ALT - Earnings call 3 2023 | Altimmune, Inc.

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Operator

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

Third Quarter 2023 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, Rich Eisenstadt, Chief Financial Officer of Altimmune. Rich, you may begin.

Richard Eisenstadt

good and Olivia, you, morning, everyone. Thank for Results and you participating in Financial XXXX Quarter Third Business Altimmune's Thank Update Call. Conference Vipin the and Officer; of Chief call Officer; Ultimune joining Roberts, Garg, are Scott me Executive our Chief Scott Officer. Harris, Members our Chief on team Medical today Scientific the our

the third of will and results financial was company's this morning remarks, Following question-and-answer A XXXX the we prepared section press quarter session. be Investor found website. on can a the hold release Relations with our issued

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

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

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

Vipin Garg

and our business discussion morning, financial us you, for quarter you Thank joining third and update. appreciate everyone. of today We good XXXX Rich, the results

a GLP candidate glucagon of both the NASH. in We development for our and dual continued obesity about new agonist advancement are receptor Pemvidutide, product excited

treat the serious impact September, option results weight With fatty the subjects signals Phase other in increases in of last Pemvidutide Pemvidutide remain informed to with and placebo-controlled the was designation Altimmune's up public top with teams. reduction weight closing subjects meaningful or liver relative disease. serum trials II decision momentum Phase important quarter. those no pressure treatment we announced dyslipidemia. XX the and with obesity the approximately and growing with out IIb of being arena prevalent rate It our in were if the evaluated treatment with efficacy past in is development of of FDA NASH conditions of to there the These known on The especially combined overbaked, a target and liver significant currently effect Ib of Momentum placebo-controlled population. lipids trial. suggest and treatments. and blood nonalcoholic randomized intended NASH of last dose ratified part Fast to achieved. in X is that conditions trial of safety obesity the XX% content cardiovascular and fat robust or we important concern, by at concluded without patients in of milligram without our The X.X new weeks an Pemvidutide showed for interim this Phase FDA loss body The of designation announce to subject granted only XX.X% or and Pemvidutide unmet results obesity, data loss review with biopsy-driven is after weight and designed heart address are facilitate of the the Pemvidutide are NASH. XX-week that of drugs be line expedite medical the for In track XX% our SMB health fast this together program, has is recently Track treatment. to may Recall, to Pemvidutide that NASH point approved, clinically these reductions

compelling data from Phase trade expect data achieve fibrosis we anticipated and mass loss trial, to of weight the XXXX. improvement Given our Ib and which is readout, resibution QX significant in

and posted website AASLD. kind on new of the As also Pemvidutide [indiscernible]. We clinical details and prior abstract of at a refer announced release be will of to data late-break at anti-inflammatory the our antifibrotic at presented a that effects press

hepatitis quarter virus Finally, we and is chronic trial evidence expect from XXXX. Scott? combination of plans. of to against establish Scott significant Harris first B our designed have therapies treatment that these to discuss progress a turn that, HepTcell of Dr. to and Medical the effects B call clinical results trial HepTcell for pemvidutide role I'll show Recall clinical the HepTcell the in this of and data of With now of Chief our in hepatitis over IIb to ongoing the in antiviral our Phase Officer, of trials. upcoming readout this the

Scott Harris

X.X X.X morning, trial from Cornell obesity. start trial MOMENTUM dose enrolled XX losses pemvidutide clinical subjects The at without good pemvidutide at Weight Phase off the was were performed XXX the treatment. a leading were milligram trials analysis in for completed and subjects of X:X loss least dose XX the placebo. and trends principal observed. loss weight investigator. XX% A conjunction X.X-milligram is diet cardiometabolic X comorbidity, a X.X at the Wild positive achieved randomized XX and compared weight XX% achieved weekly prespecified exercise. but milligrams, obesity placebo by in everyone. are receiving X.X doses. Subjects diabetes. subjects weeks overweight achieved or in to Dr. to our X:X I at in to obesity factors a obesity least in milligram X.X Vipin, X.X with will Significant improvements and XX.X% were you, with of X.X% approximately administered School, of serving with and weeks week milligrams, of of at weight authority XXX Medical with subjects Thank XX% Lorraine II XX% least when or and interim at loss MOMENTUM risk subjects as milligrams the X.X Approximately

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of markers serum achieved significant corrected reduction improvement. NASH imaging, both TX also in in MRI-based We important ALT

of hepatitis clinical be as late-breaking fibrosis presented on a that of and robust data weightloss at combined will meaningful in infection. to need abstract with Vipin B effects The B to HepTcell in believe HepTcell and trial reduction antigen. pempadutide hepatitis fight continues improvement mentioned, this activate the hepatitis NASH As unmet B primary hepatitis new endpoint worldwide with antifibrotic serious we anti-inflammatory have a AASLD. a the significant activity, hepatitis is or clearance We was B an designed to a virus an hepatitis the II in clinical log announced, multicenter Also, previously represent in immunotherapeutic will enroll be Chronic The patients cell and Phase XX cells surface reduction the States enrollment United a T as active essential HepTcell commercial antigen. in trial marketplace. represents with of the X low of subjects designed for chronic and trial competitive B we product our surface and to completed chronic is B. NASH opportunity. have the

our Rich chronic on to expect trial functional treatment quarter subjects direct-acting believe once Rich? period.It provide with antivirals. of immunotherapy. may for HepTcell all in is of B third to hepatitis this the will We over And the Eissenstat announce and chronic infection antivirals XXXX hand to results both first that and novel cure direct-acting X-month to I a an now results. hepatitis the is of give effective B combined believe that highly update an we when therapy differentiated quarter complete financial will and call require general the

Richard Eisenstadt

morning you, Scott, Thank and good again.

our be with later call, the Third financial SEC million brief for on of in I $XX costs the programs, Research in in development XXXX direct million ended quarter for Pemvidutide Autoimmune clinical conduct Form our More trial related in comprehensive compared expenses XXXX. expenses activities to brief and in-life million be of today. and quarter results. including today's same total costs compared investments third increase cash the available We IMPACT Approximately with the our of to in million $XXX.X completed be For and were to for the of this XXXX million short-term the the will update third of XXXX the filed third $XXX.X anticipated a million portion XXXX. as of development million XXXX $XX.X HepTcell. providing our cash, information ramp-up during will expenses development we trial. direct to a development of MOMENTUM period the XX-Q small $XX.X were of in operating Altimmune's direct $XX.X equivalents and approximately activities $X.X end for to in and of quarter and research quarter related at

million Looking reductions expect administrative existing X will the of $X.X loss the million take winds increase expense, Net Operator, open period-over-period million income by million that XXXX, ended our quarter compared to the in be was expense for Approximately share for XX-week net trial in our in noncash Interest first lines MOMENTUM XX, primarily IMPACT per a audience loss the trial compared IMPACT as our in at same you XXXX. to to million third or $X.XX was stock questions. related XXXX the September General expenses loss for IIb $XX.X ended of $X.X we biopsy instruct expenses $X.XX that expected or would of please $XX.X net the operating We remarks, and trial and down. the third September per the and XXXX. estimate months expenses concludes us we compensation. offset net in of consistent share in through our on of ahead, the $X.X cash formal quarter procedure? the in quarterly funds the like Q&A to part were the X is quarter NASH loss months from results Could million XX, XXXX to period $X.X Phase XXXX. XXXX.

Operator

of Piper first Rahimi Certainly. Instructions] Sandler. our coming from [Operator the from And question line Yasmeen

Yasmeen Rahimi

to come can comment month. it's next this the finished know quarter, MOMENTUM for so potentially you the is month this updates. extent To going all September. enrollment the on like data, or this around Any set for Thank chance in great much for you I

in the extent just to is line weight product some expecting eligibility question they curve question that's the to modeling the a color the among be So of I given also the second really spoken desirable to to know bit it? the have we provide some at in analysis sure I then on has top could part little weightloss. you able a when provide to quarter, still is, as line of past, you guys at past, be this data? should that impact third about top look in study. is cadence enthusiasm maybe loss head just as we profile, wanted And in the and have make a occurring to sites patients what be into on the the

for I into if me, back jump could and the So tackle you those queue. X appreciate I'll

Richard Eisenstadt

Yasmine... Thanks

Vipin Garg

questions. the do Harris, want you please? for to you Thank take Scott it,

Scott Harris

I Yes, can those. take

dosing period is obviously approximately provide finished guidance time There's follow-up weeks. Yasmeen, datacleaning. current September. for can the finish the that X So we a We in we that of time that There's enrollment. at after safety

headed quarter. So I calculation much think time, is in and as the we towards you arithmetic as the the And readout the can said, at do we're as based about really public back domain. information that's information But provide. I on this this there, can

sites XX enthusiasm patients continue modeling I analysis, to loss a loss deal if would for like great compounds. at Dr. and glucocontaining as is weight been the said, of looking patients, Lou compound, principal to based particularly Aron, expected emphasize of that try beyond compounds, to investigator look what provide from weeks trial. the is XX shape of would Yes, other there's and of only the and other curve the our will on we not I the XX who in weeks but followed also weight yes. in model Regarding particular, been the

the lipid dose in marketplace fat titrate loss, he of different the profile, absence weight of serum our because for based its will particularly weight He's needs loss, lipids, interested the to need thinks with on the reduction. XX-week be that the that segmented absence that an to feels is As of reactions weight drug extremely important the in this he he that echoed feel this during be differentiated fact very great this marketplace loss patients. successful going the to will and as achieve to surgery bariatric well care of in on this a really strongly the is based type move majority product. sites think need the patients primary feel We very reading

Vipin Garg

IMPACT was Could on about loss on a the elaborate question you as well? that there trial the enrollment the Scott, properties. weight of Yes, also based

Scott Harris

sure. Yes,

what and IMPACT. from that's seeing is we're which investigators got you've have in but there They a trial in the weight will NASH, approved. loss. the coming And comments in the the IMPACT that trials their enrollment out very finally it, reflect that condition brisk NASH very when liver, with most is Pemvidutide in patients is in they're not trial for only treating the So uptake pleased of really the reaction and it We're the marketplace gets into the we the drug invisible. think reading patients

Operator

And line Jenkins of our next coming Sachs. with question the from Goldman Karin

Unknown Analyst

Karin. for on Omari is This

So what us efficacy is, to successful what respect momentum positions first outcome loss? and considerations? And with XX-week you do the question in -- given a how that do readout you for can both contextualize safety for weight tie view the then

Scott Harris

both you, of questions. answer Thank those I'll Omari. Yes.

will So not comorbidities that. loss key achieve moving Omari, as most which, we -- feel see feel loss and weight out, in we that the if all as for of And is could continue obesity. to we've be the pointed comfortable said, Ron mid-teens, we range we'll also that that in of comfortable beyond that we weight Dr.

further time less XX we'll you loss or XX weight was by not see have then weeks it my points. at weeks, seen with the obesity factors seeing risk in we agonist lipids, in that's at for or want glucagon. in continued the segment And but their time to the loss I weight pemvidutide estimate in most reduction increases content, XX fitting their meaningful weight tirzepatide been rate we'll heart see would the beyond serum XX importantly, Yasmeen, dual reduction the compounds, if patients what achieving other XX semaglutide be need not extended as positioned loss and think important who seen liver than weeks that achieved disease, to at loss especially or in emphasize at that weight rate that well to response extremely see the heart we both investors this to drug it recall, We to continue would So and mentioned have contain for of fat get And and XX-week especially cardiovascular at safely. compounds, I weeks increases in least -- the model the achieved point. marketplace, arhythmias

So is dose not weight and good, the the we the the especially we lipids care, think least loss, at going dose. in titration having safety future, to marketplace on effects dominate which profile, in hepatic obesity the primary of believe a at the solid serum and X.X-milligram convenience the

Operator

with the Jefferies. our And from Roger next coming question of line Song

Jiale Song

for and the us. thanks from few Great. A update. for Congrats progress, questions the

and II, So particularly one the which around Phase the in is we meeting probably data given II in to the -- thinking little III, ray assuming But Phase and III. Phase is to titration what you around III regarding the AE first -- discontinued bit how other Phase expectation dosing to II. lower the higher MOMENTUM Phase your similar a Phase your is design, for current the due want see

second -- your question is the the partnership. design portion? related thinking Just remind current is And us to to for what

with the year momentum the data, half make a Maybe partner. III some Phase on discussion the just you this trigger think next discussion the XX-week you will at I additional this material. call, give So start how point, in when you can around will and particularly color mentioned us partner with second to

Scott Roberts

answer and I'll the Roger, question first then...

Vipin Garg

take do go want first you to Yes, question? ahead. the Scott, Roger,

Scott Harris

Roger, Yes. answer question. second for I'll microphone the to I'll over first the question. the turn Vipin

the current titration II will with on dose of trial is given as of end with with that currently, programs. titrations having X.X duration going The short results and Phase about titration. and anticipate based weeks discussion X/X in viable doses XXXX we set in III discussions without dose forward. will used be the FDA, are very in even half Phase milligram of prolonged X doses in of the tirzepatide and and in beyond discussion a the a than year the given of That's all partners being X.X programs lower III also be other with FDA or design dosing being ultimate the the So Phase trial.We milligram MOMENTUM an X.X used the and the are see

So we forward. doses see those moving

other As rate you made mentioned, there the going tirzepatide in events expected milligram necessary have But they it the Phase program event was to X.X Phase a as adverse and if programs discontinuation and we the and II pointed higher the like not same, was they semaglutide at than towards single where programs the into less, II are you that adverse adjustments been III dose. right seen the get out, digits. now adverse that event down discontinuations Phase in their

lot opportunity of do We that. have to a

now. as adverse can that or more scheme not like We to there. are could second semaglutide partnership? allow have mentioned reduction. you titrate of we the said, than further from dose dose did event answer And the would that modify dose once patients -- the rate before, highest you got by we and other tirzepatide down that but reduce up having question about And right Vipin, get trials, you is up we as in dose as either even got they studies, as never trials in without titration we to dose our a important putting the XX% a in difference those that to really dose we the titration, can I very or reduction the think consequently, flexibility see any much

Vipin Garg

Yes. Thanks, Scott.

forward. And our multiple by partnership III there. next time second obviously, our line enough said is gives to is moving III that goal be Roger, us data XXX initiate So a before, plenty year, have as and also out partner Phase with half to already this program. that We've up time, of ready Phase renewed for discussions discussions we to of the

in are that move data us opportunity what the that feel expecting give into really that's are Phase We partner forward that a to. we with line to readout III. that to we XX-week So the executing up would best

Operator

coming of next B. Mayank question our from And Mamtani the line from Riley.

William Wood

today. This Wood Congratulations your is on for quarter. on William Mayank

of line to any couple you've your top II lean a us. body there data prioritized are sets about include So composition that readout, possibly muscle. upcoming questions MOMENTUM recently and Thinking Phase from or decided

Scott Harris

Yes. quarter weeks. the will have out William, be, ways, XX that we parameters to many in readout going similar this we're before the that read to

So me in differentiating let glycemia to will lipids. important included adverse think report that. conference. serum will events which very are It with body on will readout include repeat It on signs, and will or data include discontinuations. vital weight a loss include include waste we It include control and also on the

data expect reduction also in We to fat. liver on have

they require analysis liver body them to composition line doing because are We more have this to going for the than just trial. top not this measurements At results fat point, we do analyses. think that we're

say, probably additional results. the will So body line after come that lean mass sometime on, readout top

William Wood

Got weekend presentation mentioned up you coming have a that or then it. you and you've week. reported early next this And previously AASLD at

to You anti-inflammatory antifibrotic trial. should your envy. obviously, to expect a granting the view into Do new could properties more we IMPACT just to FDA's bit feeding mentioned go little be going you you and and color think and that data then what on see decision may you how FTD it's data we on to

Scott Harris

they and data Altimmune. and We including I because fat when will that the even we've Pemvidutide, -- data of of all believe anti-inflammatory Pemvidutide Pemvidutide, the its William. data high the of abstract AASLD you, date the embargoed roles properties the you markers in importantly, very as FDA fibrosis effects latter aware important content improvements on reduction are they point. the made but granted and anti-inflammatory to it's by additional that that saw additional of to all will the more the that that application on the in can cannot in liver see, designation discuss data that and with saw Thank only the class-leading properties highlight of result we'll abstracts. fast-track present observations data as late-breaking antifibrotic But poster that not on

William Wood

Appreciate last one it. one. then quick And

patients. is Your have FX XX% believe enrolling IMPACT you FX. I trial said be FX to

Pemvi recently Given be seen you difficulties foresee FX, do that the current to X time, trying we've at in population? the run in

Scott Harris

It's very a a at. good taking obviously look great we're That's William. question, something very,

look concentrating made haven't we're taking FX, a on clinical Right engaging now, we're a possibility very and at certainly the date. FX that population to but the separate good on in trial. cirrhosis any announcements population, of We that

William Wood

Congratulations again. Appreciate it.

Operator

Jonathan Wolleben coming question from with Securities. next our line of the And JMP

Jonathan Wolleben

from do tolerability discuss I an guess the kind X And you into we've III. sets GLP-X either up the from then even given to could structurally profile compound, you going MOMENTUM just for you Scott, from at then the this How follow tweaks question. earlier to Phase we've you think in acceptable glucagon discussed an gotten dual readout make the from all seen, me. can I of data about BI X the upcoming also or agonist, other data and point. Pemvi Merck pretty differentiation good want

be hear. I think would that helpful to

Scott Harris

Yes.

and time dose a profile look we in loss in a And the and drugs, order I that bloodstream. the of we from data were to weight complement -- X.X% X.X% Jonathan, titration And a to any out than fact the in into lot have pharmacokinetics is a is as that trials. is mentioned get before, adverse titration with right dosing Obviously, basis. the by that the as opportunity to and of point allowing leading given adjusting think to there achieve the good semaglutide for wish time, it simply to future even any down the the that same believe again, dose better So you reduction the rates date tweak at which that slow point X.X that on we has to event at at and low. the really is at point been dose without entry the without can absence when placebo-adjusted it doses, was now. discontinuation way we as still Pemvidutide get dose -- that we achieve arises of to comparable generated titration. can X.X safety is in Remember milligram tolerability the that's tolerability we been And

So we're that. about obviously optimistic

knows the domain, we from is pharmacokinetics as special unique starting conveys compounds, to addition and that other think to structural drug. ePort the viewpoint, the in the Regarding one which

which the compound. We about towards that in agonist concentration glucagon GLP-X and also contrast. glucagon glucagon are date believe GLP-X in servedutide compounds these have differentiator. the is seen. bias associated that been the Borger the ratio a Merck available have content increases is has X:X. Borgo very compound, properties a any We to highest dual that to with that important we've we heart of these But think And We've to that that X:X also with about conveys in rate agonism, important and higher of both glucagon data seen not not that note we're seeing The our X:X it's the it's rate that's announced the liver heart it's increases fat program.

the lipids. glucagon low in seeing compound. think We Some that discussion we that the they speak has they're content data, to in reflects both place are in which activity taken the comparable that compounds. glucagon compound in Merck around seeing fat, meetings liver relatively reductions And serum changes not

Operator

question And with our line Patrick H.C. from the Trucchio next coming of

Unknown Analyst

and an modulation HBV [indiscernible]. in been necessity the gears cure as going the for I'm here accepted talk way at is and a the This that bit to the change field HepTcell Louise looking about little Patrick. has a

have you don't achieve that? talk mechanism, about immune modulation a treatment your functional this So is progressing cure that can others mechanism towards could this how where

Scott Harris

our cell question appreciate already response boost that the to over demonstrated there. a cell I response we've meant What it which T to Sure. the resistance see We've T T it's the is increase that therapeutic, studies significantly HPV the that able I the safe very to it's HepTcell Phase and it's immunotherapeutic demonstrated is cell to in the has antigen. with antigens. HBV

oligonucleotides And and the so activity was or be its against since step direct used as siRNA is it combination that or felt antivirals likely own. surface on like for to monoclonal has compound to antigen, we this a the most important the antibodies example, next going show with therapy, acting

that meant with have with focus in ongoing, and the The quarter year advantages report that's is HepTcell functional in are antigen. in for a And and study is next selected of epitopes the hydrophobic to they're were this response. response that's against preliminary The be antigens important and to the that the the II Phase of known cell highly do are so And of HepTcell to represented that currently first show. T core we'll invariant, out antigen nature.

And we the and generated. pressure to response that so they're unlikely mutate to immune

genotypes important expected able we to we're replication. our therapies. combination very robust encouraging And of are to was study we to of using direct these responses, which the antigen adjuvant studies measures to is will cell response II generate is in with active with the ICXX, HBV have Phase other very surface the That what I of T be antivirals all up us that allow partnering be that with we that be looked a for discussions So have these and in us HBV. with preclinically Phase feel shown circulating set is and against combination for do and immunotherapeutic then acting going to that companies an

Unknown Analyst

great. do antigen baseline trial? to program. you at implement patients surface baseline the to Phase of Phase threshold sounds you of III going discuss if in that that stratify you're We've the the Can That with characteristics more successful, II seen you're on based forward? plan surface the And Betty if baseline. going And

Scott Harris

that's are that II that a the is inactive design and Phase great referred her really study ongoing that's as shortly of to question. report unique one selected we've out elements Sure. That's the of And patients currently carriers.

the created a reduced infected T individuals. earlier that immunotherapeutic had acting we response. would a compared represent so And basically, and chronically to that surface direct to that, have felt has received and then boost antivirals many antigen I environment cell antigen that mechanisms And the the surface by the referred has folks population work levels for low to these better

low will then don't this with HepTcell going of that in the direct acting the is combination selecting with first we antivirals the think that So We work forward, surface therapy, part antigens. see as And it patients accomplish will study. that goal.

meant study forward with So studies look would the the to patients treatment this combination themselves towards HepTcell. and for how present really is

Unknown Analyst

do quickly interferon to remind you Can interferon have and this without great. that you setting? Sounds and plan is an arm without just or with combination with me in

Scott Harris

study does treatment current the interferon regime. include the not in So

that further as I more that think little of forward, envisioned approaches there's the number be can Going about down that get we'll road. we any combination and talk that's something a

Operator

see now the for back will over Garg And call queue further time. Vipin closing in any to this Dr. remarks. turn I at I no the questions

Vipin Garg

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

Operator

today. conclude does that for for conference gentlemen, and your participation. Thank our Ladies you

You may now disconnect.

Altimmune (ALT) 7 Nov 232023 Q3 Earnings call transcript