ALT - Earnings call transcript Q3 2024

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to Altimmune, Inc.'s Third 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 call, Lee Roth of Burns McClellan, Investor Relations Adviser to Altimmune. Lee, you may begin.

Lee Roth

Thanks, operator. everyone. morning, Good thank XXXX again, participating Altimmune's in And results you and quarter financial call. business third once for update conference call, Dr. from you'll today's On hear Vipin Dr. Executive Garg, our Chief Officer; Chief our our Scott Andrew Officer; Officer. Financial Shutterly, Harris, acting Medical Chief and Dr. was third Greg and the Chief Financial earlier appointed found release Q&A issued on line session. A and are corporate will and our our as newly press company's Scot Roberts, Relations well, and Officer quarter join website. morning Weaver, results can our the the Scientific on update XXXX section Chief financial Officer the us of this covering for be Investor

Before we our those are under subject Securities that that Litigation constitute about prospects forward-looking statements remarks begin, statements XXXX. uncertainties could these cause Reform for forward-looking to Act indicated. materially the that Private of results the I'd Altimmune provision to everyone purposes cautions to expectations, harbor and from remind future and differ plans, of actual risks like safe

full obligation or reflect on today. after update our website. to XX, any occur filings Any For forward-looking does any call available press our the operations, to you review could disclaimer statements November also the this on you as that of forward-looking our issued we events is statements which this statements morning, refer to results to affect in today's company on only factors company's direct undertake read not future that the date, release and made a now SEC. I'll with the these risk of of speak XXXX, circumstances the or and

for to being website. With the Garg, call is to turn that, Executive Dr. Altimmune. this available it's reminder, a recorded, on and Vipin? pleasure of call Altimmune Officer will Chief over Vipin the my replay As audio be

Vipin Garg

and These accomplishments, that Altimmune. achieved the for call, other everyone, important we are coupled for be joining our to upcoming milestones. catalysts, third position corporate our quarter year months transformational a morning, us Good recent high X several conference in we confidence update. for thank have a of In give you us for Lee. since you, Thank last XXXX with degree

First, pemvidutide With IMPACT, top-line successful in weight XX fully expected of first data and in now improvement a be enrolled, efficacy fibrosis treatment. IMPACT XXXX. achieve the significant pemvidutide to is at readout and our Phase MASH QX MASH would IIb trial is weeks of loss both from therapy

II FDA this Following End-of-Phase meeting expect QX with in hold readout, we MASH XXXX. to an for

at meeting week, key registrational obesity to our announced FDA on program, End-of-Phase recent alignment the comprehensive as For Phase a II of with pemvidutide. leverage our last III attributes we the achieved designed program

value an indications substantial each are will preparations in enhanced XXXX, half the the for gaps we fill believe is we to trial comorbidities X believe the The potential that strategic Phase treatments of pemvidutide, the and that has that up indications plan create We of obese ready pemvidutide. We the Phase left R&D to of and treatment in in of initiation these XXXX. underway development III by first expand and benefit that obesity II of the currently investments for of of commercial clinical activity the indications of now HX shareholders. and overweight the submit the opportunity our full IND leverage we of existing -- the takeaway on market. a first of strategic glucagon into our additional XXXX end by To attributes other made to decision realize have important represents these patients, asset for the a differentiated here to potential that have

strategy continues these coming a advance launch Upon full we MASH believe provide the more centered of efforts start III months. To and overarching speed on to in ourselves, we be to moving a Phase focus details pemvidutide expect and indications the can indications these to we chosen development XXXX, development these MASH trial ahead securing while year. in by in Importantly, second were to positive we additional around as summarize, partnership develop ready of Phase data in obesity, expect the to quarter indications. next IIb program a readout IMPACT in end our from

I'll plans a We relative continue important to in to believe Scott and in the differentiated Dr. landscape. With others the strategically current over agent details. Scott? Medical disease Officer, to call more Harris, ways, discuss our our that that, highly clinical pemvidutide now is turn metabolic Chief from to

Scott Harris

you, Thank Vipin.

of of approximately noted, with in completed key for the either or and September, to for XXX potential incretin additional at followed first subjects without quarter endpoints randomized XX diabetes, completion has X:X:X the at with and to for of pemvidutide weeks. a IIb biomarker weeks achieved weeks. second data report milligrams, the The efficacy agent to only achieve of in significance is the improvement III statistical responses. Pemvidutide treatment registrational to next at X.X become treatment and the MASH Phase XX weeks are program. MASH milligrams the track the pemvidutide the on late of XX the XX an with resolution the Recall, of with weeks in efficacy rates total in Phase safety therapy, Combined and subjects As receive IMPACT in pemvidutide trial position standard placebo weight trial fibrosis these resolution pemvidutide be to year. improvement or to X.X could enrollment evaluating we MASH in care MASH of XX fibrosis loss are results top-line

both is substudy of analyze from clear also to only but excited in particularly recent Study body reported our II obesity. We're composition trials, Association of That at Conference Phase about the year. with a preferential well a the study factor as increasingly quantity, MRI-based of sustainability European this pemvidutide will our subjects visceral mass with the of studies. mass reduction in pemvidutide associated completed body demonstrated Diabetes of for of III not adipose risk. associated comorbidities September class-leading XX.X% weight fat a The has has weight, it in from of with impact X focus This meaningful and lean clinical on data type preservation Phase the preservation and that the of the cardiovascular our as the loss continue be X tissue. lean only key in treated we quality As is been results of

attribute This our II interaction completed of to registrational agency setting with on pemvidutide in the studies, each we discussed, End-of-Phase Vipin X III in specific encompassing weight Phase alignment innovative the resulted with designed last pivotal an leverage FDA As reduction. week. an the meeting program of a

and planned highly fat or in X.X body subjects. VELOCITY-X. on of program obesity, the This liver baseline. the is trial that pemvidutide sarcopenia to subjects, trial of at in release. VELOCITY-X. LDL assess clinical and trial activities This subjects X pemvidutide fat. recap will cardiovascular and Collectively, with me will enroll weight in And Phase a associated weight elevated with failed target II effects is patients cholesterol The will with these the X and in overweight effects with assess proportion Let the of in assess X.X with X,XXX subjects with Other X measures doses body will liver will elderly III pemvidutide body elevated are statin milligrams or previous an and levels. effects despite diabetes. on A overweight LDL expected include over population study press This last of XX-week subset and pemvidutide large LDL individuals past concomitant we week's design effects Phase trial lowering via taking in or patient therapy. registrational patients pemvidutide lipids weekly living with This risk Excess to period. body approximately assess will elevated increased overweight obesity include in of and pemvidutide, appeared obesity with with in body and levels. patients statins will reductions endpoints subjects be on to to overweight in obesity. emphasis without pressure. VELOCITY-X. trials trials prevalent enhance similar a individuals the LDL cholesterol subcutaneous of of outlined registrational achieve in of the trial of effects treatment a milligrams, the disease. VELOCITY-X. injection on subjects daily obesity administered blood evaluate serum circumference, X.X waist obesity and or weight programs in will X of this on composition population. The Functional milligrams, also assessed weight VELOCITY lipids,

the weight meeting start represents to is doses, a patients allowing efficacy intention approval pemvidutide in obesity has therapeutic approval demonstrated with for of path development regulatory the to also additional the de-risking are on only impacting loss. The therapy milestone pemvidutide of FDA believe obesity, these not obtain an important broad pursuing. We beyond successful pemvidutide, and in completion positively for MASH. Our indications of II each pemvidutide that the dose of for development on and we obesity for End-of-Phase the in regulatory but potential MASH

pemvidutide's up may ideally a balanced which We are for dual X profile be additional glucagon as indications agonist exploring GLP-X to suited.

results Andrew regulatory information our the I'll Shutterly, submit our for for acting initiate about with over completed. With expected discussions indication as trial call by further We'll XXXX. first to study indications first in third now We review the Officer, quarter. hand IND Phase Financial year-end the the expect application provide in to are an to financial the Andrew? that, a of half these Chief clinical to II

Andrew Shutterly

and Thank morning. good you, Scott,

of will be filed third cash overview of SEC third and XXXX. in end existing and operating IMPACT with information compared in We biopsy in comprehensive approximately fully of the quarter us quarter half call, our to $XX.X compared ended cash which expected fund second XXXX. Research million quarter XXXX be later funds a into results. XXXX, XX-Q first investments XXXX today. Altimmune project of of period $XXX expenses For at including the be our to million that cash, short-term data of MASH, to XXXX. I our the of the same the will Form million quarter $XXX.X More available and were in development top-line today's financial the of XXXX brief million readout well $XX.X third will in equivalents, providing the with trial Altimmune's the in

million related and costs the quarter $X projects. to the X primarily third costs in in to million approximately costs $XX.X due professional versus months the increase over loss XXXX will to quarter expenses of are development the million quarter for stock-based for of the expense loss same in administrative per million $X.X million and of included the expenses $X.X R&D turn and XXXX R&D increase million net million per loss September compensation compared third Net the of noncash pemvidutide the share $X.XX The General of XXXX, a of direct Vipin G&A ended was additional Our Vipin? period to his discovery activities quarter in research XXXX net XXXX. in approximately third a or a share now XXXX. in net and of remarks. $X.X in third it costs. Included XXXX. I back direct million were for $X.XX to quarter to compared $X.X loss or related services XX, for in $XX.X third million for $XX.X was closing $X.X for

Vipin Garg

Thank everything And done several CFO you thank as you, acting Andrew. our last serving have months. over you the for

XX-year led start team the a Chief life distinguished is joined As who our of companies. Q&A Officer, and the of Weaver, session. sciences Lee at for Over private has Greg function Financial the career, at mentioned public number Welcome, finance us as a the Greg. with Greg yesterday call,

We from board and expertise. on look deep his to benefiting are to have excited him forward

significant made we by We have several the strides months. the over are encouraged last

and seize that from opportunity we lines fast-moving competitive pemvidutide Operator? confident more remarks. equipped are We we our would lie to concludes open stand to to highly take well a the the in crowd, we are we are believe that like ahead. That formal has out than and space, now to ever While potential the that questions. the

Operator

Piper line from from Sandler. [Operator Instructions] question comes the Yasmeen Rahimi of Our first

Yasmeen Rahimi

you're and the That's you. forward to agency Congrats in that the and it filing additional congrats, back these on company could have VELOCITY important potentially considering for look with you're closely question is, wonderful the discussion And be if with very one. Question the are and question that they of kicking the sort Team, how alignment to would what shed kick jump the occurring for got and light guess have the helpful. you of INDs, studies studies, on joining you we working the if updates still you was then a off third really I'll strategic indications are X, off. much that -- terms for you planning you some planning exciting which same order you're is, sequential time? And alignment, that in all partnership? the queue. into question or would Greg, I a aligned now to be the at

Vipin Garg

In got milestone this clean mean, pemvidutide a of that. that for this very conducted. important full the to so the it development is have have was drug. a is, to Scott terms comprehensive really lead trials the more importantly, can and of would of bill clear are Very of important what be understanding studies pemvidutide. we our and registrational how safety, review about of significant I to all we And done, a far, that of as talk what needs approval package

potential for our partners. important very a we pemvidutide for for this So Altimmune and is think milestone

centered continue other Our indications. to obesity, strategy moving we're with speed around partnership MASH and is and a full ahead for look to

In in Scott all comment as as about sequencing of them, more would additional be but they well that parallel, the studies, ideally, terms of indications. can run

We serum in all properties to designed details We'll trial. from these haven't of lipid really glucagon focused really alignment. regulatory seen once leverage of has disclosed glucagon more of the MOMENTUM can pemvidutide talk additional indications point, the that of had but I what about around have and at we and the these say this some that is defatting liver indications are have advantages we our improvement the

later days file X the the more we'll well you the the And X trials? as IND on this provide some the We our after hopefully, talk clears XX are sorry, sequencing planning FDA VELOCITY this can IND about color more the FDA. Scott, interactions, to first as year. indications of -- on

Scott Harris

Sure.

exposed on our diabetics So extremely based include And successful. glucagon, likely pemvidutide consideration that And FDA the the an on safety the exposure. no you that from but for that, was the NDA, plan are our the now at the subjects to during looked up and in Obviously, over trials. we were of have were line XXX lot us on have gave meeting. evaluate, signals which final this like profile the meeting A completed what compliments but effects at was and have safety a impacted interaction. They thumbs be did the identified they is program, also including reasonable composition in although idea a body the number diabetes we ample studies, a to really approach most felt by of targeting including trial, X confirmed our study. not to we'll passed

sequence future. still Regarding to the that operationalize and hope the the for more as launching you of the studies, details to determined to look in near have be is we

Operator

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

Unknown Analyst

This is all Ellie. for Jasmine on on your Congratulations progress.

what now there really IMPACT is data the recent and about you GLP-X we the And are space? ESSENCE you'd thinking how MASH saw QX? trial for incretins see thinking MASH we So what in saw top-line in now from about in to fibrosis, on like what competitive

Vipin Garg

Scott?

Scott Harris

you about a recently the I Is Am question heard trial. that that? completed I correct ask ESSENCE correct? on think I

Unknown Analyst

your now what's And yes. kind just competitive you're -- Yes, of impacted how incretins how MASH? thinking in about for that's

Scott Harris

trial the Well, as results expected. were we Right.

effect You recognize to longer an so XX trial the have opportunity a see trials, longer went to other the that treatment. was of weeks. for because It than longer

This over what number so going expect with through we've done program, modest. we to subjects power an when liver seen well, another from or The effect was was of Phase show been like effects. what III in mix significance. on study liver has treatment the the statistical rather its liver. and by weight [ large move would is direct a fat robust in order increased FGFXX, As as loss than endpoints the semaglutide BARDA exerts that glucagon in when considerably ] agent like was the a on And effect effects that liver-targeted there's indirectly effects fat the more up

So the resolution have MASH That liver what and in pemvidutide, fat moving fibrosis the should improvement. been forward repeatedly the shown is drives to trials.

significant MASH reduction. We're liver and the about at meaningful in class-leading XX showed level. was liver have fibrosis fat at statistically XX%. resolution We their FGFXX weeks, and reduction effects The fat improvement XX%

effect studies pemvidutide done a and number we've direct preclinical weeks. of fibrosis XX analyses of other have defatting, that's demonstrating We on at a suggesting independent of success

current fibrosis we XX at with in is do pemvidutide, and loss weight agent MASH that resolution where efficacy successful, effects even weeks to with And loss weight at of the combined the success significance, the statistical us weight will, If MASH no the comparison the because, as really associated will only associated toward improvement either the stand actually shown So offer combined terms to we ESSENCE? at are XX with in or we the been of aware, believe we will we show have have only loss drugs that that XX and on you weeks believe agent weeks. approval. going And these incretin-based to put are compounds be at I weight first gain. front class

Vipin Garg

just I patients the to patient to that Not population combining liver, a really but going time, for solution effects weight. treating show effect complete only same in it's to these the provides for add we on thing lose this are good a X at direct want MASH.

loss. discussion doing a with So this already we combination effect pemvidutide -- of liver-acting what there's of direct about weight That's providing combination is basically combination a lot therapy. are with

Operator

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

Liisa Bayko

all the progress. on Congrats

questions Sort for line of of X me.

with up -- comes sort to is it back First think And yourselves. views cardiac something do sort including I'm I seen is something as you about in discuss that. of might Are about seems fuller of program, the that relates of really curious -- fact just something ratio to that? Or the that me really the quite It wondering data more of that to or effect? then just and you have that's before wait where should all, a they've FDA indications, to think intend you survodutide bit MASH this of ratio in those revisited. And MASH, and the they initiating glucagon, about class prioritize safety, about go III you data? have concept. it a versus off expect taking as you of to to I when timing for from interesting as curious talk the kind gets if something the that guess, you which have what do the learn I'm additional specific FDA we and Phase going this be

Vipin Garg

Scott, Liisa, you started? your let's take do want question to first. first get

Scott Harris

-- on intervals seen And coronary our of like. we've class conclusion. cardiovascular to changes evidence and studies. no of or all we've the FDA the Repeatedly, the of the MACE laid no seen of we've our for is repeatedly any came evidence disease, data this seen Liisa FDA, Yes. the effect. not arrhythmias, trials, effects a all any effects. disease, in on in And no no of also of same EKG we And all this out evidence

our we confirmation that agree would program that the on probably is be compound. what's achieved And that at the So the to opinion. been FDA survodutide described in conclusion specific they

you launch launch comes readout, and get as the goes timing actual to first the that information year. we the we'll study the in whether after half of next before next or into studies, have see for year. we'll more MASH We'll the Regarding have of

Liisa Bayko

quick One follow-up.

can X for those other they events early study? late signals us the after or those things, In they survodutide, that were in words, or the earlier events? months they all heart and Just rate in increase saw happen you do were remind

Scott Harris

to to program, comprehensive FDA, -- efficacy proceeded Liisa, know. with program. have know no the purely evaluation safety and we whole like What program all a sponsors they other in did our don't went and again, design when a we they trials. of obesity, signals, the that the And allowed of indicated us presented we we

by and to and in X,XXX total As obesity trials, and year. and VELOCITY filling efficacy usually to you have other sponsors that achieved is. we exposed aware, you are it up subjects what is And need that's for that about X, with go a X X, NDA X

a versus that the efficacy designed safety discussion With be program, could the FDA. imagine events. elected in trial, harm cardiac show trials that no to large placebo, specifically they've suggestive X conduct had which We a to smaller company very to of One is that, with don't actually survodutide know. would

that and the I really to What it unusual, about program show we is showing efficacy. design than safety can't is So of their oriented the signal. comment towards can is is more say

Vipin Garg

pemvidutide very think there to studies. with the asked the And III Phase for question interaction clear, you be a and this FDA, requirement about was do I no additional is a program, comprehensive to safety

Operator

Xiaotong next Our Jia the Jefferies. question from from comes of line

Unknown Analyst

This question for X from have X the Fiona indications. -- is Roger questions additional regarding I is My Jefferies.

-- First it in to or I is, think remember call carry forward independently ongoing a conversation mentioned going part regarding have follow-up. And these of that the I I the partnerships? are you is that indications you're

Vipin Garg

have been potential of pemvidutide. pipeline in enhance as indications many continue value said has its beginning, -- to or to really, have idea because attributes. from we The pemvidutide of a the very the Look, the a product for these improve designed

obesity And on these will potential own, not as directly. only we are look at create all partners obesity, believe be comorbidities can they're of to certain they pursue attractive we they indications not for to and designed pemvidutide, our So will really value well.

be around these those we'll So And if designed do very, discussions. keen we continue our also can very these built on own. it's but develop be really so, to partnership a can indications, to

of So indications. a optionality with move a as gives us we of lot lot flexibility, these it forward how to really

Unknown Analyst

to these X indications? 'XX runway X And the my half is, question does second cash cover

Vipin Garg

us would initial filings Phase IND initial for that that cash trials the around as sufficient initial will the II as be The -- conduct the well of plans current them, Yes. we conduct to type these.

Operator

line the Sachs. [Operator of comes next Johnson Instructions] question Goldman Karin from Our from

Unknown Analyst

what questions you beginning half How Karin. for indications couple on This the trials which select indications. you 'XX? that of Omar X the of thinking also move forward? are of have a in the to I And is you'll about size anticipate are ] [ each on first

Vipin Garg

Scott?

Scott Harris

on which based targets, And on not with are of from consequently, also indications involve but effects that and would body pemvidutide weight. effect on These demonstrated targets are obesity specific an indications X benefit these it the glucagon. all has The subjects X overweight. only

So the also it about near We'll that has once provide regulatory indications discussions. to have the in details implications further Hope the future. program obesity for we have complete very as well.

want Regarding provide to year. activities the the the expect commence proof-of-concept the to not do II But will studies of launch studies. emphasize information studies. launching these all and about These the next IND more very this that in of the and future. to will I size We to file we'll be first near be that again end trial of Phase the studies, that I by Phase year,

So we're IND all the really moving is ahead into mid-stage of clear. development indications into once these

Operator

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

William Wood

for recent William great of on Mayank. a congratulations This the on Greg. and is hiring on Congratulations quarter,

have helpful. And couple really help that your deeper, be provide will in your you bit could expecting coming a about maybe extra could up. Phase of or a a I curious data have ESSENCE insight little looking II guess ongoing we be there specifically that Phase inform for study? IMPACT confidence then I follow-up. data Any that what in We are III just the kind at of AASLD questions digging

Scott Harris

were details I the readout, of initial the statistical not about that of lot power. that were sizing represented really that we duration way think the of view study. included the effects some We in approaches, think William. study there the questions like. Again, were the think completers the Yes, don't predictable. a of long treatment We changes modest, and the effects and super the the were and

efficacy would even time modest But certainly are time it effects the cannot that the everyone just to of enhanced and that watch point a see hit that having our by will of speak would interest study. of to better those earlier really be we point to It readout presentation be effects. showing to be at effects they So details the think see else. a with the semaglutide. We soon too much an at glucagon study

William Wood

your now MOMENTUM question strategic a the curious of for time discussions around on an how then I'm getting closer readout color any the evolving the Phase broader to starting beginning partnerships and multiple X now impact, across pemvidutide, now, of they're readout. and indications. your we're that to while potential These additional of on additional color on little your have partnerships. would II -- ESSENCE obviously, conversation your helpful. Phase And evolved be been II end have expand with on just kind that if over going potential Any now

Vipin Garg

Ray, here. absolutely. Business Our do that you want Chief to question? is take Yes, Officer, Ray,

So Raymond Jordt.

Ray Jordt

think generate approach that the they executed own what's that accurate data out I feedback, the from no is XX for for programs. there to period think, advance the why trying say been continue discussions has As feedback their And leverage engaged I to been throughout other been you strategic received their do have our these still has jump with partner been I what's we've obesity. companies to have generally strategy because to strategic the been that fairly mentioned, and figure is -- they're that because the initiatives, now of XXXX, interesting, is And we always their how -- into about think, capabilities, months deals I now.

is the think genuine. feedback receiving I we're So

other into think still to how out companies they jump it. figure I are trying

is for the are I keep value think generating data, generate to to so starting for us advance the important I things think programs, And continue everyone. And what's to resonate.

is MASH a Rezdiffra for pemvidutide, I unique space. The and So in this that's very I indication, think preservation the attribute traction, lean hot think, again, mass, with launch. been more even topic the gaining that's of I a think,

value, we being be going the be there. I about broaden Scott is that combination of again, weeks is have we'll the positioned XX more how efficacy, to and the believe will direct be with I additional attention focused (inaudible). differentiating. weight and think even think more Vipin indications something there And offering And to create is loss talked going

are high Altimmune strategic So well at things in partnering benefit that these level, our as a discussions as general. think I the

Vipin Garg

that And II End-of-Phase know a important designs conclusion looks and I is just take now. how what to how this program line. forward. path and add End-of-Phase meeting of to -- going the finish would is clear cost II the to the of very much The really meeting the conclusion successful the We the moving trial in are it's these discussions milestone

seek are a all we So I think in that we'll to continue centered obesity. -- place, being partnership around

Operator

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

Vipin Garg

you, call Thank joining everyone, our for today.

we always, support we interest look again a diligently appreciate updating your Altimmune your great in to of your near day. as to Thank our time. for in you Have We the sincerely rest advance pemvidutide. progress on work you continued and future. As forward

Operator

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

disconnect. now may You

Altimmune (ALT) 12 Nov 242024 Q3 Earnings call transcript