Aptinyx (APTX) 12 Nov 202020 Q3 Earnings call transcript

Good afternoon and welcome to the Aptinyx Third Quarter 2020 Financial Results Conference Call. At this time, all participants are on listen-only mode.

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

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

recent press highlights website. Our financial describing results is available on release now our and

our like We're begin, a extend you afternoon. Chief us glad of today's to and I'd Chris coverage clinical business on On warm call, recently review discuss this Riedel, Officer, Norbert Sandler, our Chief have Officer results. will who Before and initiated to Aptinyx. and Raymond then to Financial Executive we Khanna, President welcome Officer, Ashish the Piper progress; financial will our Welcome, Chief Chris. join Business

Kidd, meaning President call Litigation the we update made the Operating cause and uncertainties Senior forward-looking any are this Medical forward-looking our differ risks pleasure today, disclaimer statements King, results turn only current statements forward-looking these the to our Pharmacovigilance. everyone Additionally, disclaim which our President and as materially. actual XXXX, made statements filings obligation financial forward-looking to statements. statements in Clinical and results the I'd the over Senior of Kathryn of to with now see release Any to Chief call, that involve the and for portion Andy can Please the and subsequent Company's like conference my of SEC. issued factors in include to Officer; afternoon risk this the will Norbert. Vice Q&A and It's call Act that of the of Vice of Rolando Development; Private Gutierrez, by we're during remind within Reform Securities joined

our I your and programs. taken turning us been I'm positive corner to levels ones development appreciate and that heading you pleased COVID-XX are to at In and as industry, good convey our a good XXXX. and Nick, Like pandemics to you, health. of pandemic, today's the of safe our all ensure finances each our response in affected. in a our very colleagues as a the professional But company you integrity call, patient durable support clinical direction hope manner. afternoon, measures manage and Thank of well have and in we and to has many believe you responsible throughout on I Aptinyx with of of and is both was challenging personnel all the loved We joining pipeline, our the from everyone. data for Clearly, advancement us on safety the studies our progress in

data was months, resulted positive and developments across of All NYX-XXX over in the announcement which of these have key the of our our most past collectively Phase the patients Among on NYX-XXXX track stress exploratory results and developments notable team NYX-XXXX, our posttraumatic to signal-seeking these from internal of three before to novel in painful of The several improvements of now study DPN receptor approach development us are with the They PTSD. for treating And in respect With in for paths pause, surpassed potential the recommend year. are extensive of due approach to meaningful NYX-XXXX results also which for we resumption during this impairment. NYX-XXX expectations living in efforts end in investigation These informative the PTSD. of Phase our of Xb study coming patients validating NYX-XXX enrollment we we with of patients clinically pleased our the demonstrated clinical in reasons. cognitive the fear validated team's COVID-XX-related fibromyalgia, to pipeline Xb efforts enrollment challenges. in we of anticipate our Thanks from and in to resume in painful therapeutic dedication mechanistic had this indications: had our we DPN And for have Phase we months. were relentless company study our patients, disorder, September, the in with fibromyalgia, previously to with few in advancing of PTSD. X positive with our study, the NMDA highly addition, thinking. the study the provide paused modulation

Accordingly, we last to financial fund our with data of multiple these readouts. $XX these report a boasted each our operations them in bring expect back online, results we strength the month, offering, common studies through As close from of catalytic to we million stock XXXX.

positioned All us may them. of modulators, advance NMDA toward receptor novel leaves our this who responsibly from benefit well progress and to equipped patients

NYX-XXXX, discussing our COVID-XX pain this clinical in Phase in and pandemic studies evaluation in in candidate DPN. late of Xb by the fibromyalgia pain chronic peripheral in development the neuropathy, chronic the two begin under or we Let's to our diabetic painful stage escalation Due March have year. enrollment both to indications; of suspend of U.S.,

Fortunately, announced were study, that to recruiting we presently Xb patients. our Phase are and in and fibromyalgia able September, actively enrolling we we recommend

progresses. While of tracking involved well. screening against NYX-XXXX are it I'm enrollment all of necessary is this U.S. study updates that the study and on the of in and patients forward this still DPN. early steps And fibromyalgia Phase safety look Xb our backdrop final We to our the taking recommence pandemic are confident enrollment the in providing to in screening taken continuing study, COVID-XX the those recommencement, future painful Alongside patient in as to ensure precautions we recruitment, have we study

risks to steps changes population, intended We we protocol DPN to certain elevated instituted to enrollment. the COVID-XX patient streamline have necessary have and taken posed the mitigate by

this will that new study anticipate end any the quality of study the cases We the us confident adjustments of to study's COVID-XX, face effectively and enable year. in made increasing will the to that the without are the design study. of We following enroll rigor initiation, even compromise to before restart this screen the patients of still and

read both of that half should is studies out expectation pain first the in current XXXX. chronic Our

Let's signals treatment. measures study score whether of in and our time scores efficacy. The XXX than enrolled of represents weeks various four posttraumatic understand seeking looked to milligrams results and No received in from could Heading patients milligrams was of XX symptoms symptom this on our with tested We of first move evaluated We with were efficacy X NYX-XXX NYX-XXX. CAPS-X patients study daily more cluster and PTSD demonstrate the with at the against study, were placebo. stress four in NYX-XXX patient over patients into the the study, now disorder. endpoints XX and associated positive Phase of dosing to treatment primary with total we the as with NYX-XXX evaluated who PTSD. NYX-XXX efficacy serving weeks

initial population future in exploratory therapeutic to and not an but guide this was powered this whether statistical study, was to significance, effect achieve rather patient to it development. As has a NYX-XXX determine

However, on statistically we better efficacy clinically both that certain We only endpoints were dose pleased effects with although dose, and to observed on placebo than of NYX-XXX a effects to XX-milligram four significant measures. demonstrated meaningful, clear treatment. numerous significant the compared had statistically weeks response find dose performing XX-milligram the mechanistically relevant with

clinically a On meaningful the we saw XX-milligram dose. total score, with mean CAPS-X the reduction

of analyses proportion treatment and each of hallmarks This on effects the and on understanding reactivity the substantial on the diverse prescribing symptom benefit showing significant These responder meaningful Potentially, our of NYX-XXX strong for the our including notably, factor demonstrate observed in provide The reliability improvement in this a results meaningful meaningful concentration response, a in NYX-XXX of CAPS-X and on irritability and, of arousal clinically patients, therapeutic physicians aligned behavior self-destructive evaluates when highly saw therefore, total hypervigilance, and of proportion aggression, decisions. many across greater In sleep. symptoms, addition, CAPS-X score. can cluster are or effects. very disruptions significantly a exaggerated that responder improvements these confidence analysis, score important patients most these arm. of score an NYX-XXX, domain startle mechanism demonstrated we PTSD of statistically enhance reproducibility in NYX-XXX clinically with achieving making the

safety and we consider cases differentiated favorable placebo. as our across critical novel stages, tremendous and treatment-related events adverse burden the we the were events. study to hallucinogenic which with therapeutic a dissociative the No profile underscores for to with receptor exhibited very further NMDA comparable was patients. profile NYX-XXX PTSD results most option are The these tolerability and AE modulators. forward are of total advancing believe which more observed, Importantly, in or novel was medical both broadly, safety We four this looking with health common NYX-XXX-related adverse mental few headache,

NYX-XXX, as results the we as provide tolerability the clear observed next in interaction study. design next this to in results feedback supportive could development intention design now on gather step study, if evidence of information the effects treatment the It for our study the preparing its positive. is and with such guide to be these it of to registration are as are FDA the well of Given this

disorders. in supports get third from along and the the demonstrated also numerous study PTS half our of half We expect highlight therapies previous NMDA is in receptor successful first our anticipate study potential candidates with to for feedback noteworthy DPN. studies the XXXX. half our This next in mission second developing Phase and first the of novel the that commencing represents X and the to CNS XXXX regulatory product platform outcome in novel of in has therapeutic that fibromyalgia continued of modulator It

for impairment. which Finally, on let's is NYX-XXX, touch cognitive treatment of in the development

our Following into we preclinical cognitive the are Based clinic on back Parkinson's to escalation pandemic, suspended primate COVID-XX disease-related study patients the eager of with NYX-XXX. in we data, exploratory get our impairment. the with compelling

and of advance have finalizing design patients past this platform several validated first activities cognitive technology year. XX study to across are evaluate to and call to NYX-XXX I able of hand accelerated next with expected our financial clinical impairment a third months. With in clinical PTSD pipeline. the resume months Ashish to in and our milestones across we now the quarter quarter to to next revised that, momentum multiple be with Altogether, We study the believe our pain, these impairment further expect well I discuss chronic candidates positioned results. over cognitive our are the over will

cash you, in compared on financials, $XX.X to XXXX with third and quarter equivalents December the $XXX.X to Norbert. ended million with quarter we million XX, cash balance With our sheet, respect starting Thank XXXX. the

to X These collaboration the of related to were same research multiple XXXX this is the period data bolstered which a activities revenues $XX common upon from XXXX. and cash And Allergan, by of October these the will proceeds of As anticipated million cash Allergan in research was for associated terms our expenses current contractual expect we of our million clinical same in the not to balance revenues rely during to our were were quarter. readouts. the came We joint And offering payments subsidiary million their in to XXXX. owned do Revenues the operations million $X.X collaboration by for $X.X Aptinyx now conclusion the compared with our XXXX enable for Phase our $XX.X collected to XXXX wholly gross previously third into period million stock the R&D compared fund operations. AbbVie. the consistent and third for quarter $X.X third discussed, quarter agreement, XXXX. fund in with research

of expenses to third period million of stock-based compensation G&A expenses our expenses. was Phase year, we R&D same restart the some slight see of noncash $X.X by of expect the XXXX to reported our DPN plans this the in primarily coming study We for XXXX. fibromyalgia increase quarters. for compared end The the in in million ramp-up recommencement to driven $X study quarter our With by the the and X

will Our of in net of compared that, was net third back loss With $XX.X for turn million call the the to a XXXX. same Norbert. over I $XX.X the loss million for XXXX quarter to period

Ashish. you, Thank

patient As turn multiple pipeline to our high page opportunity. we are modulators substantial moving across prepare to indications XXXX, excited unmet and need of receptor to clinical of forward the commercial novel, be we NMDA differentiated

begin We your happy to be questions will taking now.

Chris question from first the your And Instructions] Raymond line with [Operator Piper of Sandler. comes

the I'm year, a that's next change commencing bit of just So in just the study, little a PTSD on language. detecting

with it just you wonder think there Are give you as I additional to change? you Or when had you supportive. a could just data stylistic fill Is as something it registration out pivotal, now looks like I guys looking package it's the but any maybe is to if else? referred color. required? described that the data,

study. design question, study Great study wanted what that to of and next discuss a as the of be typically meet respect registration endpoint. you. Thank just But the we we think to with as of particular duration namely to next Chris. and clarify with well the aligned in design Look, I the have with have look that the treatment, like, with FDA, discuss be one should data will we to will

from make so communicated feedback have the we time guidance, year has study. we to meeting half And appropriate last FDA, steps think our we to But races with that get then we clear, of that results when continues next is the sure be we that off the not our in changed the and should have plan. next next that talked second our be to with the and and I right, and it

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

two questions. So

early opportunity environment as you are Parkinson's, impairment cognitive this could talk to other you've seems to there out. in of out that if X wondering with to that has XXX move I respect seen about be what First, lot companies forward area. trying mechanisms, some well, there, figure the that there. a the a was to they're just stage of out Anavex just in Sigma competitive trying

And you we have a sense what's fourth year. thoughts, mentioned bit to give pickup second, call little bit just of really the really then on going should Just a a a on ramping us your thoughts R&D what the next trying much little R&D with curious up? the in But And how quarter. of of were?

Yes.

colleagues XXX has I thanks it. if and comments as So further one my Mark, started maybe on the of always. for see questions, then with Look,

think I population that vulnerable not all is to of a of patients particularly COVID-XX way any has know we, the that Parkinson's environment course, in subsided.

environment expose anyways provide the to to our of have sure a it data make we an given. this and And unnecessarily that is study so, account precautions is necessary not responsibility into way make the we all to that sure takes intensity patients where to conducting

think have I PTSD we study. learned from the

in the to have good to form the needs again. starting learning fibromyalgia that guided study point to conduct environment. and largely in are. once making safe off, through taking our is feel with what look we comments completion. it all protocol necessary confident changes I should study to way my mentioned what handle And and to that I'm kick adjustments -- line why able we are the off that And we as We are on that like, providing I kick this And pretty we which changes a that have be pretty QX you've those

the we get at and know time. restart I think to if let you that right

Yes, Andy, here.

there I add think, few a other to there. just there, is companies out

huge is needs. you relative area lot handful a and an say is think I it just it's this when of unmet all a

recognition opportunity, area in striking So, there's increasing are. There lot probably. I think an partnership done important lot of how it that just really activities of more hasn't symptoms a the Parkinson's before is and those I of think, a and

has we know dopamine know the a Anavex agonist, one So, that that. Lilly we mentioned, you Sigma-X agonist,

forth, fear Stages Parkinson's and have about and so talked MDA. and or think Huntington's also I

mechanisms there's early out you few said, stages. relatively like they're so, And all there, a and

much area, of there's for I refreshing or some think And other and used recognition than in of don't need. the other a need. three that's activity actually, this unmet ways unmet programs think great because its great in in anything stages we've early patients I two so

R&D XXXX about XXXX. centered which and spend, operations, into R&D existing burn to balance, our funding on XXXX, cash our regard With Ashish. it's through primarily Mark, and then, And we expenditures talked are

complete studies discussed, ramp we'll you'd for frame, we As by rationally. weight I studies certainly. that those period ramp-up seek XXXX the the have relatively to at substantial think that we down of XXXX, time And in margin expenditures, see the speaking, as that a time we've look and higher

of over And so period that's apportionment that expenditure sort of how the runway. describe that of

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

would the that that staggered PTSD seen, the And post-marketing Xb something concurrent? the have that Can we to potential that geographic priority, still are first you question guys site given all follow-up distribution is consider my is questions the neuropsychiatric study, is developing the this Is hear guys you a just extended. at as Xs? approach Like of something is you successful? simple priority? X may trial the that's describe the belt restarting? this just pivotal well. study, or Phase something me. of very but guys have second, be is Glad to answer a if for? and second three all One running suspenders Phase question, could resources distribution you data, changed vagaries you from a envisioned for the Two you will like if original trials Or a And be for that serve

All on good. course, They all more Ritu. a in your going I'm right. geographic are, U.S., question but Kathryn you be distribution you, color the Kathryn, provide answer Thank sites. first to if bit any would that of of have could little

Yes, certainly.

pain, can adjustments period ways chronic getting across we or made or sites, with accommodate diversify some trying For shutdowns so across in the enrollment we flares like of U.S., to our that U.S. have the some that next those for COVID trials. things

I I enough pandemic. the facing to even across with challenges running be sites there those won't respect think across to much profile So take to sites we very those as those go the diversity we that the have again, But trials we will patients. should because new U.S. with stick the with on there's we're trial. think we're change able diversify that we to And right shift now I the centered we care in probably cognition, geographic forward geographic of think in tried U.S. that keep that

because in me that results primarily out way your I in targeted of as XXX effect at are really to really, XXXX I well the which got therefore, Ritu, we with to on we study the the point really mechanistic is which really, a shows now is the satisfied fee remarkable extension. believe very right important the act hallmark out second large. in point really clearly the And profile, And it question, tolerability XXX. for to it's also as platform

and an and there's increasing what's in a out extinction, provide are largely So therefore, or two drug the is our those mind I on more approach that the think be let's indication hasn't learn, underlying course, or drugs symptomatic that need unmet that The will And so years. the in see where there need need some mechanism don't registration, unmet XX open right? assume basically with And the desperate, fear with is FDA. required SSIs There the we but commercialization been fact is, think, seeking a path antidepressants the that to than we that of to And desperate what in towards approved better data the say. are will to a therapies and I fear should we are huge. discussion conditioning, relief, that really moved the for will than I there I today. target come out particular both be

So we'll see.

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

not color mentioned Can numbers, any quarter, but well, go on Okay. started going that you it's starting think that? would well, cognition. was then you getting PTSD was necessarily at enrollment PD characterize you're patient the Congrats additional few you it things, a a Norbert, provide how of early although on to fibromyalgia, question a I how days. these On And fibromyalgia, on good progress on and

the because in this prepped it's environment up Sites are operate. sites running. basically well we going and to which in actually do So are

the provide just we some -- And have enrollment. actual you which basically look that offer out, to, and adjustments of while as at protocol margin. screening speak further made just then don't enhancement And pointed we clearly that We to numbers. safety can

course, right are you early exactly pointing I come mentioned, to of look think we And half parameters readout. we in at mentioned, provide, as right program. that, like updates the we But all point this have the is, I path. And are first further and past we'll far, on as they so guides as the along XXXX us believe of direction. stage. we the data that advance It the

fully on you provide Okay. and the going think question. a That's primary of that? Quickly as I the PTSD, on helpful, a dosing, with to you would primary? agency, guess propose are score? be duration you're Norbert. with any think you of thinking? could And terms to of know previous be yet are you and defined. duration would But then I be domain that these I additional the so Or dosing, what stick meeting CAPS-X secondary you color Or about can endpoint? endpoint using total if follow-up to symptom the a in certain a

Thanks. Charles. Yes. Great,

think did So see only And we of I caps. domains reiterate But not be study that it's important as it's sub CAPS-X. did pointed wasn't endpoints, course, really out a did X-week see that as as And to caps I of study, it powered helpful study. in the I We really we had, total was script, right? on mentioned, separation total statistical and well as a statistical to we the clear to reiterate separation. the

weeks. for to with out has mechanistic up we so pointed of looking are a and point symptoms arousal, from to agency endpoint, of because a being to you of is that as a been statistically only also saw point significant top very out results open completely reactivity what relevant, domain But in from pointed view view we a now. primary four where highly and that And the highly endpoint consistent an hallmark I we relevant

diverse we in helpful, population think XX% had this at about study. right, this. of really really, having measured to other in study. like rate actually of measure think better especially separation in very remarkable population many a would from XX% rate when longer talking a than how I as baseline, I show And response will domains if a And out patients therapy we a that the the and a that duration pointed very, meaningful responder hugely important this benefit of well relative that's actually is we the are also clear very

so will And be than keys are reiterate, those next to the longer that I study weeks. the want just four

four We in as that studies. study patients. weeks. are will the The finding you purpose studies are had signal XX-week had with doing initially But XXXX, much X-week we than how the of from same next know safety we longer a studies and see

so will here do And we the same PTSD. in

will pivotal We the is for design that of study make registration comply will required come with the ideally meeting be a or out we course, design what as of all and finalized, with FDA.

Okay. Look forward see responder to a that to and would as love there. endpoint a secondary

quickly if Interesting total moving would there PD improvement measure candidate. cognition. number Wondering an of to or some see looking UPDRS score a in rationale at Just endpoint, setting? clear, competition, forward interesting terms stabilization or there, in that ton very or be one you of don't with being cognition your see on other I of but mechanistic

Yes. Andy that Look, like I'm going of and team to answering question. on have tag sort Rolando

question. good thanks. a It's Charles, Yes,

restart subjects. efficacy We is move And are we establish along from using effectively in most that think, those further finalizing study. set kind that of to changes. I perspective going endpoints range to able different of discriminating, restarting we'll a what those neurocognitive drug more the domain-specific we human obviously, I with those targeted. with that in process, study, the the really -- as of about of to reduced quite be an cognition we're tests We've we as stick informative So does very informative, to from before and point a approach. a the easy the are of of core it about down granular, to very all administer talked us, number are because to that view be will and But the talk

of of of used will function, endpoints see And course, of and exploratory is there's possible I the that right, still obviously, line. down with improvements a cognition, including broader those I that some if question, as competitive correlation assess our specific symptoms, we of some what you're to instruments. wants lots -- comment, anything. can be let be of I'll the additional those there the get than add and instruments perspective they're neuro he and Parkinson's other over think, to Rolando broader endpoints the But some test regulatory Now, a assess other with assess then

Yes. No, think thoroughly. I that very covered you it

focus Just the then a really It on cognition. and course, of UPDRS, mention to non-motor has component the component. doesn't motor

instruments. for there research the of a them other So frankly, of areas. are Alzheimer's borrowed, Many number that, from

So for example, civic-plus, of should clinical the so that be a good the will yes, us drug. effects what the give of sense

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

smaller for both of I amended DPN, to and you're XXX during follow-up, XXXX, just still ultimately the easier be if how it some protocols describe studies enroll been those is On have to fibro patients for the And DPN XXX enrollment targeting make Fibro challenging? to could possibility know COVID? for any the numbers

to then question, ask you your the of I'm part going second answer Kathryn part. the give to to an answer I'd first So

really to what come it's on patient about think out. numbers comment premature I things think depending on we how should

of observations this into study. and clear we the and show that get is designed on why those DPN to the earlier clinically the trials and results they endpoint. meaningful both our be really we primary builds I very are fibromyalgia from Phase definitively take in And X and reason to main think the these was study designed design that result into and because study statistical the we all paused pivotal compelling have consideration, a to studies a

difficult does it be that back really will basically where that if that offer before is way purpose very really the you that doing be decisions by does not hand right off and serve optimized, think well in around probably I environment I the we answer believe heart-pressed by us Kathryn, actually serving numbers study things -- well. would Because rather it an the cutting And very, compromise would not can have other me -- so pause the than question? then start would And that the to make be to that not study. over would we you we or to again. designed Gary, I I in Kathryn, ask But cuff, your castrate I that. to it putting is hope this

Yes, yes, absolutely. helpful. That's

Kathryn, to the COVID add then, color some And be better of can some environment? to adapted you a Okay. made changes to we

Sure. Thanks, Norbert.

think categories. come two So those changes I in

a descriptions not which, DPN diagnosed at from measure are who were can are we we to in our that fibromyalgia able are in change. gained can from baseline. general, least these that to for First so small would who still make be going that has year order screening that say, to clarifications just with prior use measure exclusion I our four that some, to the ago, pain patients population, information did baseline. COVID benefit to would years pause and patients a criteria enrollment with some in and inclusion one forward. change of enrollment change Likewise, we at of pain These We least

population studies were So by and seeking, those went what but to pause. we the able there learned aren't on were large, streamline changes on based things we we some to before

procedures what to study visits to greater looked made staff to and staff. group changes do procedures to some a to other think we're careful we to all that that the systematic of the review able at trial. risk we or we within to again, remove patient, is And risk And that had The subjects. did and risk, with pose of

disinfecting more streamlining to patients done day those an as sites they the that day week come a for into allowing down things that a their or also and the took in site can efficiently, do cleaning and to towards room eye need visits in allowing so be also well. We

efficiency at their there good then setting. also visits look our made, of getting feedback procedure-related our to were those overall think sites I under from run these current specific in an changes we're that again, we studies current And challenges. the So but ability about the

As things are Norbert said, in well days. the going early

sets data how this you on that's Or broadly, And chronic in think world, you or indication general? the the release at you of well enrollment, whenever very hand through? just to mean, pain time of helpful. at studies are pain have in those separately with would goes I the No, the just chronic the assuming everything one just data could 'XX? both same of approach Okay. you'll same half to have comes thinking time, first more perfect data to your of you rather do Just going in in it analyze both then follow-up, report

No, no.

that's Gary, a great question. So

fibromyalgia in a And XXX-patient you pointed a study, the right, as bit study behind out, that DPN so XXX-patient its study little recommencement. is a study is up and is The running. that's

at this our That's each in read they target, think we don't or other. pain a even close out means two, I of is like to chronic broadly. And course, these more know point, within much if why indications. will close month I two are

in pain. excellent, great with XXXX as chronic back directly believe this We have pain, that is pain data conditions results qualify all applicable. pain show lower for We mechanism preclinical chemotherapy-induced related excellent relevant that osteoarthritis joint and which

but forward that's are be it studies which limited the broad be as And now. of label with basically of based been XXXX, not believing and we we seeking make not clearly does up like as to of that, doing examples, chronic come ongoing course, we to on goal path the so just data they two guide our a have to And should the the is the XXXX. need all pain for in decisions, will results are and us,

Lee Securities. line Your next with Truist question of comes Joon from the

CNS, emphasizing given that in I don't it performed the of a I may Stage curve -- actually but XX-milligram results to. start include reflective find U-shaped in to the suppress X profile? U-shaped in that is the sequential And given the a more and a stick study. point type The response seems or a how response XX-milligram efficacy. drug's Stage and know, the I -- saw there could parallel Stage in know you sequential the PTSD XX-milligram in regard, the actually that is better design placebo comparator you maybe response to put interesting of longer dose, dose, And question X the that I common on way I Stage what the of In of this have doing you of X X in or FDA you part saw understand want parallel milligrams? X seem XX inverse comparator results curve. dosing, than an be the with better the to design is to Stage be reflect drug's what be in also the

we're Joon. its Great registration in that. of kick saying on guidance FDA by it off for suitable design very me parallel sequential is going again, any trial. questions, clear And comparison let take, a Yes. to that the is not kind design

in way much right sketch, active design CAP, we all separating a of So like a guidance study, to DPN more straightforward separating the could dose the study. have study, higher rate. will like which sub-domain, the placebo, one also just against separating on the that is, say with XX-milligram be total either there responder study XX-milligram I fibromyalgia just course, of the traditional

next I the as proxy is fully So use that a then study, if with design think aligned we that next of study. data the for

the patients As they is why way with to it the relates X it on Stage did.

from PTSD non-responders randomized to basically of I placebo of know to is what could, think with reduced results they a is XX a placebo a clear and of -- to dose We've of as a mg think about we about X. and also is ways because that of you to those think Stage And it that a trying milligrams. burden dosing between question XX-milligram better and sort it's by further I your I delta onto in to the next XX like important been already our I solid XX-milligram start have dose. it it separating difference course, really were And do dissect was much course betweenXX-milligram think But shown that dose. active, study? that gets then the next gives they actually the course to in response. level and have mentioned,

we are drop dose to operating to results. brain exposure you in the anything to like a a actually to dose XX Andy decided, range still off we sure that that have study showing mg actually we believe make want do of we possibility to below it? also with and optimal the offset a what add have decide, XXX Kidd, but picked basically the which in is fibromyalgia do a yet just We clearly need the that

thing Yes. would This add. only is I here. The Andy

X at numerical patients of look XX think milligrams mg XX to of conclude XX each in And I quite mg the in terms, Stage XX in the and the you numbers XX absolute group. you the a small. If and differences really XX dose-response. in the group hard in There's differences most being there's patients group are and U-shaped restrain have to

convinced. So where there numbers but and numerically, mg not XX are some references performed the I instances are better, small, we're small, think relatively that are

Joon, did question. answer that your

Actually, very a you Thank share conference? much. to Do you you. thank more any have at sorry. Actually, have I'm additional question. more one question. One medical plans data Yes, I

One people was of responded different people like share of at of placebo study, different medical suffered between seeing better better of subpopulation any while response better, of your drug or your you drivers, drug, drug, peripheral history to a wasn’t responded because PTSD subgroups, better to with you're to deep types In that responded respond any who maybe than due the neuropathy the findings differences seeing way the in placebo drivers sort additional now to patients the like trauma more study or highs data have DPN for those may longer longer plan are PTSD conference? works. as maybe the

some both additional some asked, as And way, not at didn't still, the the so those completely this is, meeting parameter future. likely we us we're I of because you that yes, imagine, a with right, medical comment from of get analysis. the of it you in finished may the answer that's for the dataset to think through I the full include which those but most at findings be I Yes, will point, same near questions can can going in

comes Your next from Laura line Chico the Wedbush with of question Securities.

is Thanks for the question for taking on Shield this on our Hi, and Kenneth progress. Laura Chico. congrats

specific in challenging five for in globally, based and ups study So, just this on for or XXXX? environment? the you any against confidence on the is in are the disease delays this U.S. in days, in starting what strategies limitation there four COVID, Parkinson's recruitment With the starting flare

Yes, so question. great

she affected. actually taking we just the way taking, experience last belief mentioned, precaution fibromyalgia I think where is And that reached require impacts the capable we I those exposure think a and in engaging we way all the are finish in with most of and as based study respect now all unnecessary are also put was all asked just now And question patients we sure I that site COVID-XX have PTSD the to the during a the and pandemic. parts a to study the and until it up making is data with Kathryn that are provided answered I prepared an to a basically would say minimize that necessary. population the we believe as patients we to fibromyalgia more particular, have on the DPN. what Namely, have in the environment already the in sure safe to in vulnerable key environment, and a when patient place of in actually is cleaning making site study. that site, they're protocol is

stay change. the far so not environment and not to So for stable I and good, them hope particularly

Yes, just the specifically, and with you would taken population COVID that. respect with in try obviously I measures will changes vigilant COVID do kind to we I to what in of control be the add to respect think in the the U.S. Parkinson's U.S. to monitoring

plan QX. in So right now, to our is restart

So, update and will to we'll be we that and able actually unfold. as restart you obviously, we be paying to close things as attention

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

versus differential Hi, Kathryn again questions. Hi. COVID-XX protocol amendments, the Thanks on on protocol wondering trial for just neuropathy effects through population, other get one trying amendment immuno a Maybe one a I'm is you compromise Norbert. in the peripheral specific because question an might trial the see get understanding and second to side versus can other. for I'm additional diabetic whether that just of we the of type is not. fibromyalgia

Yes.

I scores right which end now. a DPN. changes to started the fibro, daily think pretty focused setting did different good we in point in I from different pain in basis their a procedures a is But captured we're than homes, would have for we're still on by make think because on in have some like we patients we

safety that with And I patients they're that did have with they're they probably think site. more the focus think slight are our that businesses, but similar And the there related, differences than what we in so, streamline different. are and DPN, more I to more between because had those fibro interactions really do for

measuring we but design XX-way about the a a to when you is actually question, theoretical might as a benefits. to randomized I'm wondering extinction maybe know But prove talked extinction is. trial whether which I a fear potential actually out. fear trial dose potential really point, capture at this clinical talk cure, measure that CAPS-X end it's just then is best we And with functional about XXX. how

hypothesis on trial? how So thinking best that. pivotal in the maybe might I'm randomized wondering request I something FDA to like out relapse was your thoughts that or consensual a through study just prove

the Let's mechanism NYX-XXX. of start with

dilemma stimulizing we a the symptoms the reminded suffering learning have from unlearn even initial if PTSD initially are a is close does are can't fear also validated, allows it we as s consolidation It the actually discussed a before, extinguish caused active that of effect paradigms. fear on And I is to an fear, ongoing As paradigm, of have drug clearly the not that. in they of Myles, that animal receptor that it comma. it And synaptic related and plasticity, in of in matter to memory [indiscernible] NYX-XXX mechanism the even It's for model modulator. not the that really a the here as only matter extinction PTSD. basis, very very someone they Because counters of delegated think the NMDA paradigm,

study. that that being of there's major receptor reactivity And and as associated activity. if where to we said, where should one statistically should in mechanistically, way saw happening the we in so described hypofunction that hallmarks the where with change, in is four-week the That's arousal, that I PTSD. sort we right NMDA like brief being the of in best, cortex why it we And is primarily script is them see major, prefrontal in significant results a the of sub-domains, the that we also indeed see the a all are

So we really think have we And indicators apply. mechanistic our far, rationale to where that will I focus. for that's the right keep all

And so I don't remember.

clarify is us a question, you treatment also your to ask I looking that. but of versus that as of a want symptomatic the PTSD that if perhaps there because disease-modifying for If at rationale way this be more underlying might

studies that's withdrawal Yes, in treatment how what prove I'm asking, extinction a I relapse know an are in induced option. randomized already we monitoring fear trial. an option, maybe the out potentially that it but clinical isn't period, if you've

this get clinical I'm hypothesis So, how claims? make proven just wondering in a trial to those

Yes, yes.

that believe see might with trust be to beyond one read very domain some And we fear objective they that of very a paradigm to get a say, more, how XXX. there the sort with really else point. the extinction. fear patients like are and has also from do I I to of treatment would we about as great that think sub and way changed think And we and is would fear So could have what indicative goes

on we to under to and of take discuss that engage then one you in further back and Let's topic. our advisement this it, meetings maybe get

in try NDA, question And great to it. immediate to path plot as the that. it think development. you are as Myles, to your next I clinical detail a for mean is starting the or what's right? forward, do to easiest I things step represent first is we're forward certainly about that to think about into not may question, getting pass an allude though, best But thinking in it, first And get to

But think trying is it's to difficult and the the enough agency try path interesting could easiest our our place, discuss about we to the to think this I to So commitment endeavor is an NMDA. first on. thing something a definitely, in to find with find so --

that Thank augmentation the path to that, further you is thought question in is further find of it is can to be as used. understood yourself a to so anything not believe requirement and care out And the you meant opposed that. different further do that finish as it differentiate uniquely at Andy, today asked I Myles, Yes, I then regulatory mechanism all and of it. there line. the action? I I it development Correct? for for registration believe, to clear, Look, that with how Because just more from saying ways approval. and you, I yes. a will you be think

secondary The definitely is regulatory out. hypothesis measure this Yes, how endpoints yes, was keep the endpoint framing might question. the actual to one thing, you that it's

very Yes, clear.

from Our Ram H.C. Selvaraju of Wainwright. the next comes question with line

from be any On envision know it seek would and XXX, if being possibility in advisable the the I a think development point, what potentially to at it to a you appropriate? you stage clinical just be at wanted assessment FDA something like special would protocol that critical whether class

That's a question. great

helps the if I the responder of much well we clear just but look, as find that treatment very XX% that, and they almost strong and with only. total responder a have initially, after So a many is pointed out, clearly, It got we a remarkable rate improvement, when the in we that respect we to it but XX% four XX% for as huge remarkable right? efficacy weeks discussed is separation with PTSD especially and with XX% really clinicians, we a the have as on to and data with which when and compared we what XX% help and me the treatment that statistical focus did, part is clinicians XX% improvement other can me to ideal doesn't patients study rouse modality clinically CAPS-X, that drug meaningful as to efficacy on reaching of profile not rates. talk us of reach reactivity And patients

population different And forward so at we path what a the we like special will primary agency consider. initially that on and is, the look that to is what's see. endpoint and steps patient really But PTSD as as arrive best patients to PTSD, relevant pointed we this whether dialogue with have separable the protocol dialogue not focus in be then in basically there, this we interest to hopefully, out have assessment, should and a or next to in development. with KOLs we therefore, before, we'd a serves best And one or is of triggering can

helpful. other I may. A of very couple That's XXX, if on items

appears beyond think this PTSD. you whether Firstly, I other drug be anxiolytic leading environments, meaningful to was And there a which be is specifically could drug. in effect it to and other about deployed looks with wondering like therapeutically an demonstrate effect that potentially the contexts

if as potential So if beyond is for decrease? explore this indications with about And XXX indications we PTSD? additional likely you anxiolytic, directions what to with might new a provide that so, think to those specifically

question. No, it's finding. It's great interesting Yes. an a

anxiety generalized their population. to is a patients And with scores relatively I some sure. I on think the are are that these the think And reduction corroborates for find disorder. anxiety of we findings. with it anxiety, in that generalized not it other baseline It diagnosed anxiety to PTSD, low important remember compared instruments

So is general of this I'd anxiolytic kind the reluctant to through as showing that be reach effect. same the

lot some follow-on may corroborating I a a stage. still fear end off we've addiction, effects extinction underlying that nice robust which and think a is of warrant build know, research NYX-XXX as on on But at is work shown of nice view viewed exploration which our preclinically. been a has very similar point. we platform probably includes further And it of you mechanism to for doing, it to as which primary indications

of that's what have still in we'll focus terms major of next think say on And or in hopefully, there. be indications through future. I the thinking kind So more our that steps would to the following

discussion, don't proof-of-concept agencies, discussions one wondering was I been you since PTSD you studies And whether with potential beyond in like, government had interest already sponsored for seen government provide BAR. regarding certain you conceivably any or exploring undertaken future that's agency whether the And you item under reported may of studies this sort case, know any can PTSD? foreseeable if XXX in And your might with what that your through DoD have something Great. indeed then from government-sponsored be potentially on having, XXX of I with color the just is directly us the results. that's in study if taken example,

Ram. Great, Yes.

funding unmet data, launch for have foundation I in look an what actual many, relates patients, many now this the need, think many, the of which being So and where that think an we to actually I possible. from clinical person, inquiry we is right there as also we enormous sources into enormous it have interest data could to

at explore very guide we and profile. soon comment. is bit that clear So in that But so absolutely defense, detergent safety more side tolerability need too to little the now it mechanisms we XXX and have a offering that. are there effects now. importantly, does so the unmet us clean active And really, And data therapies to It's or will of without that that even really, would by many so but we include explore. really that is high, also sources a the other the burden PTSD especially want and clearly funding other

avenues support for well positioned organization study. additional next into those to So think I explore coming the to funding are we sub the

comes Your with of final JP from Fye question line Morgan. Jessica the

Just allow first in will to it the confirm to one data tracking into of me. that that of will restart way you take for the DPN half report study, How is the in a enrollment XXXX? long

know, typically, just time ramp-up. little to take things a as you So

or get to few so say end we or -- date be good have before state have to would in of think monitoring line is we deviate we we would the so that's And can I believe likely are as actual be norm. then particular, call from to quite And I state today say downs pretty And a can like. looks date a experience when in be offering expect don't we to months take this would whether on of ups it's that all don't steady a we be that guiding in field, a we steady or much to which you completion will a enrollment, closely we going the out. and firm I that by a measure a yet. time sense. want pretty time environment, when line we at what moved we are every that that accelerated be have needs have driven that But

are There no questions. other

continue may You remarks. any with closing

your Please your your and safe, We enjoy of and attention. operator, time thank the you all stay right. rest Bye-bye. and Thank be thoughtful well, appreciate evening. All your day. questions. you, for Good

Ladies concludes conference and gentlemen, for this call. today's Thank you participating.

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