Viking Therapeutics (VKTX) 9 Aug 182018 Q2 Earnings call transcript

Good day and welcome to the Viking Therapeutics Second Quarter 2018 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Stephanie Diaz, Manager of Investor Relations. Please go ahead.

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

Brian President President of is Michael CEO, today Vice Morneau, Finance me Lian, and Viking's and Joining and Administration.

no undertakes I'd differ to obligation revise call, involve these of uncertainties. Company's his statements, other XXXX, Company the from current now begin, the today. during a the Exchange Securities within number you the any we like matters. of update XXXX that encourage of results filings caution and turn Actual Before concerning for made initial and of call review to comments comments. the this meaning statement concerning Securities conference and contain the and today, assumptions, will or X, beliefs the risks, these Act August over Brian? could Commission I'll forward-looking Lian statements to with to I the made Company, all Brian which

VKXXXX we fracture molecule hip authorities setting. more will potential further quarterly about development thanks Today, last to this small to And hip programs molecule Stephanie. meeting for developments to briefing our related operations. a listening for forward our to in receptor providing and the in recent and on in our Since respect With be Thanks, update and I'll the progress VKXXXX dialing webcast. announcing pipeline fracture everyone We're on us allow an In for agonist update liver trial beta announced looking molecule study June, regulatory request and receptor selective the we learn in of with X completion disease. to early to Phase fall. in results of the enrollment a we evaluating our this submitted important pipeline modulator our excellent several clinical progress that package androgen requirements of May, regulatory small programs. thyroid made of

for presentation Research and that session American from results oral the fracture as Phase Meeting. selected plenary recently from for Annual patients recovering part X of we Mineral hip Bone VKXXXX have XXXX of In in of been our addition, the announced study Society

an are We excited present at to this opportunity forum. to the have prestigious data

earlier I'd results the and programs, after begin which call progress targeting to will on Mike? second good made with today's efforts Mike adrenoleukodystrophy. our disease now X-linked our glycogen review corporate call discuss Morneau, financial results. I’ll I Moving we Viking’s turn to financial have provide to stage like recent storage of in President update over an Vice quarter and of developments. Administration to our our also Finance our most a

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

partially offset expenses the in our increases compared used candidates. preclinical million June development XXXX. compensation and the same by to ended expenses for certain were due and for The three certain expense months $X.X stock-based manufacturing study in consultants for was research primarily XX, XXXX increase to third-party of efforts, Our $X.X related activities and decreased million period drug

to and Our benefits, period to second same increase franchise in the XXXX. expenses were and compared related to primarily million was compensation, salaries $X.X $X.X stock-based quarter general million administrative due The in for and increases taxes. expenses

and previously. The loss to increase in XXXX. three noted development $X.X compared XXXX increase million share share ended or $X.XX XX, XX, Viking in net period for the million June June the loss the to per of a ended months due months XXXX research was in three of $X.XX or net $X.X loss a corresponding primarily reported net in per the For expenses

offset the for compensation to in to stock-based our $X.X preclinical were decrease efforts, six development consultants VKXXXX June by program. for third-party $X.X Our due million of candidates related in certain related of expenses and use months study ended XXXX million expenses increase XX, was XXXX. period and in a clinical activities compared same drug increases to The manufacturing and primarily partially the research trial certain to

Our general XX, primarily increase expenses were compared and in months XXXX the and benefits, salaries $X.X taxes. $X.X for related administrative legal to expenses and six million compensation, XXXX. ended the increased stock-based The to period for franchise to million was June same due

a XX, loss the fair primarily value due of the for research to offset decrease the June development six in corresponding by to XXXX. XXXX in increase XXXX income the loss share consistent net in expenses ended per $XX.X reported $X.XX in June compared ended in was of per The increase other debt months million For related or noted XXXX loss in or XX, period the with an $X.XX net of feature corresponding million $XX.X net period six the months an share previously to a liability. a conversion Viking loss and for net the

balance and sheet XX, cash, equivalents $XXX.X June Our XXXX showed million. totaling at cash investments

shares I'll call XX, stock to Brian. over back concludes turn had my outstanding. now This of July financial the XX,XXX,XXX of Viking As XXXX common review and

Mike. Thanks

With During to of novel selective modulator the receptor continued for second quarter, each to inflection disorders. we Viking our VKXXXX four toward at points. androgen programs respect important advance musculoskeletal our

results the selected recovering from mentioned Bone ASBMR patients session Research my and of in American introductory in or for X Meeting. as fracture Mineral oral plenary hip presentation our the we for of announced from Annual part study have Phase I XXXX that Society As recently comments, been

by award clinical real the quality honor to It and is an VKXXXX to in the importance XXXX indication. and presentation and we've of a receive abstract outstanding abstract addition, this be as organizers. of high-profile this selected potential well for In been this it data pleasure believe notifying are conference speaks that award the as the ASBMR we received the most

such peripheral prostate. skin a in As VKXXXX stimulate with is muscle and selectively tissues reminder, as designed formation reduced to bone activity and

and many of of them placing risk Following a increased rates accelerated surgery muscle hip fracture, repair disability. prolonged and to morbidity, patients refracture at bone further at loss experience

treatment to For represent fracture these condition of increase. reasons, we hip musculoskeletal VKXXXX thereby population continue injuries the important in the endpoint study trial is may muscle belief serious to and is with significant results will in in our bone and dose-dependent for mass and statistically treatment achieved other age last which study its of continues body Phase placebo. the following muscle believe facilitating as recovery The from primary a and compared patients health total incidence VKXXXX showed X improving appendicular of stimulating fracture for lean VKXXXX the as lean option Topline November. formation lean It to is medical demonstrating by hip body secondary these our and also our were that compared an announced head, the successfully mass, with limbs demonstrating achieved that increases less mass important statistically data endpoints doses increases from placebo. The significant injury. all

assessing In addition though trends powered arms. for showed treatment physical endpoints functions not significance, favoring numerical

also tolerability events VKXXXX study in demonstrated and encouraging no adverse Importantly this safety with reported. drug-related serious

preparing the meeting the forward the the review to VKXXXX fracture. request meeting this in During discuss the in this with C development second type year, the for In future first regulatory half our team hip path program for of FDA for options FDA setting. we to to has quarter, the of submitted been potential

the to FDA the place third the accepted to has request meeting our we pleased are and report take We in that expect quarter.

discussed franchise. have with of in bone would indications musculoskeletal our best existing or a view previously, partner VKXXXX any one we executed studies in As an orthopedic subsequent by be particularly

in will the that possible. opportunities and partnering exploring optimize value allow currently efficient are most the manner VKXXXX of We program us the forward to move

been had We which second evaluated progress on-track will In is remain we trial the our and announced nonalcoholic is liver this in quarter, X report to the provide study the currently of our The disease receptor half later Phase trial, we being on warranted. and the expect in that and the provide Phase year. year. update to small an X VKXXXX as available continuing with completed thyroid patients in hypercholesterolemia. we that these molecule I’ll results agonist be beta data second updates in activities enrollment with now fatty on

In the continued the and to addition, as planned. Monitoring Safety study, receive regular the allow proceed has continues to trial Board Data to trial updates from

reminder, significant suggests of improvement both lipoprotein significantly in orally NAFLD improvements selectivity Phase tissue, model a but and subtype. receptor Preclinical VKXXXX have VKXXXX and In only hypercholesterolemia, confirmed studies A statistically LDL-cholesterol molecule proteins subject benefits also with that rapid agonist, cardiovascular liver a These steatosis, triglycerides, fibrosis, that in and in well small treated disease. disease, is VKXXXX leads potential for its possesses apolipoprotein thyroid histologic cardiovascular to animal mild alone. provided of available, including to was Billion, biopsy risks activity study, models demonstrated reduction of those that extend the demonstrated two beyond which may prior beta and to receptor a treatment increased animals VKXXXX a long-term and by As the liver associated of reduce novel, LDL not as NASH, Ib as diet-induced shown data score.

receive For and for once fatty tolerability primary off placebo promise as Patients related group fat well from oral phase. as disease. effect nonalcoholic randomized placebo in designed is LDL-cholesterol patients trial's trial The as and weeks, to liver parallel ongoing daily study will XX after lipid with to-date to to efficacy, LDL-cholesterol profile drug doses diseases of by those liver VKXXXX weeks evaluate assess dysregulation, these suggests the VKXXXX XX to of placebo. or randomized a on NASH. such compared reasons, are VKXXXX safety, followed being a The the four-week double-blind VKXXXX in X elevated endpoint Phase result controlled that of

plasma study changes sharing markers. endpoints from the this inflammatory fat results forward in later to Secondary lipids liver assessments and include this content, exploratory and We year. look of

orphan In clinical two addition disease is advancing to programs. programs, these two Viking

evaluating is first Ia storage GSD disease The or type Ia. glycogen VKXXXX in

results We've Ia setting in VKXXXX fat X-ALD, a caused with In are in and to and of as elevated of evaluating an gluconeogenesis. X-ALD. glycogen to no over adrenoleukodystrophy development production liver's The each enzyme glucose-X-phosphatase, patient's adenomas, liver deficiency progress orphan with improve disease GSD devastating hepatic evaluating and of hepatic is significant these VKXXXX program, by lead second disease an programs diseases overall glycogen treatments. of disease from and or for genetic rare potentially the This we responsible carcinoma. are storage Both, GSD triglyceride production triglyceride hepatic steatosis, glucose reduce potential available can a X-linked hepatocellular increased treatment the of a metabolic our profile. is the year. the content. Ia made past The and

for of errors the fat the reduced at additional previously animal quarter. improvements to in initiate proof-of-concept These the of disease. at seventh Ia glucose-X-phosphatase as we known that with in These Annual presentation upcoming metabolism. IND in X, expression in completed, on data has in the to and Association, filed this to Thyroid recently, results an have this GSD the last American More scheduled third the VKXXXX We Meeting and Earlier international have liver an effects been through begin dosing showing this of for Congress submitted DC. patients of we October shown trial inborn gene year GSD knockout. this presented year, Washington a liver model study been expect relevant positive histology were later work

a called of disease. the and the completed agonist subtype beta molecule for The an XX-week Kennedy defect potential Institute and XXXX, orphan approach our receptor disease We're X-ALD. a very study showed plasma and may in by molecule as devastating animal a a an for benefit. study chain XXXX. neuron very in to in of X-ALD the accumulation These receptor markers conducting commonly concept result thyroid receptor and therefore to disease. this conduct acids tissue. elevations to thyroid chain notably thyroid acids toxicities believed orally is effects the on peroxisomal VKXXXX this beta long plasma chain possesses a our VKXXXX, contribute X-ALD is to in Sustained Krieger currently IND and small of often acid program is that tissue disease, selectivity In the treatment in small caused long cerebral pharmacologic improvement long or file enabling X-linked the second represent fatty therapeutic in an IND proof collaborators evaluating levels. very disease work model for severe of very acids, an of fatty believed chain providing fatty adrenoleukodystrophy Activation the stimulate transporter at in plan is to VKXXXX patients observed the fatty metabolism study a by are a promising Viking of motor in to long characterized and Our evaluating are ABCD-X. in available program receptor X-ALD. agonist potential

milestones, which Moving corporate provides a will successful to XXXX. This $XX.X further on of second to resulted financing we our needed runway of into completed million. the advance and with gross recent us in quarter provides offering we extend during financial proceeds the that a common stock, expect pipeline assets funds

to XXXX. liver of of initiate fronts later appreciate on of we offering value trial I'd all concludes Ia to X our finally remaining absolutely support respect will to reiterate fall. is later multiple announcing GSD I'd toward the grateful disease dosing again to Viking to in conclusion, look as and progress continued Phase and a we retail, that while this and very great both are pace, move and program trial to in We the for statements investors, to to support to conducting who pre-IND selection rapid a upcoming abstract the our proof study have quarter. investors like importance of In important as your program, these respect the our this proof plenary to a our our results institutional that respect continued thorough. our expect us we the and of respect Operator? with inflection recent for points. at work the to participated and making like With data. we results speaks Thanks VKXXXX for for disease award, this of program for well rare and This the concept enrolled as prepared for today. expect And believe X-ALD we of X initiate most the at outstanding and we're And receipt questions. and Phase and hip focused session, us, fracture, clinical quality concept ASBMR programs oral VKXXXX joining With we With presentation excited of this the advance. for our allow open are hypercholesterolemia, to forward now call to

ahead. from Our Seedhouse come first Instructions] Raymond [Operator Please will James. of Steven question go

we'll Few doses upcoming some titles see data, NAFLD abstract wanted clarify just - on being on to other the are what for day AASLD. announced also already and

one submitted press release curious So just you or accepted abstract wanted had if if been had if an to or – share you'll if data? you those

being the megs placebo, abstract are an will ongoing, have submitted be that other every and And megs doses will and The AASLD data we that XX to have day, still conference. evaluated daily. from XX not the trial is

to levels the the screening beta entry, levels. just, reason need for inclusion just a And listed any and study six you data. TR consistent more be or stable just is ALT prior I Phase months for inclusion study Madrigal I NAFLD prior criteria And documented stepping criteria two back, on the weeks or NASH being curious had to AST trials, was have ALT entry. for X ask couple specific up to AST if their suggest the I to maybe agonist one with

was wondering criteria - prior your just this you I a study study speak So bit could if any AST? entry? in if baseline not, I in for And NAFLD you population in patient there guess, or to general ALT what see variation if are

a specific I two But or come don’t in based criteria that. protocol ALT, than type I'll - greater was have I there. dramatic don't some degree ALT. I but visit. an me. of But I'm that some think protocol On between of stability you the an front visit couldn't don't come like in the on any those very something front obviously believe recall you to thinking, normally you still between the in that time But or I of in don’t me, a values. have a to back and with of I I was And change the now on to have criterion a strict there stability screening ALT, criteria want there for exclusion don't randomization think

TR I And few, just touched mentioned found the this because asked that And being marker in for this off is call think metabolic past trial the in other obviously you are I agonist biomarkers pathway. a in at this this listed just presentation was thyroid because I TX T-X. looking the just reverse you - at. hormone NASH inflammatory I it the design was decreased. one beta reverse include that you last the on And [EZL] in developed they hormones, the markers another on I looked detail inflammatory the interesting And is didn't know and again you guess, on the you

a you CRP? it if if you NAFLD as well. useful agonist measured have biomarkers marker that or inflammatory versus is have do, that you NASH any if homo-beta thyroid, on curious I You and am say thoughts and

it’s Yes great question Steve.

thyroid So full know guess for would great there. but reverse don't would it a if But I I be, T-X assessed. question, of a in the yes. certain thyroid you but that I that panel. tell sort am we’re is doing is panel to - can’t it’s being definitely answer I

and ahead Can that question Phase VKXXXX the Okay, if next study And the are had just with need to that’s to for to are moving have NASH data us where say prior long-term talks just on Xb so animal helpful. from you completed you trial? let's what and stage positive. the update you timing steps

were the initiated studies tox second in chronic the so quarter. Yes,

be Primate read of next study be should and months the late would ongoing year. be study early this end available, rodent rodent the year is year. the there six completed data should the So towards the

longer a dose to available should give I guidance to That’s into XXXX move I don’t study to that. position a in the us allow that be on but XXXX? say, up we’ll be to to when would duration in data sometimes think mid-XXXX want I in So

and to the forward the the and Looking for the in data of half back taking presentations year questions. thanks

comes of Wainwright. Pantginis Please H.C. Joe question go next will Our from ahead.

Brian couple questions on please. XXXX

without any is potential despite to of obviously looking glean data data giving of away a benefit we XX-week example and from what while of having September. stopped dosing clinical upcoming that the are in First the maintenance some importance for What are the level ago?

the data want the at think a at thing in level you’d placebo. I XX-week main still the to above is muscle the look So

really and saw what signal N see it's success muscle a might noisier. significant for at we near we get stop a I a As want difficult a we little you to function, but like that's and to been show if the just to it far I would to that were power but you think XX-weeks, reported. criteria have data physical nowhere on as as that I bit look think farther out, subjects was but little achieve the study benefit small still such it's in - just significance significant. designed that statistical once and numeric advantage statistically some treat When statistical therapy get the a in saw you it a study

prepared your these to your you guess facets what impact do the since mention it then the FDA business like comments, I development will two goals? linking potentially and that And with how in you interaction look to expect importantly

might the guidance. we’re hoping would FDA acceptable guidance from what it's that's and we to always to a registration But trials endpoints or hard detailed so get glean. be specific Yes, what to for like the know

some registration of on what we know markets comments As U.S. it FDA's would you And them. know path in we to would and registration indicate like won't other on to multiple that's their speak had function look with be due in fracture, the trials, some markets, body key guidance. parties until our I the FDA and partners of but position regulatory due some what hip sort might of where base, some we've it's for potentially is but an authorities off comment to expect interest understanding interest language

helpful that at for the progress. of some parties think should be been that it I have So looking

come will Please Hsieh ahead. from Blair. question next go Our William Andy of

recruit to I and for believe Congratulations a wondering XX% the know XX%, fracture XXXX lower potentially I'm pretty on natural I mortality tough trial study, XX%, from suffering on XXXX arm? hip that for the a year the just or enrollment history the X trial on that Phase XX%, completion, patients. percentage have is just in it's patients I question about one

- are - seen generally to the over XX%. in XX% place. They're so all literature Yes, are mortality rates I've the

In out weeks. So, of went XX rates the with it's mortality like XX this the get differences studies. a range wide weeks and they - very not mortality and in lower it's no more at were there to study current study

question Capital. will ROTH from Henry come next Please go Our of Scott ahead.

Just a couple questions. of

like the should read-outs Xb on Phase it trial, it First GSD see be underway program? shortly. sounds should When expect the data program, to for Ia we that

program? GSD I the From

Correct.

quarter, first major XX-day would just little the So the sometime would XX a quarter the and have we have no to back day we on would of the in We due that little read-out, to dosing initial the back timing bit. in start I moved a study on there, on issues, hope push endpoint. hope data data, triglycerides, first second have push guess, bit to

should the think in we October And just fall, data that kind later closely, theme data be for on to the the or of read-out? obviously read-out, QX be you thinking September, should be thinking watched XXXX stay said done I is to of we

tend it it sell a safe think in the I as for to be can But timeframe. I certainly If we I Yes, report early don't think the earlier, that's October, now. think that's we'll side unreasonable. And get can. as November comments window we

Final in program partnering before you've know advanced about always either XXXX, or I XXXX the question, clinical trials. thought past

open that I best yourself? is your or are to opportunity Given more have guess more for resources, you the that seeking still preference capital you

I best that of have We value opportunities. to firmer partners we talking conversations We open do position the preclude open program. be anytime. each best a I any to do ourselves, would for on interested the further and increase have shareholders I greatest to with what's with should value not and just think that think that. the certainly go further to the the for programs, want financial certainly if do parties would keeping We're programs, get we us means, allows the and to but them much at to we think

Jen question next of Laidlaw and go come Company. will Our from Please Yale ahead.

little quarter for little First quarter housekeeping or quite I is one high million, this bit expenditure - higher last which that should the – of than bit a prior is bit the maybe say, $X R&D quarter. all, is it about

least should quarter we this the second R&D for number consider there expenditure So, of or year? this for at year could is half be each this [annualized] for reduction of a

upticks I to R&D from be it's tox of head the flat shaking shaking chronic the his year. expense are - head dramatic think spend there of second it's any Mike, his when in with payments. agreement. there - start Yes, is here shouldn't in quarter, the in so a through half here. little so. he's probably pretty going come some those studies, stay you But We upfront did second they more

been a also Maybe will - this - on to Phase little about resources the think somebody actually ultimately sort early, giving that possible feedback, for maybe you call XXXX, if out a consider of right - long know value to bit for once think this that be hand maximize upon it greater the - it on follow - say, and as trail the later program But out in value. little a study you to up hand or thinking has a maybe the it terms based FDA that possibly as may let's have, may be say approvable from economic you you you I a should endpoints on all is of best - have be early thinking you you its the thing. value, with really possible - smaller should Xb FDA, bit feel instance, And may these scale, something partner? want be now

I program think to setting our in this out. preference point this is partner orthopedic at

what expensive FDA and expectation functional X talking is be yet, point to we're But this our our to preference FDA than complicated pursue without to this time. Phase willing going that more trial is Our the for is the - settings. the but we'll larger has a expectation more is at partner probably seek at a that see to to orthopedic say, based and

will from Group. Caroline of question come ahead. Palomeque next Our go Maxim Please

of data at presenting GTX SARM VKXXXX, data the time urinary different of you'll the will that company of the another in incontinence. September, called be so Speaking end around be presenting a indication stress

So, any I'm that not so, if you I'm if large have in if partnering alter wondering your indication, that so indication? could - data just existing And discussions? just wondering

be data will urinary fall there incontinence. interesting So, SARM some another from program this in stress

That's think that we're to take data at. certainly significant I it's market. going set a look a

an extremely VKXXXX dose. has at shown very efficacy We has a robust low that efficacy. you incontinence, we have that's When at think terrific SARM urinary look the muscle involved shown stress in

look reason there. So interesting to what to from But decide an too early have then But signal a do any we'll indication see like sort every provide encouraging it's to of there. I very that and early have comment what definitive would think that indication. there, it's believe data in there's we to the

will turn Ladies to the session. conclude back gentlemen conference our Stephanie this time, I'd question-and-answer and like closing this Diaz, over At remarks. for to any

Thank you, a in to again support and forward all for months. coming updating your We you Alison. Viking Therapeutics. the continued participation again afternoon. Thank good you look of Have

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

disconnect. may You now