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Aptinyx (APTX)

Participants
Patrick Flavin Senior Manager, Corporate Development and Investor Relations
Norbert Riedel CEO & Director
Andrew Kidd President & COO
Ashish Khanna CFO & Chief Business Officer
Harald Murck VP, Clinical and Medical Affairs
Kathryn King SVP, Clinical & CMC Operations
Ritu Baral Cowen and Company
Charles Duncan Cantor Fitzgerald & Co.
Joon Lee Truist Securities
Madhumita Yennawar SVB Leerink
Myles Minter William Blair & Company
Nicole Gabreski Piper Sandler & Co.
Call transcript
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Operator

Good afternoon, and welcome to the Aptinyx Third Quarter 2021 Financial Results Conference Call. [Operator Instructions]. 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 Patrick Flavin, Senior Manager, Corporate Development and Investor Relations at Aptinyx. Patrick, please proceed.

Patrick Flavin

thanks Aptinyx's us for financial quarter XXXX. and call today's the everyone, of discuss to and afternoon, for on joining conference third Good operating results

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

Kathryn the Vice President CMC of addition, call. the on of Vice Operations; Medical and Clinical for Affairs, are In and King, Senior Clinical the Murck, of and portion Harald line President Q&A

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

Norbert Riedel

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

in months roles cell gene across to for development, welcome colleague Dr. to medical and to several CNS future including development medicine are development leadership particularly Later affairs, clinical plans, O'Neill and thrilled resource Aptinyx, period President also catalysts a we serves Aptinyx impressive leads our company's functions. of XX-year affairs on neurologists. pharmacovigilance Gilmore looking extensive Directors. CNS time year, ahead. program Sarepta extend numerous at in from previous I development, and of multiple practicing as He O'Neill, diseases, updates with we Vice a NYX-XXX confident global in I his research, of program, have where with Biogen, Therapeutics, we and a pain, PTSD. development Chief drug Gilmore aboard. been brings currently newest at and are and in guide drug begin of productive of late-stage initiate to rare the held an in would patients experience will our data from These we has Executive where marketing He Phase Board this he as and he IIb to academic and forward clinical past regulatory programs growth as Dr. numerous serve neurology, R&D the our am an therapy like tenure him an oversight to helping approvals. plan active invaluable and Medical welcome Officer our warm background execution Before

progressing NYX-XXX access strong slate million. to $XX we in in XXXX, neuropathy Meanwhile, well bolstered to a balance full We second from the have to XXXX. study in NYX-XXXX anticipated this the results quarter, and and moving a we second by are we painful up half of development With of expect respectively. very also readouts mid-XXXX cognitive gross last sheet, recently programs credit that ahead, the of facility secured in diabetic of studies impairment speed pleased NYX-XXXX during clinical providing announced with Phase to enrollment in peripheral our fibromyalgia in of quarter IIb report our is

January of Executive our we of Chairman across Kidd the announced and our transition, each to well, expected of readouts which programs, effective become the more that XXXX our the is and to to turn quarterly chronic around XXXX. X, will position transition Recall NYX-XXXX and to capital leadership rollout current pipeline of and with in assume Phase planned into during President to hit has over that call, proceed year. role will Our programs our from Patrick data our running The I continued Andy pain. fund XXXX. last new II prepared beginning call CEO, team the very will dive is detail now ground in each Andy

Andrew Kidd

Thanks, Norbert, good and afternoon, everyone.

study We're data from from previous study, followed study steady months Phase painful by enrollment predicated progress robust on patients DPN. in must across Phase patients several expecting the prior II NYX-XXXX of been DPM. for the have October, patients a As enrollment most clinical across Norbert our has painful of past longer. IIb a to XX-day made with this chronic our XX-week The in study IIb particularly both the treatment X more we report on period in our superb presented of of highlighted mid-part a with safety This chronic years data effects DPN pleased the Phase the patients with results, then sites research. our consistent the the in studies. over study course the those showed period second with environment in monitoring and living Phase pandemic In Nonetheless, with pace. patients disease, industry, XXXX. challenges recently most mechanism. we're has over of The who early of complete a is period. quarter engagement execution our IIb clearly past In study the teams to pain enrolled completed and NYX-XXXX enabled us earlier, complete very or we acting the enrolled at of over centrally the to in year Based

detect endpoint efficacy not patients not In and to We ability allow the separation analgesic in concomitant were medications using on XX-point to prior in is the from a from also pain, study take medication. saw numeric placebo change baseline daily during rating the we the to greater pain did study, patients scale. weekly X who The study. a of the of the average background XX-week patient-reported over evaluated primary period

is this neuropathic primary registration and pain. endpoint are Phase While with data study, be from we duration a study typical for further Therefore, development. study the believe studies highly the consistent for informative this II this should late-stage

is study. in In well, fibromyalgia in NYX-XXXX of dose study enrollment approximately painful This of expect a larger addition versus the to DPN NYX-XXXX target X with in levels IIb and evaluating fibromyalgia. Enrollment the study read has in we out conducting study we're the a Phase to target DPN, it of to of study also a XXX progress mid-XXXX. in XXX and patients continues patients

for we're the given cognitive of of disease relevant a Let's Phase Parkinson's data treatment function. progressing with placebo and bodies therapeutically recently strength with data new associated our neurodegenerative for in of impairment models currently this study and patients Enrollment turn of measures translatable seen period. with about in therapies disorders. we've with XX-week memory we II to incredibly dementia cognitive associated dementia candidate in steadily NYX-XXX or the our assess NYX-XXX enthusiasm a cognitive impairment. to with of in is a of product to double-blind to with approximately program with Parkinson's for detect associated now study anticipate executive Lewy bodies. of deficits, XX-milligram study and in with Furthermore, deficits under XXX over attention, the development first-in-patient preclinical second This year. tolerability exploratory Lewy NYX-XXX in continue excited on an comparing utilizing half activity a is and enhanced safety and cognitive treatment reporting cognitive evaluation disease is which next specific development impairment This NYX-XXX, is dose

in Finally, the candidate NYX-XXX, treatment stress of we'll development posttraumatic discuss our product for disorder.

IIb Phase patients symptoms of be first soon of observed on patients with This our study with among PTSD encouraging planned Phase which exploratory studies in follows II X NYX-XXX. in the will Phase PTSD. We treated we previous IIb initiating improvements in program NYX-XXX

is will the to versus milligrams The first end expected of Phase the by dosing initiate of IIb study of NYX-XXX placebo year. once-daily XX and evaluate

placebo XXXX. standard first second will once-daily positive, are treatment if which approximately XX-week endpoint IIb XXX expected enroll of used to registration a well NYX-XXX off dosing consideration CAPS-X primary The period expected in the with study, of the regulatory supportive had total studies positioned discussions is as these FDA. include Phase versus is we've of and study for milligrams on kick believe score. We based patients, the quarter Each XXX evaluate of to the

Of course, on successful. decide at agency a will prove later the this matter to the should consider for studies a and date, ultimately be

initiations and our we're next that, financial review and we third see, all disease As data across now looking of call to and upcoming series forward to will study over lot programs areas, year. have turn you to of results. Ashish of a activity can the a With I quarter readouts underway our

Ashish Khanna

Thank Andy. you,

As Andy, our heard Norbert progress from third on pleased in you with both advancing the pipeline are made we quarter. we've and the

clinical data fund development the front, secure have to access upcoming. flexibility Phase us ensure we during have On to our catalysts capital the facility runway pleased capital us capital. readouts with to under facility plan down decisions further funded up we a were made which to additional and programs all through We credit the quarter II of growth extends draw financial of key operational in provides series well KX in to across strategic the to and $XX and II financial are we through our XXXX. million Phase from The enables our HealthVentures, study operations

$X.X of for cognitive our clinical for million $X.X quarter development to chronic development to of review attributed across pain for million majority focused across Let's expenses ramp-up R&D for in $X to the were expenses impairment. clinical activities our our the portfolio. on increase We the results compared quarter. to reported was financial the and and XXXX, period in third a same in third second an million The quarter XXXX. million $XX.X studies G&A same compared spend the for research ongoing our related period

the we the end million and XXXX. the same third the million to quarter ended equivalents to million million XXXX quarter And of at $XX.X was in period of for compared loss loss net $XXX net of $XXX.X compared cash third with finally, Our XXXX. cash $XX.X in a for

expect ahead in over to data As Norbert. we year-end, both into XXXX. I'll With the the we now operationally of positioned multiple are back catalysts call head that, well turn financially we and

Norbert Riedel

Thank you Ashish. much, very

our approach year, as value remain a creation execute focused are we balance next potentially for prepared the well of XX the and by readouts With across all to the months on multiple anchored approach we patients of continuing of As sheet, alike. we and we period over start clinical II development programs. new transformative a strong Phase shareholders

your We are take questions to happy now.

Operator

[Operator Instructions].

Cowen. with Baral first question Ritu is the The from line of

Ritu Baral

the scale ask placebo around the And what final wanted or given be of rating the of what a And at for the time? DPN follow-up. enrolled. patients it the quick. more What think that's drop thinking least conduct what final with numeric to be out, then the quick I've on will study promise we should think more I is? and study study about importantly, compared I do chronic conmed, the primary got pain? next no changes the anticipating -- to the to pain be you completely last endpoint you readout is I think -- XX should be final What you the longer powering we -- XX have do since

Norbert Riedel

Ritu. the Thanks question, for

quite imagine, well KOLs, expect or our we have with to of give we you difference placebo to a Andy can you versus with meaningful thinking I'm have to and what number in discussed this treatment group. going as As clinical respect

Andrew Kidd

Thanks, Yes. Norbert.

I or single to a we've effect, difference above always a depends anything said a that cutoff It little that. of profile. In safety terms meaningful greater bit active would clinically of think the meaningful. hard between score on like obviously little X.X clinically be always bit placebo pain the It's and create

course, the I is It which we powered with things comfortable that we're know. terms we the little meaningful think a final meaningful. the the variance a see and what in discontinuations. think the signal. quite drug, I think But the better clinically enrollment of in bit, lower tolerated of turned out We depends on don't we're range difference study, of clinically yet in have is where

guess in quite mean effect. things tell. try to placebo as know did for I if a control until we see effect, we successful the was to to the few it's we hard so quite I the won't study placebo the data. But And that

Ritu Baral

there's Got secondary it. outcomes on range And then a clinicaltrials.gov. listed of

direct hierarchical use most to you ones plan? prospectively think patient sort at fleet least there score think of to I analysis medication. which are global a XX Is can analysis about impression ranging of the statistical of the to rescue as clinically important. within from you Or secondaries the

Norbert Riedel

want take as do Andy, to you that well?

Andrew Kidd

Yes, certainly.

discuss guess than statistical or of to are the about. I we'll data obviously, other detailed deferred But So I impression talk think we until certainly do think I interesting. primary -- global the discussion have measures endpoint of that plans the

measures just and daily here. interesting looking This primary a study think some on defined average other really really are pain, pain pain I a with at is of other the of weight as know, patients you lot DPN condition the which endpoint as we're is where, though than of well. has the

Operator

from The Charles the next is question of Fitzgerald. Cantor with line Duncan

Charles Duncan

question and I a then ask XXXX about Also about to wanted I you quickly. XXX had

database if could is neuropathy I medications. And was And And I there us you open-label study? fully extension study how there forward remind guess you the a had pain wondering question then that then you guess, wondering be indication. concomitant that would component I off to no I'm secondarily, safety imagine about diabetic could that a an in established they painful waiting drug? stayed that And Regarding the And so, going required in I'm period? there enrolls enrolled, the is any about that? are that if

Norbert Riedel

by questions, kick do those going Harald Andy All And in actually are and have step step. and but it X this. the to Andy I think take them Charles, tackle in off which right. asked. can you Maybe it let's order I'm

Andrew Kidd

good. sounds Yes,

can I'll -- couple hit I of points. a So

which that part to of I in off about of terms yes, of as the screening course, it conmed, the you're medication of not the no depends think was possible it or talking study. actually conmeds, period whether as wash to

physicians are of can considered to then to drugs that to come as understood study, more work can separately some from after patient the it once part that, come to. on difficult And their discontinue required drug if was that protocol. was So A that the wanted off they study. not from with screen stream they the they

period, medications weeks. screening to of acting period over of some were that washed the Within off up shorter a there X patients the

as guidance There using will is on we a the but not an Phase prior definitive we in chronic II right to have would a how until sort of But expect we of to guide, end period that was that think of certainly in have meeting requirements of pain patients are So medication? extension, extension be we details that open-label of And there open-label handled. for was you then not we back I will an terms terms future more I with FDA that data. after open-label not studies. the and Phase for cover of III that now, met do an made in sure on to have Harald, washout the we extension. any want an FDA then how sense studies kind weren't period requirements discuss with And would have think other safety going database, NDA. these on

Harald Murck

something a the would the trial. concomitant sure deviation, get of I some of a of be a are would during medical monitoring at medical course, course, day, beginning we, at medication, make reason, want if starting kind the any And perspective be same protocol the to are just any we which point trial. the for indication the end at that's, needs acceptable. of that patient from We Yes. to of patients but mean

allowed washed medications out. not So are

trial this with keep well regard general question? answer it's for versus be being, let's think your their, of doesn't only course. patients that I considered mind in Does to important in interfere those should that the say,

Charles Duncan

appreciate Yes. No, I the color. helpful. very

ask or impairment are PD if like about not brain biomarker EEG measures which study. could that or in I blood biomarker a DLB, for quantitative But collecting cognitive and question XXX, so something get the you Just hopping in you data, over of including any to data whatever? example, activity any is from

Norbert Riedel

Harald?

Harald Murck

the biomarkers. physiological not are we of but actually, number a at So looking markers, blood

example, all, they those looking So a relevant. which for plays be there to certain may role in those inflammation things, these are parameters, are

of -- biomarker variables, tests in computerized But be of us with well. kind course, to regarded cognitive should with of which move biomarkers that some step say, So people type into helps do clinical a to those an then think program experimental we we see primary They I IIb. second trying as as cognitive Phase the cognitive place. which a function. do more approach tests their what we somewhat What of course, forward have, correlate outcome are would do parameters, is as to to limited. cognitive of are let's are, solely computerized

Charles Duncan

that And Parkinson's relatively patients back anything in that then disease would the advanced you patient in I'll that, you a enrolling consider else impairment? be follow-up therefore, to and, hallucinations hop progression experience queue. cognitive possibly to beyond or sample, are to going their in

Norbert Riedel

Harald, you well. can take that as

Harald Murck

yes. yes, Yes,

not -- small basically, we neuroleptic very have a for allow we psychosis. neuroleptics So or treatment exception -- we this not allowing but sleep patients where who with a are with of treated people are induction, the

So happen expected patients particularly in level any Lewy that a or happen of body not which, they patients course, with dementia. on be didn't have to in can to hallucinations, experience

course, motor -- needs, Parkinson's these a which of in from much is the the subjects of which investigator with doing that in cognitive these much of patients has means type the during some have control. of criteria, allow interfere are make of cognitive people trial, of all subjects a are clinical one Regarding which motor really testing. range, course, capable And of to in motor if testing, is we to the so, want -- the is tested the a also the period, which on basically sure dysfunctions participation there interfere course, computerized the assessment this can, perspective, do of are you make with the severity disease how how we

is the investigator. the based So that's of assessment cutoff, a which on

Operator

from of question is line with next the Truist. The Joon Lee

Joon Lee

post-analysis on question, opposed in just be it's just it in based to a actively you is study. like our concomitant made who payments. patients the we're the that understanding concomitant enrolling prior needed of who post-analysis payment washed as like did, on of for to were on In Phase patients to study Ib Just sounds not that payments Phase they patients are DPN in the weren't group IIa DPN out because just

watching meds needed were the on they in on be that the by pain that kind Phase And them what of created So bias analysis? IIb payment, they a in post out follow-up. I have were to that of

Norbert Riedel

think who you can it a that. wash if pain patients I were clear, concomitant to it's is be only start Joon, But medication. -- allowing not not as just Andy, we off

have with on We are concomitant as medication those to as not off. that begin that a those wash well

with you as study on just so So give I clarification, wrong impression the a the don't design.

Andrew Kidd

Norbert, point Charles the to washes get Yes, was not think off medication, that a and to that that, the the into make exactly. covered that study. patient going way only I I from if was question when

number reminder, off there a the start one last patients with. not I the think to been into large study, were in in patients get a of to concomitant washing quite study. on analgesics the as study actually, have drugs those And of will

You on allowed were one only analgesic. other to

concomitant of medication did that a that few we're kind. include not last patients they actually, a in some pain of the taking quite So off, that medication study the -- washed group patients

I number may washed actually, a wash you that that the were And made we're there were think those drugs Pregabalin, to off. and point something had other taking of not a taking drugs but that Duloxetine, off. of still were in Gabapentin, like them there the have we past one lot

be likely fairly it's last think to we saw I the study. in what population to similar So a

Joon Lee

Okay.

data than believe, And more your second on meds one DPN, I'm wanted both thing But that in X better understand advanced I What are do to something years. for like Okay. is on those a they chart or X-point with slides advanced look if just like? have DPN, greater curious the you have have more patients for and I improvement you where in and those with meds a that. one slide with chart data does NRS with of a concomitant concomitant not DPN?

Norbert Riedel

Yes.

had this were strongest have X have do But can we you those a the -- benefit when on not active were we compare the and data, disease actual years So numbers. effect the a against medication, longer that placebo. hence of and concomitant up and duration look treatment longer,

Joon Lee

just been but That Yes. data that makes sense, presented. has a curious lot of if ever

Norbert Riedel

we Yes, up as we looking speak. are it

we we So find back you. away, if to can't right get it

Ashish Khanna

I sure make sure is this Ashish. correctly. I understand Joon, So, -- want I make to the want question to

patients years. the medications than You're X study looking who in DPN for last DPN not on to concomitant among were algetic with the greater effects advanced or in and equal

Joon Lee

You got it.

Ashish Khanna

I in or believe, they're on out years X And a... had alongside greater presented data, There's of XXX public Those are sort patients XXX the of presentations. our website our who advanced DPN.

Joon Lee

So That's on the XXX concomitant are the deal. med. patients not

Ashish Khanna

no. no, No,

noted, of clarify. equal presented Sorry, it's had those X XXX significantly were ends. NRS reductions separating subpopulation scale X to from of XX weeks analgesic A points DPN. X the those patients than of on were let on we with greater of and those lower And half you concomitant about a of as over saw also very in years in placebo, alongside, patients in pain me not a patients. patients were those excess very medications. profound only who subset or albeit just

Joon Lee

-- to data it. second next mid Got of quarter looking forward And to early the 'XX.

Operator

is question SVB. Marc the Goodman next The of line from with

Madhumita Yennawar

have for of the just is PTSD Madhu couple and This studies. questions line the XXX on a on Marc. I

of terms call think to the placebo mentioned more in able prior initiation. bit your you little a strategies you about that closer would rates managing to I be in talk

could of and registrational this of thinking X the -- may wondering given about of us sort kind there? studies, then be color any So the you was additional bar And what's X if the be there. what give like should I efficacy secondly, efficacy we

Norbert Riedel

help you. and or off Andy, we supplement you. accordingly. maybe Thank Terrific. Harald right. then kick Again, can I complement think can it All

Andrew Kidd

Yes.

good. part the first. second I'll Sounds take

and a the good from X% as in separation said the to that digits sufficient as low say, with believe we've long of, a statistically it's think especially to I significant. past is mid-single digits X%, drug tolerability, mid-single continue for to placebo probably in

factors about we've clinicians a the there's change from a think more I baseline to I can more on. really, the today. mitigation, are when that focused go being With think, also detail we I think, can that, initiate studies. little But the reiterate and actually talked rate placebo responder we into response on respect few points we

that one I some allows try ratio We've taken a think think, is, active Obviously, other study for randomization variables study between the and and minimizing effect to also, look placebo. side of X:X design at the I design consideration looked to things we've make placebo like on study at that. the screening as and sure we mitigating of as criteria duration or they're

can over I months. think, a the go I think And sites subjects on placebo design into we part and detail involves, the more key more also what for of a next mitigation details disclose also the some on few of study as the little include both will raters. we that full for training

Harald Murck

PTSD on to Yes. the number more took early suppose, question the to I have rate. now, visit focused huge there's as the really In a the and the both. I And effect higher, should they on previous visit and the have Also, we think celebrating half reduced the scale we that, trial, just the actually scale. one, we and which patients, we investigator investigator-rated add exposure, the trial, yes, exposure placebo well. response to out, In of response an actually placebo an did maybe just this

Operator

Minter the of William Myles is question next The from Blair. line with

Myles Minter

with. to XXXX on off Just start

the therapy, with it's that for weeks plateau. therapy outside looks And in much I'm It prior still I XX evidence XX additional data expect. of of other that the seem was trial, the like also preliminary the have efficacy fibromyalgia of On Phase of understand IIb to to the we do X-week that a evidence of response we're potential think efficacy-enhancing seeing sort deepening how just on doesn't any weeks trajectory. you the the out best of X-week trying the can data. data

Norbert Riedel

Yes.

for we see think question, pretty we our efficacy. And typically X to be saw XX-milligram some rapid thanks like to decline week we the a in to did you of from by mentioned of In very a likely already the selected the the to study, current study, earlier week So the week we onset Myles. X the see a additional see, clear And X I we with do observations, would of linear activity dose indication dose thereafter. X previous IIb week that or way. that Phase improvements very

like studies to look in typically While you this when placebo begins plateau.

very concomitant points the So dramatic scale. XX-point was both particular, what stronger that we DPN than X moment we even of reduction separation a results contribute And of rating medication mentioned those a had, very, of to better absence ago should pain in saw. and already Ashish in the advanced in the in

that supportive a study we study. a that So that you The I find very onset. had context encouraging is fibromyalgia of the and think current likewise, be to mentioned, rapid

X the quite X dose, observed dose, -- weeks about not in it did see was after XXX-milligram lower actually, lower given which was in weeks dose. we the While readily it the

the here. same was And It in that pain. It as it average was was And out, applies promised study, questionnaire. It couple, daily not so was scale. worth a we the fatigue daily Myles, pointed just pain.

We at this those very because in a to changes solid that endpoint. the how this or patient very of seems to in All results which and outcomes in the not that like that we efficacious, on addition brain direction physiology. single it relying mechanism with to study all look actually to we being be multiple strongly biomarker reported are point out actually dose support pretty XXX-milligram clearly right move correlated in part the

Myles Minter

IIb. just Phase then on a And question the number Okay. in clarification involvement

XXX participants that think clinicaltrials.gov. I it's on sit

number me whether up you can't or tell me ended the you with, you tell can If over it's under?

Norbert Riedel

If we number, like -- XXX. -- ended can we told you the the tell up we can't number we you

Myles Minter

All right.

line. in Sorry,

on preclinical one final is for The Okay. work XXX, the done. you've me that

that injections MPTP with don't primates nonhuman on data seen cause I've think dysfunction. motor I

transgenic have a you've But is inject wondering any apart alternative that how because, few, just whether patients themselves out work we model. obviously, alpha-synuclein you don't models. wondering a from in with which MPTP MPTP actually work is done preclinical in there done Just mice found additional

Andrew Kidd

that Myles, model in show alpha-synuclein I to And carefully we nonhuman a that really mice well-characterized kind there comfortable we'd considered weren't of it quite the already that or characterized it, primate really deficit was work. after at done there think model a -- meaningful it's I cognitive well the looked addressed. MPTP actually would we isn't think, be

looked So effects at I replicate not of display uncomfortable lot of disease. try to model that model the of a we the development administering deficit, seen to Parkinson's we that chronically fact doesn't same long deficits. A create does the of And motor are that at into But period it the severe and the protocol that went MPTP motor just over to MPTP time part think cognitive the that. were in deficit a severe seems not create work of with haven't time.

to thought action were the So it and translatable was comfortable and look model at. was very a we with best model

Operator

BMO with is line question from next Gary The of Capital Nachman Markets. the

Unidentified Analyst

thought what XXX-milligram first in Gary PTSD. us previous higher evaluated This if is Ed any What that there? can safety concerns were My you regarding for XXX highest going some Floss the a remind and was talks And Nachman. are question having for dose there theoretical is dose? you

Norbert Riedel

sure. Yes,

off. this kick me Let

number of know XX employ the of we which our mention. and tested safe, we is course, we that to models of which that XXX dose from already dose preclinical a quite of and important efficacious are the So

XXX is have the our data, also much which milligram We data, dose. which dose go and Phase beyond ascending single multiple I

case, our a and in to we very, very favorable tolerability really So consistently safety seen have profile. are fortunate

be safety other that case limited dose might While the development tolerability compounds. is our in these compounds concerns, with of because not or studies in

a tolerability. it And because so the entering on efficacy and dose work, based we Phase is all understanding another additional that give the of testing have without dose of that feel preclinical worth should safety at I is concerned XXX-milligram being done about us the or space better work the we

Unidentified Analyst

more follow-up then Got me. one it. And for

been enrolled tracking enrollment studies? the has due patients increase Delta studies variant? how for far studies, fibromyalgia XXX been many given those and impairment And those the cognitive XXX to have how in so in the hospitalizations For

Norbert Riedel

have Well, to great Kathryn for going that you. question. answer I'm

Kathryn King

things in of continue track XXX readout well XXXX fibromyalgia. We're on our impact to then in track. We be tracking stay And but for watching carefully we certainly been are study to of COVID Yes. the trial, on the and data cognitive the and have second mid year. half in both looking across impairment next

Operator

from is Piper Raymond The Sandler. of next question line Chris with the

Nicole Gabreski

provide can on you completion has trials date guess, sound had this know data guess, been Nicole This a now has on is bit, just XXXX, for the Gabreski change fibromyalgia, I mid Phase doesn't but Chris. looks is IIb timing modified half clarity clinical this the language? around any nitpicking around been to for it update primary guys have first June I issues. 'XX know enrollment I it 'XX. like necessarily just in I any like and from you just

a So I'm potentially around about conference. just be you thinking maybe releasing wondering could results medical if

So clarity around be would just great. that any

Norbert Riedel

question. you Thank for Okay. the

I not more of number just the correction. we in correct study. available, meant it's Let on myself, the script why website, in I patient sense that's me publicly is my said comment, I in mention government the one formally XXX the told the okay? the you did But of number course. make Just DPN And number, for to for the Nicole, that

we as study. the or fibromyalgia for the On at have is like going read we with were maybe And the study enrollment. spill out of complete really the better first will we end provide in as the quarter. for pleased this over question the second done guidance DPN likely we We're in definitive at more to are study, enrollment, fibromyalgia DPN planned. It just enrolling that, half think XXX of But a the as we bit. point, little that guidance could

XXXX body a we dementia will but still by is mentioned, XXX of study on complete is better half of we the that second numbers as as the enrollment we that We track, in course, and Lewy we And see, for of have understanding Parkinson's for have. supported enrollment.

And change communicated so lines those that time before. no we reason to actually

Nicole Gabreski

And then question XXX. quick Okay. second helpful. maybe a That's on very just

enrollment starts the that staggered. Study and between are X any know X guess, that concern could enrollment I managing is X. there I in around But than Just longer study Study take out with docs that? have enroll XXX-milligram of you to patients on guess higher any expected? of X. feedback for are holding kind kind the If dose I patients Study or heard

Norbert Riedel

Why don't Kathryn add give you can that? to you answer the that. to

Kathryn King

Yes.

to at there different investigator is put studies actually different strategy sites. the Our

will a they're important that, or running. So of enrolled advance we gives and is bias development as which not will study in They the -- both the that, think clinic, option is studies, the have reduces lands across those us be they where and clinic going sample We comfortable where that that program. also patient studies. to representative the that geographically

Operator

is question the Selvaraju H.C. from line of Wainwright. next Ram with The

Unidentified Analyst

This for is [indiscernible] Ram. on

your are of progressing programs cohesively terms in readouts. of well All enrollment very and initiation,

about to your gears, in discovery you're reveal? biology, to that or shift wish any to are in share pipeline systems, receptor and Just impact you new target excited able progress indications that you

Norbert Riedel

attention think great little it I when report. typically That's a gets too we question. And

So these just here, audience have for synthesizing to time. quite maybe a our allosteric some modulators been as positive we reminder

characterize that not differ in the Within We bind is previously the designed described have domain, And That's advanced bind. but have to we investigate compound of that new ready X-year where binding that a X,XXX synthesized tight further of we out those latest next, a as advance compound to part another programs on with and do where receptor be our profiled further. clinic, right it's one from compounds to the course, the binding And them. to the at discussed binding a characterize are also it with of compound. and biology of we pool, our effect than and abolish of of rich choose the bind. in where portfolio time, the can completely the nicely the a mutation what We more IND plan, part. molecular single a that compounds quite gives We really preclinical or number domain sites that course, compounds that tools, on before, pharmacologically. the point domain. we They the they us currently can of into domain of and from

library we it modulators there more of engagement quite receptor. data preclinical extensive the to support make a is allosteric present at an an the in us perhaps of for that the on of pharmacology acting NMDA space receptor positive little leader do the so And have I this does and broadly believe the because opportunity that us And compound. some point

Operator

with a of from Blair. is question question line next The Minter William Myles the follow-up

Myles Minter

Yes.

Sorry, Norbert, question to is Ashish. apologize. no need My to actually

you're think fund of debt and a an those and Are draw we both got facilities pipeline? readout also data continuously, just You've both of expecting how you're in facility to you utilizing going for place sort down that moving to wait of the a those do active ATM. about forward going to

Ashish Khanna

for the Myles. Thanks Yes. question,

I access the we're and about our II through incremental to attentive in at time, fibromyalgia think data, course, think right that development. PTSD need us DPN cash in sheet, really both funds the in in and don't to we're be impairment. think pipeline that we've in with we're in and the of continue balance been ahead flexibility across appropriately But a support appropriate about we'll, That gives each now. actually clinical to in program in nice with financing. capital I especially next readouts multiple Phase steps or data We'll be. good enhancement position to of both always and and sheet sheet data. the also But every the think cognitive position but balance to the strong but balance to any pleased regard of rush a and then a

Operator

to turn at to I the I am Norbert showing no for closing would further any like questions time. comments. over this call back

Norbert Riedel

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

Operator

for us you Thank today. joining

You may now disconnect.