Altimmune (ALT) 27 Mar 242023 Q4 Earnings call transcript

Company Profile

Participants

Richard Eisenstadt	executive
Vipin Garg	executive
M. Harris	executive
M. Roberts	executive
Yasmeen Rahimi	analyst
Seamus Fernandez	analyst
Jiale Song	analyst
Liisa Bayko	analyst
Corinne Jenkins	analyst
Mayank Mamtani	analyst
Jonathan Wolleben	analyst
Patrick Trucchio	analyst

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the Altimmune Inc. Full Year and Fourth Quarter 2023 Financial Results Conference Call. [Operator Instructions]

As a reminder, this call is being recorded. I will now introduce your host for today's conference call, Rich Eisenstadt, Chief Financial Officer of Altimmune. begin. may you Rich,

Richard Eisenstadt

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

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

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

company's cautionary and contained forward-looking of please morning to statement the risks future press issued other now of our factors the release results could the with filings see this I'd and that SEC. also For a direct on and the discussion and affect the some operations, in website. the read factors risk company's statements our you disclaimer in available

reflect any as to events call to occur conference company only this of date, these undertake on speak and today's or made after that of circumstances forward-looking update XX, obligation statements the date. on Wednesday, today's Any does or not any statements March XXXX,

Altimmune's will recorded is call replay for conference this reminder, audio being be and website. available a As on

over will I the With Altimmune. Chief Garg, that, turn Executive Officer of to Dr. call Vipin now

Vipin Garg

year-end morning, and good you XXXX fourth discussion for today a and joining of Rich, results business appreciate We update. us and everyone. our quarter you, Thank financial

agonist, receptor GLP-X/glucagon two the development achievements which the and for with about indications. dual excited pemvidutide, treatment XXXX are of clinical is We MASH, our obesity in important

of year, XX-week MOMENTUM Phase Phase development from biopsy-driven the the in in milestones MASH. pemvidutide key trial impact compelling positive data IIb initiation including achieved last trial of II and obesity Altimmune our

results We're ] Phase MOMENTUM of that weight obesity from loss XX.X% mass. the body with analysis from the pemvidutide, composition trial pleased also our lean II XX% came [ and fat, showing X% to extremely of of only from

Medical Officer, Chief these in Harris detail Our Scott review shortly. will results greater

with subjects in X.X more as at heart rate. robust and of receiving weight The a events, milligram pemvidutide on XX.X%, XX% and serum of MOMENTUM loss of week weight pressure XX, over loss pemvidutide along lipids, dose reductions cardiac that without or XX% blood achieved in imbalances meaningful trial clinically showed mean increases well or had in arhythmias BMI subjects in improvements as

to in In development addition, in of body impressive compounds the other distinguishes composition obesity. addition -- for treatment the data from further impressive pemvidutide the

Turning XX-week impact to announcing first XXXX. we looking biopsy-driven line to Phase in the top quarter are of the MASH trial, results IIb forward anticipated our

of study positive for of results the the mechanism liver our second of anti-fibrotic at with inflammation. liver both ALT was activity dosage achieved content in milligram cTX, direct reductions fibrosis with milligram pemvidutide and trial a in recently demonstrating fat biomarkers pemvidutide subjects X.X XX evidence a XX% this weeks, We provides of from along X.X than preclinical in considering MASH in are where and at reduction Phase will trial greater A confident relative robust reducing completed XX-week successful patients. the potential be Ib [indiscernible],

discuss Dr. our Harris clinical to Chief to our will Scott Officer, With now plans. that, over I and turn data call Medical Scott?

M. Harris

everyone. and morning, Vipin, you, good Thank

development, loss bone incretin-based exercise weight [ type ] growing the in is mass lean women evidence adipose diet trial, associated These Excessive loss increasing of of MOMENTUM with anti-obesity compelling preserve such tell with the and and analysis an obesity candidates about XX% body sarcopenia to has emphasis associated there and First, to number which best historically with comparable you body composition the in outcomes of of achieved quality lean only in from XX.X% the issue, effects programs. from drugs. With the me showed viewed negative with as been came has treatment are the an loss fractures, mass patients especially on been mass, as lean to ability and differentiator data and due elderly. the obesity. results the weight let that where important among

the visceral fat saw an associated increased as and MOMENTUM increases content lost fat result, risk. visceral is we participants fat like preferentially highly important with in dysfunction subcutaneous Additionally, fat cardiovascular metabolic hepatic over

the We to MASH. XX% lipids. composition Keep XX% MOMENTUM only these body -- improvements only our lipid reduction were XX% like in total meeting. to observed pemvidutide has that treat scientific view participants This in in upcoming that ability cholesterol, complete strengthens in in favorable up profile. triglycerides expect at [indiscernible] reduction elevated to in with an the present nearly LDL a and analysis to composition data disease cholesterol of a not we observed cardiovascular reduction body baseline and XX% serum up We're to data serum these add mind

had plateauing loss was indication II Phase pemvidutide over more X.X weight the loss with remained at milligrams MOMENTUM obesity these X.X XX. loss and week of XX% or milligram our [indiscernible] of achieved exciting trial, is What no in subjects XX. subjects at mean weight a XX.X%, that receiving weight XX% equally that week Recall curve of

improvements glucose serum hemoglobin blood heart maintained the in an [ with results Luarone in this the no of will meaningful ]. trial significant MOMENTUM present upcoming changes Dr. [indiscernible] pemvidutide trial in events, fasting [ ], in or on within imbalances conference. for AXc Glucose cardiac the increases demonstrated scientific at previously arrhythmias or effects homeostasis clinically mentioned also was pressure rate. lipids, Along with

or Approximately key without placebo for weeks. will diabetes or safety X.X be after endpoints with additional XXX The treatment biomarker IIb XX randomized talk are weeks weekly of fibrosis about subjects Now [ let and or XX biopsy-driven of being X.X an milligrams, assessment X.X ] me administered to the subjects IMPACT MASH X:X:X additional milligrams Phase trial. milligrams resolution for for XX responses. followed weeks with improvement pemvidutide

the expect rapid loss Enrollment the the top line XXXX. is and liver of We of trial going MASH eagerness quarter their well believe enrollment results to disease. of in to significant we of the to in patients achieve have of that addition treatment IMPACT weight rate reflects first

the on indication. trial. the robust for MASH FDA rapid observed this based with reported This content pemvidutide treatment of our also reduction working past Track forward important we fall, for of that designation look liver for to biomarkers the Phase and fat in [indiscernible] We of closely granted inflammation in agency the Ib in fiber Fast pemvidutide development and

trial are turning hepatitis development II development. clinical of and Phase all stopping trial the the our insufficient HepTcell in for B, so Finally, overall further response to completed further we chronic was recently

will that, Scot? recent turn Scot With preclinical call Officer, Roberts, discuss now Scientific I the findings. our to over Dr. Chief some to

M. Roberts

you recently I'd completed. Thanks, morning, we've about to that studies tell like Scott. everyone. X Good

a mechanism an The evidence pemvidutide reducing of related of treatment chemical fibrosis. now to in direct The used preclinical to first induce to anti-fibrotic NASH. We therapeutic represents for liver pemvidutide the effect important model development content. have chemical direct models mass allows separation the effects [indiscernible] on to based and The obesity of liver opposed activity as high more model fibrosis from pemvidutide. for following anti-fibrotic the liver typical the by potent fat of for

data of X our weeks bolster after about only a trial the quarter reduction obtaining the in amount in readout showed of the continued significant XX% in fibrosis treatment of data a The exposure. first of XX-week the in These successful presence XXXX. chemical pemvidutide IMPACT optimism

cholesterol study, It process is increased that of the pemvidutide removed called for widely the process cholesterol RCT treatment understood tissues of arteries, a that is In accumulation from ]. we the which and efficiency or from increased event. leading an by and transport the body. unrelated demonstrated atherosclerosis cause cardiovascular important [ RCT risk the reverse excess can cholesterol eliminated to in LDL is separate

serum was to LDL cholesterol pemvidutide by also enter but particles up of shifts by XX%, the shown we size that cannot increase the vasculatures that that amount demonstrated lowering easily. serum have pemvidutide study, the liver cholesterol only levels. we LDL In the treatment while to sizes cholesterol nnot the eliminated by lowers XXX% towards able particle of Clinically, larger

weight demonstration get cardiovascular increased activity of reductions a liver pemvidutide addition The its effects. for support fat loss to to RCT in role lipids potentially robust risk in and serum improving broad

the third financial quarter will Rich? an on call to over our update give to hand now Eisenstadt Rich results. I

Richard Eisenstadt

financial you, fourth and results. It's morning, everyone. Thank good our actually quarter Scot,

will information fourth to with and update For be Altimmune's financial Form I later and our operating be a in SEC year today's More call, be brief today. results. comprehensive on will quarter XXXX available filed the XX-K providing full

cash and short-term of funds anticipated with trial the to Altimmune our project biopsy of ends of quarter XX-week MASH, readout investments, equivalents which fully funds fourth We end half XXXX, cash, cash us approximately at QX our compared IMPACT $XXX.X into XXXX. the the million million first data. the existing top of XXXX and including XXXX $XXX of line

full negligible contract years closing was indirect revenue rate income was that and XXXX. periods on are a fourth reported in during statement. we such the government quarter XXXX to Turning adjustments and the Revenue for out. Any

[ direct XXXX. to conduct related costs in $XX.X million $XX.X for in in R&D to of and expenses $XX.X associated direct to development of quarter for compared and same development in the related HepTcell in the million development expenses of clinical activities the development pemvidutide million $XX.X programs, of direct the fourth expenses fourth were $X activities. including development Approximately were $XX.X quarter of in XXXX million ] to and quarter for Research included HepTcell. XXXX fourth total of expenses this the our with direct of costs the million direct activities related period million XXXX million pemvidutide, $X.X in for expense

compared costs pemvidutide, $X.X Research trials $XX.X with in associated in with $XX.X year. to costs and In HepTcell expenses in incurred $XX.X MOMENTUM we direct the were million in the campaign. XXXX, million year prior associated full IMPACT the million XXXX million full year development direct for and and

and General were XXXX. million $X.X million in and XXXX fourth each and $X.X administrative expenses the quarters of of

stock increase additional compensation XXXX, increased $XX.X year versus $XX.X for million For XXXX. XXXX. primarily and general due in were the well expenses year administrative million labor-related million expense full as The as costs to $X was full

loss intangible of impairment fourth research asset in-process associated was the million during $XX.X or R&D IP to development XXXX acquired and assets related on recognized the quarter HepTcell. An of with

As the deemed HepTcell. to trial have advancement be II response overall in warrant stopped is result, Phase a development trials, and clinical further insufficient related to we previously as in further the discussed, to any

million $X.X expenses operating million, or $XX.X expenses. was the fourth for noncash including the was quarter recurring quarterly just the XXXX Our for R&D IP of -- write-off

For I million the for operating or full $XX.X recurring items the $XX.X apologize. was total -- million just for I'm noncash sorry, expenses items. year, nonrecurring the

net X loss or Net loss primarily months XX, expenses. $X.XX The the the ended million of million per net lower XXXX. noncash of charge, loss research loss December $X.X the by net per quarter to $X.XX quarter fourth increase to offset the for $XX.X $XX.X was a attributable million in share loss partially development XXXX, or was in impairment million compared $XX.X share and for net

offset the to and by cash attributed earned in December per $X.XX primarily loss ended noncash million impairment for to XXXX. interest share investments. share XX, December million or XX, is for The short-term year lower was increase income partially in net research $X.X per expenses charge, XXXX, end net XXXX equivalents year and million loss or loss our $XX.X year Net on $X.XX $XX.X the the increase and a for the net in development loss compared

now turn call Vipin his I closing Vipin? remarks. over the will back for to

Vipin Garg

procedure? We to audience Thank questions. you, our the remarks. line formal concludes to would Q&A Could you Rich. Operator, open the please that instruct take like on

Operator

[Operator first Piper comes Rahimi Sandler. question from Yasmeen with Instructions] Our

Yasmeen Rahimi

more you I profile have to desirable that given Phase little are we the question where investors question III continued like engage with think obesity agency to would one. Question is, like? the been get first bit on update and of of currently? design the with That's getting a discussions would to is, in you look pemvidutide, regards product have lot number the opportunity for parts what had those number two the a

And preservation ask third lean we to time we the about really think showed for mass XX, then patients? allowing these further could thank week you how to be improved at magnitude questions. And compelling this one, think -- how you over in results could me

Vipin Garg

Scott, I do you question. take first, want to to the back will questions and the partnering come

M. Harris

Vipin then your the questions, discussions. partnering and Okay, Yasmeen, so take and I'll will third second answer

a have in that program year trials. III conclusions that has this been program And second Phase our final obesity. to we'll time, have with So But discuss design of agency similar of and our other and this in plan programs, for we meeting think is have program at half the in Phase the the established the the about the template development III. would with a to we

the Regarding ] of to seen get losing and best to week are mass. lean loss, very the body at results is incretin agents the data XX, this lean and among yes, weight avoid down and lean and is results obesity the mass loss experts saw healthy for diet with with similar [ what and class of compelling the that are composition we the exercise, the percentage emphasizing, to comorbidities in

loss weight literature, is bariatric course time. of ] [ weight may the mass the lean you over decreases As of the aware that be and percentage from loss

were go out week to So lower the potential followed whereas to there's to XX, numbers, we to week were week XX. [indiscernible] Vipin? XX.X% even subjects at

Vipin Garg

Yes. Yes.

of of partnering both discussions the discussions, with business-related terms scientific are robust In discussions, as discussions. and as partnering technical are nature well that in status we companies having

imagine, but can their you profile. differentiated all appreciate comprehensive pemvidutide each appropriate, they're they own all and particular As company focus, has

the So overall, scientific to as the update things business in pleased we with will we are future. date, and develop discussions and

Operator

Seamus Fernandez Guggenheim. from comes question next Our with

Seamus Fernandez

business questions Appreciate seems mentioned at technical ask predominantly the but It The scientific opportunity discussions. discussions, point. to me, this business Vipin, also this you is discussions a to and here. partnering discussion

commentary the remain pemvidutide So discussions, I'm the and understand there are context for an technical technical better obesity and those scientific differentiating If two. the to scientific of are trying debates just program? of what that in

still opportunity commented perhaps, of you've And the be Altimmune. in move that with opportunity seen the regard but data having potential perhaps underway. with exclusively present partner, very realistic Do a obesity is MASH we've their [indiscernible] to we for partnering, fact now will And hint fibrosis a has both have benefits separation in forward molecule program, have that, or the fibrosis? partnering and that that an either on believe robust to well NASH likely to you with that, a impact another there competitor potentially tirzepatide planned past, given term programs obesity that's a being own discussion the in near or

Vipin Garg

a lot there. There's Yes, unpack Seamus. to

have at address back time, let completely come So repeat your a part. questions, me me let -- remaining take and please one I the and if not

lipids, fat different look, of appreciating what of But with is as in the with the different obesity terms things It's companies discussions everybody terms the that's pressure. partners, serum pemvidutide. blood about been driving all cardiovascular liver have of discussions. but cardiovascular we've of in benefit you can these and talking lipid imagine, And content the the profile, the focus, benefit, is

just these. people things So outcomes combined, impact, all but cardiovascular not the ultimately, significant in these will of losing we believe, have weight,

the and that. We're are partnership, driven is discussions combined are So or people it. cardiovascular think question we of or table very the a MASH are partnership And value it, all to by we encouraged that appreciating people is, an bring of this the obesity the proposition partnership lot those together. getting because that's

we and that Clearly, will program MASH, differentiated. IIb in both of highly with we we have terms of with XXXX differentiated drive are of in other glucagon obesity moving Phase also. and in as there, So further. know, that first MASH, are you We'll being differentiated, MASH, the highly the are terms in quarter the we program. data our are program But in forward from that

on Scott, that. you can comment And maybe,

M. Harris

the encouraged in compounds results other MASH. Seamus. Yes, We're with the by

]. that we'd [indiscernible]. with the X molecule component. also have due believe as are not to in We seen is mentioned you You X and and [ And from that the molecule away much and glucagon, to our molecules, [indiscernible] the remind GLP-X effects where glucagon heavily glucagon to there's [indiscernible], biased we

potency to of the so read of the from pack, molecules actually weeks. endpoint confident we're XX feel the that We about out break our willing

reading The of periods at considerably time. compounds other are longer

trial the adverse in very, titrated weeks. Also rate with very fact to they for that that dropout event despite high XX the you reminds [indiscernible], regards was

profile comparable. think tolerability don't we with So the compound is our

all think we and confidence readout up to the date, our than generated that that potent XX of data our all very could of in out to molecule. going on of that we represents the based biomarkers, very, XX But have we the weeks confidence rather that we're read actually a weeks

Seamus Fernandez

But X.X more on the to was the was in up follow-up maybe program. MASH you dose. the saw obesity that recollection the Can plan program only the milligram at just just weight And My dose. milligram to a explore Great. where loss remind the was me meaningful doses? we X.X

see there sort weight patients, wanted So just sort weight recollection where but previously then to you Ib/II was ran out going? Phase NASH mentioned loss dose limited of is to weeks. And loss program range in my the MASH that the in of XX you that is very

to because is see get but patient you attributed from will Phase understanding the population loss a X.X-milligram didn't initial to program? that, your explore weight get we trying recruited just better II differ much my to and Phase I a guess, there, better understanding was trying Just how this of recollection I but dose Ib/II the partially

M. Harris

Seamus. Right,

in dose other future, for doses as you we weight weight it's think loss, liver to very So to the greater we're loss. the fat were fact, the of we're be curve believe go we to if weight seeing go a described, doses have opportunity weight different in but telling program. very with the response increasing we've dose along And higher are increasing than logistics of pemvidutide obesity seeing even continues with would Vipin in for loss that response that achieved, the curve we happy weight up. higher With drug. the go with We effects we obesity loss in because achieved even

[ percent further X-plus dose, there's liver really dose the ] very place little dose reduction in X.X milligram get you XX-plus, response. fat with go When to X.X milligram at the

the always trial X.X now way III. looking add was Phase opportunity doses. at X.X the design, on that II the milligram to exists milligram the but milligram designed, have that's and So us, possibility the at looking right to That's the We that Phase always in be X.X doses. and for X.X going milligram only we're a

Operator

Our next Roger from with Song comes Jefferies. question

Jiale Song

the taking our the Great. Thanks questions. and update for data and new sharing

MASH So a the or kind more let us data, related And to discussion contingent more this another different your us you at question the Can forward partnership, have is you bit II much remind in Phase of partners maybe obesity little know certain interest MOMENTUM specific. combination the II upon how programs? is data programs both a different words, moving Phase just upcoming? of discussion will detailed

Vipin Garg

the news on you most they're in say at focused of would that pemvidutide that are can is both the MASH imagine. our related Roger. that both very obesity interested Yes, players partnership looking are I good discussions because indications actually and are Most of program.

to be in very to it's hard similar of a going separate product, commercializing it's So developing them a and anyway. But terms pathway.

our of good are is most that the those news on focused partnership So programs. both discussions of

ideal these this parallel. our and we both of ultimately, to forward has player a So that multinational develop program both really obesity would take commercialize and ability in think in and MASH be the partner

the in good the proposition, brings. of message that therefore, discussions. about the partners in that clearly we're are terms pemvidutide excited those perspective. we're value differentiation shape So getting And from very The

Jiale Song

then And Got [indiscernible] it. another question.

preservation, very which seems this is it muscle So very compelling interesting.

liver do ] maintenance in the about mechanism, are hypocaloric [indiscernible] additional the of given versus lipid be pemvidutide is [ liver the you targeting rebound kind you lipid can -- how mechanism? mostly or think differentiated the more So or

Vipin Garg

that's a question, Yes, great Roger.

want do to you take Scott, that?

M. Harris

we Roger. data, mechanisms. feel We to we're incredible really with Yes, compared generate that glucagon differentiating the showing every time effect other

be on drugs have been ongoing GIP have soon completed. and loss and that clinical familiar to So trials with very we're other and benefits nice or very that seen weight effects GLP-X [ they have those also in ], are

only a healthy weight That's loss loss, brings whole outcomes. and extremely different not effects achieving having dimension maintaining weight cardiovascular here. in but valuable loss Glucagon long-term for weight

preserving discussion top So This as body a lose we really game a potent very think the We've turning seen, very has weight now point of of loss. serum fat. mentioned, weight. on absolute is quality important, especially you've been a in the lean that effects mass because on And people last maintenance. liver the and weight away in lipids glucagon for effects and the differentiation And obesity as long-term from years amount that's seeing the the that, for of changer. we're sense, on X loss are important to circle people of now,

number that's the the stops regains the to weight a hit lean. certain or and if or really ability So acutely mainly matter regains the fat doesn't drug someone not weight

we an mechanism this important could think be maintenance. for So incredibly

of fundamental suggestion changing the at that that in in the this at and data certainly something and III As expenditure in differentiation also glucagon could It think you metabolic manner in metabolism this continue a know, that the future be [ on have balance the from there going continuing a basically forward, the weight an the at represent the great study obesity We aggressive in we're score, Phase don't ]. interest that considering was energy GLP-Xs program. intermediary point. that our strongly dose of was having XX loss weeks. this to it's X.X milligram would effect GIPs and would data real We and

M. Roberts

people have, loss thing the where lion's of mass spent. ] share other amount I loss calories weight The of I [ for for the weight everybody that appreciates preservation it that the are think and continued of of is, implications because represents because this lean would muscle sheer important add maintaining has

muscle, to of maintaining those by burn weight. and an engine more maintain So more we calories mass, more to reduce lean

Operator

Bayko comes Our with next Liisa from Evercore. question

Liisa Bayko

kind of you if color I little but getting of feedback potential think from most of us answered, some my guess, the could a been maybe on more, you're give I questions have your Phase III is relates And partners into I obesity? confirm for just III plan proceeding a for strategy? partner and that to to Phase wait as wanted before to dose it

Vipin Garg

are mean yet I a launching another imagine, as in the GLP-X you differentiate even a obesity differentiation, drug idea fourth are a you going or third Liisa. if company to to GLP-X/GIP Yes, I be looking space, the forward. or going having or without partners fifth it's mean, of can difficult.

So of mechanism to believe to adding mechanism obesity into space successfully players having particularly very differentiation therefore, because, to going to addition we the the attractive, space again, in is the going new obesity is glucagon getting product key a commercially be launch forward. the

really very that's we the focusing So on. what by that, are fact encouraged partners are

important Scott about become again, a because, has longer conversation XX term, of losing conversations XX of our weight talked for weight from shift loss. initially to weeks. whatever, the if just now the component is to quality That looking going you're very

point? you weight So at the what's loss? that that quality how is weight do maintain And of the schedule what loss and maintenance

product. a those on think differentiated bring I both very we fronts, differentiated of approach So a very or

encouraged we So partners particularly very are those discussions, are the actually it. fact it focusing getting that by on and by the

Liisa Bayko

that no a much feature titrating thinking dose differentiating dosing kind what Or approach? is know of on consider are is have. about how highest titration? of more? How actually interest the low might your or you titration schedule? the to there I any And the even in improve dose? you Is dose only lower dose Like thinking they you're doses doing the for tolerability your

Vipin Garg

more. are X.X, that all many are very doses body our particularly or talking patients at we a X.X, fact losing some of that actually weight XX% XX% are X.X all important active the and more they're feature, X patients or it's losing of their about doses, even milligram, and X.X Yes,

dose patients X forward out in many of So The can at stop approval III, can active for they Phase patients that for way, have like X.X idea there. take And is X.X have milligram we they X.X. will milligrams. is is have all doses X a placebo It And the X for very at dose just tolerability there the can their doctors them. then, at lowest the by option, the doses.

if more start losing, titration dose with X.X lose to can weight, then see they even and this really and to to that patient is So no weight can required. much X.X. dose, need how They eventually they go

with simplifies So appreciating deal as doctors don't because primary differentiating -- are of pemvidutide. -- that to very moves a market important that's really into have it's feature really dose that whole this titration. But the want schedule, that's differentiation people particularly dosing Scott? care, to

M. Harris

approved Ease get escalation, of have also companies to other have here all think Yes. on that effective all them, would dose, are to to approval with I and -- the that's from And to doses. times, through in mean which And has of insurance a patients is for in are or an care, will schemes Patients Liisa, and XX% with dose, approved placebo. of titration dose, active be milligram start tolerability extremely approved X.X primary a have in give longer that similar And XX prescription these the more an effective patients not money starting the drugs to in therapy also hire weight. which extenders we escalate. real you're don't longer a option in drugs, higher the the not or with necessarily to but important. titration to offer physician that. on benefits win, with to Physicians want to of spend monitor and loss it many to is or who weight doses you time to weeks lose going each

Operator

Sachs. question next Goldman Corinne comes with Jenkins Our from

Corinne Jenkins

on have a whether the this respect could hope But management you the share to too, about you or with you for goals think has the then later huge when conversations you'd maybe, guess III something FDA have to focus. comment, anything can obviously of something Phase the you team, been kind to timelines as is I partnership I time like there guess, by get in year? established? maybe And with place to you'd

that And the in patients was you've how how or at composition question that just body patients is had is? set we robust are many the And curious data something other analysis? many just, that looked in how were included and

M. Harris

we Yes. at on XXX we've in baseline the XX XX is the statistical week and subjects data looked study, patients. data, And extremely high. its participated Corinne, have significance

feel data presenting look and in this to this we year. really scientific meeting we So forward greater later is that it at quality a detail

Vipin Garg

timelines, a very the you terms out with deals, our And has the of we half pretty difficult Phase half place obesity in because us in -- for partner have it's It's of the partner Phase Corinne, second end this have program. always nice done meeting those meeting. focus towards II before lay as us to of it's of but alongside at timeline, start critical second to when to not It in a III Phase been sort know, year. would of we of end standard have the be a our have who II

comfortable So with with alongside and that's we're FDA, we'll see but be us, conversation nice would having very partner going if possible. have it to the that to be a

Operator

from comes Mamtani question B. Mayank with next Our Riley.

Mayank Mamtani

I update comprehensive appreciate the here.

Just few follow-ups more precise technical there.

dose is in ] size? levels? but liver what Could you regarding data [ So I assume than [indiscernible] sample from analysis saw XX%, a which still, top normalization higher what's And little please to the clarify up that? pooled study, fat a you the it's

M. Harris

they was the liver the from got body right? -- liver MRI-PDFF when scanned. comes body the study, mine patients and fat scans, So have Well, MRI composition an the data being

this XX%. patients this X%. liver fat The who higher we very was We So fat. liver a in -- similar of levels normal think was NAFLD XX% study in is about high rate to liver saw we're about fat normalization. the liver much NAFLD And of started as the in very study, in seeing with mean what to it fat study

less. for So the normalization barrier was

Mayank Mamtani

be I question helpful against And could we to was you but Scott. future? [ a clarified methodology the ]. those composition body that that MRI-based, there of conducted have presented protocol? in part that being approaches are what Are Got and data [indiscernible], the on fat be related used just the not also analysis here, could it, the additional compare for like Or semaglutide have

M. Harris

MRI. for is many and technique specificity for [indiscernible] think that think a composition. MRI of is the Well, preferred good experts surrogate We not sensitivity the body the

we for this technique the on that's relied study. So

Mayank Mamtani

drugs And later provide had of commentary and could than the year we you execution, showing year MASH placebo-controlled you [indiscernible] the MASH be will enrollment that doing more seen of? you'd on therapy we've of execution the pace before. Understood. to the that is then an any Okay. the a be aware anti-fibrotic color impacted And on can the effect approved if MASH some now start the market? on the prior Anything study of on course in IMPACT approved expect trial should through trial

M. Harris

Yes.

the trial into feedback the and in subjects enrollment they that going to get from lose And quite trial come we prefer their weight. well. patients investigators their is So is can because

them community, we're And So different possibility potential going to of loss and this in being the offered. seeing that, are we're seeing the trial well patients reflects also recently amongst the with potent faced these weight offers being to drug trial we trials because head-to-head, loss effects. We available that but [indiscernible] no of in regard. weight think drugs into that. with extremely We're do that when commercial associated choosing approved, there's come our believe

to loss that generating glucagon to we especially forward regards of being that. the the changes very effects and weight to to fibrosis the out are weeks, with can of remind the XX in shown valuable, us is we seen, reduction from in on very biomarkers the and the liver benefits But front. of future. data you do inflammation, improvement drug, here other that are we're differentiating fat area to out look effects allow Regarding the by the And read and more repeatedly, actually of seeing be think quality we being which in other going especially pack this differentiate on in class-leading and that reading

Vipin Garg

Scot, And may want you anti-fibrotic we the to are talk that direct seeing. about effect

M. Roberts

Sure. are sweet we're great it weight But actually, associated jobs to wanted doing the on the reaffirm those. -- there, to I liver this Scott MASH, just I loss FGFXXs that [indiscernible] directly sweet no on there's spot, about comes we're the but talked in and spot. just acting before the when also with get in

they're great. [ the like endpoint resolution, believe hit. ], that's straight GLP/GIP of wasn't fibrosis And but not drugs why MASH just tirzepatide the or is a we With defatting hitting GLP liver that

And control very direct qualities those agent a acting inflammation we don't have very there. and in we here, loss. find that the also quickly, that X can quickly liver you defat So are the weight the competitors but out have

direct as population fibrosis FXFX study, far in [ is implications are that our example. -- which today about things here push for our our offer the really talked FX, population is for but As and we ], along a intended the second anti-fibrotic we could think have may also effect, exciting IMPACT and mechanism late-stage that for certainly

at mechanisms pemvidutide by the certainly that to to continuing MASH. adds occurring, So is this excited the we're data, and try but and that which of for we value to it we're think about understand look the

Mayank Mamtani

just X final drugs, same level with you preclinical chemical on you've maybe able weeks. seen? you you, that I question In with on experiment report, the fibrosis less anti-fibrotic experiment, think staying than what study And data are XX% [indiscernible] to Scot, comment in

And pursuing then of I technologies of for talk taking believe emerging a the [ of can question. [indiscernible] also format. about overall our there. you early lastly, you Is peptide an were again thanks update couple on pemvidutide, that And the there formulation ] oral any

M. Roberts

Absolutely. Sure.

a there lot far as at there's ], really in [ have out that drugs, MASH non-obese as this with comparison drugs other looked for So model. really nonsteatotic not

direct and apart, getting it's activity? So or really some are is we're difficult to effects been defatting there why the that's tease we anti-fibrotic liver,

demonstrating comparable and the [indiscernible] done, effects in the is for see [indiscernible], certainly as of we've study that clinic effects on III testing. mention is the fibrosis of will done same anti-fibrotic sort you similar, and has I very reduction. Phase currently example, we that in know, amount And

but out point I with an there's data. So a [indiscernible] think important there, that the that's touch lot there not

the As in We able detected there. X.X And in seeing progress milligram pemvidutide those for we these we're drugs, in levels the studies, the are. clinically, example, making that. oral at good significant we're are far fraction dose. of formulation, levels fraction what X.X know achieve we vivo a what of are milligram at the of or as to When look that achieve significant a we

approaches feel both different that and here, on them we're so right we of X promising. we evaluating, the still have And road look we're

effort that [ one putting think good, looking that hope end we year. IND of ] -- that the into by and is to we'll those candidates I report of development the So those

Operator

from with Our next comes Jonathan JMP. Wolleben question

Jonathan Wolleben

A that couple how other of and similar for if is follow-ups this context glucagon on triple dual you the body seeing changes composition semaglutide tirzepatide? pemvidutide expect study. could with with see some you're what work to I'm compares include specific pemvidutide? wondering agonist if And to and you give to

M. Harris

Jonathan. Yes,

the XX.X%, you XX%. is in So analysis, semaglutide that same remind at at I we were

So compared to semaglutide, we're clearly preserving more mass. lean

and lean the rate women information, of to in higher elderly believe achieved and to and in the the fractures that's the XX%, is weight Within loss, that emphasizes lose mass preserving lean which the of and importance associated diet highlighted, we bone semaglutide about is with the mass seen prescribing as with exercise, as get ratio close we've it people that.

XX%. it's number, data The we believe It's but presented bit abstract has to tirzepatide about difficult in exact at a form. only the see been

in we're this in space. the that clearly, So leading class of drugs

weight, words, And body XX% ratio, a to of [indiscernible] lean about recent reported out in trial. a was being in lost how compared to XX% much other lean

We why the glucagon. we more molecule [indiscernible], the are our differentiating Now that by that out in believe and body glucagon we on effects composition. seeing have we in we're would we're that point being driven our that believe that's

more better fat areas, of we've variety done, reduction liver of the and So we now a lipids, lean the mass. preservation reduction including of better think in of

Operator

last Patrick Trucchio comes Wainwright. H.C. And question from with our

Patrick Trucchio

the separately, the the Just mass body preclinical clarification doses? the I'm I'm a Phase the be potential data. to first across obesity tell if way of a on reported data lean through trial compared if if across wondering wondering design, you're about dose you updated reported thinking impacted read or and clinical how would of the And as consistent IMPACT levels such how us program or was it today preservation end mass in data lean composition titration program? or -- pemvidutide in has And points? then dosing III terms can today expected to separately, the

M. Harris

I'll guess that. I take Patrick,

the same XX% So the loss ratio was all quoted dose total XX.X% -- lean groups. in a that to we

So you that achieved regardless of ratio dose. the

the certainly X That's XX%, to XX% -- we be in we III. titrations. think that the we've has at that's [indiscernible] data program into So largest is longer there's about change design. the but look this doses. The The thinking Phase clearly been is consider that value to all has yet could make Phase been us a the dose partner reduction, program body III made incorporating if that there. not XX%, on far think decision of going a to something at composition which be to compound remarkably tolerability in with improve the We made have optionality felt so

the to position X.X Vipin that other would of to opportunity do treatment. care. XX.X% against for the at even dose, mentioned, that XX are go differentiating future weeks longer for emphasize need not the is weight loss compounds, to current -- very is But higher other we think, particularly to dose But I the feel Our is higher in We it as that -- compounds happy the larger doses, fixed durations evidence primary titrate. we achieved we at get if longer that program we longer especially we weight with -- that chose, all with loss. suggests want the getting milligram we

studies we to We'll a we includes endpoints composition. these for The and much we a trial. body in pretty -- to by established least FDA do look will the nondiabetes if actually are see do that at the if diabetes see study actually look

well options as other can detail that look we future. that have the in at to We

to the of in content effects. against the our I think Everyone In get the better has terms had even of going always on of confidence we've program, anti-fibrotic the MASH. ability We differentiate potential based the in we're that other glucagon drugs to MASH think molecule, mentioned pemvidutide.

well. having liver confidence important our as hit direct anti-fibrotic is endpoint very only we're the fibrosis fibrosis effect, the You'd going moving that of XX weeks be or we're fat to anti-fibrotic than which by Scot not treatment because also that a data XX statistical at increases rather demonstrate weeks of to described treatment. able call getting potency that The on reducing significance by

Vipin Garg

Yes.

mean, safety database. one III, only at need we're you would of I III Phase to that, as add thing going patients, terms Phase of I the in Just for that for know, thousands looking a particularly plans, to

us the have the under multiple differentiation opportunity patient III that we particularly pemvidutide. So program, to that can actually study given of can Phase the we gives test, population

to we label. the have instance, and try a serum might benefit that that high on be lipids show able For get looking and to subpopulation at

in that's terms So going that of kind we how considerations are of those -- we through are III the Phase and discussions the program. designed

Operator

Vipin question I'd the closing call remarks. answer to and over session. turn the like This for to the Garg back concludes

Vipin Garg

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

Operator

Thank you for program. your the This conclude participation. does

Good may day. now disconnect. You

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