ALT - Earnings call transcript Q4 2024

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Operator

Good day, ladies and gentlemen, and welcome to theÂ AltimmuneÂ Fourth Quarter and Full Year 2024 Financial Results Conference Call.

As a reminder, this call is being recorded. [Operator Instructions] I would now like to introduce your host for today's conference call, Lee Roth, President of Burns McClellan, Investor Relations Adviser to Altimmune. Lee, you may begin.

Lee Roth

Thanks, Gigi. Call. once Fourth you XXXX Quarter and Update and us for Financial everyone, Business Altimmune's for and Conference morning, again, all thank joining Results Good Full Year On today's hear call, from you'll Dr. Officer; Executive Chief our Garg, Dr. Vipin Scott Harris, Gregory Chief Officer. Financial Officer; Weaver, our Chief our Medical and Securities on Chief earlier the and XXXX constitute of XXXX. about fourth the our that issued we Dr.Scot under purposes update morning will website.Â Before full our year Litigation future to Officer, results Altimmune be Private Raymond quarter safe Chief and statements found made forward-looking was covering Roberts, like remind Reform Investor our Relations the Act us remarks press for release prospects section begin, Jordt, and can Business provisions financial corporate join of this the I'd Scientific of Officer; Q&A and for session.Â A expectations, plans, harbor everyone the and forward-looking uncertainties materially our subject factors SEC. you are to we the our that cautions that those could expressed and the from results these actual of today.Â For to and filings a company's affect risks the Altimmune refer operations, results review with cause risk statements to could future that you differ in to our is I forward-looking direct morning, our read press this statements also you issued disclaimer website. release on the which available available to this the the be and statements statements date.Â As a undertakes forward-looking no today's call this being today's update call for occur events speak Altimmune and of replay on website. conference is recorded XX, that made may these XXXX, company after on date, obligation Any only or reminder, on as will February or of any circumstances to reflect Dr. turn my to over that, to pleasure now the With call it's of Vipin Altimmune. Chief Garg, Officer Executive Vipin?

Vipin Garg

in we update. our in transformative have morning, quarter past Thank milestones the was XXXX in joining thank for XXXX achieved IIb NASH and of dual results, at this us align third everyone, a Phase corporate of enrollment readout full-year us registrational data end for completion and the remains Pending over catalysts be for positioned of XX the will you, of fibrosis beyond.Â Following the an Altimmune. XX for pemvidutide The with of The year months our have biopsy-based progress the IMPACT, top-line XXXX weeks. fourth quarter primary significant to trial improvement we will a Lee. you NASH, FDA on of and endpoints study Good second resolution for III track Phase of quarter II year. on our program. Phase request meeting these and

additional loss, in that will and indications our impact new agents.Â In it incretin-based meeting of attractive the press XX-week feature INDs durations indications combination addition rates will which At hold place morning determined be earnings we by we in weight NASH, achieve these fibrosis believe trials promise of on these Phase together the presentations detailed weeks opportunities. weeks represent suited.Â As improvement of would positions the in improvement loss achieve in The III ideally positive in in for mid-XXXX. even a unique obesity NASH. While disclose We XX believe the because been over announced for II will therapeutic have pemvidutide overview am weight direct this that to the Both this be of the fibrosis opportunity potency provide other us the NASH which XX is treatment positionÂ pemvidutideÂ as our of the will INDs XX. which event will and to in would on and used release, with and cleared greater that March agency, X we choice both reduce signals We candidate indications in XXXX. Phase agent pemvidutide pemvidutide the by virtual initiate in to expect clinically liver, action year, before efficacy treatment a of by pemvidutide thrilled opinion in significant response compelling start ability will the to that first timing program it at these end period. I submitted pemvidutide's longer of meaningful share commercial position R&D a and indications. R&D of additional The FDA, important us of a that progress an a meaningful readout, treatment incretin-based in the to by only this specializing quarter fibrosis early to leaders class additional we time, we first NASH, fourth any Day to the the be to XXXX.Â With in take and key

the search FDA of initiate in metabolic as Scott? to meeting this Phase Lauer successful, decades NASH his treatment next areas call therapy to who the advancing foundational grateful be Durso Notably, could therapeutics excited extremely XXXX. and position an II readout to wanted the Altimmune, of instrumental pemvidutide.Â From Scott guidance from disease with experience addition that diseases.Â I Chief our pemvidutide across phase years, of excited end pharmaceutical have of colleague to Medical perspective, clinical X pemvidutide look of readout to recently trusted NASH look are and Harris, Jerry I'll transition. and important as year to has and been us event highly I a valued late-stage plans this his commercialization Board future at for We that a share organizational and successor has sharing are to been our plans and and the and their relevant alongside the February are If remain Terry future. now for Scott retire of through leadership he including that cusp find a he respective ensure and believe IMPACT with to will ample expertise invaluable end whose has me me of readout. about plan the I forward Directors. data the an contributions.Â Lastly, over excited of other for to as time Scott informed you in MASH These the development us served the by We in has recent the Officer our they forward with the that, given Harris. embark for on and and will to industry, of work turn last now With he a pemvidutide metabolic we that the data space. them of their in and successor to smooth our the we near to development.Â I'm am

M. Harris

you, Vipin. Thank

lot As I'm my years Vipin development, I including soon. XX with the and mentioned, in anywhere the the the decided the medical I've plan company then our emphasize to excited after milestones for past not through be asset Altrammune II and the next molecule XX Vipin lead a going to significant to that, and in want in multiple anytime III-ready X shepherd exciting want in months. preclinical that next Altimmune, months, team XXXX. indications.Â You'll upcoming the Phase through readiness will early in from to for departure to as over I Phase additional progress letting about IMPACT pemvidutide a turn remain years Phase readout X in With let I'm thank all important drug indications. MASH. as initiation trials me at the to me opportunity a I XX me throughout of of the III seeing MASH well

weeks to and great development to at also the has direct and statistical antifibrotic any fat effects in liver the agent currently preclinical importantly, like weeks. learned technique FGFXX driver meaningful we fibrosis that of scoring. that loss. larger greater the FGFXXs at to of MASH, we response believe at achieving data achieve XX-week for XX top Liver power, a statistical has weeks. are rapidly agents the are MASH likelihood addition, fibrosis the placebo and But has biopsy-based will in to any is in reduction We've readout loss. significance X will higher using reduction approaching XX noted, incretins the agents regardless arms single readout. statistical we effect approved data employing efficacy ME has improvement the pemvidutide in read pemvidutide for of significance combined weeks the primary the the at reduction to pemvidutide to believe be was than milligram fibrosis XX-week achieve improvement X effects. provide candidate of agents greater successful about weeks, of loss at current will reduction Unlike clinical of when Essentially, the to power in fat development potential achieve the complete and a weight pemvidutide meaningful study line be treatment XX we As for our XX drive on ability with respect the the improvement liver assure effects placebo for impAPACT, that significant we will fibrosis molecule in number of the IMPACT also have data the metric NASH.Â Our achieve weight match fat weight readers the of the success the adequate weight the on out IMPACT incretin-based trial. a a of the without endpoint class showing deal into albeit we first the reduction, subjects than placebo significance improvement loss successful, X.X have If be pemvidutide how trials.Â First, at in of more the XX the in fibrosis both improvement. solution study with to measured.Â With endpoint successfully key the key liver-directed and first also Most therapeutic the comparison fibrosis rate treatment Controlling period. in trial Together or will trials reduce

controversial a the approaches a eliminating prior biopsies result similar II these used of achieved a to findings which know rate Second, pemvidutide manner of pegasofermin be the post-treatment how balloon do have We the to as being sample to blinded to for response readout, we end for by Both agreed example, set those rules trial, X%.Â Finally, a of when or any of trial rereading read is cells. the our introduced in of align will are not the read. bias of advantages the pathologists placebo in believe reading the biopsy atypical Phase when upon is the pre like biopsy including, all improvement biopsies, there. which fibrosis pathologists the only

robust important mortality. We pemvidutide are to In effects. note consistently context, still cardiovascular that FX cause patients, has and that this of lipid-lowering events shown FX it primary have is the

may weight we for and pemvidutide, LDL reduce and of in the NASH has body implications cholesterol disease.Â As disease reductions with for fat the III with in risk VELOCITY the the II shared liver cardiovascular meeting So effects combined only entire Phase Phase ENITUDE pemvidutide not the liver trials, previously, program. that for further both have expected we've and but obesity demonstrated the

its interactions, of our have that to To subjects to completed and XXX FDA those ongoing treated trials. signals been treated close prior in During no related review have with date, our pemvidutide pemvidutide studies. over of been XXX pemvidutide identified all safety subjects in with across

trials our indications. of our initiate compelling these receptor X IND balanced need of the on rationale.Â The X a dual clearance FDA these year. We middle II provides areas Turning to applications to medical attention unmet this the has track the highly in significant additional Phase us agonism of GLP-X indications pemvidutide for recent scientific glucagon in are which believe

information be development will and plans detailed Day our on providing We March on our including these R&D indications, XX. comprehensive at

these from for Weaver, conditions foremost pemvidutide these Financial of been hearing the hand for to the that, of strategy review be quarter treatment instrumental results who formation who X our of experts our financial in of full enthusiasm over will I'll and in Chief You have Greg share the our With our to indications. the the year.Â Greg? development fourth now call in Officer, and the

Gregory Weaver

be to XX-K, and and into trials of I'll We the fourth II of cash Altimmune's XXXX a this reported well year-end additional full in indications. IIb of NASH next the of Phase quarter afternoon. overview Scott. which total you, This and with the year through also be funding more results our $XXX detailed brief financial available quarter later readout includes half information investments expected operations our million. our position XXXX file of we'll Thank current our providing is Phase key for second XXXX fund to cash catalyst

in expenses $XX.X the in million fourth results. quarter to of the Moving in details to compared the million the quarter of 'XX were period R&D same XXXX. fourth $XX.X

fourth million as the full in XXXX. a $XX.X to Phase for loss the of in of loss expenses impairment for R&D related included year quarter was the quarter XXXX. upcoming year preparation XXXX, included II million in noncash To R&D the year. compensation included clinical G&A period XX, last $XX.X of direct in Net a million $X.X comp in onetime in the $X.X quarter in including were XXXX net in Noncash net in discontinuation trials was $XX.X the versus million of to increase development a QX. in the to of costs roughly months of activities $XXX,XXX $X.X stock same million noncash the over the expenses 'XX QX, results, expenses of charge $XX.X development R&D same in were million included million Our in with expenses stock $X.X December additional million a $XX.X the indications. our summarize related for of G&A $XX.X to ended compared the compared pemvidutide, fourth prior HepTcell program. The million quarter three 'XX, loss an million

The I'll in pemvidutide. year XXXX and to trials R&D total primarily to direct XXXX. net second development of on half includes well call were of million based compensation was anticipate XXXX. year. the by Phase loss activities compensation for clinical next to XXXX. $XX.X million highlighting for and second milestones The cost Our due of full 'XX to which the reported loss in in costs the expenses. forecast, advancing Vipin. $XX XXXX labor-related program $XX cash year a expense increase compared The included $XX we G&A for the the million compared million million XXXX our million. the XXXX launching Vipin? stock key noncash the noncash million -- approximately now compared additional million Net expenses million close turn prior NASH aforementioned the the as net for to indications, year I'll $XX funding the half charge expenses loss in into into both to stock $X.X for was related in pivotal $XX included our two a PemMv through remarks the increase $XX.X in as XXXX III which provides impairment position, of of into OpEx runway back $XX.X

Vipin Garg

deal Thank and inflection in you, XXXX points multiple Greg. have major We in accomplished entered a great near-term. XXXX the with

we indications questions. Operator? That trials IIb March NASH Phase the for to in XXth. The additional take door As and which launch we that on us, readout combination sharing we the our and efficacy Day poised of II Phase to look the incredible to each lines these remarks, next of important in and I two for open our XXXX. forward of for equipped milestones is are achieved, R&D new opportunities expect strongly believe they formal an like has to would of updates us will set at now concludes I well open the capture. larger

Operator

Our of Song from comes Jefferies. line Roger question first Instructions] the from [Operator

Fiona

Fiona for Roger. of year and a this is new for year. lot the developments, This on exciting Congrats

the two Just if if trials a question midyear. the Day announce to like preclinical simultaneously new indications. data you're going was at details you're I on to Phase start whether the the the and R&D II going wondering

Vipin Garg

Yes.

of R&D at picture comprehensive will provide the very the So that's Day coming a up. we two indications

Phase KOLs of start presentations as well. about II will our and would terms have in we two when make mentioned, we plans we share of programs As indications, that we these both will the

and providing stay that tuned, So to forward all we're looking detail.

Fiona

Yes. you. Thank

then. Congrats. And to the forward R&D Looking

Operator

from Our question Rahimi from comes of Yasmeen Piper the Sandler. line next

Yasmeen Rahimi

I year. have you XX come to you're get to that on, another update another But can't in not you years believe great work you retiring, with the for if I'm you happy more. Thank know I for

So it's been you, I honestly. working want say to a with And that. pleasure

thinking histological study? you based and IIb the guys flexibility there III be a seen into very of defatting agency, that thinking be NIT data innovative to we the one we given like think -- starting some should there some data would the is be concurrently studies And an be then on the of going about cirrhosis I the you to as Phase to would of have in design histology? with there liver a as anything love Or response, the questions supporting typical Phase incorporation post profound is think conjunction. to the about on opportunity is also you're if the MRI-PDFF understand lot about are engaging is going we study a

development of love of to the I'll strategy sort want And the queue. on to jump how what thinking you're implement? want III Phase in to about and sort you back Just understand

M. Harris

Yes. compliment. I prospect. forward years. I the Thanks, look make Yasmin, and it thanks the will hope I to for XX

have extension program a at study, II time probably meeting. Phase anything we deal we certainly, the interest will a disclosure great end can in lot toward this time. do.Â Regarding the of we that of going a We've that have III any We cirrhosis that as the a high best-in-class kind guide we information success in and we our FX like such have we And announcement, antifibrotic about liver in population. get will FDA effects on on going But the that new discussion think the an forefront this though of as as FDA resulting cirrhosis its based internally. the Akero that likelihood a believe you that what think as feel have to you talked recentÂ efruxiferminÂ readout don't around FX cirrhosis Phase to make have scarring fat it of of our really know, really in cirrhosis we the fibrosis the of But don't ascites, this this we're in population very hypertension, At with And great the believe been took view simply at have with or see well.Â We success the in So time, complications bleeding encephalopathy, is and and when chances their our we quite .We there's trial. that variceal is point I do lot these of the study in is as what this simply an on know of FX. cirrhosis there happens. of on about high. reduction right potential FX, knits want we patients clinically the it to as of don't early have we'll this very in we're [indiscernible] long and forefront the is portal improvement MRI-PDFF, interest strongly extension that we're success but knits, FDA. of that a of We discussion And significant that's are say in to I such the reversible. so of We that our stage FX as cirrhosis about extensive study. population. don't

Operator

line Our Samimy Stifel. of from next the comes Annabel question from

Annabel Samimy

about semaglutide's heard NASH how a ESENCE I not guess progress. FGFXX. going andÂ RezdiffraÂ and your obesity can IMPACT expect the we've a just on But you expectations success? competitive And are with trial, this you could talk but to talk might what that, just consider evolve. to the into Great follow how from market about a maybe evolve to market this data clinical success, lot you about

each think talk other? as just can about programs those all you play in you So asÂ pemvidutideÂ will how with well

Vipin Garg

and GLP-Xs. are we is latest successfully. NASH People that to who also their to you get even That's can there.Â really weight from And what for takingÂ Â Rezdiffra, Scott, other. need many are are are in obesity instance, I'll order NASH Maybe have. that and lose seeing the people treat taking to that We've we data showing each always started, said linked take Absolutely.

We a having combination drug both for on liver. well direct obesity have that's effect as the a of a as for

will as that's We losing benefit would long on exactly have treating impact both. weight.Â So XX% So the view population drug people really, as from in the have direct with ideal obesity the be of NASH subjects will who do it's a really run. liver NASH. that complete whatÂ pemvidutideÂ uniquely obesity lose well and solution a as treating patient with we for does. weight, It would or NASH

we comorbidities for addressing well So MASH of those same as at treating well Scott? think together, it's as the people weight both time. losing positioned very

M. Harris

for Thanks question, the Yes. Annabel.

effects mentioned only at statistical competitive the show Regarding at XX have X trial want liver. out success years direct as weeks, about significance we weeks, have ago at to semaglutide, has I that's the XX weeks. we'll that let readout size XX significant same the even incretin way conducted going to you And because alone impact you tirzepatide, semaglutide all and significance. failed if about even or success, we the attempted that II remind statistical a Phase on XX unlike weeks, has be to the which to

XX We show just at expect to it weeks.

it's much compound. a more potent So

advanced there really If a than they see you the which in in their for cirrhosis there's don't than to that listen out study on drug. using semaglutide.Â They in actually patients. rely weaker the antifibrotic who are Rezdiffra, know, and treating the did failed lot placebo better experts it of NASH, the it about being example, the We as concern they effect of

the will reading separate statistical of a at weeks incretins, XX effect us. all potent and regarding simply significance out think we more in we have So

we successful decision have can liver study make has patient weight probability you guided necessary. think both. endpoint the us be semaglutide. needs won't That is And they which weight you WithÂ pemvidutide, actually of had at at do Now doctors the the add hear when readouts for I about FGFXXs. better FX than our loss, have fibrosis. get Rezdiffra with FGFXXs, before, and be using doesÂ Rezdiffra.Â So the talking But regarding mentioned advanced reduction even FGFXXs the greater to We MASH nor success loss. the successful fat XX as not XX which because have believe weeks. weeks to we actually is we

effects potent You in and weight get loss fibrosis. the the

successful our a but to the we're evolving going terms think in competition So in terms in of drug. marketplace, we very our have of not upcoming that readout, only

Annabel Samimy

going on if I readout? to line you question. just ask be Are one could more top other exploratory or endpoints And any this releasing secondary Great.

Gregory Weaver

Yes.

in We are we so we as a still planning provide much as we'll line but do much top readout, the readout. can. can try Obviously, to there's only data

Operator

of the from comes Our from question Bayko next Liisa line Evercore.

Liisa Bayko

I pivotal if for the population through could you I'm bringing and you some as in just How wondering well pemvidutide overall from curious NASH thinking as studies kind is pursuing and here? thoughts background Just all the stuff the as well it there. talk that of on your all know about of new strategy of for prioritizing fund prioritize clarity indications. on waiting do partnership. obesity love this and of some lingering in the just prioritization But

Vipin Garg

when Lisa, mechanism to are are pemvidutide, Everything of of tied the really pemvidutide. mechanism, doing indications tied to dual are we liver with the talk question. see benefits for thank action really we the you'll the these about the you

for think on indications be that. terms validation that's best-in-class So pemvidutide in as for program speaking. know, excited The II and it We beyond think We all agent continue and the is program III will to mechanism optionality the highlighted inexpensive, focus will MASH will you in additional additional the we very be of about. MASH, on which, indications. have of the we're the Phase pursuing very executing our relatively MASH.Â Our expanding provide Phase indications,

data having the the time. end to we indications Phase these in indications we II when get be at XXXX, we data could same in parallel that NASH looking additional of by multiple could at So with pursue

Liisa Bayko

competitive data what NASH, Phase can kind sense of for you give you the weight IIb the bar in upcoming fibrosis reversal? then us the profile, have of both think is to And on Okay. loss and a

M. Harris

FGFXXs different of different Yes. readouts et effects. placebo cetera, treatment responses, the had The have

to that statistical that compare the to compete percentage. think get, a could to incretins loss. So metric never the a know as then achieve exactly is FGFXXs bit we against key something that's weight and the we We because on hard it's it significance

Vipin Garg

to better I The the add that only know response get that get at other we is is with we XX time. thing going statistical if weeks, significance would to

go The So programs treatment, beyond, XX see benefit. that higher longer will will will rate to even XX when you become time. weeks from respond. to XX we've with other and patients additional in seen that More you response

So really achieving statistical significance up sets at well. XX us week

Liisa Bayko

this and do how as think at of And you juncture? retatrutide survodutide comps

M. Harris

really and the is at you it glucagon no fibrosis liver our about not think at survodutide better.Â We the think Yes. being for effects effects. developed do that we'll that the its mechanism. NASH Their incretins. there's confirmed that's improvement. think that over major of And what that the though I Well, motion. would we emphasize retatrutide as That's of our direct We really over effects. and we've know, readout and more We a in other improvement We have is greater X molecule. benefit glucagon weeks driver fating were was drove seen indication MASH. resolution years point data the XX clear additional And were RS defatting indication have is this nice. XX% that is effects That old, of observed XX%.

differentiate importantly, on more we even think I tolerability. safety and

doing was with front, well. Â We've We of between programs, with With a up doing done It's that. an at not their not X all show saw told titration. in don't for We the GI in with does dose they're adverse even Phase end XX no a in And to fact, we're of experiencing believe other even the for XX% XX a NASH in our the they're in the survodutide, versus trials, a side very the enormous. of that an we where of No the want effects FDA. cardiovascular of the titration. and the we just conversation seeing weeks.Â So forward platform That's rates. that the compound like compound the giving they And where signals know in dose, apparently and reducing safety our tolerability harm profile safety but On FDA of without over had was and went the important at details, the lowest that's safety the other tolerability cardiovascular survodutide, signals meeting standard XXX trials conversation not dose confirmed their we clearly emphasize that.Â When not FDA, the committed pemvidutide. in having molecule. II we're event approach that to of without And maintained profile They not and that safety going the that the incretin compound. had case different for tolerability. placebo And titration with obesity, FDA, know don't now showed titration. want that were was cardiac where SELECT we've over care. XXX, safety. to And no play efficacy extending the compound. can the indications some Remember, We're with without to get to rates that's very, X trials identified of our close completed look but the had in rates, weeks we but pemvidutide not us proceed ongoing benefit safety trial. you trial.Â It's you I they with space don't subjects XX to and they're we and discontinuation to as in to trials, differentiate including on of also no everyone remind dose

arrhythmias, you don't and have with they substantial of signal We recall, heart retatrutide, know that they very a increases. saw As that. rate have we

Liisa Bayko

form has there?Â That's there expect any your Great. update been then any pemvidutide? And at your And on just Day R&D question. my Okay. of should we final oral progress

Vipin Garg

you to that? take want do Jordt, Raymond

Ray Jordt

Yes.

focusing Day, at think the the indications. be R&D I on we'll that new

that's attention where that I everybody's is. think

so And day. be of will that the focus that

here. excited progress far the seeing about we're As as oral we're on formulations, what

we're you're on of a oral an That's always have when think As closing in makes commercial to consideration I've formulation, we that drug we're number of a as tracks talking that as before, investigating.Â I which mentioned about be less administer. sense. always amount you have the that the efficient bioavailability parallel will far

making. excited stay just on about the tuned So that, progress but we're

Operator

comes UBS. line next the Merle Ellie Our question from of from

Jasmine Fels

Ellie. on This for is Jasmine

get the confirmation. additional I for to indications, So just want

about up Xs to you X And see be So were can additional you data potentially for cases I think year? previously, we the these Phase X thinking would this indications. said proof-of-concept year, then where next starting

will IND So see R&D we would third at Day? could potential any that any this about also more others this or from And learn an the be one we year? something

Vipin Garg

the and Let the me second question, can answer the take of Scott part. part first

up our what we'll said being. INDs continue that's got think as look happy having X We'll we're X on we time evaluate indications. far to X NASH. up active to at indications and at the very -- X this we on pursuing to point, indications. But for plenty additional the X, additional We've As beyond is that which precisely plate,

Scott? there. shape good really in we're So

M. Harris

thanks, And Jas. Yes.

of of to but be studies So yes, for at for And There's time. indications, these a committing we will data proof-of-concept we're to at least Phase second, these not XXXX. potential a X one have this in studies. both expect that

year. the the additional have at data the one these and to do least about the cut of we'll Phase expect see makes whether end proof-of-concept in we So X in that indications, of have to of these some by second, XXXX, studies.

Operator

Our next B. from question Mayank line Mamtani from Riley comes of Securities. the

William Wood

for data coming up. that William is events to the and looking very on forward Congratulations on This year are and a some nice definitely of Mayank.

be did be you'll just effect me we you're then there.Â But significance, a expecting we'll we endpoint? fat more improvement I on was line and expecting would IMPACT. be then if if need fibrosis on I you and I'm I of also stat the speak statistical and thinking what liver follow-up. treatment NASH And know have And resolution hit correct could data -- little fibrosis sort should want top that that a on that sort to combined to I fibrosis endpoint. So that of dig just curious reduction, at if to please in bit wrong the

M. Harris

readouts readout combined fibrosis resolution the include and will and also the and to expect improvement all NASH both endpoint, of in those endpoints. Yes, we hit

the liver primary -- which subjects going greater XX power other we and we've treatment we're and In terms treatment what been into driver say in fat study of weeks.Â We actually that powered statistical differences say would is trials these between out studies relative actually But the for with read success have the a actual our significance. higher FGFXX that is power that reduction, also treatment have studies hit the have to to of be There's the effects. of the effect, goal to would terms is per chance we study endpoints. of at arm, the more

in not and powered, FGFXXs both think we weeks. XX subjects we're better if the by effects a terms sufficiently to of treatment of that having effect the achieve to numbers So it higher show at more were powered that seen

William Wood

color, curious could these could, to when expecting when if safe even a we be Or about these us these? bit of give something or subgroup? actually just little assume cardiovascular or the unveil indications maybe be then obesity And outside to it indications. obesity MASH something directly will you be or sort -- some based new or that a Is on surprise should to -- you may we they us the actually of more in X akin

Vipin Garg

can to just about -- in be time. me that I well, provide going color this talking of only let say X all The we're weeks'

we But is look provide do forward to that color It's results comorbidities. that across stay of comorbidity there. cuts into I a and these obesity please the So tuned, seeing other indications. all you can

weight So will a losing benefit of all be would indications. these people -- in there

So weight while it.Â One pemvidutide at looking the achieve is that's loss of health. are improving to of component the liver meaningful ability also we critical how

X theme looking leverage going of you'll that doing at combination well. that's molecule. indications really we're is So to as we see how through And of trying is differentiation additional pemvidutide the forward these And these features. a are develop everything that

William Wood

best again of Scott, for you congratulations forward. luck nice very on And a And going year. Congratulations.

Operator

Thank You.

from next question Citizens of the JMP. Jonathan Our from Wolleben line comes

Jonathan Wolleben

pretty sustained same past, being elephant How population.Â I buck real-world the do long-term. the a could the is there then and anything reduced about programs. low Phase seeing from than wondering non-MASH you'll evolved not in real data We've from in but real-world a the world? since could your if in drugs loss other metabolic the in And due more the thinking some was in suggest a if me. use patients for weight have I potentially there's little dysfunction trend incretins, we've the adherence. seen different In discontinuations talked programs it's data drugs guess III other bit current room profile for NASH that in to you that seen you Two we've think

M. Harris

achieve we're potent first question, offering some a cardiovascular to reduction, different will your such extent, will to saying response as going in that Phase to understand drugs, milligram trial, the X.X the meaningful effect distinguish for loss. III our probably believe weight than we and the liver answer by on MASH fat our and risk. and that trials would which opted ourselves I weight have be loss the we from actual is I in also The if by that's loss that in greater the effects FGFXXs liver Rezdiffra Jonathan, has use we've direct-acting in effects because weight dose dose because

going. to study study and decided But we loss that trial. So target in real-world we milligram this a by over that product add back very type way that simply an to the and to view success. terms of And discontinuations. is in saw of adverse create also have compounds, the with we the feet, trial, in you in program run going with and efficient MASH data the X.X the XX,XXX way, our seen dose we a been to of milligrams optionality that carry going diabetes competitive IMPACT can discontinuation the to potent profile And trials to other that to Phase weight very so going also the we're MOMENTUM say think With trial. our that. adherence, have low way but and believe I would a of to trial, trial we rates. to that's can't the from regards dose demonstrate the response event also give very happy X.X compliance effects, not this III is we X.X we're MASLD only preview saw be and in I the with is a not trial

Operator

the H.C. from from Trucchio comes Patrick question next Wainwright Our line & of Company.

Patrick Trucchio

on follow-ups few MASH. A

First on IMPACT.

How in when on program Phase you II prioritize just other in by you to was sequence would trial approaches meeting last MASH planning, used parallel prior if trials model the begin? timing, year-end, the wondering and blinded And Phase triple could indications? I that could I effect? III of of run registrational more -- trials end the elaborate MASH Phase Phase regarding III MASH, III design will on bit compare reader How control you at to a regarding was the with Specifically, Phase Secondly, rereads. the in occurs additional MASH placebo that little in does III development? metabolic technique

M. Harris

first and turn to X, handle I'll to I'll Vipin third. the Patrick, then the answer

they each uncommonly. very happens X, that. of go X, none X we it's by agree, of advocated And identical used reader pegozafermin approach XXBio reads by that is to on this X their And agreement if that And using fine, We the you X-reader the is their approach X-reader that the all predecessors. then trial. the And way So tremendous they know works in there think Harrison. if learned was take of is individually. we're approach then by the Stephen a to amount it if an adjudication,

on mode different. to pathologists So strict with Using that's to combined sponsor a score getting the the guidances And on for get bias reading they're able the and and placebo out X%. help are patients down when rate they a are trying to what's they severity a lower score of the pathologists by reading early response believe the later because the the into approach. takes to the post-treatment that, called higher that, their blinded are similar with biopsy, see placebo had program, approach effects time they somewhat so the the given semaglutide But when XX% the the because study, in biopsies, them biopsy do in you placebo bias, know biopsies, we placebo rereading study, the the response. of Rezdiffra any that our you like And of of and reader didn't without pegozafermin pathologists sequence responses. the the the -- a program, can it's and get although all scrambling simply to they totally can trial

get to we're X-mode going us pathologists, will approach response we that very aid believe the statistical approach the rates So -- controllable in given combined also placebo guidance mode X-reader with getting and significance. that that, the

Phase an Regarding over FDA for III program end we year-end, turn question. do enable mic with quarter that have by the expect of of in our us question, And the the your Phase the Vipin second II to commence meeting yes, would XXXX. first third and to to I'll

Vipin Garg

Yes.

it's think really it's also everyone I XX-week endpoint trial. primary even to IMPACT our XX a -- important weeks, a though that are it's at trial, remind is we -- the

the So data. still be additional collecting would IMPACT we trial,

end in, have the as and biomarker of of all once data to we're be that way II becomes safety through the will XX the all our as Phase data well weeks. collecting that we data submit available, is actually planning So we'll that data meeting before

So it's a XX-week trial.

ongoing. So to or data enrolled of fully that matter collecting and trial that. the making it the around of is III already all after point. this available compiling of and It's meeting the at simply time It's FDA the a it Phase

So that's how that play out. will

as quickly that executing XXXX. on and We Phase as III program are in fully as focused efficiently possible

proof-of-concept happening now Phase IMPACT trial, the much are II additional those the And right as on are information parallel far in for the waiting of As trial. have that's as efficacy pemvidutide -- all create stated sort there, indications take leverage mechanism all for really we while along, to additional expansion goal of the with. that studies. working we've The that of we is been smaller

from So it's a data we data to III program have still these we for them sequence Phase studies MASH. are -- additional and think easy initiating while

Operator

now would closing Garg back to you. At I for conference time, over Vipin Thank this like remarks. turn the to

Vipin Garg

today. you, call everyone, Thank joining our for

Thank As support time as pemvidutide. for Altimmune interest today. always, we work you diligently sincerely to appreciate again in advance your your and continued we

Operator

for Thank today's you call. concludes conference This participating.

You disconnect. may now

Altimmune (ALT) 27 Feb 252024 Q4 Earnings call transcript