Viking Therapeutics (VKTX) 29 Jul 212021 Q2 Earnings call transcript

Welcome to the Viking Therapeutics’ 2021 Second Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following management’s prepared remarks, we will hold a Q&A session. [Operator instructions] As a reminder, this conference call is being recorded today, July 28, 2021. I would now like to turn the conference over to Viking’s Manager of Investor Relations, Stephanie Diaz. Stephanie. ahead, go Please

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

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

during milestones. Securities statements Viking's development under I’d that Safe statements Harbor July begin, about to the the Act XXXX, this US activities, of of made including Private XX, forward-looking we its today, Reform conference timelines expectations contain Before will regarding provisions and call Litigation like comments caution XXXX,

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

to update and and with of XXXX everyone our our results, programs quarter on as or by the thanks progress phone. an Today second Stephanie, Thanks, financial well and operations. as overview on webcast recent we'll an provide listening pipeline developments

continued half evaluating new has at enrollments NASH fibrosis. of for VKXXXX, second and VOYAGE XXXX patient we we steady steatohepatitis, to hormone lead into novel our of made patients in pace. our first nonalcoholic The respect quarter, of the the With Phase thyroid development During receptor VKXXXX steady in a two progress our continued programs. with study setting the beta Xb over enrollment rate of agonist

encouraging data. trial we initiated second development in volunteers the a Phase VKXXXX the additional program. We forward we clinical made financial great announced completed XALD our quarter, Based and thyroid excited initial provide recently XALD. last in agonist on we are of Phase receptor be we important Xb our and the the after VKXXXX VKXXXX, for in X treatment moving evaluate for healthy I’ll X-linked quarter with During or which results. is second hormones adrenoleukodystrophy with month progress beta on this also detail to to these development activities results, review patients trial with

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

In I'd like file Brian. to that my Thanks, and the the XX-Q Form with I'll details. June today Commission, to with beginning and go additional quarter. we Exchange financial with months for comments, to over the our XXXX quarter results XX, refer for the participants filing recommend expect now which for results conjunction Viking's Securities ended later six second

expenses $X.X the compensation. the $XX.X period candidates, and increase related benefits clinical three stock-based company’s XXXX. Our the to and to preclinical for research for primarily The was for and in months million compared June partially salaries XXXX XX, decreased development drug expenses million, manufacturing to offset to by and were related ended due same expenses studies, increased

June XX, ended decreased professional were related to consultants, salaries related same stock-based offset compensation, to XXXX. expenses million the fees and was administrative expenses Our $X.X increased XXXX partially decrease for months third-party to and general in to and due million, for expenses The and primarily $X.X three benefits the compared by period insurance.

as the for administrative to primarily over of period XXXX results the June the in ended XXXX. primarily second during now ended share, six $X.X per months of decreased corresponding and million increase months per or per as net research throughout a loss due million second in increase for net in the compared XXXX, three compared as loss well three due in of months the June available $XX.X For Viking share or decrease interest quarter the net in to was of the by XX, net to a $X.XX the expenses loss The noted $X.XX the loss offset reported XX, to and interest I’ll development of expenses, the general income go XXXX. XXXX. prevailing first in rates XXXX, partially interest previously, and decline as rates quarter share

increased Our XXXX. for June to and compared clinical were expenses $XX.X for provided six preclinical studies, The months due services the in manufacturing to research increase related expenses partially the expenses decreased XXXX and company’s development offset third-party by by period was ended same compensation, stock-based candidates, million, to the XX, for million primarily $XX.X to drug and related consultants.

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

decrease months expenses, in as primarily during interest in the due million June ended loss six XXXX, income June noted The reported as and six of XX loss increase a per XXXX. as share months the net offset $XX.X the to share For $XX.X the share, net six development in per $X.XX compared loss rates and increase well by ended in prevailing same net the XX, the in previously, XX, interest in per general June loss in $X.XX or period or of interest million decreased XXXX. administrative rates XXXX the a Viking for months was XXXX, throughout expenses to and compared due ended to the to primarily period partially research net corresponding decline

$XXX.X XXXX. cash, compared June review to short-term balance the of turn to million, call and XXXX, back I'll sheet, December over cash Viking equivalents Brian. Turning totaling investments and as XX, This held financial $XXX.X my to million at concludes the now XX,

VKXXXX. lead Thanks our Greg. I'll the programs provide progress on program now an development beginning update our with with

of In as well receptor available, tissue, liver beta selectivity VKXXXX the VKXXXX has lipid Throughout X reductions As subjects that with developments, atherogenic plasma triglycerides consistent treatment this an as is disorders. cholesterol, compelling a and the agonist possesses mild reminder, metabolic hormone subtype. a proteins. for and in small demonstrated receptor significant in molecule profile orally thyroid LDL treatment Phase the produced lipids, hypercholesterolemia, VKXXXX including for and studies of with

as LDL lipoprotein performed cholesterol. as A. well significant Phase in apolipoprotein Our with reductions B, Xa liver both disease, measures this and study as fat in patients secondary endpoints, in primary achieved secondary such statistically content, demonstrating non-alcoholic successfully in highly treated study reductions also well hypercholesterolemia and patients fatty significant its on lipids in VKXXXX liver other triglycerides, and plasma demonstrating improvements with

been patients compared patients NASH median week VKXXXX in EASL four to conference, factors. XX% oral significant Importantly, EASL. in and receiving reduction subject trial recent a at these initial data serious reported highlighted The completion adverse The were Xa XX, weeks liver follow-up patients the At meetings including of XX-week among events after and data Phase with a follow-up statistically demonstrating fat the no scientific key study, reduction patients content, including the at presentations among in XXXX study Congress of placebo. benefits, maintained and made most have key period this VKXXXX's VKXXXX this or the presentations AASLD placebo. Liver of receiving the treated from was International risk XX% among durable or treatment

in patients or evaluated a XX% which In maintained a at XX, liver all addition, the of than lowest in the greater as patients maintained a to reduction from XX% was treated response VKXXXX at dose fat of defined baseline. experiencing receiving daily XX. five equal content response milligrams Notably, week relative VKXXXX week study

compared hypertension Hispanic ethnicity. A significant results of and excellent with XX, as effects, Further we other presence maybe a the ALT, profile, well observed baseline safety reducing than and establishes in believe encouraging treatment fat compound a tolerability for an liver we NASH its compared among the factors, important profile plasma results elevations exceptional NASH believe reductions advantage, in known greater lipids a study in for compared potency VKXXXX distinction, development for placebo, increase demonstrates XX key Combined, receiving development in patients with as In treatment liver lipids, these including with addition, of fat indicator lipids and fibrosis. VKXXXX’s associated cardiometabolic which reductions best-in-class when the other of body suggest other for believe regardless mass of We levels of week demonstrated to represents therapies risk. compelling risk an that mechanisms in NASH patients. to cardiovascular of patients as that in elevated or with common durable the as benefits have index been NASH. that low-dose VKXXXX, has advantages

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biopsy hepatic XX objectives of of evaluations after treatment. changes by weeks assessed Secondary the include histologic

During US. in and outside both has enrollment rate. at over the the quarter, VOYAGE of continued first steady within XXXX study Patient sites and enrollment of a second half screening at the continued

study We XX enrollment. data expect update this weeks VKXXXX. we in second continue to program our XX the data now and of anticipate completion after provide on an clinical to from XXXX I'll initial report to approximately

significant VKXXXX of receptor successful in a molecule first-in-human small receptor X subtype. novel, gained patients. for beta selectivity program thyroid Like hormone Phase with with this is the study agonist a of the VKXXXX, quarter, a and Phase available initiation orally second the the During Xb momentum completion study

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development. Finally, we steps carefully and advance continue into This and for our we’ll in support again cash prepared open remarks later call order ongoing stage Thanks to questions. us our a for our strong Operator? them take balance today. maintain and now to for trials the sheet manage joining to concludes

go Our Truist Instructions] first Lee ahead. Securities. question with Joon comes Please [Operator from

you still terms of XXXX, talked which you healthy patients how are is questions but are Hi. expect is, XXXX by where is showed it you then in ABCDX could patients and track XALD trying on the of over in it you of of the so, on what which of the in effect ABCDX question end that enrollments versus – these the year? the the comment is due I functional enhancing how complete to We effect in for through and you updates. defected subsidy ABCDX, ABCDX? to enrollment? the of our data specific to about. second know the the just which still you Thanks is in for for taking XXXX, is the much are volunteers enhancing Brian And understand expected

that wanted specific. you. understand Thank to Just

Thanks, Sure. Yes. Joon the for questions.

So, XXXX a with the on give little that. respect to VOYAGE I study, more will color

the We really later in of enrolments have an coming yet And the pretty of on been, through half steady the the first has modeling have seen in of throughout of uptick remained the part year. that. spring the summer. we and first not through Enrollment year the half kind

Now, screening June restrictions most of enrollment window timeframe. six to the up that in May, to these randomization. started lift, from it pick weeks of still to could XX sort And

we more So, push is feels at into enrollment at point end an see XXXX it uptick, could XXXX. but this likely the that rather of going than to

Okay.

to respect study I that the Phase beta X related were in some we that thyroid VKXXXX, of With just mechanism. data saw the think so, to activation

you cholesterol of transport specific because in metabolism. more very gene expression really little So long-chain associated proteins LDL reduction with of is for fatty ABCDX triglycerides acids. in B for a apo see improvement their

we so, we release said saw – very we some reduction fatty the think long-chain in just in acids. that and And

in So, pan that what’s it’s those efficacy so really which fatty in encouraged we we and for the very changes important lipid the see do nice adrenoleukodystrophy. we’re is acid long-chain CXX, nonetheless really a see function there. effect were But we do they ABCDX, probably X-linked lowering increase understand but to really the driving think due hard and ABCDX have normal to because really hard it’s an to tell

it’s at so not saw baselines in it could Brian, more were high one squeeze healthy all. was question, the if hard – – I guess, you in I And volunteers,

which reduction but show to effect need XX% just Phase clinical is study have patients? in in to reduction, You how encouraging, would saw the a much you Xb

I see benefit. the reduction don’t of at heard some level of clinical an Yes. anybody We’ve answer what has to. the you’ll one think That’s estimates knows from to question translation experts, but a varying no

we don’t So, to know answer that. the

Thank you.

Joon. Thanks,

next Please The with Matthew Capital. question Luchini is go ahead. BMO from

Hi. the the and for update. questions guys. afternoon, for Thanks Good taking

from couple So, a me.

First, VOYAGE, you on if a more little could. bit

still more sites getting trouble sounds about higher issue broad rather it are seeing you it is, a say, So, is of having effect And this existing How dose come then like more expected on since ex-U.S. an to is safety or you little . sites and than more acceleration on to data selection wanted claim subtypes the enrolling like of Phase than versus XXX new sites Xb, it productive to patients not a or sort drop. or about certain the up much seeing based is rational needing the for of that healthy mg look obviously given to XXXX, failure. just had a

So, about I a started if talk settled please. bit to and how on little you think get could just you – XX the XX

Sure. Matt. Thanks, Yes.

coming the getting we that difficult weigh uptick the with yet this of there in see been, year. then adding seeing get about or we’ve on to sites end enrollment through screening but the that we into end in the sort a flash is sure. it’s pretty that been sites half the the are are in might pandemic summer. have and sites the with I the translate Study, adding year really and toward of good project Delta growth They VOYAGE underperforming. So, with think, first And variant. some for recent onboard of increasingly an But These churn the at queue of seen more there. the we’ve of we things And little bit sites shutdown, not

look air the With So, we lipid exposures seem enrollment getting on at we lipid sometimes, XX the reductions improvements lipids on that a the range. are VKXXXX, wider modeling. and right mg into plateau the see in XX effect mg, get onset we of reductions, see when XX we bars XXX dose mg mg mg, around up XX when XX mg. and XX And mg – to

then the dose. pretty a thought good XX So mg a nice be would be that we should dose that initial and

We the the are some to we at team looking going level doses. blinded add have look that’s There for of the higher dose to on in at was the a selection dose fashion. ability – the reason And But lipids a review these there. be higher doses. will plateau data

want guidance could Great. one any the given to in So, the you back I just any us Greg more – you you want the do want change or you’ve discussed want to revolving And color timelines, Thanks. share spending to OpEx directional if on XX% enrollment squeeze changing sort VOYAGE to of previously XX% give that any you – for actually? of stand half Okay. year? – for the to give on do to

It’s changes little at to said a anything probably early this point. we’ve to any make

enrollments. think, air pretty Brian are said as that on the wide I bars for modeling

it’d we I So, different be think, radically at this talked thought about point. than we’ve

I at major what point. this at say anyway. changes I think this No that’s point would

Okay. for the questions. all taking Thanks

Sure.

Thanks, Matt.

Raymond question James. Seedhouse with Steven The is next Please ahead. go from

I Hey, one? if safety Brian you safety on additional doses analysis. And the you study prior in am the are am it efficacy this the determine VLCFAs in that’s to whether going more or side? or then in like ABCDX more expression Will curious good also XALD the or be the I are curious afternoon. something to go blinded study measuring

question. a That’s good

good We level are the pretty dose But ABCDX not measuring we as profile. tolerability review at and as about that they far team, feel the everything, safety expression. look when

a leveling with see dose. would on off be efficacy think driven where blinded when expect I to you still can I at is things cohort we is So, if blinded. going see some the this it to there level more be But if

data? then, sense you are in the in some to acids going this that’s a elevation the And have very out you of long-chain in of where the of terms check Do study? expecting patients baseline what of just in fatty Okay.

and a The probably healthy volunteer higher most than the data the I baseline units one Xx and – the important forgot about there. is Yes. that’s CXX

like about something say micrograms level. I to So, the times per It’s – should X.X six that. normal healthy need volunteer it’s

just Yes. second That’s part, amount. relative the a

Yes.

the just you see measuring then, points? the able like On if have you healthy of time saw last knock have? long-chain the study, Are you upcoming animal this to if sort did either question. data in time volunteers that you acids And multiple in or fatty in the ABCDX decrease it’s very on continuing do to you

Yes. be multiple There will draws.

it’s – it think I is weekly?

Yes.

I mean, It’s Mancini, Marianne Yes. weekly there that. days. with so, be on XX COO, our will draws

that – time was not in not, a point just single But the…

No, in the healthy well. day. as volunteers, I was there also, yes every was periodic, is periodic, that I don’t single remember But

with able Pretty say is… Okay. decreasing or if to what was it time achieve

And healthy, see other Honestly baselines at baseline, just at major a drop day in lipids like I the so we when expected pretty you XX a change few there. wouldn’t look just But loaded with. I again were after we LDL, compare a leveling. days to a and X good because mean, then the day

just was it very it exploratory But that versus there. surprise acids we fatty day at long-chain for me So, so looked baseline. wouldn’t XX

go day the back at we and We look have can it though.

Well, event, helpful taking any Sorry. Thanks. I appreciate the in questions. that’s

Steve. Thanks,

with Blair. go The Andy next ahead. is Hsieh Please question from William

all for questions. on Congratulations and Great. the thanks my taking progress

regulators groups forward about or kind the VKXXXX. with So, with XALD as the thinking they think since with patient for Brian, could engagement your strong development a thinking be about you could speaking late-stage us share maybe ally advocacy you of

groups. advocacy Andy. recent presented the Thanks, Foundation the We had We’ve Meeting. Leukodystrophy with United really – good at Yes. think, patient I engagements

ALD the with met organization. Connect have We

probably or screwing version am up the invited name the but Leukodystrophy European of Leukodystrophy Foundation European are to Foundation. I that, of We

But high good interest websites groups anyway the on through So, their part there patients. they from are and job interest. interest of on word to out doing channels the getting and patient advocacy a had is their the generate we’ve good

Okay.

And think regulators high so, moment duration or study. endpoints help you to regarding the plan thoughts you on have could the engaged and potentially level with about maybe the size the the other question us real development is, for at this

Yes.

have We not.

the you X looks XALD, looking to have it like, looked we think, one more GATE endpoints at rapid year in consider data from study, will. form, primarily I two GATE. this when the But X, metrics. the past at over at seems declining when Phase window, functional we in some looking AMN to studies a among be functional primarily they’ve

like lot we a So, we’ll in more or six FDA minute that. be meter color to test on talk we the a ballpark endpoints. But would about expected that once the kind something walk registration to XX that expect for get of walk

very That’s so you Okay. helpful. Brian. Thank much,

Andy. Thanks,

The next question is from go Oppenheimer. Jay Olson Please ahead. with

XXXX? data for Thanks you mechanisms a please there out with especially are Brian, that talk anything potential in taking you any And the near-term? for NASH in the that competitor the are questions. excited what dynamics could about Hey. promising watching are can about or combination on new horizon be you as

of the with insulin Yes. that be We contributed there. some is things. things issues GLP-X of the are think NASH patients, weight, sorts believed to the mechanism interesting really to those sensitivity, It of seems to steatohepatitis, hitting a lot

affecting interesting. targeting data, it interest pretty at access consistent we GLP-X syndrome, anything think when the beta far the well. receptor in looks that’s So, a us of is pretty as as But as like, metabolic the look access. attractive mean, Obviously, also I I is to

horizon Okay. the are partnership then, separately, And asset for developments hip potential your there XXXX? on any fracture

a That’s there question. is I in great as parties Yes. years had, said, past the hesitation related continue. We’ve with pretty think the And those conversations path interested consistent regulatory that fracture. most for previously, and hip the on to of I three dialogue

settings, interested on sort dystrophies this the on of the But with some orphan muscular of Now, that parties in of give color rare discussions some anymore had we and thing. I that call. going some have to probably not

Okay. Great. taking Thanks for the questions.

Jay. Thanks,

Company. & from with Laidlaw Jen ahead. next The Yale is question Please go

VOYAGE last the for you Good versus taking mentioned afternoon interpret the that have in the nation more you European and patients a questions. even trial. time, I patient U.S. remember thanks Brian,

COVID the in other more your Or changes Given maybe and any terms recent thoughts? aspects, think still of that do on case? you have dynamics you the do

I the contribution outsize we think are U.S. still expecting No, an from Yale. Hi,

in U.S. sites come few the past we’ve contribution but ex most the the from to going increased U.S. general, the think European that is Over months, and I of still sites

one you Okay. Great. to Is which a question in on timeline is maybe get another potentially adding more And – that there adding XXXX, another of cohort. terms decision?

Not just underway. at getting this point. We trial the are

timelines to So, study. some would don’t the a think first We talking to it’s I for and we certainly those think I – data so, need of will – decisions. about need see randomized

congrats keep the half. Great. Okay. second And and on

Yale. Thanks,

The next ahead. with BTIG. from question Zelin is Please go Justin

congrats Hi and team. the Thanks question on progress. the for taking

ask recent patients the the want GLP-X GLP-X mentioned would if on excluded clause are interesting So, from approvals Brian, be you for to VOYAGE given is currently a I obesity and treatment? just they whether

wouldn’t be. dose six be They to No. on months. for have a They stable

no, they patients require may enrollment. to exposure have of Any not are NASH excluded. some a So, stable prior therapies in benefit that those

Great. it. for taking Got question. the Thanks

Justin. Thanks,

Please ahead. next with Securities. question Mayank Mamtani is B. The from Riley go

on Hi. the just Maybe we reductions readout, Good CXX? Mayank. question forward upcoming on able for afternoon. to CXX a look expect the as what This is Sahil XXXX. then, to Kazmi And to of you comment which across quick Are maybe to on you statistically lipid significant? see were

release. lipids, the P very the long-chain Yes. we values in very numerical Well, I think the generally, long-chain in in B triglycerides press for that we acids. other fatty LDL press what improvements and acids saw we and we fatty the apo had the said the improvements release in saw just numerical But

taking progress. the the it. on for Thanks Congrats question. Got

Thanks a lot.

H.C. Please Joseph Wainwright. go is ahead. question The with next Pantginis from

for for the Xb couple my A guys. study Thank designs Emanuela regarding of me Phase afternoon for you on the question. for VKXXXX. taking Good is This Joe.

XX trial would So you for be XX moving days was behind time patients? regimen the dosing comment forward, in current point. volunteers I XX you rather and if the rationale wondering what’s maybe, will could also the daily days regimen. the can And like, just healthy tested envision whether days test you the what in

Phase to wanted ABCDX. up a In functional some endpoint. Yes. of We long-chain beta the have really think, provide reduction that the regulations expect longer, Thanks for to trial of for study, enough we the are acids we that case, at we here dose efficacy of time does moving going looking be to up proof-of-concept to had in primary presumably through receptor this ensure fatty forward is occurred. assessment activation to question. long the the the regulation Xb very be And would because

when though those an days, quick we handle whether we but seems effect. XX And happen on it other that good not thought like reductions or we we we at so, lipids, XX for pretty are so get seeing about a and we days, and thought about days evaluate look XX could

of regarding analysis, I are it. Thank sure for that. also expecting. am the the you recruitment targeted how of add? what’s would – number you worth not many it. the you terms patient to And mentioned you in preliminary of patients And expect you Got Got patients data

Yes.

X per to it’s cohort. up randomized And I said we think nine to X.

team may we’ll dose and the to so, to what level signal. a the not enrollment see And see review all sees. each goes cohort But how up we way nine go in

So, would per math the be nine cohort.

expect you Got how it. have? patients for to the analysis many And preliminary would

answer. that same in that sees. depend make we on But the It evaluation. review or what level will to each the depends that available of eight have would enroll would it’s I on how Well, team kind we six cohort. hope many dose

Okay. Got it. Thanks.

Thanks. Okay.

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

Therapeutics. updating months. for again all you of Thank coming and look today in for now the your being you Thank again continued and participation may here you forward support Viking We disconnect. you Bye-bye. to

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

disconnect. You may now