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Aptinyx (APTX)

Participants
Nick Smith Vice President of Corporate Development & Investor Relations
Norbert Riedel Chief Executive Officer
Ashish Khanna Chief Financial Officer & Chief Business Officer
Andy Kidd President & Chief Operating Officer
Kathryn King Senior Vice President of Clinical Development
Harald Murck Vice President of Medical & Pharmacovigilance
Ritu Baral Cowen
Rudy Li SVB Leerink
Chris Raymond Piper Sandler
Joon Lee Truist Securities
Gary Nachman BMO Capital Markets
Charles Duncan Cantor Fitzgerald
Laura Chico Wedbush Securities
Myles Minter William Blair
Jessica Fye JPMorgan
Call transcript
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Operator

Good afternoon, and welcome to the Aptinyx Fourth Quarter and Year-End 2020 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 of Aptinyx. proceed. please Nick,

Nick Smith

and call everyone, XXXX for us joining and Good discuss thank Aptinyx' today's to results. year-end fourth on operating afternoon, you quarter financial and

now results Our Chief describing our Financial Khanna, Business clinical Chief discuss Chief today's and development available will Riedel, on Officer, Officer, Officer our business business call, press and Norbert our financial financial will our highlights our release Executive progress, On website. Ashish results. is review and and

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

Norbert Riedel

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

remained exploratory the October. marked been X the highlights on of from a And of Aptinyx. pandemic, challenging rate first Among stress you disorder, reported productive, was Despite key by responsible in year in at NYX-XXX decision-making today, has we programs. us as We which our following posttraumatic focused are and year team the several Phase what albeit with COVID-XX the excited the data our global study result, a in to our year achievements development advancing important past for talk execution. was

the at the We with due isolation when loss encouraged many. particularly results is so at trauma, to mental and the by are by being NYX-XXX, forefront truly experienced time early a health

studies year early pain execution very in chronic positive. Xb and enrollment Phase of the are last and metrics late resumed Our of NYX-XXXX looking

Our cognitive presented given clinical greater pandemic, this due the the patient efforts development population. vulnerability with of NYX-XXX impairment in even to challenges

suspended However, the we each again in this recommencing will be in year. last then had studies coming study enrolling Phase days of will patients the X we and that be

executing manner lay We these novel are our quality them to from improve XXXX. of of only whom detail have about team. members our are to of studies focused and first modulators, of with very the all attention This the four All of study. the proud team safe, I with on X conditions. challenging at and half for Aptinyx, data mission, the foundation execution here study attention will a very each readouts in Phase are out efficient is resilient we receptor beginning the this expeditiously, durable coming dedicated keenly particular in the possible am the NMDA CNS perseverance of to who and important to complete passionate work, suffering patients lives with

through We into expect multiple we over a and fund XXXX. X year-end, with to have cash which readouts strong at million study $XXX position Phase operations our

painful starting DPN. of neuropathy conditions, diabetic clinical-stage fibromyalgia under programs, with each and chronic or our development in development discuss Let's candidates centralized peripheral two evaluation our pain NYX-XXXX,

them pandemic Following towards reinitiated enrollment of last the the both and of escalation fibromyalgia both to end COVID-XX we last of pause DPN the in year. in due the study, March, the

the against safety evaluating NYX-XXXX placebo targeted not daily milligrams study. incorporated have of we designs of of in backdrop and are the the In study COVID-XX, study effects durable changed. dosing Phase of X personnel ensure have to XXX against the milligrams facilitate a certain execution of and the XX-week elements fibromyalgia, of key study modifications protocol we patients While in XX

primary enroll study. In of the expect of over expect this DPN, also to XXX study, numeric daily against XXX advanced this scale. patients a approximately treatment studies pain rating the by baseline average effect score patients with is zero the We we approximately both in as evaluating XX-week enroll In to The on period. placebo, NYX-XXXX XX milligrams DPN. point endpoint from are change measured to for XX we the

has enrollment tracking progress, that enrollment expectations. steady of both chronic half reading pain each the first we these of our with Based pleased line in on XXXX. from been this studies out anticipate are we in far, and in studies So execution data

move endpoints Phase efficacy demonstrated is clinically on our from effects weeks Let's of stress in development NYX-XXX meaningful the this post-traumatic in treatment. of we exploratory which multiple for X announced NYX-XXX, after treatment now October, In In patients with disorder. PTSD. study, positive results four to study

the where with The NYX-XXX two our experienced over of study against symptoms by four were measured which effects we on with is very of the range Importantly, of consistent doses of NYX-XXX. in mechanism evaluation placebo the signals The evaluated a people weeks. holistic of the PTSD. observed patients CAPS-X, understanding XXX

that NYX-XXX safety future an NYX-XXX were was the primarily patients degree with PTSD, profile what’s the exploratory endpoints. focused including which to array our the powered inform efficacy we and across signals well study parameters evaluating tolerability on time design and studies, this evaluated could exhibited of first and an As in of

not NYX-XXX in over option and therapeutic an We new has are new indication encouraged that in target approved by the had XX years. to the potential from study a has data that we obtained this a become believe

clinical first As development, ahead will to key following from observations we future we built study. on look the this

a XX-milligram On the improvement meaningful clinically the CAPS-X saw baseline from total we dose. score, with

by to a the were score a with total on compared adverse responder serious CAPS-X score placebo consistent receiving scores. that patients clinically of across with effects and looking meaningful favorable events CAPS improvements overall in from milligrams robust – and exhibited baseline CAPS-X an These its proportion significantly drug-related profile at NYX-XXX the on safety very observed group. four Importantly, total no greater was total XX improvement three a rates, the adverse symptom achieved placebo. line events of driven cluster profile

certain also that We indication. provide forward with about response signals to we with influence in next into patient appears of seen the the confidence weeks study. of have to we learned treatment incorporate us four move characteristics which which will the NYX-XXX, These this promising overall design to

We at place Meeting, Society Psychiatry Annual XX of May are data upcoming Biological presentation X. April been for accepted through pleased to the take that these virtually have scheduled

an we meeting discuss in April the the granted the C Type In the been FDA have a and of addition, on path to design with study PTSD. XX NDA next to

While of provides other foundation most maybe pain PTSD. data modulators progress II our second receptor Across We this a design at the the year, finalized, from platform. on more the that half the more us platform IIb the pivotal this focused we registration-supportive study show with in activity been details with signals from confirm studies NYX-XXX. novel solid validated have of score, clinical in provide now we Phase study, the from pleased studies PTSD this appropriate clinical study studies. our endpoints, a importantly, third study NMDA giving Phase with the a two have plan will the expect details study compounds time. next study on CAPS-X we of improvements a these conclusive to clinical specific validation be to to and design, seen with And a consistent not total and this our chronic commence be am larger, in I

discuss relevant updates treatment now NYX-XXX, which development is the Let's for cognitive on of impairment. in

pleased report days our that away screening March, we I study recommencing am in of this suspension to from just are the Xa Following study. patient last Phase now

optimize to have study designed incorporated ensuring of chances This started impairment efficacy, patients detecting protocol simplify XXX Recall, NYX-XXX evaluate cognitive were Phase patients of with and Parkinson's study potential course, several signals and while, in changes study, we to the of we safety enrolling of for double-blind, benefits safety personnel. in placebo-controlled initially our the mild We this X cognitive approximately disease. targeted and execution patients. when study

population. will NMDA And or and over We, receptor XX-week patients to in dementia effects this with cognitive with involve will two assessments milligrams been study cognitive that mechanism cooperative expression with has impaired of the suited that patient the with this impairment. tolerability, computerized evaluate evaluate in the us in the this dosing NYX-XXX Lewy impairment. to explore activity. is and buildup safety, same implicated result NMDA recognized as causal It mild study either In across a continuum to multiple a NYX-XXX to of we expanding This pathophysiology, to potential arms, NYX-XXX. for α-synuclein-related for will further, factor activity well disease competitive represent this demonstrated domains address Accordingly, first to now α-synuclein is and critical Parkinson's and we is key activity XX endpoints it been the diagnosis decreased has in patients and it receptor of NYX-XXX the particular, on of new The cognitive multiple α-synuclein patient enhancement characterize bodies. of our population believe neurocognitive dementia are a treatment also believe impairment include is therefore, We levels a daily has in address. placebo, period. in leverage cognitive which increases effects the

a months, will progress last to screening few over investigator significant pleased the begin March are then we XXth patients. Following meeting, virtual and enrolling and be hosting

preclinical feedback and the from of our have XXXX I with advance To we are immensely challenges efforts up call will anticipate across that, the tremendous our I'm of now to to incorporating of our past We half With Ashish on year clinical results. discuss has year. our summarize, of programs. studies to in data get fourth XXXX. this XXXX, and The the us changes back have sites readout our over from in study study each initial good full enabled way the reporting development the received combined quarter the team hand and to proud work data running, financial the second navigated we

Ashish Khanna

income have historically support of of this we jointly conclusion you, our research XXXX. subsidiary With funded million at remarks, fund respect to collaboration cash equivalents multiple cash revenues milestones. expect Norbert. Thank Allergan, compared and Norbert's sheet, AbbVie. $XXX in quarter our a earlier Beginning To now the important our came XXXX. to balance $XX.X with under August XXXX our to collaboration related in research we cash to achieving operations the reiterate clinical current of and with fourth activities our been ended statement, their the end to with into contractual The million

$X compared to quarter compared revenue X as expected, had did XXXX. to the fourth the activities Since ongoing collaboration have quarter revenues $X.X XXXX. of as for research year we to million the were XXXX the we the as million full for fourth So year full million in XXXX, $X.X in XXXX up for August of

revenues $XX.X spend as remains XXXX. the $XX.X our as Importantly, totalled we PTSD. our to and in are operations. conclusion The heavily of concentrated R&D quarter million was II and Phase and X reliant full the pauses not as studies, our for periods development. respectively, across same $X.X expenses million of of fourth these in expenses XXXX to for in the the XXXX, result study R&D of million decrease on patient $XX.X Phase well the compared research to majority million and primarily fund year in enrolment II The X temporary the in

$XX.X expect million G&A and for $XX as fourth reported XXXX, quarter We full the for of to spend year to million respectively, and up increase and $X.X expenses million the XXXX. periods throughout in the year studies We X back all and $X.X running. same R&D million compared with

$XX.X same loss will fourth call $XX.X I net turn Finally, and full for periods over as the Norbert. million a to we the quarter XXXX. and and a loss million respectively, million million net for in year reported of back XXXX compared the of now to $XX.X $XX.X

Norbert Riedel

Thank you, Ashish.

cognitive potentially beginning the candidates chronic development catalytic pain, year. our multiple advance to we milestones impairment, PTSD we As half of look and forward across next first in

and across Turning page financially to operations receptor modulators both clinical forward. XXXX, are the pleased our to continue differentiated be NMDA moving we to of our novel, pipeline well positioned

taking begin to now. happy be questions will your We

Operator

of [Operator Instructions] line Cowen. We the Ritu from coming our with Baral have question first

open. Your line is

Ritu Baral

is likely Norbert, other the criteria would the what Good topics the and need on you'll would are afternoon, inclusion patients the But is talk that, FDA XXX. for focus of points, you of design, contribute, database April you FDA meeting safety guess before about main meeting? guys. questions here end the that XX I'm thinking asking trial discussion be I mentioned to like, that obviously, or at taking primary What question. Thanks my endpoint could pivotal around severity other that for say, the you secondary dataset? that TBD.

Norbert Riedel

Yes.

I'll kick here. in off, chime can maybe Ritu, Andy So, it and then

You, of have of goal questions daily of the exploratory that signal-finding PTSD thinking already mainly it a and a that population. was questions path, includes, of serve study heterogeneity a really discussion with I course, are development questions, study a know for and manner, to that's the patient example, population, we that completed of as say. points, study It it actually, next about nature relatively that but next good duration what to the therapy that duration the I should the around. given an of study, say, study the towards have that us mentioned, the patient And the or key treatment, related informs design and key to the FDA will the as NDA guidance with of registration-supportive can being our really that should do in has center I

Andy Kidd

Yes.

isn't I the what to, understanding alluded only in that. really, on I'd have to is meeting add key although Norbert of better to an of our the PTSD. output thing reach try a goal study, guidance are will requirements published in next think, the NDA inform the to the the is as a There discussion

wanted we at discussion stage. the therefore, And this have to so,

registration the So the needed. as for as can and and be the development close foundation next the as serve study supportive We program. of basically lay everything possible rest that's understand

expect, design of study would you would most major to we as elements, the understand. need So

Some of question than them others. are more open

up for set really confirmation. NDA. the what them to context But the in goal, more to is just looking study that's of kind are Some an it of takes of achieve the next

Ritu Baral

XXXX. And it. quick a on just follow-up Got

As your waves shutdowns initial across in enrollment your geographical has world distribution COVID now? the expectations, from been proceeding, enrollment reopenings varied has just given of the the and right

Norbert Riedel

to Great. express you. have that Kathryn? I'm question going Kathryn for

Kathryn King

Yes. Thanks.

are Our the U.S. sites in

so, enrollment centers. we're pretty seeing U.S. across according-to-plan our And much

this time, in function impact seeing some of of we But time pretty well on think see of an from a I or with to substitute perhaps quarantine weeks things COVID general, a couple center. we’re at time. staff,

here across working centers to all according our we're So plan of in the U.S.

Ritu Baral

questions. the taking for Thanks Great.

Norbert Riedel

you, Thank Ritu.

Operator

We Goodman with coming from Marc next Leerink. of have the question our SVB line

open. line Your is

Rudy Li

Hi. Thanks questions. my for taking

So Two for this is Rudy on the line Marc. questions.

First is regarding the Phase Xa study of NYX-XXX.

more many you're across future patients? that how you patients just just the provide them neurodegenerative XXX roughly X studies? do us about Phase since DLB for So a label can given disorders R&D XXXX, in year-end? color this in sense cash enrolling expenses running So on study you And four have in aim by burns. up to the total, cognitive plan broad to if a secondly, give be wondering works, treat impairments you And will of study

Norbert Riedel

questions. Great Great.

as the key which say tackle very pointed I one inclusive can is is think, of to point, as there regarding focus XXX synuclein patients. we receptor goal and a NMDA inclusive that sense here first hallmark of and bodies, out So think to activity and has of how out, patients a impairs are the Lewy confirm this you that you it on And underlying have common I we let's pathophysiology, expression, the looking alpha abnormalities. that at basically synuclein more be alpha at pointed to makes expand because

Parkinson's even I we dementia, distribution look distribution between answer today assume would for for clear not a Lewy think but exactly I two. fall it that will actually us how relatively between the exactly body would and is to

Andy Kidd

Yeah.

it's I think Andy here. --

expect three that groups to I Parkinson’s numbers I according on in question think respect with in of your to There all study. I good but good an broad the patients that compared disease is to there, patients exploratory are out a this as three. will there the is think across be certainly distribution. a are the I the spread, bodies think get category And we'd Lewy think fewer label, with enough dementia population, with slightly there

little So indicates, this this I believe Lewy work entire label. across main it's But remarks, mechanism potential the his we felt we at Parkinson's include do to mentioned stage. sort can that to about all was in grouping a continuum. that the And patients within the talk right premature it this Norbert body, think our of as decision of

Norbert Riedel

question a before ask address if had and that Ashish you to Let's your answers the see question. as budget pause R&D second I that there

Ashish Khanna

Okay.

the an were million. the mentioned next quarter in year overall increase earlier that R&D XXXX cognitive give project to just recommencing pain have in screening burn with these and But We lumpy I quarter-by-quarter as that -- expect we later patients in a studies, burn see remains have XXXX. study as in R&D cash further it balance and surely, last the general, guidance somewhat recommencing our are increase we'll that study we in our as $X call, with and shy we'll runway coming in give initiate as cash the typically expenses is way year to be in and a sheet We’ll we would of see of into the extends the start-up impairment. In It anticipate that initiations. cash two PTSD. the enrollment don't expectations recommenced do we'll this guidance. We current So XXXX expenses. we

Rudy Li

very That’s thanks. helpful. Yeah, it. Got

Norbert Riedel

Thank you.

Operator

from We Piper of Raymond have the our Sandler. Chris with line next coming question

is line Your open.

Chris Raymond

presented PTSD. patients that you intrigued prospective something Norbert, on comments I'm this is could assuming Hey, there some seeing your I bit can respond a us kind full about wonder of at – of was give those and of And XXX that a patients? SOBP. the you by opportunity is – in on prospective a to identification save what better prepared I when want data an maybe Thanks. characteristic for you're talking sort of is more color But for there? little maybe

Norbert Riedel

we wait not the Biological their at preempt Society is have ours I that for information information actually meeting. you would by that question. by presentation the disclosure until have Meeting. will and It Psychiatry and the we thanks to have of additional Chris, that to want our criteria to of comes had

and follow-up discussion maybe that we after So have with you. another

Chris Raymond

Got it.

And... Okay.

Andy Kidd

we’re what highlight to Just talking about.

I think population would to implemented clinical in I right that talking have would clinical at implications, the about any size it's that eligible development more patient think kind the the anything can trial. things the of just stage reduce have would development be the don't the be or of we're criteria. It's prior label of kind refine testing. ways to population – require clinical

Chris Raymond

Got it.

Okay.

on just And Okay. a then maybe follow-up XXX.

wondering into this something and XXX was the give again, focused you if detail, a know just just on – but a little you but the was simplification made led XX XX-milligram that decision, decision just So this saw is could more or bit dose, you that I otherwise? there that to

Norbert Riedel

Yes. Great question.

from thereafter. as is ranging as making just brain that fundamentally opted of should for this the Phase the dose to efficient in not it have thorough the dose sequence. in to then we readily understanding, which dose pharmacokinetics a for to and think we signal-finding in And measure we level actual And predicts dose very, X pharmacodynamics I that dose a is define is wanted as we define behavioral very efficacious compound PTSD. exploratory compounds, dose of healthy actually ranging at patient the sure to be tended sorry, DPN, because the and our where the predict more we studies, fibromyalgia, the it of a intended as very studies which it's model subsequent behaving pick characterization believe, have look compound levels exposure in preclinical done a that of we CSF surrogate volunteers, data – We to way in up studies study, actually at reason that pick of to study, the I we good a signal. well the for it's both and that be, in several earlier to the and reliably to. study, I then we do know, And a dose So the the one clinical make instead is you actually readouts now think do be in

arms. in go well, think to and outlined overall. have and are variability active I is is what the a the also studies X-arm that arms, I why us modification serving I benefits was two that serves the little that data actually It that and active more, is what is three now we rationale making from way think, the bit accuracy it typically the less

the It's rationale I that So with is it dose-ranging. but not you. comes added benefit, fundamental the outlined It's signal-finding. way for

Chris Raymond

Thank you. Great.

Norbert Riedel

Yes.

Operator

We the Joon next of coming question have Lee with Truist from our line Securities.

Joon Lee

our and taking the update. Hi, for thanks for questions

-- appears I it upcoming hope So, sub the trial. CAPS-X that there had a core Xb effect Total in score be stronger as sort you'll Phase responder play that would where that be a the of for well. for endpoints impression was or much you a analysis your as was potential pursuing under

second makes Alzheimer's, my impairment that say, totally that very out you based about patients. due that especially XXX cognitive will FDA? That's some on So, opposed what of the of question coming Lewy have question. Alzheimer's? suited to, seems to And for a the question? is your out the in strong NMDA as first competitors, something signal ask Is data of is Parkinson's in Because a the body to better

was I body your indication. Parkinson Thank strategy curious Lewy initial So, an as and just you. for about

Norbert Riedel

Yes, great. you, Thank Joon.

four of the we the reactivity October, for And it that score study, that CAPS-X So, CAPS-X is attention to trended to despite particular arousal for significance What to data needs be between placebo reported on fact only. look, and study primary four-week statistical a Total when it the exactly endpoint paid very study we the pointing in PTSD keep that we very where active clear achieved Total out, small and subscores. fact it comprised separation the is very gave trend a a clear suitable was and is us. from also us the as

speculated I when alternatives CAPS-X of to I the the that in to nice to be fabulous in not conversation that which have imply we we to So, last a when responder a we open-minded mean perhaps subscore alternatives our disclosed about it then were in an potential would October on next study, were conducting either did form rely data that those rate, confident would or study. feel

And your accessible score On created us. basically selling using CAPS-X us Naurex the not disease because four to XXXX, so comfortable guideline with very indication. as we of result X I'm Alzheimer's-related is comprised did XXX we straightforward not rights CAPS-X three today as answer. That's Aptinyx which this primary a Allergan says disease? clear, to a Alzheimer's PTSD as use is subscores, the studies not study, should by of CAP to and perfectly Alzheimer's question, a because retain total and in gave the endpoint. second in dementia why disease When in Alzheimer's an strong

and all enhancing is a learning, However, and cognition, appealing with link all us forms receptors And binding, receptor activity very between we our clean, memory NMDA we because to allosteric models. NMDA modulator pointed plasticity disease in causing and that and biological mechanism are have the result. of XXX therefore, we feel logical very and correlation out, is, the no of synoptic positive a is impairment of Parkinson's of that a particular very other course, that namely dementia α-synuclein cognitive off-target

And chosen. sense makes so us to we the say it perfect target for just have that’s

Joon Lee

it. one follow-up, Got could. quick I And if

– CAPS-X. So on and the regarding first question

-- at it – it presentation would data could be something enrich to? SOBP, you data related IIb, assume Is upcoming new how be in that will your that could related to forward to responders fair will look So is that Phase we the correct? be to is the the for

Norbert Riedel

Yes perfectly.

primarily biologically and use wanting fight in But of for The written the can think making said therapy to whatever relevant category some patient in basically this without all end not as the down niche study. we remarks helpful further course, go purpose of yet in targeted PTSD of a can considering stratify, As of -- is is that should we down looking But category. to indication. that I population, we sure crisp have is it the where the up we nailed our path target details clearly, be as to broader at be.

Joon Lee

you. Thank

Operator

We with next Gary BMO line Nachman coming question have Markets. from the our of Capital

Your line is open.

Gary Nachman

Hi to same for at and fibro guys. change the Continuing slide, the you're DPN, looking NRS. both in primary

the secondary What are So the Just you in XXX-milligram us in secondary DPN? dose be populations? the patient on better in to how but inform important will different efficacy the us that? endpoints? key remind endpoints also why remind fibro, of not And

Norbert Riedel

asked, you That's That questions that possibly answer are but X unfair, Gary. I them anyway.

DPN? the to And having to Phase which right XX that engagement XXX DPN also XXX-patient first That far XX by study. and So in I with that look, our and predict having from studies with do target dose. has studied and fibromyalgia back from I XX in studying to did XXX was in we we concluded only study, start the last our work are one, dose from I. And why that that, Phase in the the XX-milligram we again, data, and been goes preclinical able in XX,

us small. was that's in about fibromyalgia we had XX study, So be why only study It that it gave for confirmatory the patient-reported fabulous by patients. because its and fibromyalgia to wanted biomarker and FMRI very NYX-XXXX, actually of to study a being reason spectroscopy results the nature expand

And But key necessary, only the if in next the XXX reasons XXX-milligram further XX why and That with that also, we the one XX so we sure make a the broader are inform dose. will, to XX those bit do to study, by this in the wanted we and a ranged opted and it DPN in other. way, study.

asked else Now you remember early I what on. don't

Gary Nachman

ultimately, No, have to that was question, is you broader endpoints, I these bigger if look in. patient get into the populations, able Yes. a given if at to pain me And broad the you're it in X chronic different having want just that let comfortable going jump just be both. potentially guess, just you secondary just in The on how a the primary different indication? merge to indication, pain studies same chronic

Norbert Riedel

Yes.

aligned So the is fibromyalgia just score, do in captured to question just then of you as that I'm to is And are patients. results fibromyalgia and into study patients address don't with fibromyalgia daily glad that as pain it giving to good much we quickly, the just PROMISE either the do measure endpoint, is we opportunity going now taken have, rely in the we pain of for fibromyalgia studies in the population of these in have studies. one is these these question, Andy running. to But that the both that And reported DPN And asked a have in is the that I'm result. issues in in very point course move because indication Every of the ask the you. has endpoint, secondary confirmatory by as with course, chronic pain. what patient a broader Andy me hallmark the have with in symptomatology endpoint mentioned it starting now positive gives really going primary to labels given us very or us positive you on clear, the of and that it’s particular, our reiterate questionnaire studies. And to earlier answer

Andy Kidd

follow and neuropathic Yes. There how for make pain, it. to there purposes chronic had a label more of non-opiates of for of could of that had that know breadth you to different we right a get well-tolerated label was was so what And Thanks, one guidance would requirements try many pain was We be it reconsidering the now, patients. to guidance exactly central formula in to, how there think, indications peripheral because safe, on. withdrew in to studies that chronic or bring they achieve the know guidance, guidance pain, then many FDA and in pain straightforward therapies what in the published laid that how don't out label. we was And a and musculoskeletal sort rubric Gary. to language cross -- FDA language prior

discuss pain, by FDA that's Obviously, so, you we'd as we pain neuropathic an classified have to two condition. something been different very neuropathic as Phase DPN, has of these indications, agency a at obviously, said, think, meeting. be pain. X the end not Fibromyalgia keen And with I like

are other. -- and as of we know, so musculoskeletal you and And kinds and all interested pain conditions, in pain neuropathic other

be would characterized is DPN interested course, think, clearly DPN to I that diabetes, of I of more the interesting, part It's very probably -- pain. condition would work. see how by but it's So

endpoints, to interesting at mentioned, an the forth. endpoint the other some FIQ pain FIQR as on fibromyalgia walking, have PROMISE Norbert areas a do pain. and And FIQ, I -- so question as is And some mentioned, over in pain primary other look scales average revised broader we condition. Norbert important and that's the instrument so and worst how think those like as of But endpoints, well daily the fatigue of of

from view. broadly yes, watch It's end endpoints. more I'm very pursue the maybe, of at bit, of secondary the And little a kind a X. point could on positioned interested of fiber from how at of the broader the then, look keen Phase space see the label. to we're perspective do be those regulatory something to we So

Gary Nachman

one would Great. pivotal XXX. one this or then, you pivotal next the maybe file, study, that know possibility? to And study second think be in meeting. see, need Thanks. to you'll it likely scenario? and just a you study you don’t if to you possible want do is I just any would you a FDA on want have that's need preempt that Okay. one I But that just could think sufficient

Norbert Riedel

be because discussion that's right, will those of lines think much of along by study. point, this really actually results at so any speculation I really Gary, guided Look, a the

so, the what study, to and And results an see to path insufficient think, NDA. show is the comfortable that with saying, such I and on engage do the then agency much the at let's I'm time sufficient more let's extent what or understand let's

this I it's think too just at soon point.

Gary Nachman

I you're is at possible. not forefront, earlier. mean, guess, it you also said is given But PTSD maybe that ruling out. Okay. And it more like I the

Andy Kidd

numbers are are an course. a point. a of get of for urgency likely of wouldn't be clearly, unmet that the are time to always of requirements as for I this needed out there certain view from is And need such, I of to exposures we the episodic, disorder. point -- well, administration conditions this everything more perspective the other as is for pretty -- here, of to rule durations safety NDA. anything But since depends psychiatric the it on consistent at some aiming chronic think, a chronic unlike is But Yeah. PTSD much

Operator

coming have We of the Cantor Duncan from Fitzgerald. question line our with Charles next

is line open. Your

Charles Duncan

Norbert I'll a for to Lots you Thank of already. asked Okay. and questions my few great others team. out. taking question try pull

sure not study XXX, for study? for what that two give you I you the a haven't of next treatment be. in the can terms the yet could know the this Just duration on but met I quickly with time end, those caught on lines XXX considerations range In if us of I'm agency,

Andy Kidd

that we're Charles, Yeah. weeks to we'll currently see right XX and where eight of considering now, comes range at. a

Charles Duncan

sample the And approximate? size

Andy Kidd

Yeah.

think I think with you be to chronic if least larger. will at it rough line pain in guidance; slightly not sample give size, I our studies,

we make to think that sure want certainly well-powered. it's I

Norbert Riedel

still Charles, you there? are

Andy Kidd

think lost I Charles. we

Norbert Riedel

you there? Operator, Charles? still are

Operator

open. line his Yes, still is

Norbert Riedel

-- asking Charles, you. we are there from Thank before Okay. proceed. other any you question you is

Operator

question Instructions] We Laura [Operator from coming with Chico our the line next of Wedbush Securities. have

line Your open. is

Laura Chico

much. XXX. very just I a I on have Thanks Yeah. couple appreciated.

I might up, how response if revisit design, follow-up kind how have back impact in to about data. the rates just adding are take be So, thinking And to should perhaps also how thinking your Zoloft question and and believe Phase about that the for of we study, to step the and increased SOBP just and have XX. rates just wondering saw studies both coming meeting Paxil. obviously, FDA of of you perhaps wanted the between four context could you week a I'm response in bearing thinking kind that dose that on you. you Xb one that I and understand related trying a to second

Andy Kidd

think So magnitude it will time, rate yes, that definitely definitely increase not over response probably of assumption it’s think but I time. over effect will Laura, indefinitely, we and our increase

of thinking know, other the that, from rates that we're other end the compared range answer factors last discontinuation to study, been obviously – across as has X- the indications. part PTSD, I particular in some seen previous where, this of at question for we've in the spectrum and against you PTSD to to considering. higher the studies, it's our XX-week some to that's the mean, trade-off so with on And there's patient

bit of durations. so trade-off longer you have And just at as you look a to little something that's even

With kind decision So thinking that's probably would And And X- sweet we think to updating I moving obviously just think I come that. dose the whether to think, that XX-milligram that be a we'll, that as again, in spot. later still as second on with respect well. we is just also XX-week to a something on XX-milligram dose, we're comfortable, range yes, be ahead of a We dose with very have to through. dose. the or second stick the we'll

working XX would a have did than milligrams, obviously we but be it if dose, through second likely, higher we'll think be I that.

Laura Chico

from I Thanks, to more back circle wanted perspective. a That's on Okay. question one strategic helpful. then guess, And I Andy.

branching beyond we about the of not cognitive – just was and disease Norbert, Thanks. you impairment terms some that of how philosophically? you development setting think Parkinson's may guess, fundamentally, towards, neuropsychiatric plans I guess, in more I mentioned I conditions should accessible with also indications I indications related would wondering, the be currently. consider to of be more XXX But some thinking kind just

Norbert Riedel

Yes.

empirically, So data on we at get, INDs numerous of and that's very great do of various the models test or we cognition, to in profiling indications, based psychiatry, say. compounds, them look When we and a various them should our of into I extensive Laura. we across these behavioral disease, compounds pain, assign question, models do we how

by and best pain impairment. psychiatric models compound So our the far XXXX models, in cognition in in XXX the is XXX

think And is shape within or suited those of I expansion the would how which so view with those along of cognition/memory a psychiatry for on. categories either That's best pain expand and indication we set compound more lines but compounds, of along point lines, from of indications. and those strategic actually so or we choose

Laura Chico

Thanks, guys. Appreciate.

Operator

have Minter next Myles William We our with from of question the coming line Blair.

Your line open. is

Myles Minter

for guys. Hi, taking Thanks the question.

curious XXX. dose Just potential a for on higher

the and you You’re really molecules of here. How curve go if at active little the another theoretically into mix from with bringing into response in above a in the characterizing you that’s good just increasing And balance rest placebo the expect high efficacy? models shaped pre-clinical still how a you of would bringing obviously that could I trial, expectations like trial? the bias guess, dose

Norbert Riedel

range period two daily to of to daily a it XX-milligram the to XXX-milligram I plateau if in to of it hard from dose longer week however, dose began will, we human require but dosing, sort the continued that administration, over preclinical XXX four. a milligrams improvement back, week from whereas say, week very one to show like I was XX linear of It's efficacious, to would directly XXXX that week that to three you where answer chose because study conditions. DPN to Myles, we to take a the of extrapolate

plateauing we a go I think would begin see would would really that can us of it when study have higher, so to tell we but a And to be effect.

concerns. my would tolerability Let the of with phone I unique, to see We and to best dose safety begin don't rather many and me are say, have push that other compounds, to right? limited team that a where the have and you tolerability of sort index make opportunity issue this the narrow because and on get compounds basically share relates you have high the therapeutic superb you the of like opportunity here our the we this it safety profile very to dose before that as window by

not to relevant adverse less and Phase view point But gone so studies like any a from we the what gram of important. in And X point view, single in dose of much, seen therapeutic from have administration that much quantities actually our effects. of that's

out into to earlier my turned that and we to say, predictable sweet we station has learned back pretty comment where be go have studies I in and actually is think our now the so where models done three And as cases go in I preclinical with it. have clinical we spot

animal at it. like models and so because answer XXX% direct you way a a better sort human preclinical I of that's no And patient can't there between looking probably correlation population. of give is

Myles Minter

And to to on on trial. to able fair based trying enough. be involved I'm tasks most any what's motor whether in exclusion these you're them to you're criteria the those those in in the they patients Yes, that I complications do and wondering the then tasks population just Parkinson's specifically, foresee subjecting function assess? to cognitive dysfunction complete to have the tasks, and just you be because for on assume of XXX, being pass able cognitive disease But curious patients? computerized side

Andy Kidd

No, absolutely, Myles.

they all whose say, series a definitely a diagnostic motor the of that inclusion/exclusion the measure symptoms to sure is to patients criteria alpha-synuclein allowed have groups is we maybe be on ability And broaden the And -- time Parkinson's part these progression criteria those to well. think things, to that the mask the for this there's some and the as definitely criteria patients. we kind make accurately within that of for of overall symptoms as are we are but cognitive few same that family, inclusion/exclusion others the So, have all reason, as aren't included playing also good I cognitive a for severe inclusion/exclusion stat broader of so symptoms to patients motor impairment. they criteria of of different we exact pay

be criteria of about, is we to patients look alpha-synuclein kind you we making that at that a now diagnosis. could want lot decided – So same had what already the the to patient continuum confounding already applying of within be those considered potential and population heterogeneity, the of things all or worried and introducing

Myles Minter

guys. Hi

body into the Assessment trial? Lewy Cognitive than Montreal clarify have still greater coming to just of scores whether it's required regardless PD those points or dementia by patients, So XX they

Andy Kidd

a really example. That's Exactly. good

floor, MCI we dementia comfortable part dementia broadening believe mild that So to as a to in like, score the which that going we you up out. lower you as And range that, that we again have. are rationale quite lower haven't still is few from is, it band in changed the for with pick have of our of go very mild and that to patients band being MoCA grouping, dementia, body if Lewy the

Myles Minter

Thanks. Appreciate the clarity.

Operator

Selvaraju We with Ram from line have of question Wainwright. H.C. the next our coming

open. Your is line

Unidentified Analyst

This is Hello Mas discussion. behalf speaking everyone. of Ram. great on questions, Great

at also the Phase the release. to in in readouts affected of X given particularly vaccination We SARS-CoV-X this acceleration me, and XXXX eligible press efforts been all? trial IIb vaccination? be these would or in Has detailed have XXX group question if And the first This the for timing in for age especially X of since the among terms the appreciate applies XXX recent I ongoing well. may. to those the as

Norbert Riedel

XXX I'm and the are conducting going and is, safe address sites which these comments that environment to we Parkinson's, waiting out the at just hoping is by don't for know enough add looking study in the we have Kathryn that that were speaking, turns studies, monitored think maybe to I rate have that to the be to think, fundamentally course, have color different I are me in generally we I study of clinical confirmed Kathryn patients made. enrolment again what upcoming for the but additional getting. let question you. for and But

Kathryn King

an remove very plan. for – now has general, obstacle I right vaccination patients. we’re progressing to much think in acceleration according enrolment on I think to that’s Yes, But track perhaps we're enrolment, with some helped to

Unidentified Analyst

kind the here? forward meeting give we're XXth of presenting? of us a anything what Perfect. to And be Will be analysis data on you'll new SOBP April. there Can of looking flavor you then

Norbert Riedel

address was a because difficult Harald, maybe to that okay, little the question. hear. -- Harald, It you go question, you ahead. understand Did

Harald Murck

I Yes, got this. think I

of fishing are will data which we the things plausible. was which about. things So this which what literature We basically, guided looked described which expedition did, the on but understanding things present data described by set. literature our analysis, science, based the we predicting in data a which And quite been into we pattern we of not by themselves. extensive which We have the This our of and in did is in found outcome. an something really into order looked is definitely the have been

for this So you and gives trial. for confidence will there is signal us those the what are the precedence with describing, improve determinations, we upcoming that

Unidentified Analyst

so And a recent package PTSD if neuropsychiatry Drug Excellent. were -- in Okay. wondering review? we review cognitive focus centralized data regarding to review impairment more your or chronic Medicine are data Discovery, Thanks. pain; you addition in a -- your to maybe, Excellent. for in any packaging

Norbert Riedel

you're speak ask clearly. think Can line don't your get is -- question that The clear apologize. review hear him speaking on. not I to to up? I we could we

Nick Smith

asking about other that review articles we you Were anticipate? might

Unidentified Analyst

chronic articles neuropsychiatry cognitive review so impairment? Other Yes. to addition or maybe in pain,

Andy Kidd

Yes.

absolutely. think, I

data kind we're queue our And -- have clinical because action can and paper a of of even in understand that other we’ll pulling that to data, paper areas. that indications, do up as mechanism in I other -- lot -- published that the the look we future for always a I publication. that great review not certainly work have one lot preclinical -- was we certainly tie additional So publication pain remains preclinical in place, in ongoing, want we that I'm the things better. we we to that chronic don't together but some terms anything in that kind teed think we of a think, on the of in imminently in data that sure the and would look in together published do kind of works, we of opportunity to that to accumulate repeat of

Norbert Riedel

opportunity keep clinic very add do out the in extensive conduct. We maybe that that. think preclinical I to what on we we we on pointing to based have the is work

as we showing into in really to before IND elevate the so, the mechanistic we to do XXXX substantiate amount in go the of numerous and enormous human a paper studies. work was actually meant models pain ready paper, become particular, of chronic And compounds activity

on course, have we data comprehensive as in as well data preclinical XXX similarly so, And in models decks, of psychiatric XXX.

in of publication actually format. Andy the how it make actually like we And so, appropriate that I will as put we in visible think more said, sort time, over

Operator

our JPMorgan. line coming of next question Fye from have We the with Jessica

is open. line Your

Jessica Fye

Quick taking Good evening. question. one, the Thanks questions. for following on my guys. DPN Hey, up

So, guess, the from study around Phase that X? a want feel X? For X? buffer what study much do you'll would how clinically meaningful in do see placebo to Phase signal you Phase that in X have for that to XXXX, what represent clinically I confident in to meaningful separation in a a Phase want have you And

Andy Kidd

But I Obviously, and gets does in if from scale, NRS feel typically, X.X about safety conversation. it is the bit sort a it -- on strong. you ask there safety tolerability clinicians, placebo our tolerability a think, on depend of little is difference Yes. mean, profile very is you we the I validation in as study Thanks, recall, the clinical of profile. this that tolerability out against prior Jess. calibrated And I we you drugs something a the and It's There question. essentially good a the are think the DPN has be profile. safety prospective meaningfulness to found study. what and

study. that's would obviously, DPN disease So than I that think where in larger saw we was in in anything in difference with comfortable first We, that. the and population a be longer much the around duration that

so range looking think sort I in. the And we're that that's of

the to think, be based the clinically end prior study I detect powered that we but We to down are, lower would the meaningful that. hopeful above on range, of

Jessica Fye

you. Thank Great.

Operator

from Cantor the Duncan coming line Fitzgerald. Charles our have question with of last We

line open. Your is

Charles Duncan

to that, for going and impairment IT stage you the On this dev. it, a wondering, be with cognitive not, condo apologize follow-up to a these is you quick And mentioned in of XXX, XXX One issues. everyone study, on if terms Are looking of on patients. signal-seeking patients call perhaps question broader that at therapy? for I our on study? biz call background taking earlier dopa follow-up compounder Thank I'm Yeah. guess, clearly, then conduct and our to the regarding is the the regard to study,

Norbert Riedel

Great. Thanks, that you please? question, can Charles. Harald, take

Harald Murck

when are These particularly dysfunction, who partners Yes. patients dementia. disease show their motor

let's to allowed a be into the they be the We not medications, particularly are not focusing the see that patients those those bit medication. on I be have get cognitive any medications have on compounds motivational which to aspect, actually treating little can broadened important on. medication, necessarily an think trial. to aspects, which stable. on, be say, We is have do on on motor to stable But that So effect that but major expect those they interference but we dysfunctions, are

which in that of independence. expect something, definitely that's don't So any We has certain level treatment regard.

Charles Duncan

hypofunction imputative with Okay. wondering, with concept helpful. then mechanism you indications, I'm say, see prevalent the XXX program perhaps guess dysfunction disorders and as expanded involves of That's Very schizophrenia, good. NMDA other such likely could moving to these to, regard And you associated I cognitive neurodevelopmental being you where this orphan could space cognitive NMDA the highly disease to it with or hypofunction see more impairment? that see in

Norbert Riedel

a the because touched underlying categories of you rationale on. would just it pointed is NMDA’s and of both be think answer would as by you the I both, saying indications Charles, in to I activity, a if disregulation there scientific hypofunction that out, consider

Charles Duncan

look collaboration across when more pan-global? there's US-type perhaps that looking might I'm corporate indications regarding the you're XXXX? II? activity I broadening – about activity you at, question it collaboration consider if wondering, activity. point highly perhaps wondering, would for some And corporate data in collaboration be Phase I'm which And your Last guess ex do would higher make prevalent, as more sense think you broad or a it post you of at Okay. – pipeline, call for it,

Ashish Khanna

Yes. Thanks, is Ashish. Charles. This

We year. later studies funded collaborative recommencing studies pipeline and and meaningful indications, all and initiated of the with that well that be underway be the input enhance next very offer and would or those discussions. meaningfully well that the are our data data and We this inform think in any ongoing, would are to either value focused much across in of equipped getting soon

to focused have on the do so getting in of and investors that. our And balance support we're those sheet

of a a II the I opportunity points area pain, very with about most commercialization. addressed that that probably the about effects we're our saw to the chronic we it our replication in think call to if credibly studies, when very, is we've in therapeutic as think that a first pipeline, partnership see is comes talked past addresses able number of and Phase of we physician that broad

opportunity interested And that shareholder well something so by to meaningful take to that it and are – be advancement responsible we but we the the when offer an value. to and the program. for studies and certainly rapid can that think add you that ensure next know, we'd that data juncture that's efficient in next at time and as equipped be add as value It's We that we exploring far can value. a informed the need

about open are advancing not collaborations question different areas of Your partnership to any scopes programs. think, good that can we'd we actively And and our such meaningfully progress endpoints. are coming we next, I data any types of certain be one. are where enhance towards we very discussion structures are There programs and that those, toward advancing getting again, we're inform would the discussions. think, and that are again, making on regulatory reliant these much the But which we're meaningfully focused not on

Charles Duncan

my That’s helpful, Norbert, for follow-up. thanks Ashish, taking

Norbert Riedel

Thank you, Charles.

Operator

There time. back this will now are closing call at remarks. for the over Norbert I turn no to further questions

Norbert Riedel

Talk all And your thoughtful your enjoy you the for safe, Thank Bye-bye. your to the you. soon. the We you, Thank attention. and your be thank for time upcoming your questions week springtime. rest well, and operator. call. the on rest of Please and days, appreciate being you stay

Operator

today's call. conference This concludes

You disconnect. may now