Aptinyx (APTX)

Nick Smith Vice President, Corporate Development & IR
Norbert Riedel Chief Executive Officer
Andy Kidd President & Chief Operating Officer
Ashish Khanna Chief Financial Officer & Chief Business Officer
Harald Murck Vice President, Medical and Pharmacovigilance
Laura Chico Wedbush Securities
Charles Duncan Cantor Fitzgerald
Ritu Baral Cowen
Myles Minter William Blair
Edmond Choi BMO Capital Markets
Ram Selvaraju H.C. Wainwright
Call transcript
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Good afternoon, and welcome to the Aptinyx Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open up the call for your questions. Please be advised that the call is being recorded at the company's request. At this time, I would like to turn the call over to Nick Smith, Vice President of Corporate Development and Investor Relations at Aptinyx. proceed. please Nick,

Nick Smith

Good us operator. financial and you of thank operating Thank today's afternoon, conference joining XXXX. quarter second on for Aptinyx's call for results you, the everyone, to and discuss

Chief financial the our then Chief updates on on Executive describing release will President Today press results by recent the the progress our now Kidd, our website. Officer across Ashish Riedel, and followed development programs, highlights financial Norbert call, Officer, and review Business review Andy and Chief Chief our will our review Officer, available Khanna, Officer, Financial and will is our Operating who results. business Our recent

Kathryn portion Harald on will addition, Clinical be our Vice of of line and President Development; Murck, the for the Pharmacovigilance In the and call. Q&A Senior President King, Vice our of Medical

kick I'd during made actual risks within Securities differ begin, to results only Any which and of the that forward-looking we forward-looking this materially. results company's meaning XXXX, any and Please issued conference like as the Litigation these of made to off. statements everyone our statements can will forward-looking cause turn the to uncertainties subsequent Private to filings statements that things and today, to include Act the current remind the statements of are to I'd afternoon release financial like Before disclaimer Reform call SEC. forward-looking obligation and call see this now involve risk factors in the statements. update we disclaim in Norbert the with over

Norbert Riedel

call. join time appreciate We Thank us hello, you you, everyone. and on afternoon's this the to taking Nick

have Andy I to our to of our Before CEO to that current we role and in place quarter, the plan share a Officer. Kidd, Operating second get am over set of to pleased President Chief transition the productive discussion we

has now, January the through last been roles XXXX. of This this announcing and appointment on place plan President, until which the Andy effective change role succession of will took and of not follows the While become we in well are plan to responsibilities December. thought

a knowledge ideal our record growing the all Directors on am our is I within the And many the are deep of Andy XXXX, as everyone our leading that crucial the teams, teams, joining product role that role Andy this the great teammate him he in no involved to and is have our during of intimately executive with of in the has been organization. of I He organization, to continuing success CEO. over his CEO. lead internal confident take of aspects Since after my partnership and excel Andy and to of for been transition. development Given building serving person of I forward his the functions and of business. in business Board the and will Aptinyx looking doubt has track

a R&D to the exciting the period at this ahead, leadership year. during of ensure to be our to and closer change is initiating move significant we As it next now progresses readouts pace, ideal execution continuity pretentious growth important time an

our confident the patients And programs. updates clinical I following the from and who innovative shareholders. that with and is As for role other value our Board and deliver ahead. to conditions. options the Andy therapeutic fully plan for I members Aligned focus our involved on patients our this CNS I will underserved on part platform novel the the ask for of condition upcoming plan, with to will transition, am in alongside suffering major promise consistent recognizing remain pleased believe deliver this technology Executive transition end actively Andy of remain I milestones of Chair into the of

proceed. please Andy, So,

Andy Kidd

team to honored This XXXX and to the of to in at need Norbert. We're I'm you, of milestones, recent joining opportunity I'm cusp work colleagues. since programs for I've the I'm the have for glad the that to to discuss them. Aptinyx. forward experience a lead our these some and highlights exciting Aptinyx had crucial bring Thank several is great patients fantastic on across medicines looking is an group a future. to the the also important progress continuing plans chapter important our and doing

pain and by to progress our We've patients studies in forward I'm significant involved subjects could chronic both both area, Phase prioritizing start studies progresses. painful especially implemented developing fibromyalgia. well. the important United present, many the look conducting Xb a throughout novel is of therapeutic We for safe, these together while readout of novel each substantial affect the dedication additional to data from continued therapies medical of currently make unmet suffering pain. this first on these measures particularly a summer of We schedule study our of XXXX. timelines two and We the these the are therapy indications indications. neuropathy a amid space NYX-XXXX the indications Xb to and address who've and in differentiated States enrollment to Phase in potential. from the chronic as qualified tolerated with to with without the pandemic, of We're that as providing remain has we're of are in symptoms believe ongoing in that updates the a for alleviate on NYX-XXXX, well the At need. be each studies. diabetic tracking NYX-XXXX in solution enrollment better and to of enrollment which alone potential half Let's needs very of who of safety two in represent unmet streamline just peripheral millions and of people pain It's team pleased all

stemming Lewy the place overall The significant of Parkinson's our move NYX-XXX, impairment Lewy can in deficits from both disease burden product patients the dementia with Let's of life on for cognitive cognitive with Parkinson's quality associated development candidate function dementia a Unfortunately, in learning, treatment on disorders. for to and in memory XX and measures currently and relevant some prospects with assess the caregivers. therapeutic schedule XXX and by bodies. with that evaluating a very there memory, and given To over period. is viable treatment the we've primates. in utilizing We're past by approximately We're bodies NYX-XXX therapies excited to double-blind neurodegenerative patients non-human steady address of And two and made X decline available mechanism progression progress attention, preclinical compelling sufficiently its executive brought data these of on their this milligram data the NYX-XXX, are the to of no novel cognitive today I'm executive pleased XX-week months to details, function. and a report of very deficits, study from in activity we recap dose placebo exploratory a few this study arm and to half detect on study a Phase of on the safety specific study being NYX-XXX and the second of tolerability on comparing can remain enrollment. the with XXXX. over

conditions. the starting modulation, bodies, further in NYX-XXX positive to we recognize the NMDA broad and Parkinson's of numerous While relevance develop and opportunity cognitive with across receptor dementia Lewy we're

doses of studies double-blind a The the NYX-XXX of across daily deliver milligrams is CAPS-X were health Finally, PTSD harmful from These the backgrounds to Both people the post-traumatic which development or very its current of and symptoms. a The as accepted we'll will performed that be a potential NYX-XXX. exploratory disorder stage controlled well will of from range NYX-XXX in exposed plans this SSRIs which who've stress the endpoint randomized approved NYX-XXX activity and disorder of Phase independent pandemic placebo two study, in that enroll common treatment clinical endpoint. PTSD. can area consist Total a encouraging in effects on XX-week our studies. evaluate traumatize. two tolerability, has only stark serious of XX score discuss our study studies once powered of use approved on been for affect In in more observed to to Due approximately placebo. dose this X and learnings variety studies we PTSD ago. a clinically and an mental efficacy PTSD, signals years study of FDA of of will we is XXX remains include we next believe our in in future the currently well patients milligram and primary Phase served One as disease. of a XX expected show against the PTSD, significant prior pharmacotherapies to reminder build need. impact in June, meaningful will period both study X There unmet daily demonstrated than XX the plans are Each study. outlined dosing that development evaluating inconsistent larger

will evaluate daily once study milligrams against dosing XXX placebo. other of The

profile and decided conduct Our earlier of placebo placebo preclinical reduce reason that effects A clinical tolerability significant two numbers XXX psychiatric milligrams we've and It's studies can data. and positive in of variability. safety is studies based well-described trials separate efficacy larger on to to mitigate our effect. demonstrated a is increase strong selection arms

April. Based FDA you arms feedback also worked of these experts ability psychiatric supportive. leading believe of Type designs to impact in a our In We've studies additional discussions on meeting, significantly the variability the in the received of the studies, during and these if number that separate can increase on sufficiently be as you also data introduce sites from our and in from potentially that multiple meeting can study placebo. addition, positive, with number we C the are registration sources incorporated

a course, review the be consideration by Of that FDA. will always for matter

commence in clinical quarter study fourth and first to milligram quarter XXX expect the plans the finalized, XXXX. milligram XXXX of these study we XX With of in the the

initiation we and medical of up shaping to year associated there financial unmet with will be we to studies, multiple programs, significant review updated over the I was With lot Ashish of readouts. forward the Across results. needs a about we momentum and is excited coming these I look approached remain address a the incredibly its you keeping As our positive NYX-XXX that, exciting second the as approach PTSD. quarter these turn to call important to one. our to now potential very

Ashish Khanna

Thank you, Andy.

from our period same clinical the in multiple each readouts cash quarter be strong were sheet, and the impairment. operations $XX.X with into compared research to are to balance by equivalents of our fortunate for across and XXXX. chronic our cash cash million the $XXX related million of progress with will the quarter spend fund we make clinical programs, we our was year anticipate XXXX. XXXX cash supported cognitive Phase As development across in ended studies expenses compared million we majority position. to X and Beginning enable second ongoing We R&D end current The our second at million for of the in pain XXXX. $X.X $XXX studies focused to on and a the

XXXX. net for loss to of to on was of $X.X PTSD for the $X.X We period as over expect turn same Xb in back that, of I'll of quarter the loss period compared well based We clinical call second expenses finally, G&A to in $XX.X program compared $XX.X ongoing the net end million the Norbert. for as same second increase expenses a three our studies, And million the our XXXX. million XXXX With now our R&D to reported year. in the quarter this Phase throughout initiation million the toward

Norbert Riedel

Aptinyx. be time. their next to a a of program, we to have potential and continued to this four you, strong team execution With Ashish. The exciting financial focused be very dedicated Thank for on XX XX transformation position these this period months a expect the

to are take We your questions happy now.


comes the question with Chico Laura of Instructions] [Operator first from your Wedbush line Securities. And

Laura Chico

this expand of And you both alluded I'm you. I but on in Good you one afternoon. But congratulations Maybe the follow-up. succession Norbert, think Norbert question the Andy timing for later. to on prepared transition. and have again, to and the and on and move taking wondering plan then now congratulations rationale versus question the I could for the the upcoming remarks, Thanks if a both the to

Norbert Riedel

Thank for you Yeah. Thank the you, Laura. congratulations.

glad asked I'm the So, question. you

of will the effective of responsibilities all, as looked be transition CEO. have I one any planning not January of key XXXX. of always at first succession So, until the

course, way have there's all planful of we this -- I'm be to of development next on pain Andy steps with COO cause and stakeholder I ideal of with last studies. But the President and time the Board be reasons. concerns, want in for employee ask of still promotion very all as now, sensitive Chair starting very or to this and commitment the of enough felt but and an to as the the to so, data of have When going with more the other being and this in of you readouts to commitments clear why serve at form company. in in a coming helm was any seemed time have, to the window, our literally come December. a And Board completely the thoughtful shareholder end really the in organization, to And primary after worked I my the to that. will way, we been activities company. with The the very The back Executive Board timing disclosed to an more terrific way to privilege month, ideal. a have remaining away years, six years are family. I not of we I PTSD. the because we way old also to from same spend felt Aptinyx of want And very, CEO October, our XX far this it's that turn I'm our personal

into January a it's over. -- transition And it and announcing be leadership to of. today in time I I'm off that's this basically giving be it Andy the led into basically seamless that quite more actual will actually translate be change proud and framework to fluids, it and the even And I now it's to us now so that very, way think acceptable the very of for change typically

it but thank leave for Laura, with you that commentary. I the So,

Laura Chico

that a both June studies the Phase we Thank Maybe XXXX, to primary of one this question, the follow-up with. in are but up naive completion with of and quick coming noticed there. trials probably you. in the is readouts respect dates half And showing clinical X the of go first

here. be in congratulations readouts better and Should like Thank anticipating a again. just be trials? single the announcement? I we to strategy understand the So communication for separate would this Or you

Norbert Riedel


Laura, we before that as both mentioned planned. So, are trials enrolling

readouts the are results think not be is to provide bit further on will a until very studies of And We and first half that but point, that the more able enrollment. at at completing I closer we both the guidance, little comment this of we to XXXX for still we can are their confident trails. point timeframe

Laura Chico

you. Thank


Leerink. Goodman comes question line next your of the And from Marc with SVB

Unidentified Analyst

on XXX any observed provide regarding the milligram for that you dose, us the for the taking support folks Thanks selecting shape the response you've any trial do color data pre-clinical of inverse U Marc. Xb you question. Have This so NYX-XXX. there. question one is you so quick far? Thanks. Phase Rudy line as Can remind rationale And about -- the to dose have can mentioned, the

Andy Kidd

that. answer to Happy Yeah.

went response, milligram off. a the a trade factors it's inverse the thinking you bit of So, little that the shape of And dose U mentioned XXX into dose. selecting one that's in our

The and mentioned. and in point we're not tolerability preclinical tolerability that constrained safety of then view, doses ones yet were from two our the and data. I by The fact safety selecting other a

worried So, be that we then a that going preclinical selecting your also have were high thinking are because as were shows we be higher shape about on the the do that in visible. that the maybe dose, would doses effect some about U to we dose, point range data too effective. that inverse But concerned we're would we fact

both XX think also a to the So, effective milligram. about well-differentiated from well those it preclinical we seems between was trade range, a that And while balance it milligrams being the factors. XXX is within two and off what liked I be

informed why inverse point question to your we the settled it very shape. so U XXX, but much the in with And was on that's

Unidentified Analyst

helpful on transition. very good CEO That's luck Thanks. the and

Andy Kidd

Thank you.

Norbert Riedel

very Thanks much.


question And comes your line next with from Duncan Fitzgerald. Cantor the of Charles

Charles Duncan

to a question. in Thanks clinical on to and and going the my my of did And me particular Norbert Andy, Yeah. I in add regard ask with design. opportunity taking trial you large want some team us XXX, or They to for both forward. behavior looked types help you all that's you congratulations let questions to But and Could new few for occur be to the a you'll the phenotypes include study? cognitive Also, conducting at, will all relatively comers, we've understand enrollment news. studies? good seem do you therapy then, you compared two where allow during so set of

Andy Kidd

Charles. Thanks,

So, thanks of and for all those congrats the yes, to happy questions. answer

through I the think, we're feasibility studies, for going duration of right kind the now. -- the for sorry -- location of

quite possible certainly specific going we're further we'll actually with confirm be in able before when of as can and quite we the a the line with the with to those though. respect down about to certainly sites, patients comers, conduct we've think Then, all within enroll I I that's and that that selecting important. thinking it's talked a population both to our that. that to goal of our U.S., little is broad intention that's But studies the our think phenotype representative PTSD

believe with is important. something discussed we Something we FDA,

And patient various diversity so, characteristics, of around trauma of in there terms some and be there. will sort parameters different background

are we've we We is not which of therapy intensive occurs XX the I what evidence-based is trauma, you background. one couple about at with all of [indiscernible] of intend to talked Exposure the be to and than is think types XX CAPS the being Cognitive the will in times a durations so. least years since minimum forms But would trauma likely to when cognitive time forth. and patients of we or include which and since months, during psychotherapy PTSD is others. XX outside psychotherapy With the with study will behavioral is towards trauma we allow population where not of think psychotherapy that will certain within clinical another, of allow of -- that, therapy, other to to is behavioral therapy provided time stratification so Really achieve do during change terms respect median years the for regimen study. less for in undertake in we sample end alive study. the consider there's skewed no of a forms some have more of actually a shorter the to what psychotherapy be the representative them. of trials,

Charles Duncan

Very Yeah, yeah. helpful. Yeah.

a enrollment reduction question to no the answered is Do Andy. You Last and/or that from change limited question randomization? criteria regarding require or or to very screen placebo have CAPS you baseline variability very, score effects. change well, intend of certain

Andy Kidd

So, respect a things that with I quite manage effect. placebo to we'll there effects, think to attempt to placebo are looking few be the at

I were think think, we and detail more play that I we some can of the some on of of about those the more might are initiating we'll When, things, those include that. will that at into things talk the detail studies. finality that time what in in screening course, go role

to in as better I detail more kick comment think off probably it's the studies. we

Charles Duncan

again, Super. to Thanks my and questions taking to and congrats you for Norbert.

Norbert Riedel

you. Thank you, Charles. Thank


Cowen. Your next comes of the question from Baral with Ritu line

Ritu Baral

Good for the taking question. Thanks afternoon, guys.

actually you have hang I a dementia Phase the that mentioned wait, X and in endpoints attention, on. Lewy XXX Andy, in looking Yeah. body. disease memory And -- question So, no, Parkinson's at on you'll be

in disease see of how think? attention, also and suggests those of Or it's the the which first mechanism would If infer? and might would three the rank I those and you executive ask the you greatest function. memory you endpoints you what to -- of think functions cognitive benefit I sort sort you importance benefit, to order

Andy Kidd

think on be comment Thanks receptor And debilitating. all they're they linked But Harald think I individual depending as MDMA I'm well, simple maybe. I clearly function Yeah. to patient, answer the that can to extremely all little to -- I'll Ritu. going is that ask actually. the a

way hard they And those the other a interact be little it's that rank So, them I in ways. with each can also to think, disabling.

deficits be you memory problems. and So, that for have in if executive significant that that can function, both example, more

ranking difficult them. it's talk sort think I to So, a of about concept

as mechanism And applicable. the all. our to be I should obviously we mechanism good news our should applicable selected is them, that's think be why

point, this the holistic drug each interested maybe perspective different more. I'll have I on we're within We at does comment domains. those is a But each them. and And really a tasks what do little think what more let for of of in Harald across

Harald Murck


this what's think important fairly in I strong that, within element keep to So, there's quite a trial. exploratory is mind

to in So, to is from patient right population deliberately of, broader allows biologically provide the concept this disease the these a to for the to into those originally bit data cognitive spot trial. the sweet the let's population. trial find very where Xb would and to dementia the us subjects we the available just deeper little particular identify Phase subjects say, best dysfunction do similar, do which the And [indiscernible] of diseases. best to which patient basis they're see soft when Parkinson's also respond dig the in We best, who in the areas but respond for following extended the context

Ritu Baral

Got you as follow-up. quick And look just then, a it. -- I'm sorry,

of As PDD you agency, sort similar? may understood conditions with had conversations DRP I'm of agency's have across change the be over of underlying a dysfunction versus about you different understanding in sample thinking with either look to time. that the the with how condition pathologies and just at cognitive these LBD,

Andy Kidd


news common a to that same But underlying in relevant is biology it's to means And to discussion endpoints be think, that together good certainly for I it's point. think That be with is same studying the great it's the question. had. drug. there quite a I them us Harald's the

see But discussions regulatory how those our I that so, that side are and we have And there's wait all these to common we biology. that patients we'll a think think think is good for of I think drug. the patients And unfold.

Ritu Baral

the it. Got for Thanks taking questions.


Myles Minter William of question the And with from your next comes line Blair.

Myles Minter

and they more to And serve the higher Andy that bit pivotal for questions questions Norbert what say the to would Thanks -- trial PTSD trials. on the the with in it's -- and positive, the do My taking confidence if level. as that transition. guys. congrats Hi, a design

meeting. And then, setbacks given how with the of I of division psychiatry maybe like I'm the with at FDA, -- three have out because had just I where been recently and there's few of you C once been Type are gone has guys confident just shocked can by FDA the through You that. asked the count recent in, it's coming that us. filing alignment wondering was interaction a

trying that degree some to just is what at Thanks. of around I'm clarity readout is get those confidence support if this claims. your trials, to So, This definitely need least efficacy you they positive. on the

Andy Kidd

Myles. Thanks Thanks.

everything think, that we've I have to was that. we has seeking meeting don't understand be not FDA meeting, had going sufficiently meeting. confidence. be a have These we nor of it of TYPE a X end been is agreement can designs review. is complete what we NDA, but positive, C contained an within Phase saying ultimately to that serve were as a was full pivotal we We if a The matter that that

that example, of don't position efficacy done be think NDA, pivotal as There as that the are be of So, still to needed. to would should one the were that, beyond studies, these pivotal support in way both studies pivotal are for I designed studies same and I be way as positive, that claims. think these that we really or could but that I there our each an certain they're studies them them two the would it development FDA designed more therefore, -- alluded to in of aspects can the trying be think other we serve that. is positioning work you were discussion for of only these

is discussion these dose. be different to two perspective more studies. be to the whether our positive get two or would those a doses same We think as to have can are I at independent would It's studies an pivotal matter of approval. of need

So, development I positive and our chance by conservator pivotal, of another good that expectation that is studies, development. there doing stage a hugely phase so of is have derisk these then next will but studies be think obviously that these after there

Myles Minter


you're trial on patients just question PTSD. following the complex sure. design, Understood. correct? And Charles For up follow-up Is then, XXX exclude to going that on to maybe with --

Andy Kidd

may PTSD of the will would complex So, one complex DSM, exclusion, specific will There excluding formerly PTSD. complex in that of a complex diagnosis because isn't be but there formerly as separate PTSD not we other characteristics excluded, patients be of a with not be otherwise PTSD them. be

Myles Minter

Okay. and again. congrats Thanks for the questions

Norbert Riedel

Thank you, Myles.


Gary your from of question next Capital And Markets. comes with BMO Nachman the line

Edmond Choi

Edmond just on Hi. This I had Gary. Thanks question well. to -- wanted Yeah. doing in NYX-XXX, for for is Choi taking a as my I question.

So, based on your what the would a based Thanks. that clinically registration expect on need considered And supportive? Type FDA, with CAPS-X with would C actually be you on meeting to show you score to Total as what KOLs, is discussions considered meaningful?

Andy Kidd


that separate from difference So, real whether from a how the a rate patient. change baseline, thing remarks the that. from separate the a have able our that the need obviously, separate depends study you number order a placebo, do about drug think placebo think, given of response digits how to would be is on talked, KOL of from the we is variance sufficient so and mid in little to it bit be factors, that's key you the particular I the CAPS-X powered about obviously on to though, It's to of interesting in to we're some show assumption in our of would lot prescribed be the more single score baseline. that magnitude in CAPS-X like you think when And In patients course, scores well should to a place they separation. I successfully. that placebo? from strategies is what separation that world, talk talk manage to to they way putting therefore And about the in a

we design digits a separate the the CAPS-X. the there's course, of strong to patients. somewhere is wanting that. little think to meaningful can that probably way rate study single show across balance of from a But still where also So, a then clinically a placebo in in satisfying, with number a good requirement I think in we response of bit improvement a reasonably of And

Edmond Choi

Thanks. it. Got


last comes H.C. from question your Wainwright. of Selvaraju And with Ram line

Ram Selvaraju

questions the Hi. role taking Norbert here. transitions Thanks my congrats, for on Andy and and

about implications, bit in on their of clarify are points measures to LBD outcome XXX indications, outcome if and couple well of the little measures wanted these relating neuropsychiatric XXX suicidality. understanding trial. a these evaluating efficacy as context of impact those of Just to potential measures you for a that more My some you is the specifically these on see robust a in the PDB level? talk domains, development including Can psychiatric as

Andy Kidd

safety that specific as is measure. So measure, Ram, included a really more being

that key important we study that function. we towards are are be the directed primarily neurocognitive is efficacy looking outcomes six total, looking those the attention, So, a very tests that The and There assess cognition specific neurocognitive memory, executive talked about tests to and assess we're for in bit tolerability. three at we'll it as little in efficacy. at safety domains,

So, more I is mentioned safety side. you on think the specific the scale

Ram Selvaraju

then, see be XXX Great. impact think on Okay. read-through extrapolatable, of on what efficacy utilization you if the a And readily stress-related in the will, significant you be that CAPS-X CAPS-X do other measure? respect you for that the measure, measurement, might disorders? assuming with to impact particular might How

Andy Kidd

for clearly difficult a instruments criteria essentially obviously question for CAPS-X is contains it's it's -- specifically PTSD, the to -- diagnostic is the I developed the answer, mean, because PTSD.

think, pattern So, of lead little to different people to that, response draw the comment conclusions. questions may difficult I it's and different a because on particularly and

PTSD XXX. with we're I focused really think, mostly right on now,

other that a abuse. interesting have develop lie as substance indications about of abuse more alcohol to area XXX the in and we The us for being talked

from move substance not on will study. think to very We in one that's study, those in areas, I the data areas. are as would this indications. into next the We because clinical see those think pursue plans high list excluding still great do that those go And had preclinical of abuse and But studies. up we we have we -- areas forward I terms of likely the of alcohol much we in very that into would

Ram Selvaraju

you. Thank


like no comments. at Norbert further are over questions to call turn there sure I'm closing back any for to time. the I'd this

Norbert Riedel

your of enjoy be for and you thank And operator. Bye-bye. your rest your attention. day. you, Please We time Thank appreciate all and well questions. the


joining for you today. Thank us

may disconnect. You now