VKTX - Earnings call transcript Q3 2024 | Viking Therapeutics, Inc.

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Operator

Welcome to the Viking Therapeutics Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, October 23, 2024.

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz

Hello, and thank you all for participating in today's call.

Brian CFO. President is Greg CEO; today Viking's Zante, me Lian, and Viking's and Joining

begin, like XXXX, development regarding we of of conference milestones. statements Before XXXX, I'd and the activities, the call during comments under about Litigation today, time this U.S. made including Private lines October Reform harbor statements its XX, safe will Securities forward-looking to contain provisions caution Act that expectations Viking's

of to differ statements as the could results Forward-looking Exchange performance. subject update undertakes cause today. you and results made speak reported and to concerning an the date, statements as only future obligation to considered with and that all uncertainties materially these encourage should company are the Securities risks company's any and of Commission other filings and These be and statement revise or forward-looking matters. of adversely actual I not indication today's review no to

I'll Lian now turn the initial comments. Brian his for call over to

Brian Lian

Thanks, afternoon to in webcast. on listening Stephanie, and or good by the phone everyone

Today, the X XX, operations. for September and ended an clinical X and our our we'll provide with months on XXXX, financial update and programs recent review progress results

quarters the as from of been The first program. data preclinical positive in Viking, X with from have X vivo for company clinical data-rich promising programs XXXX well data delivering as a new

obesity. the weight of positive of the body II Phase weeks treatment evaluating trial reductions from VKXXXX we results in treatment. the first for announced XX quarter, Beginning VENTURE trial demonstrated after subcutaneous in This impressive

encouraging oral showing novel a announced weight. I the evaluating Phase excellent reductions formulation a body this also results of from compound, in XX-day We initial tolerability and trial,

Viking VOYAGE its These at calcitonin quarter, food improvement the VKXXXX improved agonist results a the company weight results X secondary from and fat study Also decreased body resolution from achieved and the metabolic in fibrosis. developed after endpoints, successfully demonstrated rate of and announced This XX second announced weeks. treatment series primary in in receptors. weeks, in quarter, reductions liver NASH of Phase compounds the During during and and NASH second profile evaluating amylin animal exploratory showing models. the fibrosis study dual the intake reductions, for internally vivo histology IIb of an

treatment to be subsequent of we once-daily or the announced patients with results of oral study quarter, in Phase end a safe the positive Ib tolerated Finally, well XX-day X-ALD. third the and following this XX-day VKXXXX dosing period. Results VKXXXX to adrenoleukodystrophy showed X-linked from from trial over

in and long In levels significant as reductions compared fatty very observed plasma chain of acids placebo. were addition, other lipids to

of to proud further year progress quarters are our ahead. pipeline this in forward we've look We and programs made the of advancement clinical the

third September have results our the ending and after comments I'll we review for development and additional months financial XX. X our activities on operations quarter

that, I'll the over Greg turn Chief to Officer. For call Financial Zante, Viking's

Gregory Zante

In my file comments, to Brian. Commission, expect Exchange filing with with XX-Q Securities participants we later which and conjunction refer recommend to Thanks, Form that to Viking's today. the I'd like

ended salaries September the months partially by The expenses XXXX. for XXXX, same expenses increase XX, services, candidates, our offset regulatory ended benefits for XXXX, manufacturing and to drug results to the due studies preclinical Research clinical the months XX, company's studies. the for and period X million compared the $XX.X for in related quarter. increased $XX.X were I'll third September expenses quarter now with over decreased to go compensation, beginning primarily for million to and X results the related and and was development stock-based

services for compensation, compared primarily the ended increase in provided months insurance. increased stock-based due patent related consultants to million administrative by for General million $XX.X September third-party was expenses $X.X to services, XXXX. were to and XXXX, expenses period X same and the XX, legal The and

X compared corresponding loss net in loss per a of the million $XX.X The XXXX. of ended net XX, or period share For in in $X.XX share a $X.XX September to the for per increase was XXXX. primarily reported XXXX, X to Viking $XX.X XXXX, the months million same noted due and in expenses months income and previously, interest offset and increase ended period September general to expenses loss increased partially net by administrative XX, research the the development in or compared

now months over ended XXXX. go X results for September the our I'll XX,

ended to months million drug related preclinical same Our research clinical the to and to salaries compared and our $XX.X million increased candidates, primarily in the expenses studies, due were period for XXXX. for and manufacturing development $XX.X September increase for compensation, XXXX, studies was expenses X XX, The stock-based benefits.

September administrative related to partially and stock-based compensation, million salaries by services. XX, ended to offset primarily decreased legal increased insurance, period were consultants the XXXX, in $XX.X to The for increase to general compared expenses million expenses benefits, the was months third-party for XXXX. expenses X provided and related due by and same patent services $XX Our and

share income to previously, the For a months the share period the or a per ended months to in the period research increase administrative corresponding in and $XX.X increased development XX, of XXXX, partially XXXX. XXXX. $X.XX X million or general to in net reported XXXX, noted loss offset The expenses expenses for $X.XX interest in loss same by compared the per of loss primarily ended in Viking September net net compared increase September X and $XX.X was million XX, and due

XX, XXXX, of Turning equivalents XX, XXXX. to million Viking At compared of cash September short-term the held cash, and investments balance as million $XXX $XXX sheet. December to

review, This and concludes to financial over I'll Brian. back call the now turn my

Brian Lian

Thanks, Greg.

pipeline clinical next and provide programs. summary highlights outline recent steps of now with I'll a our

to Viking's agonist multiple begin compound demonstrated in injection of subcutaneous Phase trial receptor insulinotropic I X up The approximately XX with days GLP-X single as receptor. obesity weight the company's VKXXXX, dual Subjects the GIP dose lead and a peptide after plateau. or the or weekly promising polypeptide, program, X, glucagon-like no with X% baseline VKXXXX for I'll to loss from ascending glucose-dependent up and initial this of pharmacokinetics for a weeks. safety, tolerability of signs demonstrated study and administered when the

Phase Following these randomized, the for the and a initiated the VENTURE pharmacokinetics placebo-controlled loss weeks. known was of II VKXXXX, XX that results, safety, trial. study as tolerability, efficacy multicenter of subcutaneously evaluated weekly weight company This double-blind, study VKXXXX, trial once administered a

for VKXXXX In at that maintained throughout to of XX baseline, top of With this treated the achieved weeks significant did body be all course weight X significant patients first study. positive could placebo compared this statistically ranging potentially was primary evidence in and VENTURE XX.X%. mean dosing the period the observed the demonstrated endpoint, were loss quarter the Weight the weight and Viking differences Statistically announced to results study. of year, from cohorts study. line starting receiving to respect reductions of up show through VKXXXX extended from loss suggesting all study's further week doses plateauing, XX-week in through progressive not also beyond

safe from tolerability, early treatment, adverse safety well to majority shown with XX-week to occurring expected trial the mild resulting activation of primarily over characterized moderate, the be VKXXXX Regarding tolerated related generally effects receptor. and and or as in treatment-emergent events course the was the GLP-X and of being GI of

will presentation also known at the The results describing scheduled be abstract Obesity Annual of an Obesity the session for evening submitted for we as the Week. a summer, study VENTURE highlighted results Society, poster of the November the at Meeting This in X. conference the of

Based VKXXXX of III inform of Type in steps VKXXXX. for plan obesity. Phase To the in study, for from Phase our a this agency, the later completion development next next with steps will development agency VENTURE requested the into program. to the of III an Following advance we the we the meeting plan to end, we end feedback II on to have FDA with meeting C which help intend the us serve Phase quarter, this for scheduled written

the trial of the subcutaneous who attractive oral execution subcutaneous with loss same to to oral to for formulation, seeking for key they or molecule. Viking the formulation company the represent already Phase utilizes I could the which are tablet believes option those conducted is VKXXXX, patients regard hesitant this Concurrent formulation also have initiate the a potential evaluate an injection-based patients study an for treatment in to formulation. The A achieved. VENTURE to maintain therapy transition an from advantage tablet the weight

safety double-blind, Viking unexpected believes of be squared. reduce and option index for XX XX daily of or of the a with in challenges was The per tolerability attractive evaluate meter days. primary to body kilograms and a this tolerability and patients Phase healthy I the clinicians. objective a for tablet risk once placebo-controlled safety study as an could VKXXXX may was both study The administered mass adults randomized, minimum

and the of pharmacokinetics in evaluation objectives as exploratory as weight oral and include metrics. changes body well Secondary an of VKXXXX other

the placebo. in and reported adverse study initial receiving we compared differences VKXXXX, were majority doses up reported from meaningful which treated safe demonstrated following or to XX oral dosing with well adverse moderate quarter, were No tolerated for with severity as reported gastrointestinal milligrams. mild. to mild first VKXXXX treatment-emergent clinically for of the once-daily all data Among that at XX this subjects as days up with subjects the events VKXXXX In events was reported among

and window study progressive weight, over dose-dependent to patients was up this observed. dose levels XX-milligram addition, loss XX-milligram approximately at Weight VKXXXX demonstrated X.X% In oral reductions reaching with body baseline. in plateau XX-day no the receiving from the of

at Given of milligrams milligrams day, dose XX the elected escalation XX with weight promising profile excellent of to per milligrams at XXX tolerability day. loss up doses the company along to observed, XX the per continue and milligrams, all doses

poster II the describing for Phase the X. presentation, submission for a trial of ObesityWeek accepted the with at late-breaking was submitted which the This conference. evening As November results, is VENTURE abstract study I presentation for Phase scheduled we

we details initiation. study As year. get a in initiate we this the closer trial We'll later to Phase study provide as step, plan design obesity next II XX-week to regarding

as of isoform I'll the now is orally tissue agonist available the hormone selected Viking's that as to small molecule receptor. for liver beta the VKXXXX, turn thyroid of well receptor

IIb fibrosis. the in positive with of VKXXXX double-blind, During safety tolerability NASH study This VKXXXX multicenter we trial, was placebo-controlled NASH the of quarter, VOYAGE in and patients second a international the announced biopsy-confirmed and XX-week results study and to histology efficacy, with fibrosis. randomized, assess patients from designed Phase

achieved receiving from its Last with end reductions year, study successfully primary demonstrating point had In of evaluating the with XX patients reporting achievement content initial biopsy VKXXXX week to statistically from after weeks treatment. the fat June assessed in data liver by compared Viking significant Viking hepatic XX announced of baseline announced the that year, endpoints of placebo. successful the secondary changes trial's this as VOYAGE, histologic

statistically and NASH patients rate, endpoint resolution NASH VKXXXX showed in improvements stage resolution that The histology of improvement. results and fibrosis fibrosis receiving combination significant clinically experienced and the

of worsening resolution rates with XX% without VKXXXX-treated XX% resolution On compared the NASH endpoint placebo. fibrosis, XX% patients to of for ranging from demonstrated

On least no evaluating the compared this fibrosis achieving secondary endpoint placebo. at worsening the with VKXXXX-treated to of NASH, a X-stage proportion of of with demonstrating patients patients XX%, for range the XX% from XX% endpoint in proportion improvement

gastrointestinal weeks resolution the XX the the of as rates with events and patients a excellent receiving majority previous XX% The from treatment XX% nausea, reported The ranged mild On XX% patients VKXXXX-treated at improvement both stool to tolerability of to week the VKXXXX-treated results or vomiting as compared for when placebo. reported to also both weeks safety frequency XX of reported with among of XX. tolerable similar from achieving experiencing compared for secondary evaluating encouraging VKXXXX diarrhea, of an NASH proportion moderate. profile placebo. and also treatment were compared adverse measures demonstrated proportion fibrosis. endpoint of VKXXXX VKXXXX through patients through in minimal least with treatment-related differences patients and of demonstrated X-stage XX%

of results Earlier for for or results the for Meeting presentation, of Association AASLD we Disease of Annual been this November have VOYAGE presentation in an Study the submitted fall, for Liver which XX. the XXXX accepted the American November. oral at These study scheduled the is

for program. II the and we VKXXXX. this the Earlier from in them we submitted regarding agency, Phase we the this the evaluating of and earlier end meeting week, study to written reviewing for responses Phase FDA plan proposed received III are quarter, process addition, of a next package an In steps

an drug neuromuscular Turning rare VKXXXX, VKXXXX small of program. clinical recently now the the with trial is or molecule results patients our a X-linked XX-day adrenoleukodystrophy X-ALD. called Ib we reported to Phase our disorder fourth candidate, Like long VKXXXX available in from chain of debilitating the the by of small a very selected function of thyroid that receptor. X-ALD is for disable that the fatty that is transporter peroxisomal hormone metabolic rare genetic molecule mutations isoform beta is disorder acids. and caused orally

to unable of is believed these contribute X-ALD. a and the and are As accumulation metabolize their to patients result, to onset efficiently progression acids

AMN multicenter, randomized, X-ALD. placebo the trial Our grams of patients Phase VKXXXX the placebo-controlled male XX The with enrolled XX adult was with subjects international of milligrams to were of X daily. study evaluate Ib the this cohorts, safety patients was Exploratory a in doses long-chain to plasma AMN. double-blind, The of population. or acids and fatty objective across levels tolerability evaluate VKXXXX form and primary and adrenomyeloneuropathy in study in objectives on of VKXXXX effects very

following to Results XX-day this once-daily VKXXXX be tolerated from oral dosing the study treatment and over showed period. safe well

this chain Treatment acids VKXXXX long reductions with levels of resulted important by approximately significant levels acid observed placebo. addition, XX-milligram both in very to at to XX% to reductions long In long now. relative placebo. carbon other chain levels reduced fatty very significant acid XX Plasma chain very were compared compared in in fatty plasma XX-milligram fatty the doses and of lipids were and the mean

subjects VKXXXX treatment. received addition, and following other In of lipoprotein days experienced plasma were apolipoprotein who to lipids. baseline placebo LDL-cholesterol reductions A and Mean for B important observed relative in XX reductions

moderate. and this with as reported In adverse to treatment-emergent generally events tolerability encouraging demonstrated VKXXXX safety mild study,

next the We are following We're very complete from will data the this and pleased continuing with data steps receive a the determine of outcome of study review program the for study. set. to

with on program. we balance fortunate our clinical the objectives we're move clinical execute as to forward providing have programs, a each key with strong runway to sheet Finally,

X oral has an as VKXXXX, exciting have XXXX programs: results Viking for for conclusion, subcutaneous their each endpoints. successfully and from we study delivered In been clinical VKXXXX positive trials year VKXXXX, VKXXXX, achieved

continue executing opportunities these we explore with addition to pipeline new In to programs. innovative programs,

To for that developed a obesity. new end, the treatment program amylin of internally agonist Viking recently announced

updates it the about program as this advances. look excited forward are and sharing We for new potential to

meeting our with III which we later an which end ahead of Looking will following FDA, to II respect preparing Phase initiate for a for place subcutaneous to VKXXXX, take Phase quarter programs, obesity we're actively the with plan this study.

to and plan For next study month, year. later oral to Phase additional initiate a preparing at II are data we VKXXXX, XX-week we this ObesityWeek present

VKXXXX data this fibrosis, regarding program VKXXXX, our meeting path for we steps recent to treatment responses respect With X-ALD, for this decide following the an chance had Phase once we With full for next II evaluating review with and next our the of final of are registration and program. of receipt written molecule small we steps FDA the a to NASH from the await we'll to package. data end

clinical with in for programs, our resources ahead. we forward third of in Finally, to we at believe reach to the further million reporting end the $XXX quarter, cash financial we the equivalents the milestones of and required have progress look each and quarters

open very This concludes the for we'll now much and our prepared call Thanks comments joining today. questions. for Operator? for us,

Operator

Lee [Operator Joon Instructions] Truist. comes from first question The with

Joon Lee

are it a Or or a And subcu as VKXXXX quickly you for meeting II also Phase what agonist how your how called there, start call to after it's your like FDA? benchmarking in semantics, follow-up, And DACRA? III of just quick able agonist it? agonist is amylin vis-a-vis amylin whether And out what's Phase DACRA? some you with the iron this you'd you are to be that? out end the the things Regarding would quarter, what is

Brian Lian

Thanks, Joon. Yes.

amylin With also it the hitting agonist, is calcitonin.

calcitonin pramlintide, and agonist. agonists. use receptor known benchmark amylin amylin dual a cagrilintide. it's So generally We we we And against use

mechanism. we as compounds are the use far generally bellwethers of that as So sort

proposed And II respect try then protocol, Phase of study. will overlooked to the FDA, review there's and or if that the size, the anything we meeting FDA the proposed anything that things. end all doses, the the we With those in trial understand proposed with to -- of include it's recommends

designs. little just So trial a feedback proposed on the

Operator

next The with Stifel. Annabel from question comes Samimy

Annabel Samimy

the you dosing? talked additional oral Or separate activity it dosing incorporating post same trial? that the for that -- And guess program? dosing given be the be additional PK dosing, You've question in exploring III you're past. monthly about I you its are we a regimens will for exploring into potential Will -- continued the And data? seeing and Phase is

Brian Lian

Yes.

With PK think monthly but poster, we some will we poster. data dose, dosing. feasible. the the data to in much dosing of VENTURE Not that we support going the do disclose what's too And the monthly monthly have think that PK very is in

III, far stand-alone there to statistical Phase you As transition monthly included inclusion mid-study as probably Phase do we'll in program, the gets the a of challenging monthly. the more a regimen in treatment III the not when

as target can. would start a probably So we there stand-alone soon to as we

Annabel Samimy

given you post you Okay. And saw at in study? looking the are regimens oral, that for the activity dosing X-week dosing different its

Brian Lian

may. the disclose get we once the actual to study We'll We XX-week closer design initiation. study

Annabel Samimy

you trials? that Okay. at and Great. about your personnel could do if guess infrastructure I you your you the expectations to increasing infrastructure have the next stage? to I to Or for are expands question. And this Can have another What just build these base? committed that run talk how capacity have your

Brian Lian

Yes. Annabel. on vendors. external heavily We've Thanks, relied typically

I to development, clinical it we've works us. manufacturing, We've think clinical pretty said, that's well very affairs, added model in for for access, formulation, operations, now. quality it's an regulatory That -- us, been biostatistics. staff efficient market and the adding aggressively been been

here. add. And it's pretty continuing we've So in we're a broad-based grow continued and increase staff to to

prepared III II than Phase be going for is it. we're trial Phase trial, the different a and lot the So to

Operator

Raymond question Seedhouse comes next with The James. Steve from

Steven Seedhouse

protocol of questions. couple A

study with it and study. Just you have of having available about in if pros one control an whether commercially I'm this to of be conversation think FDA. the the that Phase for that's mechanisms cons necessary anticipate III a with advisable like the and you or the wondering will arm how active

Brian Lian

a study. Steve. to planning Thanks, do Right we're now, placebo-controlled Yes.

study comparator a in these be But be active will X studies, placebo-controlled. first interest of would an think future in it I study.

Steven Seedhouse

Okay.

Sounds good. as then on And question development strategy amylin, clinical well.

development But about are another or use guess general combination could with, thinking you when thinking how to looking in in you early how in GLP? or the the Just and testing I combinations? start appropriate that you program are this case, how about at it's XXXX best

Brian Lian

-- a In And in another real value another in bump top you conjunction when a mechanism what it Yes. XX% see a is of typically, with greatest nice improvement add that mechanism. amylin efficacy so. the see or With with mechanism. view, the on our you GLP-X, you is

were if the it it a to and dual a likely profile. to on agonist, be that improvement, add industry in So you efficacy showed would similar the best

And so with. something think that high-value we really proceed exercise that's is a to

in combinations. So we'll we clinic at potential hopefully the into bringing but look would that single follow agent be with XXXX. a compound And rapidly a

Steven Seedhouse

a just And something your used in future with that that, you studies? that you've and the follow-up orally using co-formulate same approach is could with XXXX, on formulate oral

Brian Lian

yes. so, think We

Steven Seedhouse

lastly, was you longer just in But clarify, just I made to benefits want obvious release, with the Phase press dosing you but on sort the based the And periods. be of that from dosing hoping think I the further could Okay. in it's you might elaborate anticipated that press oral does statement say an I study. observations release

data to referring can it. what So about anything to like conclude or just you say elaborate what specific observations on you you're points led there,

Brian Lian

look negative. XX-milligram Yes. far, days and is When still at. at were cohorts, the slopes the a to what's been -- short at And XX window you the look XX- such reported those trajectory the so

dosing extending there. really referring likely extend what the would So we trajectory further. to the window think we're That's

Steven Seedhouse

Okay.

And disclosed data XX reference the so mg that's already essentially, to not... a

Brian Lian

yes. right, That's right. That's

cohorts. the with We subsequent haven't disclosed anything

Operator

with The next Roger Song question Jefferies. from comes

Jiale Song

Great.

with Brian. start maybe clarification, So a

XXX the dose? dose dose GI So qualitatively XXXX for oral the that's the And you that on the rates up can could escalation on higher comment confirm loss case, for the response to weight you if milligram. and your completed already you the

Brian Lian

the about Roger. dose up milligrams. It's XX to the XXX think to Yes, the We did of only days. we'll leave disclosure And I results poster. further

that communication information getting we it as was sufficient study, to we to further the successful going that execute Phase look underway forward think provide soon The was Phase as plan we're study and a there. So and to Phase and limit in probably possible. regard, to I intended II II

Jiale Song

subcu That the already sense. for capacity, of Got focusing makes maybe it. trial have the understanding the oral Yes. then probably manufacturing, the Phase on for clinical the then Phase III for And capacity you and in II. terms

couple capacity? we of past what the to months, the started -- Can further commercial think manufacturing increase for capacity those for you curious have the about done Just to have candidates? you potential

Brian Lian

the Thanks, and Yes. for our on forward, do We supplies position dialogue will appropriate the currently and a the sufficient and activities hand the product continue right. oral. in to proceed you're meantime, both drug to And the are working with suppliers supply formulations, that towards support supply long-term as global agreements, planned the to are Roger. time. key peptide at in subcu we development confident blockbuster have have Yes, size we we a we be

Operator

The next question comes with Oppenheimer. from Jay Olson

Jay Olson

enable Congrats level comment you dose doses testing might of and the in Can the on oral to on all II see that Phase for safety higher would what the study? tolerability progress. like XXX-milligram you

Brian Lian

Yes. the And need the was level escalation. means team never discontinue every decisions from there a cohort. team up review after to tolerability that recommendation We that dose of completion to

very profile. comfortable So with tolerability feel we the

Jay Olson

the end the is front? how away, supplier could year. those And years on a commercial manufacturing launch are And updates be on please other the comment Could manufacturing Okay. recognizing synthetic that you any outlined an discussions indicated route you recently by then that external Great. with of going?

Brian Lian

Thanks, Yes. Jay.

mentioned can peptide So have do as scale global dialogue continue I've minute up. who we ago, with a to suppliers

of some focused synthetic on discussion And routes. that various is

under that of progress development. active and So is in all

more it, as all process talk that that utilized So in scale of is up, the about but when still speak. we we be a decision make for route for will we'll

Jay Olson

big Okay. maybe one Great. And picture question.

VKXXXX, you oral how between the think and value about As the just is value subcu for total that talk can about you forms? split

Brian Lian

the a you with view who subcutaneous Yes. piece depends being the nice It's an franchise to oral very We formulation it really interesting question. ask. anchor the on oftentimes, is the And we're modality. current going be you to from look drugs. right obesity at And probably revenue billion $XX when in major now, unlikely utilization the exceed but the total to the add-on,

to are those we'll rapidly expanding, in is some which time so oral, so And of do absence the off. continue an and

think to is how a XX% is. I would dominate, We oral an the likely and don't an opportunity in and So injectable XX% probably opportunity. that the probably oral know see come is

Operator

The next comes BTIG. question Zelin from Justin with

Justin Zelin

Congrats coming on separate the progress. with look that? transition use entail, that Phase Brian, you on an the you have III us injectable about, format need the would that talk And could study? a up, whether subcu might Or to auto-injector to study to to a an what you for if for you're follow-up. looking I auto-injector,

Brian Lian

Justin. Thanks, Yes.

auto-injector So the trial we vial we design, but enough, in we of auto-injector. about soon seek that be the an If the and from we from study. to to would not, transition syringe people If it's onset would will available a that the haven't much study. utilize using talked a

Justin Zelin

Okay. Great.

auto-injector discussions the that. some in in like be materials securing of with might prepare So order it you sounds to for

Brian Lian

right. That's yes. yes, Oh,

Justin Zelin

just Okay. Excellent. Would that considered be next step registrational the clinical that And the progress question on then FDA into if study. looking recent II correctly, like to a study development, you're mean the the a that a Phase would be to X-ALD. study? Remembering

Brian Lian

anyway in and what Phase question. it's studies good look biomarker proceed indication we That's a you whether registration think. these Yes, Phase study, this III. initially then II, to or III Typically, a at

on long forward That's focused the likely assets. not well, just functional endpoint, very of as X-ALD. of in chain fatty a here the or expectation our been be quality historical a life more path would that So

Operator

from The question Instructions] Smith Thomas [Operator with next Leerink Partners. comes

Thomas Smith

Thanks for the updates.

in wanted And level on know question. you forward looking the earlier XXXX, to yet committee review that mg at up seeing the the follow to dose XXX review the oral ObesityWeek. on I from First I to data cohort. back an commented met just data Brian, hasn't September

this wondering may they point or higher setting, I you level II? desire to Phase or you if and whether there's the here something whether a is explore consider still just at Phase doing could met dose in clarify any potential comment on in is So the this

Brian Lian

-- we It's to root the Yes. the getting of higher. would question, so dose

ObesityWeek the was possible when any to certainly the further There the the nothing start and in really from comment indicate But precluded we'd actual until data we at data I study. we the that conference. disclose present that of up. guess we'd it's would be would dosing read think higher, I II dose Phase rather initial refrain we

Thomas Smith

it. Got

quick steps Okay. then to looking maybe tease That XXXX that a and seeing and sense. of can NASH update on analysis the makes forward about strategically then, you're look data the in additional any to Can we thinking at the perhaps the how at on some question Liver for And forward Meeting you late-breaking next there with and partners? maybe data respect engaging AASLD. program with to

Brian Lian

various fibrosis, severities look on as fat liver characteristics certainly differences well. in Yes. any fibrosis, changes, We'll the the in that's Tom. among people Thanks, baseline at think histologic response in with response in of changes any most depending differences I the thing are interested

of, So interest think, that would be I to of look sort at.

conjunction the it. would pharma feel here, NASH program be felt steps in always the we about we've And that's collaborator. with that Next a handled still larger way best

the review FDA the received we'll and proceed from So from there. we responses

Operator

with comes from Company. The I-Eh next question Jen Laidlaw &

Yale Jen

Congrats progress. on the

Just two here.

terms in of XXXX. is one first The

got You feedback it. and FDA you're reviewing

versus your up. Just follow I curious, And And impact any surprises potential what's a the anything have. may that have expectation? you partnering would then on

Brian Lian

of those responses process comments at XX just the far, received but them. hours, No, No looking still unexpected or we're in real them. thus them good in within surprises reviewing We last question. and

Yale Jen

or you do on program year-end any year, what this design. you about you're which have impact follow-up one potential on readout maybe color as a there's in or And recent is well the fourth your of as the of the could or quarter design think the Once So just meeting, lot be not? the talk Great. EASD Okay. available readout that amylin here, the about in thinking the or there? might

Brian Lian

Well, yes, a you really to and different via appetite think the than on behavior, is mechanism mechanism when effect feeding GLP-X seems we and GIP. exciting. it act the And think about

you see So should add-on effect. a nice

see successfully able if data year. to later I program for expect to would or bode when that would think combine things pipeline. our So it exciting VKXXXX own well the it's I in we're this other reported And with

what really that's from looks promising, one reasons we've seen we're and far, it. amylin So excited of about the

Operator

next with Parikh comes Hardik The from question JPMorgan.

Hardik Parikh

of question you is to I I to the And not make the oral the wanted in have a just want XXX just doses in ask just one have format? you trial, first just or then more above I Phase clarification. second tested is a sure, high-level milligrams you -- question.

in kind for wanted a overall Roche out readouts forth. I you I of on so just your at those of think we to saw example, and data from readouts EASD. obesity, learned what and thoughts Novo competitive of number get

Brian Lian

We XX Yes. Thanks, lot of With were in X.X the with do XX said like weeks. I really injectable programs have -- hot a really have comforting best went I earlier, was the and space the cohorts mode the respect we guess oral. feel that of about Hardik. we is oral milligrams But EASD, And in to like data interesting the the right what and subsequent now. is we'll programs milligrams, two XXX of really, think I us to delivery, the milligrams. respect up in to

right to we're that the And today, to early conference would value the and studies good both of Everything I feel subsequent EASD with think forward so the and of and with pretty coming looking of now. us ADA VKXXXX lead program. the is pipeline otherwise. amylin both formulations there the still the believe at But about out was nothing we

Operator

with The William next question comes Ramsey Blair. from Alex

Alexandra Ramsey

a have you questions, I could and So one I ask at don't time. them mind, X if

about the standpoint. So and our opportunity a more about for from you maintenance really the we're dosing first specifically, setting think about the how and VKXXXX, and curious is question philosophical

that more driven little So setting, differ but is the for question context, sustaining provide is on to maintenance deficit, where will more the a weight setting the about just to in loss is the goal equilibrium. dynamic my observation caloric goal the that stimulate

experiments dosing are you So questions the in we're address how asking you key how around that what designing about and just you're wondering the some dosing? think are that to questions those And setting?

Brian Lian

Alex. Yes. Thanks,

than regimen more as a view weight-loss regimen. we really regimen, monthly maintenance the a With it of

it range weekly continue and use weight downward. reached setting. an most our so a thought the to the be to keep transition further And for would be their be sustained, target would and maintenance really, weight likely option to really who would in their But from monthly someone the possibly has

So just mechanism. convenience the that I the to the a there of forgot, part aspect or compound was furthers question? second

Alexandra Ramsey

Yes. No, that makes sense.

So as of kind for you're caloric difference the stimulating versus driving between and equilibrium continuous longer mechanism deficit? intervals looking just that kind of dosing like nature

Brian Lian

of kind both. little bit It's Yes. of a

at You're intake, re-equilibrating that's the would hope a caloric lower anyway. be what maybe

Alexandra Ramsey

And question in second Perfect. amylin asset. sense. our the then That to is Okay. regard makes

therapies when you look with the across be So towards to investigational you mechanism, calcitonin earlier. mentioned that this component that various seem most companies gravitating

views curious amylin agonism just program. terms bias the if of dual about wondering VKXXXX, your balanced? ratio for you also, calcitonin. and do there's agonism on And agonism in work with is also optimal is So and the then we're we're think informs an which how And agonist you

Brian Lian

Yes.

compound calcitonin. -- first receptor are away it's both. the from difficult the I programs the was most intentional, compound. don't that's targeting recently, and know very calcitonin more think And was Pramlintide amylin on amylin historically, to so heavily active So or tease very I receptor. that less the just on if

We on balance skew ones profile both slightly have than that a it loss and better or that weight both more have just of worked show like seems way the target that another. on ones a one compounds receptors

more least what at ratio. that's led to overall. one, the get balanced like better to don't so isn't it's know you the closer is by well the understood, seems to And ideal has look profile the But me, mechanism. seems it just that I really us the It what

Operator

back for I conference closing remarks. to to Stephanie any the session. would question-and-answer our over Diaz turn like concludes This

Stephanie Diaz

and continued again you. for you participation you Thank Thank of months. updating coming look We support your in the again Viking to Therapeutics. forward

Operator

The Thank presentation. now conference for concluded. you today's attending has

may disconnect. now You

Viking Therapeutics (VKTX) 23 Oct 242024 Q3 Earnings call transcript