extension a for up, protect term think No, of the XX. MS. which here XX into there's plus -- would a this patent treatment no. will certain dose So and strengths the which it and but is it's into the

So.

Jessica Breu

XX is... No,

Daniel Vitt

but XX in or That's is XX right things the the have making. right. so we number more -- here,

Matthew Kaplan

been then as as well? in terms view Okay. Great. And activator. that does be of of drug the the -- you've NurrX a Vidofludimus the from characterizing point ability well of its the What to mean

Daniel Vitt

very good very question hand, scale, and maybe on The the inflammation. so independent one I inflammation. What and relapses impairment we the in signals, have which MS of is from treat protect for I'm because the drugs death thing piece really are is and that treatment cell the triggers Yes. missing far good -- on elephant that's we on that to MS in by thankful this the doing room reducing think. options and focal is to and from maybe neurons have

something relapses down, relapsing progressive is example, secondary MS MS, which, progress go where for still but they So from disability once patients happening is into there.

obtained neuro a a a data option give think, target, the NfL from untreatable offers MS NurrX for information, on think the relapsing pieces X is also PMS, and and NurrX groups conclusion in and signal, with I reported literature active neurons protection, a and with activation this this treatment inhibition, secondary data was, strike offers inflammation of progresses the progressive draw and like our for of drug known we that have done have reduction combining the I here which important now in protective thus on may far us whereas it with a here in believe and treating double and scientific other primary no independent patients MS. of which the well the way for focal a kind direct has also specifically DHODH that We signal is we community. what combination And

Matthew Kaplan

DHODH inhibitor and to unique be characteristic Vidofludimus effects this of something and to just other an separate clear, totally is not that's from And DHODH... the not

Daniel Vitt

It's both something DHODH other molecule which one hand. ability Exactly. on It's to and NurrX on to and not binding linked a DHODH. to hand the its of is to a property the

a Merck, an year, published have We with that this paper data together showing buys. to the is our the collaborators that there There's drug showing molecule directly in as paper protein. a earlier Daniel directly ICT binding academic this around NurrX

Matthew Kaplan

Perfect. Great.

Jessica Breu

BD. in Q&A maybe on up direction. a follow X into go received which the regarding question to similar tool Yes, writing here questions via Matt's We

raise describe your strategy please fruition. results. one, clinical for plan to through liquidity first great second to maintaining these The the to What's one, the see adequate And opportunities cash?

Maybe give again? Danny, thoughts you you can here

Daniel Vitt

Yes.

years. the we company the at an And the to be if ways be follow therefore, assets development that's on think business of also worth next but day. to as it's the maybe fund I course, we said, end one Of one or partnering for sure important or earn piece of of the different some the partnerships activity, make to territorial not And fruits X the launching. important pieces could --

of option be is could for project financing any Another and nonrelative equity third example, one financing. of the for kind financing, kind

also the capital we on I the what's keep think on in table, options markets. So considering but going those

Jessica Breu

Thank Daniel. Yes. you,

Tom guest live from Smith is next here Our Leerink Partners.

Thomas Smith

expect if or learn like And advancing Great. program more you timing do pipeline to was this have asset? update on wondering the on for when any there's I early we visibility programs on can the this IMU-XXX? any just clinic into

Daniel Vitt

you, question. Tom, Thank Yes. for the

clinical we based the was data the think company the now for prioritizing from resource now right clearly, I time is CALDOSE initiated the But reasons. and trial. generated programs program on positive

part steps for clearly, trials and of progress the right and resource Vidofludimus focus completed, is company the the of ongoing, So continuing on next the now. focusing preparation and Calcium we all that have -- the the work XXX for but performing

Thomas Smith

ground just on terms enroll Daniel, out, guess, I call of there gating if there? And off helpful. getting the in that the just an ] you any study, That's starting factors, would are earlier that XXX patients I the DAX it. follow program cleared Got specific can and IND to and up getting question, [ on

Daniel Vitt

physically As trial that mentioned, preparing material and trial the also on the we are side. means preparing the

So production first to And also think it's we indication trying celiac already trials selected of so for that today partnering to will make we're that little disease. development beyond broaden also our a other and be have to late the question -- we also at. But about bit the have we priority stated material as forth. look also answered could sense is

is in which is going So this program. any something also an so priorities, with the important forth aspect and consider speed to forward

setup that KOL So, interaction -- from trials don't a make in also can the the good the aspects goes our also so is not far, and regulators lot limited U.S. of prepared, good own learn we win of into preparation, you regulators, really having this proper with network It here, the still a we also on trial European to all the treatment. is make with have feet other to sure our our trial disease fall discussing just to in with world different sure a data, we Celiac on this

it's as And on next we think will soon are as forward. I market that. I update steps, going making think the So we

Thomas Smith

That Understood. makes sense.

Jessica Breu

more live, one from be have is we Riley. here And which who with Instructions] Mayank to wants [Operator Mamtani us B.

William Wood

the Mayank results. Congratulations really on William for today. on nice actually quarter on is third This

I just your on one NfL data us It from nice. really think looks from CALLIPER. really,

subpopulations, curious all just about the across data SPMS. slightly active broader including population. I'm the got PMS You've nice

path sort of out readout, I'm appreciate curious into kind potentially trying this out when exactly one think end at the to partnering trying PMS, to keep to for or and pretty final of for your a drug? choosing activities? -- you of how your III sort over got more figure then trying there. when potentially there. I forward be doing a then of we figure going And smaller or subpopulations really You broader Are as Just path about get just the or to you other we're it. forward a we these subset Phase looking the low also will the number IV there but should -- the

Daniel Vitt

for you that Thank question.

should is any think I think prioritize we we I is regulatory on, because how track approvals important do things. the towards something this that's what touch more and

I mentioned, a very progressive and the on think PPMS the population, as is non-active is the specifically authority, we for the one nonactive secondary excited data really have been population. I which population

responded nicely they U.S., to have in fall very RMS active treatments, NfL, the I think the FDA-regulated but in the of space The into basically. populations

EMPhASIS is therefore, U.S. this So when if we by covered forward with mainly treatments, study we focus we will on insurer discuss is PMS, -- our on those And little or there population if no go the the what relapse patients have activity and reconfirms focus patients therefore, basically. Phase II active that is the -- seen remaining. By you of study in on mentioned way, this what we superiority also those patients. they

And think this population have this I going or in of forward, and indication a for it choice we that likely now less for pick is generated the need. unmet if also treatment real want available And there data it's think and choice. patients, and think secondary nonactive our confirmation no progressively. is side is more nice by think regulatory we definitely think There was need so RMS on data approval. good earlier. But I to our the it that by is the the you comes dictated clearly the of right I NfL to as things X indication the best So well to I

see the signals 'XX want first in have April on the if we data readout. course, as look see we Of same we seen clinical to to on NfL the

William Wood

again. congratulations It's helpful. very appreciate I it. And

Jessica Breu

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

Daniel Vitt

you continuation we on enrollment development during CALLIPER II have continued attendees trial, this In the enrollment Yes. ENSURE summary, the make to questions. the completion our Thanks, the Phase Calcium as of positive data today's quarter. interim insightful from well CALLIPER tangible with Jessica, III for of progress Phase of and as trial, the trial thank of past your the clinical of Vidofludimus

update disease. With I joining, on very close to ongoing an is we Phase are like II our to to in call. progress patients active answer for with made, IMU-XXX provide celiac much As preparations and trial would happy we clinical of Thank you that, also questions. a additional for expect any today's

Jessica Breu

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

disconnect. now may You

Immunic (IMUX) 14 Nov 232023 Q3 Earnings call transcript