Viking Therapeutics (VKTX) 1 Aug 192019 Q2 Earnings call transcript

Welcome to the Viking Therapeutics 2019 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 August 1, 2019.

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 of CEO; is me President Finance Brian Administration. President Joining Vice Lian, and Morneau, and and Michael

the during differ like assumptions, today. no will the company concerning XXXX, forward-looking company, beliefs risks number review of statements of matters. and a that begin, XXXX August meaning contain to uncertainties. of company’s the which these and SEC update I made with Securities and the we call filings to undertakes today, involve could I’d to statements from comments Before or results of you revise all made the obligation of other this within these concerning conference the statements, Actual any X, encourage current caution Act the

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

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

of XXXX quarter Viking. active exceptionally second The at was

a day While X observed mg the of poster appeared per it VKXXXX. demonstrated that from was that results higher mg XX These efficacy VKXXXX similar quiet outside, great can from EASL at conference as previously. highlighting doses presented the trial data dosed low X the new may as at assure Phase the this that our progress relatively I that inside at when reported to produced quarter, in company. you Late-Breaker Early the we have time a Vienna in was

clinical We this IND trial FDA, our and Xb further with are we upcoming excited to planned VKXXXX outline best-in-class NASH. biopsy potential which confirmed nonalcoholic worked new possesses evaluate Phase provides filing the that diligently during These with quarter belief prepare our will for of the our or further for treatment for in steatohepatitis to patients NASH. data support agent characteristics the

in the a to second to Michael call will on I Finance turn additional of Administration but financial like discuss detail quarter President provide minutes, our I’ll results. our few quarter development Mike? Vice financial now and results. over to first activities Viking’s, Morneau, we’d our second review

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

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

salaries and and increase administrative expenses in of XXXX, stock-based due professional fees. compensation months were and benefits, was million ended general consultants period use to primarily to June expense, Our compared million XXXX. same three $X.X $X.X for the The for increased the third-party XX,

or the million XXXX. loss $X.XX in or period three net the For June report Viking corresponding share compared XX, to $X.X months a a loss of per of ended XXXX, million in $X.X per net share $X.XX

the June interest ended previously, in an partially income. research the expenses due net was in and administrative for and in development increase XX, The offset increases increase and to XXXX, loss primarily noted by general three months

offering. June through versus at the issued given outstanding June since by equity June per primarily XX, those loss the net shares three shares at in XX, XXXX, XX, June months decrease to share the additional XXXX for ended is the due company XXXX, XXXX, The primarily additional a public outstanding

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

same of insurance Our months stock-based increase expenses and administrative XXXX. to general to professional for expense increased primarily benefits, fees. million and June XX, were for The compensation compared salaries six $X.X and $X.X is third-party the XXXX, ended consultants, due million use in the expense, period

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

for since June primarily A months June the in public additional driven XXXX, XXXX, outstanding those June outstanding XXXX, the the XXXX, offerings. primarily shares decrease through XX, versus issued the by net June XX, XX, XX, is company at shares equity at by loss six ended additional per share given

June XX, totaling balance investments at the million. XXXX, $XXX.X to we Turning cash had cash, and sheet, equivalents

XX,XXX,XXX of stock As outstanding. Viking had shares of XX, common July XXXX,

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

Thanks Mike.

nonalcoholic quarter, diligently to second VKXXXX continued working the we our Xb Phase for prepare upcoming in of During study steatohepatitis.

in small is receptor as well VKXXXX liver for subtype, tissue available possesses potential hormone selectivity of the range receptor as including reminder, the suggesting promising a beta therapeutic disorders of orally a that As molecule thyroid lipid an agonist NASH.

we fatty in its patients of X Phase trial disease. annual and meeting end Association and the AASLD. last at In hypercholesterolemia secondary of points American late-breaker VKXXXX measures. the potent presented reductions demonstrating the trial primary improvements September The in positive content achieved a year, from with results liver fat plasma announced were both oral and November results for Liver the liver session or Diseases These during of Study of lipid in last

weeks assessed MRI for VKXXXX presented Additionally, European updated proton placebo. the compared placebo other of weeks. daily, evaluated endpoint day trial The EASL. dosing density after poster primary as for the liver to MRI-PDFF. key of fat fraction, of X evaluated change patients effect secondary mg Association every annual by receive for LDL The this trial’s XX on Liver VKXXXX XX results XX fat the The cholesterol endpoint at Study Phase the late-breaking in or to April past of daily, mg randomized or a in the meeting mg were XX X doses of

As statistically to we with compared and reported reductions endpoint, primary at patients patients. achieved EASL AASLD placebo-treated respect with both LDL in VKXXXX-treated significant trial’s the conferences, the

In proteins the patients statistically apolipoprotein improvements other addition, VKXXXX-treated and experienced atherogenic lipoprotein (a). including triglycerides significant in B and lipids,

key secondary VKXXXX-treated remains With in significant reductions the The in assessed to development of as oral respect today. this endpoint, unmatched experienced agents response liver fat MRI-PDFF. among patients magnitude by

liver And XX% from of of VKXXXX fat in VKXXXX a patients median mg Specifically, at XX% content relative daily every patients weeks dosed of experienced of liver other mg reduction fat mg of doses baseline. from experienced XX approximately XX content liver Patients VKXXXX receiving baseline. relative receiving X approximately a receiving a median doses relative in daily experienced from XX median approximately day fat reduction XX% baseline. for reduction

cohorts, fat relative XX%. VKXXXX all approximately was reduction Across median the in liver

liver By a relative patients approximately in median experienced comparison, X%. placebo receiving reduction fat of

to may more odds a liver whether threshold studies they demonstrated The fat improved observed to experienced correlates intended interest of trial predict with broader characterized responder were increased in equal than if Patients of greater is overall assess reduction analysis, a that reduction the XX% as also or histology. fat content. included in fat which have clinical benefit. liver liver or was XX% reduction This as of multiple responders

with XX treated a day, least experienced least In experienced approximately reduction at a VKXXXX reduction content. this dosed every XX mg in fat. at Approximately mg other XX% XX% least patients fat at of X XX% with of among at And daily a receiving in in mg study, demonstrated at VKXXXX VKXXXX fat dosed liver all doses per liver patients reduction day XX% treated patients liver content. XX%

rate response. was approximately patients this XX%. receiving across a study VKXXXX By XX% approximately of placebo in demonstrated The comparison, responder cohorts all

VKXXXX reported among safety were adverse an and events receiving patients were encouraging across study. No demonstrated tolerability events and or also serious profile the relatively distributed placebo, treatment in of VKXXXX this adverse arms. evenly numbers overall

VKXXXX the potential of believe Given the treatment development today safety as one promising compounds for of the this demonstrated is we NASH. in and positioned promising in study, potency most

development for factor cardiovascular VKXXXX currently to is setting. while benefits to lipids many improve in agents providing of systemic health a also through unique global other differentiating liver when compared potential key the reductions

study we a of we have plan later with previously discussed, to Xb VKXXXX patients year, in NASH. biopsy-confirmed initiate As this Phase

pre-IND To briefing to in initiate the that of anticipation to study. end, filing an package the a IND we recently submitted FDA

reminder, a our X of agents FDA targeting and metabolism endocrinology XX-week where filed which conducted. many was study which IND are our products, division existing As lipid Phase under with the It’s reviewed. is

reviewed. which filed and drugs will typically Gastroenterology IND with planned Our Products, the the are Errors be NASH Inborn division of FDA’s Division

FX the as patients as number of FX anticipate our currently by Phase with informed target the and details interactions, will trial FX well fibrosis. be limited While FDA planned will our we with study that Xb fibrosis the

for VKXXXX study, to allow closer initiation. the to we providing We the We months. in up patients the look as for to been place In more to study we after dose to possible resources XX at of soon begin enrolling we’ve move to as one information forward proceed. evaluate as to preparation clear are hard further work putting about expect than us

as disease called neuron and are I’ll of in a Defects VKXXXX result is plasma long being can chain in the motor acids to for accumulation These or a thyroid the it acid intervention believed potential for characteristic peroxisomal chain by in X-ALD, X-ALD. cerebral are receptor fatty an disease. metabolism. tissue. now in The our severe beta long ABCDX. and to regulator, VKXXXX in treatment fatty caused is this the target a is update very therapeutic important a transporter known X-ALD potential as is transporter program. of devastating on evaluated that adrenoleukodystrophy, elevations X-linked a toxicities very an an provide defect contribute

that agonist subtype. VKXXXX receptor receptor VKXXXX, possesses molecule orally selectivity an small available thyroid beta the for Like is

To date, a very of of VKXXXX VKXXXX therapeutic to vitro in demonstrated encouraging. a vivo fatty significant chain leading and from benefit. administration studies acids results both potentially have These and plasma data been long the has tissue resulting in of reduction in in

the a and in early humans are We this program year. for plan study IND-enabling currently proof-of-concept to initiate conducting work next

VKXXXX into be program clinic potential debilitating believe to and first this this the advancing pharmacologic the excited are for We represent that disease. agent may

continue to we matters, maintain a corporate sheet. Moving strong to balance

we indicated, Mike with second As quarter in $XXX cash million equivalents. and over completed the

burn quarter $X.X net Our burn which the is million our month. $X in $X per million, to of consistent was million historical with approximately

increase with balance we points NASH, expenses multiple believe our including the While as initiation clinical is completion studies clinical proof-of-concept confirmed Phase expect of cash VKXXXX study to allow with sufficient planned and inflection as to current VKXXXX studies, biopsy in our of new we of well Xb X-ALD.

focused remained managing Despite spent. and controlling keenly financial on this resources development our runway, our we

ATM For filing we concurrent quarterly at-the-market be evening, or will form with XX-Q with the perspectives end, SEC. filing this this our of the an also

point. not with clear, the this do stage companies many Rather, we a of To filing facility matter anticipate line our good in other of in we for to as utilize the do housekeeping term the development. at nor documents capital are we a plan near at need additional be

across of member Dr. like of newest announced years the this with Lastly, to Viking’s discovery gastroenterology, our therapeutic including nearly XX industry areas to experience opportunity pharmaceutical recently Rouan drug range the Kathy development of of welcome immunology, expertise and oncology. Board. I’d We Dr. has appointment disease, Directors. and Rouan of cardiovascular Board to take a

the are to welcome Rouan Dr. We to team. pleased

NASH safety further at unique VKXXXX’s to The starting with clinical presented of In cardiovascular broad lowest X the of validated conclusion, and These in VKXXXX, benefits, and second the EASL dose new liver improve and VKXXXX. data the studies per quarter to our providing planned toward results X continued compounds, evidence general. even VKXXXX provide NAFLD was at it mg distinguishing day. Phase progress by from health potential highlighted while potency other

development of the on prepare our filing the remain a and Based during for an on IND planned diligently second worked VKXXXX findings, for biopsy quarter Phase and year. our clinical We initiate these Xb file NASH this to IND study to confirmed continued of team later VKXXXX. track

for VKXXXX VKXXXX, the year. early our next with pre-IND to progress proof-of-concept expect to our work for of and a we to study addition advance In continued treatment X-ALD initiate

to continue maintained endeavors, clinical company Finally, our these balance including to support key that sheet studies. through a carefully believe planned strong and we’ll the we spending have milestones see manage we

for This and the for concludes again our I’d prepared now like for today. to call us comments joining questions. open Thanks Operator?

We Lee of The will Instructions] session. question SunTrust. ahead. Please from first go question-and-answer [Operator begin the now Joon is

for? particular Thank the differentiate of you’re Thanks hope trial from VKXXXX we any Hi. the versus the – any have there the all that upcoming half to any share your regarding FDA on endpoints submission? that congrats Xb Any the are second the you NASH interests you may your can extent able, differences XXXX, questions be and with feedback had Phase for discussions in And progress. on To so you. you you should can secondary competitors? regarding lookout pre-IND of study the incorporate

Joon. question. Hey, Thanks the for

with So, term, that expect package lot with respect isn’t We the FDA back the there near was in of forth really relatively do after no submission. the to a submitted. but dialogue that and

you’ll going to based there. other now we Phase parameters, study, FDA Phase but guidance it’s X December. have I in conform at. like a the think studies that change to to been back it’s Xb to a have going the that studies on completed, right out of have And date published then similar things receive may You response to was regarding all look going Phase other Xb of the feedback, be that design design the the it’s are We don’t that

Thank That was you. great.

Well, thanks Joon.

of The Raymond ahead. Seedhouse Please next Steve is James. question from go

you. Good afternoon. Brian. Thank

nature understanding meeting, of face FDA response meeting written on pre-IND the here, is only. the the can request Just the phone, with a interaction face my a you when sponsor or by request to

anything did Viking up strategically package my in just would type talk meeting decided be only go? request why that Viking you of written whether you see front, controversial if did question maybe that’s the So because data about and what request, response is, didn’t direction the or to

wasn’t didn’t were anything request a decision. to response written and be other day a or that when it be received would only. response we and pre-IND was the We a a go Well, filled our we than and would back response. be written requested yes, debate we told meeting it it We going that

the Xa safety reports submitted And preclinical animal were I studies the and package. final for you. Okay. clinical the Thank assume pre-IND in VKXXXX study for Phase from data six-month

general nonhuman So that results is, be to is of have one question that studies are the studies part of any share? XX-month willing primate also on the completed? And you those second comments do you'd

studies are said that's briefing No, GLP we the across in was pre-IND not through completed always consistent the the submitted what going from industry. to to data we're was package, What we've tox and not go itemize going there. the submitted pretty

go actual referred study not You typically clinical appendices completed study pre-IND the with key summaries passages the from a reports to package, you summarize page briefing package the studies, findings several the In the reports. IND. into that in key the reports. the study of submit thousand But

question year? Okay. last this to abstracts The Thanks. any submitted AASLD

yet. submit Not one a come past bit deadline, the Thanks. late-breaker know may little deadline original later. Sure. I yet. we're has but the up not We

submit one may we for late-breaker. So a

from follow-up, additional data study something would there or else? to Just the Phase be Xa

study, Xa be yes. from Yes, the Phase it would

right. All Thank you.

Yes, thanks Steve.

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

do study questions. for Will please how taking you can sites the use you the considering that for you enroll used that also Phase the in that thanks if And Hi, study? then you studying Phase you same Xa? wondering Xb. think you're I on doses comment could was fast

the question. for thanks Jay, Hey,

recent you details said – the what of as that the recent to And some given like doses. Xd that's look have the studies we from lower the haven't, as as doses is Xa Xb been at completed, there the Xa we soon think, from representation as of that if on I in the Phase parallel. Phase but, the we some well that as as far would timing overlap study, be possible, some be Phase study, studies. kind of timing Phase will will the So There

the so if estimate, think seems know until that quarters readout four data to till like the get we won't six initial of you reasonable a And from study fairly initiation we underway.

we'll far use as to Xa sites, And sites. going the Phase it's a clinical probably as from couple the study, be but more

won't couple. a we So won't use there a just overlap of there, lot – be

Will it be study? a global

U.S. be will we the on focused No,

the taking for Thanks Great. questions.

Jay. Thanks

is of The Joe question next from H.C. go Please Pantginis Wainwright. ahead.

Hey you Brian your you say questions, wanted probably of when have my scenes. but go the afternoon. can't of sort how guys to Good prepared off to guys. too busy behind much been I you said comments

to development. So how or any for see do you have with interest, that focus any And had what for Maybe on VKXXXX. things said wanted early I about calls you wanted VKXXXX? phone have if comment be might going or business to you potential

Yes, great question Joe.

Philadelphia, about we meeting had are back and always And bio in think, guide was that back I that with in but VKXXXX we've say seems challenging schedule safe here on stuffed June probably the parties shelf path a fifty-fifty to to in busy there, to a was good to close yes program. registration but, think, it's pretty timing I that company. VKXXXX. not with and said there split very a VKXXXX, it's Hard still interested there, So at and some, the forgotten

more has on the And won't that yes any to aware dialogue we've everybody and watched probably had development, continues of VKXXXX, give that there. compound the development. is the I and than With color the watch

helpful. term sheet the is won't of No, I that's when coming, very course, you Thanks. ask but

Joe. Thanks

Research. Bautz from of go Please question Zacks ahead. The next Small Cap David is

any in enrollment would with study going drug-drug on interaction that you do a And what reason I'm to that statin do? there'd believe required restrictions you're Hey, to trial? good be the other any also NASH Brian curious to had if to afternoon. Phase to Xb have companies expectation have you conduct be similar

and So, VKXXXX’s course in to an a what to not of briefing be complete of studies I IMD. to developments was going standard kind a the the And certainly question, what the we're earlier said will drug-drug would expect of think development. I that's included or in we itemize through packet interaction included course

of believe prognosticate that restrictions, is come that hard to same would Phase me far applied. but aware evidence Phase don't very the restriction will But the Xa Xb. FDA what applied But difficult as we allow. to to suggest will back held The be the with, be FDA As that the those we should again, restrictions to guess what should enrollment for or it's we're enrollment that not the no restrictions. will there should from be

Okay. for can And is VKXXXX be what left to an before filed? IND do

work challenging. the with Well is second on a of And year. half studies working formulation the compound, GLP we've of that we be formulation done tox will lot the somewhat in

taking for Thanks the questions. Great.

David. Thanks

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

taking progress. the Hi, all on thanks my for congratulations and questions

or kind I before know perspective, the response want us you design the when to half. from And are initiating in when flow news second of study the in the planning kind the has Street of sense disclosure kind from you Just FDA with let of written of, timing study? would get the a of of following you finalize Just on that the the terms occurred? kind communicating

be item initiation news of on study with the biggest will the the think, study design. the I details Yes,

answer I out questions are will think there. that that

anybody the disclose from decide certainly is written we response, information And that to going wouldn't far received pre-IND help details IND anything, the when FDA. not not itself. the receive as we any As mean I that's a we

what know FDA won't exact And patient we with we the IMD we the protocol response. with file until really thinks our a population and recommended so the get

most So once details of and disclose response we that begin it's enrolling, get we when will those

correct? after is good IND XX becomes basically that news my And understanding days. it's time during no Is Okay. news. So that of the that of active period immediately

generally, Yes, hear is news day-XX. what that yes. something yes, means good on you news normally But no

hear proceed. don't anything, you're going to You

obviously And a there's NASH. Okay. of, X, Phase X Phase ongoing trials terms lastly, enrollment, lot in of in

in there's sort curious employ others? to study Just patients that strategy relative any if to to you to incentivize of can up speed your enroll or

will we We and very Yes, a this been it's of our understanding focus at think we'll to from of them sites There enrollment lot a CRO high know a failures the minimize typically our the both they lot are timeline. And when participating employing, of enter over great have us from have studies hope from and we than to the that been will the CRO out hopefully there I sites give internally be all enthusiasm screening queries studies responsive collected for think, years the hearing we real question. a to be has to of completed this sent a And some that reasonably And are are more learnings that seeing. that select right according the been productive that, high area. process. patients there's program. screen

answering for Thanks cool. Okay, questions. my all

Okay. Thanks Andy.

question go next Please of from Yale is Laidlaw. The ahead. Jen

and And questions. progress. afternoon the the congrats Good taking for thanks on

clear or finalize more, Just the phone sort just want any the that exchange you but of process. calls regular Is to will that of face anticipate of mails to sort IND my meetings, to not correct? a filing that face for be

yes. Yale, correct, That's

you second if shown is last low And robust rather of a guys a presentation dose, question make the that. I my have outcomes from very here that part

time the contemplating of some having on after maybe and question type the think maintenance, other still being are Xb? study, into guys things Phase much those you Phase or X scheme are that, the loading is you of you later do those case – a placed a in should later So sort

great a question Yale. it's Yes,

about dose a followed had loading low or about internally talked I spoken we to least dose. originally maintenance by at that, think that

regimen is without that sort of trial challenging as enough complex and a an exploratory the think I implementing arm.

it that be study. this separate in separate subsequent we a think study You And at study study study. in do see could would another time, I it to or something could a this we'll but that goes. a won't But still of be part this pursue how

congrats great progress. Okay, thanks. for the and And

lot a Thanks Yale.

FBR. [Operator from Mamtani Instructions] Please Mayank ahead. B.Riley go The next of question is

Thanks my and progress. congrats on taking for question the

Just for Brian but about target this little VKXXXX? VKXXXX bit a structural Brian, could and you the one and think from and I format, the you I mentioned maybe pro-drug obviously two for Mike. talk differences understand formulation was And for And you and/or have different. the That there's of a maybe if on I great. CYPXA anything ketone vinyl as on byproduct effect would could derivative a then be each comment them. follow-up.

Yes, way a and aromatic And disclosed, the different yes, between but is write on molecules. the structure of these pattern on rings is is those hand VKXXXX different two right structure. part to the left. the polar rings we extend has is, VKXXXX the never of normally been substitution the the side The kind

does them effective it always different. as And studies we different. side and in NASH. So subcomponents animal when just parameters run vivo. We When are vitro bit the by at a it little little in you bit NASH selective a the a a for bit have the very It's the little profile do And more different side beta well. receptor. in certainly it's looks look PK

pursuing And I now, right mean the X-ALD that course there. is best so think just we

That's really helpful insight.

to been any be you both either/or has months than then, nine on together, where follow-up with? different for as in on there the the to last you that work your six observation plans and Just that started do of kind any made together

in last nine six to based data months. the changes No. No on

doses placebo was anything an on last thing placebo the that I know the response on earlier? or anything X Was reported that all similar different? then there responds And saw mg, noses. you to for the Excellent. different basis absolute you was there

two added impact No. the in think dataset any me. right to And patients. placebo numbers did patients data. have added front have more placebo overall No, on placebo not I arm that that meaningful cohort, the I don't of those

No.

increase were spend previous whether question. you buckets buckets color Okay, driven was you And from like just I any mean, give to or spend. of Mike, R&D six anything by great. or, one be the months or months four There manufacturing or pre-IND two the expense said in one any the able there, last three would else?

spend together. of Yes, combination as preclinical as it's well the some the of pulled efforts of in getting some of on their preclinical a manufacturing terms efforts side the

great. Okay, for digging Thanks my questions

Thanks, Mayank.

next Scott of Capital. Henry The question Roth Please go from is ahead.

Thank you afternoon. and good

questions. of couple a Just

First turnaround from the get not you talk what typical written about you submission a when to would feedback? VKXXXX, on pre-IND could is

It's XX days.

from XX point it's XX? an that IND to final, days XX that days then the is overlapping the or

no, get submit information new from a package, a later IND some you at starts. then clock an and XX-day you No, file date or you them

what And my that's understanding was.

days the as So it's for XX submission. well IND pre

That's right.

into Okay. Just Thank question color for could you we're you it fall would mid-summer if seem And is given give for any that that great. color. still mid-summer, comments the mid-summer? be original beyond target there I the was would recall pushed like was it the today's second IND or the was anything that

is it lot there. It's, of middle the the still to I'm so give Yes, of additional a summer. around color going not

to in we levels? certainly it QX these should about it Okay. did Separate the you imply year of it expect as XQ. up about enough. a that in the growth? terms reflection this we maintaining before Which to trial a R&D, think significantly would think dip should How tied of trial this in question, starts, happen the Fair bit Or of very of the sequential soon. until is the little jump – it rest should all or

year of spend Phase ramp we Xb here in R&D the second the up going side tick up the study. half to the for the On as it's

should That great. do questions. Okay, it for the me. for you taking Thank

of the to summer, we're the just summer Yes, referring to middle there. is thanks calendar clarify, Scott. And what

summer calendar something from never indicated the the of given But specific have middle So, previously we there. we hear expected is a when FDA. to date we had

clarify to Just though, that

summer? the a calendar follow-up as is what Just then, exactly

third is June the June – the of week of to September. Well, calendar week third

Okay, great. that's you. helpful. Thank That,

Okay.

question next comes with Maxim the go Okay, ahead. from McCarthy Jason Group. Please

a everyone. line the It's Hi for on Jason. day

couple a quick questions here. had of Just

eventually that's road any with setting you approval. focusing Europe? something achieved of was kind So just understand Is thinking this perhaps once on meetings getting and regulatory wondering are of are FDA you and that corresponding currently guys with working I of care the you intention down in do the have about? authorities taken as But I hope up guys

into now. interactions. right Phase Europe study. up is be near major there but we mean, U.S. is I queue in than will term some regulatory enrollment won't in And likely the event focus any planned moving in European slower Xb sites Not the the that the

to the as great. on And using VKXXXX, the with therapies? a any do it other therapy, this standard-of-care in of or using it guys this respect Okay, of plan then Thanks. front you with is conjunction primarily evaluating current in you have line context intention do primarily

the in think data setting. used that it be We suggest and could either mechanism the

I be could now greatest But the therapy provide expectation and the likely the the we to think combination is other will enhance of mechanisms mechanisms. think certainly in complimentary think mechanism stage combination benefit. probably from early patients we right some of and that and it could benefit the existing some

lot. Thanks really That's I appreciate helpful. a it. Great.

you. Thank Okay.

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

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

and a great can you You have all afternoon. Thank disconnect.

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

disconnect. may now You