IMUX - Earnings call transcript Q1 2024

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Jessica Breu

Good morning, and welcome to Immunic's First Quarter 2024 Earnings Call. My name is Jessica Breu, Vice President, Investor Relations and Communications here at Immunic. I will also be the moderator today.

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

Daniel Vitt

thank XX, release. also the welcome quarter earnings March on today's results our in morning, like Earlier our first would you, this Jessica. everybody call. for we ended to announced Yes, press XXXX, I financial

upcoming During XXXX results highlights, anticipated our financial development today, as clinical will and well first the milestones. call achievements walk including through programs, operating we quarter and subsequent as our

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

and XXXX. led covers multiple Investors, the and are Partners, first potentially of up of BVF vidofludimus Phase into of Investments CALLIPER three-tranche new a of January by with Adage top-tier group II start private read-out and third capitalized Capital, the we April quarter nicely groundbreaking our sclerosis, Partners, existing round, XXXX. The lead Soleus of well progressive Avidity $XXX review Janus investors, asset, trial XXXX of is the announcement Henderson participation With million, Capital to included subsequent a our anticipated Partners. of completion Let's early quarter This highlights. from in which the RTW in of calcium, our including our placement

As a first $XX reminder, on tranche, we received total in January million the X, which of XXXX. closed a

tranche second for conditioned the which CALLIPER the trial. Phase on line of announcement $XX of top is a million, II The the purchase is data

reinforcing our The Fox it vidofludimus in of broad-spectrum of the strong of positive this vidofludimus after II enormous the Clinic, saw occur impacts, Manager ACTRIMS like third may ACTRIMS financing, Epstein-Barr across is a relevant all second to Forum Alexandra all CALLIPER PMS likely $XX an more potential million to to calcium's potential of of XXXX, and as clinically from Forum later Translation a neurofilament difficult potential. who Cleveland from separation no Also presented February, from ENSURE environment that MS Hermann, vidofludimus beyond outcome previous group our Phase activity evidence serum CALLIPER and prevent as Phase XXXX. at contribute interim II the activity of CALVID-X Dr. worsening. biomarker anti-inflammatory calcium's key X tranche the ability all positive light provide dataset as programs. In affirms of a investors, at this the chain reactivation that capital investigator and of our points Immunic, -- in analysis, in patients fatigue interim calcium presented trial. Because of reduction All Bob on at trial the the clinical extremely antiviral to such our calcium disability clear poster placebo Pharmacology for analysis is virus, than inherent vidofludimus patients. Dr. the of previously points market also well a as CALLIPER in the we a secondary its strong all, believe completed [ observed with further also years the ] programs, subtypes. We for prevention From tranche. well trial data extends cycle This levels neuroprotective the overall in end coordinating

of While to influencing fatigue in most unsolved dominant from is it the symptoms patients, clinical activities, perspective. social one the life of MS and quality among largely the ability greatly participate remains

the clinical signal initial arm. the third-party placebo post-COVID showed vidofludimus patient cause this Our of for less post-COVID the treated fatigue frequently a an reactivation trial exhibited identified patients patients calcium Recent in with group. in potential data in than that patients patients fatigue COVID-XX EBV as symptom in

confirm and in our reactivation with patients neuroprotective visibility EBV in the candidate. In Society sclerosis as further activation to Our in result vidofludimus feature the to goal Virology of at the key March, presentation for Annual potent could of medication factor, activity calcium Frontiers its vitro. in as program the calcium's Phase vidofludimus Chemistry, our Medicinal III broad-spectrum of ongoing well relapsing extend in multiple another the this and ability potent this is trials yet had the influence highlighting differentiating for opportunity of NurrX, to fatigue we Meeting of a antiviral transcription data both ENSURE as

from received for a production of of Office Allowance reported with U.S. Trademark known as be its covering lead addition last around II believe related and NurrX events the the in of of Phase inhibitor confirmed that This in method contribute a year, of a confirmed in of to As previously as patients may to MS layer that disability and effects as of material. provides intellectual and potent Patent postulated neuroprotective patent responsible vidofludimus could our property reminder, the calcium EMPhASIS patent asset. preclinical reduction in we worsening of vidofludimus we the polymorph composition-of-matter of a trial NurrX patients of specific in from mode acts proprietary activation the protection We action testing the DHODH. for another our relapsing MS. Also calcium activator drug's Notice March,

remain protecting directed in patent III we to patent Phase the Importantly, that technology vidofludimus calcium. We to much the the addition use protecting of committed this by been behind which vidofludimus has multiple of calcium stronger currently U.S. have this made X asset, sclerosis. deeply families

a patent expected the result, least our extensive internationally further. is XXXX into protection unless at portfolio extended States in United XXXX to As provide and

which Multiple disability data therapies. we compared well Sclerosis Day, month, the highly hosted important latest last encouraging with with and potential as reduced the worsening Just currently the vidofludimus our highlighting available a as clinical neuroprotective distinctions landscape R&D developments preclinical in and associated MS calcium, presents MS supporting

We XXXX Thank today's to made spectrum the our solution manage designed care I who a and smoldering with holistic MS patients, by in of that us clinical first also belief of join providing elevate it MS this components is quarter recording. That across the its summary selectively vidofludimus was could the were calcium X am given shared antiviral most pleased able everyone the and standard the recent event full or you person to to our highlights. all to our programs. of strong anti-inflammatory for achievements very to we effects. of concludes that of able neuroprotective have and who listen scientific for with

would patients we relapsing ENSURE partnering provide continue companies. with and both on both call. I with lot to could III in later with relates II trial of program, gastrointestinal As our trials Phase program a game a progressive discussions global There's advance I more which and multiple now existing on Phase to the going over to continue for to strong broad sclerosis. Based regional changer financial the our also Glenn this of our to vidofludimus this will in in it we the turn a IMU-XXX CALLIPER call pharmaceutical Glenn? date, twin clinical on provide become to calcium, range treatment MS disorders. evidence overview. detail like

Glenn Whaley

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

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

noted, with operations quarter funds, Daniel expect able the third of in fund As we XXXX. to our to be these

compared March was primarily X period interest expenses $XX.X March $X.X increase partially ended G&A This million million March The months X due the months months for expenses. Interest XXXX, related an XX, the ended development as XXXX, mainly results. as were was costs. increase costs. March ended clinical increase million was for XXXX. million as R&D the in ended the expenses XX, in rates. same XX, offset higher same was This to for slight by XXXX. $X.X to compared XX, $X.X months million by operating the March were XXXX, XXXX. personnel $XX.X for reductions compared X income the the period Regarding $X.X driven March to personnel X for to ended to ended This XX, decrease for million XX, was

or and of as of The recognizing XX.X compared weighted that, XXXX, to the upcoming German and million will stock. million rights our over the Therefore, period and of million tranche financing XXXX, but to rights share the expense development tranche approximately the Finance $XX.X turn approximately decrease XXXX, reclassified the shares I tranche loss for equity. Other diluted million to of was for of ended value XX, the $X.XX charge X was on established January net approximately to of XXXX. With based compared for shares $X.X approved same X closing XX.X XXXX. were rights months the X approximately as of XX, of ended from of March as costs to per common to XXXX, March of X a fair the rights $X.X tranches of of company's our in March the $X.X January a and needed change common X, of equity months and for an the common authorized million review pipeline the XX, grant. The tranche XXXX that XXXX ended increase the outstanding negative per a time weighted related a to the of XX, X the a March million a on when attributable The reported from call revalued of well Ministry basic basic timing XXXX. months XXXX, tranches ended the loss on reclassification the income period to also XXX in Federal be liability as to related charge initially value the to on were XXX for value or on milestones. fair shareholders related We million million Daniel X were diluted net share $X.XX X X, the average XX, to shares the primarily classified March change as $X.X outstanding the Daniel? for the at million noncash ended tranche financing. These $XX.X tranche X tranche average the the with million was to upon was associated same back X closing shares future portion March based March January

Daniel Vitt

now you, April top on could upcoming progressive Thank This very forward anticipated provide MS development I CALLIPER to point clinical be from data in update our II and a an transforming in our programs would for Immunic. much Phase like Glenn. reporting value look milestones. to trial We read-out line XXXX. inflection

observed MS. the the regulatory of III neuroprotective to will line we safety in program report the approval of XXXX, this potential ENSURE III for if an able treatment a analysis to multiple in may CALLIPER design Phase ENSURE highest based far, our relapsing progressive data the trials the half medical of Phase clinical to twin to strong MS It as later vidofludimus ENSURE on subtypes program that and tolerability non-relapsing On trial the secondary patients, as calcium's expect vidofludimus clinical need. trials. of provide well. The of second first second second year XXXX. [ futility We straightforward continues quarter top MS progressive observed calcium ], bears this, relapsing expected evidence Additionally, interim repeating in the unrivaled in show ENSURE in unmet the MS our a first believe profile we PMS thus the with of the path identical in and read-out were effect to position of the read-out oral III Phase be our top

meaningfully will We also clinical activate the in trials the MS. expect drug's first-in-class ongoing NurrX that potential ability to benefit

a noted to complex and believe have of the pathophysiology has be targeted we effects. combined the option calcium [indiscernible], on its neuroprotective, treatment based As potential MS before, that vidofludimus to anti-inflammatory antiviral unique we

of absence orally serious to program uniquely the epithelial an IMU-XXX, suited action Sirtuin small range are program, broad second our first-in-class with modulator to physiological acting broad mode Turning excited and immunosuppression. we wall healing gastrointestinal achieving targeting very a treat of and that of systemically X, is intestinal its about available gut disorders believe innovative molecule regeneration, of this by

Ib gluten-free reminder, nutrient data targeted of today. gluten architecture, in clinical our initial new strong outcomes data Phase patients key gastrointestinal regarding trial mechanism meaningful protection provides a of clinical celiac absorption in a clinical for seen utilizing of response. We from a gastrointestinal barrier symptoms, and IMU-XXX approach gut a a celiac immunosuppression with diet therapy of potentially over believe of during placebo avoiding As and the disorders dimensions demonstrated protection of regeneration proof-of-concept improvements of periods disease: physiological while wall innovative new multitude medications the oral also patients in enhancement through this biomarker to proof-of-concept of X disease function, many disease in celiac challenge

applications Phase on addition of the inflammatory where treatment the GI of II the our potential presentation. diseases we for disease, call end session. is testing bowel of wall celiac the potential formal to important, paradigm-shifting gut previously renewal multiple our including, reported, clinical or the additional clinical for please exploring its for begun we us brings the preparing open to bowel example, syndrome. This Jessica, Based are also in As Q&A IMU-XXX. have short disease of

Jessica Breu

as [Operator Yes. quarter first for is guest Ladenburg Glenn Instructions] inflection Kaplan and and and the development us points. Our as walking our subsequent Thank today well highlights you, through clinical Matt upcoming from pipeline Daniel first Thalmann. value

Matthew Kaplan

on the the that was guess meeting study received program. when that you interim in analysis? A progress. NfL I how on observed the that? on at impact CALLIPER Congrats the How was presented the the questions few ACTRIMS vidofludimus you

Daniel Vitt

say would of we with I aware seen here far, data Yes. so comparable such very we to reduction would any on Thank not you, strong because what some share I Matt. say, I'm here. broadly, I happy reduction. is appreciated have from feedback much Generally, a are think other experts NfL

a the attended. as that take positive feedback all we here from so And conferences we

Matthew Kaplan

read-outs helpful. Okay. what futility the in to program, year? later of ENSURE then this that this interim analysis from That's potential for the terms And the expecting analysis you're announce are

Daniel Vitt

you because Phase rarely really that will is any really III Good since program, is asked, this a we this -- Yes. get data.

go to we all a there. response size the -- as ahead Monitoring We either some questions planned the sample from will to just get to Committee, Safety from committee, or the the coming suggest basically read-out on adjustment. That's to can

So from that any medical biomarkers not analysis. any we results see will futility or

an more And we an it's made the initially. we statistical our based when So really estimates our it's assumptions reconfirming events started trial, have to we event-driven study. is do on have since this enough important eye on trial

Jessica Breu

you, Piper queue Yasmeen Matt. with Thank the Rahimi in Sandler. one next is here The

Jun-Goo Kwak

Jun-Goo is Yas. This on for

on was The basis if ENSURE had you could if blinded rates event to a had first comment visibility any across trials. we you question

provide you prep regards Could are in had color you any study event If of agency II you XXX? do, secondly, have the and to you meet with Phase design? like in terms these line are expectations? And a rates to with in chance where

Daniel Vitt

for you Thank questions. Okay. the

first with also don't is can't tell coming track. closer start with time, on disability No, updates have And is we the current Let event the on an that can to so analysis on may share blinded worsening studies. so far, rates What study we that. futility on some me the have the the I data comment we be may can I far, to eye so have public. ongoing

interactions, plans those. XXX we Regarding are working further and on regulatory

are a with regulators. for planning U.S. meeting We the

indications, several preparing II I presentation. the as Phase in so We said are studies,

for concepts. is ideas get molecule. appropriate that #X looking that's way the and also the team on at. But that sense a of indication the have very all look think good of funding we with beyond develop different lot actively preclinical disease in on is makes I working looking this here also how the we drug the we're indications, also the further of wonderful celiac it's, best to of -- So a -- disease, couple and data, the what celiac And it to mentioned proof-of-concept course, will given we and other

Jessica Breu

here [Operator next you. is B. with Mamtani The Instructions] Thank Mayank Riley. one

Mayank Mamtani

on the updates. Congrats

depleting are Phase ] us And of schematics follow-up. B-cell the Just end functional talk secondly, think out vidofludimus' say, DHODH volume in could II? And dual which quickly you ones then attributed the and on changes what noted you that NfL, remind to evaluated to studies other I can the of, II relative that study, in there, on a mechanism you've based CALLIPER have [ to brain Phase with maybe then seen NurrX being the ] be agents. points [ there quick plan

Daniel Vitt

Thank for the Yes. you questions.

an So the of limited we really the all is make to lot that good the non-relapsing -- since here important and the of questions. or is a of that patients lot study sense these data analysis can really study, answers of and think set functional this here CALLIPER patients, a mentioned give to

of So role, thing, secondary functional and also completely EDSS other a worsening end classical medical confirmed also that top covered the end point. in of disability important think this, change read-out's scores not this the seen [indiscernible] that EDSS. I companies, in point the On key established is and other is they're study, of was and first course, the studies and important most secondary more playing the from

walk XX-foot So one established; peg which test specifically. testing; cognition thing nine-hole and is test, is the pretty the

established So also those study. tests which recorded three during the the are are

clinical end of So EDSS on read-out. points we just top will those also expect data the on

Mayank Mamtani

brain any analysis interim at volume final then XX-week? and NfL, XX-week And to your changes obviously, comment given at the the it. on Got relative schematics

Daniel Vitt

Yes.

neurodegeneration of brain in and a believed volume is patients. change measure MS think be I robust sensitive to

full CALLIPER study. long time have comes we Specifically, a if uptime to the XXX-week line, in it the

of many that change we -- strong NfL, knowledge, all they correlate on with the the patients. volume my usually is too expected and is they to volume the to with refer be disability here. are to brain signal but changes. There not And correlation then of has think on between contrast in as I from change NfL. know if side, is, progressive should all a patients, traditionally change usually to think also we and nicely activities recent overlying the any I is brain office in in separated I noninflammatory in And this risk is, specifically, months, publications know, very NfL So couple think, because an direct disability inflammatory there which relapsing, the where publications signal NfL to MS high quantify good NfL important signal there a were relapse of a for overlay the

Mayank Mamtani

active Yes. Makes of an you're in patient size just have expedite the where later don't sample what you terms us there if expect reassessment of competitor you just have a maybe on you futility scenarios positive there to loop Phase versa? sense. given here, you or how rates And in the -- you increase the program? you or vice than seeing the the scenario seeing number could ENSURE different versus better or then maybe year, scenarios Is could that? because high the for placebo, a in could So III -- event good the you're remind -- you reassessment. the Could also that from

Daniel Vitt

a because you does study, acceleration for the -- that for of not size that will The as FDA analysis, need you the What option, of response this the I is It's proceed statistical or -- most stopping important that, we to be Thank to of repeat have committee. we Yes. to allow if feedback but these any due is a that. What things they do of for such can a the which futility signals asked times. We early exclude scenarios sense. program couple hope can't from we such sample planned we likely we couple planning of a only so question. adjustment, we think. could that a ones so makes also -- it's so did get

number doesn't it sample patients make of I huge sense getting to make to if it's size a think adjustment that.

will stop only maybe And an the analysis. approaches answer study. else, we that viable then could to have an we should these be So answer that

Jessica Breu

you, Thank Mayank.

the have Smith in We queue, more Leerink Partners. Tom one with

Thomas Smith

on respect on across how help Just our entire -- preclinical Phase for I the could is with variability guess, MS of much guess, how couple us then on light activator you the and whether I comment any a extends you're life first, IP that NurrX and chain, end. management, cycle franchise? compounds you're measuring can measuring with for additional your And just this remind marker? can using can what or there to CALLIPER extend you're you you neurofilament working program, II calcium but assay vidofludimus study,

Daniel Vitt

Yes. questions. good Thank you, Tom, for the

a -- First the of lot past, we all, in the technologies here. commented on I think we

also we newest are technology We by or I technology. think test for this system state-of-the-art what using less the more there is dual-antibody Simoa use Quanterix.

I is, with to ratio really as that So the goal the as reduce much think, signal/noise possible.

we that is one. we do the measure thing Another in all parallel -- batches in

really in any testing we operational to So that. variability try avoid

of -- from I think every as will technology the you, as But level. right a view on I So has own precise technology its point think remind this absolute data to NfL be now. possible

just So look changes always at need on relative on NfL the we read-out. to

the that. of of clinics we at you is This makes importantly management, when And that. This of this attractive like something lines to activator platform. of what course, molecule a if talk it think really we gene is can on year, to you, at technology side is much [ the but increase in the and side. On -- telling identified NurrX, really we get ] what last an calcium up regulation. that in what all, to upper regulation, the means about, and between we're the I So are test IP life the on cycle too we XXX% doing my you'll we also and see on the knowledge, potent an only gene on don't more vidofludimus strategic read that's end

to of it platform collaboration towards with [ at opens internally, modulation. in also other at the up Immunic And vidofludimus that are on trick, the is what working wonderful, chemistry, has avenue but only not NurrX neuroprotection, doing hand, gives the here universities ] on on the because a one broaden and it's the here. this on we're another also researchers we So us different biology, also hand, which

IP on We filed have this. some

Parkinson's Yes, We so think think which is think published interesting of And lot of vidofludimus further a role. absolutely, of where clinical other work play have and -- done NurrX some we major I great this this was and for to about research. in And and on believed biology where a derivatives work a was great disease diseases is neurodegenerative later. calcium lot opens platform. up potential a just the preclinical

Jessica Breu

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

Daniel Vitt

development Thank To have advanced various today. Jessica, development. thank With a questions we today's your to III of and ongoing our summarize, of pipeline calcium. we from progress vidofludimus for meaningful top our Phase Phase in year you, ENSURE line next to the April you the clinical attendees well-differentiated continue stages Yes. II of insightful trials, executed clinical and CALLIPER trial enrollment of make on data in

company to property capitalized our into that the fund to our strengthen on are successful earlier with and which balance to we $XX.X XXXX. this remain to continue quarter expected also committed of We PIPE the three-tranche third year means execute, effort. Further, the position is financing well sheet, intellectual million that

Phase to gastrointestinal you a of any serious and broad of clinical additional call. one-on-one. Thank of disorders. With a for treatment that, and is we're II happy for to very today's close its progress trial questions expect preparations made, on array IMU-XXX also an we joining, As I the for much potential would update very answer our like to provide

Jessica Breu

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

now may You disconnect.

Immunic (IMUX) 8 May 242024 Q1 Earnings call transcript