Aptinyx (APTX)

Nick Smith Senior Director, Corporate Development & IR
Norbert Riedel President & CEO
Ashish Khanna CFO & Chief Business Officer
Andy Kidd COO
Kathryn King SVP, Clinical Development
Rolando Gutierrez SVP. Medical and Pharmacovigilance
Joon Lee Truist Securities
Charles Duncan Cantor Fitzgerald
Marc Goodman SVB Leerink
Gary Nachman BMO Capital Markets
Ritu Baral Cowen
Myles Minter William Blair
Call transcript
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Good afternoon and welcome to the Aptinyx Second Quarter 2020 Financial Results Conference Call. At this time, all participants are on listen-only mode.

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

Nick Smith

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

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

I'd who clinical will today's and we Securities, have a followed warm from initiated Norbert join excited and call to will coverage financial on President discuss Khanna, us Riedel, Chief to welcome Before by like spend results. On Joon to and started, Lee Officer we're our business our June. get Ashish Executive Chief recently Chief Truist our Business review the progress, Financial Officer Officer, who Company, the

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

Norbert Riedel

colleagues in milestone programs, taking to a months good file have The your been our our We achievement and pipeline team's clinical past health. appreciate us the your advance significant dedicated few X in loved of exploratory our we and Thank you, employment on afternoon hope marked are ones good to in the everyone. you, of Nick, in of highlighted time and call Phase our PTSD. NYX-XXX today, by completion join of efforts study you

we with NYX-XXXX studies stages chronic escalation the you in study September, extended following Phase share in implementing final fibromyalgia NYX-XXXX followed recommence Xb are DPN in year. the in the of COVID-XX by study Additionally, of March we're our pain. next pleased very that painful studies the paused are of to year pandemic. this our We to we late very of early These or in

against ongoing our this is am the noteworthy the All dedication I backdrop pandemic the of of especially by progress and of proud team. demonstrated

this of study. in programs. we discuss involved some XXX from the Phase of this enrollment an evaluate Phase announced We'll primary update to of exploratory the study NYX-XXX guide a we patients and in Recall, begin to and future completion insights patients and patients design development. study on specifics of goal in of efficacy NYX-XXX study the all to under is obtain is is generated this NYX-XXX. PTSD, pipeline with evaluation our June, In Let's This time, in with first X study with PTSD. X initial the our is data safety subsequent and which

design, weeks we two milligrams, compared of placebo of treatment. once of and XX reminder brief NYX-XXX, four XX levels milligrams study As the are to evaluating daily dose over

CAPS-X utilizing design population the and a detection exhibit parallel signal sequential study, we efficacy trust in the scale points. to known comparison of are placebo enhance the risk employing to sub-scores score total In the to evaluate are high We a NYX-XXX.

other DSM-X and function evaluates exploratory various CAPS-X across The of end all to of disorder. the of understand according the moods, enable profile sleep secondary including points symptoms, through efficacy combination NYX-XXX cognitive other will which PTSD multiple different symptoms the manifestations with the use to evaluating also are points. we us end Importantly, and of in

unique As patients experience dose effect inclusion first in in There's fourth more around our and focus but mechanism we in may and completed have design still size impact anticipate all quarter the order our the larger, get XXXX. we end expectations of we any exclusion conduct points, our level, evaluate efficiency last closeout studies. far, COVID-XX just closeout to to on for learn and of the ready the some for The activities, collected expect NYX-XXX to subject the employ about results the reporting multiple have on the study of us based time, to more data and definitive and patient recently empowering we shifted in uncertainty assessments the thus criteria activities, study, pandemic to the analysis. of in the

management the As on final highlight Stein. our from presentations like This as team Dr. data authority comprehensive that of our event R&D Dr. on NYX-XXX, medical team Xth. mechanism and a to virtual PTSD-focused would comment presentation a Murray distinguished I provided of our pogrom featured Diego, in would on leading on PTSD, Presentations to all NYX-XXX well San the the learning presentation comprehensive this is as need. the medical to current pre-clinical and a August from the PTSD hosted anyone and of Stein a in view unmet about section a and professor of encourage substantial websites. University psychiatry program overview more Events I our of the treatments at California, PTSD, interested

a pain to NYX-XXXX peripheral chronic in painful and with development Let's diabetic neuropathy now move two fibromyalgia or DPN. indications, clinical

recently Phase all-in in resume fibromyalgia, begun in to as accelerate NYX-XXXX IRB gained study patient we served we of extensive efforts experience these had pandemic patients the executing during in and to PTSD we with Following data have our and study and a approval we of have our focus the studies the Xb well. integrity. received Those the been the safety expect as well diligently suspension working studies, to and on two September. as pandemic, X Phase due We recommencing on COVID-XX

later Xb in hard patient working A or Phase will this this year been COVID-XX. our study also XXXX. We recommend that DPN. painful anticipate is in early have resume now population risk to higher study to We

we recommence committed and as remain sidesteps the forward top and safety patients with well our these investigative we As to being priority. studies, of moving

current Our of in the to the that first out these can able read the should timing on Once expectation from of during of both the pandemic, ongoing half studies these guidance environments, the we XXXX. will anticipated is of be studies. gauge provide results updated pace we

suspended treatment we In light initiated cognitive mild XXX touch Parkinson's Recall, Finally, for NYX-XXX X patients study associated throughout pandemic, with requires due because to the study let's patients XX-week to of vulnerability of frequent station cognitive disease. performance population COVID-XX exploratory the with undergo we cognitive and assess on in treatment. of the the interactions the Phase first to site in-patient the impairments. our the impairment design

the advancing timelines the date. plans shown of very We incredibly evaluate we these our guidance consideration, forwards quarter chronic studies we cognitive pleased the PTSD a As by setbacks am progress including we NYX-XXX deficits determining and effects from next innovative fourth models I pipeline are Despite the of the in remain in introduced cognitive best expected translatable all reversal in COVID-XX, primate our provide made potential to about Phase three and path excited into factors updated on to significant NYX-XXX, X overall of impairment, compelling pipeline. the our cognitive we demonstrated non-human expect XX pain, various over of impairments, XX and marked our important With the the a resumption future in best with the to at in module. data highly readouts of on data have months. of take we expect which has

address excited including in quarter With unmet medical have to our that, treating each potential the hand Ashish will call our We are product over devastating CNS very needs, financial discuss results. candidates second I about now of to the major to disorders.

Ashish Khanna

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

data up which terms contractual of the coming subsidiary upon non-cash multiple XXXX of rely wholly-owned our revenues revenues Phase to to to expenses not million was $X.X $X.X compensation We The reported G&A collaboration consistent of our research a the million quarter the we insight, research to Revenues quarter quarter X period quarter clinical the of compared chronic in research were and XXXX in to R&D R&D this driven was two slight the expect their related for now these our balance second third second Allergan, same We expenses pain expenses $X.X The million do collaboration, operations quarter for XXXX to with in of anticipated These recommencement The AbbVie. operations, on the of expect of Aptinyx is expect to for fund for spend conclusions $X.X XXXX. in by to majority focused this in compared million, stock-based period development. for with come fund agreements in and Allergan to to same our increase and research the payments now cash XXXX. readouts. $X.X our related $X.X the were million enable XXXX. see XXXX year. million second some same compared the quarters. ramp studies period the primarily of the for were of by The in our expenses. we for

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

Norbert Riedel

Thanks Ashish.

Further, like the COVID-XX. investigators the affected Before to the X appreciation sincere the gratitude completion. would healthcare to involved want to of call, professionals successful study diligently we I working to to to of communities treat in the our by bringing move in portion our PTSD Phase those a Q&A our express patients involvement I and express to our

look to the The the disorders to programs, this novel an suffering important clinical our advancement from to period of for moving be second closer our goal half medicines patients year bringing us of report of of ultimate the promises studies coming updated from PTSD data we quarter. keeping in central as chronic nervous forward months, system. two you to our study fourth as our the we We importantly pain and recommend in

We will begin now. questions be your to happy taking


question Truist with Joon Lee [Operator from comes of Instructions] line first the Securities. Your

Joon Lee

studies soon. will thanks my on taking getting really Thanks and questions, be back that it's track see the the nice for warm to and welcome,

So, so that have a I we study couple enrollment to have how a prior and you. for you you then about earlier that, neuropathy than FM, And FM there painful where related percent of Phase resuming diabetic you the in study. any fibromyalgia as terms reason until questions. readout? can get Is what more go the studies And more why complete enrollment to to, much data DPN? Xb, pause, peripheral to and sense compete to Thank

Norbert Riedel

thanks. Joon, I this go being Okay, questions through as we the delegate various actually team And that would questions are to asked.

if Let shortly me that, we say, recall had you pulled that plug, and will enrollment. on regarding before decided we a studies put to the the you pause just pause, might we

patients. been mostly running busy in have We basically and getting with tied-up cleaning

had numbers, reasons we fibromyalgia relatively finished actually but I that pause question won't and can give and the So, also that of we it actual the our the studies. to as ramp we Kathryn just of these begun up communicated enrolled for of DPN numbers study second. have are be specific the really be relatively the analysis numbers we But part patients obsessed is but to numbers, will complete first basically before. small, all decided small

hand I to it And her so, over now.

Kathryn King

Norbert. you, Thank

I think two Norbert main way which general components. and thinking has restart, really about pause of the our described

First like terms of in things study that. visits is, the demands and of and in study. then the second is population patient the the And procedures

were who a that to the fibromyalgia environment understanding ability investigator our bring And staff. come clinic with patients felt so, to patients and streamline our willing do working Where populations has we make protections requires simplify to patient in find the design, we're our good within program different pain all able I procedures, that positive for with are into to the under patients certain I in. things chronic study pretty and were also think changes to about to to think some the to restart We with study. COVID

reason understand and careful done the about start, think relative I our patients but think the we to We've analysis good patient ability slightly to related data needed offset COVID-XX risk diabetic neuropathy. more a those that time with emerging we I are that to peripheral feel to in for bit population.

Joon Lee

makes that think sense. I

are diabetics increased think COVID-XX. risk for I

So, that makes sense.

your Regarding, in you study, to out PTSD fourth expected read quarter.

psychometric tracking or While for an to wait good and plasticity you patiently, not. thing, we assessments? the your to ability you improve of whether other be are a CAPS-X that data impact should there CAPS-X mean, your I plasticity in of independent is addition biomarker because

for the Phase CAPS-X, question what decision then we the while help end And path you in primary a in I capturing are the ongoing make and more CAPS-X else So, results? is waiting to point results you forward on that. that a after are will X have one addition

Norbert Riedel

thanks Wait, Joon.

just me questions before comment have. one address Andy you Let make the ask other I to

with agreed As interested generally looking an use us proper are to as fibromyalgia biomarker very, we done very objective clean starting. elevated of to you very that in hyper-connectivity a already, it and successfully and disease completed engagement, was PTSD that well brain region pictures biomarker biomarkers, target action, had clear at we already one know did from We guides respect those our level. patients target as there is mechanism we not fibromyalgia because measure isn't the in as In points upon of of and that our therapies. engagement glutamate that with

So, biomarker we a didn't for need surface. that

just and Let's a as the Andy clusters then of as question address next that part. can prelude

Andy Kidd

focused. The the are study measures in clinically

have CAPS-X, mood, sleep, the to other a and cognition, so measures addition the on. in end we of of points, So PCL-X, number

of So, biomarkers we look positive healthy you with a not where saw plasticity that. for of plasticity this biomarkers recall, and we're did did at XXXX, study of biomarker we very and specifically reasons volunteers a There's is, results. One study. a if we electrophysiological couple measuring in

modulate aware the we plasticity. in pathways I do So generally our that subjects do compounds enhance human NMBA are we that think

really, do least plasticity prefrontal unfortunately, medial And clinically so cortex at isn't, in applies that impact the that, a to measure it and is, I to we've what we our of as though measuring. all of think XXXX we The compounds. other for established question, biomarker type for specific pre-extinction feel than And specifically to relates there key PTSD. we're the and though,

wanted startle with have we is like will to on lots But the people we that. study, of which this to in Some be it think, I given felt the population the be, wanted things focused think we clinical things measures, best reflex most the I that and enroll that size informative.

this outcomes. by impact in as are study key plasticity, at we around think demonstrated So feel whether we I questions the mechanism, our clinical like and already we're looking in

Joon Lee

think I'm Right, Correct would is, thing. I But plasticity that did so, wrong. your the improving think. good question if me, I would

cognitive any CAPS-X the active else but such what image potentially or there potential study anything to Thank so, functions much to could benefit doing benefit, I'm think there but is volunteer That's healthy kind question a the envision related attachment. just or in any this, Maybe this. of that But, anecdotal Were functional And too In that capture PTSD out Were a getting you. Thank of is imaging recall you improvements evidence meaning, you that one get it. one down rathole thinking had. if and studies? like could is into a and benefit? is PET some you. I one, something And I'm that? of question just there is. other as to

Andy Kidd

and development activated. of and where past first as is take The drug brain. lots kind point of are time whether the think, of terms like that that feel you question targets questioning the where part, though because mechanistic the So fairly think binds I I are the critical say, can we're is in of the things the widespread we I more we're do studies. there to not pathways target But target in

shown particular has will that to have we answering seen particular in we're a to human the that studies that findings to this relates states, be are, tied subjects. preclinical phenomenon disease specific questions the that due So in also

focused more we clinical So, points. end scan can lots of with else. are or I end XXX those feel we there's yes, approval now regulatory types the like really do points, But that on studies of to PET program, do, close anything for

second the was? the part of Sorry, question

Joon Lee

study. volunteer healthy Yes,

Andy Kidd

Yes, right.

and adverse, we reported for X, I there's anecdotal very XXX, like, ascending had reports not a studies. have of volunteer of widespread those strong and expected that, events any I'm we wasn't, events at we So, And two in many was anything tough of dose would cognitive improvement, see We see would reported all, quite Phase single it's type there sure that frankly, study types did -- say, profile. study to in didn't multiple traditional studies, healthy the safety type that.

So don't in think healthy I study, XXXX. with the was was first place, I terms in that volunteer likely referring the just of to but

our different platform, of of drugs, without those studies within that into going obviously but details all here. in the still So we,

I fair healthy of evidence we to volunteers. and improvement see improvement and evidence in say did think of plasticity, cognition in it's significant some a


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

Charles Duncan

Hi, signal, thanks of progress end team dose the signal response study, have the in PTSD in just here? consistency why I for second a guess, inverse what than the that kind quarter a secondary wondering, wondering, signal would see did And points, or I would be I would camps? response guess define changes a terms lack an you demonstrate it of a of it's lack I'm across study lot environment. or to take of was Since to I'm study bit the XXX. congrats a of really not and on be of regard empowered I efficacy. that provide taking and seeking a dose couple what kind asked wanted and a questions really of guess, aspects is. despite my the this is approach I to With challenging questions. meant of of Norbert to on different little the

Norbert Riedel

start, thanks Charles, question. the Maybe I really for

root data cause fear preclinical underlying our focused extension PTSD. and what that triggers particularly of is think the on I

a CAPS-X preclinical dose CAPS-X of very really at us, for thoughtfully doses already based data so although course, in results doses of correlating the we choose clinical and action levels outcome but mechanism volunteers. looking in very, the classes we of it's with and to And on study, get and XXX correlate of our of to with two have CSF healthy sense

should So the CAPS-X is signals have CAPS-X, that end the to secondary right active we of we I is actually in We as that make points. in informs I how there study in asked saying those up just reasons you or and signals along you subclasses all script, hope want are and the with informs done the next the drug mentioned they DPN sure as have with study design the aligned that believe we the us. then pick of

that look at evaluating. signal a So are being it actually to those seeking is, we along parameters with exploratory study various this we how respect that

Charles Duncan

in would And needs what you, steps next study, let thoughts be me the actually I out I 'XX? lay helpful. in what look you on It’s ongoing would to now brush you it you be and of by you, next on kind know any can designed if you it a but could be guess very informed what really of in it duration Thank is. second study Have be at? could terms that that Norbert. study, the see started that and and multi-dose that strokes broad step follow ask

Norbert Riedel

So, great. Thank you, Charles.

we then from inform So, and how very analyze have had, are we actually much sort next of studies. previous we like discussions data-driven you as in know

of pretty pain in much all I the multi you be the quite and when here, give study next be the derived of about the size glad next set thing will I'm be of kicking-off will as like is framework of we week than This but us study What levels that of is It next with four trial, which that that, sort And the to what current show That's like what drug learn we do. suited sort week our exactly study. namely question longer treatment a be that our clinical study, requirements we only much to because is four that be that's can do and have do as studies. duration of would next study. parameters study, dose the in for I study next well first actually a ask regulatory the what patient clear am so, right? A you week experience so study is XXXX confident aligned a daily within the really is And be asked I will study would a from on the do, can more active, profile study. timeframe. XX to, the we that answer yes, in anticipate a

Charles Duncan

you helpful. And XXXX one all quick my questions. appreciate That's taking I on one and Okay.

the that it that guess her may pretty the clearly, population considering But COVID. I I to Kathryn if patient any regard wondering, change well criteria laid I that think I'd fibromyalgia in DPN of there out have to enrollment with year, heard was sample? risks I'm ask

Norbert Riedel

that. back give will can She to I on Kathryn. elaborate

Kathryn King


to process, substantial think could I to sort allow screening that opposed looking what with no the done actually of the we're to more you patient and thought fibromyalgia. as changes be remotely operations, safe but elements streamline has definition When we that our to ways onsite, certain population. of perhaps about at do in to


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

Marc Goodman

about, DPN if studies. talk the I wondering fibro and was Norbert, you the could

they're 'XX in these when that just presume positive. let's and report out So,

into be, one another for before would pivotal of each such you're study, each starting the Is this? will need is out? study you be there these any what that So, a you thought that any to indications. it of finish process thinking consider how And more you

Norbert Riedel

for by Marc, the question thanks the way.

point on really consistent in authentication a FDA for to is looking data, as best depends case, it's as study right? a daily trial. a be We study. know self-treat serve designed end can the actually on the pivotal this this the response We designed fairly pain you to it primary as have slightly think I

they asked us enough of a agency the I my study relatively problem finish line. of does those then be At it would just will studies. will a study what think of the what the to timelines done, to as study, aggressively they to be then analyze and for take un-blind So, higher to claim and and we have the question data when of in we out short actually will point, the the they wait get this try for just Understand and be we the data? then And us that looking DPN period guidance time. data actually to result discuss current say


Instructions] [Operator Nachman next of BMO the Capital question Your from comes Gary Markets. line with

Gary Nachman

PTSD, XXX level on your the quality of with discuss comfort data Back the and just in the X. Phase

about different post-COVID You've be the opening to you're assuming up COVID, monitoring especially person doing talked work during But analysis. hard doing some a virtual, patients, guess doing some that I now maybe differently, things pre-and are bit. sites maybe I'm in things

how the you've place, has of you that the front put some that those talk on ensure things if few Just over anything can the of months? consistency data? in changed So about and last

Norbert Riedel

a didn't rely and time impaired, accommodate, to extent And the needed is what of Kathryn have modifications that a from Thanks prepared COVID-XX of previous can he to time call so have study, now We cause Gary. the so done that of COVID-XX, was just going XX% the Kathryn you actually it it need in by address remember we and we on compete. or basically therefore need patients COVID-XX. the address period really during on to discussions those for I to fraction hit. but we that, what long-term already to am bulk

Kathryn King

weren't be provide allowed found allow earliest patients are support study accommodation were did care a sites, by in of patient. Yes, the for in would to patients. I drug who of taking delivery much We to required. the how days pandemic, what many, of need We those many sure some our we motivated the for cases, these was we and think remote

many pre-COVID so was collection. visits site in way expected on them have the full happens cases, And would data we to

that'll data. purpose carefully Now quality and good seen are excellent, variations site general, for the are data, in followed the set monitoring we've data for what very whether we analysis. or But is whether there there missing by be in are

Gary Nachman

one to And think in a Phase day, behavior ways. a said opposed more R&D as X improving thought. data then just to to will follow challenging another up lot response I new be avoidance But of you might your an intrusive show

safe So that to it's a issue it that's the a Phase way? we Thanks. don't And the avoidance in if it more the you or hard that show X? could way, be it behavior of even if dose duration, potentially as show plays need tell out to in

Norbert Riedel

want you that? Andy, to take

Andy Kidd

I think have Yes, study in impacts the a good as it's to the draw we'll time point of data. we from that as mind we conclusions bear

So of of attractive times. bear was may different the study, clinical I in that, very even I have of be that much looks the if in doses dose, next instance profile to this mind asked And week is, earlier we'll number in still number one more the someone mind the think about think it about study. only that's four in bear study facts response, will for that and

all effect. there's think an to I a there's I symptom if any reasonable, that that's do specific But that in don't avoidance PTSD. So I important or necessary overall an on says, domains, effect think an reasonable that is it's a show algorithm very point. know

the So that our show an point think that I is most would path this appealing CAPS presumption to be improvement overall. at forward in

I think necessary. know the in of is in improvement include any out over any that I scale, the stuff given other than may two XX patient our avoidance. It's CAPS an well time necessary expectation that's domain more is any questions in don't

pattern improvement. looking I of overall clinical an think for we’re


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

Ritu Baral

for And allowing assessment? this or Hey, year are protocol any the any the allow patient Are to promote you level, taking going COVID like the guys, increased to trials. levels you with at amendments restarting recommence I'm to their progression start supply thanks drug question. allow of year? issues, with XXX in for the and future next for for

Norbert Riedel

that. address definitely can Cathy,

Kathryn King

are we looking so studies those that are at carefully conducted. going the be Yes, way to

we're I particularly conjunction ways difficult. becomes But think and remote assessment follow-up parameters. follow-up to the to looking drug for for safety provide onsite with what are providing are with increasing at safety we for are that balancing study visits options the be in is we patients. more think I done event remote the needed for COVID together don't need need with

also conduct efficient we've think for which streamlined patients it procedures the that sites I and for to a and safe manner. those in both relatively will are make easier required to visits visits,

I about allow approach. amendments. for have amendments general modification think sorry, Protocol asked our these -- I'm that been studies you Both changes. that's protocol

Ritu Baral

I And it? to you're been plan has costs, close PTSD now the getting finalized. study Got am database upcoming the assuming that statistical analysis the

can walk designated us secondary analysis support now, prospectively would important stands the as our data? you you end either it secondary analysis? line as guys secondary or what through As that most top see points And been what's CAPS-X

Norbert Riedel

arousal Look, and can think And to us. give as other particular that I earlier, to much a that sure that they plan, up, domains we test as then that basically then sleep, us to like to looking already we score, have Anything address mood, think results are the the asked to we the details and safety the CAPS-X score, can And better team various of sub secondary inform information ask fainted saying, mentioned going respect we comes we're mind? looking intrusion, with changes for along contribute next understand Andy we not point the study end cognitive will we actually that we for total to that function and analysis affect and secondary study avoidance that for. level score have so CAPS-X and Andy those domains I'm it team. analyze have and we by to as clusters results. primary but us provide to total the that the I sub are how the to

Andy Kidd

The the of number set design possible points, the to add result maybe is, patient multiplying the that only use just of and the one that, point altogether, end expectations some does of I would you also in study, create enormous segment of them the if sort to population analysis. dimensions multiple number of parameters could an

be think interesting think have to may to or pre-specify to deliberately look we but everything critical I eventually pre-specify at. we So, tried that, not we ones, absolutely not may some trying

kind not some wouldn't setup So, at and given all of I by are be data, when of the communicating design and the are the surprised study. intentional if the pre-specified insights we of that's

Ritu Baral

talk most in about what's cognitive you're scales this for and it. at that you population? Can using, Got function specific appropriate mood least

Norbert Riedel

don't why Rolando. that? For you, you Rolando, Maybe take

Rolando Gutierrez


we're different to satisfaction mood, base. initial that conditions. seeing a and the bed, using the guide these which quality doing sleep, so, sleep insomnia, the with scale, the to hostile in heads had And we're the two the scale, depression For to pretty received rating of we you've of symptoms number rich speaks time are the sleep, Pittsburgh scale hours to for

kinds those For functions that cognitive use we're effects, couple one and of those memory, working careful kind the toward efficacy. a yes, loaded is function, test of of main are


[Audio Your Gap]. next question

Unidentified Analyst

for the Thanks guys. question. taking Hey,

up that, that data longer us specifically, weeks? much then XXX, on signals. course that the coverage a guess permit and could of you of about PTSD care. and quick chronic dosing that the came talking different the do data? with talk have just now mainstay psychotherapy being One a about you And standard event would remind little have four product of generating XXX, of how safety we're by you And you're at follow-up, current I a really bit thing tox was that One Dr. lot Stein, a beyond that,

not you're in really thing this one that's study. examining So,

very you're how you curious about future psychotherapy in incorporating thinking think or I'm you studies, much. need to. if So, Thanks

Norbert Riedel


Okay. lot. a Thanks

study. reported Rolando going Phase in the currently safety X we that X X. just on keep let's off result So, Rolando speak from glean talk this the support longer it how But Phase studies as and with then we have our we as can course, to after study. are Andy, address of four talk what well Phase term to because week can And

Rolando Gutierrez

so We to events in were labs reported as also events. that was the and there we a benign. no clean, drugs, really fatigue related there. moderate nothing measuring else. Certainly, and patients, dissociation so adverse And There volunteers mild pattern were study would in dedicated be a headache, say. to scale, seen exactly through the was in extraordinarily two The were we the also have ongoing adverse signal also

to again, remain that because able benign relatedness be events treatment of blind, to tell will these we We adverse the but pattern. you

Norbert Riedel

Thank you, Gutierrez. Rolando Andy?

Andy Kidd


that necessary of steps the enable So, mentioned. we're to completed many studies to through able and working we longer have duration be the

and weeks like for next should point-of-view early process, to we, plan which a of toxicology said, stage, in year. be still there's XX in we up able to our from I next So for work, that and the currently, study time support be of all instance, completed few most wrapped a studies

of done to nine would plan, studies, talk six plan of have might that to not we the So that's yet stage long-term next development. months part as do we've

enable would obviously use. clinical longer term that So even

well. it something There which, from we And So there in a to the valuable a of think obviously, to study it has psychotherapy benefit past. something clinical not briefly about about course, a standardized, would in it is as of has from into value. quite are clinical I thought be mainstream while, when incorporating be or point psychotherapy are to synergistic thinking in utility psychotherapy with on challenges also be our the trial, drug. that to that could we with it that be a might of weigh I some and it do or view, Whether just has was would itself we if

drug think if that would the And to that think And we that we data. where alongside so path. those a at. I by we'll we factors path, psychotherapy, pursue examine some the say look data be are earlier, point in don't really pursuing guided of Norbert's it's supports fair I the the the But would probably

it's be time the to of looks a that we'd it instead my In for. idea in things pursue in thinking it psychotherapy. like that, kinds Those good are addition, of or

Unidentified Analyst

much. very you Thank

Norbert Riedel

very to psychotherapy. also We mono assess introduce intentionally, example, make that to actually for point. one question? complexity, therapy it own Does actually additional able a we its We're further combination of your by be makes a before with light answer in XXX we effects the

Unidentified Analyst

much, Norbert. very you Thank Yes.


first next and name. your And last state please caller

Unidentified Analyst

Wainwright. from H.C. Maz [ph]

taking of team questions, possible. and congrats I'll progress. Norbert quick have the So try for rest my few and continued as and having on I'll questions on to forum, your a as thanks

Norbert Riedel


Unidentified Analyst

assess can disorder, be XXX use for you provide Starting to possible any so, in have development to if clinical alcohol you with XXX, it details? plan would a

Norbert Riedel

That which event as So, separate of only Xth, question. during during really XXX of that compelling task thank benefit not but ongoing hopefully data our And clear a really, mentioned, on in We, that use. I indication. comprehensive that contribute alcohol itself that related our you nicely what that shows Andy we is significant PTSD substance disorder. in a some development hosted data part indeed for lends independent R&D preclinical for sets to to data very or And which will PTSD us sets will very looking have that considering are a in use in we August on a to NYX-XXX. studies,

met supported but we And preclinical yet protecting clearly, to well season while as our out, not other NMDA not we among have by high data. we receptor or choices have find also priority that are so high only to that we CNS disorders that related finalized be this abnormalities, of

Unidentified Analyst

pipeline Okay. agree opportunities. that We exciting would an

I make the am population, In future think trial per you the operation you? measure what patient, in utility I feel Or the sense guess, XXX in to do of insomnia put to to PSQI that is. terms in we on? potential -- trials, incorporating has sleep Does asking you simply assessing a going separate the proof would of concept do assessment, PTSD metrics

Norbert Riedel

good as they Yes, healthy look supported I as and that can where commercial should measured the we opportunity well. volunteer that our design modulators needs. the sleep. we study, and Phase it to fully sleep preclinical an data show as improve Up to we in non-REM mention as time X and at it's done we total as question for unmet a which asset that status And our really, consistently use have well REM really now when

Andy We be But ourselves holistic But I indication it high PTSD, significant a through not a sleep approach diseases. we compounds. clearly component these separate insomnia it of approach. because somehow. he the assessing to is at commercial comorbidity our in priority of believe a chronic for insomnia to have a mood comorbidity, is think point what well. very bullish a causes a we more as namely believe our disorders as as we And really root comment underlying pain, where probably of this our believe about for don't can that's runs that resulted analysis

Andy Kidd

of the of to that am don't but trying proof kind assess patients. issue something establish there Pittsburgh to Yes, that's be I think data the PTSD concept insomnia. would this sleep that's sleep study is that I right. we're on may measurement the consider especially might If in think really because of be with independent purpose is of striking. those we in patients particular That and the in in

Unidentified Analyst

any Defense? plans Thanks for government that could as sources what you And are comment color. seeking of from funding Department such your for agencies, from the non-dilutive on PTSD, such And with sticking support perhaps these? in XXX as get you might

Norbert Riedel

take can I'm at Ashish team here. that. Maybe the you looking

Ashish Khanna

Yes. Hi, Maz [ph].

groups, a need we to and those our with relationships perspective of also an which on important funding. across and very governmental we So, programs. to maintain have and remain advocacy patients both And good access number had really patient speak nice non-governmental interactions a unmet

to study, our We COVID-XX have from that the not the PTSD a sites. in and support have especially But from discuss down affiliated in funding especially seen pick seek think certain first some sites or the can need with yet exploratory DoD engaged in our data VA of to of extensively. are that that We study endorse the studies. those we environment regard challenging, be with to the

as and our you directly symptoms such to might to what present, doing efforts. impact inform and like PTSD, inform to at support so. maybe sort we're agencies But of focused how might expect studies these planning will on discussion on supportive We the funding of

Unidentified Analyst

and you, COVID be it Okay. Thank Ashish. I'll then one squeeze final one would question. And

being So, Would Parkinson's testing. something looking test like MOCA in the XXX used -- adaptive that's you most an I that? consider for was

Norbert Riedel

don't you that? take why Andy,

Andy Kidd

There point. ways Yes. It's assess a definitely be would great cognition remotely. to

really of more they I really administer much cognitive our our could do is remotely accompany alongside that we neurocognitive on tests were to think number like instrument neurocognitive And like perspective this but MOCA improvement that think we though of concern was a back and very what of effect detailed very are the give a assessment just that, point But that's you MOCA. those the would the them it on lot and difficult view. were drug kinds to study, are intent nuanced still never and incorporated they don't were a potentially, a there concern more from to scalable if them. is, remember a using accomplish, us themselves can to a good that. want of purpose like measures I is what of scales the And to original

with. think I what part that's of we are grappling So,

switching patient about do of a As at more in risk steps, way higher it's we think kind also more just, in that, next assessment an it's not population to older this how obviously complications. pelvic just you the is which population of granular that Parkinson's, do is in-depth, environment. But probably

this, impairment different on still Cognitive actively critical So we are range working us. very is of options. a considering domain for a

that from and we on the in a more long-term very committed near think give guidance that we plans concrete works to our is still exploring can topic more It of active I creation very So we're future. current a perspective, side? are hoping on value

Unidentified Analyst

I appreciate it.

you Do the in package and exciting don't that have targets You indications updates years? data. quality on want or the coming are to compromise new months any on

Norbert Riedel

that question? repeat you Can

Unidentified Analyst

question. just it's a general want, I So

targets, you new any platforms? new modulations updates allosteric new receptor had If on perhaps indications from

Norbert Riedel

done So, years only function, a in clearly the as academic many, been of but array many labs, CNS pivotal work wide industry not many labs, disorders. over involved normal receptors, that that shows NMDA brain well for by labs, has as

that cognitive in as pain, as chronic impairments. work PTSD prioritized areas currently the have well We the

data think there the pipeline this we will very us Phase that have. on think talked because just primary X actually we guides There about on very, there. I of us in alcohol point, We as I money in deciding we interested a when is extend and further are But it's others matter are disorder literally the use our at guides only beyond. example. focus

additional we indications. the a at appropriate IND priority future to work the new into and to at phase. indications same compounds out But existing ones While our find adjacencies top further moment. very came in advance bit our us goal are pre-clinical time, the new all for either continue this And


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

Myles Minter

whether on compared work there focus that Xb can the a that this that any Just you patient enroll those? question, probably stay trial, and you so improvements these dealing criteria disorder but differentiating that? of to in primary go naive there quality treatment of actually factor to be much? on pain a bit patients improved in fatigues forced any would improvements Phase symptoms, has question out inclusion/exclusion here, any like experiencing evidence secondly, fibromyalgia actually measure but can wondering approved and obviously, a what's I'm in time It's currently home not to a with things can and ensure during there -- themselves fatigue life, Are is a trial exert is might actually effect this as is there. maybe a considering of even patients And

Norbert Riedel

addresses which in sleep of only not this the talked me these fibromyalgia a before. about these a we Let remind study patients meiosis shows just also of significant an and you questionnaire, biomarker the wide we reported did, combined make for in instance component improvement of a statistically of pretty clearly was opportunity data life in and quality. maybe but this I patients scores, think which pain The quality to subjects, life Fibromyalgia large a array study with

we of to any memories as it impairments. or sort sort population symptoms Rolando, that. that of has our Maybe, that versus no that thoughts active patient what is, we compound And information COVID-XX. have something Fibromyalgia. of endurance affecting unlikely like these is spectrum of current is procedures. that Pre have current I the extent across that is So define we that perception know, is on changes of likely, you on in know

Rolando Gutierrez

instruments fatigue is There the fibromyalgia of the Norbert. applying are subscale in you, a that measure Thank we Yes. that promise study.

answer So, we will be question. able that to

effect an I previous makes expect what sense, yes in would from the we domain. study, Now -- that

Myles Minter

say patient finite of know I neuropathy then enrollment And expectations a chronic file. population. painful for the terms you're a in enrolling just your DPN diabetic Cool. brief

whether these And population? risk generalized relative that impact there? wondering population higher DPN COVID-XX other compared on Just that be going any of the to cadence you to infection the on trials foresee enrollment patients particular are at may whether of out of DPN

Norbert Riedel

strides, these with more COVID-XX. they executed neuropathy that the assumption actually longer pain, diabetic diabetic are I with thoughtfully that So, have COVID-XX patients as how in way higher broadly the look, we we and my to that other need is a discussed Kathryn our where safe are population looked make should not be next or study, chronic be going think into pain only is trials make of an have be have. one provides report that we speaking this, not COVID-XX job for for for and I and as of concern at two assume of of investigative we COVID-XX sides. has patients all that time, that part vulnerability rush the that's will to the ongoing be the described to studies unnecessary over of period we design several DPN, end are to and looking And so can at all a these our will to about months be, the out, think completion to a for conducting in actually And population that's concern that taking a off not exposure And we environment as the sure the to that minimizes sure to an but have our at we us strides but that also conduct much of again, U.S. environment successfully had part probably pointed that as

Andy Kidd

are reasons protocol. briefly level question to important glycemic that as already out. and had inclusion indication those to we don't limiting criteria in I of just the on I looked a it. lot of someone bit do to a have, an the a carefully kidney feel think think the though the exclusion safety mentioned the control, quite we that's data duration there's at with -- reasonable diabetes, track be reduced yet for and already I any more protocol levels, But kept clear earlier think, from making Carmelites careful the liver do as We've we've et emerging that's more Yes, keep think I independent very But factor. eye And come function there's sure COVID. that that the we'll had seem in factors with cetera of from disease, HbAXc analysis on comes we


And next with from question Joon Securities. line Lee Truist of comes your

Joon Lee

for follow-up just couple of I Thanks the clarify taking question. XXXX. things guys. wanted for to a Hey

more I will I that's have reasonable, and completion? asked concluding he question studies me expected one And question sounds it a wanted for think DPN asked fibromyalgia mean, confirm. that Marc Xb if but I and XXXX. forgive the assuming the I misheard, Phase Is just to but study follow-up. be in time

Norbert Riedel

No, can glad we address I'm great. actually that.

So, is with don't sense and overall we in have COVID-XX new previous study because would situation. that, the enrollment know like We a environment to from to what really a like we as enrollment what closest exactly good duration -- it already. in the the and DPN done environment respect study a be

we now also for on better And be the the that of or and depending enrollment study, are says provided basically making assumptions on so, as back unfolds to and that we down and half into go guidance enrollment, cumulative timeline be completion can to are activity revised, of engage COVID-XX. depending that that phase happens, try we state, first we a adjusted slow provide enrollment to dates which we XXXX projected on how seeding, accelerate

half currently first making is So, best projection of the we XXXX. can

Joon Lee

you. Thank Great.

enrollment in As for weeks you The eight PTSD, complete XXth. long. June are study is

should September we So, taking are expected timing that line? the of be top October, other top-line into, the so there is is or or considerations

Norbert Riedel

for the the up tweeting pointed I on we into in completing all were So, out, to we account remaining database, a because what the is out. we fourth making the think quarter, information first of it we're a data, the come some communicated the sure within had timeframe this moved uncertainties after looking of so we collecting we And where previously recognized study. we year, data, we that process which projection is that basically that's that to hold to of And now, data. the the going actually project getting we end guided are we and to quarter takes getting the that's that's get from that we But that currently

Joon Lee

validated questions around the than, CAPS-X, end PTSD? the CAPS-X CAPS-X of scale used question of is has CAPS-X And a PTSD? me in use been a for for the And is. point primary action. Could but approvable could situation other point of you. last [indiscernible] could but There's be where other you be historical Thank very mechanism a deemed envision as appropriate? lot different approval, than even a given of something the for end the different

Norbert Riedel

Rolando. Yes,

Rolando Gutierrez

so listed for every PTSD, symptoms dimensions. Yes, includes whole actually CAPS-X the the DSM-X in

measure. of validated be number factor robust been in in signs. and in the has it fact found a So, to analyzed And a

cognitions, and got Now, that dimensions impairment or disease, measure to very clusters, the lead and the in important Those cetera. and hopefully quality life. assets clusters like et functioning reduction also clusters, the avoidance of intuitions negative and actually sub and of

And discuss they to the an would think say we have think fatigue, course CAPS-X and patients. I'd comprehensive silver would present I to of certainly? regulators. another effect or taken meaningful value for So, of but is we of segments the the be clusters seek in individually with symptomology that What meaningful that, is one PTSD? the

Norbert Riedel

its we PTSD guest of that in my any hosted an if we that would with Stein, He the our of and the worth I is own make, that make its clusters script unmet sharing this clinically that completely. and meaningful his pursuing, Murray thoughts isolation. and very consider with second agreed if way, in can expert When enormous as think need impact anybody can in in clear mentioned R&D medical so speaker, session absolutely he was he day I Dr. PTSD on

Joon Lee

for or yes pivotal Is different study? that potentially a point end a

Norbert Riedel

as and we the a agency as this. long supports with have dialogue is can agency the It

data. be it perfect They I that would think cannot to so. community I ultimately compelling preemptive as to but that why because open be the very to will decide, minded me to So provided they like seems that to we in should because be sense


And now remarks closing Norbert, for any to back you,

Norbert Riedel

your was actually We you, questions. be well, day. of for thank time. Bye-bye. appreciate your attention. stay Please all terrific. We operator. appreciate your you That and Okay, enjoy Thank rest safe, your the


does This call. conclude today's conference

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