Altimmune (ALT) 9 May 242024 Q1 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Altimmune Inc.

First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded.I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer of Altimmune. Rich, you may begin.

Thank you, Gigi, and good morning, everyone. are session. in conference quarter team question we our answer call.Members on from call Harris, participating and financial joining Scott Chief for Chief Vipin, Officer.Following the update our hold the Scott will and business of today Chief Scientific you Officer; Altimmune's Scot myself, Harris, XXXX first a results me Executive and Thank Officer; Garg, our Roberts, Medical Vipin and the remarks Altimmune prepared A our and results be website.Before Relations with future like press issued found was plans, provisions prospects cautions constitute differ about the indicated. and remarks I'd results under of Reform of expectations, materially Investor financial release to and these Securities that XXXX uncertainties quarter first that actual remind the those this forward-looking company's can subject morning begin, XXXX.Altimmune section Act Litigation everyone that we statements Private for to Harbor to statements from Safe the are forward-looking cause risks could purposes of on

today's occur X, these after this morning on our that forward-looking company's May also Any the speak discussion of read in other and reflect call the conference please with forward-looking the affect date. events on update factors could as and that results press does in future and our SEC.I'd to any only obligation issued on statement company's the some or a today's contained the statements release not risk made statements the factors see of cautionary direct to of available risks Thursday, XXXX, and now statements you and For disclaimer filings the undertake operations, or this company of date, website. circumstances to any

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and poised could our XXXX, to of the a advantage candidates the other late-stage to in will a and Phase of which position and be incretin partnering continued meeting, aware, to incretin-based of and the as remains XX Study, joining and in quarter about meaningful for of we our for of of the came lean receptor development.As we GLP-X third placebo programs.Looking the clinical characterizes a fat.These in read package quarter exercise the impressive with effects evaluating in you from at only I competitive finding just we data drug MASH, are in patients to prior individuals of loss on conduct subjects.Top-line first optimistic pemvidutide, Program a MASH.We goal differentiated corporate thank committed for program will IMPACT our could pursuing.We well FDA to candidate morning, diseases, part data.This of end the mass towards results and about once the advancement leverage as plan respect quarter dyslipidemia who indications.In III pemvidutide on obesity pemvidutide. last Good to comprehensive are X these MASH, with the weeks treatment, Altimmune our And dual body for obesity, Phase meeting, everyone. us fibrosis long-term we ongoing in of if results the dosages shareholders, therapy Thanks, all potential and against agonist in update. IIb each of the with potential We from a as MASH candidate this of accomplishments look data liver to these for the strengthen trial, with lipids excess of out degree liver maximize near biopsy-based further to end first -based pemvidutide pemvidutide the came comparable after position present are On glucagon XXXX and again, that we held obesity significant MASH, enroll additional II to continuing the weight in and with pipeline inflammation historical fat and of in ability pemvidutide enter MASH, over other obesity we be currently with XX.X% taking MASH diet significant being remain believe further potential in first and to for parallel our firmly forward to will weight that in to of best-in-class of of in each recognizes of Phase reflection our XX.X% of expected MOMENTUM in taking overall our is are reductions of give you our clinical are that potential associated or these at and to of the at these approximately XXX our that be a in excitement together fat partner guide our partner late which serum the to preclinical in our indications expect pemvidutide to as to of XXXX. and long-term is observed that advancement mass Registrational This Rich. call, biopsy-driven lean from help trials, first liver obesity.Turning preservation, continue robust pemvidutide. data, loss loss the a of our patients and based positive, efforts treatment pemvidutide endpoint therapeutic pemvidutide as design milestones the our contribute our steps Trial and pemvidutide the X the we in March weight body reported important studied we value ability the a Phase next II the composition working demonstrated confidence of we treat shared with and

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you, Vipin. Thank

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top-line important medical quarter. these treatment liver may ultimately potentially readout We data preclinical decreased treatment also will this data changes type first and the action at highlighting, to of If to pemvidutide believe be alongside metabolism objective long ultimately differentiators cholesterol the improved Altimmune with and to how the total administered reporting over choice months of to weight of the of financial an first Officer, I story a in patients can triglycerides, natural developing the later transport. could process other and with magnitude life receptor glucagon the are robust proposition, treatment pemvidutide that of expect cholesterol.Recall best will will be that reverse be effects the several stated which the on condition, that orally the an cycle reported choice risk. taken, we elimination the year, the now has an conference is that efforts provide by We lipid future we results trial, Those and for We Rich broadly call called will the quarter consideration important and demonstrating not effects turn to among optionality explained patients but lipids, successful, pemvidutide are these the data believe clinical describe cholesterol presenting study this also pursuing. that beneficial and recently agonism including will towards management should next the we in important Chief lipid patients and for forward are continue of a pemvidutide diseases on that we physicians. over look the and review only from through important XXXX.Looking recognized more our pemvidutide be that, the we things, cardiovascular an value in support associated To cholesterol, we be be Executive approved.We in an metabolic has pemvidutide.With pemvidutide. will Eisenstadt previously serum make our be of for formulation in that progress end, Rich? that continuing loss, LDL

again, Scott, and you, morning Thank good everyone.

of million a are Any I providing in Altimmune's compared results. XXXX million $XX.X with XXXX. the expenses. $X.X was in XXXX be pemvidutide ended $XX.X $XXX.X cash with million the XXXX. the period direct of million clinical a for included be in We $X.X to available that approximately rate update HepTcell the $X.X development during at the of first be to information in administrative trial income the labor-related expenses Form million our versus us XXXX. of the total today.Altimmune in of $XX.X first of Approximately and related this XXXX brief IMPACT compared expenses the of including our equivalents, for existing stock operating first to were quarter in XXXX the quarter programs, XX-Q where first same cash increase followed an quarter end XXXX negligible was quarter which For will conduct in million million and for on first comprehensive with will half XXXX.R&D SEC million the increase The activities funds XXXX. XXXX of indirect development that first $X.X fully in expenses investments, $XXX,XXX XXXX, we on development direct and as $XXX financial costs closing primarily costs quarter million later closing is expenses today's pemvidutide March direct the and project of HepTcell, activities.General and and million short-term to the More associated on contract and the first to first expenses call, our to and in to direct compensation out.Research into for government due in expenses of the XXXX, of and were million $XX.X revenue XX, development other wind-down related periods in $X direct first in quarter adjustments related of to Revenue Mash.Turning reported announced our funds such quarter and statement. in of quarter cash, of

of ended the loss share, $X.X March for XX, net compared share or net of expenses million, per $XX.X are first loss XXXX to development $X.XX Phase IMPACT as XXXX loss operating was research million his quarter X net in it recurring of or in the the first million, $X.XX up and Vipin? will was $X.X expenses.Net months for is ramp increase primarily million, and attributable all to the quarterly MASH.I closing for now of net trial the the loss loss which quarter over to $XX.X turn back expenses Our for IIb higher quarter The we non-cash remarks. XXXX. per Vipin

development in for concludes the for the continue as several would questions. take and we what important formal holds. excited remarks, pemvidutide.Operator, Altimmune Rich. that we months, remain open our milestones value well-positioned that coming to advancing to the is we We With Thank the you, of future long-term line like creation, believe

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

us. from couple A

The to related II first obesity one the end-of-Phase with your FDA program. your meeting is upcoming for

pleiotropic has a differentiate. to Given effect in different pemvidutide many ways

curious how question then those what your differentiations Just label? to plan your I of you have to related really endpoints into a potential program capitalize development. to And -- kind will follow-up in the new incorporate

Scott, do want to take you that?

-- as want will across to most Yes, out choose just the with best studies. pemvidutide, pivotal looking will to have meaningfully meeting. be -- X composition, X,XXX oversight, body effects and that those to to say, whether as around the for II nail the lipids, on taking the value we're the or be of the of conduct, enhancing we good Roger. be.I end-of-Phase make We're to look X the patients. really on head I a the program to to value think really what effects you've effects a forward bring that forward the meeting maximize choosing liver the key the think objective mean, patients. going the expect discussion the population will set We're our proposition. greatly thing I the trials we think effects about an the on to population center lot the the hit the greatly will But it's on of the We fat.So program And X,XXX

important even body potential a better at optimal we treatment we're XX% to results a loss better other great ratio selecting weeks. at lean down in really the of the over here forward loss goes I fat We duration. and XX time had mass, for of composition weeks, results some will think mass points is be point? the XX even making decision know, got weight longer XX% at But there to loss getting that FDA.As lean with That's looking you fat but time. of

of even longer its if of a the of So over that followed should in ratio mass. top its and pemvidutide of at preservation time, further put period out class drop lean terms

and liver when things that to of the we So, them. population the selection of the with body the of the are to duration trials, agreement number particularly fat, the treatment meet the aim lipids, get maximize agency value with all composition, proposition, the we

new Got quickly for new it. Maybe indication on on your the potential development X ends. One is pemvidutide.

yet, your you kind Just MASH but And the obesity obesity, do to curious the oral disclosed curious, be you're population. comorbidity And pretty something a of will that just understand I in current formulation? development, peptide? or terms just how scalability curious of not your orthogonal pemvidutide think the with about in for what and MASH, oral

about development emerging about the turn to question answer oral Roberts the program, then Scot question answer and to specifically the over it the I'll I'll formulation.

are value new is Altimmune, indications regards in are their specifically, pointed proposition.With indications surrounding know, value the looking So, out, of companies reflect as glucagon, to order for differentiating. to as obesity maximize that you very you we proposition which pursuing

what So the glucagon or future. we about to glucagon effects hopeful liver table, will near diseases with the for lipids, are we're indications body believe effects decision brings fatty serum reflect a example, new specifically programs associated and composition, obesity.So on the liver in of very on of that the to the the even and that make also

about Scot? to answer I'm over Roberts the it the going to formulation. Scot oral Now question turn to

types pemvidutide. approaches, studies an Those matrices oral pursuing of as work of The are we're formulations, to different is incremental. for in number a indicated we've formulation So, ongoing. different obtain the different past,

it's merit find that You and some it's then looking good, formulation a has and and optimized retested.

number a in process, the a different and of it's reiterative we're middle So with approaches. that of

criteria that one be the for and by appropriate is expecting to year.As set that oral to required of end a useful. formulation scalability candidate substance development as amount ensure are would for of we specific a level of the for We question, and nominate hoping drug the still bioavailability and the the of far attainable successful that

So we continue to have formulation, an scalability, will fronts. and on be issue, all successful not a if progress we make

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

on Jim for Yas. is This

regards the of And own you to increase results? Conference, First, to program IMPACT MASH the from in partner? probability right your secondly, Is gain could comment hope the to into continuing finding shed EASL upcoming you do light success? and presentations this with what to competitor

Scott, want to the you question take second first?

Yes.

asking I you're meetings? correct? correctly, Europe, I and EASL in Is meetings if if I So think upcoming not, the apologize the I about liver did that heard

correct. that's Yes,

Right. start a across are have we that saying that of Well, presentations by the planned let variety entire year. me say and meetings for

So we at will represented be EASL.

value EASL pemvidutide on We to the the have Those year. effects on impact science, attention, have the continue differentiation, its much congresses these the EASL. specific all gotten effects of of presentations lipids will will we in on that aspects as of on impact over that the at on proposition, aspects And composition data, effects the differentiating. Those metabolism, course out that key address and have the the the metabolism. on things the scientific be the not X come been posted the But lipids, at of its other think and website. body will effects really MASH

from on And do we you other what want presentations? expect to to learn comment

EASL, also will example. presentations We will know, presentations that Well, tirzepatide. on presented some you for data be on be survodutide compounds, and will at be some anticipate there the other there

tirzepatide they've that the didn't statistical fibrosis endpoint. have presence expected glucagon hearing hit something the or announced we had at press glucagon. to fibrosis And did of by we data readouts in emphasize look that's looking that, of mechanism to that due And a achieved is they they've which that have does have we We're and we releases. survodutide least reached know, have glucagon. in you their to endpoint, results, they've know, you and amount much the significance that.As would the a on As greater but forward forward top-line a molecule, glucagon, in would the not

that's they So the our in we can success next coming beat feel that of in any year. readout up first that quarter we build,

and has your of it, very partner, we as about always think you in both terms we've the kind data, MASH. of about developing in to the in other. MASH Yes, that right perfect combination compelling if to patient that think X And maintained compound intersect these as obesity of pemvidutide each because things. people also MASH well question obesity are populations we a really bring in It's most these hard line, to going weight.So be down we differentiate lose with the need

would So our of terms been our help right find focus has to us develop parallel. partner, partners value on is both has of partner the indications, that of been, a these that in in goal and these indications both

Sachs. the comes Johnson Our next Corinne question of from line from Goldman

This is on Corinne. Omari for

So you bring to pursue a provide how on the and update the want to pemvidutide? Could from are partner you us. partnership plan you in for an discussions a progressing, couple do with of questions indication new

say the to efforts I of our terms partnering of be What I can a partnership topic ongoing. continues in is are Yes. interest. mean, that that discussion,

mentioned II going as development that we information, be -- on -- to data. efforts the are are value that into discussion, Those partner a we factors earlier well that's to there Phase as tuned. and driving, Phase before are as so having end have finalizing for additional stay we numerous come partnership of expect play into very in We the sort getting think ready we ongoing, We of for III meeting. call, obesity.We a have go

to of have trying sort mean, indications mainly the maximum are figure of compound I value-creation in yes, terms MASH, MASH, that out extension an to our additional these we're GLP-X really the In other where of compounds obesity are focused. differentiation indication opportunity, obesity and broader and opportunity indications, and relative does the

Guggenheim. Lelo of from Our next comes from question Alana the line

to I just SYNERGY-NASH study partnerships on potential again. little wanted the circle the to the and bit back back of a outcome

of benefit, was said was that meaningful that on clinically with in my whether turns understanding, but that NASH? benefit not. direct hit it was had If from to So, -- on or significant they SYNERGY-NASH, tirzepatide PET statistically commentary they see statistically does there how do a impacting significant lead fibrosis out no the you fibrosis, it that prospects

drugs So, continued or these effect to not liver the a state, in have as rich we've improvement effects compound has. that same defatting on do fibrosis glucagon

have long from a that drugs caloric could that the can But out presence they enough. our that statistically endpoint, effect if time. that patients given in out in are enhanced meaningful have where And they eventually, follow get of possible from fibrosis of reduction and data and you would read you've eventually enough robustness know and will it is original enough on we and enough have you significant. tremendously we glucagon, it think I intake.So, an effects patients the an effects the simply seen such them of potentially the results, treatment So, bariatric actually earlier surgery, speed that's These time point. better hit a

they would believe congratulate we them significance, would also that we highlight achieve do fact statistical the better. that will we but we So, if

on timing, or might are that data for thinking respect secured Thank just year, partnerships, that be still you likely can NASH a that then, to very XQ confident this And you after Great. are the partner quickly, the hits you more with clarification. it be 'XX?

timeline partnering. Look, Yes, is difficult the it Alana. the for thanks for pinpoint to question,

our III the said, before our partner we start that things to have obesity of I've develop the ongoing. have are remains We Phase end would program. front. let's year, to the love goal see As But efforts how -- on a before

know at obesity. in better. Phase board of a start we'll partner are the this on progress, committed point, having before But we As to our discussions III

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

-- questions, to Phase II see taking for calendared. our Thanks the Phase meeting of and being good in II

similar wave you step-in follow-up. be drugs to, loss have you wonder of may couple plans correspondence of surmount outcome big weight believe I able could so comment Amgen a around you share that your could on how just relative specific how FDA commitment, next from FDA say, be, same then program? having if, time, are guidance also And So, are vary big quickly, an any the obviously, standpoint relevant to the maybe a I benefit. this And also, trial I here. lipid on that if could on given, have to be able

sure please not entirety answer the if heard I'm I so it Mayank, I the completely. of question, don't first persist

table treatment and that that look, X And more obesity be but value-enhancing in became of role later expectation. trial will what provide obesity glucagon enhance there as will meeting safety So, segments meeting the hypertension expecting there become of the that than know, way segmented, objectives, meeting across differentiated. populations and we Right for a the there's look probably there's year the done things that glucagon lot those with distributing creating endpoints diabetics, as same will we're to trials. X of specifically for not like. a pemvidutide obesity more this that likely, not be market to the well We going is room are in can have with of differentiated and value will place great that the into of proposition subjects expected, more going know this over and this treatment now, is database becomes what in the still segmented.So, brings we're at and company. be We're without it really of population things diabetics with that going the extremely glucagon we those great certainty around a to be now and differentiation goals subjects, and trials are time. there certain enhance get X,XXX obesity.So that the to our And right about the

example, of weight different So the to the also we a population, know pointed particularly and loss best body the XX composition, is before, composition treatment loss changes with mechanism. elderly And choosing glucagon on in our of can and differentiation include order to that as enrich you weeks stress I and of for as lipid over amount based mass steeply ride ways fractures, maximize higher looking at body function in improvement effects, to find and of time, that out know, of looking really on the that at body wave could composition.Now, since, to goal to at durations rate in with weight lean women. continuing the of loss in also trial we loss the was is respect bone associated the that

loss, in and saw natural natural weight in mass, the of elderly. which lean with semaglutide mass lean a that is the fractures XX% of loss, exceeds loss what So they women we achieved. they of a trial, which had is XX%, diet loss the which the lean about their XX% exercise, we in from label, But and report higher rate

the segment differentiation example, osteoporosis extra or weight, recognizing of immediate carrying risk, elderly, its individuals, with of for the the market on ideally increases the women risk be implications huge or see lean mass, are frail around lean of the fractures. that with could women of segments.For especially a preservation suited you which now mass and because can on the treating the So population, bone which is pemvidutide

are So discussions endpoints. that FDA all-in-all, these have our choose we'll and our with as population target the we

Super helpful.

I lot. a think you covered

you scope, trial, lipid given the a big you have comment and If could scale on outcome benefit?

going to benefit Right. a Obviously, to that's us. great be

of major was at are really there aware, reduction on cholesterol basis cardiac a the serum I just think LDL minimal on the correctly, at we to that's serum where the reduction loss best. XX% in as comparable MACE, about X% trial, a you're of I adverse alone. our of effects of and of effects XX% LDL, lipids population in believe, weight to we events, data which Because lipids differentiate. is saw subjects I'm range reduction only select can if the cholesterol that statins. of their the with elevated quoting total the in X%.Recognize baseline, of are And

seen that really semaglutide. we that going with So have that trial, into very could exceed excellent effects

not cholesterol, and very We lipidomics lipids the to conducting also about LDL the the and soon the that are it it with inflammatory liver, lipids. does time diacylglycerols.So have is pemvidutide like the That are damage system III we're we past, that that something that the a we'd reported have amount get that ceramides out of And optimistic showing so to of reduce that like known in trial. Phase also those achieve discussion that changes trial total on start data of circulating, only in nature as and would the and cardiovascular possible, FDA. in market that with around be as results to the authorization. we'd Optimistically, hope very

it. preliminary look Got -- impact. development, based also for development could loss, you Phase just track MASH and biopsy. get could you if track enrollment no some complete like. on just And I late-stage on NIT fast Are guidance the on XQ? has maybe curious now on on glucagon-directed in III enrollment remind what just weight us your the was to program, you MRI-PDFF, then And have another which MASH endpoints, there's

to Yes, division. be with endocrine Mayank. The obesity meeting the is going

liver Our NASH program is going division. to be with the

to NASH opportunity think information So there's a about the get going development. immediate to I really don't be

NASH We silent effects MASH information the a disease. interchange any body they their can clearly have development.Regarding that, we is obesity and fact well. And it's going this what visible, NASH that a clear them Of ideas, course, day-to-day they is from overlap on seeking can enhance there's on are reflect to weight. we take basis of see forward get enrollment, patients treatments with see. extremely that and think

to is trial first trial, enrollment And robust we've So of opportunity said, support, very given the weight as the rates. to the the they're in readout rate into of handsome the quarter next in at going year. lose this coming

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

about are the We diabetic data class? last how I And to GLP patients showed thoughts But read-through see glucagon as that your heard and for some detrimental data thinking in wondering, wondering some for had pemvidutide? do from And you Chinese said data even another be any night superiority this set? dulaglutide. population may I you opportunity glucagon others saw. pemvidutide Because if we've guys an effective to And that critiques agonist. on not diabetics. the and was was you agonist that

Jonathan. thanks, Well,

something And derive blood the that populations, variety control of you've diabetics. GLP-X/glucagon we data tirzepatide, compounds, diabetics, that just talked excellent seem a possible would So, based its studies loss because attractive, drug of about whole drive are all glucagon haircut data, as benefits.So effectiveness But safety it to extremely seen into where believe the maintains seeing supports and in it interest our a diabetic clearly in in the that something is hemoglobin emphasize weight in GLP-X on to sugar patients well to we diabetics safely program. about, this our great own mechanism is designed to including of other is in of equivalent the as or like forward drug population. go of is AXc. to non-diabetics. to as and with Phase glucose preserved as III, that's know, our is that This would we've loss semaglutide diabetics I the unique it the weight not weight down based loss a be in specifically take we there ratio the which blood because, while emphasize, us you in continue

that operate are the diabetes in that and believe extremely could space. very we nicely So we pursuing interested in

one Okay. if may. more, And then I

guys the from you -- with think shorter how and lot importance about Phase about the III? profile seen you the your you like a improving of your for versus, the Just into talk are both and titration, other which slower in thoughts program, going tolerability have you we've the as past, programs, trade-off guys the Phase between the about planning III talked can titration,

and something that's great Jonathan, Well, we're lot of that question, giving a to. thought

first placebo, is want without extremely attractive. The would discontinuation is profile, rate given an an similar I to I adverse pemvidutide it's that dose to thing X.X It has everybody event adverse titration. dose event say of and remind

a achieving the as dose into X.X milligram But X.X to and not could pemvidutide patients some that as to drugs milligrams how and like drugs milligram, literally it, pursue started well of we're loss that's have approved, on XX% in that titrate a to were doctors the natural dose weight X.X patients III. these milligrams these clinical is the doses physician Phase going on prescribe up forward. of So going wait, and are dose, that.And then see as practice lowest they the other the X.X to doses use go do, increase

So pemvidutide this as very that program. discussions the optionality population, pursue a and discontinuations We're our adverse FDA. to in is dose, in trials. low and from and practice, next next currently no in we've our was observing, adverse to trials, waiting, trials, reported.So is with profile that all, trials know of about in single-digit regards of aside then naturally and happy practice, allowance very at Phase a all in the the titration which go dose.Now, specifically scheme talking of rates clinical It's our something all the case, on NAFLD the the event enhance doctors We the discontinuation titration the of other considered. to something into saw reduction, compound. tolerability but the being there there nausea as at dose titrate by It's obesity profile will That practice, the the you're that clinical of the on going in dose time MASH with event trials. no the dose, construct obesity in tolerated. III is that X.X clinical only construct greatly really with we In the the forward seeing happens table starting We longer-dose a we've allowed the developed. drug well tolerability of -- milligram diabetes we're

Very them. helpful, details seeing to looking you color. I'm announce Scott, those when forward

I showing am now remarks. I over to closing conference Garg time, this the to no like for At you. further turn Thank back Vipin questions. would

day. Thank you. you, with thank Thank results Have you for and support. everyone, for to outlook participating share continued your you our today. this a We appreciate and wonderful opportunity

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

now You disconnect. may